| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2848937 | 18 | F | VA | 07/08/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMB064A |
Product preparation issue
Product preparation issue
|
Only diluent administered; Only diluent administered; This non-serious case was reported by a pharma...
Only diluent administered; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMB064A, expiry date 31-DEC-2025) for prophylaxis. On 03-JUL-2025, the patient received Menveo. On 03-JUL-2025, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 03-JUL-2025 On 3rd July 2025, a pharmacist called to report that an 18-year-old patient had received only the diluent component of Menveo earlier that day (date of reporting), which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The pharmacist stated, he/she had not mixed it beforehand. They also mentioned that the dose would be readministered later that same day just to be safe.
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| 2848938 | F | CO | 07/08/2025 |
COVID19 |
MODERNA |
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COVID-19, Chronic obstructive pulmonary disease
COVID-19, Chronic obstructive pulmonary disease
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currently has COVID-19; also has COPD; This spontaneous case was reported by a consumer and describe...
currently has COVID-19; also has COPD; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (currently has COVID-19) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (also has COPD) in a female patient of an unknown age 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 COVID-19 (currently has COVID-19) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (also has COPD). At the time of the report, COVID-19 (currently has COVID-19) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (also has COPD) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. Patient currently had COVID-19 and also COPD. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787946 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787946:Patient 1 (Master case)
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| 2848939 | NC | 07/08/2025 |
PNC20 |
PFIZER\WYETH |
LN4929 |
Device breakage, Device leakage
Device breakage, Device leakage
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Cap and like the little piece that you put the needle on, it come completely off and the medication ...
Cap and like the little piece that you put the needle on, it come completely off and the medication leaked out; Cap and like the little piece that you put the needle on, it come completely off and the medication leaked out; The initial case was missing the following minimum criteria: This case has been considered invalid as Info not qualifying for AE reporting - Product Complaint: no indication that the consumer experienced an event under Product Prevnar 20. Upon receipt of follow-up information, this case now contains all required information to be considered valid. This is a spontaneous report received from a Nurse from product quality group. No patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown (Lot number: LN4929, Expiration Date: Jul2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), DEVICE LEAKAGE (non-serious), outcome "unknown" and all described as "Cap and like the little piece that you put the needle on, it come completely off and the medication leaked out". The reporter considered "cap and like the little piece that you put the needle on, it come completely off and the medication leaked out" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "cap and like the little piece that you put the needle on, it come completely off and the medication leaked out" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: NDC Number: 0005200001. While taking the cap off, unscrewing the cap, the cap and like the little piece that you put the needle on, it come completely off and the medication leaked out. It was like the top of the glass vial broke in half. Packaging was sealed and intact. Follow-up (26Jun2025): This is a spontaneous follow-up report received from product quality group. Updated information: device reportability assessment; case has been considered valid.
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| 2848940 | 74 | M | CA | 07/08/2025 |
PNC20 |
PFIZER\WYETH |
LN4930 |
Cellulitis, Injection site pain
Cellulitis, Injection site pain
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Cellulitis in the elbow; Severe pain upon administration of Prevnar 20; This is a spontaneous report...
Cellulitis in the elbow; Severe pain upon administration of Prevnar 20; This is a spontaneous report received from a Nurse. A 74-year-old male patient received pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (PREVNAR 20), on 24Jun2025 as dose number unknown, single (Lot number: LN4930, Expiration Date: 24Jul2026) at the age of 74 years intramuscular, in left deltoid for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CELLULITIS (non-serious), outcome "unknown", described as "Cellulitis in the elbow"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Severe pain upon administration of Prevnar 20". The events "cellulitis in the elbow" and "severe pain upon administration of prevnar 20" required physician office visit. Additional information: The reporting nurse stated, "I am calling because we have had 3 patients complaint of severe pain upon administration of Prevnar 20. Two of which have seen the doctor for cellulitis and cellulitis in the elbow. They both have been assessed by the doctor." Causality was reported as "Yes". Causality for "cellulitis in the elbow" and "severe pain upon administration of prevnar 20" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (dipht CRM197 protein) (malfunction).
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| 2848941 | 74 | F | MD | 07/08/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Investigation, Magnetic resonance imaging, Transient ischaemic attack
Investigation, Magnetic resonance imaging, Transient ischaemic attack
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TIA; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female p...
TIA; This is a spontaneous report received from a Consumer or other non HCP. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 28May2025 as dose 1, single (Lot number: MD3414) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic", start date: 2006 (ongoing), notes: Diabetic, Stated that she was diagnosed around 2006 or somewhere around there.; "Hypertension" (ongoing), notes: Hypertension. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (Primary immunization series completed,, Manufacturer: Pfizer , Dose number in series: Dose 1, Vaccination batch/lot number: FH8028, Location of injection/shot: Believes in was the Left Arm, First Hospitalization was 12Dec2021 and was discharged on 13Dec2021.), administration date: 11Dec2021, for Covid-19 Immunization, reaction(s): "TIA". The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization) with onset 02Jun2025, outcome "recovering", described as "TIA". The patient was hospitalized for transient ischaemic attack (start date: 02Jun2025, discharge date: 04Jun2025, hospitalization duration: 3 day(s)). The patient underwent the following laboratory tests and procedures: lot of testing: showed the TIA,but there was no damage toher brain, notes: Did a lot of testing and MRI's and a whole lot of other tests. The tests that she had showed the TIA, but there was no damage to her brain; Magnetic resonance imaging: showed the TIA,but there was no damage toher brain.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500135136 same patient/event, different vaccine dose;
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✓ | |||||
| 2848942 | F | MO | 07/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Inappropriate schedule of product administration, Multiple sclerosis
Inappropriate schedule of product administration, Multiple sclerosis
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Dose 1: Oct2020, Dose 2: Apr2021; slurred speech and eye issues/eventually diagnosed as Multiple Scl...
Dose 1: Oct2020, Dose 2: Apr2021; slurred speech and eye issues/eventually diagnosed as Multiple Sclerosis; This is a spontaneous report received from a Consumer or other non HCP. An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient has known allergies. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Oct2020, for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (disability, medically significant) with onset Apr2021, outcome "not recovered", described as "slurred speech and eye issues/eventually diagnosed as Multiple Sclerosis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose 1: Oct2020, Dose 2: Apr2021". It was unknown if therapeutic measures were taken as a result of multiple sclerosis. Clinical course: After the 2nd Covid shot, the patient began having a slurred speech and eye issues. This was eventually diagnosed as Multiple Sclerosis. The event Multiple Sclerosis resulted to disability or permanent damage. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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✓ | ||||||
| 2848943 | M | 07/08/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I had covid once before; I had covid once before; This is a spontaneous report received from a Consu...
I had covid once before; I had covid once before; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. An 81-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 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: COMIRNATY OMICRON XBB.1.5 (Dose 1, single, lot number unknown), administration date: Mar2024, for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had covid once before". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2848945 | 07/08/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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died; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient...
died; 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. The following information was reported: DEATH (death), 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. Clinical course: 3 of reporter's good friends died, after getting the so called mRNA covid shot (Covid vaccine). 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-PV202500081194 same product/event, different patient; US-PFIZER INC-PV202500081195 same product/event, different patient;; Reported Cause(s) of Death: died
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✓ | ||||||||
| 2848946 | 07/08/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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died; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient...
died; 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. The following information was reported: DEATH (death), 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. Clinical course: 3 of reporter's good friends died, after getting the so called mRNA covid shot (Covid vaccine). 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-PV202500081193 same product/event, different patient;US-PFIZER INC-PV202500081195 same product/event, different patient;; Reported Cause(s) of Death: died
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✓ | ||||||||
| 2848947 | F | 07/08/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Epistaxis
Epistaxis
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severe and persistent nosebleeds; This is a spontaneous report received from a Consumer or other non...
severe and persistent nosebleeds; This is a spontaneous report received from a Consumer or other non HCP, Program ID. 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. The following information was reported: EPISTAXIS (medically significant), outcome "unknown", described as "severe and persistent nosebleeds". Additional information: The patient reported experiencing severe and persistent nosebleeds after receiving a Pfizer COVID-19 vaccine. The patient inquired about related studies and side effects. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2848948 | 1.25 | WA | 07/08/2025 |
HIBV |
SANOFI PASTEUR |
UK328AA |
Product preparation error
Product preparation error
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administered ACTHIB with the wrong diluent to a patient, with no reported adverse event; Initial inf...
administered ACTHIB with the wrong diluent to a patient, with no reported adverse event; Initial information received on 07-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] with the wrong diluent, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Immunization. On 30-Jun-2025, the patient received 0.5 ml of HIB (PRP/T) vaccine Powder and solvent for solution for injection with standard strength (expiry date- 31-May-2026 and lot UK328AA) once via unknown route in unknown administration site for Immunization, with the wrong diluent with no reported adverse event (product preparation error) (latency- same day). Reportedly, they said that they did not observe any adverse reactions afterwards. They wanted to know what the possible effects would be on the patient. 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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| 2848954 | 1 | M | AK | 07/08/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5H95B |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient received a dose of Kinrix out of the recommended age/ patient is less than 4 years old; This...
Patient received a dose of Kinrix out of the recommended age/ patient is less than 4 years old; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis. On 08-AUG-2024, the patient received Kinrix. On 08-AUG-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix out of the recommended age/ patient is less than 4 years old). The outcome of the inappropriate age at vaccine administration was not applicable. 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: 18-JUN-2025 The RN (registered nurse) called to report that they administered a dose of Kinrix to 6 different patients under the age of 4 years old, which led to an inappropriate age at vaccine administration. The reporter wanted to know did they need to continue with the same schedule as recommended in the PI (package insert). This was 1 of 6 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2025076584:Same reporter/Diffrent patient US-GSK-US2025076587:Same reporter/Diffrent patient US-GSK-US2025076583:Same reporter/Diffrent patient US-GSK-US2025076592:Same reporter/Diffrent patient US-GSK-US2025076595:Same reporter/Diffrent patient
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| 2848955 | 20 | F | 07/08/2025 |
HEPA |
MERCK & CO. INC. |
Y013274 |
Underdose
Underdose
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Administered pediatric/adolescent vaccine (0.5 mL), FDA approved for up to age 18, to a 20 year-old ...
Administered pediatric/adolescent vaccine (0.5 mL), FDA approved for up to age 18, to a 20 year-old patient who requires an adult dose (1 mL) in single IM injection.
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| 2848956 | 17 | F | 07/08/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
52N4S 343DD |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Administered an extra dose of Bexsero, not knowing second dose was completed already in previous yea...
Administered an extra dose of Bexsero, not knowing second dose was completed already in previous year.
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| 2848957 | 70 | M | AZ | 07/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
E754F |
Erythema, Herpes zoster, Mass, Pruritus
Erythema, Herpes zoster, Mass, Pruritus
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Patient presented to clinic for evaluation of spider bite (painful itchy spot on back). Zoster vacc...
Patient presented to clinic for evaluation of spider bite (painful itchy spot on back). Zoster vaccine administered. Small red bumps noted on back but also on abdomen. Provider diagnosed patient with active shingles at that visit.
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| 2848969 | 1 | M | ME | 07/08/2025 |
PNC20 VARCEL |
PFIZER\WYETH MERCK & CO. INC. |
LG5578 Y011018 |
Pyrexia, Urticaria; Pyrexia, Urticaria
Pyrexia, Urticaria; Pyrexia, Urticaria
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Urticaria all over. Fever 100-101.5F Benadryl given. Claritin given. Fever lasted x24 hours. Urticar...
Urticaria all over. Fever 100-101.5F Benadryl given. Claritin given. Fever lasted x24 hours. Urticaria abated in 2 days.
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| 2848970 | 25 | F | AL | 07/08/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
MZ474 |
Underdose
Underdose
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Incorrect dose administered. Patient received a pediatric dose instead of adult dose.
Incorrect dose administered. Patient received a pediatric dose instead of adult dose.
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| 2848971 | 30 | F | NJ | 07/08/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Blood test, Burning sensation, Chest X-ray, Chest pain
Blood test, Burning sensation, Chest X-ray, Chest pain
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Burning feeling in arms, legs, head, neck, chest
Burning feeling in arms, legs, head, neck, chest
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✓ | |||||
| 2848972 | 55 | M | WI | 07/08/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EL3248 EN5318 |
Prostate cancer, Prostatic specific antigen increased; Prostate cancer, Prostati...
Prostate cancer, Prostatic specific antigen increased; Prostate cancer, Prostatic specific antigen increased
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Prostate Cancer - Adenocarcinoma of the prostate
Prostate Cancer - Adenocarcinoma of the prostate
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✓ | |||||
| 2848973 | 18 | F | 07/08/2025 |
MNQ |
SANOFI PASTEUR |
U8438AA |
Dizziness
Dizziness
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Right after administration of vaccine, pt states she feels dizzy. She was instructed to stay in the ...
Right after administration of vaccine, pt states she feels dizzy. She was instructed to stay in the clinic, I asked her to lay down. I checked her VS and are within normal. She was monitored for approx 25-30mins, symptoms resolved on it's own. She called her parent to take her home, I did not allow her to drive in case dizziness came back. I instructed if symptoms return or more symptoms occur should go to ER.
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| 2848974 | 54 | M | TX | 07/08/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
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Arthralgia, Chills, Fatigue, Injection site erythema, Injection site warmth; Mal...
Arthralgia, Chills, Fatigue, Injection site erythema, Injection site warmth; Malaise, Pyrexia
More
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6 Hours Post Vaccination: onset chills; fever of upwards of 101 degrees for 3 days; 6 Hours Post Vac...
6 Hours Post Vaccination: onset chills; fever of upwards of 101 degrees for 3 days; 6 Hours Post Vaccination: fatigue, malaise, joint pain felt all over the body (symptoms current); 24 Hours Post Vaccination Injection Site: red and warm to touch (~5"x5") and continues to grow in size
More
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| 2848975 | 49 | F | NY | 07/08/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
324BY |
Lip swelling, Swelling face, Throat tightness
Lip swelling, Swelling face, Throat tightness
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Patient received her 3rd Twinrix shot and approximately 15 minutes later she experienced swelling of...
Patient received her 3rd Twinrix shot and approximately 15 minutes later she experienced swelling of her face and lips and tightness in her throat. She went to urgent care to be seen. She was give and antihistamine and observed for 45 minutes and then released with an rx for zyrtec 10mg once daily for 10 days
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| 2848976 | 52 | M | CA | 07/08/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Angina pectoris, Bundle branch block right, Computerised tomogram, Electrocardio...
Angina pectoris, Bundle branch block right, Computerised tomogram, Electrocardiogram abnormal, Influenza like illness; Magnetic resonance imaging heart abnormal, Myocardial fibrosis, Myopericarditis, Sinus bradycardia, Supraventricular tachycardia
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Initially felt flue like symptoms and then pain in heart area next day
Initially felt flue like symptoms and then pain in heart area next day
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| 2848977 | 67 | M | MD | 07/08/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Chills, Gait disturbance, Pain, Peripheral swelling, Swelling; Vertigo positiona...
Chills, Gait disturbance, Pain, Peripheral swelling, Swelling; Vertigo positional
More
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Post injection, nothing happened initially to at least 2AM next day, when the patient went to sleep....
Post injection, nothing happened initially to at least 2AM next day, when the patient went to sleep. Only symptom was slight swelling as expected. On wake up 8AM the patient ,(a Ph.D. neuroscientist) reported a mild horizontal vertigo that persisted for at least 6 hours. The injected left forearm was swollen but not edematous. Some body aches. Chills were experience but no temperature was taken. Fan used. The patient was basically unable to ambulate safely down stairs and went back to bed where vertigo declined. Slept 5 hours. Upon rising around 4PM 7/8/25 symptoms had declined, and patient could ambulate normally with good balance. The patient has had no previous reported history of vertigo or Menniers.
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| 2848978 | 50 | F | VA | 07/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7ZM55 |
Injected limb mobility decreased, Pain in extremity
Injected limb mobility decreased, Pain in extremity
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Patient reports pain in left arm and inability to raise arm
Patient reports pain in left arm and inability to raise arm
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| 2848979 | 31 | F | NE | 07/08/2025 |
COVID19 |
PFIZER\BIONTECH |
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Amnesia, Pain, Seizure
Amnesia, Pain, Seizure
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Seizures, memory loss, pain, years of treatments
Seizures, memory loss, pain, years of treatments
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| 2848550 | AL | 07/07/2025 |
MMRV |
MERCK & CO. INC. |
Z007214 |
No adverse event, Product storage error
No adverse event, Product storage error
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no adverse event; administered post excursion to a patient on 06/30/2025; This spontaneous report wa...
no adverse event; administered post excursion to a patient on 06/30/2025; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 18-Jun-2025, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z007214, expiration date: 05-Oct-2026) was exposed to a temperature excursion (6.8 degrees Fahrenheit [F] for 47 minutes). On 30-Jun-2025, the patient was vaccinated with the improperly stored vaccine of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Z007214, expiration date: 05-Oct-2026), 0.5 mL, administered by Health Professional as prophylaxis (route of administration not reported) (product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The patient did not experience any adverse side effects from administered dose (no adverse event).
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| 2848551 | 50 | F | 07/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site discolouration, Injection site pruritus, Injection site rash
Injection site discolouration, Injection site pruritus, Injection site rash
|
Rash around injection site, flushing and itchiness.; flushing; itchiness; This non-serious case was ...
Rash around injection site, flushing and itchiness.; flushing; itchiness; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 18-JUN-2025, the patient received the 1st dose of Shingrix (left deltoid). On 20-JUN-2025, 2 days after receiving Shingrix, the patient experienced injection site rash (Verbatim: Rash around injection site, flushing and itchiness.), flushing (Verbatim: flushing) and pruritus (Verbatim: itchiness). The outcome of the injection site rash, flushing and pruritus were not resolved. The reporter considered the injection site rash, flushing and pruritus to be related to Shingrix. The company considered the injection site rash, flushing and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 26-JUN-2025 The Medical assistant reported that a female patient received the first dose of Shingrix vaccine and experienced rash around injection site, flushing and itchiness
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| 2848552 | 74 | F | MI | 07/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Diarrhoea, Fatigue, Nausea, Retching
Diarrhoea, Fatigue, Nausea, Retching
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Nausea; Gagging; Diarrhea; Fatigue; This non-serious case was reported by a consumer via call center...
Nausea; Gagging; Diarrhea; Fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 27-MAR-2025, the patient received the 1st dose of Shingrix. On 28-MAR-2025, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), gagging (Verbatim: Gagging), diarrhea (Verbatim: Diarrhea) and fatigue (Verbatim: Fatigue). The outcome of the nausea, gagging, diarrhea and fatigue were resolved. It was unknown if the reporter considered the nausea, gagging, diarrhea and fatigue to be related to Shingrix. It was unknown if the company considered the nausea, gagging, diarrhea and fatigue to be related to Shingrix. Additional Information: GSK Receipt Date: 27-JUN-2025 This report was submitted via the online direct entry reporting system. Reporter was the patient, who received her first dose of SHINGRIX on March 27. She stated that a day later, she experienced nausea, gagging, diarrhea, and fatigue. Symptoms resolved for a day and a half.
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| 2848553 | 07/07/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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arm was still sore from the vaccine; This non-serious case was reported by a consumer via interactiv...
arm was still sore from the vaccine; 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 RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: arm was still sore from the vaccine). The outcome of the pain in arm was not resolved. It was unknown if the reporter considered the pain in arm to be related to RSV vaccine. It was unknown if the company considered the pain in arm to be related to RSV vaccine. Additional Information: GSK Receipt Date: 29-JUN-2025 This case was reported by a patient via interactive digital media. The patient arm was still sore from the vaccine that got almost a year ago.
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| 2848554 | 07/07/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Expired product administered
Expired product administered
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TDAP that was administered unfortunately it was expired; This non-serious case was reported by a con...
TDAP that was administered unfortunately it was expired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: TDAP that was administered unfortunately it was expired). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 26-JUN-2025 This case was reported by a patient via (chatbot) interactive digital media. The patient had GSK product TDAP that was administered. Unfortunately it was expired which was Expired vaccine administered.
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| 2848555 | 07/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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got first Shingrix shot 2 years ago but forgot to get 2nd shot; This non-serious case was reported b...
got first Shingrix shot 2 years ago but forgot to get 2nd shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (shot 2 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got first Shingrix shot 2 years ago but forgot to get 2nd shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 27-JUN-2025 This case was reported by a patient via (chatbot) interactive digital media. The patient got first Shingrix shot 2 years ago but forgot to get 2nd shot. 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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| 2848556 | 07/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received first shot seven years ago, but did not get the second shot; This non-serious case was repo...
received first shot seven years ago, but did not get the second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (shot seven years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received first shot seven years ago, but did not get the second shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 27-JUN-2025 This case was reported by a patient via (chatbot) interactive digital media. The patient received a Shingrix shot seven years ago, but did not get the second shot. Now his/her doctor wanted to get the second shot. 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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| 2848557 | 0.5 | M | KY | 07/07/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
GG39D |
Expired product administered
Expired product administered
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Maladministration After the Expiration Date; This non-serious case was reported by a nurse via call ...
Maladministration After the Expiration Date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis. On 25-JUN-2025, the patient received Infanrix. On 25-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Maladministration After the Expiration Date). The outcome of the expired vaccine used was not applicable. 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: 25-JUN-2025 A Registered nurse called to report that a patient had been administered an expired dose of Infanrix, which led to Expired vaccine used. and inquired whether it needed to be repeated.
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| 2848558 | WI | 07/07/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Incorrect route of product administration
Incorrect route of product administration
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possibly administered subcutaneously; This non-serious case was reported by a other health professio...
possibly administered subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. On an unknown date, the patient received Pediarix (subcutaneous). On an unknown date, an unknown time after receiving Pediarix, the patient experienced intramuscular formulation administered by other route (Verbatim: possibly administered subcutaneously). The outcome of the intramuscular formulation administered by other route was not applicable. 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: 30-JUN-2025 The clinic supervisor for a pediatric primary care clinic reported that while the medical assistant administered Pediarix was sure it was given intramuscular and the parent who worked in healthcare thought it was given subcutaneously instead, which led to intramuscular formulation administered by other route. The reporter asked was there concern if this is the case.
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| 2848559 | 54 | M | NJ | 07/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product preparation issue
Product preparation issue
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Administered Shingrix liquid without mixing the powder; Administered Shingrix liquid without mixing ...
Administered Shingrix liquid without mixing the powder; Administered Shingrix liquid without mixing the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 11-JUN-2025, the patient received Shingrix. On 11-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered Shingrix liquid without mixing the powder) and inappropriate dose of vaccine administered (Verbatim: Administered Shingrix liquid without mixing the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 01-JUL-2025 The registered nurse reported that a nurse gave Shingrix liquid without mixing the powder to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had 2 different lot numbers for Shingrix on the date of administration, and they did not know which one was administered to the patients, it could be 3J2S2 with expiration date of 27th March, 2027, or 2HJ99 with expiration date of 4th April, 2027. This case has been linked with US2025082620, by same reporter for different patient; Sender's Comments: GSK-US2025082620:Same reporter/Diffrent patient
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| 2848560 | 54 | M | NJ | 07/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product preparation issue
Product preparation issue
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Administered Shingrix liquid without mixing the powder; Administered Shingrix liquid without mixing ...
Administered Shingrix liquid without mixing the powder; Administered Shingrix liquid without mixing the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 11-JUN-2025, the patient received Shingrix. On 11-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered Shingrix liquid without mixing the powder) and inappropriate dose of vaccine administered (Verbatim: Administered Shingrix liquid without mixing the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 01-JUL-2025 The registered nurse reported that a nurse gave Shingrix liquid without mixing the powder to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had 2 different lot numbers for Shingrix on the date of administration, and they did not know which one was administered to the patients, it could be 3J2S2 with expiration date of 27th March, 2027, or 2HJ99 with expiration date of 4th April, 2027. This case has been linked with US2025082618, by same reporter for different patient; Sender's Comments: US-GSK-US2025082618:Same reporter/Diffrent patient
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| 2848561 | 5 | TX | 07/07/2025 |
DTAP TDAP |
UNKNOWN MANUFACTURER SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered
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5-year-old twins who received ADACEL instead of DTaP, with no reported adverse event; Initial inform...
5-year-old twins who received ADACEL instead of DTaP, with no reported adverse event; Initial information received on 02-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves 5 years old and unknown gender patient who received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] instead of diphtheria, tetanus and acellular pertussis vaccine 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 diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for immunization instead of diphtheria, tetanus and acellular pertussis vaccine with no reported adverse event (wrong product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. No follow-up is possible as Reporter cannot be contacted by Sanofi. Reportedly, Immunization medical director states that he was made aware of a situation where there were 5-year old twins who received ADACEL instead of DTaP. 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.; Sender's Comments: US-SA-2025SA184064:
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| 2848562 | CT | 07/07/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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No adverse event, Product preparation error
No adverse event, Product preparation error
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dtap-ipv portion of pentacel is used to reconstitute priorix with no reported adverse event; Initial...
dtap-ipv portion of pentacel is used to reconstitute priorix with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was received with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] portion of pentacel is used to reconstitute priorix 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 Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine,unknown (lot, expiry date and strength not reported) via unknown route in unknown administration site for Immunization, portion of pentacel is used to reconstitute priorix with no reported adverse event (product preparation error). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Pharmacist confirms that the DTaP-IPV portion of PENTACEL was used to reconstitute Priorix. He explains that he is surprised that this even happened, although PENTACEL and MMR are typically given together, it was still weird that this happened. when the DTaP-IPV portion of PENTACEL is used to reconstitute Priorix; advised that the DTaP-IPV portion of PENTACEL should only be used with the HIB portion of PENTACEL. 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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| 2848563 | 0.5 | F | NM | 07/07/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK167AA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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administered a pentacel and a pediarix to a 6 month old patient, when they should have administered ...
administered a pentacel and a pediarix to a 6 month old patient, when they should have administered the act hib along with the pediarix with no reported ae; Initial information received on 02-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old female patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] and pediarix when they should have administered the act hib along with the pediarix with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid(Pediarix) ,Pneumococcal vaccine conj 20v (CRM197) (Pneumococcal vaccine conj 20v (CRM197) and Rotavirus vaccine (Rotavirus vaccine) for Immunisation. On 01-Jul-2025, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, lot UK167AA,expiry date: 31-Oct-2025,strength: standard, frequency: once via intramuscular route in the left thigh for immunisation and a pediarix to a 6 month old patient, when they should have administered the act hib along with the pediarix with no reported adverse event (wrong 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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| 2848567 | 07/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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but never got the second; This non-serious case was reported by a consumer via interactive digital m...
but never got the second; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2021). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after not receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: but never got the second). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 26-JUN-2025 This case was reported by a patient via (Shingrix GRC Chatbot) interactive digital media. Patient got the first dose of Shingrix but never got the second dose. The patient wanted to know did he/she now need one more dose or did he/she need two. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
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| 2848568 | 29 | F | NY | 07/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
9237Y |
Underdose
Underdose
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Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This non...
Pediatric dose administered to adult patient; Pediatric dose administered to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 29-year-old female patient who received HBV (Engerix B pediatric) (batch number 9237Y, expiry date 27-OCT-2025) for prophylaxis. On 22-MAY-2025, the patient received Engerix B pediatric. On 22-MAY-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose administered to adult patient) and underdose (Verbatim: Pediatric dose administered to adult patient). The outcome of the adult use of a child product and underdose were not applicable. 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: 27-JUN-2025 The Licensed Practical Nurse explained that a patient was about to start her adult series of Engerix B vaccine, but instead they gave pediatric dose which led to adult use of a child product and underdose.
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| 2848569 | F | NY | 07/07/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
93N4J 93N4J |
Injection site erythema, Injection site irritation, Injection site mass, Injecti...
Injection site erythema, Injection site irritation, Injection site mass, Injection site pain, Injection site pruritus; Injection site reaction, Injection site swelling, Injection site warmth, Myosclerosis
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Muscle hardening; pretty irritated and a lump; pretty irritated and a lump; she presented a signific...
Muscle hardening; pretty irritated and a lump; pretty irritated and a lump; she presented a significant redness near the injection site; she presented a significant warmth near the injection site; she presented a significant swelling near the injection site; she presented a significant pain near the injection site; Itching in the upper left arm (injection site); Irritation at the injection site; Lump at the injection site; This serious case was reported by a pharmacist via call center representative and described the occurrence of muscle induration in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 93N4J, expiry date 25-APR-2027) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On 23-JUN-2025, the patient received the 2nd dose of Shingrix (left deltoid). In JUN-2025, less than a week after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she presented a significant redness near the injection site), injection site warmth (Verbatim: she presented a significant warmth near the injection site), injection site swelling (Verbatim: she presented a significant swelling near the injection site), injection site pain (Verbatim: she presented a significant pain near the injection site), injection site itching (Verbatim: Itching in the upper left arm (injection site)), injection site irritation (Verbatim: Irritation at the injection site) and injection site lump (Verbatim: Lump at the injection site ). On 24-JUN-2025, the patient experienced muscle induration (Verbatim: Muscle hardening) (serious criteria GSK medically significant), skin irritation (Verbatim: pretty irritated and a lump) and mass (Verbatim: pretty irritated and a lump). In JUN-2025, the outcome of the muscle induration, skin irritation and mass were resolved. The outcome of the injection site erythema, injection site warmth, injection site swelling and injection site pain were resolving and the outcome of the injection site itching, injection site irritation and injection site lump were unknown. It was unknown if the reporter considered the muscle induration, injection site erythema, injection site warmth, injection site swelling, injection site pain, injection site itching, injection site irritation, injection site lump, skin irritation and mass to be related to Shingrix. The company considered the muscle induration to be unrelated to Shingrix. It was unknown if the company considered the injection site erythema, injection site warmth, injection site swelling, injection site pain, injection site itching, injection site irritation, injection site lump, skin irritation and mass to be related to Shingrix. Additional Information: GSK Receipt Date: 27-JUN-2025 The registered pharmacist reported that a series of adverse reactions presented in a patient that received the second dose of Shingrix after that at the injection site she presented a significant warmth, redness and swelling, pain near the injection site. She improved on the day of reporting (27-JUN-2025) but had just itching in the upper (left) arm, where she received the vaccine. 1 day after vaccination, the patient had her muscle harden, pretty irritated and a lump, but now that has resolved. The vaccine administration facility was the same as primary reporter.; Sender's Comments: Myosclerosis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2848571 | 37 | F | PA | 07/07/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Antinuclear antibody positive, Antisynthetase syndrome, Electromyogram abnormal,...
Antinuclear antibody positive, Antisynthetase syndrome, Electromyogram abnormal, Interstitial lung disease, Myopathy; Pulmonary function test abnormal, Rash, Ventilation/perfusion scan
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I received two Moderna shots the initial and the booster. The first was around Jan/Feb 2021. The sec...
I received two Moderna shots the initial and the booster. The first was around Jan/Feb 2021. The second was around April 2021. Both were at different pharmacies. Had a rash and symptoms appear in Sept 2021.
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✓ | ✓ | ||||
| 2848617 | 87 | F | IA | 07/07/2025 |
COVID19 |
MODERNA |
3043332 |
Death
Death
|
Resident passed away
Resident passed away
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✓ | |||||
| 2848618 | 19 | F | CT | 07/07/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
2005455 2005455 |
Dizziness, Flushing, Hyperhidrosis, Hypotension, Syncope; Unresponsive to stimul...
Dizziness, Flushing, Hyperhidrosis, Hypotension, Syncope; Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
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| 2848619 | 70 | F | IL | 07/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55th4 |
Injection site pain, Joint injury
Injection site pain, Joint injury
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Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-,...
Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines: VaccineTypeBrand: TDap; Manufacturer: ; LotNumber: ; Route: IM; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2848620 | 54 | F | CA | 07/07/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LG5576 LG5576 |
Arthralgia, Muscle spasms, Pain, Pain in extremity, Paraesthesia; Sleep disorder...
Arthralgia, Muscle spasms, Pain, Pain in extremity, Paraesthesia; Sleep disorder, X-ray abnormal
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Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic:...
Systemic: Joint Pain-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Patient reports severe burning pain when she wakes up in the morning. Sometimes it wakes her up in the middle of the night. The pain is in her hands, palms, fingers. Fingers tend to cramp/curl up and causes her pain. She hs gotten an xray which showed it could be nerve damage or arthritis, but she states it cannot be arthritis. She has taken gabapentin but can only take it at night since it makes her drowsy. She has a hard time driving and carrying things. She is diabetic.
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| 2848621 | 76 | F | CT | 07/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55th4 |
Syncope, Unresponsive to stimuli, Vomiting
Syncope, Unresponsive to stimuli, Vomiting
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Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Medium, Additional Details: She fainted...
Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Medium, Additional Details: She fainted in the front of the store collapsing on her cart and to the floor. She was responsive to the staff and they got her a chair. She sat in the chair then vomited on the floor. I recieved a phone call from the front store after this happened and went up front to check on her. They had called an ambulance and it was arriving while I was up front. Patient was saying she didn't want to go to the doctor but we recommended she get checked out. She left with the ambulance.
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| 2848622 | 75 | F | CA | 07/07/2025 |
COVID19-2 COVID19-2 |
PFIZER\BIONTECH PFIZER\BIONTECH |
ME6072 ME6072 |
Abdominal pain, Asthenia, Confusional state, Decreased appetite, Diarrhoea; Dizz...
Abdominal pain, Asthenia, Confusional state, Decreased appetite, Diarrhoea; Dizziness, Fatigue, Injection site pain, Lethargy, Pain
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Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-M...
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Loss of appetite-Severe, Systemic: Weakness-Medium, Additional Details: According to the patient, She had these symptoms developed 2 days after receiving her vaccine on 6/25/2025. She stated that her confusion was more of realizing that she is experiencing side effects after vaccine because she had never experienced such reactions in the past and described as "I talked my self into believing this because I was very confused." On 6/25/2025, she felt really tired, had diarrhea and no appetite. However, she feels much better, improved today 6/28/2025
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