| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2829918 | 6 | M | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered
Expired product administered
|
Vaccine was administered after the BUD which was 2/5/2025.
Vaccine was administered after the BUD which was 2/5/2025.
|
|||||||
| 2829919 | 8 | M | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered
Expired product administered
|
Vaccine was administered after the BUD of 2/3/2025
Vaccine was administered after the BUD of 2/3/2025
|
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| 2829920 | 0.83 | F | AL | 03/06/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
9543Y |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
Patient received DTAP, IPV and HIB before actual due date. No adverse reactions.
Patient received DTAP, IPV and HIB before actual due date. No adverse reactions.
|
||||||
| 2829921 | 82 | F | OR | 03/06/2025 |
PNC20 |
PFIZER\WYETH |
LK6650 |
Chills, Heart rate increased, Pain
Chills, Heart rate increased, Pain
|
Patient states experienced body aches and chills as well as elevated heart rate after receiving the ...
Patient states experienced body aches and chills as well as elevated heart rate after receiving the vaccine. Patient states the elevated heart rate lasted around 24 hours then resolved on its own.
More
|
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| 2829922 | 37 | M | 03/06/2025 |
FLU3 |
SANOFI PASTEUR |
|
Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Paraesthesia
Arthralgia, Hypoaesthesia, Injected limb mobility decreased, Paraesthesia
|
Left shoulder pain, left arm numbness, pins and needles feeling from shoulder to finger tips, can...
Left shoulder pain, left arm numbness, pins and needles feeling from shoulder to finger tips, can't lift left shoulder
More
|
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| 2829923 | 10 | F | KY | 03/06/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
47Y5M |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
Patient was due for Tdap and received in Dtap at approximately 0845 on 3/6/25. No adverse signs or s...
Patient was due for Tdap and received in Dtap at approximately 0845 on 3/6/25. No adverse signs or symptoms noted. Patient present with family member. Family member made aware of event with no further questions or concerns.
More
|
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| 2829924 | 14 | F | NJ | 03/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
4LM54 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Pt received flu vaccine on 3/1/25 but pt had already received a dose for this season on 9/30/24. Spo...
Pt received flu vaccine on 3/1/25 but pt had already received a dose for this season on 9/30/24. Spoke with patient and advised no harm to patient.
More
|
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| 2829925 | 45 | F | NJ | 03/06/2025 |
PNC20 |
PFIZER\WYETH |
LJ5281 |
Skin discolouration
Skin discolouration
|
Left leg skin discoloration 1 day later. No other areas of the body affected. Claritin daily &...
Left leg skin discoloration 1 day later. No other areas of the body affected. Claritin daily & derm f/u if not resolved recommended.
More
|
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| 2829926 | 0.42 | F | OK | 03/06/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UJ985AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Expired vaccine administered. No adverse reactions noted. Parent notified
Expired vaccine administered. No adverse reactions noted. Parent notified
|
||||||
| 2829928 | 11 | F | WA | 03/06/2025 |
TDAP |
SANOFI PASTEUR |
U8232AA |
Erythema, Skin warm, Swelling
Erythema, Skin warm, Swelling
|
Redness, swelling and warmth to area.
Redness, swelling and warmth to area.
|
||||||
| 2829929 | 60 | M | NY | 03/06/2025 |
COVID19 |
MODERNA |
|
Blood disorder, Laboratory test, Polymyalgia rheumatica, Rash, Skin cancer
Blood disorder, Laboratory test, Polymyalgia rheumatica, Rash, Skin cancer
|
Started with a rash and then diagnosed with PMR and many other blood disorders, skin cancer tumors.
Started with a rash and then diagnosed with PMR and many other blood disorders, skin cancer tumors.
|
β | |||||
| 2829930 | 30 | M | TX | 03/06/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Patient was given an expired Meningococcal Vaccine, pt was monitored no adverse events happened. Pat...
Patient was given an expired Meningococcal Vaccine, pt was monitored no adverse events happened. Patient was notified and educated on the incident.
More
|
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| 2829931 | 58 | F | IN | 03/06/2025 |
HEPAB HEPAB MMR MMR PNC21 PNC21 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
D4774 D4774 Y008077 Y008077 Y011819 Y011819 |
Diarrhoea, Dizziness, Injection site erythema, Injection site pain, Injection si...
Diarrhoea, Dizziness, Injection site erythema, Injection site pain, Injection site rash; Injection site swelling, Nausea, Pyrexia, Vomiting; Diarrhoea, Dizziness, Injection site erythema, Injection site pain, Injection site rash; Injection site swelling, Nausea, Pyrexia, Vomiting; Diarrhoea, Dizziness, Injection site erythema, Injection site pain, Injection site rash; Injection site swelling, Nausea, Pyrexia, Vomiting
More
|
Patient received vaccines on a Friday afternoon. By Saturday evening she claimed to have nausea and...
Patient received vaccines on a Friday afternoon. By Saturday evening she claimed to have nausea and vomiting, dizziness, fever, loose stools and pain and redness at the injection site. At this time a rash began to form on her Right arm. She presented to the pharmacy today (7 days later) still suffering with an extensive rash and swelling from the shoulder to the elbow. All other symptoms subsided. Despite using ice and Benadryl, the rash has not subsided.
More
|
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| 2829932 | 0.17 | F | CA | 03/06/2025 |
PNC20 |
PFIZER\WYETH |
HN2630 |
Injection site bruising, Injection site nodule
Injection site bruising, Injection site nodule
|
"Subcutaneous nodule" has persisted on L thigh since vaccination. Per mother of patient, ...
"Subcutaneous nodule" has persisted on L thigh since vaccination. Per mother of patient, initially had bruise in the location, then a small bump appeared and has stayed the same size.
More
|
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| 2829933 | 26 | F | TX | 03/06/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y019176 Y011018 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
Pt. was seen in OB/GYN office today for wellness exam, her titers for Varicella and Rubella showed l...
Pt. was seen in OB/GYN office today for wellness exam, her titers for Varicella and Rubella showed low, so Dr. recommend pt get MMR and VARICELLA prior to getting pregnant. I Lvn accidently gave pt. a double dose of Varicella. While pulling vaccine out of freezer I just saw MMR and pulled a Varicella vial. After administering the vaccines while going to log vaccines noticed I gave MMRV and Varicella. Had pt. stay in office for 20 minutes to see if she had any adverse reaction and she had no redness or swelling to inj. site. The made my Dr. and Supervisor aware of incident and called CDC and gave me VARES.HSS.GOV website to fill out medication error.
More
|
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| 2829934 | 0.5 | M | TX | 03/06/2025 |
RV5 |
MERCK & CO. INC. |
208619 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
6 month old patient received a rotavirus vaccine when the vaccine history showed no previous doses. ...
6 month old patient received a rotavirus vaccine when the vaccine history showed no previous doses. Therefore this dose was not needed at this age. No harm to Patient. Provider attempted to notify family but is unable to reach at this time.
More
|
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| 2829935 | 1.25 | M | CT | 03/06/2025 |
VARCEL |
MERCK & CO. INC. |
Y015101 |
Varicella
Varicella
|
Contracted mild case of varicella
Contracted mild case of varicella
|
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| 2829936 | 64 | F | AK | 03/06/2025 |
PNC20 |
PFIZER\WYETH |
LC1279 |
Injection site erythema, Injection site oedema, Injection site pruritus, Injecti...
Injection site erythema, Injection site oedema, Injection site pruritus, Injection site reaction
More
|
Injection site reaction: erythema, inflammation, itching, edema.
Injection site reaction: erythema, inflammation, itching, edema.
|
||||||
| 2829937 | 65 | F | OH | 03/06/2025 |
RSV |
PFIZER\WYETH |
LN5464 |
Extra dose administered
Extra dose administered
|
**Patient was inadvertently given a second dose of RSV vaccine. She had received one dose previously...
**Patient was inadvertently given a second dose of RSV vaccine. She had received one dose previously on 1-31-25.
More
|
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| 2829938 | 65 | M | PA | 03/06/2025 |
PNC20 |
PFIZER\WYETH |
|
Atrial fibrillation, Electrocardiogram ambulatory abnormal, Myalgia, Palpitation...
Atrial fibrillation, Electrocardiogram ambulatory abnormal, Myalgia, Palpitations, Tachycardia
More
|
Several days of muscle pain after the vaccine and leading up to the ?event? on March 1st. At approx...
Several days of muscle pain after the vaccine and leading up to the ?event? on March 1st. At approximately 11:00 on 3/1/2025, I developed significant tachycardia with exercise. I felt palpitations. Apple Watch determined it to be Atrial Fibrillation. Despite ceasing exercise, and increasing hydration, it took 6 hours to revert to normal sinus rhythm.
More
|
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| 2829939 | 14 | M | TX | 03/06/2025 |
MNQ TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8361AA LX494 |
Cough, Dizziness, Pruritus, Urticaria; Cough, Dizziness, Pruritus, Urticaria
Cough, Dizziness, Pruritus, Urticaria; Cough, Dizziness, Pruritus, Urticaria
|
Hives all over his face, especially around the eyes, arms, torso. 911 was called at 11:34 am, EMS ar...
Hives all over his face, especially around the eyes, arms, torso. 911 was called at 11:34 am, EMS arrived at 11:40 am. EMS transported the student to ER. IV was inserted and Benadryl 0.5ml was administered. V/S Pulse 118, BP 133/76, O2 sat 94-95. Student was dizzy and felt itchy with slight cough noted. Denied shortnes of breath
More
|
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| 2829940 | 84 | M | MI | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1776 |
Extra dose administered
Extra dose administered
|
This patient was given 2 shots (same lot and exp.)
This patient was given 2 shots (same lot and exp.)
|
||||||
| 2829941 | 4 | F | MA | 03/06/2025 |
DTAP HEPA IPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
3CA25C1 Y012054 X1D141M Y017207 |
Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripher...
Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripheral swelling
More
|
Swelling of right arm with redness
Swelling of right arm with redness
|
||||||
| 2829942 | 2 | M | VA | 03/06/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
B532G |
Extra dose administered, No adverse event, Wrong product administered
Extra dose administered, No adverse event, Wrong product administered
|
12:08 PM Pt came in with mom and dad for a 2 year check up. Pt immunization record reviewed and pt...
12:08 PM Pt came in with mom and dad for a 2 year check up. Pt immunization record reviewed and pt needed #2 of Hep A, DTap, and was behind on Prevnar 20. RN offered for Prevnar 20 to be administered and parents agreed. Pt vaccines prepared and administered safely in the allocated immunization room with both parents present along with a younger sibling. Pt identification verified correctly from both parents. Parents stated before child receiving vaccines pt did not have any adverse reactions to any immunizations previously given. Immunization vaccines teaching provided for parents to wait in clinic 15-20 minutes to see if pt develops adverse reactions. Post vaccine administration, RN was charting vaccine details and RN saw the pt received pediarix versus infarix giving the pt an extra dose of polio and hep b. After the notice of mistake, RN searched for pt in the clinic and pt was already gone. Multiple phone calls were made to (three times) and two times to with voice messages for parents to call Clinic back at . RN still awaiting for a return phone call. Patient Safety Reporting questionnaire filled out and VAERS completed. 1558: Pt's mother called the clinic back and was informed of what happened. Questions answered and pt's mom was appreciative of letting her know what happened. Pt's mom states the pt did not have any adverse reactions.
More
|
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| 2829944 | 73 | M | NH | 03/06/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
3E99M |
Product preparation error
Product preparation error
|
Tuberculin solution mixed with Meningococcal Oligosaccharide (Menveo) and administered IM.
Tuberculin solution mixed with Meningococcal Oligosaccharide (Menveo) and administered IM.
|
||||||
| 2829945 | 47 | F | NC | 03/06/2025 |
COVID19 COVID19 UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Injection site erythema, Injection site mass, Injection site pain, Injection sit...
Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pain; Pain in extremity, Ultrasound scan normal; Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Pain; Pain in extremity, Ultrasound scan normal
More
|
Had covid and influenza vaccine on same day. Doesn't remember which are received which vaccine....
Had covid and influenza vaccine on same day. Doesn't remember which are received which vaccine. Started having pain left arm with the injection. Radiates from injection site to lateral epicondyle, and anterior forearm. Has associated erythema, warmth, and soft issue mass. This was her first f/u since the vaccine admin.
More
|
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| 2829946 | 39 | M | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
FL3198 |
Feeling abnormal, Heart rate increased
Feeling abnormal, Heart rate increased
|
patient experienced fast heart rate over time and body did not feel right
patient experienced fast heart rate over time and body did not feel right
|
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| 2829947 | 20 | F | IN | 03/06/2025 |
FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
388534 388534 388534 |
Arthralgia, Cough, Decreased appetite, Dyspnoea, Headache; Immediate post-inject...
Arthralgia, Cough, Decreased appetite, Dyspnoea, Headache; Immediate post-injection reaction, Injection site pain, Injection site warmth, Neck pain, Pyrexia; Urticaria
More
|
Immediatley after recieving flu shot, had pain upon injection site and skin felt hot. Driving back f...
Immediatley after recieving flu shot, had pain upon injection site and skin felt hot. Driving back from appointment still felt hot and had pain upon injection site. When I got back to my room, I saw that I had hives on my abdomen. Later that night I had pain upon injection site, joint pain, and loss of appetite. Since then have experienced a cough, shortness of breath, constant headaches, joint pain, and developed a high fever and neck pain.
More
|
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| 2829948 | 75 | F | FL | 03/06/2025 |
RSV |
PFIZER\WYETH |
HY1813 |
Extra dose administered
Extra dose administered
|
This vaccine was given once in December of 2023, and again in March of 2025.
This vaccine was given once in December of 2023, and again in March of 2025.
|
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| 2829949 | 12 | F | FL | 03/06/2025 |
FLU3 FLU3 FLU3 HPV9 HPV9 HPV9 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
|
Alopecia, Angioedema, Anti-thyroid antibody increased, Antinuclear antibody incr...
Alopecia, Angioedema, Anti-thyroid antibody increased, Antinuclear antibody increased, Autoimmune disorder; Autonomic nervous system imbalance, Brain fog, Butterfly rash, Dizziness, Fatigue; Gluten sensitivity, Menstruation irregular, Neurological symptom, Palpitations, Photosensitivity reaction; Alopecia, Angioedema, Anti-thyroid antibody increased, Antinuclear antibody increased, Autoimmune disorder; Autonomic nervous system imbalance, Brain fog, Butterfly rash, Dizziness, Fatigue; Gluten sensitivity, Menstruation irregular, Neurological symptom, Palpitations, Photosensitivity reaction
More
|
Patient received the 3rd dose of Gardasil on 11/16/2016 along with her flu shot for that year. She t...
Patient received the 3rd dose of Gardasil on 11/16/2016 along with her flu shot for that year. She then returned to school and we had to pick her up because her lips started swelling (we have pictures from that day because of the severity of the swelling). We called the nurse line and asked about it and she told us that "if she was breathing ok then it should go away and she will be fine". Fast forward many years later and she is dealing with chronic autoimmune disorders. She lost almost all of her hair and was diagnosed with severe alopecia and now has to be on a lifelong Jak inhibitor for hair growth. We have spent countless hours at specialists' doctors' offices (rheumatologist, endocrinologist, dermatologist) and many hours battling health insurance companies for coverage. We've had to come out of pocket for more comprehensive blood panels to try and find answers. Since the shot in 2016, Patient has dealt with many symptoms such as POTS type symptoms, dysautonomia, severe alopecia (which led to mental trauma from losing almost all of her hair), sun sensitivity, and always high autoimmune panels. Patient will now have to be on a very expensive JAK Inhibitor for life to keep her hair. Patient had no preexisting conditions, and we believe that this 3rd round of Gardasil was the trigger for these autoimmune disorders and feel that this should be tracked for vaccine-related injuries. Signs and Symptoms that developed over the years after the 3rd dose of Gardasil: Severe swelling of lips, same day as Gardasil shot. Sun sensitivity Dizzy spells Racing heart rate Lupus type flareups with butterfly rashes Severe alopecia, which required wigs and now lifelong, very expensive medicine to grow hair Depression from hair loss Elevated ANA levels Gluten sensitivity Fatigued Brain Fog POTS symptoms Irregular periods Elevated thyroid antibodies indicating Hashimoto's
More
|
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| 2829950 | 60 | M | OH | 03/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
k72s4 |
Extra dose administered
Extra dose administered
|
Patient's caregiver brought this patient in for vaccines and after administration stated "...
Patient's caregiver brought this patient in for vaccines and after administration stated " her boss texted her and he already received a flu vaccine in November."
More
|
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| 2829951 | 56 | F | IL | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3334Y |
Injection site cellulitis
Injection site cellulitis
|
patient received immunization and called two days later to report to us that she had developed cell...
patient received immunization and called two days later to report to us that she had developed cellulitis at the injection site. Patient received amoxicillin for treatment.
More
|
||||||
| 2829952 | 84 | M | AZ | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
k2bb7 |
Contusion, Pain in extremity
Contusion, Pain in extremity
|
Pt came to pharmacy on 03/05/2025 after receiving vaccine on 02/28/2025 stating his arm was sore and...
Pt came to pharmacy on 03/05/2025 after receiving vaccine on 02/28/2025 stating his arm was sore and had a bruise. He showed me a bruise on his right arm which appeared to start 2-3 inches from the middle of his deltoid, where the vaccine was administered. The bruise also appeared to have "leaked" down the from of his arm. I did notice a number of similar appearing bruises on his left arm which appeared to have been there longer. He stated the bruise seemed to be improving, so I recommended he continue to monitor.
More
|
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| 2829953 | 59 | M | OH | 03/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
K72S4 |
Extra dose administered
Extra dose administered
|
Patient's caregiver brought this patient in for vaccines and after administration stated "...
Patient's caregiver brought this patient in for vaccines and after administration stated " her boss texted her and he already received a flu vaccine in November."
More
|
||||||
| 2829954 | 1 | M | CT | 03/06/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
43G92 |
Seizure, Unresponsive to stimuli
Seizure, Unresponsive to stimuli
|
Child was given MMR vaccine. Left the clinic. Returned about 15 minutes later seizing and unresponsi...
Child was given MMR vaccine. Left the clinic. Returned about 15 minutes later seizing and unresponsive. Oxygen given. IM Ativan given x3. Patient transported to nearest hospital by EMS.
More
|
β | β | ||||
| 2829955 | 46 | F | WA | 03/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8432AA |
Injected limb mobility decreased, Injection site pain, Muscle atrophy, Pain
Injected limb mobility decreased, Injection site pain, Muscle atrophy, Pain
|
Patient reported feeling pain in injection site on 10/8/2024 a few days after receiving the vaccine ...
Patient reported feeling pain in injection site on 10/8/2024 a few days after receiving the vaccine on 10/4/2024. Patient reported unable to use the left arm to reach across her body nor could she lift the left arm. She took acetaminophen and ibuprofen on 10/31/24 for her arm pain and did some massage and physical therapy. She also had lidocaine patch and prednisone 20mg once daily prescribed to her on 11/22/24 for her arm pain. The doctor noticed she had lost muscle in the left arm at that time. On 2/6/25, she had a physical exam with her doctor, and she still has some residual pain. Today on 3/6/25 she called our pharmacy and reported the injury and that she feels better but some movements still hurt and the injection site still tender, but the pain is very mild now. She stated that taking the prednisone 20mg once daily for 5 days in November really helped with her pain.
More
|
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| 2829956 | 71 | F | IN | 03/06/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
|
Blood test, Electromyogram, Hypoaesthesia, Lumbar puncture, Mobility decreased; ...
Blood test, Electromyogram, Hypoaesthesia, Lumbar puncture, Mobility decreased; Paraesthesia, Syncope, Urinary tract infection
More
|
late November I started to have numbness and tingling in my hands and feet, on the morning of Decemb...
late November I started to have numbness and tingling in my hands and feet, on the morning of December 4 I tried to stand up and collapsed to the floor. I was unable to get up and was taken by ambulance to Hospital At the emergency room they found that I had a UTI, but, could not move my arms and legs. At that time they called in a neurologist and he thought I might have GBS
More
|
β | |||||
| 2829957 | 46 | F | CO | 03/06/2025 |
MMRV |
MERCK & CO. INC. |
Y006767 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
MMRV given to a 46 year old pt. Vaccine not recommended for that age. No adverse symptoms. pt was no...
MMRV given to a 46 year old pt. Vaccine not recommended for that age. No adverse symptoms. pt was notified.
More
|
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| 2829958 | 1 | M | VI | 03/06/2025 |
HIBV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
j4k4X Y003499 Y007637 |
Cough, Pyrexia, Stridor, Use of accessory respiratory muscles; Cough, Pyrexia, S...
Cough, Pyrexia, Stridor, Use of accessory respiratory muscles; Cough, Pyrexia, Stridor, Use of accessory respiratory muscles; Cough, Pyrexia, Stridor, Use of accessory respiratory muscles
More
|
24 hours later, child came down with high fevers and cough, becoming very barky. Stridor at rest sta...
24 hours later, child came down with high fevers and cough, becoming very barky. Stridor at rest started the next morning and persistent the next day. Child returned to office with heart rate of 185, room air sats of 94%. Retractions seen with access muscle use, and significant inspiratory stridor. Temp of 101.7
More
|
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| 2829959 | 66 | F | WA | 03/06/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Erythema, Peripheral swelling, Pruritus, Skin reaction, Skin warm
Erythema, Peripheral swelling, Pruritus, Skin reaction, Skin warm
|
Patient had PCV 20 last week and came in today. The entire upper arm was red swollen and hot to the ...
Patient had PCV 20 last week and came in today. The entire upper arm was red swollen and hot to the touch. Dr. went and looked and stated it was just a localized allergic reaction. Dr. advised patient to take Benadryl and use hydrocortisone cream for itching.
More
|
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| 2829960 | 66 | F | TX | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
KB2YT |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
More
|
Extensive redness, itching, and pain at injection site. Skin is warm to the touch and tender.
Extensive redness, itching, and pain at injection site. Skin is warm to the touch and tender.
|
||||||
| 2829961 | 65 | F | PA | 03/06/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LP1780 U8499DA |
Erythema, Pain, Skin warm, Swelling, Tenderness; Erythema, Pain, Skin warm, Swel...
Erythema, Pain, Skin warm, Swelling, Tenderness; Erythema, Pain, Skin warm, Swelling, Tenderness
More
|
Patient received Flu and Covid vaccines in left arm on 3/3/25. She presented to pharmacy on 3/6 wit...
Patient received Flu and Covid vaccines in left arm on 3/3/25. She presented to pharmacy on 3/6 with complaints of local allergic reaction (pain, redness, swelling, tender, area feels warm to touch). She did not complain of any fever. She stated taking Tylenol for the pain.
More
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| 2829993 | M | CA | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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Covid; Covid; This case is considered as invalid since the country of primary reporter changed at fo...
Covid; Covid; This case is considered as invalid since the country of primary reporter changed at follow-up, determining an incorrect sender's unique case identifier number. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "Covid". The patient date of death was Jan2022. Reported cause of death: "COVID-19". Clinical courses is as follows: patient passed away in Jan2022 after getting the Pfizer covid 19 shot the second one he was diagnosed with covid. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. Follow-up (28Feb2025): This is a spontaneous follow-up report received from Pfizer colleague. Updated information: State and Postal code added in reporter, the country of primary reporter changed at follow-up. The information on the batch/lot number for (BNT162B2) will be requested and submitted if and when received. Nullification reason: the country of primary reporter changed at follow-up. A new case [US-PFIZER INC-202500048023] was copied from this case to create with the correct Primary reporter's country; Reported Cause(s) of Death: COVID-19; COVID-19
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| 2829994 | 60 | F | SC | 03/06/2025 |
PNC21 |
MERCK & CO. INC. |
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Headache, Injection site pain, Myalgia, Pyrexia
Headache, Injection site pain, Myalgia, Pyrexia
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symptoms of fever, muscle aches, injection site pain and headaches; symptoms of fever, muscle aches,...
symptoms of fever, muscle aches, injection site pain and headaches; symptoms of fever, muscle aches, injection site pain and headaches; symptoms of fever, muscle aches, injection site pain and headaches; symptoms of fever, muscle aches, injection site pain and headaches; This spontaneous report was received from a pharmacist and refers to a 60-year-old female patient. The patient's medical history included Neuropathy, and Leukemia. The patient's concurrent condition included compromised immune system. Concomitant medication included Gabapentin . On 06-FEB-2025 (reported as last Thursday), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL once, (strength, lot # and expiration date were not reported) for pneumonia prevention. On 07-FEB-2025 (also reported as the day after), the patient started having symptoms of fever, muscle aches, injection site pain and headaches. The patient hadn't seen their doctor to discuss their symptoms, but they were still dealing with the headaches and fever currently. They said that it wasn't something that was life threatening, but they were concerned because of their health history. At the reporting time, the patient had not recovered from the events. The action taken was not applicable. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported.
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| 2829995 | PA | 03/06/2025 |
HPV9 |
MERCK & CO. INC. |
X019862 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional adverse event was reported; Specialist transferred Medical Assistant calling to report...
No additional adverse event was reported; Specialist transferred Medical Assistant calling to report inadvertently administering an expired dose of GARDASIL 9 to a patient. Patient did not report any symptoms. Vaccine was supported per Post-Expiry Memo. Permission to contact HCP was granted.; This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 26-Feb-2025, the patient was vaccinated with expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9), (lot #X019862, expiration date: 14-Feb-2025) for prophylaxis (Expired vaccine used).
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| 2829997 | 16 | F | MO | 03/06/2025 |
HPV9 |
MERCK & CO. INC. |
Y010656 |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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No additional AE; HCP called to report a patient received a dose of GARDASIL 9 via subcutaneous rout...
No additional AE; HCP called to report a patient received a dose of GARDASIL 9 via subcutaneous route instead of intramuscularly. No side effects or symptoms have been reported. No Additional information provided. No Additional AE/PQC.; This spontaneous report has been received from a physician assistant, regarding to a 16-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 05-MAR-2025, the patient was vaccinated with a dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) 0.5 mL (Lot No. y010656 has been verified to be a valid lot number for [human papillomavirus 9-valent vaccine, recombinant suspension for injection], expiration date reported and upon internal validation established as 29-NOV-2026) (strength, dose number, anatomical location of administration and vaccination scheme frequency were not reported) that was administered as prophylaxis by subcutaneous route instead of intramuscular route (incorrect route of product administration) No additional adverse events were reported (no adverse event).
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| 2829998 | 1 | F | NV | 03/06/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
3A2KF |
Device connection issue, Exposure via skin contact, Foreign body in skin or subc...
Device connection issue, Exposure via skin contact, Foreign body in skin or subcutaneous tissue, Underdose
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leur lock adapters becoming loose and detaching Sometimes the leur lock adaptor spins when the cap i...
leur lock adapters becoming loose and detaching Sometimes the leur lock adaptor spins when the cap is removed; Product complaint; Partially administered; the needle stayed in the patient; Product splashed onto patient; Product splashed onto patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental needle stick in a 12-month-old female patient who received Hib (Hiberix) (batch number 3A2KF, expiry date 14-JUL-2026) for prophylaxis. This case was associated with a product complaint. On 25-FEB-2025, the patient received Hiberix. On 25-FEB-2025, immediately after receiving Hiberix, the patient experienced accidental needle stick (Verbatim: the needle stayed in the patient), inadvertent exposure to vaccine (Verbatim: Product splashed onto patient), exposure via skin contact (Verbatim: Product splashed onto patient) and accidental underdose (Verbatim: Partially administered). On an unknown date, the patient experienced syringe connection issue (Verbatim: leur lock adapters becoming loose and detaching Sometimes the leur lock adaptor spins when the cap is removed) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental needle stick was unknown and the outcome of the inadvertent exposure to vaccine, exposure via skin contact, syringe connection issue, accidental underdose and pharmaceutical product complaint were not applicable. The reporter considered the accidental needle stick and syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. The company considered the accidental needle stick and syringe connection issue to be related to Hiberix and Hiberix And Diluent Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-FEB-2025 The office manager reported the complaint of the rotating and detachment of the leur lock adapters and it was confirmed a leur lock needles were used and they had several issues with the leur lock adapters becoming loose and detaching and sometimes the leur lock adaptor spinned when the cap was removed, it spin when the needle was attached and also came completely off along with the needle during the injection. The reporter reported that during preparation for administration the defect was discovered for this current lot it was after partial use of the multipack and was partially administered, which led to accidental underdose. The luer lock adapter detached during injection and product splashed onto the HCP and the patient and the needle stayed in the patient, which led to inadvertent exposure to vaccine and exposure via skin contact. The reporter was unable to tell how much of the product was given and McKesson Thin Wall Needle 25g of 1 inch was used.
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| 2830000 | F | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9HM59 |
Malaise
Malaise
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got sick again; This non-serious case was reported by a consumer via call center representative and ...
got sick again; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30-SEP-2023) for prophylaxis. On 01-DEC-2022, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: got sick again). The outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to Shingrix. It was unknown if the company considered the sickness to be related to Shingrix. Additional Information: GSK receipt date: 27-FEB-2025 The reporter was the patient she declined all demographics and her date of birth. The patient reported that she received the first dose of Shingrix and never got the second dose of Shingrix. The patient did take other chronic medications (Declined Providing Unknown Product Information), but did not remember if she took them that same day before she got the first dose of the Shingrix vaccine. The patient did had a rare health conditions, but it was unknown if these were pre-existing receiving the first dose of Shingrix (Declined Providing Medical History Information) and, the patient reported that she did not get her second dose of Shingrix per the recommended dosing schedule because her Physician wanted her to get over the acute phase of her rare health condition first, which lasted a long time. The patient reported that then she forgot to get the second dose of Shingrix once she was over the acute phase of her rare health condition, but then got sick again. No further information was provided. The patient states that she was sensitive to other medications, but not vaccines (no further information provided).
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| 2830001 | 11 | M | AR | 03/06/2025 |
DTAPIPV DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
34mf9 UNK |
Product administered to patient of inappropriate age, Wrong product administered...
Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered
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received 1st dose of Kinrix vaccine at the age of 7 years; another nurse accidentally administered ...
received 1st dose of Kinrix vaccine at the age of 7 years; another nurse accidentally administered KINRIX today to a patient instead of boostrix; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis and DTPa-IPV (Kinrix) for prophylaxis. On 28-FEB-2025, the patient received the 2nd dose of Kinrix. On an unknown date, the patient received Boostrix and the 1st dose of Kinrix. On 28-FEB-2025, an unknown time after receiving Kinrix and not applicable after receiving Boostrix and Kinrix, the patient experienced wrong vaccine administered (Verbatim: another nurse accidentally administered KINRIX today to a patient instead of boostrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: received 1st dose of Kinrix vaccine at the age of 7 years). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration 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:2 8-FEB-2025 Reporter was the Health Care Professional who stated that another nurse accidentally administered KINRIX today to a patient instead of Boostrix which led to wrong vaccine administered and Inappropriate age at vaccine administration. The patient received their first dose of KINRIX when they were 7 years old which led to inappropriate age at vaccine administration This case was one of the three case reported by the same reporter for different patient.; Sender's Comments: US-GSK-US2025025495:same reporter US-GSK-US2025025491:same reporter US-GSK-US2023044436:same reporter
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| 2830002 | F | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Ageusia, Anosmia, Depression, Weight decreased
Ageusia, Anosmia, Depression, Weight decreased
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no smell; no taste; I am feeling depressed; lost weight; This non-serious case was reported by a con...
no smell; no taste; I am feeling depressed; lost weight; This non-serious case was reported by a consumer and described the occurrence of anosmia in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included anosmia (4 months of no smell). On 07-NOV-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anosmia (Verbatim: no smell), taste absent (Verbatim: no taste), depressed mood (Verbatim: I am feeling depressed) and weight loss (Verbatim: lost weight). The outcome of the anosmia and taste absent were not resolved and the outcome of the depressed mood and weight loss were not reported. It was unknown if the reporter considered the anosmia, taste absent, depressed mood and weight loss to be related to Shingrix. It was unknown if the company considered the anosmia, taste absent, depressed mood and weight loss to be related to Shingrix. Additional Information: GSK receipt date: 04-MAR-2025 The patient reported that she had recived Shingrix vaccine and experienced 4 months of no smell, no taste. Also, she was feeling depressed and had lost weight.
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