| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843429 | 21 | F | AZ | 05/30/2025 |
IPV |
SANOFI PASTEUR |
Y1A212M |
Syncope
Syncope
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A few minutes after the patient was given the shot they fainted. Patient was with her mother and fat...
A few minutes after the patient was given the shot they fainted. Patient was with her mother and father who are aware of her history of fainting (has happened with blood draws in the past). Patient was monitored closely for about 20 min and recovered. Patient did not report any harm as a result of fainting
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| 2843430 | 38 | F | MN | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Injection site pain
Injection site pain
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Ongoing pain after the initial vaccination. That was Moderna. My next 3 vaccine boosters have been p...
Ongoing pain after the initial vaccination. That was Moderna. My next 3 vaccine boosters have been phizer. My shoulder site of vaccine either aches or stings periodically still 5 years later.
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| 2843507 | 0.17 | M | IL | 05/30/2025 |
DTPPVHBHPB DTPPVHBHPB PNC20 PNC20 RV1 RV1 DTPPVHBHPB DTPPVHBHPB PNC20 PNC20 |
MSP VACCINE COMPANY MSP VACCINE COMPANY PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MSP VACCINE COMPANY MSP VACCINE COMPANY PFIZER\WYETH PFIZER\WYETH |
U8265AA U8265AA LJ5282 LJ5282 HP495 HP495 U8265AA U8265AA LJ5282 LJ5282 |
Injection site reaction, Rash, Rash erythematous, Rash macular, Rash maculo-papu...
Injection site reaction, Rash, Rash erythematous, Rash macular, Rash maculo-papular; Rash, Urticaria; Injection site reaction, Rash, Rash erythematous, Rash macular, Rash maculo-papular; Rash, Urticaria; Injection site reaction, Rash, Rash erythematous, Rash macular, Rash maculo-papular; Rash, Urticaria; Injection site reaction, Rash, Rash erythematous, Rash macular, Rash maculo-papular; Rash, Urticaria; Injection site reaction, Rash, Rash erythematous, Rash macular, Rash maculo-papular; Rash, Urticaria
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Diffuse erythematous maculopapular rash began about two hours after injection, on face, back, chest ...
Diffuse erythematous maculopapular rash began about two hours after injection, on face, back, chest / abdomen, upper arms and legs, sparing palms/soles. Annular erythematous macules over bilateral injection sites. No vomiting, diarrhea, fussiness, facial/oral swelling, difficulty breathing, fever, lethargy. 5/30/2025 Update information: Attempted to contact parents and no answer to obtain updates on health status. A voice mail was left in parent's phone to contact clinic for any updates and also instructed to go to Emergency Room if any shortness of breath, swelling, fever.
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| 2843508 | 61 | M | WA | 05/30/2025 |
PNC20 |
PFIZER\WYETH |
LY8609 |
Joint range of motion decreased, Muscle spasms
Joint range of motion decreased, Muscle spasms
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- Muscle Spasms - Decreased range of motion
- Muscle Spasms - Decreased range of motion
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| 2843101 | 05/29/2025 |
HEPA |
MERCK & CO. INC. |
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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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No additional AE; they inadvertently gave VAQTA to a 6 month and 15 day old today on 23May2025. The ...
No additional AE; they inadvertently gave VAQTA to a 6 month and 15 day old today on 23May2025. The baby is not having any problem and the physician not worried; This spontaneous report was received from a consumer or other non-health professional and refers to a 6-month-old patient (reported as 6-month and 15-day-old) of unknown gender (it was stated that the reporter believed that was a male patient but was not sure) The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 23-May-2025, the patient was inadvertently vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA), 0.5 mL (two dose series) administered as prophylaxis (strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (product administered to patient of inappropriate age). It was stated that the patient was not having any problem. No additional adverse event was reported (no adverse event).
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| 2843102 | 55 | F | NC | 05/29/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
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Alanine aminotransferase, Antineutrophil cytoplasmic antibody, Antinuclear antib...
Alanine aminotransferase, Antineutrophil cytoplasmic antibody, Antinuclear antibody, Aspartate aminotransferase, Biopsy skin; Blood alkaline phosphatase, Blood calcium, Blood chloride, Blood creatinine, Blood culture; Blood potassium, Blood sodium, Blood test, Blood urea, C-reactive protein; Complement factor, Cryoglobulins, Cutaneous vasculitis, Dermatologic examination, Eosinophil count; Fibrin D dimer, HIV test, Haemoglobin, Hepatitis viral test, Immunology test; Inflammatory marker test, Metabolic function test, Platelet count, Urine analysis, White blood cell count
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confirmed the final diagnosis of CSVV due to COVID-19 vaccine; This literature-non-study case was re...
confirmed the final diagnosis of CSVV due to COVID-19 vaccine; This literature-non-study case was reported in a literature article and describes the occurrence of CUTANEOUS VASCULITIS (confirmed the final diagnosis of CSVV due to COVID-19 vaccine) in a 55-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. LITERATURE REFERENCE: Previously administered products included for COVID-19 prophylaxis: mRNA COVID-19 Moderna vaccines (Dose 1) and mRNA COVID-19 Moderna vaccines (Dose 2); for Drug use for unknown indication: Penicillin. Past adverse reactions to the above products included Allergic rash with Penicillin; and No adverse effect with mRNA COVID-19 Moderna vaccines and mRNA COVID-19 Moderna vaccines. Concurrent medical conditions included Chronic back pain. Concomitant products included Gabapentin for Chronic back pain. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced CUTANEOUS VASCULITIS (confirmed the final diagnosis of CSVV due to COVID-19 vaccine) (seriousness criteria hospitalization and medically significant). The patient was treated with Hydroxyzine hydrochloride (Hydroxyzine) at an unspecified dose and frequency and Prednisone (oral use) at a dose of taper for a 30-day duration. At the time of the report, CUTANEOUS VASCULITIS (confirmed the final diagnosis of CSVV due to COVID-19 vaccine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (10-30 U/L): 17 U/L. On an unknown date, Antineutrophil cytoplasmic antibody: Negative. On an unknown date, Antinuclear antibody: Negative. On an unknown date, Aspartate aminotransferase (10-36 U/L): 13 U/L. On an unknown date, Biopsy skin: Histopathology of Hematoxylin-eosin-stained skin biopsy with 20๏ฟฝ (left) and 40๏ฟฝ (right) magnification showed neutrophilic inflammation of dermal vessels with leukocytoclasia. On an unknown date, Blood alkaline phosphatase (32-104 U/L): 115 U/L. On an unknown date, Blood calcium (2.2-2.6 millimole per litre): 2.47 millimole per litre. On an unknown date, Blood chloride (98-105 millimole per litre): 101 millimole per litre. On an unknown date, Blood creatinine (61.9-115 micromole per litre): 70.72 micromole per litre. On an unknown date, Blood culture: Negative. On an unknown date, Blood potassium (3.5-5 millimole per litre): 4.5 millimole per litre. On an unknown date, Blood sodium (135-145 millimole per litre): 141 millimole per litre. On an unknown date, Blood test: Blood investigations revealed normal blood cell counts.. On an unknown date, Blood urea (2.9-7.1 millimole per litre): 6.78 millimole per litre. On an unknown date, C-reactive protein (0-5 milligram per litre): 4.29 milligram per litre. On an unknown date, Complement factor (30-75): 57 kU/L. On an unknown date, Cryoglobulins: Negative. On an unknown date, Dermatologic examination: revealed maculopapular, erythematous lesions on thighs and forearms, non-blanching lesions predominantly involving bilateral upper and lower extremities (day 2 since symptom onset). and coalescing erythematous patches with palpable purpura involving upper and lower extremities with areas of desquamation were observed at the time of hospital admission (day 5 since symptom onset).. On an unknown date, Eosinophil count (0-0.7 10^9/L): 0 10^9/L. On an unknown date, Fibrin D dimer (0-0.5 milligram per litre): 8.13 milligram per litre. On an unknown date, HIV test: Negative. On an unknown date, Haemoglobin (120-160 gram per litre): 127 gram per litre. On an unknown date, Hepatitis viral test: Negative. On an unknown date, Immunology test: unremarkable. On an unknown date, Inflammatory marker test: unremarkable. On an unknown date, Metabolic function test: unremarkable. On an unknown date, Platelet count (150-450 10^9/L): 473 10^9/L. On an unknown date, Urine analysis: unremarkable. On an unknown date, White blood cell count (4-11 10^9/L): 12.9 10^9/L. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered CUTANEOUS VASCULITIS (confirmed the final diagnosis of CSVV due to COVID-19 vaccine) to be related. Patient presented to outpatient clinic with a diffuse pruritic rash that started 48 hours after vaccine. She did not report past or family history of neoplasm or autoimmune disease. There was no change in her medication use. Basic blood investigations and a 3-mm punch biopsy of a skin lesion on the leg were obtained. Patient was prescribed with topical steroid and hydroxyzine. The patient followed up 72 hours later (5 days since the onset of rash) with a worsening rash-larger in size with itching and burning pain associated with bilateral ankle pain. She was hospitalized, and intravenous steroid was initiated. There was no evidence of venous thrombosis on the lower extremities. Temporality of her symptoms post vaccination and exclusion of other differential diagnoses confirmed the final diagnosis of Cutaneous small-vessel vasculitis (CSVV) due to COVID-19 vaccine. The patient responded with decreasing erythema, pruritus, and pain within 48 hours. With no new lesions appearing, she was discharged on prednisone taper for a 30-day duration. She had significant improvement of her symptoms 1 week after discharge. The patient had improving violaceous patches on legs (day 10 since symptom onset) with near-complete resolution of rash on forearms (day 30 since symptom onset). It was reported that this case highlighted importance of keeping a strong suspicion to allow prompt recognition and appropriate treatment.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2843103 | 1 | M | MO | 05/29/2025 |
HIBV |
SANOFI PASTEUR |
UK03611 |
No adverse event, Product preparation error
No adverse event, Product preparation error
|
administered ACTHIB but they did not use the provided diluent, instead, they used sterile water with...
administered ACTHIB but they did not use the provided diluent, instead, they used sterile water with no reported adverse event; Initial information received on 27-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1-year-old male patient who was administered with HIB (PRP/T) vaccine [ACT-HIB] but they did not use the provided diluent, instead, they used sterile water 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 Measles vaccine, mumps vaccine, rubella vaccine (MMR); Varicella zoster vaccine (varicella vaccine); and Hepatitis A vaccine (Hepatitis A) all for Immunisation. On 12-May-2025, the patient received a 0.5ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength (lot UK03611) (expiry date-unknown) via intramuscular route in the right thigh for Immunization but they did not use the provided diluent, instead, they used sterile water with no reported adverse event (product preparation error) (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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| 2843113 | 56 | F | CO | 05/29/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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C-reactive protein increased, Chest pain, Full blood count, Injection site eryth...
C-reactive protein increased, Chest pain, Full blood count, Injection site erythema, Injection site pain; Injection site swelling, Metabolic function test, Pain in extremity, Troponin
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pain at and around injection site, redness and swelling at injection site, pain down right arm and i...
pain at and around injection site, redness and swelling at injection site, pain down right arm and into R chest.
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| 2843117 | F | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Immune thrombocytopenia, Inappropriate schedule of product administration
Immune thrombocytopenia, Inappropriate schedule of product administration
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I stopped getting the vaccine because I was diagnosed with ITP; This serious case was reported by a ...
I stopped getting the vaccine because I was diagnosed with ITP; This serious case was reported by a consumer via call center representative and described the occurrence of idiopathic thrombocytopenic purpura in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2021, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced idiopathic thrombocytopenic purpura (Verbatim: I stopped getting the vaccine because I was diagnosed with ITP) (serious criteria GSK medically significant). The outcome of the idiopathic thrombocytopenic purpura was not reported. It was unknown if the reporter considered the idiopathic thrombocytopenic purpura to be related to Shingrix. The company considered the idiopathic thrombocytopenic purpura to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 05-MAY-2025 The reporter was the patient. The patient received the 1st dose of Shingrix at a local pharmacy in October 2021. The vaccine was administered in the left arm. The patient reported due to medical reasons she was unable to get the 2nd dose 2 to 6 months after; and received the 2nd dose at her doctor's office in April 2025 in the left arm. The patient reported that recently in the past 3 years he stopped getting the vaccine because he was diagnosed with ITP The customer denied demographics, and the agent was unable to obtain any additional information.; Sender's Comments: Immune thrombocytopenia is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2843118 | 05/29/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; I got the 2 part injection but still got the shingles; This serious c...
Suspected vaccination failure; I got the 2 part injection but still got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (have had shingles 7 times all on the back left side). Concurrent medical conditions included nerve pain (nerve pain was still going on in back now but did might be 12 to 15 months pain free now pain was back and seems like could not get any relief ). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the 2 part injection but still got the shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 22-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the 2 part injection but still got the shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles-7 times, insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2843119 | F | 05/29/2025 |
VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administ...
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure
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Suspeceted vaccination failure; still got shingles; had three shingles shots; This serious case was ...
Suspeceted vaccination failure; still got shingles; had three shingles shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and extra dose administered (Verbatim: had three shingles shots). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 22-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter wife (patient) had three Shingles shots and still got shingles and was down for a week. The reporter stated that the shot did not work. The patient received 3 doses of Shingles vaccine, which led to an extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, Dose 2 and Dose 3).
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| 2843120 | 05/29/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; now have shingles; This serious case was reported by a consumer via i...
Suspected vaccination failure; now have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: now have shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got both Shingle shots and now had a shingles. Reporter mentioned shots were only lesson the systems. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of shingles) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2843121 | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; had all the shots, just recently got shingles; This serious case was ...
Suspected vaccination failure; had all the shots, just recently got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had all the shots, just recently got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 24-MAY-2025 This case was reported by a patient via interactive digital media. Patient had all the shots, just recently got shingles. Patient thought he/she was safe from getting them, not true. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2843122 | F | NC | 05/29/2025 |
TD TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U5013AA |
No adverse event, Underdose; No adverse event, Underdose
No adverse event, Underdose; No adverse event, Underdose
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an inappropriate use due to patient mentioning she never wanted or approved to receive the TDAP/ADAC...
an inappropriate use due to patient mentioning she never wanted or approved to receive the TDAP/ADACEL vaccine with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Adult female patient who experienced an inappropriate use due administration of Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] instead of Diphtheria-2/Tetanus-5 Adsorbed toxoids no preservative adult [Tenivac] that she never wanted or approved to receive it with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis vaccine Suspension for injection (lot U5013AA and expiry date, strength-unknown) via unknown route in unknown administration site for Immunization and she never wanted or approved to receive it with no reported adverse event (wrong product administered) (latency-same day). Reportedly-She wanted the tetanus vaccine but not a combination vaccine or one without the whooping cough component. 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.; Reporter's Comments: . Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Adult female patient who experienced an inappropriate use due to patient mentioning she never wanted or approved to receive the tdap/adacel vaccine with no reported adverse event while receiving vaccines DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5013AA via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via unknown route in unknown administration site. On an unknown date the patient developed a non-serious an inappropriate use due to patient mentioning she never wanted or approved to receive the tdap/adacel vaccine with no reported adverse event (wrong product administered) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT. Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) and DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable. It was not reported if the patient received a corrective treatment for the event (an inappropriate use due to patient mentioning she never wanted or approved to receive the TDAP/ADACEL vaccine with no reported adverse event). At time of reporting, the outcome was Unknown for the event an inappropriate use due to patient mentioning she never wanted or approved to receive the tdap/adacel vaccine with no reported adverse event. 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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| 2843165 | TX | 05/29/2025 |
MMRV |
MERCK & CO. INC. |
Y015355 |
No adverse event, Product storage error
No adverse event, Product storage error
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No adverse event; Caller reported PROQUAD administered after temperature excursion. No additional i...
No adverse event; Caller reported PROQUAD administered after temperature excursion. No additional information provided. No additional AE/PQC reported. ? Names of vaccines involved (including lot/exp) PROQUAD Y015355 3/10/2026 ? Temperature -14C; This spontaneous report was received from an Other health professional 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 08-May-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, (lot #Y015355, expiration date: 10-Mar-2026) at a dose of 0.5 mL administered by Subcutaneous route for prophylaxis. It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was administered after temperature excursion of -14 Celsius degrees (C) for the timeframe of 15 minutes (Product storage error). No additional information was provided. No additional AE/PQC was reported (No adverse event).
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| 2843167 | F | MS | 05/29/2025 |
HPV4 HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Inappropriate schedule of product administration, Smear cervix abnormal; Inappro...
Inappropriate schedule of product administration, Smear cervix abnormal; Inappropriate schedule of product administration, Smear cervix abnormal; Inappropriate schedule of product administration, Smear cervix abnormal
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pap smear came back "abnormal"; Patient received one dose of GARDASIL in AUG 2007, one dos...
pap smear came back "abnormal"; Patient received one dose of GARDASIL in AUG 2007, one dose of GARDASIL in AUG 2008, and one dose of GARDASIL in AUG 2009; Patient received one dose of GARDASIL in AUG 2007, one dose of GARDASIL in AUG 2008, and one dose of GARDASIL in AUG 2009; This spontaneous report was received from a Nurse and referring to a 27-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. The patient received one dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, route, lot # and expiration date were not reported) in August 2007, one dose in August 2008 (Inappropriate schedule of product administration) and one dose in August 2009 (Inappropriate schedule of product administration). On an unknown date (reported as recently), when patient came in for routine appointment, pap smear came back "abnormal". No treatment was given. At the reporting time, the outcome of the event was unknown. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not applicable. The causal relationship between the event of pap smear came back "abnormal" and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was unknown.
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| 2843168 | 05/29/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Lung hyperinflation, Pulmonary thrombosis
Lung hyperinflation, Pulmonary thrombosis
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blood clot in both lungs; This serious case was reported by a consumer via interactive digital media...
blood clot in both lungs; This serious case was reported by a consumer via interactive digital media and described the occurrence of pulmonary thrombosis in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, less than a week after receiving Arexvy, the patient experienced pulmonary thrombosis (Verbatim: blood clot in both lungs) (serious criteria GSK medically significant). The outcome of the pulmonary thrombosis was not reported. It was unknown if the reporter considered the pulmonary thrombosis to be related to Arexvy. The company considered the pulmonary thrombosis to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 26-MAY-2025 Patient took RSV shot and developed blood clots in both lungs and an unspecified enlargment within a week.; Sender's Comments: Pulmonary thrombosis is an unlisted event which is considered unrelated to GSK vaccine Arexvy
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| 2843169 | 05/29/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Asthenia, Balance disorder, Metapneumovirus infection
Asthenia, Balance disorder, Metapneumovirus infection
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left me weak; no balance; think I had it; HMPV; This serious case was reported by a consumer via int...
left me weak; no balance; think I had it; HMPV; This serious case was reported by a consumer via interactive digital media and described the occurrence of weakness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced weakness (Verbatim: left me weak) (serious criteria hospitalization), balance disorder (Verbatim: no balance) (serious criteria hospitalization), pneumonia (Verbatim: think I had it) (serious criteria hospitalization and GSK medically significant) and metapneumovirus infection (Verbatim: HMPV) (serious criteria hospitalization). The outcome of the weakness and balance disorder were not resolved and the outcome of the pneumonia and metapneumovirus infection were not reported. It was unknown if the reporter considered the weakness, balance disorder, pneumonia and metapneumovirus infection to be related to RSV vaccine. The company considered the weakness, balance disorder and metapneumovirus infection to be unrelated to RSV vaccine. It was unknown if the company considered the pneumonia to be related to RSV vaccine. Additional Information: GSK Receipt Date: 24-MAY-2025 This case was reported by a patient via interactive digital media. The reporter got RSV shot but a month ago the reporter got a virus related to this. It was a new respiratory virus that was no treatment for it nor vaccine. The reporter ended up in hospital for 3 days ,it was left reporter weak have no balance now after 3 weeks. The reporter doctor did put reporter on antibiotics after coming home. It was called HMPV it was really bad could go into pneumonia which think the reporter had. It was the worst thing the reporter had ever had, did not know where the reporter got the germ for did not go out much. The reporter get all vaccines.; Sender's Comments: Asthenia, Balance Disorder, Pneumonia and Metapneumovirus infection are unlisted events which are considered unrelated to GSK RSV vaccine.
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| 2843170 | 69 | F | FL | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site pain, Injection site pruritus, Injection site rash, Injection sit...
Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth, Skin warm
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Rash on her right arm; Itchy on her right arm; warmness on her right arm; soreness on her right arm;...
Rash on her right arm; Itchy on her right arm; warmness on her right arm; soreness on her right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 12-MAY-2025, the patient received Shingrix (right arm). In MAY-2025, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash on her right arm), itchy upper limbs (Verbatim: Itchy on her right arm), skin warm (Verbatim: warmness on her right arm) and pain in arm (Verbatim: soreness on her right arm). The outcome of the rash was resolving and the outcome of the itchy upper limbs was not resolved and the outcome of the skin warm and pain in arm were resolved. It was unknown if the reporter considered the rash, itchy upper limbs, skin warm and pain in arm to be related to Shingrix. It was unknown if the company considered the rash, itchy upper limbs, skin warm and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 22-MAY-2025 The patient self-reported this case for herself. The patient received her first dose of Shingrix, she had soreness, a rash, itchiness, and warmness on her right arm where she received the vaccine. The soreness and warmness went away but the rash and itchiness was still present. The rash was about 3 inches long but was fading.
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| 2843171 | F | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Product administered to patient of inappropriate age, Rash
Product administered to patient of inappropriate age, Rash
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Rash on chest; 48 year old patient received shingles vaccine; This non-serious case was reported by ...
Rash on chest; 48 year old patient received shingles vaccine; This non-serious case was reported by a consumer and described the occurrence of rash in a 48-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 24-MAY-2025, the patient received Shingles vaccine. On 24-MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: 48 year old patient received shingles vaccine). On 25-MAY-2025, the patient experienced rash (Verbatim: Rash on chest). The outcome of the rash was not resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the rash to be related to Shingles vaccine. It was unknown if the company considered the rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-MAY-2025 The reporter reported that she had experience rash on chest. 48 year old patient received shingles vaccine which led to inappropriate age at vaccine administration.
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| 2843172 | F | MO | 05/29/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
KR75K |
Accidental exposure to product, Syringe issue
Accidental exposure to product, Syringe issue
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Accidental exposure to product/the vaccine, spilled onto the HCP's pant; Accidental exposure to...
Accidental exposure to product/the vaccine, spilled onto the HCP's pant; Accidental exposure to product; The plunger from one BOOSTRIX slipped out of the syringe; product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KR75K) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: Accidental exposure to product/the vaccine, spilled onto the HCP's pant), exposure via skin contact (Verbatim: Accidental exposure to product), syringe issue (Verbatim: The plunger from one BOOSTRIX slipped out of the syringe) and pharmaceutical product complaint (Verbatim: product complaint). The outcome of the occupational exposure while preparing product for administration, exposure via skin contact, syringe issue and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe issue to be related to Boostrix. It was unknown if the company considered the syringe issue to be related to Boostrix. Additional Information: GSK Receipt Date: 27-MAY-2025 The nurse reported that the plunger from one Boostrix slipped out of the syringe during preparation for administration. Because of this the vaccine, spilled onto the healthcare professional's pants. The defect was discovered during preparation for administration, while the needle was being attached to the syringe, the suspect syringe was the first syringe removed from the multipack. The rod was very slick; there was no stopping point for it. The stopper did not appear to be screwed all the way, was wobbly. There did not appear to be any damage or other defects to the syringe.
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| 2843173 | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Had them last year; This serious case was reported by a consumer via ...
Suspected vaccination failure; Had them last year; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had them last year). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-MAY-2025 The case was received from the patient via interactive digital media. The reporter had them last year. The reporter stated that shingles shot caused worse problems. The reporter was not a antivaxxer but that shot was not good. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2843174 | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shingles jab because the physician recommended it to because of age. The patient never had shingles until he/she got the shot for it. About a month later had to go to the hospital because of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2843175 | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; took the vaccine and still got the shingles; This serious case was re...
Suspected vaccination failure; took the vaccine and still got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: took the vaccine and still got the shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 24-MAY-2025 This case was reported by a patient via interactive digital media. The patient took the vaccine and still got the shingles. This patient's case was quite severe. The patient suffered from the after effects in arm for about one year. The patient needed to go to different neurologists for treatment. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine.
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| 2843176 | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; had shingles 3 times since then; This serious case was reported by a ...
Suspected vaccination failure; had shingles 3 times since then; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles 3 times since then). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-MAY-2025 The case was received from the patient via interactive digital media. The reporter had the vaccine and had shingles 3 times since then. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2843177 | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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my arm hurt bad for 2.5 days/ sore arm; This non-serious case was reported by a consumer via interac...
my arm hurt bad for 2.5 days/ sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In MAY-2025, the patient received the 1st dose of Shingles vaccine. In MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm hurt bad for 2.5 days/ sore arm). The outcome of the pain in arm was resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient via interactive digital media. The patient got his/her first shot of Shingles vaccine in reporting week however sore arm but not that bad for 2.5 days.
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| 2843178 | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Feeling abnormal, Herpes zoster, Vaccination failure
Feeling abnormal, Herpes zoster, Vaccination failure
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Suspected vaccination failure; Have shingles at this time; This serious case was reported by a consu...
Suspected vaccination failure; Have shingles at this time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Have shingles at this time). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-MAY-2025 The case was received from the patient via interactive digital media. The patient had shingles at this time and he/she was miserable. Second time and this time was worse. The patient stated that might would be worse if he/she was not vaccinated. No fun. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2843179 | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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shingles vaccine made me pretty sick; This non-serious case was reported by a consumer via interacti...
shingles vaccine made me pretty sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included COVID-19 vaccine and Shingles vaccine (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: shingles vaccine made me pretty sick). Rechallenge with Shingles vaccine was positive. The outcome of the sickness was resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR065532 Additional Information: GSK Receipt Date: 24-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that everybody reacts differently to drugs and vaccines. Covid vaccines did not make him/her felt a thing but both doses of the shingles vaccine made him/her pretty sick for 2 to 3 days after. It was still worth it because shingles could be really terrible and last a long time (like a year for some people).; Sender's Comments: US-GSK-US2025AMR065532:
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| 2843180 | F | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Death, Herpes zoster, Vaccination failure
Death, Herpes zoster, Vaccination failure
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Suspected Vaccination failure; died from shingles; This serious case was reported by a consumer via ...
Suspected Vaccination failure; died from shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria death and GSK medically significant) and shingles (Verbatim: died from shingles) (serious criteria death). The outcome of the vaccination failure was not reported. The reported cause of death was herpes zoster. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date :27-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that his/her mom got the shot and died from shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.; Reported Cause(s) of Death: Herpes zoster
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| 2843181 | 05/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
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It hurt; This non-serious case was reported by a consumer via interactive digital media and describe...
It hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: It hurt). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 26-MAY-2025 This case was reported by a patient via interactive digital media. Patient had just received first dose of the vaccine. It hurt, but he/she guessed that shingles would have been worse.
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| 2843182 | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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I inadvertently gave a 19 year old healthy patient a Shingrix vaccine. I know it can be given to 18+...
I inadvertently gave a 19 year old healthy patient a Shingrix vaccine. I know it can be given to 18+ with immunocompromised situations; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: I inadvertently gave a 19 year old healthy patient a Shingrix vaccine. I know it can be given to 18+ with immunocompromised situations). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 27-MAY-2025 The pharmacist inadvertently gave a 19 year old healthy patient a Shingrix vaccine, which led to inappropriate age at vaccine administration. The reporter know it could be given to 18 years with immunocompromised situations. The reporter was ask any information on response in healthy individuals.
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| 2843183 | 05/29/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; got shingles before and after the Shingrix vaccines; This serious cas...
Suspected vaccination failure; got shingles before and after the Shingrix vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles before and after the Shingrix vaccines). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 02-MAY-2025 This case was reported by the patient via interactive digital media. The patient contracted with shingles before and after receiving both doses of Shingrix vaccines. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
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| 2843184 | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Blood glucose increased
Blood glucose increased
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I got the first shot on wed and my blood sugar has been really high ever since; This non-serious cas...
I got the first shot on wed and my blood sugar has been really high ever since; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of blood sugar increased in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced blood sugar increased (Verbatim: I got the first shot on wed and my blood sugar has been really high ever since). The outcome of the blood sugar increased was not reported. It was unknown if the reporter considered the blood sugar increased to be related to Shingrix. It was unknown if the company considered the blood sugar increased to be related to Shingrix. Additional Information: GSK receipt date: 25-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had received the first shot on Wednesday, and his/her blood sugar had been really high ever since. The patient was wondered if it was caused by the shot.
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| 2843185 | 95 | F | CT | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
J32PB |
Product preparation issue
Product preparation issue
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administration of only adjuvant component of the Shingrix; administration of only adjuvant component...
administration of only adjuvant component of the Shingrix; administration of only adjuvant component of the Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 95-year-old female patient who received Herpes zoster (Shingrix) (batch number J32PB, expiry date 31-MAR-2027) for prophylaxis. On 23-MAY-2025, the patient received Shingrix. On 23-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administration of only adjuvant component of the Shingrix) and inappropriate dose of vaccine administered (Verbatim: administration of only adjuvant component of the Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 23-MAY-2025 The nurse requested guidance and data regarding how to proceed following the administration of only the adjuvant component of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
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| 2843186 | F | CA | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
J32PB |
Product preparation issue
Product preparation issue
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patient was administered only the adjuvant portion of Shingrix; a patient was administered only the ...
patient was administered only the adjuvant portion of Shingrix; a patient was administered only the adjuvant portion of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) (batch number J32PB, expiry date 31-MAR-2027) for prophylaxis. On 20-MAY-2025, the patient received the 1st dose of Shingrix. On 20-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: a patient was administered only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date :23-MAY-2025 The reporter questioned that how to proceed after a patient was administered only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2843187 | 54 | M | NH | 05/29/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793PT |
Incorrect route of product administration
Incorrect route of product administration
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Intravenously administration; This non-serious case was reported by a other health professional via ...
Intravenously administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 54-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 793PT, expiry date 29-AUG-2027) for prophylaxis. On 27-MAY-2025, the patient received Boostrix. On 27-MAY-2025, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Intravenously administration). The outcome of the intramuscular formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 27-MAY-2025 The health care professional reported that a nurse upstairs administered the Boostrix vaccine intravenously instead of intramuscularly, which led to intramuscular formulation administered by other route. Then the reporter just concern what the potential ramifications of that. The vaccine administration facility was the same as primary reporter.
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| 2843188 | F | CA | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5y9ca |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Shingrix Late second dose; This non-serious case was reported by a pharmacist via call center repres...
Shingrix Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) (batch number 5y9ca, expiry date 31-JAN-2027) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2023). In MAR-2025, the patient received the 2nd dose of Shingrix. In MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix Late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 27-MAY-2025 The pharmacist reported that a female adult received Shingrix first dose back in 2023 (no additional data), but then her second dose was on march 2025 which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
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| 2843189 | F | MN | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Autoimmune disorder
Autoimmune disorder
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two autoimmune diseases; This is a spontaneous report received from a Consumer or other non HCP, Pro...
two autoimmune diseases; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "two autoimmune diseases". Clinical course: Three high school sport athlete and two college sport daughters had to give up their swimming and track career after taking the Covid shot. One now has a bad heart and has POTS and the other has two autoimmune diseases. 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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| 2843190 | M | 05/29/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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COVID-19, Drug ineffective; COVID-19, Drug ineffective
COVID-19, Drug ineffective; COVID-19, Drug ineffective
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He has gotten Covid twice after getting the Pfizer Covid 19 Vaccines; He has gotten Covid twice afte...
He has gotten Covid twice after getting the Pfizer Covid 19 Vaccines; He has gotten Covid twice after getting the Pfizer Covid 19 Vaccines; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He has gotten Covid twice after getting the Pfizer Covid 19 Vaccines". The reporter stated that the the vaccine caused nothing but harm, the antibodies were gone after 6 weeks, and it didn't protect him at all, he has gotten Covid twice after getting the Pfizer Covid 19 Vaccines. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300133675 Same patient, same product, different AE;
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| 2843191 | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood glucose, Diabetes mellitus
Blood glucose, Diabetes mellitus
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Glucose spike/Diabetic; This is a spontaneous report received from a Consumer or other non HCP from ...
Glucose spike/Diabetic; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 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: DIABETES MELLITUS (medically significant), outcome "unknown", described as "Glucose spike/Diabetic". The patient underwent the following laboratory tests and procedures: Blood glucose: Spike, notes: went from 100 to 267. Additional information: Caller states he has gotten so many problems from the Pfizer Covid 19 Vaccine. Caller states he just got his Glucose tested and it went from 100 to 402 and he was passing out. Caller states his doctor said it was from the Covid Vaccine. He states he has talked to 2 other friends and they git a Glucose spike, one went from 100 to 267. Caller states they are Diabetic now, everybody was Diabetic now. 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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| 2843192 | F | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood glucose, Diabetes mellitus
Blood glucose, Diabetes mellitus
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Got a Glucose spike / Diabetic; This is a spontaneous report received from a Consumer or other non H...
Got a Glucose spike / Diabetic; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "Got a Glucose spike / Diabetic". The patient underwent the following laboratory tests and procedures: Blood glucose: 367, notes: spike/went up to. Clinical course: Caller stated that he had experienced many problems following the Pfizer COVID-19 vaccine. He reported that he had recently had his glucose tested and it had increased from 100 to 402, and that he was experiencing episodes of passing out. Caller stated that his doctor told him the spike was related to the COVID-19 vaccine. He mentioned that he had spoken with two friends who also experienced glucose spikes one went from 100 to 267 and another went up to 460 and his sister went up to 367, Caller questioned What is the deal with the Covid Vaccine spiking Glucose that you guys said it was safe and effective. Caller stated that he and others are now diabetic, saying, Everybody was diabetic now. Caller stated his Doctor said he has shortened his life by 5 years, 5-10 years. 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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| 2843193 | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood glucose, Blood glucose increased
Blood glucose, Blood glucose increased
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got the same glucose spike; This is a spontaneous report received from a Consumer or other non HCP f...
got the same glucose spike; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 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: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "got the same glucose spike". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated 3 other friends got the same glucose spike that he just talked to. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500109803 Same reporter/product/event; different patient;US-PFIZER INC-202500109802 Same reporter/product/event; different patient;
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| 2843194 | 56 | F | PA | 05/29/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
HG2649 UT8040KA |
Cardiac flutter, Extrasystoles, Palpitations, Ventricular extrasystoles; Cardiac...
Cardiac flutter, Extrasystoles, Palpitations, Ventricular extrasystoles; Cardiac flutter, Extrasystoles, Palpitations, Ventricular extrasystoles
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Heart Palpitations which began the next morning. I was put on a heart monitor and diagnosed with (P...
Heart Palpitations which began the next morning. I was put on a heart monitor and diagnosed with (PVC) Premature Ventricular Contractions. My heart was fluttering every 3-7 minutes every day until bedtime for 5 days then it started 3 days later. This went on for 6 months straight. The skipping, palpitation, & fluttering slowed down tremendously but haven't completely gone away. From time to time at least weekly my heart goes into palpitations.
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| 2843195 | 79 | F | NY | 05/29/2025 |
COVID19 |
MODERNA |
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Autonomic nervous system imbalance, Myalgia, Myelitis transverse
Autonomic nervous system imbalance, Myalgia, Myelitis transverse
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Autonomic dysfunction, transverse myelitis, muscle pain
Autonomic dysfunction, transverse myelitis, muscle pain
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| 2843196 | 62 | F | OH | 05/29/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 |
Chills, Erythema, Fatigue, Pain, Pain in extremity; Tenderness
Chills, Erythema, Fatigue, Pain, Pain in extremity; Tenderness
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Right arm is painful, soreness when its touched, redness, body aches, chills, fatigued.
Right arm is painful, soreness when its touched, redness, body aches, chills, fatigued.
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| 2843197 | 10 | M | TN | 05/29/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Pt in clinic for vaccines, given HepA vaccine too early.
Pt in clinic for vaccines, given HepA vaccine too early.
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| 2843198 | 1.17 | M | MI | 05/29/2025 |
DTAPIPVHIB HIBV PNC20 |
SANOFI PASTEUR MERCK & CO. INC. PFIZER\WYETH |
UK199AA X019562 MF0415 |
No adverse event; No adverse event; No adverse event
No adverse event; No adverse event; No adverse event
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No adverse reaction at this time.
No adverse reaction at this time.
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| 2843200 | 60 | F | CA | 05/29/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
XA53Y_4T443_4JT |
Erythema, Pain, Pain of skin, Skin warm, Urticaria
Erythema, Pain, Pain of skin, Skin warm, Urticaria
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*COVID Vaccine (a mRNA vaccine) 1/15/21, 2/10/21, &11/18/21): SIGNIFICANT and PERMANENT increas...
*COVID Vaccine (a mRNA vaccine) 1/15/21, 2/10/21, &11/18/21): SIGNIFICANT and PERMANENT increase in Proteinuria & Glomerulonephritis, which was found 6 weeks later during routine labs. CKD decline after first two covid vaccines, AND AGAIN (more damage) after 11/2021 vaccine. Was reported on VAERS. Of note: I got a Tetanus vaccine booster: Tdap (ADACEL) (Tetanus, diphtheria, acellular pertussis) on 4/21/25 & had no NO PROBLEMS. *RSV Vaccine (a mRNA vaccine, Arexvy) 5/27/25: At 12 hours, welts, red, & painful. At 24 hours, less ?welty,? still red and painful. At 36 hours, now warm, red, and more painful, still slightly raised (cortisone to site and ice x 1 hour). At 42 hours, still red, warm, and painful to light touch, still slightly raised (took Zyrtec). Will not know if this mRNA vaccine will cause another decline in renal function until next lab draw in July, unless nephrologist wants to do earlier. Dr informed of allergic reaction. *I do not think [remember] if I had a localized reaction to the Covid vaccines.
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| 2843201 | 58 | F | AZ | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
GJ3277 |
Arthralgia, Palpitations, Swollen tongue
Arthralgia, Palpitations, Swollen tongue
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16 minutes after the vaccine my tongue swelled. The pharmacy said to walk around the store for 15 mi...
16 minutes after the vaccine my tongue swelled. The pharmacy said to walk around the store for 15 minutes. I walked out to the car and my tongue swelled, my heart raced. I turned around and went back into the store. I reported it to the pharmacist but the swelling subsided. I don't know if the pharmacist reported this in the system. Since this vaccine, I have not received any more covid vaccines. I have had joint pain since this date also.
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| 2843202 | 5 | F | OR | 05/29/2025 |
DTPPVHBHPB MMR PNC20 |
MSP VACCINE COMPANY GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
2CA52C1 N3429 LC5484 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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Gave Vaxelis for ages 6 weeks through 4 years, pt is age 5. Pt had not received any vaccines there...
Gave Vaxelis for ages 6 weeks through 4 years, pt is age 5. Pt had not received any vaccines therefore needed several. RN focused on decreasing number of needle sticks and overlooked age limit. Should have given Pediarix. Ct did not experience any adverse SE's. no clinic or ER etc visit required. Upon discovering error this RN contacted VFC help desk who advised "no vaccines have to be re given but VAERS report should be done".
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