| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2840863 | M | WI | 05/14/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
|
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
administering pentacel but only the dtap-ipv dose was given with no reported adverse event; Initial ...
administering pentacel but only the dtap-ipv dose was given with no reported adverse event; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age male patient who was administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] but only the DTAP-IPV dose was given with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Apr-2025, the patient received an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) via unknown route in unknown administration site for Immunization but only the DTAP-IPV dose was given with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, the nurse called to ask if the dose given to a patient is valid- only the liquid part of PENTACEL was administered. She further asked if they had to revaccinate or when can they give the Hib component. Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA135329:
More
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| 2840864 | 0.58 | 05/14/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
|
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
supposed to be administered with pentacel but they were only able to inject the liquid part with no ...
supposed to be administered with pentacel but they were only able to inject the liquid part with no reported ae; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old and unknown gender patient to whom administered with Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] but they were only able to inject the liquid part with no reported ae (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 unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization and supposed to be administered with pentacel but they were only able to inject the liquid part with no reported ae (product preparation error) (same day latency). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly: Caller asked for the diluent to be mix the powder part with and if they can use other Hib vaccines. 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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| 2840878 | 48 | M | CA | 05/14/2025 |
MMR TDAP VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
X026404 EB499 9L944 |
Muscle spasms, Myalgia, Seizure; Muscle spasms, Myalgia, Seizure; Muscle spasms,...
Muscle spasms, Myalgia, Seizure; Muscle spasms, Myalgia, Seizure; Muscle spasms, Myalgia, Seizure
More
|
generalized seizure lasting no more than 2 minutes, seizure was treated by giving midazolam (in spra...
generalized seizure lasting no more than 2 minutes, seizure was treated by giving midazolam (in spray - 1 dose), which allowed patient to calm down and recover. It took 30 minutes for patient to get back to being situated in time and space. It took 24 hours to recover from muscle pain and cramps.
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| 2840938 | 61 | M | NC | 05/14/2025 |
PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z005765 Z005765 Z005765 Z005765 |
Acute respiratory failure, Blood creatine phosphokinase normal, Endotracheal int...
Acute respiratory failure, Blood creatine phosphokinase normal, Endotracheal intubation, Heavy metal test, Hypoaesthesia; Immunoglobulin therapy, Intensive care, Pain, Paraesthesia, West Nile virus test; Guillain-Barre syndrome, Headache, Hypoaesthesia, Intensive care, Laboratory test; Mechanical ventilation, Myalgia, Pain, Paralysis; Acute respiratory failure, Blood creatine phosphokinase normal, Endotracheal intubation, Heavy metal test, Hypoaesthesia; Immunoglobulin therapy, Intensive care, Pain, Paraesthesia, West Nile virus test; Guillain-Barre syndrome, Headache, Hypoaesthesia, Intensive care, Laboratory test; Mechanical ventilation, Myalgia, Pain, Paralysis; Acute respiratory failure, Blood creatine phosphokinase normal, Endotracheal intubation, Heavy metal test, Hypoaesthesia; Immunoglobulin therapy, Intensive care, Pain, Paraesthesia, West Nile virus test; Guillain-Barre syndrome, Headache, Hypoaesthesia, Intensive care, Laboratory test; Mechanical ventilation, Myalgia, Pain, Paralysis
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|
61yr old patient with history of gout (recent attack 4/18, patient took colchicine), HTN (baseline 1...
61yr old patient with history of gout (recent attack 4/18, patient took colchicine), HTN (baseline 120s/70s on amlodipine and lisinopril at home), and other comorbidities presented on 4/22 for check up with new concern for tinnitus. During visit, patient was prescribed to start rosuvastatin 10mg PO daily (# 850215666) due to risk of CAD. MD also ordered patient to receive Pneumococcal (PCV21) (>=19YRS) Vaccine (Capvaxive) (aka PCV21) [IMM6051] during visit. CMA administered Pneumococcal (PCV21 >=19yrs) vaccine (Capvaxive) LOT # Z005765 IM in patient's left deltoid. On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and On 4/28, patient presented to Urgent Care with severe body aches and numbness (started in lower back and spread to hips, legs, shoulders, arms, neck and head). Pain described by "tingly" and accompanied by numbness in fingers and toes. Patient took acetaminophen without relief. Patient sent to ED for further management. Per H&P, patient reported receiving RSV vaccine on 4/24 (however, not listed within Immunizations,(redacted site name), nor state database). Patient admitted to ICU. Rosuvastatin held on admission however symptoms did not improve (CK levels normal). Patient later intubated 4/29 1550 due to acute respiratory failure. Patient given IVIG x 5 days. Concern for acute inflammatory demyelinating polyradiculoneuropathy (Guillan-Barre Syndrome), pending West Nile virus and heavy metals test. Per online service, myalgia (6-17%) listed as possible adverse reaction for Pneumococcal conjugate vaccine 21 valent as well as rosuvastatin. Team continues to manage symptoms. Unable to identify cause of AIDP. 535587
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β | |||||
| 2840939 | 67 | F | OH | 05/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Injection site reaction, Rash pruritic
Injection site reaction, Rash pruritic
|
Patient said that after getting the vaccination she developed a rash around the injection site and s...
Patient said that after getting the vaccination she developed a rash around the injection site and said that rash was itchy, Said that the rash lasted for a few days and then went away. Patient said the Shingles Vaccination was the only thing she had gotten that day nothing else was new for her.
More
|
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| 2840940 | 18 | M | OH | 05/14/2025 |
MENB MENB MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
49M9N 49M9N 3E99M 3E99M |
Epistaxis, Erythema, Feeling hot, Nasal congestion, Ocular hyperaemia; Urticaria...
Epistaxis, Erythema, Feeling hot, Nasal congestion, Ocular hyperaemia; Urticaria; Epistaxis, Erythema, Feeling hot, Nasal congestion, Ocular hyperaemia; Urticaria
More
|
3:15 Vaccine's given; Approximately 10 mins later Nose bleed, nasal congestion, then continued ...
3:15 Vaccine's given; Approximately 10 mins later Nose bleed, nasal congestion, then continued with Hives on arms, chest, back. Eyes blood shot, face red and warm. Arrived at ER at 4:45p. Per mom, pt given Benadryl, IV steroid. Discharged home at 6p.
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|
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| 2840941 | 6 | M | PA | 05/14/2025 |
HEPA HEPA |
MERCK & CO. INC. MERCK & CO. INC. |
Y013274 Y013274 |
Arthropod bite, Blister, Dermatitis, Dyspnoea, Gait inability; Pain, Pruritus, R...
Arthropod bite, Blister, Dermatitis, Dyspnoea, Gait inability; Pain, Pruritus, Rash, Swelling
More
|
Developed rash on left leg 1-2 days after receiving Hep A vaccine. Rash spread to bilateral feet and...
Developed rash on left leg 1-2 days after receiving Hep A vaccine. Rash spread to bilateral feet and included swelling and itching. Presented to urgent care on 5/11/2025. Diagnosed with bug bite and prescribed Keflex and prednisone. Unfortunately, I do not have the records at this time. Later that same day, he started to develop blisters on both feet and shortness of breath, so he went to the ED Diagnosed with dermatitis and prescribed a steroid cream and given Benadryl. He only used the steroid cream once and washed it off because it caused pain. The swelling continued and caused enough pain that he was unable to walk for a time. Patient then presented here to his PCP's office on 5/14/2025 for an ED follow up, still with swelling and blisters on both feet. Patient finally took a turn for the better on 5/13/2025 and was able to walk and put on loose rainboots for his appointment on 5/14/2025. Patient instructed to complete course of prednisone and discontinue the Keflex prescribed by the hospital.
More
|
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| 2840942 | 33 | F | KY | 05/14/2025 |
VARCEL |
MERCK & CO. INC. |
X024648 |
Injection site erythema, Injection site induration, Injection site mass, Injecti...
Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
More
|
pt reported soreness and redness at injection site. reported back to clinic with symptoms, firm lump...
pt reported soreness and redness at injection site. reported back to clinic with symptoms, firm lump under skin 2x3 inches , warm to touch, redness at lump site
More
|
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| 2840943 | 57 | F | FL | 05/14/2025 |
PNC21 |
MERCK & CO. INC. |
|
Diarrhoea, Gait disturbance, Muscle spasms
Diarrhoea, Gait disturbance, Muscle spasms
|
Four days of severe leg cramps around the knees making walking difficult. One loose stool 4 days aft...
Four days of severe leg cramps around the knees making walking difficult. One loose stool 4 days after vaccine. Symptoms resolved.
More
|
||||||
| 2840944 | 1.25 | F | GA | 05/14/2025 |
HIBV TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y011267 235D2 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
More
|
Tdap given instead of Dtap.
Tdap given instead of Dtap.
|
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| 2840945 | 0.83 | M | OH | 05/14/2025 |
MMR |
MERCK & CO. INC. |
Y015995 |
Febrile convulsion, Rash morbilliform, Rhinorrhoea
Febrile convulsion, Rash morbilliform, Rhinorrhoea
|
Febrile seizure, followed by measles like rash, runny nose
Febrile seizure, followed by measles like rash, runny nose
|
||||||
| 2840946 | 0.5 | F | NY | 05/14/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7392AA |
Expired product administered
Expired product administered
|
VACCINE EXPIRED ON 05/13/2025
VACCINE EXPIRED ON 05/13/2025
|
||||||
| 2840947 | 1 | M | MI | 05/14/2025 |
HIBV |
SANOFI PASTEUR |
UK169AB |
Product preparation error, Underdose
Product preparation error, Underdose
|
The patient did not receive the full dose of HIB the diluent was not added. Called and informed pare...
The patient did not receive the full dose of HIB the diluent was not added. Called and informed parents, and an appointment was made to get full vaccine. My Practice leader also was informed of this event.
More
|
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| 2840948 | 1.25 | M | VA | 05/14/2025 |
MMR MMR MMR HIBV HIBV HIBV MMR MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y015995 Y015995 Y015995 UK113AB UK113AB UK113AB Y015995 Y015995 Y015995 |
Influenza virus test, Laboratory test, Pyrexia, Rash, Respiratory viral panel; S...
Influenza virus test, Laboratory test, Pyrexia, Rash, Respiratory viral panel; SARS-CoV-2 test; Dermatitis diaper, Pyrexia, Rash morbilliform; Influenza virus test, Laboratory test, Pyrexia, Rash, Respiratory viral panel; SARS-CoV-2 test; Dermatitis diaper, Pyrexia, Rash morbilliform; Influenza virus test, Laboratory test, Pyrexia, Rash, Respiratory viral panel; SARS-CoV-2 test; Dermatitis diaper, Pyrexia, Rash morbilliform
More
|
Full body rash and fevers 12 days after the vaccine
Full body rash and fevers 12 days after the vaccine
|
||||||
| 2840949 | 42 | M | MI | 05/14/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
XG9AF |
No adverse event
No adverse event
|
No adverse events
No adverse events
|
||||||
| 2840950 | 59 | M | FL | 05/14/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA PFIZER\BIONTECH PFIZER\BIONTECH |
067H21A 017B22A EN6206 ER8732 |
Audiogram, Tinnitus; Audiogram, Tinnitus; Audiogram, Tinnitus; Audiogram, Tinnit...
Audiogram, Tinnitus; Audiogram, Tinnitus; Audiogram, Tinnitus; Audiogram, Tinnitus
More
|
I developed tinnitus within a month of the first shot
I developed tinnitus within a month of the first shot
|
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| 2840951 | 64 | F | NC | 05/14/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Z002626 Z002626 |
Fatigue, Influenza like illness, Injection site erythema, Injection site pain, I...
Fatigue, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling; Injection site warmth, Pyrexia
More
|
Site red/painful/swollen/hot - patient experienced flu like symptoms (fever and fatigue)
Site red/painful/swollen/hot - patient experienced flu like symptoms (fever and fatigue)
|
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| 2840952 | 27 | M | MI | 05/14/2025 |
HEP HEPA TDAP |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
945665 2345B Y3Z9P |
Hyperhidrosis, Presyncope; Hyperhidrosis, Presyncope; Hyperhidrosis, Presyncope
Hyperhidrosis, Presyncope; Hyperhidrosis, Presyncope; Hyperhidrosis, Presyncope
|
Vasovagal reaction Patient did experience a vasovagal response after receiving immunizations. No LOC...
Vasovagal reaction Patient did experience a vasovagal response after receiving immunizations. No LOC. Still conscious, alert to stimuli. She was placed in supine position with feet elevated, cool towels applied to forehead. Initial vital signs on evaluation included diaphoresis, alert, blood pressure 120/100, heart rate 58. O2 98. Patient was given apple juice, we were at bedside. No syncopal. Patient's blood pressure on discharge was 111/75, heart rate 89. Verbalized this has happened in the past.
More
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| 2840953 | 9 | M | NC | 05/14/2025 |
FLU3 |
SEQIRUS, INC. |
946591 |
Juvenile idiopathic arthritis, Laboratory test abnormal
Juvenile idiopathic arthritis, Laboratory test abnormal
|
Patient began having symptoms of JIA within 6 weeks of vaccination
Patient began having symptoms of JIA within 6 weeks of vaccination
|
β | |||||
| 2840954 | 47 | F | OR | 05/14/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
J4K4X |
Unevaluable event
Unevaluable event
|
NONE
NONE
|
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| 2840955 | 19 | F | VA | 05/14/2025 |
YF |
SANOFI PASTEUR |
UK134AA |
Product preparation error
Product preparation error
|
Yf-Vax was mixed with Sterile water instead of Nacl
Yf-Vax was mixed with Sterile water instead of Nacl
|
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| 2840956 | 0.17 | F | OH | 05/14/2025 |
HIBV PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
|
Vomiting projectile; Vomiting projectile
Vomiting projectile; Vomiting projectile
|
Projectile vomit. Vaccines given in the morning, fine throughout the day. Bottle fed the following m...
Projectile vomit. Vaccines given in the morning, fine throughout the day. Bottle fed the following morning and projectile vomited after. No symptoms or vomiting after.
More
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| 2840957 | 93 | F | MA | 05/14/2025 |
COVID19 |
MODERNA |
3046731 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
Received a dose on 04/17/2025: was not due for a second dose today/ No ill effects noted at this tim...
Received a dose on 04/17/2025: was not due for a second dose today/ No ill effects noted at this time
More
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| 2840959 | 12 | F | OR | 05/14/2025 |
MNQ |
SANOFI PASTEUR |
U8438AA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Patient was due for her second dose of HPV vaccine. When preparing the vaccine I grabbed MCV(menactr...
Patient was due for her second dose of HPV vaccine. When preparing the vaccine I grabbed MCV(menactra) instead of HPV and didn't realize the error until after giving the vaccine. Patient received her first dose of MCV vaccine 02/21/2024. The patient showed no signs of reactions after receiving the erroneous vaccine. The patient and accompanying parent were informed by myself and provider who saw the patient today.
More
|
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| 2840960 | 79 | F | PA | 05/14/2025 |
COVID19 |
MODERNA |
8080469 |
Injection site bruising, Injection site mass
Injection site bruising, Injection site mass
|
SMALL LUMP AT SITE OF INJECTION, BRUISING.
SMALL LUMP AT SITE OF INJECTION, BRUISING.
|
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| 2840961 | 17 | F | CA | 05/14/2025 |
HPV9 |
MERCK & CO. INC. |
Y012865 |
Injection site reaction, Injection site swelling, Rash, Rash pruritic, Swelling ...
Injection site reaction, Injection site swelling, Rash, Rash pruritic, Swelling face
More
|
Seen last week for allergic reaction to Fe supplement Given IM benadryl in clinic, and prescribed be...
Seen last week for allergic reaction to Fe supplement Given IM benadryl in clinic, and prescribed benadryl, cetirizine and Epi-pen Was seen 2 days later, symptoms had improved, was given HPV Several hours later that day, on 5/7/25, developed swelling and itchy rash on left upper arm (site of HPV vaccine) and left side of face Seen at ER, no rash seen at time of visit, given oral benadryl Swelling and rash have since resolved Not taking benadryl or cetirizine currently Referred to Allergist- appt ready to be scheduled
More
|
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| 2840962 | 83 | F | VA | 05/14/2025 |
DTAP |
SANOFI PASTEUR |
U8232AA |
Wrong patient received product
Wrong patient received product
|
patient received a vaccination that was not meant to her - incorrect patient
patient received a vaccination that was not meant to her - incorrect patient
|
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| 2840963 | 3 | F | UT | 05/14/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
223Y9 |
Urticaria
Urticaria
|
Diffuse urticaria shortly after event. Loratadine given with improvement in symptoms.
Diffuse urticaria shortly after event. Loratadine given with improvement in symptoms.
|
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| 2840964 | 76 | M | PA | 05/14/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Acoustic stimulation tests, Arthralgia, Magnetic resonance imaging, Mobility dec...
Acoustic stimulation tests, Arthralgia, Magnetic resonance imaging, Mobility decreased, Tinnitus; Vertigo
More
|
Patient reports joint pain following initial Covid 19 vaccine. States pain has been consistent since...
Patient reports joint pain following initial Covid 19 vaccine. States pain has been consistent since first dose and mainly affects his knees and shoulders (difficult to raise arms overhead). Patient also reports a constant hum in one ear that does not resolve. Patient says he had vertigo symptoms in July of 2024 that led to a hospital admission.
More
|
β | |||||
| 2840965 | 48 | F | WV | 05/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
946623 LN0591 |
Laboratory test, Musculoskeletal disorder, Paralysis; Laboratory test, Musculosk...
Laboratory test, Musculoskeletal disorder, Paralysis; Laboratory test, Musculoskeletal disorder, Paralysis
More
|
Patient states that 2 days after vaccines were given she went to the hospital. Her symptoms were : n...
Patient states that 2 days after vaccines were given she went to the hospital. Her symptoms were : not able to lift her arms or move her arms or legs and was paralyzed. She was in the hospital from 1/25/2025 to 1/29/2025 then went back in on 04/24/2025 to 04/29/2025. She spoke with the doctors there and they would not listen to her. She then came into the pharmacy today 5/14/2025 and I was speaking with her and she was telling me her reactions she had to the vaccines and I spoke with my Pharmacy Manager, and the symptoms sounded like Guillian-Barre Syndrome and we advised her to reach out to her doctor and speak with them and let her know we will be submitting this VEARS reaction form.
More
|
β | |||||
| 2840966 | 1 | F | GA | 05/14/2025 |
HEPA MMRV PNC20 VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
J4K4X Y0009983 LJ5282 Y015558 |
Extra dose administered; Extra dose administered; Extra dose administered; Extra...
Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered
More
|
PT WAS TO GET MMR AND VARICELLA BUT WAS INADVERTLY GIVEN PROQUAD AND VARIVAX DUE TO THE SIMILAR LOOK...
PT WAS TO GET MMR AND VARICELLA BUT WAS INADVERTLY GIVEN PROQUAD AND VARIVAX DUE TO THE SIMILAR LOOK OF VIALS OF PROQUAD AND MMR. UNKNOWN SYMPTOMS OF CHILD AT THIS TIME.
More
|
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| 2840967 | 11 | F | GA | 05/14/2025 |
DTAP HPV9 TDAP |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
9KB9G Y007197 9YB4G |
Extra dose administered, Product administered to patient of inappropriate age; E...
Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age
More
|
Per the manufacturer the patient should only have local reactions | per the provider the patient...
Per the manufacturer the patient should only have local reactions | per the provider the patient's guardian does not need to be notified
More
|
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| 2840968 | 7 | M | ND | 05/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN7302 2H2S9 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
|
Was informed on 4/24/25 by Pfizer that there was an error during shipping and shipment is no longer ...
Was informed on 4/24/25 by Pfizer that there was an error during shipping and shipment is no longer valid. Recalled patient, no adverse side effects reported.
More
|
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| 2840969 | 69 | F | MO | 05/14/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Chills, Dyspnoea, Fatigue, Injection site erythema, Pain in extremity; Pyrexia
Chills, Dyspnoea, Fatigue, Injection site erythema, Pain in extremity; Pyrexia
|
pt says when she got the vaccine the pharmacist explained that she may have a few side effects but s...
pt says when she got the vaccine the pharmacist explained that she may have a few side effects but she starting feeling fatigued and her left arm was sore. She went to bed and woke up feverish. She had chills from the inside out, from head to toe. She started having a hard time breathing. She got her comforter and got back in bed but had to raise back up because she was still having a hard time breathing. About 8 the next morning, she woke up, she was a tired from not having a good nights sleep but she did feel better. No longer had fever or chills but she did notice some red spots around the injection site but had disappeared by the end of the day. She called her doctors office and spoke to the nurse and let them know about her symptoms. She feels like has recovered from all of the symptoms.
More
|
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| 2840970 | 7 | F | ND | 05/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN7302 2H2S9 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
|
On 4/24/25 was notified by Pfizer that there was an error during shipment and shipment was no longer...
On 4/24/25 was notified by Pfizer that there was an error during shipment and shipment was no longer valid. Recalled patient, no adverse side effects reported.
More
|
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| 2840971 | 32 | F | NM | 05/14/2025 |
HPV9 |
MERCK & CO. INC. |
xo24251 |
Rash
Rash
|
patient developed rash
patient developed rash
|
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| 2840972 | 46 | M | MD | 05/14/2025 |
CHIK |
VALNEVA USA, INC. |
24B011 |
Fatigue, Headache, Heart rate increased, Influenza like illness, Myalgia
Fatigue, Headache, Heart rate increased, Influenza like illness, Myalgia
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Felt flu-like symptoms, starting 2 days after the vaccine was received. Symptoms lasted 4-5 days - f...
Felt flu-like symptoms, starting 2 days after the vaccine was received. Symptoms lasted 4-5 days - fatigue, muscle ache, headache, increased heart rate.
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| 2840973 | 11 | F | CA | 05/14/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
7C747 |
Tic, Tremor
Tic, Tremor
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Patient was given the TDAP during an ER visit because she cut herself and required stiches. Due to ...
Patient was given the TDAP during an ER visit because she cut herself and required stiches. Due to Patient having weird tourette tic like symptoms after immunizations when she was younger, we requested strictly the tetanus - but she was given the full dtap. Her episodes have come back so we put her on a on a zeolite detox
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| 2840974 | 75 | F | NV | 05/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site pain, Injection site swelling, Injection site warmth
Injection site pain, Injection site swelling, Injection site warmth
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swelling, pain, and warm to touch at injection site
swelling, pain, and warm to touch at injection site
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| 2840975 | 16 | F | MI | 05/14/2025 |
HPV9 MENB |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
2014790 77KA5 |
Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain in ex...
Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain in extremity, Paraesthesia; Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Pain in extremity, Paraesthesia
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Hello, (Email from on 05/13/25) Just some questions on patient (Questions and answers from PA-C who ...
Hello, (Email from on 05/13/25) Just some questions on patient (Questions and answers from PA-C who emailed back.) 1. Could you see the actual injection site? If so, was placement correct? Yes, on my physical exam on 5/12/25 I could see where she received the injection as there was a small puncture mark still visible on her left lateral deltoid and that was the point of maximum tenderness. 2. What did the actual injection site look like? Besides the small puncture mark, there was no other visible abnormalities of the injection site (ie. No swelling, bruising, redness) 3. Pt was seen for shoulder/body injury on the 7th, seen at facility on the 8th for neck pain, then another facility on the 11th for shoulder pain, and then another facility on the 12th for left arm pain. All re: shoulder, neck, upper back pain. Adverse effect of vaccine??? Recommend not getting the MenB #2 of 2??? Per patient history she was knocked over by a friend on 5/7/25 which caused her to fall and hit her upper back/neck which she was evaluated for on 5/8/25. She did not complain of any shoulder or arm pain at that time. She received 2 immunizations, MEN B in the left deltoid and HPV dose #2 in the right deltoid, at the 5/8/25 OV. Patient reported some injection site tenderness of Left shoulder on Friday 5/9/25 to her parent and they decided to monitor. Patient reported that pain turned into numbness/tingling of her left arm as the day progressed on Friday, then it worsened on Saturday where she could barely move her left arm, so then parent took her to facility on 5/11/25 for evaluation. Patient stated they did not give her any clear answers and said she may have torn a muscle in her arm and told her to take OTC acetaminophen and ibuprofen as needed. Patient seen on 5/12/25 for worsening left arm pain/tingling and upon further history and progression of symptoms it was determined that symptoms were highly likely related to MEN B immunization on 5/8/25 as that was the immunization given in that arm. Patient denied doing any activity that would have injured her left arm or caused her to tear a muscle. Physical exam did not align with impingement syndrome from previous neck pain complaint and with maximum tenderness still at the injection site this provider determined this likely was a vaccine adverse effect. Patient had limited range of motion of left arm and pain with movement, facility gave her an arm sling to wear due to symptoms. Patient still wore arm sling on 5/12/25 and unable to move arm actively or passively without moderate pain. Per progression and severity of symptoms this provider recommended that patient not get MEN B dose #2. I?m just making sure before I complete this VEARS Report and put an alert in the chart. Thanks.
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| 2840976 | 16 | M | OH | 05/14/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
Z002903 U7996AA |
Dyspnoea, Flushing, Staring, Unresponsive to stimuli; Dyspnoea, Flushing, Starin...
Dyspnoea, Flushing, Staring, Unresponsive to stimuli; Dyspnoea, Flushing, Staring, Unresponsive to stimuli
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After receiving the HPV in the right deltoid and meningococcal in the left deltoid vaccine the Pt wa...
After receiving the HPV in the right deltoid and meningococcal in the left deltoid vaccine the Pt was in sitting position and stated he needed some water and he couldn't breath very well and laid his head back on the bed. His face turned very flushed and he was starring off into space and not responding when asked if he was okay. I put the back of the bed all the way down and rolled him onto his left side. He was back alert once I got him onto his side. The pt shook his head from side to side when asked if he was okay. I called another nurse into the room for assistance so I could stay with the pt and his mother. He was provided some water, fast sugar, an cold towels for his forehead. The pt mom states he passes out when he is very anxious and he had not ate today besides a coffee this morning. The patient has not had a reaction to the HPV shot before and this was his last dose. I stayed in the room with the patient until he stated he felt better and felt like he could breath and was ready to go home to eat. I walked to the car with the pt and mom. The pt was stable, walking without assist from vaccine room to car. Mom was advised to seek care from the ER if anything was to happen in the car or at home.
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| 2840977 | 48 | F | TX | 05/14/2025 |
TDAP |
SANOFI PASTEUR |
u8232aa |
Back pain
Back pain
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Pt received Adacel and states that same day started experiencing lower back pain
Pt received Adacel and states that same day started experiencing lower back pain
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| 2840978 | 27 | F | MN | 05/14/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
95BJ9 |
Underdose
Underdose
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Client was given the pediatric dose of Engerix B instead of adult dose.
Client was given the pediatric dose of Engerix B instead of adult dose.
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| 2840979 | 0.17 | F | MD | 05/14/2025 |
DTAPHEPBIP HIBV PNC20 RV1 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
2G273 UK201AC LC5483 3Z34X |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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After administration of vaccinations, this RN noticed patient's vaccination history had updated...
After administration of vaccinations, this RN noticed patient's vaccination history had updated to show patient received the above vaccinations on 5/6/25 at another office - this information was not available the day prior to the appt when the appt was prepped. These vaccinations were intended to be the 1st set of vaccinations. However, patient received an invalid dose of the vaccinations on 5/14/25. No immediate adverse reactions observed in office.
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| 2840980 | 64 | M | NH | 05/14/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9YB4G |
No adverse event
No adverse event
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No adverse reaction
No adverse reaction
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| 2840981 | 0.5 | F | WA | 05/14/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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Extra dose of rotarix was given. EHR is set to recognize a 3-dose series of rotavirus vaccinations, ...
Extra dose of rotarix was given. EHR is set to recognize a 3-dose series of rotavirus vaccinations, not the 2-dose rotarix series. Nurse gave dose of rotarix thinking it was needed. Mother of patient was notified. Reviewed warning signs of adverse effects which may arise along with timeline.
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| 2840982 | 17 | F | TN | 05/14/2025 |
HPV9 |
MERCK & CO. INC. |
X025115 |
Erythema, Injection site erythema, Paraesthesia
Erythema, Injection site erythema, Paraesthesia
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Patient called nurse line today reports redness at site of injection. reports the redness radiating ...
Patient called nurse line today reports redness at site of injection. reports the redness radiating down left arm since Monday 5/12/25. Did admit to tingling in fingers of left hand. Denies any swelling, trouble breathing or or swallowing. Patient instructed to take benedryl and ibuprofen, also instructed her to do cold compresses. Instructed patient to seek emergent care for any swelling, trouble breathing, etc. Patient voiced understanding and agreed to comply.
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| 2840983 | 5 | M | MA | 05/14/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
Y97N7 |
Erythema, Induration, Mobility decreased, Oedema peripheral, Skin warm
Erythema, Induration, Mobility decreased, Oedema peripheral, Skin warm
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Erythema, Edema, extremely hot, and hard from deltoid down to bicep, stopping at elbow. Unable to ra...
Erythema, Edema, extremely hot, and hard from deltoid down to bicep, stopping at elbow. Unable to raise arm laterally and anteriorly. No fever at this time. Two days of ice, Benadryl and Motrin/Tylenol with worsening pain and swelling. MD seen on 5/14/25 given rx for keflex.
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| 2840987 | 12 | F | TX | 05/14/2025 |
HPV9 |
MERCK & CO. INC. |
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Expired product administered
Expired product administered
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HCP called to report a patient received an expired dose of GARDASIL 9. The product expired 02/14/202...
HCP called to report a patient received an expired dose of GARDASIL 9. The product expired 02/14/2025 and was administered to one patient 04/28/2025. No side effects or symptoms have been reported, and product had not undergone a temperature excursio; HCP called to report a patient received an expired dose of GARDASIL 9. The product expired 02/14/2025 and was administered to one patient 04/28/2025. No side effects or symptoms have been reported, and product had not undergone a temperature excursio; This spontaneous report was received from a physician concerning a 12-year-old female patient. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On 28-APR-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9) ( lot number not reported, expiration date: 14-FEB-2025) 0.5 mL (0.5ml), (lot # was not reported) as prophylaxis. No side effects or symptoms have been reported and product had not undergone a temperature excursion. No additional information provided. The operator of device was health professional. Lot # is being requested and will be submitted if received.
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| 2840988 | 4 | F | HI | 05/14/2025 |
DTAP FLU3 IPV MMR VARCEL |
UNKNOWN MANUFACTURER SANOFI PASTEUR UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. |
BCA20Cl US4424A BCA20Cl Y000225 Y011019 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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No adverse event; Improper storage of product in use; This spontaneous report was received from a pe...
No adverse event; Improper storage of product in use; This spontaneous report was received from a pediatric referring to a 4-year-old female patient. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported. On 03-MAR-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot#: Y000225, expiration date: 03-JAN-2026; dose and strength were not provided) subcutaneously in the left thigh; the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot#:Y011019, expiration date: 18-JUN-2026; dose and strength were not provided) subcutaneously in the left thigh. The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (dose, strength, and expiration date were not reported) for prophylaxis. On the same day, the patient was vaccinated with the fifth dose of Diphtheria vaccine toxoid ()+ Pertussis vaccine acellular (+) Tetanus vaccine toxoid (DTAP) (lot#: BCA20Cl, expiration date: 28-FEB-2026) intramuscularly in the right thigh; the forth dose of Polio vaccine inact (IPV) (lot#: BCA20Cl, expiration date: 17-NOV-2026) intramuscularly in the right thigh; and the forth dose of fluconazole (FLUZONE) (lot#: US4424A, expiration date: 30-JUN-2025) intramuscularly in the right thigh. A temperature excursion as a result of digital data logger at -9.8 C for 2 hours a minutes occurred to the vaccines mentioned above (product storage issue). No addition adverse events occurred (no adverse event).
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