| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2842162 | 05/21/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
|
Pain in extremity; Pain in extremity
Pain in extremity; Pain in extremity
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a little soreness in my arm/ a slight pain for a couple of hours; This is a spontaneous report recei...
a little soreness in my arm/ a slight pain for a couple of hours; This is a spontaneous report received from a Consumer or other non HCP. 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; influenza vaccine (FLU VACCINE VII), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little soreness in my arm/ a slight pain for a couple of hours". 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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| 2842163 | 05/21/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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No adverse event, Product preparation issue
No adverse event, Product preparation issue
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pre-assessed as an off-label use as per local labelling due to mixing pentacel and not using acthib ...
pre-assessed as an off-label use as per local labelling due to mixing pentacel and not using acthib component with no reported ae; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received only vial 1 (DTaP-IPV component) due to mixing Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine [Pentacel] and not using ACTHIB component with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Mrc5)/Hib(Prp/T) Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination [immunization], and acthib component was not mixed t o vaccine with no reported ae (single component of a two-component product administered) (unknown latency). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, Patient was inadvertently given only vial 1 (DTaP-IPV component) in office for his 2 month vaccines. 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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| 2842164 | 20 | M | CA | 05/21/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
KR75K |
Oedema peripheral
Oedema peripheral
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The day after vaccine administered, patient develop axillary swelling, worsen next day and then grad...
The day after vaccine administered, patient develop axillary swelling, worsen next day and then gradually resolved.
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| 2842165 | 62 | F | 05/21/2025 |
PNC20 |
PFIZER\WYETH |
LK6655 |
Pruritus, Rash, Throat tightness, Urticaria
Pruritus, Rash, Throat tightness, Urticaria
|
In the evening after receiving vaccine patient developed urticarial rash and pruritis of the neck. R...
In the evening after receiving vaccine patient developed urticarial rash and pruritis of the neck. Rash spread to left arm and face the following day and patient began feeling "throat tightness". Presented to emergency department. Denies any difficulty swallowing, change in her voice. Denies any nausea, vomiting, shortness of breath, wheezing, lightheadedness or syncopal episodes. Pruritus resolved after over-the-counter treatment. Given sensation in her throat given intramuscular epinephrine, steroids along with antihistamines. After several hours of monitoring, patient was able to discharge home in stable condition.
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| 2842166 | 87 | M | MI | 05/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Dizziness, Electrocardiogram normal, Gait disturbance, Magnetic resonance imagin...
Dizziness, Electrocardiogram normal, Gait disturbance, Magnetic resonance imaging, Walking aid user
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Wife called that patient felt very dizzy next day after getting second dose of shingles shot. His ga...
Wife called that patient felt very dizzy next day after getting second dose of shingles shot. His gait was changed and he had to use cane and then walker. Patient's vital are stable.
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| 2842167 | 63 | F | 05/21/2025 |
PNC20 |
PFIZER\WYETH |
LN4931 |
Diarrhoea, Headache, Nausea, Pruritus, Vomiting
Diarrhoea, Headache, Nausea, Pruritus, Vomiting
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Patient reports approximately 8 hours after vaccine experiencing symptoms of fiery itch from top of ...
Patient reports approximately 8 hours after vaccine experiencing symptoms of fiery itch from top of head to knees, nausea, vomiting x1 and headache. Took Benadryl and did feel that it helped but developed diarrhea. No hives or rash appeared. Symptoms resolved.
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| 2842168 | 65 | F | AZ | 05/21/2025 |
COVID19 |
MODERNA |
3042648 |
Chills, Diarrhoea, Nausea, Palpitations
Chills, Diarrhoea, Nausea, Palpitations
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Patient called pharmacy on 05-21-2025 stating that after receiving the immunization she did not feel...
Patient called pharmacy on 05-21-2025 stating that after receiving the immunization she did not feel good, had chills, diarrhea, nauseous. Recently she had heart racing. She stated not having a COVID Immunization over a year. Counsel patient to get medical attention
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| 2842170 | 87 | F | MS | 05/21/2025 |
RSV VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
a9kr2 f95ys |
Pain in extremity; Pain in extremity
Pain in extremity; Pain in extremity
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Patient reports arm pain lasting over one week with no redness or swelling.
Patient reports arm pain lasting over one week with no redness or swelling.
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| 2842171 | 57 | M | TX | 05/21/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
939901 939901 045j21a 045j21a |
C-reactive protein increased, Deep vein thrombosis, Fibrin D dimer increased, Fu...
C-reactive protein increased, Deep vein thrombosis, Fibrin D dimer increased, Full blood count, International normalised ratio; Prothrombin time, Red blood cell sedimentation rate, Vocal cord paralysis; C-reactive protein increased, Deep vein thrombosis, Fibrin D dimer increased, Full blood count, International normalised ratio; Prothrombin time, Red blood cell sedimentation rate, Vocal cord paralysis
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right lower leg dvt. elevated dimer, elevated crp. ended up with paralyzed vocal cord
right lower leg dvt. elevated dimer, elevated crp. ended up with paralyzed vocal cord
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| 2842172 | 62 | F | MO | 05/21/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
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Asthenia, Dry skin, Erythema, Fatigue, Hypersomnia; Pain in extremity, Pruritus,...
Asthenia, Dry skin, Erythema, Fatigue, Hypersomnia; Pain in extremity, Pruritus, Skin discolouration, Skin warm, Swelling
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Twenty-four hours after vaccine, incredible fatigue, arm hot to the touch and really hurt. Ran a lo...
Twenty-four hours after vaccine, incredible fatigue, arm hot to the touch and really hurt. Ran a low grade fever of 99.7 degrees. Felt the worst I have in a very long time. Slept most of the day another 12 hours. The next day, I recovered but weak. The arm has not recovered from being hot to the touch. As of today, 5/21/2025, 6 days later, it is incredibly itchy, red, swollen, white dry patches, and hot to the touch.
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| 2842173 | 69 | F | OR | 05/21/2025 |
PNC20 |
PFIZER\WYETH |
LG5574 |
Allergy to vaccine, Erythema, Pruritus, Skin warm, Tenderness
Allergy to vaccine, Erythema, Pruritus, Skin warm, Tenderness
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The vaccine was administered on 5/15/25. The patient called the clinic on 5/21 to report a large red...
The vaccine was administered on 5/15/25. The patient called the clinic on 5/21 to report a large red area to arm and shoulder that was warm and tender to touch, that was very itchy. She reported the redness to be very large almost larger than the size of her hand. Patient was scheduled to visit with a provider same day. The provider recommended use of OTC medications to help the symptoms. Added Pneumococcal vaccine to her allergy list.
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| 2842194 | 56 | F | OK | 05/21/2025 |
PNC20 |
PFIZER\WYETH |
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Erythema, Hypersensitivity, Pruritus, Urticaria
Erythema, Hypersensitivity, Pruritus, Urticaria
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Pt had classic urticaria and erythematous splotches consistent with hypersensitivity reaction that ...
Pt had classic urticaria and erythematous splotches consistent with hypersensitivity reaction that started 10 hours after vaccine given. Has started to subside 24 hours after vaccination given, but still she is very itchy. She never had any throat swelling, shortness of breath, or fever.
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| 2842195 | 57 | F | 05/21/2025 |
MNQ |
SANOFI PASTEUR |
U8361AA |
Local reaction
Local reaction
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Pt had large local reaction in the area 2 days post injection
Pt had large local reaction in the area 2 days post injection
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| 2842196 | 46 | M | CA | 05/21/2025 |
COVID19 |
MODERNA |
037k20a |
Tinnitus
Tinnitus
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Tinnitus
Tinnitus
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| 2842197 | 1.25 | M | MI | 05/21/2025 |
HIBV PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
UK092AA LX4482 |
Product preparation issue; Product preparation issue
Product preparation issue; Product preparation issue
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HIB not reconstituted, only sterile diluent given.
HIB not reconstituted, only sterile diluent given.
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| 2842198 | 0.17 | F | HI | 05/21/2025 |
DTAPHEPBIP HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
5YBYL UK107AB LN4928 2091233 |
Immediate post-injection reaction, Lethargy; Immediate post-injection reaction, ...
Immediate post-injection reaction, Lethargy; Immediate post-injection reaction, Lethargy; Immediate post-injection reaction, Lethargy; Immediate post-injection reaction, Lethargy
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Lethargy x/15 minutes, immediately after receiving vaccinations. Patient remained in doctor's o...
Lethargy x/15 minutes, immediately after receiving vaccinations. Patient remained in doctor's office until stable.
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| 2842199 | 1.25 | M | NY | 05/21/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK199AA |
Erythema, Peripheral swelling, Skin warm
Erythema, Peripheral swelling, Skin warm
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noticed 5/1/25 9 am, Redness, warm to touch and swelling to left deltoid. No treatment at home (motr...
noticed 5/1/25 9 am, Redness, warm to touch and swelling to left deltoid. No treatment at home (motrin/tylenol/ice). Area of pink, warm, discoloration measuring 4.5 in x 2.5 in. Advised benadryl & cool compresses
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| 2842210 | 1.08 | M | CA | 05/21/2025 |
HEPA MMR PNC15 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
J4K4X Y004116 Y010035 Y017062 |
Rash papular; Rash papular; Rash papular; Rash papular
Rash papular; Rash papular; Rash papular; Rash papular
|
14 mo came to clinic with concern about papulovesicular rash beginning on 5/19. Denise fever, had sc...
14 mo came to clinic with concern about papulovesicular rash beginning on 5/19. Denise fever, had scattered papuloesicles on lower trunk groin and lesser number on upper trunk/distal extremities. Considering diagnosis of vaccine related rash from Varivax or also hand foot mouth/other viral exanthem. Child is well appearing. Due to potential for vaccine adverse event this report is being filed.
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| 2842211 | 0.33 | F | OK | 05/21/2025 |
DTAPHEPBIP HIBV PNC20 RV1 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
AC295 YA3G3 LN4927 7Y593 |
Urticaria; Urticaria; Urticaria; Urticaria
Urticaria; Urticaria; Urticaria; Urticaria
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Urticaria on feet and lower legs bilateral observed for 20 minutes & released / resolved.
Urticaria on feet and lower legs bilateral observed for 20 minutes & released / resolved.
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| 2841718 | 4 | F | HI | 05/20/2025 |
MMRV |
MERCK & CO. INC. |
Y017511 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AEs/PQC reported.; Caller reported vaccines administered after temperature excursions;...
No additional AEs/PQC reported.; Caller reported vaccines administered after temperature excursions; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (Dtap), Polio vaccine inact (Ipv), and Influenza vaccine. On 17-Mar-2025, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017511, expiration date: 15-Apr-2026), dose number 1, administered by subcutaneous route in left thigh for prophylaxis, and diluted with sterile diluent (MERCK STERILE DILUENT), administered by subcutaneous route (indication, expiration date, and lot # were not reported). Temperature excursion occurred at -9.8C for 2 hours and 3 minutes. Previous temperature excursion was not reported. No additional adverse event was reported. This is one of several reports from the same reporter.
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| 2841719 | HI | 05/20/2025 |
HPV9 |
MERCK & CO. INC. |
Y012864 |
No adverse event, Product storage error
No adverse event, Product storage error
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No symptoms. No additional AE; HCP reported improperly stored administered GARDASIL 9.; This spontan...
No symptoms. No additional AE; HCP reported improperly stored administered GARDASIL 9.; This spontaneous report was received from a medical assistant concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 21-Apr-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe, lot #Y012864 has been verified to be a valid batch/lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal validation established as 29-May-2026, 0.5 mL (dosage regimen, anatomical location and route of administration was not provided) administered as prophylaxis (product storage error). At the time of vaccination, the vaccine administered underwent a temperature excursion at 8.5 degrees Celsius (C) for 0 hours 4 minutes 0 seconds, with a previous temperature excursion at 1.5 C for 90 hours 35 minutes 0 seconds There were no symptoms nor additional adverse events (AE) (no adverse event.) This was one of two reports received from the same reporter.
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| 2841720 | 1 | M | PA | 05/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
EB499 exp |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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18 month old patient was ordered to get Infanrix but they got Boostrix instead; 18 month old patient...
18 month old patient was ordered to get Infanrix but they got Boostrix instead; 18 month old patient was ordered to get Infanrix but they got Boostrix instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499 exp, expiry date 26-AUG-2027) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On 09-MAY-2025, the patient received Boostrix. On an unknown date, the patient did not receive Infanrix. On 09-MAY-2025, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: 18 month old patient was ordered to get Infanrix but they got Boostrix instead) and inappropriate age at vaccine administration (Verbatim: 18 month old patient was ordered to get Infanrix but they got Boostrix instead). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-MAY-2025 Licensed Practical Nurse explained that on 09 May 2025, an 18 month old patient was ordered to get Infanrix but they got Boostrix instead which led to wrong vaccine administered and inappropriate age at vaccine administration. Consented to follow up.
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| 2841721 | CO | 05/20/2025 |
DTAPIPVHIB DTP |
SANOFI PASTEUR UNKNOWN MANUFACTURER |
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Extra dose administered, No adverse event, Wrong product administered; Extra dos...
Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered
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The product administered in error was PENTACEL and the PENTACEL dose should have been the ACT-HIB wi...
The product administered in error was PENTACEL and the PENTACEL dose should have been the ACT-HIB with no reported adverse event; an inappropriate use due to administration of an extra dose of DTaP from PENTACEL with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves Child and unknown gender patient where product administered in error was diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] and the pentacel dose should have been the act-hib and an inappropriate use due to administration of an extra dose of diphtheria, tetanus and nos pertussis vaccine from pentacel 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 a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (Strength- standard and frequency- once) lot number not reported via unknown route in unknown administration site (dose and expiration date: not provided) and received a dose of suspect diphtheria, tetanus and nos pertussis vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for prophylactic vaccination (immunization) and the product administered in error was pentacel and the pentacel dose should have been the act-hib with no reported adverse event (wrong product administered) and inappropriate use due to administration of an extra dose of dtap from pentacel with no reported adverse event (extra dose administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. Reportedly, no other vaccines had been used. Product used : Used. Action taken- 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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| 2841722 | 19 | F | VA | 05/20/2025 |
YF |
SANOFI PASTEUR |
UK134AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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Merck sterile water was used to reconstitute the vaccine and that the vaccine was administered to a ...
Merck sterile water was used to reconstitute the vaccine and that the vaccine was administered to a patient with no reported adverse event; Merck sterile water was used to reconstitute the vaccine and that the vaccine was administered to a patient with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 19 years old female patient who was administered with Yellow Fever Vaccine - [Yf-Vax] which was reconstituted with merck 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 Water for injection (Sterile water). On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection (lot UK134AA, expiry date 30-Nov-2025; strength not reported) via subcutaneous route in the left arm for Immunisation and patient who was administered with Yellow Fever Vaccine - Yf-Vax] which was reconstituted with merck sterile water with no reported adverse event (product preparation error) and (poor quality product administered). Action taken was not applicable. Reportedly, wanted to know if they use Merck's sodium chloride diluent, will it affect the vaccine. 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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| 2841723 | 11 | M | 05/20/2025 |
DTAP |
SANOFI PASTEUR |
3CA03C3 |
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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stated that an 11 year-old patient was given daptacel instead of adacel with no reported adverse eve...
stated that an 11 year-old patient was given daptacel instead of adacel with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 11 years old male patient who received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] Instead of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 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 Meningococcal Vaccine A/C/Y/W Conj (Tet Tox) (Menquadfi) for Immunisation. On 09-May-2025, the 11 year-old patient received 0.5ml dose (once) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, strength standard, Expiry date: 30-Sep-2025 and lot 3CA03C3 via intramuscular route in the left arm instead of suspect, Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination [immunisation] with no reported adverse event (wrong product administered) (Latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2841724 | AZ | 05/20/2025 |
HIBV |
SANOFI PASTEUR |
UK111AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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stated that a patient was given ACTHIB, however the diluent that was given was a diluent that they u...
stated that a patient was given ACTHIB, however the diluent that was given was a diluent that they use for MMR and Varicella vaccines and not the one for ACTHIB with no reported adverse event; Initial information received on 15-May-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 was administered with HIB (PRP/T) vaccine [ACT-HIB] however the diluent that was given was a diluent that they use for MMR and varicella vaccines with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-May-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength (lot UK111AA) (expiry date-unknown) via unknown route in unknown administration site for Immunization however the diluent that was given was a diluent that they use for MMR and varicella vaccines with no reported adverse event (product preparation error) (latency-same day). Reportedly- Patient age '<'1 year enter as 2m, 4m, etc, the ACTHIB wasn't reconstituted using its accompanying diluent. 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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| 2841725 | FL | 05/20/2025 |
DTAP |
SANOFI PASTEUR |
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Expired product administered, No adverse event
Expired product administered, No adverse event
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inappropriate use due to administration of an expired vaccine with no reported adverse event; Initia...
inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 16-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who had inappropriate use due to administration of an expired diphtheria-15/tetanus/5 AC pertussis vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and had inappropriate use due to administration of an expired vaccine with no reported adverse event (expired product administered) (unknown latency). 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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| 2841741 | 0.5 | M | MN | 05/20/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
3E99M |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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6-month old male was given the incorrect product formulation for his age; This non-serious case was ...
6-month old male was given the incorrect product formulation for his age; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3E99M, expiry date 31-DEC-2025) for prophylaxis. On 21-JAN-2025, the patient received Menveo (intramuscular). On 21-JAN-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 6-month old male was given the incorrect product formulation for his age). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK receipt date: 05-MAY-2025 The physician reported that they discovered an error that occurred in January 2025. The 6-month old patient was given the incorrect product formulation (Menveo) for his age, which led to inappropriate age at vaccine administration. He was given the formulation meant for older children.
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| 2841742 | 50 | M | TX | 05/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
e754f |
Exposure via skin contact, Incorrect dose administered
Exposure via skin contact, Incorrect dose administered
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Inadvertent exposure to vaccine; residual amount of vaccine leaked on the patients arm after injecti...
Inadvertent exposure to vaccine; residual amount of vaccine leaked on the patients arm after injection; The consumer is concerned he did not receive the full dose of vaccine (potential underdose.); This non-serious case was reported by a other health professional via call center representative and described the occurrence of inadvertent exposure to vaccine in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number e754f, expiry date 27-MAR-2027) for prophylaxis. On 09-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid) .5 ml. On 09-MAY-2025, an unknown time after receiving Shingrix, the patient experienced inadvertent exposure to vaccine (Verbatim: Inadvertent exposure to vaccine), exposure via skin contact (Verbatim: residual amount of vaccine leaked on the patients arm after injection) and underdose (Verbatim: The consumer is concerned he did not receive the full dose of vaccine (potential underdose.)). On 09-MAY-2025, the outcome of the exposure via skin contact and underdose were not applicable. The outcome of the inadvertent exposure to vaccine was not applicable. Additional Information: GSK Receipt Date: 12-MAY-2025 The patient was vaccinated with first dose of Shingrix. The health care professional states she was using a retractable needle and the upon removing the needle from the deltoid the needle automatically retracted and some vaccine leaked on the patient's arm, which led inadvertent exposure to vaccine and exposure via skin contact. The patient was concerned he did not receive the full dose of vaccine (potential underdose/potential administration error.)
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| 2841743 | F | WA | 05/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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interval too long between dose 1st and 2nd dose; This non-serious case was reported by a consumer v...
interval too long between dose 1st and 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 09-OCT-2021). On 16-MAY-2025, the patient received the 2nd dose of Shingrix. On 16-MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: interval too long between dose 1st and 2nd dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 16-MAY-2025 The patient self-reported this case for herself. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
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| 2841744 | 1.25 | F | MA | 05/20/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK196AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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inappropriate use due to the administration of the PENTACEL DTaP-IPV component to a patient, without...
inappropriate use due to the administration of the PENTACEL DTaP-IPV component to a patient, without the HIB component with no reported adverse event; Initial information received on 16-May-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 15 months old female patient who was administered with dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], and the Hib component was not included with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A Vaccine for Immunisation. On 16-May-2025, the patient received 0.5ml (once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, Strength standard, lot UK196AA and expiry date 31-Mar-2026 via intramuscular route in the right thigh for immunization, However, only the DTaP-IPV component was administered, and the Hib component was not included with no reported adverse event (single component of a two-component product administered) (Latency Same day). Reportedly, Reportedly, the patient only received the liquid component of Pentacel and did not receive the 'powder' component. The pharmacist inquired whether ACTHIB can be administered to the patient instead of using the Hib component from Pentacel. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2841747 | 1 | F | IL | 05/20/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
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Extra dose administered, Pyrexia; Extra dose administered, Pyrexia
Extra dose administered, Pyrexia; Extra dose administered, Pyrexia
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MMRV given instead of MMR resulting in double dose of Varicella vaccine given. Fever starting on day...
MMRV given instead of MMR resulting in double dose of Varicella vaccine given. Fever starting on day 4, still ongoing on day 7
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| 2841748 | 1.17 | M | CA | 05/20/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
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Aphasia, Blood iron decreased, Confusional state, Decreased appetite, Fatigue; F...
Aphasia, Blood iron decreased, Confusional state, Decreased appetite, Fatigue; Feeling abnormal, Fine motor skill dysfunction, Social avoidant behaviour, Staring, Unresponsive to stimuli
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OK, I need to clear up some things before the seizure happened. Got one vaccine named Japanese. Ence...
OK, I need to clear up some things before the seizure happened. Got one vaccine named Japanese. Encephalitis few days after that vaccine child got a high fever then seizure happened child was in the hospital March 16, 17and 18 of 2025. Then got a doctors appointment for April 3, 2025, which was given quite a few vaccine on the health record stated that the child got the MMR on March 13, 2025, but that isn?t true. The child was not yet back home until March 31 of 2025, so the clinic gave MMR plus 2 other all at once at first they wanted to give five all in one time I said no it was too much so only got three. I don?t know why they lied on the record for a different date, but I have proof to show that the MMR and two other vaccine was given on April 3 of 2025 after receiving that shot on April 3, 2025, the child start having withdrawn Symptoms not wanting to eat lost appetite, fatigue, and also lost speech skills no more babbling no more words even motor skills started to decline child was always active outgoing but after April 3, 2025 child look withdrawn spacing out a lot not responding when called and just stare off into space With a confusion look in, would not eat anything but only drink milk which cause him to go into low iron right now after the vaccine on April 3 the sign is so noticeable that the vaccine had a negative effect on the child and for the other vaccine, the Japanese one that might?ve caused the fever that led to the seizure Right now the child is seen by the pediatrician already and is referred to a specialist neurology to get an EEG scan. My child is no longer the same all because of the vaccine and I know it.
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| 2841753 | M | OR | 05/20/2025 |
HIBV |
SANOFI PASTEUR |
UK328AA |
Product contamination
Product contamination
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NICU RN called down to pharmacy requesting a new saline diluent vial for an ActHib vaccine for her p...
NICU RN called down to pharmacy requesting a new saline diluent vial for an ActHib vaccine for her patient. I prompted the RN to see what was wrong with the diluent vial that was sent up. The RN said when she introduced air to the vial (to draw up the medication), I asked the nurse to please send the vials back down to pharmacy so we can evaluate. Upon return to the pharmacy the saline diluent vial contained bright red liquid inside (doxorubicin red). I tubed up the last dose in the box to replace the defective one and had not heard of any more issues from the RN for that room. Expiration on vials: 05/2026 LOT: UK328AA MFD: Sanofi Pastuer SA
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| 2841754 | 17 | F | IN | 05/20/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
99G34 |
Injection site erythema, Injection site swelling, Injection site warmth, Pain in...
Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
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Per mother, currently has 2x5 inch swollen area on left arm at injection site, left deltoid. Red, wa...
Per mother, currently has 2x5 inch swollen area on left arm at injection site, left deltoid. Red, warm to touch. Did not check temp. Left arm is sore. Received Bexsero injection in left deltoid 5-7-25. Swelling noted 5-8-2025. Swelling has increased today, 5-9-25.
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| 2841755 | 53 | F | 05/20/2025 |
COVID19 |
PFIZER\BIONTECH |
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Angina pectoris, Presyncope
Angina pectoris, Presyncope
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Heart incident after first dose of Pfizer Covid vaccination. Extreme angina and near fainting the da...
Heart incident after first dose of Pfizer Covid vaccination. Extreme angina and near fainting the day after Pfizer covid vaccine
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| 2841756 | 67 | F | SC | 05/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site warmth, Vaccination site discolouration
Injection site warmth, Vaccination site discolouration
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2nd shingle vaccination on April 16th. Within days the area around the vaccination started turning b...
2nd shingle vaccination on April 16th. Within days the area around the vaccination started turning brown. I am (redacted). It has been 4 weeks today. Still brown and still with fever at the injection site. Please advise how to treat now.. the brown color and the fever.
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| 2841757 | F | OR | 05/20/2025 |
TD |
MASS. PUB HLTH BIOL LAB |
A147A |
Expired product administered
Expired product administered
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Describe Event, Problem, or Product Use Error: The patient received an expired Vaccine. The Vaccine ...
Describe Event, Problem, or Product Use Error: The patient received an expired Vaccine. The Vaccine expired on 3/10/2025 and the vaccine was administered on 5/11/2025.
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| 2841817 | 1.08 | F | NC | 05/20/2025 |
MMR |
MERCK & CO. INC. |
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Irritability, Rash, Respiratory tract congestion
Irritability, Rash, Respiratory tract congestion
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Spotted rash on torso, limbs began about 8-10:00 AM 5/19/25. Irritability and congestion followed.
Spotted rash on torso, limbs began about 8-10:00 AM 5/19/25. Irritability and congestion followed.
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| 2841818 | 52 | M | NY | 05/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
e754f |
Erythema, Malaise, Pain, Pyrexia, Skin warm
Erythema, Malaise, Pain, Pyrexia, Skin warm
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patient developed redness over all biceps area, area warm to the touch, had fever over 101 , severe...
patient developed redness over all biceps area, area warm to the touch, had fever over 101 , severe body aches and malaise for a few days
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| 2841820 | 75 | F | AR | 05/20/2025 |
COVID19 |
MODERNA |
3032712 |
COVID-19
COVID-19
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covid infection with hospitalization after vaccination
covid infection with hospitalization after vaccination
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| 2841821 | 5 | F | MA | 05/20/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7970BA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient should have received Kinrix- Dtap and IPV, however she was administered Vaxelis. Patient di...
Patient should have received Kinrix- Dtap and IPV, however she was administered Vaxelis. Patient did not have any symptoms or side effects.
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| 2841822 | 1 | F | NC | 05/20/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y014440 Y017062 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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MMR, Varicella and Hep A was ordered by provider. MA pulled the Hep A, Varicella, and Pro Quad (look...
MMR, Varicella and Hep A was ordered by provider. MA pulled the Hep A, Varicella, and Pro Quad (looking and seeing Measles Mumps and Rubella Overlooked Varicella by mistake). Vaccines were given and labs was obtained. Upon documentation MA discovered that Pro Quad was given instead of MMR. Provider, director of physicians and director was notified. Parents were attempted to be contact but no answer on serval attempts. Vaccines were documented in patient's chart and database noting the vaccine given by mistake.
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| 2841823 | 83 | F | WV | 05/20/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8366AA U8366AA |
Agonal respiration, Cardiac arrest, Chest discomfort, Chest pain, Death; Respira...
Agonal respiration, Cardiac arrest, Chest discomfort, Chest pain, Death; Respiratory arrest
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Patient called out "help me" and patient tech responded to patient. Patient stated that sh...
Patient called out "help me" and patient tech responded to patient. Patient stated that she was having chest pain that was heavy like she had never had. Physician was notified of the complaint and ordered nitroglycerin, stat troponin, stat EKG, repeat EKG with morning labs. Patient continued having conversation about her chest pain to another RN that responded. At 0238, patient was noted to have agonal breathing and NRP mask was placed on patient. Patient noted to be without respirations and heart rate at 0245 (patient was a DNR). Patient subsequently pronounced at 0250 as the ED doctor responded from the ED as the hospitalist does not remain in house at night.
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| 2841824 | 71 | F | FL | 05/20/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Erythema, Pain, Pruritus, Swelling
Erythema, Pain, Pruritus, Swelling
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It started swelling and getting red and hurting and not at first was it itching. It started itching ...
It started swelling and getting red and hurting and not at first was it itching. It started itching 2 days and i was putting Benadryl cream on it.
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| 2841825 | 81 | F | NJ | 05/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Circumstance or information capable of leading to medication error
Circumstance or information capable of leading to medication error
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PATIENT PRESENTED TO PHARMACY REQUESTING HER FIRST SHINGRIX VACCINATION. IN THE HEALTH SERVICES ROOM...
PATIENT PRESENTED TO PHARMACY REQUESTING HER FIRST SHINGRIX VACCINATION. IN THE HEALTH SERVICES ROOM, I CONFIRMED THIS WAS HER FIRST IN THE SERIES AND THAT WE WOULD SCHEDULE HER SECOND SHOT AFTER WE COMPLETED THE FIRST ONE. AFTER I GAVE HER THE SHOT, SHE SHOWED ME SORES ON HER BACK THAT PRESENTED LIKE SHINGLES. I REFERRED HER TO HER DOCTOR AND LET HER KNOW I WOULDN'T HAVE GIVEN HER THE SHOT IF THERE WAS A CHANCE SHE HAD AN ACTIVE SHINGLES VIRUS.
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| 2841826 | 58 | F | 05/20/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
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No adverse event
No adverse event
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There were no adverse events.
There were no adverse events.
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| 2841827 | 48 | F | TN | 05/20/2025 |
PNC21 TDAP |
MERCK & CO. INC. SANOFI PASTEUR |
Y013009 U8115AA |
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
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pt states redness, swelling, warm, and some itching, redness has spread to above elbow, pt just trie...
pt states redness, swelling, warm, and some itching, redness has spread to above elbow, pt just tried benadryl this morning and cold compress
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| 2841828 | 58 | M | TX | 05/20/2025 |
PNC20 PNC20 PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
LN4927 LN4927 LN4927 LN4927 LN4927 |
Alanine aminotransferase increased, Aspartate aminotransferase increased, Balanc...
Alanine aminotransferase increased, Aspartate aminotransferase increased, Balance disorder, Computerised tomogram head normal, Computerised tomogram neck normal; Diplopia, Dizziness, Echocardiogram, Echocardiogram normal, Eye movement disorder; Glycosylated haemoglobin normal, Hypoaesthesia, Low density lipoprotein normal, Magnetic resonance imaging abnormal, Magnetic resonance imaging head; Magnetic resonance imaging head normal, NIH stroke scale abnormal, Red blood cell sedimentation rate increased, Scan with contrast normal, Sensory loss; Sinusitis, Transient ischaemic attack, Visual field defect, Visual field tests normal
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acute onset left facial and left upper extremity numbness, peripheral vision loss associated with di...
acute onset left facial and left upper extremity numbness, peripheral vision loss associated with dizziness and gait imbalance. Per patient above symptoms started around 630 AM. admitted on 05/12/2025 with PMH of HTN, hypothyroidism, asthma, arthritis who presented for acute left facial and arm numbness, vision loss, and dizziness with last known well time at 2230 on 5/11/2025. Neurological examination revealed decreased sensation over left V1-V3 distribution, monocular left eye double vision with left lateral gaze, and NIHSS of 1 for mild-to-moderate sensory loss. CT/CTA head and neck were negative for acute findings with no large vessel occlusion, and MRI Brain and Orbit with and without contrast on 5/12/2025 showed no evidence of acute stroke. The patient was not a thrombolysis candidate as last known well time was beyond 4.5 hours, and was started on ASA 81 mg daily. By 5/13/2025, all neurological symptoms had completely resolved, and TIA was determined to be the most likely diagnosis with secondary stroke prevention measures recommended, including initiation of Crestor 20 mg daily to target LDL <70 mg/dL Patient deferred this for now, advised to discuss with his PCP. Blood pressure was managed with home medications (amlodipine 10 mg daily and lisinopril 40 mg daily) plus PRN IV labetalol/hydralazine with a goal SBP <140 mmHg. The patient's other medical conditions included hypothyroidism (on levothyroxine 125 mcg daily), gout (on allopurinol 450 mg daily), respiratory conditions (asthma, COPD, OSA requiring CPAP), and GERD with esophageal stricture (on pantoprazole 40 mg daily). Incidental findings included sinusitis on MRI, mildly elevated liver enzymes (AST 42 U/L, ALT 38 U/L), and elevated sedimentation rate (13 mm/hr), with a transthoracic echocardiogram with no PFO , no thrombus, no shunts
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| 2841829 | 18 | F | AL | 05/20/2025 |
HPV9 |
MERCK & CO. INC. |
y009051 |
Extra dose administered
Extra dose administered
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Patient received additional dose of vaccine.
Patient received additional dose of vaccine.
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