| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2819578 | M | 01/06/2025 |
HEPA |
MERCK & CO. INC. |
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Expired product administered, No adverse event, Product administered to patient ...
Expired product administered, No adverse event, Product administered to patient of inappropriate age
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No additional adverse event; Voicemail received in voice mailbox on 30DEC2024 at 4:35 PM ET with the...
No additional adverse event; Voicemail received in voice mailbox on 30DEC2024 at 4:35 PM ET with the following: "My name is (redacted), I'm a physician assistant with One Medical. My call back number is XXX-XXX-XXX. The best time to call me back is Tuesday, December 31st at 1; Inappropriate age at vaccine administration; This spontaneous report was received from other health professional and refers to an 11-day-old male. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 24-DEC-2024, the patient was vaccinated with rxpired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, expiration date: 13-DEC-2024, administered for prophylaxis (strength, lot #, and route of administration were not provided) (Expired product administered and product administered to patient of inappropriate age). No additional adverse event was reported.
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| 2819579 | 62 | F | IL | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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This season?s COVID vaccine was ineffective. I showed symptoms of COVID-19 on Dec 26, less than 3 mo...
This season?s COVID vaccine was ineffective. I showed symptoms of COVID-19 on Dec 26, less than 3 months after vaccination. Discontinue vaccine administration, or update your vaccines appropriately.
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| 2819580 | 9 | F | MI | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LD1776 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient was given Comirnaty 30 mcg but does not meet age requirement for dosage.
Patient was given Comirnaty 30 mcg but does not meet age requirement for dosage.
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| 2819581 | 11 | F | MI | 01/06/2025 |
COVID19 FLU3 HPV9 MNQ TDAP |
PFIZER\BIONTECH SANOFI PASTEUR MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
LD1776 ut8434la 2014790 u8113cc u7870aa |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Given Covid-19 dose for ages 12 and up
Given Covid-19 dose for ages 12 and up
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| 2819582 | 66 | F | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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patient received 2 doses of arexvy vaccine. she has not reported any adverse effects.
patient received 2 doses of arexvy vaccine. she has not reported any adverse effects.
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| 2819583 | 11 | M | NM | 01/06/2025 |
MMR |
MERCK & CO. INC. |
Y006773 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient was given MMR in his left deltoid intramuscular mistakenly instead of the MCV4 that was need...
Patient was given MMR in his left deltoid intramuscular mistakenly instead of the MCV4 that was needed. Patient tolerated it well on 1/3/2025 about 11:00 a.m. No adverse reaction to this vaccine given.
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| 2819584 | 0.08 | F | LA | 01/06/2025 |
DTAPIPVHIB DTAPIPVHIB DTAPIPVHIB PNC15 PNC15 PNC15 RV5 RV5 RV5 DTAPIPVHIB DTAPIPVHIB DTAPIPVHIB PNC15 PNC15 PNC15 RV5 RV5 RV5 DTAPIPVHIB DTAPIPVHIB DTAPIPVHIB |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
UK024AA UK024AA UK024AA Y002963 Y002963 Y002963 2073367 2073367 2073367 Y002963 Y002963 Y002963 2073367 2073367 2073367 UK024AA UK024AA UK024AA |
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, Wrong patient; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age, Wrong patient; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age, Wrong patient; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age, Wrong patient; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age, Wrong patient; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age, Wrong patient; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age, Wrong patient; No adverse event, Product administered to patient of inappropriate age
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Patient received vaccines too early. No adverse effects noted.
Patient received vaccines too early. No adverse effects noted.
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| 2819585 | 4 | M | NY | 01/06/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
42Y93 Y015355 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Set of twins were given DTAP, PIV and MMRV on 12/24/2024 by LPN. As per nurse, parent denied childre...
Set of twins were given DTAP, PIV and MMRV on 12/24/2024 by LPN. As per nurse, parent denied children getting vaccines elsewhere. State System was not verified before administration. Staff received a call from NP from Pts' school to advise me that these vaccines were already administered by her on 12/04/2024, as per State System. Provider Dr. advised. Provider stated no harm done and vaccines will be invalid. Nurse unable to contact parent at this current time.
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| 2819586 | 1 | F | NY | 01/06/2025 |
VARCEL |
MERCK & CO. INC. |
X026319 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional Ae reported; HCP called to report T/E. T/E occurred on 12/21/2024.; This spontaneous r...
No additional Ae reported; HCP called to report T/E. T/E occurred on 12/21/2024.; This spontaneous report has been received from a physician regarding a 12-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 23-DEC-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered as a first dose for prophylaxis (lot number reported as X026319, which has been verified as valid, expiration date reported and validated as 07-NOV-2025) (strength, dose, route of administration, and anatomical site of injection were not provided). The administered dose was exposed to a temperature excursion of 20.0 Fahrenheit degree (F) for 3 hours and 42 minutes (Product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
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| 2819587 | U | TX | 01/06/2025 |
VARCEL |
MERCK & CO. INC. |
Y011015 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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No adverse event; Caller reported VARIVAX administered after temperature excursions.; This spontaneo...
No adverse event; Caller reported VARIVAX administered after temperature excursions.; This spontaneous report was received from a technician referring to a patient, age and gender was not reported. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided. On 19-DEC-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location were not reported, valid lot number Y011015 and expiration date on 18-JUN-2026). The administered dose of the vaccine experienced a temperature excursion 01 degrees Celsius for 14 hours and 22minutes, it was not reported if the information was recorded by a data logger or not. There was no adverse effect reported.
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| 2819588 | U | KY | 01/06/2025 |
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 healthcare worker referring to a patient with unknown age and gender. The patient's pertinent medical history and drug reactions/ allergies and concomitant medication were not reported. On 31-DEC-2024, the patient received 1 dose of 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) after experiencing a temperature excursion (Temperature: 46.6F; Time frame: 1 hour 55 minutes) (product storage error). No additional adverse event (AE) information was reported (no adverse event). No additional information/clarification. No previous temperature excursion.
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| 2819589 | U | TX | 01/06/2025 |
VARCEL |
MERCK & CO. INC. |
Y011015 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AEs; Caller reported VARIVAX administered after temperature excursions.; This spontane...
No additional AEs; Caller reported VARIVAX administered after temperature excursions.; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-DEC-2024, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y011015, expiration date: 18-JUN-2026, administered for prophylaxis (exact dose, dose number, route of administration and anatomical location were not provided). The aforementioned dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of 1 degree Celsius for 14 hours and 22 minutes (Product storage error). There was no previous temperature excursion. No additional adverse events were reported.
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| 2819590 | U | PA | 01/06/2025 |
RAB RAB RAB RAB RAB |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
Unknown Unknown Unknown Unknown Unknown |
Alanine aminotransferase increased, Aspartate aminotransferase increased, Bile d...
Alanine aminotransferase increased, Aspartate aminotransferase increased, Bile duct stenosis, Bile duct stent insertion, Bile duct stent removal; Biliary tract dilation procedure, Bilirubin conjugated increased, Biopsy bile duct normal, Biopsy liver abnormal, Blood bilirubin increased; Endoscopic retrograde cholangiopancreatography abnormal, Endoscopic ultrasound abnormal, Fatigue, Hepatitis cholestatic, Jaundice; Laboratory test normal, Lymphadenopathy, Lyssavirus test positive, Magnetic resonance cholangiopancreatography, Magnetic resonance imaging abnormal; Rash
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biliary strictures; rash, fatigue, and jaundice, periportal lymphadenopathy (Subsequent liver biopsy...
biliary strictures; rash, fatigue, and jaundice, periportal lymphadenopathy (Subsequent liver biopsy consistent with cholestatic hepatitis); Literature citation: Case reference number US-BN-2024-002935 is a spontaneous literature case report, title as stated above, identified on 31-Dec-2024, and concerns a 30-years-old male patient. The aim of the article was to investigate importance of a thorough history and physical, as well as prompt imaging to establish a diagnosis of biliary strictures. Biliary strictures can be a challenging diagnosis. Work-up includes basic lab work, abdominal imaging, and even invasive procedures such as endoscopic retrograde cholangiopancreatography (FRCP). Although up to 30% of strictures are benign, the majority are malignant in the form of pancreatic adenocarcinoma and cholangiocarcinoma. As a result, a multidisciplinary approach is vital to differentiate between the 2. The patient's had no medical history. The patient's concomitant medication was not provided. As reported, the patient denied alcohol use, drug use, recent travel, new medications/supplements, or high-risk sexual behavior. On unspecified date, the patient was exposed to a bat and tested positive for rabies. On unspecified date, unknown time after exposed to bat, reported as 'five days prior arrival', the patient started and completed three series of rabies vaccine along with device constituents prefilled syringe, needle for injection and needle for reconstitution (brand name: unknown; batch number: unknown), at an unknown dose, route, and site of administration, for indication rabies vaccination. On unspecified date, unknown time after vaccination with rabies vaccine, the patient presented with a rash, fatigue, and jaundice for one week. On unspecified date, as reported on arrival, the patient's laboratory examinations showed aspartate aminotransferase was165, alanine transaminase was 372, total bilirubin was 9.2, and direct bilirubin was 6.6 (units not reported). Serological and infectious work-up unrevealing. Magnetic resonance cholangiopancreatography showed focal narrowing of common hepatic duct. Endoscopic retrograde cholangiopancreatography (ERCP)/endoscopic ultrasound showed reactive periportal lymphadenopathy causing compression of common hepatic duct. The stricture was dilated and the patient received two biliary stents in left and right hepatic duct. Subsequent liver biopsy consistent with cholestatic hepatitis. Surgical pathology following stent removal negative for malignancy. Liver function tests normalized on outpatient follow-up. As reported, in individuals with accompanying obstructive jaundice, the stricture should be considered malignant unless proven otherwise. Common etiologies of benign biliary strictures include iatrogenic (post-procedure), chronic pancreatitis, and primary sclerosing cholangitis. Rarely in the literature is reactive lymphadenopathy a cause of obstruction. This case highlights the importance of a thorough history and physical, as well as prompt imaging to establish a diagnosis At the time of initial report, it was unknown if the patient recovered from the events of 'bile duct stenosis', and 'cholestatic hepatitis'. The reported assessed the event of 'bile duct stenosis', and 'cholestatic hepatitis' as serious due to criteria of hospitalization, additionally, the events were considered as serious due to criteria of medical significance. The reporter did not provide causality assessment for the events of 'bile duct stenosis', and 'cholestatic hepatitis' as reported the exact incidence of biliary strictures was unknown. No further information was provided.; Reporter's Comments: A 30-year-old male patient started and completed three series of rabies vaccine for indication rabies vaccination. On unspecified date, an unknown time after the vaccination with rabies vaccine, the patient experienced serious events of bile duct stenosis and cholestatic hepatitis (hospitalization and medical significance). Bile duct stenosis and hepatitis cholestatic are unlisted and unexpected for Rabies Vaccine per CCDS v4 and USPI. The patient's had no medical history, concomitant medication was not provided. As reported, the patient denied alcohol use, drug use, recent travel, new medications or high-risk sexual behaviour. The outcome was unknown. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship nor a plausible biological mechanism of action between the reported events and Rabies Vaccine, therefore the causality is assessed as not related. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: A 30-year-old male patient started and completed three series of rabies vaccine for indication rabies vaccination. On unspecified date, an unknown time after the vaccination with rabies vaccine, the patient experienced serious events of bile duct stenosis and cholestatic hepatitis (hospitalization and medical significance). Bile duct stenosis and hepatitis cholestatic are unlisted and unexpected for Rabies Vaccine per CCDS v4 and USPI. The patient's had no medical history, concomitant medication was not provided. As reported, the patient denied alcohol use, drug use, recent travel, new medications or high-risk sexual behaviour. The outcome was unknown. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship nor a plausible biological mechanism of action between the reported events and Rabies Vaccine, therefore the causality is assessed as not related. This case is considered as serious due to hospitalization and medical significance.
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| 2819591 | F | WA | 01/06/2025 |
FLUX FLUX FLUX FLUX FLUX FLUX FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase i...
Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatine phosphokinase increased; Blood creatinine increased, Blood urea increased, Body temperature increased, Bone pain, Dyspnoea; Electromyogram abnormal, Foot deformity, Haemodialysis, Hepatic failure, Hyperaesthesia; Hypoaesthesia, Limb discomfort, Liver function test, Nerve compression, Nerve conduction studies abnormal; Neuropathy peripheral, Oedema peripheral, Pain in extremity, Pallor, Paraesthesia; Peripheral nerve palsy, Polyuria, Protein urine present, Renal failure, Rhabdomyolysis; Syncope, Tachypnoea, Tinel's sign, Xerosis
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Rhabdomyolysis; episodic pain; profound weakness/generalized weakness; abdominal pain; bilateral leg...
Rhabdomyolysis; episodic pain; profound weakness/generalized weakness; abdominal pain; bilateral leg pain; shortness of breath; syncopal episode; tachypnea; pallorous; moderate pitting edema extending to both her thighs; collapsing upon completion of a 2-mile run; renal failure following rhabdomyolysis; liver failure following rhabdomyolysis; tibial nerve palsy following rhabdomyolysis; tingling type neuropathy from her midarch distally; lower extremity parasthesias; xerosis of the right foot; Tinel's sign; hammering of the lesser toes; hyperesthesias of the feet and posterior lower leg bilaterally; The authors present an unusual case that has been seldom reported in the literature. The clinical rhabdomyolysis syndrome, resulting from muscle disintegration, can be the result of numerous etiologic events and have serious sequelae. The pedal manifestations result from muscular and neurologic insult. The patient in this reported case survived rhabdomyolysis despite renal and hepatic failure requiring diuresis and hemodialysis. The only permanent long-term sequelae the patient suffered was flexible hammertoe deformities and parasthesias of all lesser digits of both feet. The follow-up is over 8 years. Initial information received on 30-Dec-2024 via other healthcare professional regarding an unsolicited valid serious case issued from a literature article: This case involves a 30-year-old female patient who experienced rhabdomyolysis (Latency: 1 week), renal failure, tibial nerve palsy and liver failure following rhabdomyolysis (Hepatic failure) (Renal failure) while receiving influenza vaccine (Latency: unknown). The patient's past medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site 1 week earlier. The patient recalled a previous reaction to the influenza vaccine 1 year earlier that consisted of high fever, rigor, and myalgia exactly 1 week postimmunization. Patient presented to Medical Center after collapsing upon completion of a 2-mile run (Circulatory collapse). The patient related profound weakness (asthenia), abdominal pain, bilateral leg pain (pain in extremity), lower extremity parasthesias (Paraesthesia), and shortness of breath (dyspnoea) followed by a syncopal episode (syncope). Prior to admission, she denied any illness, medication use, allergies, diet changes, or drug use. Initial objective findings were a pulse of 150, oral temperature of 103F, tachypnea (tachypnoea), and a blood pressure of 53/83. Overall, she was pallorous (pallor) and had generalized weakness (asthenia). The lower extremity exam showed palpable pulses, moderate pitting edema extending to both her thighs (oedema), and hyperesthesias of the feet and posterior lower leg bilaterally (Hyperaesthesia). Her lab studies were remarkable for elevated creatinine phosphokinase of greater then 150,000 units, BUN (blood urea nitrogen) of 74, serum creatinine of 12.1, and elevated LFT' s (liver function tests) (SGOT (Serum Glutamic-Oxaloacetic Transaminase)= 7373, SGPT (Serum Glutamic Pyruvic Transaminase)= 3707) and the presence of heme proteins on the urinalysis. The patient was admitted to the hospital with a diagnosis of rhabdomyolysis with concurrent hepatic and renal failure, and tibial nerve palsy (Peripheral nerve palsy). Diagnosis was made based on the history, clinical symptomatology, and laboratory diagnostic testing. The patient was treated with aggressive diuresis and hemodialysis for 11/2months, and was discharged from the hospital with improved musculoskeletal, hepatic, and renal function. Approximately 18 months following the episode of rhabdomyolysis, the patient fully recovered from renal and liver failure. The only residual symptoms noted were confined to her lower extremities, in association with her nerve palsy. Her chief complaint consisted of episodic pain (pain) with minimal pressure (sub metatarsals on weightbearing) and a the sensation of "a rolled up sock in her right shoe." She also noted the development of hammering of the lesser toes (foot deformity). Upon physical examination, there was xerosis of the right foot (xerosis). There was also decreased sensation in both feet from plantar mid arch and lesser metatarsophalangeal joints distally and the posterior distal one third of the leg, bilaterally. A positive Tinel's sign and valleix phenomenon were noted over the posterior tibial nerves . Flexible hammertoes (2-5) were noted bilateral with the right foot being worse. EMG (electromyogram)/nerve conduction studies were performed and revealed a decreased amplitude and conduction velocity of both posterior tibial nerves. The right side demonstrated more severe pathologic changes. The findings were consistent with right tibial nerve palsy and left partial tibial nerve palsy. After over 8 years of follow-up, the patient still has bilateral lesser digit hammertoes and experiences tingling type neuropathy from her mid arch distally (Neuropathy peripheral). She feels her symptoms now are permanent. Seriousness criteria: medically significant and hospitalization for all events Action taken: not applicable Corrective treatment: diuresis and hemodialysis for renal failure; not reported for other events Outcome: recovering for renal failure, hepatic failure, rhabdomyolysis and not recovered for tibial nerve palsy Reporter causality: related; Sender's Comments: Sanofi company comment dated 06-JAN-2025: This case involves a 30-year-old female patient who experienced rhabdomyolysis (Latency: 1 week), renal failure, tibial nerve palsy and liver failure following rhabdomyolysis while receiving influenza vaccine. Based on the limited information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed completely.
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| 2819592 | 57 | M | 01/06/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Chills, Influenza like illness, Insomnia, Pain, Pyrexia
Chills, Influenza like illness, Insomnia, Pain, Pyrexia
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All over body pain; Fever; Chills; not sleeping; This non-serious case was reported by a consumer an...
All over body pain; Fever; Chills; not sleeping; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 57-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine with an associated reaction of adverse drug reaction (1st dose of Shingles vaccine received on an unknown date). Concomitant products included evolocumab (Repatha). On 06-DEC-2024, the patient received the 2nd dose of Shingles vaccine. On 06-DEC-2024, less than a day after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: All over body pain), fever (Verbatim: Fever), chills (Verbatim: Chills) and insomnia (Verbatim: not sleeping). The outcome of the general body pain, fever, chills and insomnia were not resolved. It was unknown if the reporter considered the general body pain, fever, chills and insomnia to be related to Shingles vaccine. It was unknown if the company considered the general body pain, fever, chills and insomnia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-DEC-2024 The patient self-reported this case for himself. Patient reported that he took second shot, and the side effects were as bad as the first shot. Days of feeling flu like symptoms was reported as all over body pain, fever, chills and not sleeping. The symptoms were treated.
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| 2819593 | U | 01/06/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Provider mistakenly gave Pediarix to newborn infant instead of HepB; This non-serious case was repor...
Provider mistakenly gave Pediarix to newborn infant instead of HepB; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. On an unknown date, the patient received the 1st dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Provider mistakenly gave Pediarix to newborn infant instead of HepB). The outcome of the wrong vaccine administered 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: 07-DEC-2024 The nurse reported that a provider mistakenly gave Pediarix to newborn infant instead of HepB, which led to wrong vaccine administered. Provider stated this happened recently but did not gave exact date also stated that baby did not have any adverse reactions following error.
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| 2819594 | F | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site pain, Oral pain
Injection site pain, Oral pain
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Injection site pain; Sore muscles; This non-serious case was reported by a consumer via patient supp...
Injection site pain; Sore muscles; This non-serious case was reported by a consumer via patient support programs and described the occurrence of injection site pain in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On 15-NOV-2024, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain) and muscle soreness (Verbatim: Sore muscles). The outcome of the injection site pain and muscle soreness were unknown. It was unknown if the reporter considered the injection site pain and muscle soreness to be related to Arexvy. It was unknown if the company considered the injection site pain and muscle soreness to be related to Arexvy. Additional Information: GSK Receipt Date: 11-DEC-2024 The reporter reported that the patient had received a dose of Arexvy vaccine and had experienced injection site pain and muscle soreness.
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| 2819595 | 40 | M | NV | 01/06/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
58160-0842-52 58160-0842-52 |
Amnesia, Confusional state, Deafness, Dizziness, Malaise; Pain, Rash, Vision blu...
Amnesia, Confusional state, Deafness, Dizziness, Malaise; Pain, Rash, Vision blurred, Vitreous floaters
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some weird unexplainable rashes; hearing loss; Extreme dizziness, after 7 months after vaccination s...
some weird unexplainable rashes; hearing loss; Extreme dizziness, after 7 months after vaccination symptoms got worse; had confusion; memory loss; blurry vision; floaters; horrible body aches; malaise feeling all the time; This serious case was reported by a consumer and described the occurrence of hearing loss in a 41-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 58160-0842-52) for prophylaxis. On 03-JUL-2023, the patient received Boostrix .5 ml. On 01-SEP-2023, 60 days after receiving Boostrix, the patient experienced hearing loss (Verbatim: hearing loss) (serious criteria GSK medically significant), dizziness (Verbatim: Extreme dizziness, after 7 months after vaccination symptoms got worse), confusion (Verbatim: had confusion), memory loss (Verbatim: memory loss), blurred vision (Verbatim: blurry vision), floaters (Verbatim: floaters), general body pain (Verbatim: horrible body aches) and malaise (Verbatim: malaise feeling all the time). On an unknown date, the patient experienced rash (Verbatim: some weird unexplainable rashes). The outcome of the hearing loss, dizziness, confusion, memory loss, blurred vision, floaters, general body pain and malaise were not resolved and the outcome of the rash was not reported. It was unknown if the reporter considered the hearing loss, dizziness, confusion, memory loss, blurred vision, floaters, general body pain, malaise and rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device. The company considered the hearing loss to be unrelated to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the dizziness, confusion, memory loss, blurred vision, floaters, general body pain, malaise and rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device. 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: 22-DEC-2024 The patient reported that all started with a little dizziness progressed to extreme dizziness after 4 to 5 months after seven months he had extreme, horrible malaise, feeling bodyaches, confusion, memory loss, blurred vision, and hearing loss and some weird unexplainable rashes. Reporter did not provided consent to contact.; Sender's Comments: Deafness is an unlisted event which is considered unrelated to GSK vaccine Boostrix and Boostrix PRE-FILLED SYRINGE DEVICE.
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| 2819596 | M | 01/06/2025 |
COVID19 FLU3 RSV |
UNKNOWN MANUFACTURER SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
6024MF013 U8429CA 2FP37 |
Erythema, Injection site rash, Rash erythematous; Erythema, Injection site rash,...
Erythema, Injection site rash, Rash erythematous; Erythema, Injection site rash, Rash erythematous; Erythema, Injection site rash, Rash erythematous
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injection site rash; rash erythematous; erythema; This non-serious case was reported by a consumer v...
injection site rash; rash erythematous; erythema; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site rash in a 80-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 2FP37) for prophylaxis. Co-suspect products included Influenza vaccine inact split 3v (Fluzone high dose) (batch number U8429CA) for prophylaxis and COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) (batch number 6024MF013) for prophylaxis. On 16-SEP-2024, the patient received Arexvy (intramuscular), Fluzone high dose (intramuscular) and Novavax COVID-19 Vaccine (intramuscular). On 17-SEP-2024, 1 days after receiving Arexvy, the patient experienced injection site rash (Verbatim: injection site rash), red rash (Verbatim: rash erythematous) and erythema (Verbatim: erythema). The outcome of the injection site rash, red rash and erythema were not resolved. It was unknown if the reporter considered the injection site rash, red rash and erythema to be related to Arexvy. It was unknown if the company considered the injection site rash, red rash and erythema to be related to Arexvy. Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter reported that this involves a 80 years old male patient who had erythema, injection site rash and rash erythematous after receiving RSV vaccine subunit PREF3 (Arexvy), COVID 19 vaccine prot subunit NVX COV 2373, Novavax COVID 19 Vaccine and influenza USP trival A-B high dose subvirion vaccine fluzone high dose. On 16th September 2024, the patient received unknown dose of suspect Arexvy (RSV vaccine prot. subunit PREF3) not produced by Sanofi Pasteur via intramuscular route in unknown administration site for prophylactic vaccination, unknown dose of COVID-19 vaccine prot. subunit not produced by Sanofi Pasteur via intramuscular route in unknown administration site for COVID-19 immunization and influenza USP trival A B high dose SUB VIRION vaccine Suspension for injection in prefilled syringe via intramuscular route in unknown administration site for prophylactic vaccination, On 17th September 2024 the patient developed erythema, injection site rash and rash erythematous following the administration of RSV vaccine prot subunit PREF3, OVID-19 vaccine prot subunit and influenza USP trival A-B high dose vaccine. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was not recovered not resolved for all the events.
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| 2819597 | U | 01/06/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity, Pyrexia
Pain in extremity, Pyrexia
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sore arm; fever; This non-serious case was reported by a pharmacist via market research programs and...
sore arm; fever; This non-serious case was reported by a pharmacist via market research programs and described the occurrence of pain in arm in an unspecified number of 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 pain in arm (Verbatim: sore arm) and fever (Verbatim: fever). The outcome of the pain in arm and fever were resolved. The reporter considered the pain in arm and fever to be related to Shingles vaccine. The company considered the pain in arm and fever to be related to Shingles vaccine. Additional Information: GSK receipt date: 11-DEC-2024 The case was reported for unspecified group of patients. The reporter reported that the patients received Shingles vaccine and experienced fever and sore arm. It was implied in conversation that the reporter had personally seen individuals experience these side effects. The adverse event start and stop date was unknown.
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| 2819598 | F | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site pruritus, Pain in extremity
Injection site pruritus, Pain in extremity
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local itching around the injection site; soreness on the arm; This non-serious case was reported by ...
local itching around the injection site; soreness on the arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site itching (Verbatim: local itching around the injection site) and pain in arm (Verbatim: soreness on the arm). The outcome of the injection site itching and pain in arm were unknown. It was unknown if the reporter considered the injection site itching and pain in arm to be related to Shingrix. It was unknown if the company considered the injection site itching and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 10-DEC-2024 The patient self-reported this case. The patient after receiving the first dose of Shingrix, she started experiencing soreness on the arm and local itching around the injection site.
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| 2819599 | 13 | F | TX | 01/06/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
5JA57 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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less than six month interval stated in the prescribing information; This non-serious case was report...
less than six month interval stated in the prescribing information; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 13-year-old female patient who received HAV (Havrix) (batch number 5JA57, expiry date 24-APR-2026) for prophylaxis. Concomitant products included Hepatitis a vaccine inact (Havrix). On 10-DEC-2024, the patient received Havrix. On 10-DEC-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: less than six month interval stated in the prescribing information). The outcome of the drug dose administration interval too short 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: 09-DEC-2024 Nurse reported that a thirteen-year-old patient was administered a second dose of Havrix (less than six month interval stated in the Prescribing information). Previous dose (first dose) was given in on 13-NOV-2024. Nurse Practitioner wanted information about safety (adverse event) or what to expect. Vaccination date, vaccine detail and patient demographics were retrieved from the Nurse Practitioner๏ฟฝs end in this call. No further information was obtained during this call. The patient received second dose (booster dose) of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
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| 2819600 | 54 | F | TN | 01/06/2025 |
COVID19 |
MODERNA |
3043409 |
Fatigue, Headache, Laziness, Pain, Pyrexia
Fatigue, Headache, Laziness, Pain, Pyrexia
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freezing and shaking, freezing that had never happened, body ache like you wouldn't believe; la...
freezing and shaking, freezing that had never happened, body ache like you wouldn't believe; lazy; feeling "worn out"; one thing that she does not remember getting a strange headache; fever when she was in bed; This spontaneous case was reported by a patient and describes the occurrence of PAIN ( freezing and shaking, freezing that had never happened, body ache like you wouldn't believe), LAZINESS (lazy), FATIGUE (feeling "worn out"), PYREXIA (fever when she was in bed) and HEADACHE (one thing that she does not remember getting a strange headache) in a 54-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043409) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: FLU on 28-Dec-2024 and Pfizer (all previous COVID-19 vaccines.). Past adverse reactions to the above products included No adverse effect with FLU and Pfizer. On 31-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 31-Dec-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PYREXIA (fever when she was in bed). On an unknown date, the patient experienced PAIN ( freezing and shaking, freezing that had never happened, body ache like you wouldn't believe), LAZINESS (lazy), FATIGUE (feeling "worn out") and HEADACHE (one thing that she does not remember getting a strange headache). At the time of the report, PAIN ( freezing and shaking, freezing that had never happened, body ache like you wouldn't believe), LAZINESS (lazy), FATIGUE (feeling "worn out"), PYREXIA (fever when she was in bed) and HEADACHE (one thing that she does not remember getting a strange headache) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. No concomitant medications were reported. The reporter stated that she woke up from taking a nap and did not take naps. The patient had symptoms from the COVID shot and she can't remember if that got bad last year and felt all those symptoms horribly when she got them. The reporter stated that headache was not constant, and it was weird headache that comes and goes. The patient reported that she was feeling much better. No treatment medications were reported.
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| 2819601 | M | HI | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7623AA |
Product storage error
Product storage error
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temp excursion on 7-23-2024. 3:59 am. Max 8.8 C, Low 4:35am 5.0 C; This non-serious spontaneous safe...
temp excursion on 7-23-2024. 3:59 am. Max 8.8 C, Low 4:35am 5.0 C; This non-serious spontaneous safety report, with reference number 02661776 (interaction number: 02661747), was received by partner on 26-AUG-2024 and forwarded to agency on 26-AUG-2024 from other health professional. This case was considered non-valid due to no patient identifiers provided (temperature excursion). Due to the nature of the event, the causality between the event "Vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable. Further information is expected. NON-SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 10-SEP-2024 and forwarded to agency on 11-SEP-2024 by a health care professional. The case is maintained as non-valid and non-serious. Due to the nature of the event, the causality between the event "Vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable. No further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 24-SEP-2024 and forwarded to agency on same day by a health care professional. The case is maintained as non-valid and non-serious. Due to the nature of the event, the causality between the event "Vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable. No further information is expected. SIGNIFICANT FOLLOW-UP INFORMATION was received by partner on 01-OCT-2024 and forwarded to agency on 02-OCT-2024 by a health care professional. The case is now valid and non-serious. Due to the nature of the event, the causality between the event "temp excursion on 7-23-2024. 3:59 am. Max 8.8 C, Low 4:35am 5.0 C" and Vaxelis was not applicable. No further information is expected.
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| 2819602 | M | WA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7801BA |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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MA reports that she administered the VAXELIS to an 11-year-old patient; 11-year old male received VA...
MA reports that she administered the VAXELIS to an 11-year-old patient; 11-year old male received VAXELIS in error instead of a flu vaccine; This non-serious spontaneous safety report, with reference number 2024SA278272, was received by partner on 25-SEP-2024 and forwarded to agency on 26-SEP-2024 from other health professional. Due to the nature of the event, the causality between the event 'MA reports that she administered the VAXELIS to an 11-year-old patient', '11-year old male received VAXELIS in error instead of a flu vaccine' and Vaxelis was not applicable. Off-label classification was added due to Vaxelis being administered to an 11-year-old patient. Further information is expected.
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| 2819605 | M | HI | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7623AA |
Product storage error
Product storage error
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HCP calling to report vaccines were administered after experiencing a temperature excursion; This no...
HCP calling to report vaccines were administered after experiencing a temperature excursion; This non-serious spontaneous safety report, with reference number 02661776 (interaction number: 02661747), was received by partner on 26-SEP-2024 and forwarded to agency on 26-SEP-2024 from a physician. Due to the nature of the event, the causality between the event 'HCP calling to report vaccines were administered after experiencing a temperature excursion' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-006896, MCM-006897. Further information is expected. Significant follow-up information was received by the partner on 01-OCT-2024 and forwarded to agency on 02-OCT-2024, from other health professional. The case is maintained as non-serious but became valid as patient identifiers were provided and route and site of product administration was provided along with dose number. Due to the nature of the event, the causality between the event "HCP calling to report vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable. No further information is expected.
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| 2819606 | F | HI | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7623AA |
Product storage error
Product storage error
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HCP calling to report vaccines were administered after experiencing a temperature excursion.; This n...
HCP calling to report vaccines were administered after experiencing a temperature excursion.; This non-serious spontaneous safety report, with reference number 02661776 (interaction number: 02661747), was received by partner on 26-SEP-2024 and forwarded to agency on 26-SEP-2024 from a physician. Due to the nature of the event, the causality between the event 'HCP calling to report vaccines were administered after experiencing a temperature excursion' and Vaxelis was not applicable. For reference purposes the case is linked to: MCM-006896, MCM-006898 and MCM-006827. Further information is expected. Significant follow-up information was received by the partner on 01-OCT-2024 and forwarded to agency on 02-OCT-2024, from other health professional. The case is maintained as non-serious. Due to the nature of the event, the causality between the event "HCP calling to report vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable. No further information is expected.
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| 2819607 | 0.17 | M | HI | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7623AA |
Product storage error
Product storage error
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HCP calling to report vaccines were administered after experiencing a temperature excursion.; This n...
HCP calling to report vaccines were administered after experiencing a temperature excursion.; This non-serious spontaneous safety report, with reference number 02661776 (interaction number: 02661747), was received by partner on 26-SEP-2024 and forwarded to agency on 26-SEP-2024 from a physician. Due to the nature of the event, the causality between the event 'HCP calling to report vaccines were administered after experiencing a temperature excursion' and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-006896, MCM-006897. Further information is expected. Significant follow-up information was received by the partner on 01-OCT-2024 and forwarded to agency on 02-OCT-2024, from other health professional. The case is maintained as non-serious but became valid as patient identifiers were provided and route and site of product administration was provided along with dose number. Due to the nature of the event, the causality between the event "HCP calling to report vaccines were administered after experiencing a temperature excursion" and Vaxelis was not applicable. No further information is expected.
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| 2819610 | M | FL | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7767BA |
Extra dose administered
Extra dose administered
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a medication error/an inappropriate use due to the patient accidentally received 2 doses of VAXELIS;...
a medication error/an inappropriate use due to the patient accidentally received 2 doses of VAXELIS; a medication error/an inappropriate use due to the patient accidentally received 2 doses of VAXELIS; a medication error/an inappropriate use due to the patient accidentally received 2 doses of VAXELIS; This non-serious spontaneous safety report, with reference number 2024SA288921, was received by partner on 04-OCT-2024 and forwarded to agencyon 07-OCT-2024 from other health professional. Additional information was received on 04-OCT-2024 and forwarded to agency on 08-OCT-2024 from other health professional. Due to the nature of the event, the causality between the event 'a medication error/an inappropriate use due to the patient accidentally received 2 doses of VAXELIS', 'and Vaxelis was not applicable. Further information is expected.
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| 2819611 | U | OK | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
u7899aa |
Product storage error
Product storage error
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HBP calling to request temperature excursion evaluation for VAXELIS The vaccines were administered a...
HBP calling to request temperature excursion evaluation for VAXELIS The vaccines were administered after the excursion. Temperature: 32.7F.; This spontaneous safety report, with reference number 02686879 (Interaction # 02686873), was received by the partner on 09-OCT-2024 and forwarded to agency on the same day from a consumer. The reporter did not assess the causal relationship between Vaxelis and the reported event of "HBP calling to request temperature excursion evaluation for VAXELIS The vaccines were administered after the excursion. Temperature: 32.7F." Due to the nature of the event, the causality between the event "HBP calling to request temperature excursion evaluation for VAXELIS The vaccines were administered after the excursion. Temperature: 32.7F." and Vaxelis was not applicable. Further information is expected.
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| 2819612 | F | ID | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
u7767ba |
No adverse event, Product storage error
No adverse event, Product storage error
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HCP called to report TE where Products have been administered. No Side effects or symptoms reported....
HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.; This non-serious spontaneous safety report, with reference number 02687975 (interaction number: 02687961), was received by partner on 10-OCT-2024 and forwarded to agency on 10-OCT-2024 from other health professional. This case was considered non-valid due to no patient identifiers provided (temperature excursion only). Due to the nature of the event, the causality between the event 'HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.' and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was forwarded to agency on 18-NOV-2024 from a health professional. The case was considered valid due to patient identifiers reported. Due to the nature of the event, the causality between the event 'HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.' and Vaxelis was not applicable. Further information is not expected.
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| 2819613 | F | NJ | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7776AA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Vaxelis administered to 5 year-old child; This non-serious spontaneous safety report, with reference...
Vaxelis administered to 5 year-old child; This non-serious spontaneous safety report, with reference number 2024SA311435 (inquiry number: 02280630), was received by partner on 25-OCT-2024 and forwarded to agency on 28-OCT-2024 from other health professional. Off-label classification was added due to Vaxelis being administered to an 5-year-old patient. Due to the nature of the event, the causality between the event and Vaxelis was not applicable. Further information is expected. Significant follow-up information was received by the HCP on 18-NOV-2024 and forwarded to agency on 18-NOV-2024. The case is maintained as non-serious and confirmed no adverse events were experienced. Off-label classification was added due to Vaxelis being administered to an 5-year-old patient. Due to the nature of the event, the causality between the event and Vaxelis was not applicable. Further information is not expected.
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| 2819614 | U | MO | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7921AA |
Extra dose administered, Off label use
Extra dose administered, Off label use
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Patient received 4th dose of Vaxelis; Patient received 4th dose of Vaxelis; This non-serious spontan...
Patient received 4th dose of Vaxelis; Patient received 4th dose of Vaxelis; This non-serious spontaneous safety report, with the reference number: 02699483 was received by a partner on 31-OCT-2024 and forwarded to agency on 001-NOV-2024 from a healthcare professional. This case is considered off-label use due to extra dose of Vaxelis administered to the patient. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Patient received 4th dose of Vaxelis". Further information is expected
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| 2819615 | F | PA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
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Dark circles under eyes, Decreased activity, Injection site erythema, Injection ...
Dark circles under eyes, Decreased activity, Injection site erythema, Injection site swelling, Injection site warmth
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She hasn't been playing like she usually does and she's had these bags of dark circles und...
She hasn't been playing like she usually does and she's had these bags of dark circles under her eyes too.; she's had these bags of dark circles under her eyes too.; Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm; Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm; Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm; Third dose in left thigh...spot that looked like a bug bite on her left thight, by the afternoon ...her leg was hurting her; This non-serious spontaneous safety report was received by agency on 04-NOV-2024 and forwarded to agency on 04-NOV-2024 with reference number # 02700418 from a consumer. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events: "Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm" and "She hasn't been playing like she usually does, and she's had these bags of dark circles under her eyes too". No further information is expected. Significant follow-up information was received by the partner on 11-NOV-2024 and forwarded to agency on 12-NOV-2024, from consumer. The case is maintained as non-serious. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events: "Spot that looked like a bug bite on her left thigh around where she had the injection/area was swollen, red and warm", "She hasn't been playing like she usually does, and she's had these bags of dark circles under her eyes too" and "Third dose in left thigh...spot that looked like a bug bite on her left thigh, by the afternoon...her leg was hurting her". Further information is not expected.
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| 2819616 | M | PA | 01/06/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U7801BA HR3650 |
Product administered to patient of inappropriate age, Wrong product administered...
Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered
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Nurse ordered Fluzone and the Medical Assistant inadvertently gave Rotateq instead.; This non-seriou...
Nurse ordered Fluzone and the Medical Assistant inadvertently gave Rotateq instead.; This non-serious spontaneous safety report, with reference number 02700153 (interaction number: 02700150), was received by partner on 01-NOV-2024 and forwarded to agency on 01-NOV-2024 from other health professional. This case was considered non-valid due to wrong product administered (event does not concern Vaxelis). Due to the nature of the event, the causality between the event and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was received by Fax from HCP on 02-DEC-2024. The case is maintained as non-serious. This case was considered non-valid due to wrong product administered (event does not concern Vaxelis). Due to the nature of the event, the causality between the event and Vaxelis was not applicable. No further information is expected. FOLLOW-UP INFORMATION was received, on 02-DEC-2024 and forwarded to agency on 04-DEC-2024 from a physician. The case is maintained as non-serious. The case becomes valid. Due to the nature of the event, the causality between the event and Vaxelis was not applicable. No further information is expected.
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| 2819617 | U | MD | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
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Pyrexia
Pyrexia
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a 6-month-old developed a high fever after receiving VAXELIS; This non-serious spontaneous safety re...
a 6-month-old developed a high fever after receiving VAXELIS; This non-serious spontaneous safety report was received by MSD on 04-NOV-2024 and forwarded to agency on 07-NOV-2024 with Case ID: 02701884 from a field employee. The reporter did not provide an assessment of the causal relationship between the reported events: "Fever" and Vaxelis. Further information is expected.
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| 2819618 | F | TX | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7295AA |
Product storage error
Product storage error
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vaccines were administered following a temperature excursion; This non-serious spontaneous safety re...
vaccines were administered following a temperature excursion; This non-serious spontaneous safety report with the reference number: 02705316 was received by a partner on 12-NOV-2024 and forwarded to agency on 12-NOV-2024 from a physician. The reporter did not provide an assessment of the causal relationship between and Vaxelis and the reported events; "vaccines were administered following a temperature excursion" Further information is expected. FOLLOW-UP INFORMATION was received on 26-NOV-2024 from a physician. The case is now valid. The reporter assessed the reported events; "vaccines were administered following a temperature excursion" as not related to Vaxelis. Further information is not expected.
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| 2819620 | U | CA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7899AA |
Product storage error
Product storage error
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A HCP called to report a temperature excursion and stated doses were administered after the excursio...
A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients; This non-serious spontaneous safety report, with reference number 02707692 (interaction number: 02707678), was received by partner on 15-NOV-2024 and forwarded to agency on 15-NOV-2024 from other health professional. Due to the nature of the event, the causality between the event 'A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients' and Vaxelis was not applicable. Further information is expected.
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| 2819621 | U | CA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7899AA |
Product storage error
Product storage error
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A HCP called to report a temperature excursion and stated doses were administered after the excursio...
A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients; This non-serious spontaneous safety report, with reference number 02707685 (interaction number: 02707678), was received by partner on 15-NOV-2024 and forwarded to agency on 15-NOV-2024 from other health professional. Due to the nature of the event, the causality between the event 'A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients' and Vaxelis was not applicable. Further information is expected.
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| 2819622 | F | GA | 01/06/2025 |
DTPPVHBHPB PNC20 |
MSP VACCINE COMPANY PFIZER\WYETH |
U7296AA |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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There is no adverse event occurred with the use of this vaccine at all. The query was regarding temp...
There is no adverse event occurred with the use of this vaccine at all. The query was regarding temperature stability. No adverse event occurred to report at this time.; The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This non-serious spontaneous safety report was received by agency on 18-NOV-2024 and forwarded to agency on 18-NOV-2024 with case ID: 02708409 from a physician. This case was considered non-valid due to no patient identifiers provided (temperature excursion only). Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. Further information is expected. Non-significant follow-up information was received by the partner on 19-NOV-2024 and forwarded to agency on 20-NOV-2024, from a physician. The case is maintained as non-serious and non-valid. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. Further information is expected. Non-significant follow-up information was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. The case is maintained as non-serious and non-valid. Confirmed no adverse event. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C", "There is no adverse event occurred with the use of this vaccine at all. The query was regarding temperature stability. No adverse event occurred to report at this time." and Vaxelis was not applicable. Further information is not expected.
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| 2819623 | U | CA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7899AA |
Product storage error
Product storage error
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A HCP called to report a temperature excursion and stated doses were administered after the excursio...
A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients; This non-serious spontaneous safety report, with reference number 02707695 (interaction number: 02707678), was received by partner on 15-NOV-2024 and forwarded to agency on 18-NOV-2024 from other health professional. Due to the nature of the event, the causality between the event 'A HCP called to report a temperature excursion and stated doses were administered after the excursion to three different patients' and Vaxelis was not applicable. Further information is expected.
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| 2819624 | F | ID | 01/06/2025 |
DTPPVHBHPB PNC20 |
MSP VACCINE COMPANY PFIZER\WYETH |
u7536aa |
Incorrect dose administered, No adverse event; Incorrect dose administered, No a...
Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event
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HCP called to report TE where Products have been administered. No Side effects or symptoms reported....
HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.; This non-serious spontaneous safety report, with reference number 02687975 (interaction number: 02687961), was received by partner on 18-NOV-2024 and forwarded to agency on 18-NOV-2024 from other health professional. Due to the nature of the event, the causality between the event 'HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided' and Vaxelis was not applicable. Further information is not expected.
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| 2819625 | M | ID | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
u7536aa |
Product storage error
Product storage error
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HCP called to report TE where Products have been administered. No Side effects or symptoms reported....
HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided.; This non-serious spontaneous safety report, with reference number 02687975 (interaction number: 02687961), was received by partner on 18-NOV-2024 and forwarded to agency on 18-NOV-2024 from other health professional. Due to the nature of the event, the causality between the event 'HCP called to report TE where Products have been administered. No Side effects or symptoms reported. Caller is unsure of how many patients were involved. No Additional information provided' and Vaxelis was not applicable. Further information is not expected.
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| 2819626 | M | LA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7217AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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no adverse event; administered a VAXELIS on Nov 15th that expired on Nov 12th; This non-serious spon...
no adverse event; administered a VAXELIS on Nov 15th that expired on Nov 12th; This non-serious spontaneous safety report, with reference number 2024SA345002, was received by partner on 25-NOV-2024 and forwarded to agency on 26-NOV-2024 from other health professional. Due to the nature of the event, the causality between the events 'administered a VAXELIS on Nov 15th that expired on Nov 12th' and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was received by email and duplicate follow-up information was received by fax on 12-DEC-2024 from other health professional. The case is maintained as non-serious. Due to the nature of the events, the causality between the events 'administered a VAXELIS on Nov 15th that expired on Nov 12th' and 'no adverse event' and Vaxelis was not applicable. No further information is expected.
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| 2819627 | M | GA | 01/06/2025 |
DTPPVHBHPB PNC20 |
MSP VACCINE COMPANY PFIZER\WYETH |
U7296AA |
Product storage error; Product storage error
Product storage error; Product storage error
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The physician is reporting that unknown number of patients received improperly stored vaccines. Temp...
The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007147. Further information is not expected.
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| 2819628 | F | GA | 01/06/2025 |
DTPPVHBHPB MMRV PNC20 |
MSP VACCINE COMPANY MERCK & CO. INC. PFIZER\WYETH |
U7296AA |
Product storage error; Product storage error; Product storage error
Product storage error; Product storage error; Product storage error
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The physician is reporting that unknown number of patients received improperly stored vaccines. Temp...
The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007147. Further information is not expected.
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| 2819629 | F | GA | 01/06/2025 |
DTPPVHBHPB PNC20 |
MSP VACCINE COMPANY PFIZER\WYETH |
U7296AA |
Product storage error; Product storage error
Product storage error; Product storage error
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The physician is reporting that unknown number of patients received improperly stored vaccines. Temp...
The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007147. Further information is not expected.
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| 2819630 | M | GA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7296AA |
Product storage error
Product storage error
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The physician is reporting that unknown number of patients received improperly stored vaccines. Temp...
The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007147. Further information is not expected.
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| 2819631 | M | GA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
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Product storage error
Product storage error
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The physician is reporting that unknown number of patients received improperly stored vaccines. Temp...
The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This non-serious spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007147. Further information is not expected.
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| 2819632 | F | GA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
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Product storage error
Product storage error
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The physician is reporting that unknown number of patients received improperly stored vaccines. Temp...
The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007147. Further information is not expected.
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