| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2831803 | M | 03/17/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Condition aggravated, Lumbar radiculopathy, Neuropathy peripheral
Condition aggravated, Lumbar radiculopathy, Neuropathy peripheral
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Lumbar radiculopathy; pain running down from his back all the way to his foot; Lumbar radiculopathy;...
Lumbar radiculopathy; pain running down from his back all the way to his foot; Lumbar radiculopathy; pain running down from his back all the way to his foot; Neuropathy; tingling sensations on the bottom of his foot; This is a spontaneous report received from a consumer. Other Case identifier(s): NOV25-00101 (Novavax). A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Oct2024 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Lumbar radiculopathy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: LUMBAR RADICULOPATHY (medically significant), CONDITION AGGRAVATED (medically significant), outcome "not recovered" and all described as "Lumbar radiculopathy; pain running down from his back all the way to his foot"; NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Neuropathy; tingling sensations on the bottom of his foot". Therapeutic measures were taken as a result of lumbar radiculopathy, condition aggravated. The patient is going to try NOVAVAX COVID-19, if he and his wife could find a place that gives it, because the website that gave the patient's wife information didn't turn out to be true. They haven't even heard of NOVAVAX, which is kind of alarming. So, the patient had Moderna and Pfizer before (not a bad reaction to the Moderna), but he has an underlying issue with lumbar radiculopathy, he had 3 failed spine surgeries and the last time he had Moderna on 04Oct2024, he always has pain running down from his back all the way to his foot. It's part of his problem, why he had the surgeries and unfortunately, he is worse than before. It's sad, it doesn't work to take pills, so he doesn't do it, but the patient's wife does everything to help him. But when he had the last shot, he had a bit of neuropathy so, he started to have like these tingling sensations on the bottom of his foot, which was kind of unusual for him. So, he had had Moderna before, all the shots they can ever have, they are very careful, since they both have underlying medical conditions, they are still wearing masks and they never had COVID-19. But the patient's wife asked their doctor, what to think and the doctor said it sounds like maybe the Moderna caused inflammation that irritated his issues with his nerves in his spine. The doctor agreed with the patient's wife when she said the patient should try NOVAVAX. The doctor agreed to switch to NOVAVAX next time. So, the patient has some medical procedures coming up where he will have to be unmasked so, the patient's wife would really like to get him protected before then. So, one thought the wife has been working on the assumption that, at least with Moderna and Pfizer, they usually say it won't be effective for about 2 weeks after the shot has been given, so she thought to try maybe Novavax. They should check and see what the interval is because his next event where he must have his mouth open without a mask on, is on 31Mar2025 and then he has another one at the end of Apr2025. They have a usually a six-month interval between, at least Moderna and Pfizer they make them wait six months between vaccines. It's quite been six months, but the wife was pretty sure his doctor would write a prescription for it. The last one the patient took was on 04Oct2024, they usually spread them out, because they get side effects. The patient's wife was just curious, she doesn't know what Moderna and Pfizer what their actual level of effectiveness is these days. She thinks they felt like maybe 50% or something it's not like it used to be in the initial days of the first COVID-19 vaccines effectiveness against the variants. She asked if the company knows what kind of percentage they give the patients, well like Novavax with the current strains is 45% effective. She asked if they have any information or is that still pretty uncertain. The wife knows there are different ways of describing effectiveness like sometimes they will say it may not be as effective, maybe only 30% effective against getting, protection against having the infection but it's 50% effective against people being hospitalized. There are different ways to explain. So many people are like they're not going to bother. The wife knows somebody just took the shot and they still got COVID-19. So, the wife knows people telling me that, not necessarily Anti-vaxxers but sort of shrugging their shoulders and it's like the flu. The wife understands that is probably hard keeping up with all the variants that are coming in that are different and go for it. They know they could easily be those people who say, they don't want to get a vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2831804 | F | TX | 03/17/2025 |
FLU3 |
SANOFI PASTEUR |
UT8514A |
Exposure via skin contact, No adverse event
Exposure via skin contact, No adverse event
|
The serum fell on the table which is where it got into contact with her wrist (skin) later on with n...
The serum fell on the table which is where it got into contact with her wrist (skin) later on with no reported adverse event; The serum fell on the table which is where it got into contact with her wrist (skin) later on with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves unknown age adult medical assistant female patient who was exposed to influenza USP trival A-B subvirion no preservative vaccine [Fluzone] after it fell on the table, where it got into contact with her wrist (skin) 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, patient was exposed to an unknown dose of influenza USP trival A-B subvirion no preservative vaccine, Unknown strength, Suspension for injection, Expiry date 30-Jun-2025 and lot UT8514A via unknown route in unknown administration site for inlufenza due to serum fell on the table which is where it got into contact with her wrist (skin) later on with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency Same day) Reportedly, the vaccine serum leaked on the table during preparation, due to which it came in contact with medical assistant's wrist later on. This incident did not occurred with other vaccines when caps were opened, and she was advised to contact the manufacturer. 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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| 2831805 | 29 | PA | 03/17/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered
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patient received Fluzone HD yesterday instead of Fluzone Tri with no reported adverse event; Initial...
patient received Fluzone HD yesterday instead of Fluzone Tri with no reported adverse event; Initial information received on 07-Mar-2025 (with live follow up processed together CSD: 07-Mar-2025) regarding an unsolicited valid non-serious case received from a other health professional. This case involves 29 years old (unknown gender) patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] yesterday instead of influenza USP trival A-B subvirion no preservative vaccine [Fluzone] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Mar-2025, the patient received an unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe instead of influenza USP trival A-B subvirion no preservative vaccine, Suspension for injection both with (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (wrong product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, The caller would like to know if there are any next steps. The caller was asked for additional AE information and she states, that is all I have and that the patient was given the wrong dose. The caller called again to report that a 5/8 inch needle was used for administration instead of the recommended 1 inch needle. 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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| 2831806 | 13 | F | GA | 03/17/2025 |
FLU3 |
SANOFI PASTEUR |
UT8468MA |
No adverse event
No adverse event
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FLUZONE NP is given with Varivax on the same day. Both were given in the left arm, with no reported ...
FLUZONE NP is given with Varivax on the same day. Both were given in the left arm, with no reported AE; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 13 years old female patient who was administered Quadrivalent Influenza Vaccine [FLUZONE] NP with Varicella zoster vaccine live (Oka/Merck) [Varivax] on the same day and both were given in the left arm, 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 Varicella zoster vaccine live (Oka/Merck) (Varivax) for influenza immunization. On 05-Mar-2025, the patient received 0.5mL of suspect Quadrivalent Influenza Vaccine, Suspension for injection (lot UT8468MA, expiry date 30-Jun-2025, strength standard and frequency once) via intramuscular route in the left arm for Influenza (Influenza immunisation) and fluzone np is given with varivax on the same day. both were given in the left arm, with no reported adverse event (Lack of vaccination site rotation) (latency same day). Action taken was not applicable.
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| 2831807 | MS | 03/17/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
|
Expired product administered
Expired product administered
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administration of an expired pentacel to a patient with no reported ae; Initial information received...
administration of an expired pentacel to a patient with no reported ae; Initial information received on 12-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received an expired 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. On an unknown date in 2025, the patient received an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] Suspension for injection, unknown strength expiry date 12-Feb-2025 and lot number not reported via unknown route in unknown administration site for immunization with no reported adverse event(Expired product administered) (Latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Reporter relationship : Healthcare professional, Product used : Used; Age Group: Unknown 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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| 2831808 | 8 | M | NJ | 03/17/2025 |
DTAP |
SANOFI PASTEUR |
3CA11C1 |
No adverse event, Product administered to patient of inappropriate age, Wrong pr...
No adverse event, Product administered to patient of inappropriate age, Wrong product administered
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daptacel to a patient that was already 8 years old with no reported ae instead of adacel; Initial in...
daptacel to a patient that was already 8 years old with no reported ae instead of adacel; Initial information received on 12-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 years old male patient who received Diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] to a patient that was already 8 years old instead of Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 Polio vaccine for Polio immunisation; and Influenza vaccine for Influenza immunisation. On 17-Feb-2025, the patient received an unknown dose 4 of suspect Diphtheria-15/tetanus/5 AC pertussis vaccine suspension for injection (formulation, strength-unknown) (lot 3CA11C1) via intramuscular route in the right arm for Immunization instead of Diphtheria-2/tetanus/5 AC pertussis vaccine with no reported AE (wrong product administered). 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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| 2831809 | 21 | F | TX | 03/17/2025 |
FLU3 |
SANOFI PASTEUR |
UT8514NA |
Exposure during pregnancy, Extra dose administered, No adverse event
Exposure during pregnancy, Extra dose administered, No adverse event
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administered a second dose of FLUZONE NP to a pregnant patient with no reported adverse event; admin...
administered a second dose of FLUZONE NP to a pregnant patient with no reported adverse event; administered a second dose of FLUZONE NP to a pregnant patient with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 years old pregnant female patient who received a second dose of influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 17 weeks of pregnancy. The date of last menstrual period was reported as 28-Nov-2024. The estimated due date is 04-Sep-2025. The patient's past vaccination(s) included Influenza vaccine in OCT-2021 and Influenza vaccine on 13-JAN-2025. The patient's past medical history, medical treatment(s) and family history were not provided. The patient had unknown number of previous pregnancy/ies. On 12-Mar-2025, the pregnant patient received 0.5 ml of dose 3 of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date- 30-JUN-2025 and lot UT8514NA) via intramuscular route in the left deltoid for Influenza immunization. with no reported adverse event (exposure during pregnancy) (extra dose administered) (latency- same day). There was no information regarding relevant prenatal testing after exposure. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing. 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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| 2831810 | CO | 03/17/2025 |
UNK |
UNKNOWN MANUFACTURER |
AW1696A |
Dyspnoea, Injection site erythema, Injection site pain, Wheezing
Dyspnoea, Injection site erythema, Injection site pain, Wheezing
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Shortness of breath; Wheezing; Site of injection erythema and pain; Site of injection erythema and p...
Shortness of breath; Wheezing; Site of injection erythema and pain; Site of injection erythema and pain; This spontaneous case, initially received on 25-Feb-2025, was reported by a health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On an unknown date, the patient received Afluria (TIV) for unknown indication, dose, route of administration and anatomical location not reported. Lot number: AW1696A. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Shortness of breath (outcome: Not Reported), Wheezing (outcome: Not Reported), Site of injection erythema and pain (outcome: Not Reported), Site of injection erythema and pain (outcome: Not Reported). Afluria (TIV) action taken: Not Applicable Reporter assessment: the reporter did not provide seriousness and causality assessment for the events.; Reporter's Comments: The events are related to Afluria
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| 2831811 | 73 | F | CA | 03/17/2025 |
FLUX |
UNKNOWN MANUFACTURER |
No batch number |
Influenza
Influenza
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The patient was reported to be infected with Influenza A variant subtype H1N1, although the patient ...
The patient was reported to be infected with Influenza A variant subtype H1N1, although the patient was vaccinated in the year of presentation; This literature report (initial receipt: 04-Mar-2025) concerns an elderly female patient (Patient 3) diagnosed with Influenza A. The patient was reported to be infected with Influenza A variant subtype H1N1, although the patient was vaccinated with influenza virus vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up) in the year of presentation.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. 100% success rate cannot be reasonably assumed in every patient. Furthermore, due to lack of more detailed information (e.g. patients risk factors and medical history, dosing details and brand of vaccine) causality cannot be excluded.
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| 2831815 | PR | 03/17/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y015108 |
Product storage error; Product storage error
Product storage error; Product storage error
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incorrect product storage; This spontaneous report was received from nurse and refers to a patient o...
incorrect product storage; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 10-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y015108, expiration date: 06-Sep-2026) 0.5 mL (0.5ML, route of administration was not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). The vaccine was administered after temperature excursion.
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| 2831816 | 03/17/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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had Shingrix vaccination in 2022 and again today March 8 2025; This non-serious case was reported by...
had Shingrix vaccination in 2022 and again today March 8 2025; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose of vaccine in 2022). On 08-MAR-2025, the patient received the 2nd dose of Shingrix. On 08-MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: had Shingrix vaccination in 2022 and again today March 8 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 08-MAR-2025 This case was reported by a patient via (chatbot) interactive digital media. The patient received 2nd dose of Shingrix vaccine later than the recommended schedule, which led to lengthening of vaccination schedule.. The reporter wanted to know if a third dose was necessary for efficacy.
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| 2831817 | M | IN | 03/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dizziness, Dyspnoea
Dizziness, Dyspnoea
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Shortness of breath; Dizziness; This is a spontaneous report received from a Consumer or other non H...
Shortness of breath; Dizziness; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; DIZZINESS (non-serious), outcome "unknown". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2831818 | M | KY | 03/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Influenza virus test, SARS-CoV-2 test
COVID-19, Drug ineffective, Influenza virus test, SARS-CoV-2 test
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COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A...
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 64-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER)), for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The event "covid" required physician office visit. Clinical course: the patient stated he was leaving to go out of the country, and he thought he had a little bit of a cold. The patient thought he should get tested for the flu, which was negative. The results, however, found that he had COVID. The patient stated that he had all the "past vaccinations and boosters and everything I had had, but the very last one back about a year ago I didn't get, and they diagnosed me with that, and so the doctor said you need to start taking (nirmatrelvir, ritonavir) PAXLOVID today, because if you take it today then by the time you leave Monday it will run the course." The patient then stated he didn't feel bad at all, but he was told he was positive for COVID, and they were calling in a prescription for nirmatrelvir, ritonavir. Later, the patient then confirmed they had taken "all the vaccinations" (as reported). The patient was seen by a nurse practitioner; however, he spoke to a doctor and the patient was told he definitely need to take nirmatrelvir, ritonavir." The patient underwent the following laboratory tests and procedures: Influenza virus test: Negative; SARS-CoV-2 test: Positive. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2831819 | M | 03/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19
COVID-19
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Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elder...
Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An elderly male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 09Mar2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pneumonia" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COVID-19 (non-serious) with onset 12Mar2025, outcome "unknown", described as "Covid". Additional information: The reporter is calling on behalf of her husband which had Covid yesterday (12Mar2025). She mentioned that he had a Pfizer Covid shot which he is fine when he got this but three days later, he got covid. She also mentioned that he is a high risk because he is older and had pneumonia a couple of times. She was told to buy Paxlovid but it will cost them which they need help for it. The patient had (health insurance name redacted) and he has supplement with (redacted). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2831820 | 1 | F | UT | 03/17/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK107AA |
Product preparation issue
Product preparation issue
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PENTACEL was administered but only the liquid portion containing the DTap-IPV with no reported AE; I...
PENTACEL was administered but only the liquid portion containing the DTap-IPV with no reported AE; Initial information received on 12-Mar-2025 (with live follow up process together with CSD: 12-Mar-2025) regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 1 years 2 month old female patient whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] pentacel was administered but only the liquid portion containing the dtap-ipv with no reported AE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination (Immunisation). On 05-Mar-2025, the patient received an unknown dose (0.5ml) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine; Suspension for injection with unknown strength (lot UK107AA with expiry date 30-Sep-2025) via intramuscular route in unknown administration site for Immunization. On 05-Mar-2025 the patient developed pentacel was administered but only the liquid portion containing the dtap-ipv with no reported ae (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. Additional information was received on 12-Mar-2025
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| 2831821 | 0.17 | F | ID | 03/17/2025 |
DTPPVHBHPB IPV PNC20 RV5 |
MSP VACCINE COMPANY SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
U7801AA W1B511M LC5484 X026992 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Administration error. I gave both Vaxelis and IPOC polio vaccines. Neither I nor the person who veri...
Administration error. I gave both Vaxelis and IPOC polio vaccines. Neither I nor the person who verified realized that Vaxelis contained a dose of polio vaccine. I immediately called facility and spoke to a representative who advised me that it "should be okay." Called pt's mom and informed her of the error, asked her to monitor patient for any adverse reactions and bring her back to the clinic if she had any concerns. She stated that patient had not has any adverse reactions.
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| 2831836 | 78 | F | 03/17/2025 |
PNC20 |
PFIZER\WYETH |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Prevnar20 pneumococcal vaccine given on 5/14/24 and 3/13/25 which exceeds recommendation interval
Prevnar20 pneumococcal vaccine given on 5/14/24 and 3/13/25 which exceeds recommendation interval
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| 2831837 | 47 | M | OR | 03/17/2025 |
FLU3 |
SEQIRUS, INC. |
U85000BA |
Rash
Rash
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Pt came to clinic with rash covering trunk, back and arms on 03/12/25 that started on 03/07/25 after...
Pt came to clinic with rash covering trunk, back and arms on 03/12/25 that started on 03/07/25 after getting vaccines on 02/26/25. Provider contributed rash to reaction from vaccines. Unknown which vaccine.
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| 2831838 | 84 | M | WA | 03/17/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Bell's palsy, Facial paralysis
Bell's palsy, Facial paralysis
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Patient developed left facial eyelid and lip drooping two days after vaccine administration and was ...
Patient developed left facial eyelid and lip drooping two days after vaccine administration and was diagnosed with Bell's palsy.
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| 2831839 | 54 | M | IN | 03/17/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
2me34 |
No adverse event, Underdose
No adverse event, Underdose
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No adverse event. Patient was administered the pediatric dose of Hep B instead of the Adult dose o...
No adverse event. Patient was administered the pediatric dose of Hep B instead of the Adult dose of HEP B Energix. No complications
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| 2831840 | 37 | M | OR | 03/17/2025 |
HPV9 |
MERCK & CO. INC. |
y005835 |
Chest pain, Myalgia
Chest pain, Myalgia
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severe chest pain started on the evening on day of vaccination. Called today (Monday 3/17/2025) and...
severe chest pain started on the evening on day of vaccination. Called today (Monday 3/17/2025) and reported that he still has chest pain and muscle pain all over the body. The pain was less intense than the night of vaccination. He took ibuprofen but did not help with the pain. I referred him to see his PCP.
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| 2831841 | 67 | F | PA | 03/17/2025 |
COVID19 |
MODERNA |
3043823 |
Injection site erythema, Injection site pain
Injection site erythema, Injection site pain
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Patient developed red spots and soreness around injection site on the day following immunization (03...
Patient developed red spots and soreness around injection site on the day following immunization (03/16/25). Two days after immunization (03/17/25), the redness spread and there is a larger red spot around injection site with continued soreness. Patient denied hives, swelling, difficulty breathing, or anaphylactic reaction.
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| 2831842 | 36 | M | FL | 03/17/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
IK6650 7zm55 |
Herpes zoster; Herpes zoster
Herpes zoster; Herpes zoster
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Patients states he developed a shingles outbreak today 03/17/2025 on his lower back, He saw a doctor...
Patients states he developed a shingles outbreak today 03/17/2025 on his lower back, He saw a doctor virtually and was prescribed Valacyclovir 1 gram 1 tablet three times a day for 7 days
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| 2831843 | 67 | F | UT | 03/17/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Urticaria
Urticaria
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Hives
Hives
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| 2831844 | 21 | M | WA | 03/17/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0590 |
Syncope, Vomiting
Syncope, Vomiting
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Patient informed pharmacist and technician that patient has a tendency to faint after vaccines or bl...
Patient informed pharmacist and technician that patient has a tendency to faint after vaccines or blood draws. Pharmacist and staff were alerted before giving a COVID vaccine. COVID vaccine was delivered by pharmacy technician, and patient fainted after the vaccination. Pharmacist was present checking for pulse, and breath. Patient was still breathing and responding when name was called. After drinking water, patient stated he was getting better. Then, patient had a second episode. Patient was still conscious at the moment. Patient vomited, and mentioned patient has not had any food after breakfast. Patient felt better after drinking more water and eating chocolate. Patient was escorted out after feeling better.
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| 2831845 | 4 | M | LA | 03/17/2025 |
PPV |
MERCK & CO. INC. |
Y009239 |
Urticaria
Urticaria
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Hives. Lasting13+ weeks. (Still has them)
Hives. Lasting13+ weeks. (Still has them)
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| 2831846 | 45 | M | FL | 03/17/2025 |
PNC20 |
PFIZER\WYETH |
lk6650 |
Extra dose administered
Extra dose administered
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Patient received vaccination on on 8-2-24 and received it again on 3-15-25
Patient received vaccination on on 8-2-24 and received it again on 3-15-25
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| 2831847 | 0.33 | F | MN | 03/17/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Diarrhoea, Faeces discoloured; Diarrhoea, Faeces discoloured
Diarrhoea, Faeces discoloured; Diarrhoea, Faeces discoloured
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Diarrhea lasted for 4 weeks. 3-6 watery green-gray colored bowel movements a day. Mostly in the midd...
Diarrhea lasted for 4 weeks. 3-6 watery green-gray colored bowel movements a day. Mostly in the middle of the night. about 36 hrs after 4 month shots. No dehydration symptoms. Occasional cramping but baby was overall content.b was seen for a cold 10 days in and pediatrician said if it lasted a month out would Be concerning, unless there was signs of dehydration. Probiotic was given after about a week. One dose Every day. Didn?t help.
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| 2831848 | 90 | F | IL | 03/17/2025 |
PNC21 RSV VARZOS |
MERCK & CO. INC. PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
Y013009 LG9828 MG5S9 |
Hypersensitivity; Hypersensitivity; Hypersensitivity
Hypersensitivity; Hypersensitivity; Hypersensitivity
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PATIENT HAD ALLERGIC REACTION TO THE VACCINES AND WAS TAKEN THE ER. PATIENT WAS IN THE HOSPITAL FO...
PATIENT HAD ALLERGIC REACTION TO THE VACCINES AND WAS TAKEN THE ER. PATIENT WAS IN THE HOSPITAL FOR 2 DAYS WAS DISCHARGED
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✓ | |||||
| 2831849 | 71 | M | 03/17/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Deep vein thrombosis, Pulmonary embolism
Deep vein thrombosis, Pulmonary embolism
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Patient received RSV vaccine approximately 6 weeks prior to ED visit for bilateral pulmonary embolis...
Patient received RSV vaccine approximately 6 weeks prior to ED visit for bilateral pulmonary embolism with saddle, and bilateral lower extremity DVT. No other obvious causes for development of blood clots. Specific vaccine unknown.
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✓ | ||||||
| 2831610 | 2 | F | TX | 03/16/2025 |
HPV9 |
MERCK & CO. INC. |
LG5574 |
Wrong patient
Wrong patient
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My daughter was going to her 30 month check up and the doctor stated my sons were only getting shots...
My daughter was going to her 30 month check up and the doctor stated my sons were only getting shots since it was there 6 month appointment so when the nurse came into the room she said my daughter was going first with shots I stated that I thought she wasn t getting shots the doctor said. The nurse told me she does get a shot so I thought maybe it was a miss communication. I went to go book our next appointment and asked the lady at check out do they get shots at 30 months. She stated no and called the nurse asking why did patient received a shot. The nurse told her she gave her another patient shot. I didn t know anything about that shot and my rights was taking away from me on a mistake. I didn t get a chance to decide if I wanted my daughter to get the shot.
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| 2831611 | 14 | F | MO | 03/16/2025 |
HPV9 |
MERCK & CO. INC. |
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Arthralgia, Depression, Migraine, Premature menopause
Arthralgia, Depression, Migraine, Premature menopause
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Chronic worsening joint pain, onset of chronic severe migraines, depression anxiety onset - all with...
Chronic worsening joint pain, onset of chronic severe migraines, depression anxiety onset - all within a few months of vaccine. Now at the age of 33, in premature ovarian failure (but symptoms have been present and worsening for at least 5 years)
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| 2831612 | 11 | M | CA | 03/16/2025 |
HPV9 HPV9 HPV9 MNQ MNQ MNQ TDAP TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Cough, Fear, Loss of personal independence in daily activities, Malaise, Middle ...
Cough, Fear, Loss of personal independence in daily activities, Malaise, Middle insomnia; Oropharyngeal pain, Pain in extremity, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative; Speech disorder; Cough, Fear, Loss of personal independence in daily activities, Malaise, Middle insomnia; Oropharyngeal pain, Pain in extremity, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative; Speech disorder; Cough, Fear, Loss of personal independence in daily activities, Malaise, Middle insomnia; Oropharyngeal pain, Pain in extremity, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative; Speech disorder
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My son started feeling pain to both arms Wednesday 3/12 5pm and his waterpolo coach sent him home. T...
My son started feeling pain to both arms Wednesday 3/12 5pm and his waterpolo coach sent him home. Thursday 3/13, the school sent him home at 10am due to low fever and congestion, cough. Friday 3/14, he is still out of school and unable to joing waterpolo and jiujitsu practice due to being sick. COVID test negative. Children?s Tylenol given as needed for fever. Friday night, he dropped a glass of water and broke it. He also woke up from his sleep and started talking nonsense and random things. He felt fine after and went back to bed. Saturday 3/15, still with some low grade fever, congestion, body malaise, cough, sore throat and congestion. Children?s Tylenol as needed. Tonight 3/15 at about 11:15pm, I heard a thud in his bedroom. I went to check on him and he said that he missed a step on his bunkbed and his foot landed on the floor. He then stated he doesn?t know why but he is feeling aftraid and then he started talking about random things and nothing was making sense. This went on for 10mins. I did a mini neuro check - A&O x4, no headache, no balance issues. When he started feeling okay, he said he doesn?t remember what I am talking about with him about talking nonsense.
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| 2831613 | 51 | F | FL | 03/16/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y011819 93KK4 |
Dizziness, Influenza virus test negative, Nausea, Pain, SARS-CoV-2 test negative...
Dizziness, Influenza virus test negative, Nausea, Pain, SARS-CoV-2 test negative; Dizziness, Influenza virus test negative, Nausea, Pain, SARS-CoV-2 test negative
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Patient had pain, body aches, nausea, lightheadedness
Patient had pain, body aches, nausea, lightheadedness
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| 2831614 | 58 | F | IN | 03/16/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EN6198 EN6198 EN6198 |
Blood potassium decreased, Bone pain, Cytogenetic analysis, Familial periodic pa...
Blood potassium decreased, Bone pain, Cytogenetic analysis, Familial periodic paralysis, Hypersensitivity; Hypertension, Immunodeficiency, Impaired work ability, Influenza, Myalgia; Pyrexia
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Low grade temp., flu symptoms, muscle aches and bone pain
Low grade temp., flu symptoms, muscle aches and bone pain
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✓ | ✓ | ✓ | |||
| 2831615 | 7 | F | NV | 03/16/2025 |
MMR MMR VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
N013279 N013279 N017399 N017399 |
Abdominal pain, Anxiety, Asthma, Attention deficit hyperactivity disorder, Const...
Abdominal pain, Anxiety, Asthma, Attention deficit hyperactivity disorder, Constipation; Eczema, Endoscopy gastrointestinal abnormal, Gastrointestinal disorder, Gastrooesophageal reflux disease, Intestinal obstruction; Abdominal pain, Anxiety, Asthma, Attention deficit hyperactivity disorder, Constipation; Eczema, Endoscopy gastrointestinal abnormal, Gastrointestinal disorder, Gastrooesophageal reflux disease, Intestinal obstruction
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My child was completely healthy prior to vaccination. After receiving 21 vaccines between 8/8/2017 a...
My child was completely healthy prior to vaccination. After receiving 21 vaccines between 8/8/2017 and 1/18/2022, my child developed: ADHD (diagnosed), Asthma (diagnosed), GERD (diagnosed), Eczema (diagnosed), Anxiety (diagnosed), and severe digestive issues (abdominal pain, constipation, and bowel impaction requiring endoscopy). Symptoms progressively worsened after each vaccination. ADHD symptoms, digestive issues, and asthma became severe and required medical intervention. Treatments received are as follows: ADHD- ongoing therapy, behavioral interventions, and a 504 plan in school; Asthma- prescribed inhaler and allergy management; GERD- acid reflux medication and dietary changes; Eczema- prescription creams and allergy testing; Anxiety- ongoing therapy, behavioral support and medication; Digestive Issues- endoscopy between 2018-2019, Miralax for 6 weeks, ongoing dietary changes. Outcome: My child now requires lifelong management and medical care for these conditions. These adverse events have significantly impacted my child's daily life and ability to function normally.
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✓ | |||||
| 2831616 | 30 | F | TX | 03/16/2025 |
VARCEL |
MERCK & CO. INC. |
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Pruritus
Pruritus
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It was really itchy for a few days, but no rash.
It was really itchy for a few days, but no rash.
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| 2831617 | 63 | F | FL | 03/16/2025 |
FLU3 |
SEQIRUS, INC. |
946614 |
Burning sensation, Pruritus, Rash
Burning sensation, Pruritus, Rash
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Patient stated rash from head to toe, burning sensation, and itching for almost 2 weeks.
Patient stated rash from head to toe, burning sensation, and itching for almost 2 weeks.
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| 2831618 | 4 | M | NV | 03/16/2025 |
DTAP DTAP DTAP HIBV HIBV HIBV IPV IPV IPV MMR MMR MMR PNC13 PNC13 PNC13 VARCEL VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Adenoidectomy, Anxiety, Coordination abnormal, Dyscalculia, Dysgraphia; Dyslexia...
Adenoidectomy, Anxiety, Coordination abnormal, Dyscalculia, Dysgraphia; Dyslexia, Eczema, Gait disturbance, Hypersensitivity, Learning disorder; Muscular weakness; Adenoidectomy, Anxiety, Coordination abnormal, Dyscalculia, Dysgraphia; Dyslexia, Eczema, Gait disturbance, Hypersensitivity, Learning disorder; Muscular weakness; Adenoidectomy, Anxiety, Coordination abnormal, Dyscalculia, Dysgraphia; Dyslexia, Eczema, Gait disturbance, Hypersensitivity, Learning disorder; Muscular weakness; Adenoidectomy, Anxiety, Coordination abnormal, Dyscalculia, Dysgraphia; Dyslexia, Eczema, Gait disturbance, Hypersensitivity, Learning disorder; Muscular weakness; Adenoidectomy, Anxiety, Coordination abnormal, Dyscalculia, Dysgraphia; Dyslexia, Eczema, Gait disturbance, Hypersensitivity, Learning disorder; Muscular weakness; Adenoidectomy, Anxiety, Coordination abnormal, Dyscalculia, Dysgraphia; Dyslexia, Eczema, Gait disturbance, Hypersensitivity, Learning disorder; Muscular weakness
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After receiving vaccines on 9/8/17, my child began experiencing trouble walking, loss of coordinatio...
After receiving vaccines on 9/8/17, my child began experiencing trouble walking, loss of coordination, and weakening of leg muscles, which were significant enough to cause concern, This issue gradually improved after undergoing an intense holistic detox treatment, which seemed to alleviate the symptoms. In addition to the leg muscle issues, my child developed the following long-term health conditions after receiving a total of 25 vaccines from 8/8/17 through 1/10/23, which began shortly after vaccination: Specific Learning Disorders (diagnosed with Dyslexia, Dysgraphia, and Dyscalculia; Eczema (diagnosed); Anxiety (diagnosed); and Allergies (disgnoased, requiring adenoid removal and ongoing medication). These health conditions have persisted and worsened over time, leading to chronic issues and requiring continuous medication and therapy managment. Treatments Received: Leg Muscle Weakness- underwent an intense holistic detox treatment, which improved walking, loss of coodination, and leg muscle strength; Specific Learning Disorders- ongoing educational interventions and accommodations; Eczema- ongoing topical treatments to manage flare-ups; Anxiety- ongoing therapy and behavioral support; Allergies- adenoid removal surgery and ongoing medication to manage chronic allergy symptoms. Outcome: These adverse events, including the leg muscle weakness and development of ongoing conditions, have permantently impacted my child's health. The leg muscle weakness improved with holistic detox treatment, but the other conditions - Specific Learning Disorders, Eczema, Anxiety, and Allergies - have persisted and require ongoing medical and educational managment. These conditions continue to significantly affect my child's daily life and functioning, and they have required long-term intervention.
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| 2831619 | 64 | M | NJ | 03/16/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
y013009 y013009 |
Dizziness, Erythema, Feeling cold, Injection site induration, Injection site mas...
Dizziness, Erythema, Feeling cold, Injection site induration, Injection site mass; Pain in extremity, Pruritus
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patient experienced arm pain/dizziness/feeling cold start night of immunization. Patient came in tod...
patient experienced arm pain/dizziness/feeling cold start night of immunization. Patient came in today big red patch traveling down arm and has hard lump by injection site. Also arm is itchy
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| 2831620 | 81 | F | AL | 03/16/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient had previously received the shot in 2022. Patient is not experiencing any side effects.
Patient had previously received the shot in 2022. Patient is not experiencing any side effects.
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| 2831621 | 11 | M | MI | 03/16/2025 |
DTAPIPV |
SANOFI PASTEUR |
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Wrong product administered
Wrong product administered
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Quadracel was given instead of Menactra that he was due for
Quadracel was given instead of Menactra that he was due for
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| 2831622 | 11 | M | MI | 03/16/2025 |
DTAPIPV |
SANOFI PASTEUR |
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Wrong product administered
Wrong product administered
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Quadracel was given instead of the Menactra he was due for
Quadracel was given instead of the Menactra he was due for
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| 2831623 | 61 | F | PA | 03/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
fj9a7 |
Extra dose administered, No adverse event, Wrong patient received product
Extra dose administered, No adverse event, Wrong patient received product
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Patient was miss-identified and received a dose of Shingrix intended for her mother. She has already...
Patient was miss-identified and received a dose of Shingrix intended for her mother. She has already received 2 doses of Shingrix in prior months
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| 2831624 | 71 | F | SC | 03/16/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
GH9693 GH9693 |
Biopsy skin abnormal, Cutaneous T-cell lymphoma, Exfoliative rash, Pruritus, Ras...
Biopsy skin abnormal, Cutaneous T-cell lymphoma, Exfoliative rash, Pruritus, Rash; Rash macular, Urticaria
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Initially, itching over most of body, then red blotches over body, finally scaly rash on lower back
Initially, itching over most of body, then red blotches over body, finally scaly rash on lower back
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| 2831625 | 78 | F | FL | 03/16/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
JB27A |
Extra dose administered
Extra dose administered
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unnecessary vaccine given. series previously completed
unnecessary vaccine given. series previously completed
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| 2831626 | 88 | F | MI | 03/16/2025 |
COVID19 |
MODERNA |
8081561 |
Dyspnoea, Pericardial effusion, Pleural effusion
Dyspnoea, Pericardial effusion, Pleural effusion
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Per patient she was very short of breath the next day. She went to her MD and has been on Lasix eve...
Per patient she was very short of breath the next day. She went to her MD and has been on Lasix ever since. She believes the vaccine has caused her to retain fluid on her heart and lungs
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✓ | |||||
| 2831627 | 82 | M | KY | 03/16/2025 |
PNC21 |
MERCK & CO. INC. |
t019157 |
Injection site erythema, Pyrexia
Injection site erythema, Pyrexia
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fever for 2 days post injection and redness around injection site. still some redness 5 days later
fever for 2 days post injection and redness around injection site. still some redness 5 days later
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| 2831628 | 63 | F | FL | 03/16/2025 |
FLU3 |
SEQIRUS, INC. |
946626 |
No adverse event
No adverse event
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No adverse events reported by patient. called on 3/16/25
No adverse events reported by patient. called on 3/16/25
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| 2831629 | 0.33 | M | MN | 03/16/2025 |
FLU3 HEPA MMR VARCEL |
SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
u8523da y013274 y005808 y013346 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Officer for further Immunization plan and will contact mother back with plan on next business day Mo...
Officer for further Immunization plan and will contact mother back with plan on next business day Monday March 17. Mother was called back with this plan via phone Interpreter. No further questions from patients mother.
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