| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2861802 | 50 | F | 09/26/2025 |
PNC21 |
MERCK & CO. INC. |
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Injection site erythema, Injection site warmth, Pain, Pyrexia, Swelling
Injection site erythema, Injection site warmth, Pain, Pyrexia, Swelling
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Fever on following day after receiving Pneumonia Vaccines (CAPVAXIVE), injection site became red and...
Fever on following day after receiving Pneumonia Vaccines (CAPVAXIVE), injection site became red and hot on third day after receiving vaccine; currently using cold compress and taking NSAIDs to assist with pain and swelling
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| 2861803 | 76 | M | NV | 09/26/2025 |
COVID19 FLU3 TDAP VARZOS |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
u8837ba |
Eye swelling, Lip swelling, Pharyngeal swelling; Eye swelling, Lip swelling, Pha...
Eye swelling, Lip swelling, Pharyngeal swelling; Eye swelling, Lip swelling, Pharyngeal swelling; Eye swelling, Lip swelling, Pharyngeal swelling; Eye swelling, Lip swelling, Pharyngeal swelling
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While driving home, his lips throat and eyes swelled. He administered his last epipen dose. He is no...
While driving home, his lips throat and eyes swelled. He administered his last epipen dose. He is now okay.
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| 2861804 | 15 | F | TX | 09/26/2025 |
HPV9 |
MERCK & CO. INC. |
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Malaise
Malaise
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She didn't feel well since having the vaccine and its gotten progressively worse with no real e...
She didn't feel well since having the vaccine and its gotten progressively worse with no real explanation.
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| 2861969 | 6 | M | MN | 09/26/2025 |
FLU3 |
SEQIRUS, INC. |
406997 |
Injection site erythema, Injection site induration, Injection site swelling, Inj...
Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Vaccine positive rechallenge
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Patient was given annual influenza vaccine in clinic. Everything was done appropriately by nurse. af...
Patient was given annual influenza vaccine in clinic. Everything was done appropriately by nurse. afer 45 mins his arm started to well, harden and became warm ot the touch about the size of 2 golf balls. beandryl, zertec and ice was done at that point. Arms continued to sell and harden over the next sever hours to about the size of a baseball the full shoulder. When patient woke the next day the arm was red, swollen, hard and warm to the touch from top of shoulder to almost the elbow. to note:This also happened last year to him. was unsure if it was from the vaccine or the administration so we attempted the vaccine again this year.
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| 2861220 | 1 | F | OH | 09/25/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y020300 Y019319 |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
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No adverse events; wrong vaccine administered; A HCP called to report an AE involving VARIVAX and PR...
No adverse events; wrong vaccine administered; A HCP called to report an AE involving VARIVAX and PROQUAD. The HCP stated that the facility doctor ordered separate doses of MMR II and VARIVAX to be administered to a patient on 09/22/2025, but the patient inadvertently received VARIVAX and PROQUAD; This spontaneous report was received from a medical assistant concerning a 1-year-old female patient. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. The health care professional (HCP) stated that the facility doctor ordered separate doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (MMR II) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) to be administered to a patient on 22-SEP-2025, but the patient inadvertently received Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y019319, expiration date: 21-NOV-2026) (0.5mL/once) and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y020300, expiration date: 09-JUN-2026) (0.5m /once). Both vaccines were administered as prophylaxis (dose, anatomical location and route were not reported) on 22-SEP-2025 instead. The patient did not receive the individual dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine (MMR II) as ordered. The HCP stated the patient did not experience any other adverse issues or side effect from the administered vaccines. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not reported). The operator of device was HCP. Lot # is being requested and will be submitted if received.
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| 2861221 | 70 | F | 09/25/2025 |
COVID19-2 COVID19-2 FLUX FLUX |
MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
AS7184B AS7184B |
Fatigue, Headache, Myalgia, Nausea, Pain in extremity; Tenderness; Fatigue, Head...
Fatigue, Headache, Myalgia, Nausea, Pain in extremity; Tenderness; Fatigue, Headache, Myalgia, Nausea, Pain in extremity; Tenderness
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soreness and tenderness in the arm; soreness and tenderness in the arm; headache; muscle ache; nause...
soreness and tenderness in the arm; soreness and tenderness in the arm; headache; muscle ache; nausea; tiredness/Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache) and NAUSEA (nausea) in an 8-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7184B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 08-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea) and FATIGUE (tiredness/Fatigue). At the time of the report, TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea) and FATIGUE (tiredness/Fatigue) outcome was unknown. No concomitant medication was reported. She had fatigue, headache, muscle ache, soreness and tenderness in the arm, nausea, and tiredness after her previous Covid vaccines and Flu vaccine. However, she noted that those side effects were not severe enough to require medical assistance or hospitalization. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to MOD-2025-789525 (Patient Link). Reporter did not allow further contact
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| 2861222 | F | CA | 09/25/2025 |
COVID19 |
NOVAVAX |
4302MF023 |
Chills, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Chills, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
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Fever; Chills; Possibly sore throat; Tested positive for COVID-19; This non serious initial spontane...
Fever; Chills; Possibly sore throat; Tested positive for COVID-19; This non serious initial spontaneous report was reported by a consumer or other non-health professional via contact center and concerns a 71-year-old Female who experienced "FEVER", "CHILLS", "POSSIBLY SORE THROAT", and "Tested positive for COVID-19" on unspecified dates after receiving Novavax COVID-19 Vaccine, Adjuvanted, on an unspecified date in Oct 2022. At the time of the report, the outcome of the Pyrexia, Chills, Oropharyngeal pain, and SARS-CoV-2 test positive was Recovered/Resolved (Unspecified date).; Sender's Comments: This 71-year-old Female experienced Pyrexia, Chills, Oropharyngeal pain, and SARS-CoV-2 test positive after vaccination with Novavax COVID-19 Vaccine, Adjuvanted. The event Pyrexia was reported as non-serious. The event Chills was reported as non-serious. The event Oropharyngeal pain was reported as non-serious. The event SARS-CoV-2 test positive was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Pyrexia, Chills, Oropharyngeal pain and SARS-CoV-2 test positive is considered Possible.
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| 2861223 | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Asthenia, Malaise
Asthenia, Malaise
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Didn't feel too good after taking it.; feeling weak; This is a spontaneous report received from...
Didn't feel too good after taking it.; feeling weak; 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 (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Didn't feel too good after taking it."; ASTHENIA (non-serious), outcome "unknown", described as "feeling weak". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2861224 | 28 | F | PA | 09/25/2025 |
FLU3 |
SANOFI PASTEUR |
4T8792LA |
Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
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Pregnant women given flu zone tiv with no reported ae; Initial information received on 19-Sep-2025 r...
Pregnant women given flu zone tiv with no reported ae; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 28 years old female patient who was exposed to vaccine influenza USP trival A-B SUBVIRION NO preservative vaccine [Fluzone] in context of pregnant women given flu zone tiv with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Pregnant women given flu zone tiv with no reported ae occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date is 20-Jan-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Hypoglycaemia. The patient had unknown previous pregnancy/ies. On 19-Sep-2025, the patient received dose 1 of suspect influenza USP trival A-B SUBVIRION NO preservative vaccine Suspension for injection (unknown strength and expiry date) with lot 4T8792LA via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) with no reported adverse event (exposure during pregnancy) (Latency same day) There were no information related to relevant prenatal testing after exposure. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing.
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| 2861225 | 108 | OH | 09/25/2025 |
TDAP |
SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Intentional Age Prescription by HCP: The patient is 108 years old/ Adacel is approved for use in per...
Intentional Age Prescription by HCP: The patient is 108 years old/ Adacel is approved for use in persons 10 through 64 years of age with no adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 108 years old and unknown gender patient who was prescribed with Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] which is for people through 64 years of age with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, a 108 years old patient received prescription for dose of 1 DF (dosage form) of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number, strength and expiry date-unknown) for helping protect against tetanus, diphtheria, and pertussis dis (Immunisation) which is for people through 64 years of age with no adverse event (off label use) (latency-same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable.
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| 2861226 | 1.33 | M | FL | 09/25/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK226AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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gave PENTACEL, but they only gave the diluent and not the vaccine with no reported AE; Initial infor...
gave PENTACEL, but they only gave the diluent and not the vaccine with no reported AE; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with other cases, US-SA-2025SA283520 and US-SA-2025SA283466. This case involves a 16 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but only received the diluent and not the vaccine 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 pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (YEAST), HIB vaccine CONJ (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (Vaxelis), both for Immunisation. On 13-Sep-2025, the patient received 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 UK226AA and expiry date 31-Aug-2026 via intramuscular route in the left thigh for Immunization but only received the diluent and not the vaccine with no reported Adverse event (Single component of a two-component 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.; Sender's Comments: US-SA-2025SA283520: US-SA-2025SA283466:
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| 2861227 | 1.25 | M | FL | 09/25/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK226AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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gave PENTACEL, but they only gave the diluent and not the vaccine with no reported AE; Initial infor...
gave PENTACEL, but they only gave the diluent and not the vaccine with no reported AE; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] but they only gave the diluent and not the vaccine with no reported ae (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), Hib Vaccine Conj (Menigococcal Protein), Pertussis Vaccine Acellular 5-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Vaxelis) for Immunisation; And Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) for Immunisation. On 05-Sep-2025, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] Suspension for injection (lot UK226AA and expiry date-Aug-2026) via intramuscular route in the left thigh for TB skin test (Skin test) where the patient was only given the diluent and not the vaccine with no reported ae (single component of a two-component product) frequency-once, standard strength, (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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| 2861228 | 62 | M | FL | 09/25/2025 |
UNK |
UNKNOWN MANUFACTURER |
TFAA2536 |
No adverse event, Product storage error
No adverse event, Product storage error
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administration of FLUBLOK to a patient after the excursion took place with no reported AE; Initial i...
administration of FLUBLOK to a patient after the excursion took place with no reported AE; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 62-year-old male patient who was administered with Influenza Trivalent Recombinant Vaccine [Flublok TIV] to a patient after the excursion with no reported ae (adverse event) The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other immunizations. On 19-Sep-2025, the patient received a dose of 0.5ml suspect Influenza Trivalent Recombinant Vaccine Solution for injection (lot TFAA2536 and expiry date-30-Jun-2026) standard-strength, frequency-once via intramuscular route in the right deltoid for Immunization after the excursion took place with no reported ae (poor quality product administered) (latency- same day). Reportedly- Human error was involved; extended stability data does not cover the excursion; There was no previous excursion. Power failure Max/low temperature reached: 29 F (negative 1.667 C) Duration: 30 minutes. 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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| 2861229 | 3 | M | CA | 09/25/2025 |
FLU3 |
SANOFI PASTEUR |
UT8779LA |
Circumstance or information capable of leading to medication error, Incorrect do...
Circumstance or information capable of leading to medication error, Incorrect dose administered
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child pulled away in the middle of the injection so that he received only a partial dose with no rep...
child pulled away in the middle of the injection so that he received only a partial dose with no reported adverse event; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3-year-old male patient who pulled away in the middle of the injection influenza USP trival A-B subvirion no preservative vaccine [Fluzone] so that he received only a partial dose with no reported adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant vaccines. On 17-Sep-2025, child pulled away in the middle of the Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection of lot UT8779LA and expiry date: 30-Jun-2026 via intramuscular route in the lateral thigh for Immunization so that he received only a partial dose with no reported adverse event (incorrect dose administered) (latency: on same day). Reportedly, medical assistant asked also for any information related to how soon the repeat dose of FLUZONE PFS can be administered in situations where a dose is not valid. 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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| 2861230 | 40 | F | IL | 09/25/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2531 |
Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity
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experiencing arm pain and having a hard time lifting the arm; experiencing arm pain and having a har...
experiencing arm pain and having a hard time lifting the arm; experiencing arm pain and having a hard time lifting the arm; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 40-year-old female patient who experienced arm pain and having a hard time lifting the arm after receiving influenza trivalent recombinant vaccine [Flublok]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant: no other vaccines On 15-Sep-2025, the patient received a 0.5 ml dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection strength: standard and frequency: once of lot TFAA2531 and expiry date: 31-May-2026 via unknown route in the left deltoid for immunization. On 18-SEP-2025 the patient experienced arm pain and having a hard time lifting the arm (pain in extremity) (muscular weakness) (latency: 3 days) Action taken was not applicable. The patient was treated with Ibuprofen (Advil) for Muscular weakness and Pain in extremity. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
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| 2861231 | OK | 09/25/2025 |
FLU3 |
SANOFI PASTEUR |
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Wrong technique in product usage process
Wrong technique in product usage process
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Technician administered product incorrectly, seeking guidance in how to move forward with no reporte...
Technician administered product incorrectly, seeking guidance in how to move forward with no reported adverse event; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient with unknown age and gender who was administered to Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] by technician incorrectly, seeking guidance in how to move forward 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 Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and technician administered product incorrectly, seeking guidance in how to move forward with no reported adverse event (wrong technique in product usage process) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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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| 2861232 | 1.17 | F | 09/25/2025 |
DTAP |
SANOFI PASTEUR |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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administered a DTaP vaccine to a 14-month-old infant a full month earlier than scheduled with no rep...
administered a DTaP vaccine to a 14-month-old infant a full month earlier than scheduled with no reported adverse event; Initial information received on 22-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 14 months old female patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel], a full month earlier than scheduled 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-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for Prophylactic vaccination [immunisation], a full month earlier than scheduled with no reported adverse event (inappropriate schedule of product administration) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, The five dose immunization series consists of a 0.5 mL intramuscular injection administered at 2, 4, 6 and 15-20 months of age, and at 4-6 years of age. The Centers for Disease Control and Prevention (CDC) states that doses of any vaccine administered '>' 4 days earlier than the minimum interval or age should not be counted as valid doses and should be repeated as age appropriate. 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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| 2861250 | 17 | F | OR | 09/25/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
FH4YR FH4YR |
Abdominal pain upper, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram; ...
Abdominal pain upper, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram; Full blood count, Hypoaesthesia, Metabolic function test, Pregnancy test, Syncope
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PT developed chest pressure, then dizziness, shortness of breath, feeling like face was numb, and st...
PT developed chest pressure, then dizziness, shortness of breath, feeling like face was numb, and stomach pain. Occurred within a couple minutes (1-2) of vaccine administration. Symptoms resolved within 10 minutes. However, she later presented to the ER (later that evening, ~6-8 hours after vaccine) for syncopal event
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| 2861256 | F | 09/25/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Paraesthesia oral, Transient ischaemic attack
Paraesthesia oral, Transient ischaemic attack
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Transient ischemic attack; Tingling lips; This serious case was reported by a other health professio...
Transient ischemic attack; Tingling lips; This serious case was reported by a other health professional via other manufacturer and described the occurrence of transient ischemic attack in a 76-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero with an associated reaction of allergy to vaccine (For first dose refer US2025AMR115173). On 08-FEB-2024, the patient received Bexsero. On 08-FEB-2024, less than a day after receiving Bexsero, the patient experienced tingling lips (Verbatim: Tingling lips) (serious criteria other: Serious as per reporter). On 03-MAR-2024, the patient experienced transient ischemic attack (Verbatim: Transient ischemic attack) (serious criteria hospitalization and GSK medically significant). On 08-FEB-2024, the outcome of the tingling lips was resolved (duration 1 day). On 05-MAR-2024, the outcome of the transient ischemic attack was resolved (duration 2 days). It was unknown if the reporter considered the transient ischemic attack and tingling lips to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the transient ischemic attack and tingling lips to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2025AMR115173 Additional Information: GSK Receipt Date: 05-SEP-2025 On 08 Feb 2024, the subject again received co-suspect Bexsero for the treatment of prophylaxis at an unknown dose. On 08 Feb 2024, 1 month and 20 days after the first dose of the study medication, the subject developed after the vaccine was administered subject reports tingling lips (paraesthesia oral). On the same day (in 1 day), the subject completely recovered from paraesthesia oral. On 03 Mar 2024, 2 months and 13 days after the first dose of the suspect vaccines, the subject developed transient ischaemic attack.; Sender's Comments: A case of Transient ischaemic attack and Paraesthesia oral, 24 days and less than a day respectively after receiving Bexsero and Bexsero Pre-Filled Syringe Device, in a 76-year-old female patient. 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. US-GSK-US2025AMR115173:1st dose
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| 2861264 | 09/25/2025 |
MMRV |
MERCK & CO. INC. |
Y015120 |
Device connection issue
Device connection issue
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Administering Proquad (MMRV) vaccine, when I started pushing the vaccine to administered it immediat...
Administering Proquad (MMRV) vaccine, when I started pushing the vaccine to administered it immediately started to spray out the side of the cap and cap & need came unattached from the rest of the syringe. Patient was not harmed. Due to all the vaccine spraying out, the vaccine was repeated. Sterile dilutant syringe used to dilute vaccine and draw back up into to administer lot # was Y015120, this was where the cap came off. Needle lot number for 25 gauge need was 25D088
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| 2861265 | 77 | F | KY | 09/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Inadequate aseptic technique in use of product
Inadequate aseptic technique in use of product
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Went to pharmacy to get Covid vaccine. Tech had excessively long fingernails and no gloves. Probably...
Went to pharmacy to get Covid vaccine. Tech had excessively long fingernails and no gloves. Probably impossible to wear. I know artificial nails harbor bacteria and make it hard to wash hands successfully. It was difficult for her to write on my form. I received the vaccine but worried later.
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| 2861266 | 58 | M | KS | 09/25/2025 |
MENB MENB MENB MENB MNQ MNQ MNQ MNQ PNC20 PNC20 PNC20 PNC20 |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
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Agitation, Biopsy kidney abnormal, C3 glomerulopathy, Death, Disseminated intrav...
Agitation, Biopsy kidney abnormal, C3 glomerulopathy, Death, Disseminated intravascular coagulation; Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Endotracheal intubation, Intensive care; Livedo reticularis, Malaise, Meningococcal infection, Platelet count decreased, Renal replacement therapy; Respiratory distress, Shock, Troponin increased; Agitation, Biopsy kidney abnormal, C3 glomerulopathy, Death, Disseminated intravascular coagulation; Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Endotracheal intubation, Intensive care; Livedo reticularis, Malaise, Meningococcal infection, Platelet count decreased, Renal replacement therapy; Respiratory distress, Shock, Troponin increased; Agitation, Biopsy kidney abnormal, C3 glomerulopathy, Death, Disseminated intravascular coagulation; Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased, Endotracheal intubation, Intensive care; Livedo reticularis, Malaise, Meningococcal infection, Platelet count decreased, Renal replacement therapy; Respiratory distress, Shock, Troponin increased
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Patient with biopsy-proven C3 glomerulopathy. Who was started on Iptacopan on 06/24/2025. Prior to i...
Patient with biopsy-proven C3 glomerulopathy. Who was started on Iptacopan on 06/24/2025. Prior to initiation of Iptacopan, he underwent prophylactic vaccinations according to the protocol and he received Menveo, Bexsero, PCV 20 on 04/15/2025; he also received booster doses 06/16/2025. On 9/2/2025, patient started feeling unwell, complaining of shortness of breath and was found to have respiratory distress, mottling of skin and agitation by EMS on arrival to his house. He was brought to the hospital emergently, eventually he got intubated on arrival in the emergency room due to respiratory distress and agitation. Subsequently, patient was admitted to intensive care unit and was found to have profound DIC with low platelets, severe acute kidney injury requiring initiation of renal replacement therapy, shock that required initiation of pressors then later on he was able to be weaned off pressors, his troponin levels were extremely elevated and his echo showed low ejection fraction. He was started on antibiotics empirically and ID team, Nephrology, Cardiology, Hematology and intensivist were managing his critical situation. Unfortunately, due to extremely low platelets it was unsafe to perform LP. Based on clinical data, it was thought that the most likely cause of his sickness was an infection cased by Neisseria meningitidis likely due to complement inhibition with Iptacopan. ID team recommended continuation of empiric treatment with antibiotics. Patient clinical status deteriorated and family decided to pursue comfort care. Patient was extubated to comfort. Unfortunately patient passed away immediately after extubation.
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| 2861267 | VA | 09/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Inadequate aseptic technique in use of product, Injection site pain, Wrong techn...
Inadequate aseptic technique in use of product, Injection site pain, Wrong technique in product usage process
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Today around 9:20 AM, I went to pharmacy for a vaccine, and my experience was extremely concerning. ...
Today around 9:20 AM, I went to pharmacy for a vaccine, and my experience was extremely concerning. The pharmacy technician appeared nervous, and I noticed her hands were shaking. She attempted to administer the vaccine twice, fully inserting the needle both times without actually giving the injection. During this process, she said that she had never used that type of needle for the shingles vaccine, even though she mentioned giving a different vaccine to a gentleman earlier. It seemed she was unfamiliar with the equipment she was using. After these failed attempts, the pharmacist was called over and finally administered the vaccine on the third attempt. I am deeply concerned that a sterile, unused needle may not have been used. The syringe was already open and placed on a tray, and the same needle was inserted into my arm multiple times before the vaccine was actually given. This violates standard vaccine safety protocol, as a needle should only be used once to maintain sterility and prevent infection. I am now worried about the risk of infection from this improper procedure, and I am experiencing significant pain at the injection site. This incident raises serious safety concerns and should be addressed immediately with additional staff training and oversight to ensure patient safety.
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| 2861268 | 56 | CO | 09/25/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052671 U8832DA |
Malaise, Pain, Pyrexia; Malaise, Pain, Pyrexia
Malaise, Pain, Pyrexia; Malaise, Pain, Pyrexia
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I'm a patient who is also a nurse. On 20Sep2025 at 1600 MDT, I received Sanofi's Flublok 0...
I'm a patient who is also a nurse. On 20Sep2025 at 1600 MDT, I received Sanofi's Flublok 0.5mL 2025-26 (NDC 49281-0725-10, LOT U8832DA or U8B32DA), Serial 13214KD21EAKMH, Exp 06/31/26) and Moderna's Spikevax 05mcg/0.5mL (NDC 80777-0112-96, LOT 3052671, Serial 2XFFSBFVT3T9 or 2XFFSBFV73T9, Exp 06/16/26). Both were given IM in my right deltoid. on 21Sep2025 at approximately 0400 MDT, I began to experience a low-grade fever, aches, and generally feeling as if I'm getting sick. While I consider these signs that my body is doing exactly what it's supposed to do in response to these vaccines, as a HCP, I still wanted to report them.
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| 2861269 | 14 | M | MN | 09/25/2025 |
HPV9 |
MERCK & CO. INC. |
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Dizziness, Fall, Neck pain, Syncope, Tooth fracture
Dizziness, Fall, Neck pain, Syncope, Tooth fracture
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My son received the HPV vaccine on 9/11/25 at 4pm. Today, after getting up from the sofa, he got diz...
My son received the HPV vaccine on 9/11/25 at 4pm. Today, after getting up from the sofa, he got dizzy, lost control of his entire body and collapsed onto the ground. He hit his front teeth on the wall and chipped both of them. His neck hurts from this collision. He has always been healthy and has never fainted. Nothing else in his diet nor medications were changed. This is absolutely a side effect of the vaccination.
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| 2861272 | 56 | F | IN | 09/25/2025 |
FLU3 |
SANOFI PASTEUR |
UT8852JA |
Extra dose administered
Extra dose administered
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In advertly given 2 doses of Influenza
In advertly given 2 doses of Influenza
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| 2861274 | 1.17 | M | MS | 09/25/2025 |
FLUX HEPA MMR VARCEL |
UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
G79C4 Y008290 X024648 |
Expired product administered; Expired product administered; Expired product admi...
Expired product administered; Expired product administered; Expired product administered; Expired product administered
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On Sept. 22, 2025 I was not away that the Hep A vaccine had expired over the weekend before I had ad...
On Sept. 22, 2025 I was not away that the Hep A vaccine had expired over the weekend before I had administered the vaccine to the patient. Immediately I notify my supervisor Dr (withheld), as well as the patient parent and explain to the parent about the expired vaccine that was administered and also check on the patient and also to the let parent know to bring patient back to the clinic within 30 days to get another Hep A vaccine.
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| 2861359 | 4 | F | 09/25/2025 |
MMR |
MERCK & CO. INC. |
Y008290 |
Wrong product administered
Wrong product administered
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varicella vaccine ordered, administered MMR by mistake
varicella vaccine ordered, administered MMR by mistake
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| 2861360 | 67 | F | IA | 09/25/2025 |
RSV |
PFIZER\WYETH |
LN5489 |
Arthralgia
Arthralgia
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Patient came in complaining of shoulder related pain after receiving the Abrysvo vaccine earlier tha...
Patient came in complaining of shoulder related pain after receiving the Abrysvo vaccine earlier that day. Patient had tried tylenol and ice to help relieve the pain and stated that was still not helping. Was recommended to seek further care if still having problems. Unknown at this time if patient required further treatment.
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| 2861361 | 42 | M | FL | 09/25/2025 |
COVID19 |
MODERNA |
014C21A |
Blood test, Electroencephalogram, Magnetic resonance imaging, Malaise, Presyncop...
Blood test, Electroencephalogram, Magnetic resonance imaging, Malaise, Presyncope
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Patient never ever had any seisures or epilepsy in his entire life. After taking Moderna covid shot,...
Patient never ever had any seisures or epilepsy in his entire life. After taking Moderna covid shot, patient started to have presincope episodes. He was admitted to the hospital. When doctor asks when patient had episodes what does he feel, patient answers that he feels he is dyging during episodes. Extensive tests were done, and the doctors didn't find the reason except that Moderna vaccine could cause him these episodes. patient's neurologist ordered an MRI and EEG to test if there is anything else.
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| 2861362 | 16 | M | ND | 09/25/2025 |
MNQ |
SANOFI PASTEUR |
U8661AA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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PATIENT WAS GIVEN 3 DOSES OF MCV4, AT TIME OF REPORTING ADMINISTRATION OF 3RD DOSE, PATIENT WAS BEIN...
PATIENT WAS GIVEN 3 DOSES OF MCV4, AT TIME OF REPORTING ADMINISTRATION OF 3RD DOSE, PATIENT WAS BEING MONITORED FOR SIDE EFFECTS AS ADVISED BY PCP ACCORDING TO SCHOOL NURSE WHO SPOKE WITH MOM. AT THAT TIME, PATIENT WAS NOT EXPERIENCING ANY SIDE EFFECTS.
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| 2861363 | 40 | M | MS | 09/25/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA 30135BA |
Abdominal distension, Abdominal pain, Agitation, Altered visual depth perception...
Abdominal distension, Abdominal pain, Agitation, Altered visual depth perception, Amnesia; Anger, Angina pectoris, Aphasia, Arthralgia, Asthenia; Ataxia, Autoimmune disorder, Autonomic nervous system imbalance, Back pain, Balance disorder; Bladder dysfunction, Blepharospasm, Blood pressure fluctuation, Blood test, Bradycardia; Brain fog, Burning sensation, Central nervous system inflammation, Chest discomfort, Chest pain; Chills, Choking, Chronic sinusitis, Cognitive disorder, Computerised tomogram; Computerised tomogram head, Confusional state, Coordination abnormal, Craniotomy, Cyanosis; Decreased appetite, Demyelination, Depression, Diarrhoea, Disturbance in attention; Dizziness, Dysarthria, Dysphagia, Dysphonia, Dyspnoea; Dyspnoea exertional, Echocardiogram, Erectile dysfunction, Fatigue, Fibromyalgia; Flushing, Gait disturbance, Headache, Heart rate decreased, Heart rate increased; Hypersomnia, Hypertension, Hypoaesthesia, Idiopathic intracranial hypertension, Immediate post-injection reaction; Insomnia, Irritability, Joint swelling, Magnetic resonance imaging, Magnetic resonance imaging head; Magnetic resonance imaging heart, Mast cell activation syndrome, Migraine, Muscle spasms, Muscle twitching; Musculoskeletal chest pain, Myalgia, Nerve conduction studies, Neuralgia, Neuritis; Neurological symptom, Night sweats, Oral fungal infection, Pain of skin, Palpitations; Panic attack, Paraesthesia, Photophobia, Poor peripheral circulation, Post-acute COVID-19 syndrome; Presyncope, Pruritus, Pyrexia, Rash, Sensory disturbance; Sensory overload, Sinusitis, Skin reaction, Small fibre neuropathy, Staring; Subdural haematoma, Syncope, Temperature intolerance, Temperature regulation disorder, Tinnitus; Transient ischaemic attack, Tremor, Ventricular extrasystoles, Ventricular tachycardia, Vision blurred; Abdominal distension, Abdominal pain, Agitation, Altered visual depth perception, Amnesia; Anger, Angina pectoris, Aphasia, Arthralgia, Asthenia; Ataxia, Autoimmune disorder, Autonomic nervous system imbalance, Back pain, Balance disorder; Bladder dysfunction, Blepharospasm, Blood pressure fluctuation, Blood test, Bradycardia; Brain fog, Burning sensation, Central nervous system inflammation, Chest discomfort, Chest pain; Chills, Choking, Chronic sinusitis, Cognitive disorder, Computerised tomogram; Computerised tomogram head, Confusional state, Coordination abnormal, Craniotomy, Cyanosis; Decreased appetite, Demyelination, Depression, Diarrhoea, Disturbance in attention; Dizziness, Dysarthria, Dysphagia, Dysphonia, Dyspnoea; Dyspnoea exertional, Echocardiogram, Erectile dysfunction, Fatigue, Fibromyalgia; Flushing, Gait disturbance, Headache, Heart rate decreased, Heart rate increased; Hypersomnia, Hypertension, Hypoaesthesia, Idiopathic intracranial hypertension, Immediate post-injection reaction; Insomnia, Irritability, Joint swelling, Magnetic resonance imaging, Magnetic resonance imaging head; Magnetic resonance imaging heart, Mast cell activation syndrome, Migraine, Muscle spasms, Muscle twitching; Musculoskeletal chest pain, Myalgia, Nerve conduction studies, Neuralgia, Neuritis; Neurological symptom, Night sweats, Oral fungal infection, Pain of skin, Palpitations; Panic attack, Paraesthesia, Photophobia, Poor peripheral circulation, Post-acute COVID-19 syndrome; Presyncope, Pruritus, Pyrexia, Rash, Sensory disturbance; Sensory overload, Sinusitis, Skin reaction, Small fibre neuropathy, Staring; Subdural haematoma, Syncope, Temperature intolerance, Temperature regulation disorder, Tinnitus; Transient ischaemic attack, Tremor, Ventricular extrasystoles, Ventricular tachycardia, Vision blurred
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Reaction started immediately with fever, chills, severe headache, BP fluctuating between very low an...
Reaction started immediately with fever, chills, severe headache, BP fluctuating between very low and very high, full body shaking, numb,tingling, burning sensation all over body but worse in both hands and feet, tremor in hands. After the 2nd dose on 11/18/2021 pt lost conciousness at home, abulance was called, EMTs stated normal reaction after vaccination, monitor and go to ER if condition worsens. Pt showed worsening symptoms between this time and hospitalization on 02.05.2022. Cognitive issues with memory, word finding, slurring words, inability to focus, lessened reasoning and understanding. Pt began to run into things, trip over own feet. Went to ER on 02.05.2022, symptoms had worsened, stroke-like symptoms. Massive chronic subdural hematoma discovered requring emergency burr hole brain surgery and 5 day hospital stay. Pt's diagnoses to date include: Diagnoses: Chronic Subdural hematoma, Left sided Ataxia, Post-Covid vaccine injury, Mast Cell Activation Syndrome, Fibromyalgia, Small fiber neuropathy, Transient Ischemic Attack (TIA), Neuritis, Dysautonomia, Demyelinating syndrome of CNS, unspecified, autoimmune, Chronic progressive CNS inflammatory process, Intractable headache/migraine, Chronic diarrhea, Severe abdominal pain and bloating, Rash, nonspecific skin reaction, Blurred vision, inability to focus, Paresthesias, Myalgia, Shortness of breath on exertion, Loss of depth perception, Chest pain & tightness, Hypertension, Disease of nerves in arms and legs, hands and feet, Palpitations, Premature ventricular depolarization, Ventricular tachycardia, Bradycardia, Voiding dysfunction, Erectile dysfunction, Tinnitus, Frequent oral fungal infections, Anxiety/depression, Panic attacks, Angry outbursts/Irritability, Shortness of breath, Weakness, Dizziness, Syncope, Tremor, Insomnia, Chronic severe fatigue, Post-COVID syndrome, Anomia, Psuedotumor/CSF Hypertension, idiopathic, Chronic maxillary sinusitis/Chronic panusitis. Symptoms Include: Neurological Symptoms: Mental/Cognitive deficits, Short and long term memory loss, Brain fog/ inability to concentrate, Aphasia ๏ฟฝ inability to talk, difficulty speaking, trouble finding words, Using incorrect words/phrases, easily loses train of thought, repeating self, Loses focus easily/trouble concentrating, Easily confused, cannot follow complex conversations, Inability to multitask, Easily agitated or angered, Starring off into space/blank stare, Neuropathy/Small fiber neuropathy ๏ฟฝ constant pain, Dizziness/Light headed, Paresthesia ๏ฟฝ tingling/pins and needles/numbness in arms/hands and legs/feet, Bee sting sensations, Vibration sensations in thighs and arms, Intense itching on arms, legs, Sunburn/burning feeling across upper back/shoulders/neck, Twitching of eyelids on both eyes (upper and lower), Syncope/near syncope, Sensory Overload; Cannot tolerate crowds of people, lots of sounds, loud sounds, traffic, constant movement, too much social interaction, etc, Intractable headaches/migraines,Muscle twitching, shaking, tremors, trembling, weakness, Activity makes symptoms worse, Light sensitivity, Flushing, Night sweats, Insomnia with periods of excessive sleep, Hoarse/Low/Monotone voice, Temperature intolerance ๏ฟฝ inability to regulate body temperature, Anxiety, Depression, Panic attacks, Unsteady gait/balance problems, Impaired depth perception, Poor circulation in hand and feet, skin turning purplish blue, Choking ๏ฟฝ trouble swallowing food, drink, saliva, Vision issues ๏ฟฝ focusing on things, visual disturbances ๏ฟฝ 3D like or psychedelic, Chronic fatigue and exhaustion, Temperature Intolerance ๏ฟฝ cannot tolerate extremes in hot or cold temperatures Cardiac symptoms: Heart rate and BP that fluctuate high and low, Palpitations, Chest pain, Ventricular premature depolarization Gastrointestinal:Extreme abdominal cramping/bloating/pain, Diarrhea 5-10 times daily, Eat 1 meal a day usually due to pain, Loss of appetite due to pain Musculoskeletal - Fibromyalgia, Poor circulation in hands and feet - Skin turning purplish blue , Joint pain with fever & swelling in joint areas (knees and wrist are the worst), Muscle spasms ๏ฟฝ location depending on the day , Muscle pain/aches ๏ฟฝ usually across chest, neck and back - location depending on the day
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| 2861364 | 41 | M | TN | 09/25/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL 1284 EL 1284 EL1284 EL1284 |
Arthritis, Atrial fibrillation, Cardiac ablation, Inflammatory marker increased,...
Arthritis, Atrial fibrillation, Cardiac ablation, Inflammatory marker increased, Laboratory test; Metabolic dysfunction-associated liver disease, Poor quality sleep, Renal cyst, Serum ferritin increased; Arthritis, Atrial fibrillation, Cardiac ablation, Inflammatory marker increased, Laboratory test; Metabolic dysfunction-associated liver disease, Poor quality sleep, Renal cyst, Serum ferritin increased
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A-Fib (3 different heart medication & heart surgery ablation / facility stopped monitoring ) Non...
A-Fib (3 different heart medication & heart surgery ablation / facility stopped monitoring ) Non Alcoholic Fatty Liver Disease ( facility stopped monitoring & self supported liver detox supplements) kidney Polyps (facility stopped monitoring & self supported kidney detox supplements) Blood/Ferritin levels 1800?s ng/mL 6 x the normal range (No Treatment / self monitoring / detox supplements) Blood Inflammation Marks 4 x the normal range (No Treatment /self monitoring / detox supplements) Disrupted Poor Quality Sleep (No Treatment) Joint Inflammation - Knees, Feet, Ankles, Hips, Back, shoulders, Elbows, Wrists, Hands ( No Treatment
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| 2861365 | 16 | F | MI | 09/25/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
49M9N |
Paraesthesia oral, Urticaria
Paraesthesia oral, Urticaria
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Pt broke out in hives of left arm, right third digit, left forehead with tongue tingling w/in 3 minu...
Pt broke out in hives of left arm, right third digit, left forehead with tongue tingling w/in 3 minutes of receiving Bexsero.
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| 2861366 | 12 | F | FL | 09/25/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
7742A |
Wrong product administered
Wrong product administered
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Patient was due for Bexsero and Gardasil at the time of the visit. Patient was administered Bexsero ...
Patient was due for Bexsero and Gardasil at the time of the visit. Patient was administered Bexsero and Menveo instead. Patient had already had a dose of Menveo administered 08/19/2024. Staff member called the parent to inform them immediately. Mother expressed understanding and scheduled appointment for patient to receive Gardasil on 10/02/2025. The following day 09/25/2025 parent was called to check on patient post vaccine administration.
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| 2861367 | 0.17 | M | VA | 09/25/2025 |
DTAPHEPBIP HIBV PNC20 RV1 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
TE499 C47XX MA2523 5DH4A |
Crying; Crying; Crying; Crying
Crying; Crying; Crying; Crying
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Patient had prolonged (greater than 5 hours) of loud, inconsolable crying. 1ml dose of Tylenol was ...
Patient had prolonged (greater than 5 hours) of loud, inconsolable crying. 1ml dose of Tylenol was given per provider direction at home by parents.
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| 2861368 | 44 | F | CO | 09/25/2025 |
FLU3 HEP IPV TDAP UNK |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER |
F4A7R 9K34M Y1D03P1 X449Y Y013583 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration
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No abnormal signs and symptoms noted. Invalid dose and will readminister MMR alone in 4 weeks.
No abnormal signs and symptoms noted. Invalid dose and will readminister MMR alone in 4 weeks.
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| 2861369 | 50 | F | 09/25/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Chest discomfort, Eye pruritus, Hypersensitivity, Injection site swelling, Pruri...
Chest discomfort, Eye pruritus, Hypersensitivity, Injection site swelling, Pruritus; Rash
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Allergic reaction (itchy eyes, intense itching of hands with spots of rashes, tight chest), swelling...
Allergic reaction (itchy eyes, intense itching of hands with spots of rashes, tight chest), swelling of injection site to size of 1/2 a baseball and lingering rash days later
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| 2861370 | 42 | M | CO | 09/25/2025 |
FLU3 HEP IPV UNK |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR UNKNOWN MANUFACTURER |
F4A7R 9K34M Y1D03P1 Y013583 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration
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No abnormal signs and symptoms noted. Invalid dose and will readminister MMR alone in 4 weeks.
No abnormal signs and symptoms noted. Invalid dose and will readminister MMR alone in 4 weeks.
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| 2861371 | 3 | M | KY | 09/25/2025 |
DTAP DTAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9PT2F 9PT2F |
Erythema, Injection site erythema, Injection site oedema, Injection site pruritu...
Erythema, Injection site erythema, Injection site oedema, Injection site pruritus, Localised oedema; Oedema peripheral
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Mom reports redness at site on evening of 09/23. When he woke up on 09/24 redness and edema had spr...
Mom reports redness at site on evening of 09/23. When he woke up on 09/24 redness and edema had spread from elbow to top of shoulder/neck along with itching
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| 2861372 | 16 | F | 09/25/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
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Agitation, Speech disorder; Agitation, Speech disorder
Agitation, Speech disorder; Agitation, Speech disorder
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agitation, speech impairment
agitation, speech impairment
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| 2861373 | 13 | M | MI | 09/25/2025 |
MENB |
PFIZER\WYETH |
LF5302 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient did not have adverse event, but the wrong meningitis shot was given at age 13. Patient shou...
Patient did not have adverse event, but the wrong meningitis shot was given at age 13. Patient should have had Menquadfi
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| 2861374 | 4 | F | AL | 09/25/2025 |
PNC20 VARCEL |
PFIZER\WYETH MERCK & CO. INC. |
LX4486 z005455 |
Injection site erythema, Injection site reaction, Injection site swelling, Skin ...
Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion; Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
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patient developed a localized erythematous raised lesion measuring appx 2 cm x 3 cm on the left thig...
patient developed a localized erythematous raised lesion measuring appx 2 cm x 3 cm on the left thigh following vaccine administration. she denies generalized hives, pruritis or fever. MOP reports the lesion has remained unchanged in size over the past 2 weeks.
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| 2861375 | 22 | F | TX | 09/25/2025 |
FLU3 |
SEQIRUS, INC. |
409108 |
Headache, Heart rate increased, Muscular weakness
Headache, Heart rate increased, Muscular weakness
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After I recieved the vaccine my heart rate was racing super fast it was above 120bpm, I had a headac...
After I recieved the vaccine my heart rate was racing super fast it was above 120bpm, I had a headache, my extremities felt very weak, as well as I felt like I was short of breath.
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| 2861376 | 34 | M | TN | 09/25/2025 |
COVID19 COVID19 COVID19 COVID19 |
NOVAVAX NOVAVAX NOVAVAX NOVAVAX |
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Arthralgia, Back pain, Delirium, Dizziness, Dizziness postural; Exfoliative rash...
Arthralgia, Back pain, Delirium, Dizziness, Dizziness postural; Exfoliative rash, Head discomfort, Headache, Injection site pain, Malaise; Nausea, Neck pain, Pruritus, Pyrexia, Rash; Syncope
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Throughout and continuing: Post-injection site pain. 6am, Tues 9/23: Fever. 8am: Fever, dizziness u...
Throughout and continuing: Post-injection site pain. 6am, Tues 9/23: Fever. 8am: Fever, dizziness upon standing, nausea, feeling ill. On feeling need to vomit, fainting instead. Fainted twice. Fever continues throughout day, changing in strength. Full bedrest throughout day, 2x Ibuprophen (220mg) taken orally. Fever breaks, returns, breaks again, returns again late evening. Deliriousness, dizziness, and constant, powerful joint, head, neck, hip, and low back pain, reaching 6~7 / 10 throughout day. Fever breaks Morning of 9/24. Vitals taken by nurse at Rheumatology Clinic, BP normal (122/79). Blood drawn for normal treatment/monitoring of CREST syndrome. Headache and powerful, if brief (1~2 seconds) head pain and pressure upon changing from sitting -to-standing, coughing, laughing, shaking, etc. continuing and has not abated throughout. Late evening 9/24, itching on right-side neck (opposite injection side), rash discovered. 1ft in diameter, non-bite related, non-scaly, non-circular but contiguous. Rashes also discovered on left elbow and left ventral glute. Left outer elbow rash is almost precisely circular, non-itchy, but slightly scaly and dry. Left Ventral Glute rash is non-circular and not itchy. Rashes calm post-shower and sleep, have yet to strongly reappear as of writing (10:45am, 9/25). Headache upon changing position (standing-to-sitting-to-standing again) has not abated.
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| 2861377 | 64 | F | FL | 09/25/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
tfaa2503 z003579 |
Condition aggravated, Headache; Condition aggravated, Headache
Condition aggravated, Headache; Condition aggravated, Headache
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patient states that the headache that they were experiencing got worst and has been almost a week si...
patient states that the headache that they were experiencing got worst and has been almost a week since the vaccination
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| 2861378 | 40 | F | IL | 09/25/2025 |
HPV9 |
MERCK & CO. INC. |
2018414 |
Pruritus
Pruritus
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itching on palms of hands after vaccination
itching on palms of hands after vaccination
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| 2861379 | 58 | F | OH | 09/25/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
H3N97 |
Underdose
Underdose
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It was discovered on 9/24/25 by her doctor's office (we sent them confirmation of vaccines we a...
It was discovered on 9/24/25 by her doctor's office (we sent them confirmation of vaccines we administered) that we administered the Pediatric dose (720) instead of the Adult dose (1440) on 9/19/25. We notified the patient of this error by phone on 9/24/25. We reviewed a website which recommends the dose be repeated with the adult dose since the error was not realized on the day it was administered. We ordered the adult dose in and told the patient we would contact her when in so her dose can be repeated.
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| 2861380 | 0.5 | M | NM | 09/25/2025 |
DTPPVHBHPB PNC20 |
MSP VACCINE COMPANY PFIZER\WYETH |
U8313AA LP4946 |
Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negativ...
Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative; Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
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1-2 days after receiving vaccines, pt developed subjective fever. Able to measure temperatures star...
1-2 days after receiving vaccines, pt developed subjective fever. Able to measure temperatures starting 3 days after receiving vaccines, and had fever up to 105.2 on one day and 105.4 on another day. No other significant symptoms; viral swab tested to ensure no virus causing his fever. Fever eventually downtrended and pt recovered on his own. Concerned this high fever above 105 likely related to DTAP vaccine received.
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| 2861381 | 70 | F | NH | 09/25/2025 |
FLU3 |
SANOFI PASTEUR |
U8855CA |
Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
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I gave pt the inj, she flinches and stated it really hurt. She called today to notify me that her ar...
I gave pt the inj, she flinches and stated it really hurt. She called today to notify me that her arm was swollen, sore, and hot to the touch
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