| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2857712 | 09/09/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Pulmonary embolism
Pulmonary embolism
|
pulmonary embolisms in both lungs; This is a spontaneous report received from a Consumer or other no...
pulmonary embolisms in both lungs; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-020662 (BioNTech). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown (booster), 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: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "pulmonary embolisms in both lungs". Specifically, the patient shared that she regrets receiving the Pfizer-BioNTech booster in 2022, which she says led to pulmonary embolisms in both lungs. She is now allegedly on lifelong Apixaban blood thinners. She described taking the vaccine as "the biggest regret of my life." Therapeutic measures were taken as a result of pulmonary embolism. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. BNT162b2 is under agreement with BIONTECH SE.
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| 2857713 | 16 | F | 09/09/2025 |
MENB |
PFIZER\WYETH |
|
Chest discomfort, Injection site rash, Pyrexia, Rash, Vomiting
Chest discomfort, Injection site rash, Pyrexia, Rash, Vomiting
|
chest felt heavy; rash all over stomach; vomiting; 102 degree fever; rash on the vaccine injection s...
chest felt heavy; rash all over stomach; vomiting; 102 degree fever; rash on the vaccine injection site; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2025SA236343 (Sanofi). A 16-year-old female patient (unknown if pregnant) received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) at the age of 16 years, in right arm for immunisation; meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), on 11Jul2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "food allergy" (ongoing); "syncope with vasovagal syncope" (not ongoing). Concomitant medication(s) included: ETHINYLESTRADIOL taken for contraception, heavy menstrual bleeding; JUNEL taken for contraception, heavy menstrual bleeding; XYZAL taken for hypersensitivity; FERROUS SULFATE taken for blood iron decreased. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 12Jul2025, outcome "unknown", described as "rash on the vaccine injection site"; PYREXIA (non-serious) with onset 13Jul2025, outcome "unknown", described as "102 degree fever"; RASH (non-serious) with onset 13Jul2025, outcome "unknown", described as "rash all over stomach"; VOMITING (non-serious) with onset 13Jul2025, outcome "unknown"; CHEST DISCOMFORT (non-serious) with onset 14Jul2025, outcome "unknown", described as "chest felt heavy". Additional information: the patient had syncope with vasovagal syncope from about two years ago, was related to the low iron to: had not had episode of that in a year, takes iron so didn't come to that since patient was passing out ail of the lime. Batch/lot number is not provided, and it cannot be obtained.
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| 2857714 | 26 | F | PA | 09/09/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
|
administration of fluzone during pregnancy with no reported adverse event; Initial information recei...
administration of fluzone during pregnancy with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 26-year-old female patient who was exposed to influenza USP trival A-B subvirion no preservative vaccine [Fluzone] during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported administration of fluzone during pregnancy with no reported adverse event occurred at 27 weeks of pregnancy during third pregnancy trimester. The date of last menstrual period was reported as 28-Feb-2025. The estimated due date is 07-Dec-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 04-Sep-2025, the patient received an unknown (Dose 1) of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection of lot UT8792LA via intramuscular route (strength, expiry date: not reported) in unknown administration site for prophylactic vaccination (immunization) during pregnancy with no reported adverse event (exposure during pregnancy) (latency: on same day). Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
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| 2857715 | 57 | M | IL | 09/09/2025 |
TDAP |
SANOFI PASTEUR |
|
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
Received 2 doses of ADACEL about 5 months apart, with no reported adverse event; Initial information...
Received 2 doses of ADACEL about 5 months apart, with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 57 years old male patient who received 2 doses of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] about 5 months apart, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Apr-2025, the patient received an unknown dose (dose 1) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot, expiry date, strength not reported) via unknown route in the unknown site and on 03-Sep-2025, 0.5mL (dose 2) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot U8670BA, expiry date 31-Aug-2027, strength standard and frequency once) via intramuscular route in the right deltoid and for Immunisation and 2 doses received about 5 months apart, with no reported adverse event (Extra dose administered) (latency same day). Reportedly, they received one yesterday on 03-Sep-2025, but it was found out they also received one on 02-Apr-2025 that was not documented properly and the nurse said that the patient had no adverse reaction. No other immunizations. 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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| 2857716 | 10 | M | NC | 09/09/2025 |
HEP |
MERCK & CO. INC. |
Y018844 |
Wrong patient received product
Wrong patient received product
|
TB given to patient , it was intended for his brother , he did not need it
TB given to patient , it was intended for his brother , he did not need it
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| 2857717 | 55 | F | MI | 09/09/2025 |
FLU3 PNC20 VARZOS |
SEQIRUS, INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
406984 y019158 5a4xg |
Axillary pain, Injection site erythema, Injection site pruritus; Axillary pain, ...
Axillary pain, Injection site erythema, Injection site pruritus; Axillary pain, Injection site erythema, Injection site pruritus; Axillary pain, Injection site erythema, Injection site pruritus
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Patient began experiencing a red itchy arm (left arm a few inches below and to the back of the vacci...
Patient began experiencing a red itchy arm (left arm a few inches below and to the back of the vaccine injection sites) and sore armpit approximately 24 hours after her vaccines.
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| 2857718 | 4 | M | WA | 09/09/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8383AB |
Circumstance or information capable of leading to medication error, Injection si...
Circumstance or information capable of leading to medication error, Injection site pruritus, Injection site swelling
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During vaccine administration by RMA, pt moved arm and RMA stated he observed needle move inside arm...
During vaccine administration by RMA, pt moved arm and RMA stated he observed needle move inside arm mid-administration, possibly into subcutaneous tissue. Vaccine was administered. 2-3 minutes after administration, a small, flat, raised bump with irregular borders appeared on arm and was observed to grow in size. Pt reported mild itchiness at the site, no pain. No redness. Assessed by RN and MD. MD ordered 2.5mL cetirizine, administered and pt was observed for 10 minutes in clinic. MD provided education to parent to what to watch for and reasons to seek additional medical care. Pt discharged home with parent.
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| 2857719 | 83 | F | OH | 09/09/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3052296 3052296 |
Confusional state, Dry mouth, Fatigue, Hypotension, Nausea; Pain in extremity, S...
Confusional state, Dry mouth, Fatigue, Hypotension, Nausea; Pain in extremity, Somnolence
More
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Arm pain, Dry mouth and nausea in the night after getting vaccine. Pt was extremely tired and husba...
Arm pain, Dry mouth and nausea in the night after getting vaccine. Pt was extremely tired and husband could not easily wake her up. She stated she was confused and had low blood pressure. Her family took her to the hospital after she awoke.
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| 2857736 | 69 | F | NY | 09/09/2025 |
COVID19 |
MODERNA |
|
Alopecia, Computerised tomogram, Magnetic resonance imaging, Myasthenia gravis, ...
Alopecia, Computerised tomogram, Magnetic resonance imaging, Myasthenia gravis, X-ray
More
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Hair started falling out bald spots then diagnosed with alopecia then one year later myasthenia grav...
Hair started falling out bald spots then diagnosed with alopecia then one year later myasthenia gravis
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โ | โ | ||||
| 2857737 | 73 | F | OR | 09/09/2025 |
FLU3 FLU3 TDAP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
u8800ba u8800ba u8389a4 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
|
Patient should have received a flu and Tdap vaccine, received two flu vaccine instead.
Patient should have received a flu and Tdap vaccine, received two flu vaccine instead.
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| 2857738 | 72 | M | CA | 09/09/2025 |
COVID19 |
PFIZER\BIONTECH |
|
C-reactive protein increased, Pericarditis, Red blood cell sedimentation rate in...
C-reactive protein increased, Pericarditis, Red blood cell sedimentation rate increased, Troponin increased
More
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Pericarditis developed 1 month after the Covid booster (# 5 in total). The patient has been treated ...
Pericarditis developed 1 month after the Covid booster (# 5 in total). The patient has been treated with colchicine 0.6 mg BID and Ibuprofen 60 mg TID. The Ibuprofen was discontinued after two weeks. The patient has had two recurrences during the course, one while still on colchicine, and one while off of colchicine X 6 weeks. He is now back on the colchicine for three more months.
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| 2857739 | 66 | F | FL | 09/09/2025 |
FLU3 RSV |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UT8781AA BG5J4 |
Fatigue, Hyperhidrosis; Fatigue, Hyperhidrosis
Fatigue, Hyperhidrosis; Fatigue, Hyperhidrosis
|
WE CONTACTED THE PATIENT THE NEXT DAY AFTER RECEIVING AN EMAIL FROM OUR CLINICAL DEPARTMENT ABOUT TH...
WE CONTACTED THE PATIENT THE NEXT DAY AFTER RECEIVING AN EMAIL FROM OUR CLINICAL DEPARTMENT ABOUT THE ERROR. I CALLED THE PATIENT AND SPOKE TO HER HUSBAND SINCE SHE WAS AT WORK. HE SAID SHE FELT FINE, WAS FEELING A LITTLE TIRED AND SWEATING WHEN SHE WOKE UP THIS MORNING BUT OTHERWISE FINE.
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| 2857740 | 58 | F | KS | 09/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
pj353 |
Arthralgia, Limb discomfort, Pain, Pain in extremity
Arthralgia, Limb discomfort, Pain, Pain in extremity
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2nd shingrix shot administered at 1:13pm in left deltoid, patient called at 5 pm same day 9/9/25 to ...
2nd shingrix shot administered at 1:13pm in left deltoid, patient called at 5 pm same day 9/9/25 to report went to physical therapy where she was on the sit down eliptical machine then came home and pain in shot arm and radiating down arm started at 4:38pm, feels heavy, no swelling or redness at that this time, patient reported even her other shoulder was hurting also. Patient reported she remembers her first shingrix shot keeping her out of work for 3 days, followed up with patient at 6:14pm 9/9/25 and patient is still waiting on acetaminophen to kick in-her condition has not progressed
More
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| 2857741 | 25 | F | CO | 09/09/2025 |
FLU3 |
SANOFI PASTEUR |
U8837CA |
Incorrect dose administered
Incorrect dose administered
|
Wrong flu vaccines given fluzone HD given to patient under 65 without solid organ transplant.
Wrong flu vaccines given fluzone HD given to patient under 65 without solid organ transplant.
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| 2857742 | 51 | M | NV | 09/09/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EN6204 EN6204 |
Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increase...
Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart abnormal, Magnetic resonance imaging renal; Myocarditis, Nephrectomy, Papillary renal cell carcinoma, Troponin increased
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In late 2022, developed papillary renal cell carcinoma, resulting in partial nephrectomy 4/13/2023....
In late 2022, developed papillary renal cell carcinoma, resulting in partial nephrectomy 4/13/2023. Following that, development of cardiac issues tracked over following year, resulting in cardiac mri suggesting myocarditis. Myocarditis confirmed by 2nd cardiac mri 6/24/25
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โ | โ | ||||
| 2857743 | 56 | F | OR | 09/09/2025 |
PNC20 |
PFIZER\WYETH |
LX2498 |
Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
|
Significant erythema, warmth, swelling to left upper arm when patient was seen on 9/9/25. Swelling ...
Significant erythema, warmth, swelling to left upper arm when patient was seen on 9/9/25. Swelling and erythema has improved slightly over the past 6 days per patient. Recommended daily antihistamine such as Claritin, Allegra or Zyrtec for the next week. Has betamethasone crem at home that can be applied to affected areas of left arm twice daily and recommended Benadryl at night if needed to help reduce itching.
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| 2857744 | 55 | F | CA | 09/09/2025 |
FLU3 |
SANOFI PASTEUR |
U8800CA |
Circumstance or information capable of leading to medication error, Incorrect do...
Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
More
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Patient was given influenza vaccine high dose instead of influenza regular dose vaccine due to a mi...
Patient was given influenza vaccine high dose instead of influenza regular dose vaccine due to a mispackaging issue from manufacturer. physician and patient aware. patient tolerated vaccine well. no adverse reactions noted and reported. patient was contacted the following day 9/9/25 patient reports no adverse reaction to vaccine.
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| 2857745 | 11 | F | WA | 09/09/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Z002903 U8494AA X449Y |
Syncope; Syncope; Syncope
Syncope; Syncope; Syncope
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Syncope patient was then given juice and crackers and blood pressure was retaken. Provider PA-C came...
Syncope patient was then given juice and crackers and blood pressure was retaken. Provider PA-C came into the room to check on patient after syncope episode.
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| 2857746 | 61 | M | FL | 09/09/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781AA |
Incorrect dose administered, No adverse event, Wrong product administered
Incorrect dose administered, No adverse event, Wrong product administered
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Patience was given the high dose of flu vaccine (FLUZONE) and was supposed to receive the FLUBLOCK ....
Patience was given the high dose of flu vaccine (FLUZONE) and was supposed to receive the FLUBLOCK . No adverse effect or symptoms refported by the patient.
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| 2857747 | 38 | M | VA | 09/09/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
|
Diarrhoea, Nasopharyngitis, Oral disorder, Pyrexia, Skin lesion; Tooth infection
Diarrhoea, Nasopharyngitis, Oral disorder, Pyrexia, Skin lesion; Tooth infection
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Dozens of lesions, in total over one hundred, some quite large, half the size of my cheek began deve...
Dozens of lesions, in total over one hundred, some quite large, half the size of my cheek began developing 16 days after the shot, they spread to my arms, one formed on my eye, several in my mouth which may have caused a molar infection. There was mild fever/cold symptoms and diarrhea. As of 20 days since the shot the symptoms have subsided but still remain.
More
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| 2857748 | 69 | F | CA | 09/09/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0587 UT8763HA |
Abdominal pain, Nausea, Vomiting; Abdominal pain, Nausea, Vomiting
Abdominal pain, Nausea, Vomiting; Abdominal pain, Nausea, Vomiting
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Nausea, vomiting, abdominal pain/cramping. Lasted for approx 3 hours from approx 4-7pm. patient was...
Nausea, vomiting, abdominal pain/cramping. Lasted for approx 3 hours from approx 4-7pm. patient was advised to seek medical care at emergency room.
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| 2857749 | 41 | M | GA | 09/09/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FJ4989 FJ4989 |
Arrhythmia, Cardiac flutter, Cardiac monitoring, Chest discomfort, Chest pain; E...
Arrhythmia, Cardiac flutter, Cardiac monitoring, Chest discomfort, Chest pain; Erythema, Fatigue, Laboratory test, Urticaria
More
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Within days, red welps/hives. Within weeks came chest pain, heart arrhythmia, heart flutters, chest ...
Within days, red welps/hives. Within weeks came chest pain, heart arrhythmia, heart flutters, chest tightness, and fatigue. Over the next 2 years, I would be fitted with multiple heart monitors and treated with medication. Symptoms still ongoing.
More
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โ | โ | ||||
| 2857750 | 35 | F | NV | 09/09/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
|
Eye irritation, Eye pruritus; Eye irritation, Eye pruritus
Eye irritation, Eye pruritus; Eye irritation, Eye pruritus
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A few hours after receiving the two vaccines, my eyes have become and remain incredibly itchy and ir...
A few hours after receiving the two vaccines, my eyes have become and remain incredibly itchy and irritated.
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| 2857185 | 61 | NY | 09/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incorrect route of product administration
Incorrect route of product administration
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Wrong route of administration; This non-serious case was reported by a pharmacist via call center re...
Wrong route of administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong route of administration in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On 28-AUG-2025, the patient received Shingrix (unknown arm). On 28-AUG-2025, an unknown time after receiving Shingrix, the patient experienced wrong route of administration (Verbatim: Wrong route of administration). The outcome of the wrong route of administration was not applicable. Additional Information: GSK Receipt Date: 28-AUG-2025 The patient was given Shingrix via wrong route of administration. A nurse administered the vaccine via subsequent injection in the forearm.
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| 2857186 | 09/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise
Malaise
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got sick from the first one; This non-serious case was reported by a consumer via interactive digita...
got sick from the first one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: got sick from the first one). The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 26-AUG-2025 This case was reported by a patient via interactive digital media. The patient was sick from the 1st Shingrix vaccine.
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| 2857187 | 0.5 | F | IN | 09/08/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK043AA |
Expired product administered
Expired product administered
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expired dose of PENTACEL was administered to a patient with no reported adverse event; Initial infor...
expired dose of PENTACEL was administered to a patient with no reported adverse event; Initial information received on 03-Sep-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 6 months old female patient who received expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)], 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 hepatitis B vaccine and pneumococcal vaccine CONJ 7V (CRM197) (Prevnar), both for Immunisation. On 03-Sep-2025, the patient received Dose 3 of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of standard strength, frequency once with lot UK043AA and expiry date 31-Aug-2025 via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (Latency same day) Action 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.
More
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| 2857196 | 09/08/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; shingles/ended up getting it; This serious case was reported by a con...
Suspected vaccination failure; shingles/ended up getting it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/ended up getting it). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-AUG-2025 This case was reported by a patient via interactive digital media. The reporter advised against getting the shot, mentioning that they knew people who had received it and still ended up getting Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingles vaccine, in an unspecified number of patients. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2857198 | 30 | F | IA | 09/08/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2511 |
Dysphagia, Pharyngeal swelling, Throat irritation
Dysphagia, Pharyngeal swelling, Throat irritation
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The patient presents with allergic reaction, throat swelling and patient is a 30-year-old female who...
The patient presents with allergic reaction, throat swelling and patient is a 30-year-old female who presents to the emergency room complaining of some mild throat swelling. She received a flu vaccine around 10-10:30 this morning. States symptoms began noon of some mild scratchy throat. Notes states his feels as though it is difficult to swallow. She denies any shortness of breath, no nausea, no rash or hives. She does not feel as though her tongue is swollen. States the last time she had a flu shot she got some minor itching. Does have an allergy to eggs that is mild. Location: throat. The degree at onset was minimal. The dress at present is minimal. Potential allergen(s) flu shot. Risk fac
More
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| 2857237 | 0.5 | M | NY | 09/08/2025 |
DTAP |
SANOFI PASTEUR |
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Rash
Rash
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Full body rash
Full body rash
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| 2857238 | 36 | F | OH | 09/08/2025 |
COVID19 |
PFIZER\BIONTECH |
EWO165 |
Blood test, Magnetic resonance imaging, Rheumatoid arthritis, X-ray
Blood test, Magnetic resonance imaging, Rheumatoid arthritis, X-ray
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I now have Rheumatoid Arthritis, which does not run in my family at all.
I now have Rheumatoid Arthritis, which does not run in my family at all.
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โ | |||||
| 2857239 | 83 | M | IA | 09/08/2025 |
COVID19 |
MODERNA |
3046731 |
Death
Death
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resident passed away
resident passed away
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โ | |||||
| 2857240 | 59 | M | MA | 09/08/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4SB5S |
Injection site pain, Product preparation issue
Injection site pain, Product preparation issue
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Site: Pain at Injection Site-Mild, Additional Details: Vaccine was not mixed prior to administration...
Site: Pain at Injection Site-Mild, Additional Details: Vaccine was not mixed prior to administration. Patient received sterile water. Patient did not experience side effects besides the typical injection site soreness.
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| 2857241 | 62 | F | MA | 09/08/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4SB5S |
Injection site pain, Product preparation issue
Injection site pain, Product preparation issue
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Site: Pain at Injection Site-Mild, Additional Details: Vaccine was not mixed prior to administration...
Site: Pain at Injection Site-Mild, Additional Details: Vaccine was not mixed prior to administration. Patient received sterile water. No side effects besides the typical injection site soreness/pain.
More
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| 2857242 | 67 | M | MA | 09/08/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4SB5S |
Injection site pain, Product preparation issue
Injection site pain, Product preparation issue
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Site: Pain at Injection Site-Mild, Additional Details: Vaccine was not mixed prior to administration...
Site: Pain at Injection Site-Mild, Additional Details: Vaccine was not mixed prior to administration. Patient received sterile water. No adverse reactions besides the typical injection site soreness/pain.
More
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| 2857243 | 82 | F | GA | 09/08/2025 |
PNC21 |
MERCK & CO. INC. |
Z006076 |
Cellulitis, Injection site erythema, Injection site pain
Cellulitis, Injection site erythema, Injection site pain
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Pat...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient visited her doctor after she received the Fluzone High Dose and Capvaxive vaccine on the same day due to injection site reaction. Patient's MD indicated that the patient has cellulitus and is being treated for it. , Other Vaccines: VaccineTypeBrand: Fluzone High Dose; Manufacturer: Sanofi-Pasteur; LotNumber: UT8763GA; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
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| 2857244 | 65 | F | MD | 09/08/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LX4484 LX4484 |
Injection site erythema, Injection site pain, Injection site rash, Injection sit...
Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth; Pain, Rash
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Additional Details: Redness (rash), warm to touch, painful on arm and throughout from shoulder to elbow. Appeared to look like cellulitis type reaction. Symptoms resolved after 2 days - did not seek medical attention, Other Vaccines: VaccineTypeBrand: Fluzone High-Dose; Manufacturer: Sanofi; LotNumber: U8764BB; Route: Intramuscular; BodySite: Left Arm; Dose: 1; VaxDate: 08/22/2025
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| 2857245 | 54 | F | CA | 09/08/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5Y9CA 5Y9CA |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth, Pain
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PATIENT PRESENTED TO THE PHARMACY 4 DAYS AFTER THE VACCINATION WITH REDNESS AND WARM TO TOUCH IN THE DELTOID AREA. SHE REPORTED SLIGHT PAIN AND PAIN WHILE MOVING THE ARM.
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| 2857246 | 69 | F | VA | 09/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
g2ha7 |
Arthralgia, Emotional distress, Joint injury
Arthralgia, Emotional distress, Joint injury
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Joint Pain-Severe, Ad...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Joint Pain-Severe, Additional Details: very upset
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| 2857247 | 85 | F | GA | 09/08/2025 |
FLU4 |
SANOFI PASTEUR |
u8800aa |
Injection site erythema, Injection site pain, Rash
Injection site erythema, Injection site pain, Rash
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Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Ge...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient appears to be fine going about day normal just has redness around arm and pain at injection site.
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| 2857249 | 87 | F | CA | 09/08/2025 |
FLUA4 |
SEQIRUS, INC. |
388486 |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild
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| 2857250 | 19 | F | MI | 09/08/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
55n34 |
Injection site bruising, Presyncope, Tremor, Unresponsive to stimuli
Injection site bruising, Presyncope, Tremor, Unresponsive to stimuli
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Site: Bruising at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-M...
Site: Bruising at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient ALMOST fainted but did not completely lose consciousness. Head started to drop, but was awake talking to me the whole time.
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| 2857251 | 66 | M | AZ | 09/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5y9ca |
Syringe issue, Underdose
Syringe issue, Underdose
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Systemic: see note below-Mild, Additional Details: shingrix spilled out of syringe/needle with some ...
Systemic: see note below-Mild, Additional Details: shingrix spilled out of syringe/needle with some being given to patient. had to readminister another dose to the patient. patient was forgiving and understood., Other Vaccines: VaccineTypeBrand: prevnar 20; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 08/30/2025, VaccineTypeBrand: boostrix; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: 08/21/2025
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| 2857252 | 51 | F | IN | 09/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93N4J |
Injection site pain
Injection site pain
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Site: Pain at Injection Site-Medium, Additional Details: patient vaccine diluted and given . pt cont...
Site: Pain at Injection Site-Medium, Additional Details: patient vaccine diluted and given . pt contacted and doing well
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| 2857253 | 28 | F | IN | 09/08/2025 |
VARCEL |
MERCK & CO. INC. |
y005921 |
Injection site pain, Product lot number issue
Injection site pain, Product lot number issue
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Site: Pain at Injection Site-Medium, Additional Details: wrong lot number charted. right medication,...
Site: Pain at Injection Site-Medium, Additional Details: wrong lot number charted. right medication, right diluent and site used. pt doing well
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| 2857254 | 80 | F | NY | 09/08/2025 |
FLU4 |
SANOFI PASTEUR |
u8830da |
Injection site bruising
Injection site bruising
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Site: Bruising at Injection Site-Medium
Site: Bruising at Injection Site-Medium
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| 2857255 | 22 | F | FL | 09/08/2025 |
FLUC4 |
SEQIRUS, INC. |
406981 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Medium
Systemic: Fainting / Unresponsive-Medium
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| 2857256 | 72 | M | FL | 09/08/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
ut8794ba ut8794ba |
Dyspnoea, Eye swelling, Headache, Injection site pain, Injection site pruritus; ...
Dyspnoea, Eye swelling, Headache, Injection site pain, Injection site pruritus; Injection site swelling, Mouth swelling, Swelling face, Swollen tongue, Throat tightness
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Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection...
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Headache-Mild
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| 2857257 | 51 | F | NY | 09/08/2025 |
FLUC4 |
SEQIRUS, INC. |
406982 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient verbalized adverse reaction to both arms under injection site, large area of raised red, painful areas on both arms, gradually got worse over 2days, pt saw md who perscribed cephalexin as a precaution , Other Vaccines: VaccineTypeBrand: shingrix; Manufacturer: ; LotNumber: 27lr2; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: capvaxive; Manufacturer: ; LotNumber: z006076; Route: im; BodySite: rt deltoid; Dose: ; VaxDate: UNKNOWN
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| 2857258 | 61 | M | CA | 09/08/2025 |
FLUC4 |
SEQIRUS, INC. |
406981 |
Injection site bruising, Injection site pain
Injection site bruising, Injection site pain
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Site: Bruising at Injection Site-Mild, Systemic: Just pain with touch-Mild, Additional Details: Pt s...
Site: Bruising at Injection Site-Mild, Systemic: Just pain with touch-Mild, Additional Details: Pt states not bothersome just unsure if having a bruise for almost a month is a concern
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| 2857259 | 50 | M | GA | 09/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7349L |
Arthralgia, Injected limb mobility decreased, Injection site pain, Joint injury,...
Arthralgia, Injected limb mobility decreased, Injection site pain, Joint injury, Rotator cuff syndrome
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Site: Pain at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Se...
Site: Pain at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: Patient brought this issue up at follow-up. He mentioned that he has been unable to move his shoulder from his first dose, and that his arm was sore from the second dose but did not experience the lingering pain and shoulder impingement from his first dose. He said that it's been very painful (shoulder of left arm), that he hasn't been able to lift that arm and he's had to do physical therapy and get "dry needling" done. He said PT and massages haven't been helpful.
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