| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2819289 | 29 | M | WY | 01/03/2025 |
FLU3 |
SANOFI PASTEUR |
UT8419CA |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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The high dose influenza vaccine was administered instead of the regular dose. Patient had no symptom...
The high dose influenza vaccine was administered instead of the regular dose. Patient had no symptoms when he left the clinic and when called to inform him of the incident he was still asymptomatic.
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| 2819290 | 35 | F | PA | 01/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
ps2ck |
Exposure during pregnancy, Product use issue
Exposure during pregnancy, Product use issue
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Arexvy dispensed to a 35 year old female pt who was 32 weeks pregnant. Arexvy is not indicated by th...
Arexvy dispensed to a 35 year old female pt who was 32 weeks pregnant. Arexvy is not indicated by the FDA for this use, the product Abrysvo should have been administered in its place
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| 2819291 | 57 | F | MI | 01/03/2025 |
UNK UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
El9261 El9261 Ew0173 Ew0173 |
Agraphia, Alexia, Aphasia, Atrial fibrillation, Cardiac ablation; Cerebrovascula...
Agraphia, Alexia, Aphasia, Atrial fibrillation, Cardiac ablation; Cerebrovascular accident, Hypotonia, Inflammation, Magnetic resonance imaging, Orbital swelling; Agraphia, Alexia, Aphasia, Atrial fibrillation, Cardiac ablation; Cerebrovascular accident, Hypotonia, Inflammation, Magnetic resonance imaging, Orbital swelling
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Left temporal CVA. Right arm flaccid, aphasia. I still have word searching, and reading and writin...
Left temporal CVA. Right arm flaccid, aphasia. I still have word searching, and reading and writing comprehension is still an issue, however improved. I went into afib, and I have since had an ablation. I had an inflammatory response after the 2nd dose causing orbital swelling, 3 days after injection
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✓ | |||||
| 2819292 | 37 | F | CO | 01/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
3F729 |
Exposure during pregnancy, Product use issue, Wrong product administered
Exposure during pregnancy, Product use issue, Wrong product administered
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pt was pregnant, was given Arexvy instead of Abrysvo
pt was pregnant, was given Arexvy instead of Abrysvo
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| 2819293 | 13 | F | WI | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Incorrect dose given for age
Incorrect dose given for age
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| 2819294 | 44 | M | CA | 01/03/2025 |
COVID19 FLU3 HEP |
MODERNA SANOFI PASTEUR DYNAVAX TECHNOLOGIES CORPORATION |
8080433 U8509BA 944942 |
Arthralgia, Magnetic resonance imaging joint, Mobility decreased, Muscular weakn...
Arthralgia, Magnetic resonance imaging joint, Mobility decreased, Muscular weakness, Pain; Arthralgia, Magnetic resonance imaging joint, Mobility decreased, Muscular weakness, Pain; Arthralgia, Magnetic resonance imaging joint, Mobility decreased, Muscular weakness, Pain
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During office visit exam: Patient presented with shoulder pain/weakness on 11/05/2024. ...
During office visit exam: Patient presented with shoulder pain/weakness on 11/05/2024. ? The patient presents today for evaluation of right shoulder pain and weakness that started approximately one week ago, shortly after receiving three vaccines (COVID (right side), flu, and HEP B (left side)). ? They report that when the vaccines were administered, particularly the one(s) in the right arm, it felt really deep and painful. ? Within a couple of hours after the vaccines, the patient noticed weakness in the right shoulder with any movement, especially upward motion. ? The next day, the symptoms worsened. ? Currently, a week later, the patient describes some improvement but still experiences significant weakness and pain with movements involving the right arm behind the back, such as pulling up pants or putting on a jacket. ? The patient also notes a dull ache at rest in the right shoulder area. ? While the left shoulder is also affected, with some weakness and limited range of motion, the symptoms are much more pronounced on the right side. ? The patient denies any recent trauma or injury to the shoulders. ? They have been doing regular weightlifting exercises but stopped after the onset of symptoms. ? The patient has not experienced this type of issue with previous vaccinations, which typically only caused soreness to the touch at the injection site. ? The patient is concerned that the vaccine may have been injected too deeply or in the wrong location, potentially causing damage based on their research. ? They deny any significant shoulder problems prior to the vaccines. ? Musculoskeletal: Weakness in shoulder. Pain with shoulder movement. Limited range of motion in shoulder. Ache in shoulder at rest. Soreness with back movement. Exam Right shoulder: - No atrophy, swelling, ecchymosis, or deformity - No tenderness over the AC joint, SC joint, scapula, acromion, proximal humerus, biceps tendon, or trapezius muscle - slightly reduced internal rotation - Impingement testing:POS Neer?s, negative Hawkin?s - Rotator cuff testing: negative empty can test - Labral stress: POS O?Brien?s test Left shoulder: - No atrophy, swelling, ecchymosis, or deformity - No tenderness over the AC joint, SC joint, scapula, acromion, proximal humerus, biceps tendon, or trapezius muscle - slightly reduced range of motion on internal rotation - Impingement testing: negative Neer?s, negative Hawkin?s - Rotator cuff testing: negative empty can test - Labral stress: negative O?Brien?s test Assessment & Plan Concern for Shoulder Injury Related to Vaccine Administration (SIRVA), as this started right after vaccine administration. Cannot r/o other shoulder injury, but history points to SIRVA. Exam shows signs of tendonitis. Discussed options for imaging. Will order MRI as most senstive for this condition. Try naproxen daily, while awaiting imaging.
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| 2819306 | 19 | F | PA | 01/03/2025 |
HPV9 |
MERCK & CO. INC. |
Y007322 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE; Administered to a pateint during a potential temperature excursion due to a shippi...
No additional AE; Administered to a pateint during a potential temperature excursion due to a shipping issue; Administered to a pateint during a potential temperature excursion due to a shipping issue; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-DEC-2024, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided). The shipment of the product hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was received on the same day. The shipment might have been delayed in transit and the vaccine may no longer be viable (Product storage error; Product distribution issue). There was no additional adverse event (AE) or product quality complaint (PQC) reported. Follow up information was received from the nurse practitioner on 18-DEC-2024. This spontaneous report was regarding a 19-year-old female patient. There was no illness at time of vaccination. On 05-DEC-2024, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #Y007322, expiration date: 18-AUG-2026, administered intramuscularly in the deltoid for prophylaxis (strength was not provided) then after they were noticed of temperature excursion during delivery (also reported as temperature not maintained during delivery)
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| 2819307 | M | 01/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pericarditis
Pericarditis
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Pericarditis; This serious case was reported by a consumer and described the occurrence of pericardi...
Pericarditis; This serious case was reported by a consumer and described the occurrence of pericarditis in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 03-MAY-2024, the patient received Shingrix. On 05-MAY-2024, 2 days after receiving Shingrix, the patient experienced pericarditis (Verbatim: Pericarditis) (serious criteria hospitalization and GSK medically significant). On 09-MAY-2024, the outcome of the pericarditis was resolved with sequelae. It was unknown if the reporter considered the pericarditis to be related to Shingrix. The company considered the pericarditis to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 20-DEC-2024 The case was self reported by patient. The patient received Shingrix vaccine and experienced pericarditis.; Sender's Comments: Pericarditis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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✓ | |||||||
| 2819308 | F | 01/03/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Fatigue
Fatigue
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Extreme fatigue; This non-serious case was reported by a consumer via sales rep and described the oc...
Extreme fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of fatigue in a 74-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included cardiovascular syncope. Concomitant products included diltiazem. On 06-DEC-2024, the patient received RSV vaccine. In DEC-2024, an unknown time after receiving RSV vaccine, the patient experienced fatigue (Verbatim: Extreme fatigue). The outcome of the fatigue was resolving. It was unknown if the reporter considered the fatigue to be related to RSV vaccine. It was unknown if the company considered the fatigue to be related to RSV vaccine. Additional Information: GSK Receipt Date: 08-DEC-2024 The case was reported by the patient. The patient experienced extreme fatigue. The symptoms were not treated.
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| 2819309 | U | 01/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Blister, Headache, Herpes zoster, Pruritus
Blister, Headache, Herpes zoster, Pruritus
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shingles on the left side of my nose; This non-serious case was reported by a consumer via interacti...
shingles on the left side of my nose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of facial herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial herpes zoster (Verbatim: shingles on the left side of my nose). The patient was treated with aluminium sulfate, calcium acetate (Domeboro). The outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the facial herpes zoster to be related to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 04-DEC-2024 The case was received from the patient via interactive digital media. The reporter reported that got the first shot but before it was time for the second shot he/she got shingles on the left side of my nose. The reporter went to the physician the next day. The physician gave reporter something for the shingles and told me to get Domeboro. The reporter reported, maybe he/she got a mild case or the Domeboro did its job. As soon as the reporter started using that the itching mostly stopped and the blisters were drying up. The reporter reported that the after effects were that he/she get headaches on the left side and were killer. The physician told the reporter that he/she didn't need to get the second shot at the time of reporting. The reporter said the reporter must had gotten stressed recently and that caused him/her to get the shingles.
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| 2819310 | F | 01/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Depressed mood, Pain
Depressed mood, Pain
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it hurts/it makes you feel achy; it makes you feel droopy; This non-serious case was reported by a ...
it hurts/it makes you feel achy; it makes you feel droopy; This non-serious case was reported by a consumer and described the occurrence of pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: it hurts/it makes you feel achy) and feeling down (Verbatim: it makes you feel droopy). The outcome of the pain and feeling down were resolved. The reporter considered the pain and feeling down to be related to Shingrix. The company considered the pain and feeling down to be related to Shingrix. Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter reporting that while discussing the Shingrix vaccine the patient stated that It was a hot vaccine, it hurts, it makes you feel achy and droopy. The patient reported that she received the vaccine in the Spring of 2021, exact date was unknown. No additional details were provided.
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| 2819311 | U | 01/03/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; still got Shingles; This serious case was reported by a consumer via ...
Suspected vaccination failure; still got Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 20-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that he/she had both shots and still got Shingles. He/she was in his/her 3rd month of pain. This case was considered as suspected vaccination failure as details regarding completion of time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
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| 2819312 | M | 01/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Exposure via skin contact, Incorrect dose administered, Occupational exposure to...
Exposure via skin contact, Incorrect dose administered, Occupational exposure to product
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Occupational exposure (eye and mouth contact); Occupational exposure (eye and mouth contact); Occupa...
Occupational exposure (eye and mouth contact); Occupational exposure (eye and mouth contact); Occupational exposure (eye and mouth contact); Incomplete dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inadvertent exposure to vaccine in a 30-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-DEC-2024, the patient received Shingrix. On 04-DEC-2024, an unknown time after receiving Shingrix, the patient experienced inadvertent exposure to vaccine (Verbatim: Occupational exposure (eye and mouth contact)), exposure via eye contact (Verbatim: Occupational exposure (eye and mouth contact)), exposure via skin contact (Verbatim: Occupational exposure (eye and mouth contact)) and incomplete dose administered (Verbatim: Incomplete dose administered). The outcome of the inadvertent exposure to vaccine, exposure via eye contact, exposure via skin contact and incomplete dose administered were unknown. Additional Information: GSK Receipt Date: 04-DEC-2024 A Pharmacist reported that he/she was administering a vaccination, and withdrawing the Shingrix vaccine, and then reconstitute it and then essentially, while after withdrawing it and mixed it using a new syringe to withdraw the mixed product, and then essentially they was trying to get the air bubble blew out, when doing that had pushed too much and then a little bit of the vaccine went into eye and mouth, which led to inadvertent exposure to vaccine, exposure via skin contact, exposure via eye contact. It was on right eye and then my mouth. Did not consent to follow-up. The pharmacist (the reporter) had an occupational exposure while handling the Shingrix vaccine, he let us know that this situation occurred, and set the same date on suspect vaccine section, however this did not mean that he get the vaccine, which led to incomplete dose administered.
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| 2819313 | U | MO | 01/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Intercepted product prescribing error
Intercepted product prescribing error
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Doctor's prescription for RSV vaccine second dose; This non-serious case was reported by a phar...
Doctor's prescription for RSV vaccine second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Arexvy (received 1st dose of RSV vaccine last year in 2023). On an unknown date, the patient did not receive the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted product prescribing error (Verbatim: Doctor's prescription for RSV vaccine second dose). The outcome of the intercepted product prescribing error was unknown. Additional Information: GSK Receipt Date: 04-DEC-2024 The pharmacist reported that, a patient who had received an RSV (Arexvy) vaccine last year, the physician wrote a RX (prescribed) for another RSV, which led to an intercepted product prescribing error. The reporter wanted to know was it a onetime dose, or could it be given yearly. The vaccine administration facility was the same as primary reporter. This case was linked with case US2020039862 from the same reporter.; Sender's Comments: US-GSK-US2020039862:same reporter
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| 2819314 | F | TX | 01/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Myalgia, Pain in extremity, Sleep disorder
Myalgia, Pain in extremity, Sleep disorder
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muscle pain was and she said it was mostly my right leg and hip and a little bit: lower left leg; so...
muscle pain was and she said it was mostly my right leg and hip and a little bit: lower left leg; soreness of injected arm; it did keep her from sleeping/which made it difficult to sleep; This non-serious case was reported by a consumer via call center representative and described the occurrence of myalgia of lower extremities in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 02-DEC-2024, the patient received the 1st dose of Shingrix (unknown arm). In DEC-2024, less than a day after receiving Shingrix, the patient experienced myalgia of lower extremities (Verbatim: muscle pain was and she said it was mostly my right leg and hip and a little bit: lower left leg), pain in arm (Verbatim: soreness of injected arm) and difficulty sleeping (Verbatim: it did keep her from sleeping/which made it difficult to sleep). The outcome of the myalgia of lower extremities and difficulty sleeping were unknown and the outcome of the pain in arm was not resolved. It was unknown if the reporter considered the myalgia of lower extremities, pain in arm and difficulty sleeping to be related to Shingrix. It was unknown if the company considered the myalgia of lower extremities, pain in arm and difficulty sleeping to be related to Shingrix. Additional Information: GSK Receipt Date: 04-DEC-2024 The reporter reported that the patient received a Shingrix shot on Monday and experienced muscle pain, extreme muscle pain. It was at night mostly as patient relax. Patient did not know what was causing the pain but it happened monday night and a little less frequent on tuesday night. The reporter specify the muscle pain was mostly in right leg and hip and a little bit on lower left leg. The pain was not keeping her from doing her normal daily activities but it did keep her from sleeping because turning over in bed was painful. Reporter also mentioned that the injected arm is sore, but not painful.
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| 2819315 | U | CA | 01/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Hypersensitivity
Hypersensitivity
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allergic reaction; This non-serious case was reported by a other health professional via sales rep a...
allergic reaction; This non-serious case was reported by a other health professional via sales rep and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergic reaction). The outcome of the allergic reaction was not resolved. It was unknown if the reporter considered the allergic reaction to be related to Shingrix. It was unknown if the company considered the allergic reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 06-DEC-2024 Reporter informed they had a patient that claimed that she was continued to experience an allergic reaction from Shingrix a year later.
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| 2819316 | U | PA | 01/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Intercepted product preparation error
Intercepted product preparation error
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reconstituted with sterile water and not the adjuvant component; This non-serious case was reported ...
reconstituted with sterile water and not the adjuvant component; This non-serious case was reported by a other health professional via sales rep and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product preparation error (Verbatim: reconstituted with sterile water and not the adjuvant component). The outcome of the intercepted product preparation error was unknown. Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter asked how to proceed with a Shingrix dose that has been reconstituted with sterile water and not the adjuvant component which led to intercepted product preparation error. The dose was not administered to a patient. The reporter asked if the vaccine needs to be discarded. No further details provided by field rep who submitted inquiry.
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| 2819317 | F | ID | 01/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9C5T4 |
Exposure via eye contact, Exposure via mucosa, Product administered to patient o...
Exposure via eye contact, Exposure via mucosa, Product administered to patient of inappropriate age
More
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Inappropriate age at vaccine administration; She mistakenly got a little bit of Shingrix in her eye ...
Inappropriate age at vaccine administration; She mistakenly got a little bit of Shingrix in her eye and her mouth; Shingrix in her eye and her mouth; Shingrix in her mouth; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number 9C5T4, expiry date 26-OCT-2026) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration), inadvertent exposure to vaccine (Verbatim: She mistakenly got a little bit of Shingrix in her eye and her mouth), exposure via eye contact (Verbatim: Shingrix in her eye and her mouth) and exposure via oral mucosa (Verbatim: Shingrix in her mouth). The outcome of the inappropriate age at vaccine administration, exposure via eye contact and exposure via oral mucosa were unknown and the outcome of the inadvertent exposure to vaccine was unchanged. Additional Information: GSK Receipt Date: 06-DEC-2024 The reporter was the healthcare professional, medical assistant. The reporter was also the patient. The patient was mistakenly got a little bit of Shingrix in her eye and her mouth which led to Inadvertent exposure to vaccine, Exposure via eye contact and Exposure via oral mucosa. The patient was irrigated her eye and rinsed her mouth. The patient was asymptomatic. Nothing else was reported. The patient was 26 years old which led to inappropriate age at vaccine administration.
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| 2819318 | U | CA | 01/03/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Dizziness, Injection site swelling, Nausea
Dizziness, Injection site swelling, Nausea
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injection site swelling.; Extreme nausea; dizziness; This non-serious case was reported by a physici...
injection site swelling.; Extreme nausea; dizziness; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a definite number of patients who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site swelling (Verbatim: injection site swelling.), nausea (Verbatim: Extreme nausea) and dizziness (Verbatim: dizziness). The outcome of the injection site swelling, nausea and dizziness were resolved. It was unknown if the reporter considered the injection site swelling, nausea and dizziness to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the injection site swelling, nausea and dizziness to be related to Bexsero and Bexsero 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: 06-DEC-2024 Physician reported that she had 5 patients in the past month who had experienced extreme side effects from Bexsero and they were refusing to get the 2nd dose. The side effects were extreme nausea, dizziness, and injection site swelling. These symptoms had sometimes lasted up to a week long. Reporter stated lot numbers on the packages for these patients were different as well, so it did not sound like just a bad box. Physician had been using Bexsero since it came out and had not ever experienced this so she was curious to what was going on.
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| 2819319 | F | NJ | 01/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received 1st dose (Shingrix) , like 5 to 10 years ago; This non-serious case was reported by a pharm...
received 1st dose (Shingrix) , like 5 to 10 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 5 to 10 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received 1st dose (Shingrix) , like 5 to 10 years ago). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 16-DEC-2024 The pharmacist reported that a patient received 1st dose of Shingrix like 5 to 10 years ago and asked if they have to be revaccinate or how did that worked. The reporter asked was there any information or anything. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2819320 | F | PA | 01/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received her 1st Shingrix dose 3 years ago; This non-serious case was reported by a other health pro...
received her 1st Shingrix dose 3 years ago; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 3 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received her 1st Shingrix dose 3 years ago). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 19-DEC-2024 The reporter reported that they had a patient that received her 1st Shingrix dose 3 years ago. The reporter did reviewed the prescribing information, but just wanted to verify that restarting the series was still not recommended even though it had been 3 years. The Vaccine Administration Facility was the same as Primary Reporter Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
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| 2819322 | 34 | F | CO | 01/03/2025 |
COVID19 |
MODERNA |
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Urticaria chronic
Urticaria chronic
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chronic urticaria; This spontaneous case was reported by a patient and describes the occurrence of U...
chronic urticaria; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA CHRONIC (chronic urticaria) in a 34-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 22-Dec-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced URTICARIA CHRONIC (chronic urticaria). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at a dose of UNK, bid. At the time of the report, URTICARIA CHRONIC (chronic urticaria) had not resolved. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient chronic urticaria every day and it appeared after 12 days from the booster dose. There was research linking it to Spikevax and that it was a confirmed side effect. Patient was taking Benadryl twice a day to relieve the hives and dermatographia. Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms/events.
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| 2819323 | U | 01/03/2025 |
COVID19 |
MODERNA |
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Death
Death
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Another patient that died from the the Moderna vaccine; This spontaneous case was reported by an oth...
Another patient that died from the the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Another patient that died from the the Moderna vaccine) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. An autopsy was not performed. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2024-777341 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2024-777341:Case for different Patient; Reported Cause(s) of Death: Another patient that died from the the Moderna vaccine
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| 2819324 | U | 01/03/2025 |
RSV |
PFIZER\WYETH |
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Device malfunction
Device malfunction
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Abrysvo vaccine malfunction (Unknown if administered to any patient); This is a spontaneous report r...
Abrysvo vaccine malfunction (Unknown if administered to any patient); This is a spontaneous report received from a Pharmacist. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "Abrysvo vaccine malfunction (Unknown if administered to any patient)". Causality for "abrysvo vaccine malfunction (unknown if administered to any patient)" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2819325 | F | WA | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Malaise, Pyrexia
Malaise, Pyrexia
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fever; we did not feel very well; This is a spontaneous report received from a Consumer or other non...
fever; we did not feel very well; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart transplant" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; MALAISE (non-serious), outcome "unknown", described as "we did not feel very well". Additional information: When the reporter and the patient got home after their first shot, they experienced fever and did not feel very well. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400326172 same reporter/ drug, different patient;
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| 2819326 | 79 | F | NJ | 01/03/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Asthenia, Blood test, Computerised tomogram, Hip arthroplasty, Laboratory test; ...
Asthenia, Blood test, Computerised tomogram, Hip arthroplasty, Laboratory test; Magnetic resonance imaging, Paralysis
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right hip replacement; had no strength in her body; paralyzed her; This is a spontaneous report rece...
right hip replacement; had no strength in her body; paralyzed her; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in arm for covid-19 immunisation. The patient can't recall which arm. The reporter informed that the vaccination facility type was Pharmacy. The patient's relevant medical history included: "cervical myelopathy surgery", start date: 2021 (unspecified if ongoing), notes: probably 3 years ago; "glaucoma" (ongoing); "Asthma" (ongoing); "cervical myelopathy" (ongoing), notes: still had compression in neck for too long. MRI and radiology and 1 doctor said she didn't have it. The patient's family history included: "osteoarthritis" (ongoing); "Osteoporosis" (ongoing). Concomitant medications included: TRAVOPROST ophthalmic taken for glaucoma (ongoing); DULERA resp inhalation taken for asthma (ongoing). The patient also took other concomitant therapy. The patient started taking travaprost a couple years ago and started taking formoterol fumarate, mometasone furoate years ago. The patient was taking supplements. Vaccination history included: Shingle vaccine (dose 1, unknown manufacturer), for immunization; Shingle vaccine (dose 2, unknown manufacturer), for immunization; Flu vaccine (dose number unknown, manufacturer unknown), for immunization; Pneumonia vaccine (dose number unknown, manufacturer unknown), for immunization. The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 12Apr2024, outcome "unknown", described as "right hip replacement"; ASTHENIA (non-serious) with onset Apr2024, outcome "unknown", described as "had no strength in her body"; PARALYSIS (medically significant) with onset Apr2024, outcome "unknown", described as "paralyzed her". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Computerised tomogram: Unknown results; radiology report: Unknown results; Magnetic resonance imaging: didn't have it. The patient's first one was in Apr2024 before 12Apr2024, didn't have exact date to provide. She had right hip replacement 12Apr2024, so it was a week before that. She had a reaction which paralyzed her the next day. She was flat on her back for 2 days with a severe reaction. She got up to go to the bathroom and couldn't get off her bed or on her bed. She slid to the floor and spent the day on the floor waiting to call someone to help her. It was an incredible experience. She thought if she slid to the floor, she could hoist herself, but she had no strength in her body. The outcome was that she got over it rather completely she thought. She didn't know because she had hip surgery so not sure. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400334632 same patient/vaccine, different dose/AE;
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| 2819327 | 79 | F | NJ | 01/03/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood test, Computerised tomogram, Dysstasia, Fatigue, Gait inability; Inflammat...
Blood test, Computerised tomogram, Dysstasia, Fatigue, Gait inability; Inflammation, Investigation, Lethargy, Magnetic resonance imaging, Pain; Paralysis
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pain / achy; paralyzed/couldn't move her legs or feet; couldn't walk; couldn't stand;...
pain / achy; paralyzed/couldn't move her legs or feet; couldn't walk; couldn't stand; whole body inflammatory response; extreme fatigue; very lethargic; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "cervical myelopathy", start date: 2021 (unspecified if ongoing), notes: still had myelopathy compression in her neck for too long. MRI and radiology report done; one doctor said she didn't have it; "cervical myelopathy surgery", start date: 2021 (unspecified if ongoing), notes: Had the surgery probably 3 years ago; "Asthma" (ongoing); "Glaucoma" (ongoing); "Osteoporosis" (unspecified if ongoing), notes: Osteoporosis which she has; "Hip replacement", start date: 12Apr2024 (unspecified if ongoing). The patient's family history included: "osteoarthritis" (unspecified if ongoing), notes: osteoarthritis which she also has. Concomitant medication(s) included: TRAVOPROST taken for glaucoma (ongoing); DULERA taken for asthma (ongoing); INFLUENZA VACCINE taken for immunisation as dose number unknown single; PNEUMOCOCCAL VACCINE taken for immunisation as dose number unknown single; VARICELLA ZOSTER VACCINE taken for immunisation as dose 1, single as dose 2, single. The patient also took other concomitant therapy. Vaccination history included: Moderna (never had a side effect with Moderna Covid vaccines), for Covid-19 Immunization; Comirnaty (2023-2025 formula) (DOSE 1, SINGLE, doesn't recall which arm in Apr2024), administration date: Apr2024, when the patient was 79 years old, for Covid-19 Immunization, reaction(s): "paralyzed her the next day"; Comirnaty (2024-2025 formula) (DOSE 1, SINGLE, She was flat on her back for 2 days with a severe reaction.), administration date: Apr2024, when the patient was 79 years old, for Covid-19 Immunization, reaction(s): "had no strength in her body". The following information was reported: DYSSTASIA (non-serious) with onset 07Dec2024, outcome "unknown", described as "couldn't stand"; GAIT INABILITY (non-serious) with onset 07Dec2024, outcome "recovered" (08Dec2024), described as "couldn't walk"; FATIGUE (non-serious) with onset 07Dec2024, outcome "not recovered", described as "extreme fatigue"; PAIN (hospitalization) with onset 07Dec2024, outcome "not recovered", described as "pain / achy"; LETHARGY (non-serious) with onset 07Dec2024, outcome "not recovered", described as "very lethargic"; INFLAMMATION (non-serious) with onset 07Dec2024, outcome "unknown", described as "whole body inflammatory response"; PARALYSIS (hospitalization, medically significant) with onset Dec2024, outcome "not recovered", described as "paralyzed/couldn't move her legs or feet". The patient was hospitalized for paralysis, pain (start date: 07Dec2024, discharge date: 08Dec2024, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood test: (Dec2024) Unknown results; Computerised tomogram: (Dec2024) Unknown results; radiology report: (2021) Unknown results; Magnetic resonance imaging: (2021) Unknown results. Therapeutic measures were taken as a result of pain. Clinical course: The patient was taking other concomitant medications (unspecified supplements). She got the Pfizer shot again 06Dec thinking it was just a reaction that time. She ended up on 07Dec and 08Dec she couldn't walk, couldn't stand. She had whole body inflammatory response and God awful pain. She was able to walk on the 8th. She was in hospital on the 7th. They carried her out of the house by emergency squad. Had terrible pain and paralyzed, she couldn't move her legs or feet. She finally got a room at 2:30am. She was able to walk later the next day but still not over the reaction to the shot. She has extreme fatigue, very lethargic and achy. Clarifies 1st dose to Apr2024, doesn't have exact date to provide. It was before 12Apr2024. She had right hip replacement 12Apr2024. So it was a week before that. The next day she was paralyzed. She got up to go to the bathroom and couldn't get off her bed or on her bed. She slid to the floor and spent the day on the floor waiting to call someone to help her. It was an incredible experience. She thought if she slid to the floor, she could hoist herself, but she had no strength in her body. For the outcome - got over it rather completely she thinks doesn't know because she had hip surgery so not sure. It was states that this time, the pain was terrible. She got EMS because her friend couldn't get her off the floor. She couldn't move from the pain. She went to the hospital. Clarifies she got her 2nd shot on 06Dec2024. EMS carried her out of the house on 07Dec2024 because she couldn't get in a wheelchair the pain was so great. It was incredible inflammatory pain. She spent the afternoon in the ER. She got IV fluids and IV Tylenol and lidocaine patches. The next day she was still in (city withheld) and was still very weak. She came home on 08Dec2024. Clarifies she was admitted to the hospital. Rapid treatment unit. Extreme fatigue, very lethargic, and achy is just continuing from the 07Dec2024. Was pretty good on the 6th, she went shopping and came home went to bed and woke up a mess. Outcome: still has it, persisting. Has no get up and go. During investigations: They did a whole body CAT scan and a lot of blood work. This is in her records there. They called it a fall and she told them no, she didn't fall she let herself to the floor. After this happened and was sort of back and cognitive functioning level she googled side effects of covid vaccination and in the reading she did there was recommended for humans over certain age thinks 65 to get Moderna rather than Pfizer. That is on Google. When got the Moderna vaccinations she never had a side effect but had dramatic with both of Pfizer. Clarifies Moderna Covid vaccines. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400334628 same patient and vaccine, different dose and event;
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| 2819328 | U | VA | 01/03/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Myocardial infarction; COVID-19, Drug ineffective; Myocardial infarction; COVID-...
Myocardial infarction; COVID-19, Drug ineffective; Myocardial infarction; COVID-19, Drug ineffective
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heart attack; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A...
heart attack; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 70-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack". Additional information: During an inbound call from a patient seeking financial assistance, the patient states, "I have COVID, and I was prescribed Paxlovid, and they told me that it was (Withheld), and this other thing is (Withheld). I don't have either one of those." The agent clarifies the reason for the call. The patient continued later in the call and stated, "Everything's fine. It's just the coughing is so bad I think that's a part of it's respiratory I never had it. I really escaped it all these years, you know, and then the last COVID shot gave me a heart attack, so I can't take COVID shots, so apparently, I shouldn't try." The patient stated "Should I be scared of this drug or what? Is it new, and do they know anything about it? I mean I took the Pfizer shot." The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400170313 same reporter/patient, different dose/event;
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| 2819329 | F | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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died; This is a spontaneous report received from a Consumer or other non HCP. A female patient rece...
died; This is a spontaneous report received from a Consumer or other non HCP. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunizaion. The following information was reported: DEATH (death, medically significant), 4 days after the suspect product(s) administration, outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter stated that both of his aunts died four days after the second shot. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400335024 Same reporter/event, different patient;; Reported Cause(s) of Death: Unknown Cause Of Death
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| 2819330 | F | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0588 |
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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the patient and her husband had covid/they received with Lot number LN0588; the patient and her husb...
the patient and her husband had covid/they received with Lot number LN0588; the patient and her husband had covid/they received with Lot number LN0588; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LN0588, Expiration Date: 17Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patient and her husband had covid/they received with Lot number LN0588". No follow-up attempts are possible.
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| 2819331 | 40 | F | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Disease recurrence, Endometrial cancer, Vaginal haemorrhage
Disease recurrence, Endometrial cancer, Vaginal haemorrhage
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diagnosis of endometrial cancer in Mar2024; heavy and abnormal vagina bleeding 2 days post dosing fo...
diagnosis of endometrial cancer in Mar2024; heavy and abnormal vagina bleeding 2 days post dosing for all three doses which she never experienced before; heavy and abnormal vagina bleeding 2 days post dosing for all three doses which she never experienced before; This is a spontaneous report received from an Other HCP. A female patient in her 40's (not pregnant) received BNT162b2 (BNT162B2 NOS), in 2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 5 decade for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding"; Bnt162b2 (DOSE 2, SINGLE, one month apart previous dose), administration date: 2021, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding". The following information was reported: VAGINAL HAEMORRHAGE (disability, life threatening), DISEASE RECURRENCE (disability, life threatening) all with onset 2023, latency 2 days after the suspect product(s) administration, outcome "recovering" and all described as "heavy and abnormal vagina bleeding 2 days post dosing for all three doses which she never experienced before"; ENDOMETRIAL CANCER (disability, life threatening) with onset Mar2024, outcome "recovering", described as "diagnosis of endometrial cancer in Mar2024". Therapeutic measures were taken as a result of endometrial cancer including surgery, chemo and radiation. The information on the batch/lot number for BNT162B2 NOS will be requested and submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events VAGINAL HAEMORRHAGE, DISEASE RECURRENCE and the suspect drug Based on available information on the safety profile of Comirnaty so far, the product does not seem to be carcinogenic. There is limited information in the case regarding relevant risk factors including tobacco and alcohol use, human papilloma virus infection, family history of cancer, etc. Considering these factors, the reported ENDOMETRIAL CANCER is considered unlikely related to Comirnaty in this case report. However, as a cautionary measure, a relationship cannot be completely excluded since the patient received the vaccine before the event. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202500000311 same reporter/patient, partial same event, different dose;US-PFIZER INC-202500000312 same reporter/patient, partial same event, different dose;
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| 2819332 | F | CA | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Influenza, Nasopharyngitis, Oropharyngeal pain
Influenza, Nasopharyngitis, Oropharyngeal pain
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had a cold; flu; Sore throat; This is a spontaneous report and received from Consumer or other non H...
had a cold; flu; Sore throat; This is a spontaneous report and received from Consumer or other non HCPs. Other Case identifier(s): 2024US010104. A 75-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), in Nov2024 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; abaloparatide (TYMLOS), (Lot number: F601761568) at 80 ug daily, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; Manufacturer Unknown), administration date: Nov2024, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2024, outcome "unknown", described as "Sore throat"; INFLUENZA (non-serious) with onset 2024, outcome "unknown", described as "flu"; NASOPHARYNGITIS (non-serious) with onset 2024, outcome "unknown", described as "had a cold". The action taken for abaloparatide was unknown. Additional information: On an unspecified date, the patient began treatment with Tymlos (abaloparatide) 80 mcg daily. Covid-19 vaccine and an unspecified cholesterol medication were reported as co-suspect medication. On an unspecified date, the patient reported she had a cold (nasopharyngitis), flu (influenza), and sore throat (oropharyngeal pain). She stated she was unsure if it was due to the new unspecified medication she started for her cholesterol or just the reason. Additionally, she had her COVID-19 vaccine last month. No treatment information was provided. The outcome of nasopharyngitis, influenza, and oropharyngeal pain was unknown. Batch/lot number is not provided, and it cannot be obtained.
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| 2819333 | F | 01/03/2025 |
PNC13 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
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Drug ineffective, Pneumonia; Drug ineffective, Pneumonia
Drug ineffective, Pneumonia; Drug ineffective, Pneumonia
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she has gotten PREVNAR in the past and that she still gets hospitalized almost every year with pneum...
she has gotten PREVNAR in the past and that she still gets hospitalized almost every year with pneumonia; she has gotten PREVNAR in the past and that she still gets hospitalized almost every year with pneumonia; This is a spontaneous report received from a Consumer or other non HCP. A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), PNEUMONIA (hospitalization), outcome "unknown" and all described as "she has gotten PREVNAR in the past and that she still gets hospitalized almost every year with pneumonia". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2819335 | 62 | F | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Illness, Vaccination site mass
COVID-19, Drug ineffective, Illness, Vaccination site mass
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had covid back in Jul2024; had covid back in Jul2024; very sick; a lump on the arm the size of a can...
had covid back in Jul2024; had covid back in Jul2024; very sick; a lump on the arm the size of a cantaloupe; This is a spontaneous report received from an Other HCP, Program ID. A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 62 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Jan2024, outcome "unknown", described as "a lump on the arm the size of a cantaloupe"; ILLNESS (non-serious) with onset Jan2024, outcome "recovered" (2024), described as "very sick"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "unknown" and all described as "had covid back in Jul2024". The last time patient received a vaccine she got very sick. The symptoms lasted a full seven days after receiving the vaccine. Patient had a lump on the arm the size of a cantaloupe where the injection was given. Patient also had covid back in Jul2024.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
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| 2819337 | 76 | F | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Hypoaesthesia, Vaccination site pain
Hypoaesthesia, Vaccination site pain
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a lot of pain in her left arm where she received the shot; numbness in her left hand; This is a spon...
a lot of pain in her left arm where she received the shot; numbness in her left hand; This is a spontaneous report received from an Other HCP, Program ID. A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jul2024 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "unknown", described as "a lot of pain in her left arm where she received the shot"; HYPOAESTHESIA (non-serious) with onset 2024, outcome "unknown", described as "numbness in her left hand". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2819338 | 89 | F | 01/03/2025 |
COVID19 RVX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Illness; Illness
Illness; Illness
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she got very sick for two weeks after; This is a spontaneous report received from an Other HCP, Prog...
she got very sick for two weeks after; This is a spontaneous report received from an Other HCP, Program ID. An 89-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Feb2024 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 89 years intramuscular for covid-19 immunisation; rsv vaccine (RSV VACCINE), in Feb2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "she got very sick for two weeks after". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
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| 2819339 | U | 01/03/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Coma
Coma
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flu vaccination put me in a coma for a week; Initial information received on 30-Dec-2024 regarding a...
flu vaccination put me in a coma for a week; Initial information received on 30-Dec-2024 regarding an unsolicited valid Social Media serious case received from a Patient. This case involves Adult and unknown gender patient who reported flu vaccination (Influenza Vaccine) put him in a coma for a week (in the hospital 3 weeks). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received once (1X) suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. There will be no information available on the batch number for this case.. On an unknown date the patient reported flu vaccination put me in a coma for a week (coma) (unknown latency). This event was assessed as medically significant. The patient was hospitalized for this event (in the hospital 3 weeks). Action taken: Not applicable. It was not reported if the patient received a corrective treatment for the event (flu vaccination put me in a coma for a week). At time of reporting, the outcome was Unknown for the event flu vaccination put me in a coma for a week.; Sender's Comments: Sanofi Company Comment dated 03-JAN-2025: This case involves Adult and unknown gender patient who reported flu vaccination (Influenza Vaccine) put him in a coma for a week (in the hospital 3 weeks). Further information regarding concurrent condition during 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 the individual suspect vaccine cannot be assessed.
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| 2819340 | U | 01/03/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Malaise
Malaise
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was so sick for weeks; Initial information received on 21-Dec-2024 regarding an unsolicited valid So...
was so sick for weeks; Initial information received on 21-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a Non-Healthcare Professional. This case involves an unknown age and unknown gender patient who was so sick for weeks after receiving influenza vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2001, the patient received influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, dose, batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On an unknown date the patient was so sick for weeks (illness) (unknown latency). Action taken: not applicable. It was not reported if the patient received a corrective treatment for the event At time of reporting, the outcome was Unknown for the event
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| 2819353 | M | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cerebrovascular accident, Feeding disorder, Hypoxia, Near death experience
Cerebrovascular accident, Feeding disorder, Hypoxia, Near death experience
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Stroke / Massive stroke; Still dealing with the aftermath of almost dying; There was a cascade of bl...
Stroke / Massive stroke; Still dealing with the aftermath of almost dying; There was a cascade of blood, his blood cells could not hold oxygen, there were a whole of cascade of problems with his blood; Can hardly eat; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), (administration reported as three and a half years ago "the first batch that came out the very first vaccines from Pfizer" for both) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not have other vaccine on the same date of getting the Pfizer COVID-19 vaccine or 4 weeks prior getting the Pfizer COVID-19 vaccine. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke / Massive stroke"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Still dealing with the aftermath of almost dying"; HYPOXIA (medically significant), outcome "unknown", described as "There was a cascade of blood, his blood cells could not hold oxygen, there were a whole of cascade of problems with his blood"; FEEDING DISORDER (non-serious), outcome "unknown", described as "Can hardly eat". Therapeutic measures were taken as a result of cerebrovascular accident. Additional information: The reporter stated that the patient was still dealing with the aftermath of almost dying, having a stroke four days after the second vaccine and had to have two transfusions to get that stuff out of his blood system. The patient can hardly eat. He is suffering from having had a massive stroke because of that. There was a cascade of blood, his blood cells could not hold oxygen, there were a whole of cascade of problems with his blood that he had never had in his life. That was why he had to have the transfusions to save his life. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2819354 | F | DE | 01/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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Covid-19 vaccine (Pfizer) 2021/06Jan2022 bosutinib was stopped due to newly diagnosed covid; Covid-1...
Covid-19 vaccine (Pfizer) 2021/06Jan2022 bosutinib was stopped due to newly diagnosed covid; Covid-19 vaccine (Pfizer) 2021/06Jan2022 bosutinib was stopped due to newly diagnosed covid; This is a spontaneous report and received from Physicians, Program ID. A 68-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Covid-19 vaccine (Pfizer) 2021/06Jan2022 bosutinib was stopped due to newly diagnosed covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) diagnosed covid.; Sender's Comments: Based on the information provided , temporal association and the administration of the suspect drug a possible contributory role of the suspect drug in triggering the onset of the events Drug ineffective, COVID-19 cannot be excluded.
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| 2819355 | 17 | F | CA | 01/03/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
99634 |
Peripheral swelling, Tenderness
Peripheral swelling, Tenderness
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At visit on 12/23/24 patient described swollen but nontender area on L arm that lasted from 9/12/24 ...
At visit on 12/23/24 patient described swollen but nontender area on L arm that lasted from 9/12/24 to approximately holiday of that year. The person who administered the vaccine is extremely skilled
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| 2819356 | 52 | F | MI | 01/03/2025 |
TD TD |
SANOFI PASTEUR SANOFI PASTEUR |
49281021510 49281021510 |
Injected limb mobility decreased, Injection site bruising, Injection site pain, ...
Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site reaction, Loss of personal independence in daily activities; Muscular weakness, Nerve oedema, Pain
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Date of Incident: December 18, 2024 Location: Pharmacy Incident Report: On Wednesday, December 18, 2...
Date of Incident: December 18, 2024 Location: Pharmacy Incident Report: On Wednesday, December 18, 2024, I sustained an injury to my right foot that required a tetanus booster. Accordingly, I received the Td vaccination in my left shoulder at approximately 1:30 PM at the Pharmacy. While the administration of the shot was painful, the attending pharmacist assured me that this was normal and advised that I might experience soreness in the area for up to 48 hours. Initially, I was not concerned as the pharmacist indicated the discomfort would subside within the specified timeframe. However, on Sunday, December 22, 2024, the pain persisted, significantly impeding my ability to perform routine activities, such as sleeping on my left side, raising my arm, carrying items on my left side, and engaging in tasks that utilized my shoulder muscles. Subsequently, on Monday, December 23, 2024, I contacted my Primary Care Physician (PCP) but was informed that they were fully booked. The receptionist, after consulting with the Physician Assistant (PA), advised that it could take 5-7 days for the pain to resolve, prompting me to wait through the Christmas holiday. On December 26, 2024, I contacted the PCP's office again and secured an appointment for the following day. I was examined by the PA on Friday, December 27, 2024, nine days post-vaccination. The PA suggested that the injection might not have been administered in the optimal location, leading to persistent pain, bruising, and suspected nerve swelling. As a result, I was prescribed a topical pain-relieving gel and an oral steroid. Current Status: As of today, January 3, 2025, my pain has diminished slightly, but I continue to experience weakness in my left arm and pain during certain activities involving the shoulder muscles.
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| 2819357 | 16 | M | TX | 01/03/2025 |
MENB |
PFIZER\WYETH |
LF5303 |
Deep vein thrombosis, Pain in extremity, Peripheral swelling, Skin discolouratio...
Deep vein thrombosis, Pain in extremity, Peripheral swelling, Skin discolouration, Ultrasound Doppler abnormal
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Patient received vaccine on 12/10/24, started to have left arm swelling /pain and change in color. ...
Patient received vaccine on 12/10/24, started to have left arm swelling /pain and change in color. Diagnosed on 12/15/24 with DVTs in the arm. Currently on Lovenox.
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| 2819358 | 50 | F | NE | 01/03/2025 |
VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Blister, Chest discomfort, Cough, Ear discomfort, Herpes zoster; Insomnia, Letha...
Blister, Chest discomfort, Cough, Ear discomfort, Herpes zoster; Insomnia, Lethargy, Myalgia, Pyrexia, Respiratory tract congestion; Tremor
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I started a fever on 12/24/24 that lasted until 12/29/24; shaking, muscle aches, violent dry cough, ...
I started a fever on 12/24/24 that lasted until 12/29/24; shaking, muscle aches, violent dry cough, deep chest congestion, burning ears, lethargic, tight chest, minimal sleep at night like I wanted to crawl out of my skin- these symptoms lasted until 12/1/25; currently still experiencing a dry cough, chest congestion and shingles blisters under my chin (I've never had shingles before)- 1/3/25. Nobody else in my household has been sick at all since this began on 12/24/24 or prior to the vaccine. It's like my body is glitching with various symptoms like it can't decide how to recover.
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| 2819359 | 62 | F | 01/03/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Hypoaesthesia, Mobility decreased
Hypoaesthesia, Mobility decreased
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Patient complained of arm numbness and loss of mobility with a minute of vaccination. After another ...
Patient complained of arm numbness and loss of mobility with a minute of vaccination. After another minute movement and feeling was restored.
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| 2819360 | 66 | M | SC | 01/03/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Influenza like illness, Malaise
Influenza like illness, Malaise
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Pt. stated that he started feeling sick starting the day after the vaccine with flu-like symptoms. H...
Pt. stated that he started feeling sick starting the day after the vaccine with flu-like symptoms. He stated that he felt deathly sick and had to call EMS and hasn't felt right since.
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| 2819362 | 76 | F | KY | 01/03/2025 |
RSV |
PFIZER\WYETH |
LN5493 |
Blister, Pruritus, Rash
Blister, Pruritus, Rash
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Rash/blistering/itching of both feet Bilaterally. presentation 1 week after vaccination and has not ...
Rash/blistering/itching of both feet Bilaterally. presentation 1 week after vaccination and has not subsided after 2 months
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| 2819363 | 71 | F | FL | 01/03/2025 |
PNC20 RSV VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LJ5281 255T2 N77J2 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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Patient was given a duplicate dose of Prevnar 20 pneumococcal vaccine. Previous dose was administere...
Patient was given a duplicate dose of Prevnar 20 pneumococcal vaccine. Previous dose was administered on 3/17/2023.
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| 2819364 | 36 | F | 01/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Exposure during pregnancy, No adverse event, Product use issue
Exposure during pregnancy, No adverse event, Product use issue
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The patient received Arexvy instead of Abrysvo (which is approved for pregnancy). No issues or adver...
The patient received Arexvy instead of Abrysvo (which is approved for pregnancy). No issues or adverse effects reported by the patient at time of this report.
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| 2819365 | 73 | F | AL | 01/03/2025 |
PNC20 |
PFIZER\WYETH |
ig5577 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Prevnar 20 was administered to patient inappropriately on 01/03/2025 . Patient had already received ...
Prevnar 20 was administered to patient inappropriately on 01/03/2025 . Patient had already received Prevnar 20 last year (01/08/2024). Patient had made an appointment to receive this vaccination and was unaware that no further doses were required. First dose of Prevnar 20 was not registered and insurance did not reject claim as duplicate. Patient did not report any adverse events due to receiving extra Prevnar 20 dose.
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