| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2837197 | 04/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
did not receive 2nd dose; This non-serious case was reported by a consumer via interactive digital m...
did not receive 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 01-OCT-2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 15-APR-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient received his/her first Shingrix injection and wanted to know was it too late to receive his/her second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
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| 2837198 | 0.33 | F | GA | 04/22/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK225AB |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
only the liquid component was given to the patient with no adverse event; Initial information receiv...
only the liquid component was given to the patient with no adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who was administered with only the liquid component of Diphtheria/Tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR) for Immunisation; and Rotavirus vaccine for Immunisation. On 17-Apr-2025, the patient received an unknown dose only the liquid component of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine strength-0.5ml (formulation, expiry date-unknown) (lot UK225AB) via intramuscular route in the left thigh for Immunization with no adverse event (single component of a two-component product administered) (latency-same day). Reportedly- The lyophilized component was not reconstituted with the liquid component and only the liquid component was given to the patient. They wanted to know if they can give the Hib component by itself or if they need to repeat the 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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| 2837217 | F | VA | 04/22/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4N222 |
Product preparation issue
Product preparation issue
|
injected the diluent, instead of reconstitute it; injected the diluent, instead of reconstitute it; ...
injected the diluent, instead of reconstitute it; injected the diluent, instead of reconstitute it; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On 09-APR-2025, the patient received Priorix. On 09-APR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: injected the diluent, instead of reconstitute it) and inappropriate dose of vaccine administered (Verbatim: injected the diluent, instead of reconstitute it). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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: 15-APR-2025 and 17-APR-2025 On 15th April 2025, Pharmacist called and reported that he/she was using the Priorix, the MMR vaccine, and realized that he/she had just injected the diluent instead of reconstituting it, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
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| 2837218 | 25 | M | WA | 04/22/2025 |
FLU3 |
SANOFI PASTEUR |
U8442BA |
No adverse event, Product storage error
No adverse event, Product storage error
|
adminsitered post excursion with no adverse event; temperature excursion of fluzone Max/low temperat...
adminsitered post excursion with no adverse event; temperature excursion of fluzone Max/low temperature reached: 8.5 ๏ฟฝC to 8.8 ๏ฟฝC Duration: 30minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases- US-SA-2025SA113850, US-SA-2025SA113376, US-SA-2025SA113846, US-SA-2025SA113257, US-SA-2025SA113179, US-SA-2025SA113835, US-SA-2025SA113170, US-SA-2025SA113172, US-SA-2025SA114282, US-SA-2025SA112035 This case involves a 25 years old male patient who was administered INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] post excursion with no adverse event and temperature excursion of fluzone max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-APR-2025 temperature excursion of fluzone max/low temperature reached: 8.5 ๏ฟฝc to 8.8 ๏ฟฝc duration: 30minutes with no reported adverse event (product storage error) (unknown latency). On 10-Apr-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE Suspension for injection (strength standard) dose 0.5 ml1x(once) lot U8442BA expiry date-20-Jun-2025 via intramuscular route in the left deltoid for influenza adminsitered post excursion with no adverse event (poor quality product administered) (latency same day). Cause of excursion-Human error (Reason: Monthly cycle count, inventory checking) 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.; Sender's Comments: US-SA-2025SA112035: US-SA-2025SA114282: US-SA-2025SA113172: US-SA-2025SA113170: US-SA-2025SA113835: US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA113846: US-SA-2025SA113376: US-SA-2025SA113850:
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| 2837219 | 2 | F | WA | 04/22/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK199AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
giving the Pentacel and gave the diluent only and not the actual vaccine with no reported adverse ev...
giving the Pentacel and gave the diluent only and not the actual vaccine with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old female patient who was receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] but received the diluent only and not the actual 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 was receiving Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, (unknown strength) lot UK199AA and expiry date 30-Apr-2026, via unknown route in unknown administration site for prophylactic vaccination (immunisation), but received the diluent only and not the actual vaccine with no reported adverse event (single component of a two-component product administered) (latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2837220 | 2 | F | NV | 04/22/2025 |
IPV |
SANOFI PASTEUR |
X1C891M |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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2 year old receiving IPOL which was due again at age 4 years with no reported adverse event; Initial...
2 year old receiving IPOL which was due again at age 4 years with no reported adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old female patient who recieved IPV (VERO) [IPOL] which was due again at age 4 years with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine and Varicella zoster vaccine for Immunisation. On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (unknown strength, expiry date and lot number not reported,) via unknown route in unknown administration site for immunization On 17-Apr-2025, the patient received 0.5 dose of suspect IPV (VERO), Suspension for injection, lot X1C891M, Strength = standard, Frequency = once, expiry date:31-Oct-2026, via intramuscular route in the left thigh for immunization which was due again at age 4 years with no reported adverse event (extra dose 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.; Sender's Comments: US-SA-2025SA113400:IPOL
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| 2837223 | 1 | M | LA | 04/22/2025 |
DTAP HIBV PNC15 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
YC239 X022982 Y010032 |
Pyrexia, Seizure like phenomena; Pyrexia, Seizure like phenomena; Pyrexia, Seizu...
Pyrexia, Seizure like phenomena; Pyrexia, Seizure like phenomena; Pyrexia, Seizure like phenomena
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Pt came to clinic on 4/16 to get caught up on vaccines. He received HIB, DTAP, & PCV. He started...
Pt came to clinic on 4/16 to get caught up on vaccines. He received HIB, DTAP, & PCV. He started running fever around 2320 that same evening followed by seizure like activity for 3-5 min. He was brought to ER where he was cleared.
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| 2837224 | 4 | F | NJ | 04/22/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
U7838AA Y016873 |
Erythema; Erythema
Erythema; Erythema
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Rt arm 5cm red area Lt arm 2-5 cm red area.
Rt arm 5cm red area Lt arm 2-5 cm red area.
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| 2837225 | 18 | F | 04/22/2025 |
HPV9 |
MERCK & CO. INC. |
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Brain fog, Dizziness, Fatigue, Syncope
Brain fog, Dizziness, Fatigue, Syncope
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I received the vaccine and fainted on the spot and still continue to have fainting spells, fatigue d...
I received the vaccine and fainted on the spot and still continue to have fainting spells, fatigue dizziness and brain fog.
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| 2837226 | 0.08 | F | 04/22/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
47969AA |
Extra dose administered
Extra dose administered
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patient received Vaxelis twice due to vaccine not being documented the first time
patient received Vaxelis twice due to vaccine not being documented the first time
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| 2837275 | 0.08 | M | 04/22/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
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Abdominal pain upper, Infant irritability, Vomiting
Abdominal pain upper, Infant irritability, Vomiting
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Vomiting, stomach pain and irritability
Vomiting, stomach pain and irritability
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| 2837276 | 48 | F | NC | 04/22/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Z002626 Z002626 |
Dizziness, Dyspnoea, Headache, Hot flush, Injection site cellulitis; Vision blur...
Dizziness, Dyspnoea, Headache, Hot flush, Injection site cellulitis; Vision blurred
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Cellulitis of the left upper extremity surrounding the injection site. Reports headaches, dizziness...
Cellulitis of the left upper extremity surrounding the injection site. Reports headaches, dizziness, lightheadedness, blurred vision, shortness of breath and a feeling of getting flushed. Reports symptoms began Saturday 4/12/25 in the morning with a severe headache (7-8/10) on pain scale. Prescribed doxycycline 100 mg BID for 10 days for cellulitis. Continue with Tylenol PRN for headaches. Advised patient to go to the ED if headaches worsen or become more frequent, or if symptoms worsen or fail to improve.
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| 2837277 | 48 | F | NC | 04/22/2025 |
TDAP |
SANOFI PASTEUR |
U7999AA |
Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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Patient reported an onset of erythema, warmth and swelling at the site on 4/19/25. Patient was afebr...
Patient reported an onset of erythema, warmth and swelling at the site on 4/19/25. Patient was afebrile. RN consulted with virtual MD on call. Erythema border was traced with scheduled follow up in 24 hours. Patient was advised to take OTC Tylenol or OTC Ibuprofen, self monitor symptoms and seek emergency treatment if symptoms worsened per the instruction of MD.
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| 2837278 | 11 | M | PA | 04/22/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
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Syncope; Syncope; Syncope
Syncope; Syncope; Syncope
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Patient had mentioned he has fainted in the past with testing. After administering his vaccines, I s...
Patient had mentioned he has fainted in the past with testing. After administering his vaccines, I stood in front of him for a moment and he fainted. I laid him down and the provider Dr elevated his legs, he came too very quickly, and we kept him in a laying down position and gave him juice. He was then able to sit up and recovered after a few minutes, the provider examined him and determined he was okay to leave with his mother as he felt better.
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| 2837279 | AR | 04/22/2025 |
DTAP HIBV |
SANOFI PASTEUR SANOFI PASTEUR |
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Contraindicated product administered; Contraindicated product administered
Contraindicated product administered; Contraindicated product administered
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Our clinic was instructed by our Sanofi Representative in early 2012 that we could use Dtap (Daptace...
Our clinic was instructed by our Sanofi Representative in early 2012 that we could use Dtap (Daptacel) to reconstitute the ActHIB powder instead of using the provided diluent for ActHIB. These two vaccines were given as combined vaccines to a large number of our patients from March 2012 to April 2025. We have been made aware by our VFC representative and the CDC that these vaccines cannot be combined in this manner and any doses that have been administered as a combined injection should be revaccinated according to the CDC's Catch up Immunization Schedule. This combination of Daptacel and ActHib vaccines was primarily utilized for the 15 month vaccines (dose 4 of Dtap and dose 3 or 4 of Hib). All vaccines given in in this manner are currently being invalidated and patients who are eligible for revaccination are being contacted. Our reports show that approximately 2, 626 patients have been effected by this error. A full report of the patient's names, DOB, date of vaccination and lot numbers can be provided as an uploaded PDF or by email if desired.
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| 2837280 | 79 | F | MI | 04/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Injected limb mobility decreased, Injection site discomfort, Pain in extremity
Injected limb mobility decreased, Injection site discomfort, Pain in extremity
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Vaccine reconstituted per protocol. IM injection administered, Z-track used to pt's L deltoid. ...
Vaccine reconstituted per protocol. IM injection administered, Z-track used to pt's L deltoid. Pt did note at the time of injection that she felt the injection of the fluid. Pt departed the office with no further complaints. At approximately 2:15pm the patient called stating her Larm was very painful and that she was unable to move it d/t pain. PCP notified and pt was contacted by myself and they by PCP for more detailed input. Pt was instructed to move her to help alleviate pain and contacted the office the next date with an update.
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| 2837281 | 56 | F | FL | 04/22/2025 |
PNC20 |
PFIZER\WYETH |
LX4483 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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pain, redness and swelling to the injection site.
pain, redness and swelling to the injection site.
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| 2837282 | 0.33 | M | MS | 04/22/2025 |
DTAP HIBV |
SANOFI PASTEUR MERCK & CO. INC. |
3CA03C3 Y003145 |
Electroencephalogram, Fatigue, Seizure, Tremor, Ultrasound head; Electroencephal...
Electroencephalogram, Fatigue, Seizure, Tremor, Ultrasound head; Electroencephalogram, Fatigue, Seizure, Tremor, Ultrasound head
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Three days following the injections, patient began to have minor convulsions and tremors while breas...
Three days following the injections, patient began to have minor convulsions and tremors while breast-feeding. He will have full body shaking that will last anywhere from 10 to 45 seconds at a time. These tremors can take place once in a day or multiple times in a day. They follow exhaustion and settling while nursing.
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| 2837283 | 50 | F | MI | 04/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Arthralgia, Injection site discomfort, Pain in extremity
Arthralgia, Injection site discomfort, Pain in extremity
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Vaccine reconstituted per protocol, administer IM to L deltoid using Z track method. pt noted that t...
Vaccine reconstituted per protocol, administer IM to L deltoid using Z track method. pt noted that they felt the fluid being injected (0.5ml). pt departed with no further issues. patient called office at approx 1345 hrs c/o pain in her left shoulder, arm, and hand. PCP received the message and forwarded to me for follow-up. I spoke with the patient and reported pain in her left arm equal to a 7. She reported to me that she had taken 3 advil recently. She denied any redness, swelling, just an ache from her left shoulder blade to her left hand. Pt recommended to apply ice to the area and update us if her symptoms worsened.
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| 2837284 | 38 | F | PR | 04/22/2025 |
FLU3 TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
UT8423L4 3RE73 |
Extra dose administered, Headache, Oedema peripheral, Pain in extremity; Extra d...
Extra dose administered, Headache, Oedema peripheral, Pain in extremity; Extra dose administered, Headache, Oedema peripheral, Pain in extremity
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The Flu vaccine is administered to the patient , the patient already has received the Flu vaccine. ...
The Flu vaccine is administered to the patient , the patient already has received the Flu vaccine. The patient states the she has edema and pain in the arm, pain in the leg and a headache. The patient was told that if she experience complication should go to the nearest hospital.
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| 2837285 | 38 | M | IL | 04/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Cardiac disorder, Computerised tomogram, Electrocardiogram, Heart rate increased...
Cardiac disorder, Computerised tomogram, Electrocardiogram, Heart rate increased, Joint noise; Muscle tightness, Sleep study, X-ray
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Rapid heart rate muscle locked up and joints popped upon getting out of bed - heart would shock at n...
Rapid heart rate muscle locked up and joints popped upon getting out of bed - heart would shock at night upon sleeping and too this day still have symptoms. I am now wearing oxygen at night too help control symptoms
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| 2837286 | 3 | F | MA | 04/22/2025 |
HEPA HIBV PNC20 |
MERCK & CO. INC. SANOFI PASTEUR PFIZER\WYETH |
Y0133120 UK208AA LK6653 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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localized swelling and redness at injection site
localized swelling and redness at injection site
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| 2837287 | 74 | F | FL | 04/22/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Arthralgia, Asthenia, Injection site pain, Mobility decreased, Myalgia
Arthralgia, Asthenia, Injection site pain, Mobility decreased, Myalgia
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I had a very sore arm at the injection site at first . Starting a couple of nights after the inject...
I had a very sore arm at the injection site at first . Starting a couple of nights after the injection. Extreme aching of muscles and joints (especially at night, could hardly move or turn over ). The extreme pain has become less but I still have continued soreness , pain and weakness in my joints.
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| 2837288 | 59 | F | FL | 04/22/2025 |
PNC20 |
PFIZER\WYETH |
LX4483 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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pain, redness and swelling below the injection site
pain, redness and swelling below the injection site
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| 2837289 | 56 | F | AR | 04/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Abdominal pain upper, Sleep disorder, Tenderness
Abdominal pain upper, Sleep disorder, Tenderness
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severe stomach cramps or contractions, like gas pains except worse. Doubled over in pain, stomach ...
severe stomach cramps or contractions, like gas pains except worse. Doubled over in pain, stomach was sore and tender. first started 4:30 in afternoon got better with Gas X, Tylenol, heating pad and massage after about 1 hour 30 minutes. started back about 9:30 at night. more severe and lasted longer. ate a light supper was fine then except for stomach feeling sore and tender to touch. took more gas x and ibuprofen, heating pad and massage. able to go to sleep around 1:00 am. woke up at 4:30 am and pain was gone and stomach tenderness was gone also. no other symptoms except slight soreness in arm. called pharmacist to report symptoms. If it had been daytime I would have went to my family doctor. It was severe pain.
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| 2837290 | 61 | F | FL | 04/22/2025 |
PNC20 |
PFIZER\WYETH |
LX4483 |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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mild redness and swelling around the injection site
mild redness and swelling around the injection site
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| 2837292 | 5 | F | CA | 04/22/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5H95B Y009344 |
No adverse event; No adverse event
No adverse event; No adverse event
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No symptoms have been reported yet.
No symptoms have been reported yet.
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| 2837293 | 84 | F | 04/22/2025 |
COVID19 |
MODERNA |
3044069 |
Pyrexia
Pyrexia
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fever of 104 degrees the day after vaccine was given
fever of 104 degrees the day after vaccine was given
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| 2837294 | 11 | M | KY | 04/22/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
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Hyperventilation, Muscle tightness, Paraesthesia; Hyperventilation, Muscle tight...
Hyperventilation, Muscle tightness, Paraesthesia; Hyperventilation, Muscle tightness, Paraesthesia
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Approx 4h after vaccines pt reported numbness, tingling in face, jaw tightnening and hyperventilatin...
Approx 4h after vaccines pt reported numbness, tingling in face, jaw tightnening and hyperventilating
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| 2837295 | 65 | M | WI | 04/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Polymyalgia rheumatica
Polymyalgia rheumatica
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Diagnosed with Poly Myalgia Rheumitica on 4/11/2025
Diagnosed with Poly Myalgia Rheumitica on 4/11/2025
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| 2837296 | 76 | F | WV | 04/22/2025 |
COVID19 VARZOS |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NDC: 00069-2432 NDC: 58160-0823 |
Biopsy skin, Chest pain, Dry skin, Herpes zoster, Rash; Biopsy skin, Chest pain,...
Biopsy skin, Chest pain, Dry skin, Herpes zoster, Rash; Biopsy skin, Chest pain, Dry skin, Herpes zoster, Rash
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diagnosis shingles; rash on upper body, left side and around the back, rash appeared in a wide str...
diagnosis shingles; rash on upper body, left side and around the back, rash appeared in a wide stripe with rough skin; deep pain in the front left chest area
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| 2837297 | 62 | M | NC | 04/22/2025 |
FLU3 FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
N65FM Exp 06/30 N65FM Exp 06/30 N65FM Exp 06/30 |
Chills, Dyspepsia, Erythema multiforme, Fatigue, Insomnia; Pain, Pyrexia, Rash, ...
Chills, Dyspepsia, Erythema multiforme, Fatigue, Insomnia; Pain, Pyrexia, Rash, Rash erythematous, Sleep disorder; Somnolence
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started day of vaccination, Feb 24 with aches, chills, mild fever, day 2 aches were so painful I cou...
started day of vaccination, Feb 24 with aches, chills, mild fever, day 2 aches were so painful I could not lay down, no sleep, fever and chills got worse. same symptoms day 3, very fatigued but noticed a bright red rash when I laid down at 7 pm to try and go to bed. day 4, skin mostly covered with very itchy inflamed red rash.... my primary care Dr was out of the country, so I got a quick appt with my Dermatologist who is my neighbor on the afternoon of Feb 27th. Initially he thought it may be folliculitis from my spa. the next day I told him it was worsening and came by my house and was concerned when he saw that I had red bumps in many areas like my palms where there are no hair follicles. Next day Saturday morning rash was worse, still having chills, aches and fever so he opened his office and called in a nurse to do a biopsy. He diagnosed it as erythema multiforme minor and prescribed Prednisone for 18 days. Symptoms continued to worsen for a few days as the rash spread to everywhere but my face and groin. I have pictures of this. After time the rash started to recede and by the end of march was mostly gone. Was very fatigued during this time, had to have a nap every day and experienced insomnia most nights and severe indigestion. Still fatigued at this time, hard to sleep, and have indigestion. My skin has cleared up and I do not itch anymore. I'm very concerned about a reemergence of the rash in the future and potential long term consequences
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| 2837298 | 95 | F | PR | 04/22/2025 |
FLU3 |
SANOFI PASTEUR |
UT8408LA |
Extra dose administered
Extra dose administered
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She was already vaccinated with the seasonal dose (November 2024) and was vaccinated again.
She was already vaccinated with the seasonal dose (November 2024) and was vaccinated again.
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| 2837299 | 89 | M | PR | 04/22/2025 |
FLU3 |
SANOFI PASTEUR |
UT8408LA |
Extra dose administered
Extra dose administered
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She was already vaccinated with the seasonal dose (November 2024) and was vaccinated again.
She was already vaccinated with the seasonal dose (November 2024) and was vaccinated again.
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| 2837301 | 89 | F | PR | 04/22/2025 |
FLU3 |
SANOFI PASTEUR |
UT8408LA |
Extra dose administered
Extra dose administered
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She was already vaccinated with the seasonal dose (November 2024) and was vaccinated again.
She was already vaccinated with the seasonal dose (November 2024) and was vaccinated again.
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| 2837302 | 17 | F | PA | 04/22/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
F5L5E |
Expired product administered
Expired product administered
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Expired vaccine given to patient during routine office visit. Expired vaccine was comingled in offic...
Expired vaccine given to patient during routine office visit. Expired vaccine was comingled in office vaccine storage. Expired vaccine was administered before expiration was realized.
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| 2837303 | 11 | F | WA | 04/22/2025 |
DTAP |
SANOFI PASTEUR |
3CA03C3 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Daptacel was given to 11 years old when a Tdap was suppose to be given
Daptacel was given to 11 years old when a Tdap was suppose to be given
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| 2837304 | 47 | F | OH | 04/22/2025 |
SMALLMNK |
BAVARIAN NORDIC |
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Injection site vesicles
Injection site vesicles
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~48 hours after receiving the first dose of jynneos vaccine, a "blister" appeared at the i...
~48 hours after receiving the first dose of jynneos vaccine, a "blister" appeared at the injection site, the approximate size of the initial bleb (~8mm). The blister appears to be fluid filled, raised ~3mm
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| 2837305 | 65 | M | MI | 04/22/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
8080803 U8527CA |
Cellulitis, Erythema, Peripheral swelling, Skin warm; Cellulitis, Erythema, Peri...
Cellulitis, Erythema, Peripheral swelling, Skin warm; Cellulitis, Erythema, Peripheral swelling, Skin warm
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Patient had swelling, redness, hot to the touch, and soreness in both arms. Cellulitis occured, trea...
Patient had swelling, redness, hot to the touch, and soreness in both arms. Cellulitis occured, treated with Cephalexin Oral Capsule 500 MG 4 times daily.
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| 2837306 | 76 | F | CA | 04/22/2025 |
TYP |
BERNA BIOTECH, LTD. |
3004085 |
Unevaluable event
Unevaluable event
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Patient took Benadryl and stopped taking the vaccine.
Patient took Benadryl and stopped taking the vaccine.
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| 2837307 | 16 | M | WA | 04/22/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
99G34 |
Dizziness, Nausea, Pyrexia, Vomiting
Dizziness, Nausea, Pyrexia, Vomiting
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Dizziness, nausea, vomiting, and fever
Dizziness, nausea, vomiting, and fever
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| 2837308 | 74 | M | 04/22/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
DD72H |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient was due to receive this Bexsero dose on 6/27/2025 but was administered the dose on 4/21/2025
Patient was due to receive this Bexsero dose on 6/27/2025 but was administered the dose on 4/21/2025
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| 2837309 | 70 | F | KS | 04/22/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y013009 9L944 |
Injection site rash, Pain; Injection site rash, Pain
Injection site rash, Pain; Injection site rash, Pain
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Patient had local reaction of a rash below injection site that was also sore, the day before patient...
Patient had local reaction of a rash below injection site that was also sore, the day before patient had sore body but was feeling better today
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| 2837310 | 52 | M | CA | 04/22/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site rash
Injection site rash
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left deltoid rash ~7x 8 cm at vaccine administration site, patient noticed 4 days after vaccine give...
left deltoid rash ~7x 8 cm at vaccine administration site, patient noticed 4 days after vaccine given increasing size
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| 2837311 | 67 | F | MI | 04/22/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Arthralgia, Myalgia
Arthralgia, Myalgia
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Patient received COVID vaccine on 04/17/2025. On the morning of 04/18/2025 patient developed genera...
Patient received COVID vaccine on 04/17/2025. On the morning of 04/18/2025 patient developed generalized joint and muscle aches affecting the knees, and neck. No fever, no chills, no sweats. No joint swelling. No rash. Patient has been trying to keep hydrated and active. Recommendations included Tylenol 1000 mg up to 3 times daily, if there are still issues, consider Aleve 440 mg twice daily. Expect symptoms to dissipate within the next 3-5 days.
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| 2837312 | 61 | M | WI | 04/22/2025 |
COVID19 |
MODERNA |
8080473 |
Injected limb mobility decreased, Injection site pain
Injected limb mobility decreased, Injection site pain
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Per Dr.'s office visit note from 4/21/25: Patient received a vaccination for COVID-19 (Spikevax...
Per Dr.'s office visit note from 4/21/25: Patient received a vaccination for COVID-19 (Spikevax 12) on 9/17/2024 in his right shoulder during one of our vaccine clinics. Patient states that it was the single most painful immunization he has ever received. He states that ever since then, he has decreased range of motion of his right shoulder," has a classic frozen right shoulder". In fact, patient does demonstrate decreased range of motion of the right shoulder although no clicking or locking is felt. He is he is able to feed himself with his right hand. There is no numbness or tingling. Patient reports no prior injury to the right shoulder. I will have to do some investigating into this vaccine and his complaint. Also, if I cannot find any direct link or any solution, we will go ahead and order PT and proceed from there to an MRI and Ortho consult as needed
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| 2837313 | 71 | M | MO | 04/22/2025 |
HEP HEPA |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
CT327 T9TL9 |
Blood potassium decreased, Dizziness, Fall, Pallor, Unresponsive to stimuli; Blo...
Blood potassium decreased, Dizziness, Fall, Pallor, Unresponsive to stimuli; Blood potassium decreased, Dizziness, Fall, Pallor, Unresponsive to stimuli
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After receiving the immunizations, client started walking towards the door with his rolling walker a...
After receiving the immunizations, client started walking towards the door with his rolling walker and son helping him. He said he felt dizzy and began to fall. Son and this nurse were able to support him and lower him into a chair. He was unresponsive and pale for 30 seconds-1 minute. He began to rouse. Vital signs were assessed. BP 110/68 O2 86% on 5L of O2, HR 145 EMS was called and arrived shortly after. Wife and son bedside. Patient agreed to transport to ED after paramedics assessed him. After follow up on 4/22/25, patient reports that he was "low in potassium"; He was given prescription for potassium and released home on 4/21/25
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| 2837314 | 0.33 | M | MN | 04/22/2025 |
DTAPIPVHIB DTAPIPVHIB PNC13 PNC13 |
SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH |
C5026AB C5026AB M77338 M77338 |
Decreased eye contact, Developmental regression, Jaundice, Poor feeding infant, ...
Decreased eye contact, Developmental regression, Jaundice, Poor feeding infant, Screaming; Vomiting; Decreased eye contact, Developmental regression, Jaundice, Poor feeding infant, Screaming; Vomiting
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Child began losing his development after this series. He would scream in his crib for hours at a ti...
Child began losing his development after this series. He would scream in his crib for hours at a time, a purple screamer and couldn't be consoled. He wouldn't make eye contact. Regressed on his feedings, wouldn't eat and couldn't handle his feedings would often throw up after feeding. He started to become jaundiced.
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| 2837315 | 82 | F | NC | 04/22/2025 |
FLU3 |
SANOFI PASTEUR |
U8519EA |
Injection site mass, Injection site pain
Injection site mass, Injection site pain
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Pt came to pharmacy on 4/22/25 to report swollen lump at site of injection from flu shot given 1/23/...
Pt came to pharmacy on 4/22/25 to report swollen lump at site of injection from flu shot given 1/23/25. Said the bump has been there for 3 months and she has soreness in her arm and up to her neck. It did not look red or warm to the touch.
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| 2837317 | 20 | F | IN | 04/22/2025 |
MENB PNC20 |
PFIZER\WYETH PFIZER\WYETH |
HP9989 LX4482 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
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Right upper arm red, warm, and swollen. Patient reports started same evening as vaccination. Seen ...
Right upper arm red, warm, and swollen. Patient reports started same evening as vaccination. Seen in clinic the next day and patient reports very painful. Advised patient to apply cool compresses and may use ibuprofen, Tylenol, and/or Benadryl as needed for symptom management.
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