| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2835638 | 31 | F | OR | 04/10/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
B0005 UT8454CA |
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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No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine ...
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
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| 2835639 | 39 | M | 04/10/2025 |
COVID19 |
MODERNA |
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Fatigue, Tremor
Fatigue, Tremor
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Tremors; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of T...
Tremors; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors) and FATIGUE (fatigue) in a 39-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Tremors) and FATIGUE (fatigue). At the time of the report, TREMOR (Tremors) and FATIGUE (fatigue) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. This case contains information about 2nd patient out of 4 patients as described by reporter. No concomitant medications were reported. The patient had reduced his work hours due to severe tremors and fatigue that developed after receiving his Moderna shot. Previously, the physician had dismissed that it was long COVID, but the patient believed his symptoms were due to the vaccine, and now the patient who was a formerly active outdoorsman struggled with his daily family life. No treatment medications were reported. This case was linked to AU-MODERNATX, INC.-MOD-2025-784512 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2025: Live significant follow-up received. RA was updated to 07-Apr-2025. On 08-Apr-2025: Live significant follow-up received. country of incidence updated.; Sender's Comments: AU-MODERNATX, INC.-MOD-2025-784512:Same Report, patient
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| 2835640 | 57 | M | 04/10/2025 |
COVID19 |
MODERNA |
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Cardiac disorder, Feeling abnormal, Tinnitus
Cardiac disorder, Feeling abnormal, Tinnitus
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Chronic tinnitus; debilitating heart issues; Spidey senses; This spontaneous case was reported by a ...
Chronic tinnitus; debilitating heart issues; Spidey senses; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Chronic tinnitus), CARDIAC DISORDER (debilitating heart issues) and FEELING ABNORMAL (Spidey senses) in a 57-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Chronic tinnitus), CARDIAC DISORDER (debilitating heart issues) and FEELING ABNORMAL (Spidey senses). At the time of the report, TINNITUS (Chronic tinnitus), CARDIAC DISORDER (debilitating heart issues) and FEELING ABNORMAL (Spidey senses) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. This case contains information about 3 out of 4 patients reported by reporter. No concomitant medications were reported. The patient got vaccinated in 2021 to support his healthcare worker wife. Shortly after having the second shot, the patient experienced the events. The patient was dismissed by the doctors until 2023. The patient lived in constant fear, never knew what was going to happen, and just resigned himself to the fact that his days were numbered. No treatment medications were reported. This case was linked to AU-MODERNATX, INC.-MOD-2025-784512 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2025: Live significant follow-up received. RA was updated to 07-Apr-2025. On 08-Apr-2025: Live significant follow-up received. country of incidence updated.; Sender's Comments: AU-MODERNATX, INC.-MOD-2025-784512:Same Report, patient (patient 3)
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| 2835641 | 04/10/2025 |
COVID19 |
PFIZER\BIONTECH |
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Angina pectoris, Pain assessment
Angina pectoris, Pain assessment
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Occasional not lasting longer sensations around my heart; Tightness with some pain; Does not persist...
Occasional not lasting longer sensations around my heart; Tightness with some pain; Does not persist; Intense itching on the injection site; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Apr2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR. Vaccination history included: Comirnaty (DOSE 1, SINGLE, Lot: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 05Apr2025, outcome "unknown", described as "Intense itching on the injection site"; ANGINA PECTORIS (medically significant) with onset 05Apr2025, outcome "recovering", described as "Occasional not lasting longer sensations around my heart; Tightness with some pain; Does not persist". The patient underwent the following laboratory tests and procedures: Pain assessment (0-10): (05Apr2025) 4 or 5. On 03Apr2025 (reported 72 hours before 06Apr2025) the patient had Comirnaty vaccine and this was the 2nd time the patient had it. The patient's concern was patient had been having intermittent. The patient took the vaccine on Thursday (03Apr2025). For 24 hours the patient had no symptoms, not even a sensation or feeling on arm but after since 05Apr2025 (reported as yesterday) so after 48 hours the patient had intense itching on the injection site and occasional not lasting longer sensations around the patient's heart, tightness with some pain but the pain like severe like on 1 to 10 patient had say it about 4 or 5. It is like a construction and then the patient did not know. It goes away within 30 seconds. So it does not persist. so, patient's concern was maybe patient should be evaluating for steroids or something like that or should this resolve it. The patient saw a package insert said that it was a conservative management. In response to further probing: Consumer stated, this might resolve on itself. It did not seem to be getting any worse. So, the patient thought the patient will little longer and by this evening another couple of hours, if it was still bothering patient or being worse patient will go ahead and call back. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2835642 | MA | 04/10/2025 |
COVID19 |
PFIZER\BIONTECH |
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Balance disorder, Behcet's syndrome, Diplopia, Dizziness, Fall
Balance disorder, Behcet's syndrome, Diplopia, Dizziness, Fall
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bishop; Dizziness; Vertical double vision; I fell down twice. It is like balance; I fell down twice....
bishop; Dizziness; Vertical double vision; I fell down twice. It is like balance; I fell down twice. It is like balance; something in my brain; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), 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: BEHCET'S SYNDROME (medically significant), outcome "unknown", described as "bishop"; DIZZINESS (non-serious), outcome "unknown"; DIPLOPIA (non-serious), outcome "unknown", described as "Vertical double vision"; FALL (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "I fell down twice. It is like balance"; CEREBRAL DISORDER (non-serious), outcome "unknown", described as "something in my brain". Clinical course: The patient got the Pfizer COVID-19 Vaccine almost three years and half ago. The patient experienced dizziness, vertical double vision and last year on15Feb2024, the patient fell down twice, and it was like balance. The patient stated that two years and half ago in (redacted), they found something in the patient's brain, but they did not know exactly. The first time they said that it could be 'bishop'. The second time they said it was maybe tumor-like concept, and they sent the patient to (withheld) and said that it was not. After that, they told the patient that it could be inflammation. The patient needed help to get the right medicine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2835643 | M | NE | 04/10/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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Covid after Vaccines; Covid after Vaccines; This is a spontaneous report received from a Consumer or...
Covid after Vaccines; Covid after Vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 78-year-old male patient received BNT162b2 (BNT162B2 NOS), 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), outcome "unknown" and all described as "Covid after Vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: During an inbound call for Reimbursement assistance, the patient stated that on Saturday, he was getting his Paxlovid and working with his pharmacist. They tried several times to get the card and a couple of places said his birthday was wrong. He also said that he got COVID for his Birthday. The patient and his wife don't take many pills and they get vaccines usually on time. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2835644 | CT | 04/10/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chronic kidney disease
Chronic kidney disease
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chronic kidney disease; This is a spontaneous report received from a Consumer or other non HCP, Prog...
chronic kidney disease; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (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: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "fine"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "fine". The following information was reported: CHRONIC KIDNEY DISEASE (medically significant), outcome "unknown". The event "chronic kidney disease" required physician office visit. Therapeutic measures were taken as a result of chronic kidney disease. The booster shot gave to the patient chronic kidney disease and it was confirmed by a physician at this point. The patient was required to get kidney infusions twice a year. 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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| 2835645 | 38 | 04/10/2025 |
RAB |
SANOFI PASTEUR |
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No adverse event, Off label use
No adverse event, Off label use
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Intentional Off Label Prescription by HCP: Imovax is prescribed with off label diagnosis code W54.0X...
Intentional Off Label Prescription by HCP: Imovax is prescribed with off label diagnosis code W54.0XXA OKA Bitten by dog with no adverse event; Initial information received on 03-Apr-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 38 years old and unknown gender patient who had intentional off label prescription by hcp (healthcare professional): IPV (Vero) [Imovax] is prescribed with off label diagnosis code W54.0XXA oka bitten by dog with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received dose of 1mL (frequency once) suspect IPV (Vero), Suspension for injection (lot number, expiry date and strength not reported) via intramuscular route for bitten by dog (prophylactic vaccination). (Immunisation). Information on the batch number could not be requested corresponding to the one at time of event occurrence. On an unknown date, the patient had intentional off label prescription by hcp (healthecare professional): imovax is prescribed with off label diagnosis code W54.0XXA oka bitten by dog with no adverse event (off label use). Action taken was not applicable.
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| 2835646 | MI | 04/10/2025 |
IPV |
SANOFI PASTEUR |
W1C751M |
No adverse event, Product storage error
No adverse event, Product storage error
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temperature excursion for IPOL as max/low temperature reached: 53 F 45 mins with no reported adverse...
temperature excursion for IPOL as max/low temperature reached: 53 F 45 mins with no reported adverse event; Initial information received on 08-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received IPV (VERO) [IPOL] that had temperature excursion as max/low temperature reached: 53 F 45 mins with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (lot W1C751M and expiry date: 18-Nov-2025) (strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and that had temperature excursion as max/low temperature reached: 53 F 45 mins with no reported adverse event (poor quality product administered). Reportedly, Reason: Broken refrigerator. Human error was No. Extended stability data did not cover the excursion. Product was administered post excursion. The caller states that this was such a short excursion what if the dose was valid, would it hurt them to get another dose. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2835658 | 04/10/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Headache, Malaise, Myalgia, Pain in extremity, Tenderness
Headache, Malaise, Myalgia, Pain in extremity, Tenderness
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arm is hurting/ arm tender; not feeling well/ hate how it make me feel right after shot; headache; m...
arm is hurting/ arm tender; not feeling well/ hate how it make me feel right after shot; headache; muscles hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose received on an unknown date and experienced not feeling well). On 02-APR-2025, the patient received the 2nd dose of Shingles vaccine. On 02-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm is hurting/ arm tender) and feeling unwell (Verbatim: not feeling well/ hate how it make me feel right after shot). In APR-2025, the patient experienced headache (Verbatim: headache) and muscle pain (Verbatim: muscles hurt). The outcome of the pain in arm was not resolved and the outcome of the feeling unwell was not reported and the outcome of the headache and muscle pain were resolved. It was unknown if the reporter considered the pain in arm, feeling unwell, headache and muscle pain to be related to Shingles vaccine. It was unknown if the company considered the pain in arm, feeling unwell, headache and muscle pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-APR-2025 and 04-APR-2025 This case was reported by a patient via interactive digital media. The patient just got 2nd shot of Shingles and arm was hurting and not feeling well just like the first Shingles shot but would be ok tomorrow. The patient get headache and muscles hurt but it's better than shingles. The patient stated ok now(at the time of reporting) arm still tender and he/she hate how it makes felt right after Shingles shot.
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| 2835659 | 69 | F | OH | 04/10/2025 |
COVID19 |
PFIZER\BIONTECH |
ER8735 |
Influenza like illness, Malaise, Myalgia, Pyrexia
Influenza like illness, Malaise, Myalgia, Pyrexia
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sick for a couple days; like ran a fever; muscle aches and pains; muscle aches and pains; felt like ...
sick for a couple days; like ran a fever; muscle aches and pains; muscle aches and pains; felt like she had the flu and stuff like; did not feel good; This is a spontaneous report and received from Nurses from medical information team, Program ID:. A 69-year-old female patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 2, single (Lot number: ER8735) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, batch/lot number ER8727), administration date: 24Mar2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "was just sick for a couple days", "ran a fever", "muscle aches", "pains", "felt like she had the flu and stuff like". The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "sick for a couple days"; PYREXIA (non-serious), outcome "unknown", described as "like ran a fever"; MYALGIA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "muscle aches and pains"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "felt like she had the flu and stuff like"; MALAISE (non-serious), outcome "unknown", described as "did not feel good". Additional information: The patient informed that she had the first two lot number both at Hospital. The first dose she had of the vaccine was covid19 and the Pfizer purple and that was the only thing they gave her. The first one she had was lot ER8727 and on this website that was the one that was really highly toxic; her 2nd one was lot number ER8735 and that was toxic but not as bad as the first and both she had probably 3 weeks apart. She informed that this website was saying on all the ER series it was probably maybe 25 of them that were 100 percent more toxic than other batches in the ER series and the ones she got were really high like 200125 and the other ER series got to 8 or 9 and 7 and 6. The patient informed that the first two lot numbers of the Pfizer BioNTech covid vaccine were in the ER series and on a website she looked up called (redacted). She had received her 2 doses weeks apart and the website said they were highly toxic and when she looked through the ER series it looked like they were highly contaminated but some were not and the first batches were highly toxic but got better after that and they were all sent to the same city for the 1st and 2nd ER series lot numbers which was (redacted). She got both doses for the first two doses and she was just sick for a couple days like ran a fever and on the (redacted) thing she reported that and thinks she had a fever, muscle aches and pains, and felt like she had the flu and stuff like on both of the doses and probably like for 5 days, did not feel good. She wanted to know if she got something toxic that was all. She wanted to know if Pfizer has had any problems with these two batches.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021417458 same patient/product, different dose/events;
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| 2835660 | 75 | M | CT | 04/10/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
LN0591 LN0591 |
Balance disorder, Emotional distress, Loss of personal independence in daily act...
Balance disorder, Emotional distress, Loss of personal independence in daily activities, Pain, Pruritus; Sleep disorder, Urticaria, Vision blurred, Visual impairment
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itching; being deprived of his night; vision that declined considerably and gradually; it became blu...
itching; being deprived of his night; vision that declined considerably and gradually; it became blurry; high risk of losing balance; pain; emotional distress; flares of urticaria (hives) throughout his body; the hives became stronger and more aggressive; impairing him from doing even small home chores or taking care of his 70-year old disabled wife; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Feb2025 as dose 1, single (Lot number: LN0591) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19 " (unspecified if ongoing), notes: Between 16Jan2024 and 07Aug2024 ; "pneumonia" (unspecified if ongoing), notes: twice, between 16Jan2024 and 07Aug2024 ; "swallowing issues" (unspecified if ongoing), notes: with feeding tube in his belly. The patient's concomitant medications were not reported. The following information was reported: SLEEP DISORDER (non-serious) with onset Mar2025, outcome "unknown", described as "being deprived of his night"; BALANCE DISORDER (non-serious) with onset Mar2025, outcome "unknown", described as "high risk of losing balance"; VISION BLURRED (non-serious) with onset Mar2025, outcome "unknown", described as "it became blurry"; PRURITUS (non-serious) with onset Mar2025, outcome "unknown", described as "itching"; VISUAL IMPAIRMENT (non-serious) with onset Mar2025, outcome "unknown", described as "vision that declined considerably and gradually"; EMOTIONAL DISTRESS (non-serious) with onset 2025, outcome "unknown"; URTICARIA (non-serious) with onset 2025, outcome "unknown", described as "flares of urticaria (hives) throughout his body"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2025, outcome "unknown", described as "impairing him from doing even small home chores or taking care of his 70-year old disabled wife"; PAIN (non-serious) with onset 2025, outcome "unknown"; CONDITION AGGRAVATED (non-serious) with onset 2025, outcome "unknown", described as "the hives became stronger and more aggressive". Therapeutic measures were taken as a result of urticaria, condition aggravated. Additional information: A few days later after the patient received the vaccine, he started to feel flares of urticaria (hives) throughout his body, especially from the neck down to his knees. Then, little by little and day by day the hives became stronger and more aggressive impairing him from doing even small home chores or taking care of his 70-year-old disabled wife. The patient used fexofenadine hydrochloride (ALLEGRA) and diphenhydramine hydrochloride (BENADRYL) allergy tablets sold over the counter (twice a day) and did not help with anything. Since the beginning of Mar2025, the patient had to continually scratch his skin and body dozens of times trying to disperse the bothersome itching. He could not rest anymore as before, and he was also being deprived of his night sleep. He had never had any urticaria, rash, or itching on his body at any given time and for any period of time until the end of Feb2025. The vaccine negatively affected his vision that declined considerably and gradually starting with Mar2025 in the sense that it became blurry, also it created a diffraction error for seeing up close that could be or not resolved with glasses although not guaranteed. The patient had never experienced any vision problem all his life, nor he ever wore glasses. A valid explanation could be that the vaccine made opaque in some extent the lens in his eyes, also that the retina was somehow obliterated. The vaccine also made the patient unsafe for standing up for an extended period of time due to a high risk of losing balance, falling down and injuring himself. This process started gradually in the beginning of Mar2025 and forward. He currently could only stand up for 15-20 minutes without the risk of falling compared to hours before.There were absolutely no changes in the patient's lifestyle starting with 24Feb2025 and onward, including for his diet and spiritual life. The patient did not smoke, did not drink alcohol, nor used any illegal substances. These events caused a serious degradation of his body, state of mind, lifestyle and well-being. The patient wanted a compensation for infliction of emotional distress, pain and suffering caused him by the Pfizer COVID-19 vaccine as high mental aggression, stress and bodily harm. Subjecting him to unnecessary bodily harm and pain for an extended period of time up to Feb2026 - possibly permanently - due to urticaria, vision degradation and potential loss of balance and high risk of fall.
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| 2835661 | F | MD | 04/10/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I was one of the first people to get your immunization/got sick on the cruise and fortunately I had ...
I was one of the first people to get your immunization/got sick on the cruise and fortunately I had Paxlovid with me; I was one of the first people to get your immunization/got sick on the cruise and fortunately I had Paxlovid with me; This is a spontaneous report received from an Other HCP, Program ID. A 71-year-old 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was one of the first people to get your immunization/got sick on the cruise and fortunately I had Paxlovid with me". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: During an inbound call for financial assistance, the representative mentioned there are cases where patients need to use financial assistance if they're sick twice in a year, the patient replied that it had happened to her. Representative asked if patient was on Paxlovid, they replied, "Well not now, but I was at one point. I got sick on a cruise, I'm not sick at the moment." Representative clarified that patient was prescribed Paxlovid, they replied, "Yeah, to take with me. I want to be honest, I went on a cruise in August and got sick on the cruise and fortunately I had Paxlovid with me and I really don't want this to happen to me again." Later in the call the representative asked if the patient would speak with DSU, they stated, "Yes, I'd be happy to because I was one of the first people to get your immunization." The representative asked when Paxlovid was taken, they stated, "It was January."
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| 2835662 | AZ | 04/10/2025 |
HIBV |
SANOFI PASTEUR |
UK042AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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an expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial info...
an expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 08-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient whom administered expired dose of hib (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Apr-2025, the patient received a expired unknown dose of suspect hib (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown, lot UK042AA,expiry date:31-mar-2025) via unknown route in unknown administration site as immunization with no reported adverse event (expired product administered) (latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. .
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| 2835663 | 13 | F | CA | 04/10/2025 |
HPV9 |
MERCK & CO. INC. |
Y005835 |
Fall
Fall
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Patient was administered Gardasil on left deltoid, M.A. then turned to give the sibling vaccines. Af...
Patient was administered Gardasil on left deltoid, M.A. then turned to give the sibling vaccines. After administering the sibling's vaccines, the patient fell over, and M.A. noticed the patient on the floor. The M.A. immediately called for the Dr. Dr. entered and assessed the patient. 911 was called and Dr. took over the call and it was determined; emergency services were no longer needed by Dr. and the dispatcher. The patient's head was stabilized with a cushion and legs were elevated. The provider and M.A. remained in the room until the patient stabilized, patient's vitals were rechecked and vitals returned to baseline.
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| 2835664 | 21 | F | WA | 04/10/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LK6650 LK6650 |
Anxiety, Dehydration, Epistaxis, Hyperventilation, Nausea; Pallor, Syncope, Tach...
Anxiety, Dehydration, Epistaxis, Hyperventilation, Nausea; Pallor, Syncope, Tachycardia, Vomiting
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04/10/25 @ 10:40 AM PATIENT WAS SITTING ON FLOOR WITH BLOODY NOSE WHEN PROVIDER ENTERED EXAM ROOM. P...
04/10/25 @ 10:40 AM PATIENT WAS SITTING ON FLOOR WITH BLOODY NOSE WHEN PROVIDER ENTERED EXAM ROOM. PATIENT WAS ALONE, DIDN'T KNOW HOW SHE GOT BLOODY NOSE. PATIENT RECALLED SHE TRIED TO GET UP FROM CHAIR TO VOMIT AFTER SHE GOT THE PCV 20 VACCINE AND ACKNOWLEDGED SHE DIDN'T KNOW HOW SHE ENDED UP ON THE FLOOR. SYMPTOMS: NAUSEA,VOMITING,FAINT,BLOODY NOSE,APPEARED PALE. VASOVAGAL SYNCOPE AFTER IMMUNIZATION REPORT WILL BE MADE ANXIETY MOST LIKELY TRIGGERED HER TO HAVE TACHYCARDIA, WHICH MAY HAVE LEAD TO LOW BLOOD PRESSURE, WHICH WAS MADE WORSE BY DEHYDRATION (POOR PO INTAKE PRIOR TO VISIT) OR HYPERVENTILATION DURING THE ANXIETY EPISODE. I RECOMMENDED 911 TO BE CALLED EARLY DURING VISIT AND PT DECLINED (AMA FORM WAS SIGNED). SHE REMAINED IN CLINIC FOR A TOTAL OF 2 HRS AND FELT BETTER AFTER ORAL HYDRATION. HER BP IMPROVED AND LOOKED BETTER. SHE PREFERRED TO GO HOME AND HER MOM AGREED TO TAKE HER HOME TO CONT W/ ORAL HYDRATION W/ PEDIALYTE / GATORADE OR SIMILAR FLUIDS. STRICT ED PRECAUTIONS REVIEWED.
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| 2835665 | 72 | F | MA | 04/10/2025 |
COVID19 |
MODERNA |
010A21A |
Giant cell arteritis, Influenza like illness, Pain in extremity, Rheumatoid arth...
Giant cell arteritis, Influenza like illness, Pain in extremity, Rheumatoid arthritis
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Feeling flu sickness and sore arm, recoved. Rheumatoid arthritis and giant cell arteritis, ongoing
Feeling flu sickness and sore arm, recoved. Rheumatoid arthritis and giant cell arteritis, ongoing
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β | β | β | |||
| 2835666 | 10 | F | 04/10/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
|
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
More
|
Vaccine administered had beyond use date of 11/7/24, but was administered 11/9/24. Parent was conta...
Vaccine administered had beyond use date of 11/7/24, but was administered 11/9/24. Parent was contacted when this was discovered. No adverse effects reported.
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| 2835667 | 62 | F | 04/10/2025 |
HEPAB HEPAB PNC21 PNC21 RSV RSV TDAP TDAP VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Chills, Dizziness, Eye pain, Pain, Pyrexia; Vomiting; Chills, Dizziness, Eye pai...
Chills, Dizziness, Eye pain, Pain, Pyrexia; Vomiting; Chills, Dizziness, Eye pain, Pain, Pyrexia; Vomiting; Chills, Dizziness, Eye pain, Pain, Pyrexia; Vomiting; Chills, Dizziness, Eye pain, Pain, Pyrexia; Vomiting; Chills, Dizziness, Eye pain, Pain, Pyrexia; Vomiting
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Patient received twinrix, shingrix, adacel, capvaxive and arexvy on 4/9/25 and started experiencing ...
Patient received twinrix, shingrix, adacel, capvaxive and arexvy on 4/9/25 and started experiencing symptoms about 20 minutes after leaving the pharmacy which included body aches and pains, eye pain, chills, fever, vomiting and dizziness. Patient tried Tylenol and Ginger ale and saw no relief so she was advised to go to the ER.
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| 2835668 | 20 | F | OR | 04/10/2025 |
COVID19 |
MODERNA |
B0005 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine ...
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
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| 2835669 | 9 | M | 04/10/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
|
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
More
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Vaccine administered had beyond use date of 11/7/24, but was administered 11/9/24. Parent was conta...
Vaccine administered had beyond use date of 11/7/24, but was administered 11/9/24. Parent was contacted when this was discovered. No adverse effects reported.
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| 2835670 | 76 | M | MA | 04/10/2025 |
COVID19 |
MODERNA |
010A21A |
Dementia Alzheimer's type, Fall, Mobility decreased
Dementia Alzheimer's type, Fall, Mobility decreased
|
Movement problems, frequent falls, Alzheimer disease on going
Movement problems, frequent falls, Alzheimer disease on going
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| 2835671 | 68 | F | AL | 04/10/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Extra dose administered
Extra dose administered
|
Patient was given one dose of pneumo shot on 4/3 and given another shot on 4/10.
Patient was given one dose of pneumo shot on 4/3 and given another shot on 4/10.
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| 2835672 | 26 | M | OR | 04/10/2025 |
COVID19 |
MODERNA |
B0005 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine ...
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
More
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||||||
| 2835673 | 41 | M | OR | 04/10/2025 |
COVID19 FLU3 TDAP |
MODERNA SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
B0005 391417 3RE73 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
More
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No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine ...
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
More
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||||||
| 2835674 | 4 | M | AZ | 04/10/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
RT9142 FT9142 |
Aphasia, Autism spectrum disorder, Depressed level of consciousness, Foaming at ...
Aphasia, Autism spectrum disorder, Depressed level of consciousness, Foaming at mouth, Magnetic resonance imaging head normal; Aphasia, Autism spectrum disorder, Depressed level of consciousness, Foaming at mouth, Magnetic resonance imaging head normal
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Foaming at the mouth, difficult to arouse lasting minutes. EMS called. Told did not need to go to ...
Foaming at the mouth, difficult to arouse lasting minutes. EMS called. Told did not need to go to the hospital as was recovering during time of their eval. Within 2 weeks of the event described, he lost the ability to speak. He was previous speaking in sentences, describing sea animals and saying his ABC's. 2 weeks after the event, he stopped talking. He has been diagnosed with autism and no longer has any words.
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β | |||||
| 2835675 | 34 | F | TX | 04/10/2025 |
VARCEL |
MERCK & CO. INC. |
Y011020 |
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
|
PATIENT HAD SWELLING, REDNESS AND ITCHING IN AREA ON BACKSIDE OF RIGHT ARM WHERE VARIVAX VACCINE WA...
PATIENT HAD SWELLING, REDNESS AND ITCHING IN AREA ON BACKSIDE OF RIGHT ARM WHERE VARIVAX VACCINE WAS ADMINISTERED SUBCUTANEOUSLY. NO SWELLING, REDNESS OR PAIN IN AREA WHERE OTHER IM INJECTIONS WERE GIVEN IN SAME ARM. ADVISED PATIENT TO APPLY COLD COMPRESS/ICE TO AREA 2-3 TIMES PER DAY FOR THE NEXT SEVERAL DAYS, ALERT PHARMACY OF ANY WORSENING OF SYMPTOMS OR FEVER AS IT MAY BE A SIGN OF CELLULITIS. ADVISED SYMPTOMS SHOULD RESOLVE AFTER A FEW DAYS OR UP TO A WEEK
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| 2835676 | 86 | M | OR | 04/10/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
5H777 5H777 |
Atrial fibrillation, Chest X-ray normal, Dyspnoea, Electrocardiogram abnormal, F...
Atrial fibrillation, Chest X-ray normal, Dyspnoea, Electrocardiogram abnormal, Fibrin D dimer normal; Full blood count, Respiratory viral panel, Troponin normal
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The day after receiving the vaccine, patient presented to local Emergency Department with chief comp...
The day after receiving the vaccine, patient presented to local Emergency Department with chief complaint of shortness of breath. He reports that he went to go for a walk that afternoon with his walker. He normally is able to walk about 1/4 mile but was only able to make it about 10 feet before he got very short of breath. Denied recent fever, chills, abdominal pain, chest pain, or other complaints. Patient was treated with acetaminophen while in the ED.
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| 2835677 | 65 | F | OH | 04/10/2025 |
MMR |
MERCK & CO. INC. |
Y014094 |
Blood test, Full blood count, Malaise, Pyrexia
Blood test, Full blood count, Malaise, Pyrexia
|
PATIENT STATED THAT NOT LONG AFTER RECEIVING THE LIVE MMRII VACCINE THAT HE DEVELOPED MALAISE AND A ...
PATIENT STATED THAT NOT LONG AFTER RECEIVING THE LIVE MMRII VACCINE THAT HE DEVELOPED MALAISE AND A LOW GRADE FEVER. THE LOW GRADE FEVER HAS NOT SUBSIDED AS OF 4/10/25 EVEN WITH USING ACETAMINOPHEN OTC. PHYSICIAN IS AWARE AND IS DOING ONGOING BLOODWORK TO RULE OUT VACCINE INVOLVEMENT OR OTHER HEALTH CONDITIONS.
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| 2835678 | 78 | F | CA | 04/10/2025 |
RSV VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LN5482 93KK4 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
More
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Abrysvo given 4/8/2025 should not have been given as patient already had this vaccine on 1/29/2025. ...
Abrysvo given 4/8/2025 should not have been given as patient already had this vaccine on 1/29/2025. Patient reports no ill effects.
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| 2835679 | 38 | M | OR | 04/10/2025 |
COVID19 HEP TDAP |
MODERNA DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
B0005 945661 3RE73 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
More
|
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine ...
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
More
|
||||||
| 2835680 | 82 | F | MI | 04/10/2025 |
PNC20 |
PFIZER\WYETH |
LK6655 |
Dizziness, Injection site erythema, Injection site pruritus, Injection site warm...
Dizziness, Injection site erythema, Injection site pruritus, Injection site warmth
More
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The patient stated that after she got home from receiving the Prevnar vaccine, her arm was hot, itch...
The patient stated that after she got home from receiving the Prevnar vaccine, her arm was hot, itchy and red at the inject site. She also stated that she was dizzy. She did not mention it to the pharmacy until she came to pick up her prescriptions on 4/10/25.
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| 2835681 | 59 | M | OR | 04/10/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
B0005 391417 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
|
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine r...
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
More
|
||||||
| 2835682 | 67 | M | OR | 04/10/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
B0005 UT8454CA |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
|
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine ...
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
More
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||||||
| 2835683 | 56 | F | NC | 04/10/2025 |
PNC21 |
MERCK & CO. INC. |
|
Pyrexia
Pyrexia
|
102 fever
102 fever
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| 2835684 | 61 | F | OR | 04/10/2025 |
COVID19 FLU3 HEPA TDAP |
MODERNA SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
B0005 4T93R 3RE73 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
More
|
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine ...
No adverse event reported. Reporting this VAERS per Moderna after a temperature excursion, vaccine remained viable after the excursion per Moderna.
More
|
||||||
| 2835685 | 19 | M | TX | 04/10/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945657 |
Heart rate increased, Nausea
Heart rate increased, Nausea
|
Employee reported to be symptomatic at 1900 with symptoms of increase heart rate (105BPM) and nause...
Employee reported to be symptomatic at 1900 with symptoms of increase heart rate (105BPM) and nausea. No treatment due to symptoms decreasing after sitting and drinking water. Symptoms resolved at 1942.
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||||||
| 2835686 | 78 | F | NV | 04/10/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
P24D3 |
Pruritus
Pruritus
|
PATIENT CAME TO PHARMACY TODAY (4/10/25) TO REPORT TO PHARMACIST SHE HAD A REACTION TO AREXVY THAT S...
PATIENT CAME TO PHARMACY TODAY (4/10/25) TO REPORT TO PHARMACIST SHE HAD A REACTION TO AREXVY THAT SHE RECEIVED ON 2/11/25. STATED SHE GOT REALLY ITCHY AFTER RECEIVING THE VACCINE AND SAW HER DOCTOR. DOCTOR RECOMMENDED OVER THE COUNTER REMEDIES AND PATIENT WAS ASKING IF SHE WOULD HAVE TO CONTINUE TO TAKE THESE FOR LIFETIME. SHE REPORTS IT HAS GOTTEN BETTER BUT SHE DOES NOT WANT TO CONTINUE TO TAKE MEDICATIONS.
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| 2835687 | 77 | F | FL | 04/10/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Abscess drainage, Abscess limb, Erythema, Peripheral swelling
Abscess drainage, Abscess limb, Erythema, Peripheral swelling
|
Patient stated that it began with swelling and redness on her left arm after the vaccination. She ke...
Patient stated that it began with swelling and redness on her left arm after the vaccination. She kept an eye on it and as it got redder and did not heal I advised the patient to go the the doctor to have it checked out. Upon seeing a doctor she was given antibiotics and she reported that it eventually abcessed and had to be drained. That information was given to me today, 4/10/2025.
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||||||
| 2835688 | 78 | F | CA | 04/10/2025 |
COVID19 |
MODERNA |
3044069 |
Chest X-ray abnormal, Cough, Pneumonia, Rash, Wheezing
Chest X-ray abnormal, Cough, Pneumonia, Rash, Wheezing
|
Resident developed rash, wheezing, cough, and CXR (+) for PNA
Resident developed rash, wheezing, cough, and CXR (+) for PNA
|
||||||
| 2835689 | 1.42 | F | OR | 04/10/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5H95B |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
None stated.
None stated.
|
||||||
| 2835690 | 75 | M | CA | 04/10/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
y019157 y019157 |
Chills, Erythema, Feeling hot, Pruritus, Pyrexia; Swelling
Chills, Erythema, Feeling hot, Pruritus, Pyrexia; Swelling
|
Pt received IMZ and developed local redness, swelling, itching, and heat starting day of vaccine. A...
Pt received IMZ and developed local redness, swelling, itching, and heat starting day of vaccine. Also developed fever and shivering. Pt states that as of today (5 days after receiving IMZ), fever and shivering is gone. Local symptoms are slowly improving. Denies any other symptoms.
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| 2835700 | 1 | M | MI | 04/10/2025 |
VARCEL |
MERCK & CO. INC. |
|
Device connection issue
Device connection issue
|
Caller stated a patient was stuck twice while vaccinating with VARVAX; No adverse side effects were ...
Caller stated a patient was stuck twice while vaccinating with VARVAX; No adverse side effects were reported; leaky diluent syringes; YES, DURING ADMINISTRSTION- BECAUSE THE NEEDLE WAS NOT ATTACHING TO THE LUER LOCK CORRECTLY.; LUER LOCK SEEMS LIKE IT WON'T GET A TIGHT FIT, WHEN YOU GET TOO TIGHT IT KIND OF PULLS SIDEWAYS o Is there difficulty attaching the Syringe Needle to the Syringe? YES- BUT NOT SECURLEY; YES, DURING ADMINISTRSTION- BECAUSE THE NEEDLE WAS NOT ATTACHING TO THE LUER LOCK CORRECTLY.; This spontaneous report was received from a nurse via field base employee (FBE) and refers to a 1-year-old male patient. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. The reporter stated that she had a complaint regarding sterile diluent (BAXTER STERILE DILUENT) solution for injection, as "leaky diluent syringes" were reported by several nurses at the health department", she also stated that luer lock seemed like it wouldn't get a tight fit, when they got it too tight it kind of pulled sideways, they could attach the needle to the syringe but not securely, so leaking occurred while attaching the needle to the syringe. The reporter informed that this occurred with 3 syringes from the same lot#1973253 (expiration date: 22-Feb-2026), but came from different boxes. Then on an unspecified date a patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), solution for injection as prophylaxis (dose, route of administration, lot # and expiration date were not reported) reconstituted with one of these sterile diluent (BAXTER STERILE DILUENT) syringes, and stated that the patient was stuck twice while being vaccinated, but no adverse side effects were reported. The reporter stated that the syringe leaked during this administration since the needle was not attaching to the luer lock correctly. Caller did say it happened more than once with this lot (not clarified). Only one of the involved syringes could be returned. Lot # is being requested and will be submitted if received.
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| 2835702 | F | 04/10/2025 |
COVID19 |
MODERNA |
|
Multiple sclerosis relapse, Therapeutic response unexpected
Multiple sclerosis relapse, Therapeutic response unexpected
|
I found myself in a flare; Moderna COVID vaccine to have seemingly reversed my MS; This spontaneous ...
I found myself in a flare; Moderna COVID vaccine to have seemingly reversed my MS; This spontaneous case was reported by a patient and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (I found myself in a flare) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bedridden (she was placed on Ocrevus. That medication had her bedridden until it was out of her body). Previously administered products included for Relapsing-remitting multiple sclerosis: Tecfidera in 2016, Gilenya in 2019, Tysabri and Ocrevus. Past adverse reactions to the above products included No adverse effect with Gilenya, Ocrevus, Tecfidera and Tysabri. Concurrent medical conditions included Relapsing-remitting multiple sclerosis (RRMS) since 2016. Concomitant products included Teriflunomide (Aubagio) for Relapsing-remitting multiple sclerosis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In September 2022, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Moderna COVID vaccine to have seemingly reversed my MS). On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (I found myself in a flare) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (I found myself in a flare) and THERAPEUTIC RESPONSE UNEXPECTED (Moderna COVID vaccine to have seemingly reversed my MS) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. It was reported that patient was diagnosed in 2016 with RRMS and was immediately placed on Concomitant medication of Tecfidera. Due to progression of the disease (new lesions) patient was placed on Concomitant medication of Ocrevus. That medication had caused bedridden to patient until Concomitant medication Ocrevus was out of her body. After that, patient was placed on Concomitant medication of Tysabri. Concomitant medication Tysabri was worked for a year or so before new lesions were found for patient. In 2019 patient changed her doctors for the symptom. New doctor first put her on Concomitant medication of Gilenya but eventually patient was put on Concomitant medication of Aubagio and that was the last treatment she was received. Since then, she was on Concomitant medication of Aubagio for a couple of years. It was reported that patient needed a rollator or wheelchair for mobility. It was reported that patient watched deterioration of her body, and she had decided to accept her fate. After the required 4th round of the vaccine (4 doses as medically required); patient went on the cruise in July of 2022 and while she was wheelchair bound, and she had a great time. In September-2022, she began noticed that her legs felt stronger, and her balance was better. Hence patient was decided to try to take steps out of her wheelchair and she used rollator. Then She realized that she did not need her rollator. It was reported that Patient received Moderna vaccine every year since 2022 for three years. And patient condition was improved, and patient never looked back. It was also reported that the numbness in her feet went away, many of the symptoms she lived with since 2016 were either gone or diminished. However, in winter (2025) patient found a flare herself. Hence patient purchased a cane because of the spasticity, and she felt electric shock in her left leg. Patient was realized about a week into her flare that she had not had her vaccine yet. This case was linked to MOD-2025-784198 (Patient Link).; Reporter's Comments: PatientοΏ½s medical history of Relapsing-remitting multiple sclerosis remains as a risk factor for the event Multiple sclerosis flare. The benefit-risk relationship of product is not affected by this report.
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| 2835703 | F | CO | 04/10/2025 |
PNC21 |
MERCK & CO. INC. |
|
Upper respiratory tract infection
Upper respiratory tract infection
|
Upper Respiratory Infection; This spontaneous report was received from a physician assistant via com...
Upper Respiratory Infection; This spontaneous report was received from a physician assistant via company representative regarding to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 15-JAN-2025, the patient was vaccinated with pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) via intramuscular, (strength, dose, frequency, anatomical injection site, lot number and expiration date were not reported), for the treatment of immunization/prevention of pneumonia caused by strep pneumoniae. On 18-FEB-2025, the patient experienced upper respiratory infection. At the reporting time, the patient had not recovered from the event. The reporter considered the event to be related to pneumococcal 21-valent conjugate vaccine (CAPVAXIVE). Lot # is being requested and will be submitted if received.
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| 2835707 | 66 | M | MD | 04/10/2025 |
FLUX FLUX FLUX VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Computerised tomogram thorax normal, Contusion, Gait disturbance, Joint swelling...
Computerised tomogram thorax normal, Contusion, Gait disturbance, Joint swelling, Magnetic resonance imaging abnormal; Meniscus injury, Oxygen saturation decreased, Peripheral swelling, Platelet count increased, Ultrasound scan abnormal; Vascular test, X-ray; Computerised tomogram thorax normal, Contusion, Gait disturbance, Joint swelling, Magnetic resonance imaging abnormal; Meniscus injury, Oxygen saturation decreased, Peripheral swelling, Platelet count increased, Ultrasound scan abnormal; Vascular test, X-ray
More
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12/27/24 ORTHOPEDIC DR and XRAY -right knee swollen and bruised 12/30/24 MRI 1/03/25 MRI reviewed. T...
12/27/24 ORTHOPEDIC DR and XRAY -right knee swollen and bruised 12/30/24 MRI 1/03/25 MRI reviewed. Thigh and lower leg now swollen and bruised. ORTHOPEDIC DR Instructed me to go to hospital emergency. 1/04/25 ER - Ultrasound. Difficulty walking. Severe leg pain. Knee and leg continue to swell. 1/07/25 PRIMARY CARE PHYSICIAN exam. Oxygen low, back to ER 1/07/25 ER - Cat Scan lungs. Lungs clear. 1/13/25 different ORTHOPEDIC DR - more x-rays. Surgery scheduled for torn meniscus. 1/14/25 VASCULAR TEST completed 1/14/25 PRIMARY CARE DR for pre-op exam -In office blood draw. High platelets. Surgery not recommended 1/15/25 ORTHOPEDIC DR - reviewed blood results. Surgery cancelled. 1/21/25 HEMATOLOGIST DR - blood draw 1/22/25 HEMATOL DR - another blood draw 1/30/25 HEMATOLOGIST DR - follow up blood. Leg swelling and bruising diminishing. No explanation offered. 02/03/25 ORTHOPEDIC DR switch. Review MRI from 12/30. No surgery needed 03/03/25 ENDOCRINOLOGIST no new abnormalities in thyroid condition 3/13/25 - LAB - blood draw 3/27/25 - HEMATOLOGIST blood review. Platelets getting back to normal. No explanation offered.
More
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| 2835708 | 0.5 | M | WA | 04/10/2025 |
DTPPVHBHPB MENB PNC20 RV5 |
MSP VACCINE COMPANY NOVARTIS VACCINES AND DIAGNOSTICS PFIZER\WYETH MERCK & CO. INC. |
U7801BA ZK9P4 LG5574 2037483 |
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; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
More
|
Healthy 6mo male presenting for WCC & vaccines. Bexsero was ordered in error and administered al...
Healthy 6mo male presenting for WCC & vaccines. Bexsero was ordered in error and administered along with other vaccines. No side effects or bad outcomes.
More
|
||||||
| 2835709 | 3 | M | NY | 04/10/2025 |
MMR |
MERCK & CO. INC. |
Y003499 |
Rash
Rash
|
Rash.
Rash.
|
β | |||||
| 2835727 | 11 | M | GA | 04/10/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8256AB U8115AA |
Injection site discharge, Injection site erythema, Injection site swelling; Inje...
Injection site discharge, Injection site erythema, Injection site swelling; Injection site discharge, Injection site erythema, Injection site swelling
More
|
Swelling and redness at injection site. Site oozing - antibiotic given for treatment Cephalexin 750 ...
Swelling and redness at injection site. Site oozing - antibiotic given for treatment Cephalexin 750 mg 1 capsule twice a day for 7 days
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| 2065665 | F | KY | 04/09/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Death, Lymphadenopathy, Renal failure; Blood urine present, Endoscopy upper gast...
Death, Lymphadenopathy, Renal failure; Blood urine present, Endoscopy upper gastrointestinal tract, Gastric cancer, Lymphadenopathy, Malaise; Renal disorder, Sudden death, Tumour lysis syndrome
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kidney failure; lymphadenopathy; death; This is a spontaneous report received from a Consumer or oth...
kidney failure; lymphadenopathy; death; This is a spontaneous report received from a Consumer or other non HCP. A 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: DEATH (death, medically significant) with onset 26May2021, outcome "fatal"; RENAL FAILURE (medically significant), outcome "unknown", described as "kidney failure"; LYMPHADENOPATHY (non-serious), outcome "unknown". The patient date of death was 26May2021. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: As reported, her death resulted from complications of the Pfizer COVID-19 vaccine, which caused lymphadenopathy leading to kidney failure due to medical negligence. Claimed she had cancer without evidence and misrepresented her death as cancer related. The vaccine caused continuous replication of spike proteins in her bone marrow, leading to lymphadenopathy that mimicked cancer. Her kidneys were overwhelmed due to medical neglect, further worsening her condition withheld repeatedly pressured me to sign a Do Not Resuscitate (DNR) order, despite my mother's explicit wishes for 13 years to be resuscitated, which she also verbally confirmed to withheld staff. This pressure for resuscitation was intensified for me and my mother after we witnessed the wrongful deaths of her mother, withheld at withheld due to DNR and the death of my dad, withheld, who I watched suffer under similar DNR circumstances. As my dad was coerced into a DNR by withheld and withheld who is an end-of-life nurse. withheld took him the day he was released from the hospital while suffering from confusion to sign his DNR, later suffocating to death in front of me and his granddaughter withheld as the DNR ensured his head turned blue from lack of oxygen to his brain. This case involves violations of due process, medical malpractice, and wrongful death, with withheld and its staff engaging in fraudulent medical practices, coercion, and obstruction of justice to conceal the true cause of my mother's death which was the Pfizer Covid-19 shot she received in 2021 before she left for vacation in March 2021 and her surprising death on 26May2021. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: unknown cause of death
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