| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2846613 | 74 | F | OK | 06/19/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
1808798 057A22A |
Cardiac disorder, Death, Thrombosis; Cardiac disorder, Death, Thrombosis
Cardiac disorder, Death, Thrombosis; Cardiac disorder, Death, Thrombosis
|
It was the second shot booster that we started seeing the heart and blood clot problems
It was the second shot booster that we started seeing the heart and blood clot problems
|
โ | โ | ||||
| 2846619 | 80 | F | SC | 06/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ek225 |
Injection site erythema, Injection site urticaria, Injection site warmth
Injection site erythema, Injection site urticaria, Injection site warmth
|
Patient reported to pharmacy on 7th day post vaccine with large red welt on her arm at the injection...
Patient reported to pharmacy on 7th day post vaccine with large red welt on her arm at the injection site and another welt about 3 inches below injection site. Both welts were swollen and warm to the touch. Patient said no itching or pain reported. She said her arm was sore for the first 4 days following injection. Patient was instructed to take antihistamine (Benadryl) and apply cold compress as needed.
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| 2846620 | 18 | F | ID | 06/19/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
99G34 |
Wrong product administered
Wrong product administered
|
Patient given Bexsero for 2nd dose of Meng B rather then the Trumenba vaccine. Patient will need a 3...
Patient given Bexsero for 2nd dose of Meng B rather then the Trumenba vaccine. Patient will need a 3rd dose of the Bexsero or Trumenba in order to be complete on Meng B series.
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| 2846621 | 1.25 | F | CA | 06/19/2025 |
VARCEL |
MERCK & CO. INC. |
X021281 |
Rash erythematous
Rash erythematous
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Visible than Palpable Red Rash Quarter Size
Visible than Palpable Red Rash Quarter Size
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| 2846622 | 0.67 | F | SD | 06/19/2025 |
DTAPIPVHIB HIBV PNC20 RV5 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
UK194AA F45JY LN4928 2091233 |
Extra dose administered; Extra dose administered; Extra dose administered; Extra...
Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered
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Pt was given the HIB in error today in addition to the combination Pentacel which includes the HIB. ...
Pt was given the HIB in error today in addition to the combination Pentacel which includes the HIB. Poison Control was called and no treatments needed. Mother was notified of the error and informed that the 2nd HIB does not count towards patient's scheduled immunizations.
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| 2846381 | 0.33 | F | IL | 06/18/2025 |
HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER |
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Expired product administered, Inappropriate schedule of product administration; ...
Expired product administered, Inappropriate schedule of product administration; Expired product administered, Inappropriate schedule of product administration
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third dose was given as an early dose; 2nd dose administered on 16 Jan 2015; This non-serious case w...
third dose was given as an early dose; 2nd dose administered on 16 Jan 2015; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old female patient who received HBV (Engerix B) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. Concomitant products included Hepatitis b vaccine. On 06-MAR-2015, the patient received the 3rd dose of Engerix B. On 16-JAN-2015, the patient received the 2nd dose of Hepatitis B vaccine. On 16-JAN-2015, not applicable after receiving Engerix B and an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose administered on 16 Jan 2015). On 06-MAR-2015, the patient experienced drug dose administration interval too short (Verbatim: third dose was given as an early dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-JUN-2025 Physician explained that a 10 year old patient received by accident an expired forth dose of a Hepatitis B vaccine (lot number W025817, expiration date 21st May 2025, brand name not provided by the caller, but they mentioned that it was non-GSK product) on 2nd June 2025 since they noticed that their third dose was given as an early dose. First dose of Hepatitis B was given on 5th November 2014, second dose on 16th January 2015 and third dose on 6th March 2015 which led to Drug dose administration interval too short. Physician did not know what the brand name or lot number for any of the 3 prior doses was. Adverse Event report sent as a preventive measure as a potential early third dose of Engerix-B, and potential interchangeability, since the fourth dose was not a GlaxoSmithKline vaccine. Caller decided to end the call when they noticed that the fourth dose was not from GlaxoSmithKline so Medical Information did not have time to ask for consent to follow up with Safety Team. The patient received 2nd dose of Hepatitis B later than the recommended schedule, which led to lengthening of vaccination schedule.
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| 2846384 | 3 | M | CA | 06/18/2025 |
DTAP FLU3 HEPA MMR PNC20 VARCEL |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
3CA55C1 2H2S9 H3N97 Y0011709 MF0416 Y017062 |
Expired product administered; Expired product administered; Expired product admi...
Expired product administered; Expired product administered; Expired product administered; Expired product administered; Expired product administered; Expired product administered
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Vaccine Influenza Flulaval 0.5 ML was given with expiration date 6/11/25 on 6/12/25 at 4:00pm.
Vaccine Influenza Flulaval 0.5 ML was given with expiration date 6/11/25 on 6/12/25 at 4:00pm.
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| 2846385 | 20 | F | 06/18/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Limb injury
Limb injury
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Shoulder injury. Injection into rotator cuff. Sling, ice, rest, antiinflammatory. Possible MRI an...
Shoulder injury. Injection into rotator cuff. Sling, ice, rest, antiinflammatory. Possible MRI and orthopedic referral.
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| 2846437 | 31 | M | FL | 06/18/2025 |
MMR MMR MMR MMR MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y004116 Y004116 Y004116 Y0041162026FEB1 Y0041162026FEB1 Y0041162026FEB1 |
Acne, Anorectal discomfort, Erythema, Exercise tolerance decreased, Pelvic disco...
Acne, Anorectal discomfort, Erythema, Exercise tolerance decreased, Pelvic discomfort; Penile burning sensation, Pruritus, Rash; Rash, Skin discharge; Acne, Anorectal discomfort, Erythema, Exercise tolerance decreased, Pelvic discomfort; Penile burning sensation, Pruritus, Rash; Rash, Skin discharge
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rash on the back of his head as well as both hands; He reports his scalp is itchy and red; He report...
rash on the back of his head as well as both hands; He reports his scalp is itchy and red; He reports his scalp is itchy and red; pimples that hurt and when they pop blood and sometimes clear fluid oozes out; burning in his rectal and penile area and an occasional burning sensation in the pelvic area; burning in his rectal and penile area and an occasional burning sensation in the pelvic area; burning in his rectal and penile area and an occasional burning sensation in the pelvic area; He reports being hesitant to touch animals unless his hands are washed because he does not want to make them sick if he is contagious; I am also experiencing longer than normal recovery periods.; This spontaneous report was received from a consumer and refers to himself, a 31-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. He reported that he thought that he received his MMR vaccines from work in 1998 but did not have work vaccination records so he got vaccinated in order to obtain a job. He reported that he has had multiple shots and never had a reaction to a shot before. On 13-Mar-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #Y004116 and expiration date reported as 12-Feb-2026) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. The patient reported that he wanted to know the chain of custody for this vaccine "to make sure there was no foul play here." Due to this statement, this was being reported as a CDT case. Answers to CDT questions were unknown as all consumer had was a sticker which showed the lot, expiry date and serial number for the product. The patient also reported that he wanted to make sure the integrity of the vaccine was solid and reported "that is your companies name". He reported that he was not here to "ruin anybody" and that he just wanted to live his life and be healthy. On an unspecified date in March 2025 (1-2 weeks after vaccination), the patient reported a rash on the back of his head as well as both hands (rash). He reported his scalp was itchy and red (pruritus; erythema). He got what he reported to be pimples that hurt and when they pop blood and sometimes clear fluid oozes out (acne). He reported burning in his rectal and penile area and an occasional burning sensation in the pelvic area (anorectal discomfort; penile burning sensation; pelvic discomfort). He went to the clinic 3 separate times for these symptoms. He reported that they originally treated him with hydrocortisone cream and then an antifungal. He reported that he drove to the hospital for treatment, and was not admitted and they sent him home with ketoconazole and an antifungal shampoo which has not improved his symptoms. He reported being hesitant to touch animals unless his hands were washed because he did not want to make them sick if he was contagious (fear of disease). The patient was also experiencing longer than normal recovery periods (exercise tolerance decreased). The outcome of the reported adverse events was reported as not recovered. The causal relationship between the reported adverse events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported.
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| 2846438 | F | NY | 06/18/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y020531 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
More
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No additional adverse event was reported; A HCP transferred from a MVCC CRT agent called to inquire ...
No additional adverse event was reported; A HCP transferred from a MVCC CRT agent called to inquire about GARDASIL 9 and whether or not the series should be restarted for a 45-year-old patient who received an initial dose sometime in 2021 and a second dose yesterday, 06/08/2025. The HCP stat; This spontaneous report was received from a pharmacist and refers to a 45-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 2021, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), dose number 1, (indication, expiration date, and lot # were not reported). On 08-Jun-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), (lot #Y020531, expiration date: 05-Aug-2027), dose number 2, 0.5 mL for an unknown indication (Inappropriate schedule of vaccine administered). No additional adverse event was reported.
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| 2846439 | 69 | F | NY | 06/18/2025 |
FLU3 |
SANOFI PASTEUR |
UT8454DA |
Arteriogram carotid, Computerised tomogram head normal, Deafness neurosensory, S...
Arteriogram carotid, Computerised tomogram head normal, Deafness neurosensory, Scan with contrast normal, Sudden hearing loss
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Sudden Sensorineural Hearing Loss occurring on 12/21/2024
Sudden Sensorineural Hearing Loss occurring on 12/21/2024
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โ | โ | ||||
| 2846440 | 11 | M | VA | 06/18/2025 |
MNQ UNK |
SANOFI PASTEUR UNKNOWN MANUFACTURER |
TD |
Fatigue, Loss of consciousness, Pallor, Thirst, Vomiting; Fatigue, Loss of consc...
Fatigue, Loss of consciousness, Pallor, Thirst, Vomiting; Fatigue, Loss of consciousness, Pallor, Thirst, Vomiting
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06/17/2025 1600 was given TD and meningitis vaccines.1605 he started walking around in circles then...
06/17/2025 1600 was given TD and meningitis vaccines.1605 he started walking around in circles then he said he was tired then he started screaming for water I open door to get help ask for water he turns pale as a ghost and passes out in chair. I get him up grab some cold water from sink on paper towel to put around his neck and dab is face. They bring in water Dr comes in shoves a lollipop in his mouth he spits it out says I'm going to throw up. I grab a trashcan he vomits. They bring in gingerale he drinks it says still feels tired. I ask if they have any snacks or something else they bring some peanuts. His color starts coming back and his eyes look better. He said I felt like I died. Vitals were checked after 15 minutes of color return and we were able to leave.
More
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| 2846441 | 11 | F | IN | 06/18/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
3L339 |
Wrong product administered
Wrong product administered
|
Patient given Bexsero. Patient should have received Menveo.
Patient given Bexsero. Patient should have received Menveo.
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| 2846442 | 91 | M | IA | 06/18/2025 |
COVID19 |
MODERNA |
3046731 |
Death
Death
|
Passed away
Passed away
|
โ | |||||
| 2846443 | 1.67 | F | AR | 06/18/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
GG39D |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Immunization was given and noticed to be expired after given. No reactions to vaccine.
Immunization was given and noticed to be expired after given. No reactions to vaccine.
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| 2846444 | 2 | F | WI | 06/18/2025 |
IPV |
SANOFI PASTEUR |
W1B511M |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
none
none
|
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| 2846445 | 11 | F | TX | 06/18/2025 |
DTAP |
SANOFI PASTEUR |
3CA20C1 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
No adverse event happened to patient. We are documenting the incorrect vaccine given at the visit.
No adverse event happened to patient. We are documenting the incorrect vaccine given at the visit.
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| 2846446 | 84 | F | WV | 06/18/2025 |
RSV |
PFIZER\WYETH |
LN5463 |
Chest pain, Dysarthria, Dyspnoea, Fatigue, Hemiparesis
Chest pain, Dysarthria, Dyspnoea, Fatigue, Hemiparesis
|
Pt was well while at the HD. However, upon returning home pt's son reported that patient's...
Pt was well while at the HD. However, upon returning home pt's son reported that patient's speech was slurred and she was tired and went done for a nap. Upon waking at 1:30pm pt was weak and pts right side was more weak than the left. Pt complained of chest paind and shortness of breath. EMS was called and pt was taken to hospital and was later transferred to a second hospital.
More
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| 2846447 | 37 | M | TX | 06/18/2025 |
YF |
SANOFI PASTEUR |
R3M584V |
Dermatitis allergic, Gastrointestinal disorder, Rash
Dermatitis allergic, Gastrointestinal disorder, Rash
|
Gastrointestinal issues and allergic rashes on hands. Doctors have no idea what to do for it so ther...
Gastrointestinal issues and allergic rashes on hands. Doctors have no idea what to do for it so there have been no treatments and the adverse events are ongoing.
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โ | |||||
| 2846448 | 27 | F | MO | 06/18/2025 |
TDAP |
SANOFI PASTEUR |
U8232AA |
Facial pain, Fatigue, Malaise, Pain
Facial pain, Fatigue, Malaise, Pain
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patient received immunization on 6/17/25 at approximately 4:48pm. the patient presented to the phar...
patient received immunization on 6/17/25 at approximately 4:48pm. the patient presented to the pharmacy today (6/18/25) at approximately 9am and said that she has been experiencing throbbing on the right side of the face since the immunization yesterday. she said the throbbing lasts for up to a minute, then stops for a few minutes, and then starts again. she said the frequency has been constant since her immunization yesterday. the only other symptoms she is experiencing is fatigue and general malaise per patient.
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| 2846449 | F | MD | 06/18/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Z005153 Y020586 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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no additional adverse event was reported; HCP called to report an AE for PROQUAD. Caller reported t...
no additional adverse event was reported; HCP called to report an AE for PROQUAD. Caller reported that an 18 month old female patient was inadvertently administered PROQUAD and VARIVAX concomitantly today, 6/9/2025. Caller reported that patient was behind on here 12 and 15 month vaccines a; stated that they believed it was MMRII because the vials are similar.; This spontaneous report was received from a nurse and refers to a 18-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 09-Jun-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z005153, expiration date: 25-Aug-2026) 0.5 mL for an unknown indication. On 09-Jun-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y020586, expiration date: 17-Dec-2026) 0.5 mL for an unknown indication. On 09-Jun-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). On 09-Jun-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). It was reported that the patient was inadvertently administered Proquad and Varivax xonxomitantly (Accidental overdose). Caller reported that patient was behind on here 12 and 15 month vaccines and stated that they believed it was MMRII because the vials are similar (Look alike packaging). No additional adverse event was reported.
More
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| 2846450 | 69 | F | FL | 06/18/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
3031914 AS7163B 056M21A 023M20A 030L20A 030L20A |
Arthralgia, Blood test, Dermatomyositis, Muscular weakness, Rash; Arthralgia, Bl...
Arthralgia, Blood test, Dermatomyositis, Muscular weakness, Rash; Arthralgia, Blood test, Dermatomyositis, Muscular weakness, Rash; Arthralgia, Blood test, Dermatomyositis, Muscular weakness, Rash; Arthralgia, Blood test, Dermatomyositis, Muscular weakness, Rash; Arthralgia, Blood test, Dermatomyositis, Muscular weakness, Rash; Arthralgia, Blood test, Dermatomyositis, Muscular weakness, Rash
More
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Sudden onset of MDA5 Dermatomyositis. Skin rash, muscle weakness, joint pain.
Sudden onset of MDA5 Dermatomyositis. Skin rash, muscle weakness, joint pain.
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| 2846451 | 24 | F | WA | 06/18/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946062 |
Urticaria
Urticaria
|
Hives on the armpit, behind both legs, and now behind right ear
Hives on the armpit, behind both legs, and now behind right ear
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| 2846452 | 19 | F | CO | 06/18/2025 |
HEP |
MERCK & CO. INC. |
Y009436 |
Hepatitis B antibody negative
Hepatitis B antibody negative
|
Pt present to clinic asking for a Hepatitis B vaccine due to blood work not showing immunity, Pt sta...
Pt present to clinic asking for a Hepatitis B vaccine due to blood work not showing immunity, Pt states that she does not have any allergies or any side effects in the past to any vaccines, Prior to administering the vaccine Pt asked if the vaccine was an adult dosage and I did informed the patient that it was an adult dosage, I did gave a Pt a copy of the vaccine record indicating that it was an adult dosage and Pt left
More
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| 2846453 | 4 | M | AL | 06/18/2025 |
DTAP IPV MMR VARCEL |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
3CA20C1 Y1A201M Y014096 Y019319 |
Injection site erythema, Injection site induration, Type III immune complex medi...
Injection site erythema, Injection site induration, Type III immune complex mediated reaction; Injection site erythema, Injection site induration, Type III immune complex mediated reaction; Injection site erythema, Injection site induration, Type III immune complex mediated reaction; Injection site erythema, Injection site induration, Type III immune complex mediated reaction
More
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Child with Arthus Reaction: Erythematous and indurated area on left thigh
Child with Arthus Reaction: Erythematous and indurated area on left thigh
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| 2846454 | 21 | F | KY | 06/18/2025 |
HEP HEP HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
944943 944943 944943 944943 |
Arthralgia, Asthenia, Back pain, Chills, Discomfort; Dyspnoea, Feeling of body t...
Arthralgia, Asthenia, Back pain, Chills, Discomfort; Dyspnoea, Feeling of body temperature change, Headache, Impaired work ability, Influenza virus test negative; Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test negative, Sleep disorder; Tremor
More
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Symptoms started around 9:30am on 6/16/2025. Started as slight shaky and weak feeling throughout the...
Symptoms started around 9:30am on 6/16/2025. Started as slight shaky and weak feeling throughout the body, progressed to full body aches and fever with chills as well, as if body could not decide if it was hot or cold. By 11:00am symptoms were in full effect and I experienced labored breathing with fever reaching 100 degrees Fahrenheit. Before noon, joint pain in knees, arms, legs, back, and feet started, putting me in more pain and discomfort. I was struggling to focus on work and had trouble writing and typing on computer due to extreme weakness. Headaches made it difficult to concentrate on work and leg pain made it difficult to sit in chair for too long. Symptoms lessened by evening, was still experiencing leg pain and whole body aches with headaches. Took Aleve to help lessen aches, leg pain worsened during the night when I would lay down to sleep. Pain became unbearable during this time, making sleep impossible. It has now been over 48 hours since symptoms started on 6/16 and only slight leg and knee pains persist today, 6/18. Fever and chills are gone as well as whole body weakness and aches.
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| 2846455 | 11 | F | AL | 06/18/2025 |
TDAP |
SANOFI PASTEUR |
U8232AA |
Erythema, Pain, Pruritus, Swelling
Erythema, Pain, Pruritus, Swelling
|
PT RECEIVED THE TDAP VACCINE AND LATER DEVELOPED SWELLING/ITCHING, REDNESS, AND PAIN THAT GREW OVER ...
PT RECEIVED THE TDAP VACCINE AND LATER DEVELOPED SWELLING/ITCHING, REDNESS, AND PAIN THAT GREW OVER NIGHT INTO THE NEXT MORNING. PARENTS/GUARDIANS DID NOT GIVE HER ANY ANTI-HISTAMINE OR TREATMENT.
More
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| 2846456 | 52 | F | IL | 06/18/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LK6655 sv49c |
Injection site erythema, Injection site warmth; Injection site erythema, Injecti...
Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth
More
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Warmth, redness around injection sites given in left arm. Both were given in left arm; redness sprea...
Warmth, redness around injection sites given in left arm. Both were given in left arm; redness spread away from injection site and urgent care MD treating as potential skin infection as precaution.
More
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| 2846457 | 47 | F | VA | 06/18/2025 |
TDAP |
SANOFI PASTEUR |
U8232AA |
Erythema, Pain, Skin warm, Swelling
Erythema, Pain, Skin warm, Swelling
|
PT REPORTED SWELLING, REDNESS, PAIN, WARM TO TOUCH 12-24 HOURS AFTER VACCINATION
PT REPORTED SWELLING, REDNESS, PAIN, WARM TO TOUCH 12-24 HOURS AFTER VACCINATION
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| 2846458 | 18 | F | NC | 06/18/2025 |
HEP HEP MENB MENB |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH |
Y014090 Y014090 LF5302 LF5302 |
Arthralgia, Injected limb mobility decreased, Joint swelling, Muscular weakness,...
Arthralgia, Injected limb mobility decreased, Joint swelling, Muscular weakness, Musculoskeletal pain; Pain, Pain in extremity, Paraesthesia, Tenderness; Arthralgia, Injected limb mobility decreased, Joint swelling, Muscular weakness, Musculoskeletal pain; Pain, Pain in extremity, Paraesthesia, Tenderness
More
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Right deltoid shoulder pain, decreased ROM, shooting pain in right shoulder blade with movement, rig...
Right deltoid shoulder pain, decreased ROM, shooting pain in right shoulder blade with movement, right arm weakness, right arm achiness, intermittent tingling down right arm and hand. Swelling of right shoulder and shoulder blade. Tenderness to palpation. Treatment originally included NSAIDs, ice, warmth, and gentle stretching without improvement. Patient returning to care for revaluation on 06/19/2025.
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| 2846459 | 11 | M | MI | 06/18/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5AR2D |
Wrong product administered
Wrong product administered
|
Wrong vaccine given. The patient should have received Menveo not Bexsero. The patient was 11 years o...
Wrong vaccine given. The patient should have received Menveo not Bexsero. The patient was 11 years of age at the time of the vaccine administration. Per Health Department age range for Bexsero is 16-23
More
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| 2846460 | 29 | M | MD | 06/18/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FDP00683 |
Pruritus, Urticaria
Pruritus, Urticaria
|
diffuse urticarial rash, resolved with benadryl with residual itching
diffuse urticarial rash, resolved with benadryl with residual itching
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| 2846461 | 65 | M | CA | 06/18/2025 |
COVID19 |
MODERNA |
3046734 |
Asthenia, Brain fog, Decreased appetite
Asthenia, Brain fog, Decreased appetite
|
PATIENT REPORTED ONSET OF BRAIN FOGGINESS, LOSS OF APPETITE, LOSS OF ENERGY TO DO ANYTHING SINCE REC...
PATIENT REPORTED ONSET OF BRAIN FOGGINESS, LOSS OF APPETITE, LOSS OF ENERGY TO DO ANYTHING SINCE RECEIVING HIS MODERNA VACCINE ON 06/13/2025. ACCORDING TO HIM SYMPTOMS STARTED SOON AFTER THE VACCINE.
More
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| 2846462 | 16 | F | GA | 06/18/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
77KA5 57H54 |
Dizziness, Loss of consciousness, Nausea, Somnolence; Dizziness, Loss of conscio...
Dizziness, Loss of consciousness, Nausea, Somnolence; Dizziness, Loss of consciousness, Nausea, Somnolence
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Patient was administered 2 vaccines. Approximately 5 minutes later patient reported nausea and dizzi...
Patient was administered 2 vaccines. Approximately 5 minutes later patient reported nausea and dizziness. Patient passed out on the exam table a couple of minutes later. The provider was asked to come to the room for examination. Patient came to shortly thereafter. She reported feeling groggy. Patient was kept in office for 45 minutes and vitals were monitored.
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| 2846463 | 16 | F | IN | 06/18/2025 |
MENB MNQ |
PFIZER\WYETH SANOFI PASTEUR |
LW8910 U8434AA |
Erythema, Pain, Pain in extremity, Urticaria, Yellow skin; Erythema, Pain, Pain ...
Erythema, Pain, Pain in extremity, Urticaria, Yellow skin; Erythema, Pain, Pain in extremity, Urticaria, Yellow skin
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Pt's L arm started to get a hive type reaction on day one after vaccination : red large welt th...
Pt's L arm started to get a hive type reaction on day one after vaccination : red large welt that grew to cover her whole upper L arm x 5 days. Pt reports that her arm was painful to lift up. It stayed red and welted even after taking Benadryl a few times and then just started to turn yellow and go away. Was completely resolved after day 5.
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| 2846464 | 58 | M | AL | 06/18/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
P2443 |
Hepatitis B virus test positive
Hepatitis B virus test positive
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Patient received vaccine on 06/03/2025 and was tested for Hep B at blood donor center and he was tes...
Patient received vaccine on 06/03/2025 and was tested for Hep B at blood donor center and he was tested positive.
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| 2846466 | 8 | M | MI | 06/18/2025 |
COVID19 |
PFIZER\BIONTECH |
LT7425 |
No adverse event
No adverse event
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no signs or symptoms
no signs or symptoms
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| 2846467 | 23 | F | VA | 06/18/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
4BX39 |
Peripheral swelling, Pruritus
Peripheral swelling, Pruritus
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We offer Heb to our employees and on her first day she consented to get the Hep B, I gave it to her ...
We offer Heb to our employees and on her first day she consented to get the Hep B, I gave it to her the same day, Today she showed me her arm and it is swollen and itchy, no fever or anything. No treatment sought.
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| 2846468 | 11 | M | MI | 06/18/2025 |
TDAP |
SANOFI PASTEUR |
B32NG |
Expired product administered, No adverse event
Expired product administered, No adverse event
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no adverse. I gave patient Tdap that expired on 6/13/25 on 6/18/25. We did document into database...
no adverse. I gave patient Tdap that expired on 6/13/25 on 6/18/25. We did document into database.
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| 2846469 | 66 | F | MI | 06/18/2025 |
COVID19 |
MODERNA |
8080799 |
Expired product administered
Expired product administered
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Medical assistant grabbed vaccine from unit and prepped vaccine administered vaccine in left deltoid...
Medical assistant grabbed vaccine from unit and prepped vaccine administered vaccine in left deltoid of patients arm and when MA was documenting this was when they then realized this was expired, MA went to manager of site and Vaccine coordinator of company and also called CDC.
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| 2846470 | 11 | M | MI | 06/18/2025 |
HIBV HPV9 TDAP |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR |
x028615 Y005835 U8389AA |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
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Gave Patient HIB instead of Meningococcal Conjug
Gave Patient HIB instead of Meningococcal Conjug
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| 2846471 | 60 | F | OH | 06/18/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Patient had redness, swelling, pain at the injection site. patient is being treated with antibiotics...
Patient had redness, swelling, pain at the injection site. patient is being treated with antibiotics from her physician, in case it is an infection from the vaccine. vaccine was given on 5/22/2025 and started receiving antibiotics on 6/12/25 from her physician and is starting a second round of antibiotics on 6/18/25 to make sure the infection is gone.
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| 2846472 | 22 | M | UT | 06/18/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
FDP00583 |
Erythema, Tenderness
Erythema, Tenderness
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Donor developed a 3"x4" Reddened area that was tender to the touch several hours after rec...
Donor developed a 3"x4" Reddened area that was tender to the touch several hours after receiving the vaccine
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| 2846473 | 8 | M | NC | 06/18/2025 |
PPV PPV |
MERCK & CO. INC. MERCK & CO. INC. |
Y016291 Y016291 |
Arthralgia, Blood test, Body temperature increased, Chest X-ray, Pain in extremi...
Arthralgia, Blood test, Body temperature increased, Chest X-ray, Pain in extremity; Somnolence, Testicular pain, Ultrasound testes, Urine analysis, X-ray limb
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He had his pneumococcal 23 vaccine Thursday, June 12. He had the vaccine in his left arm. He woke ...
He had his pneumococcal 23 vaccine Thursday, June 12. He had the vaccine in his left arm. He woke up the following day complaining of left arm pain, though mom thought this was just because of his recent vaccine. The pain has persisted in his left shoulder today. Mom has tried Tylenol by mouth and topical lidocaine patches with some improvement of his pain. Mom took child to Emergency Department. He also complains of persistent left testicular and right hip pain, which he had been seen in the ED the day prior for. Mother reports he is also being evaluated for possible rheumatoid arthritis. She states she brought him back to the ER tonight because he took a nap this evening (06/14/25) which is highly unusual for the patient. She had been checking his temperature throughout the day today and noticed at 7 PM that he had a rectal temperature of 105.1. She did not provide any antipyretics and came went to the ER. Mother states that his doctors and specialists are all in another area as she did not feel satisfied with the care he was receiving in this area in the past. Patient denies any cough, shortness of breath, chest pain, abdominal pain, sore throat, congestion or runny nose. There has been no nausea vomiting diarrhea or constipation.
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| 2846474 | 65 | F | PA | 06/18/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Injection site erythema, Injection site pruritus, Injection site warmth
Injection site erythema, Injection site pruritus, Injection site warmth
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THE PATIENT PRESENTED TO THE PHARMACY, AND SHOWED US HER ARM, WHICH WAS RED AT INJECTION AREA, ITCHY...
THE PATIENT PRESENTED TO THE PHARMACY, AND SHOWED US HER ARM, WHICH WAS RED AT INJECTION AREA, ITCHY, AND WARM. WE RECOMMENDED PATIENT TAKE BENADRYL, AND MONITOR FOR IT TO WORSEN AND CALL DR IF IT DOES.
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| 2846475 | 18 | F | FL | 06/18/2025 |
MENB MENB |
PFIZER\WYETH PFIZER\WYETH |
LW8910 LW8910 |
Chills, Injection site induration, Injection site pain, Nausea, Pain; Skin warm
Chills, Injection site induration, Injection site pain, Nausea, Pain; Skin warm
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Later on the same day as the vaccine, patient developed tactile fever, chills, nausea and immunizati...
Later on the same day as the vaccine, patient developed tactile fever, chills, nausea and immunization site pain. She felt better the following day other than some arm pain at the immunization site. She presented to the office the next day, two days after the vaccine, with complaint of increased pain in her arm near the injection site and pain with arm movement. Area was indurated but not warm or erythematous.
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| 2846476 | 31 | F | TX | 06/18/2025 |
VARCEL |
MERCK & CO. INC. |
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Antibody test negative, Influenza
Antibody test negative, Influenza
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Consumer reported that she showed no immunity towards Varicella after the titer and VARIVAX vaccinat...
Consumer reported that she showed no immunity towards Varicella after the titer and VARIVAX vaccination series.; Consumer reported getting the Flu after receiving her second dose of the VARIVAX vaccine; she received her second dose of the VARIVAX vaccine on 06/18/2024 and completed a Varicella titer for nursing school; This spontaneous report was received from 31-year-old female referring to herself. The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported. On 18-Jun-2024, the patient was vaccinated with the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), reconstituted with sterile diluent (MERCK STERILE DILUENT) (formulation, strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age) (conflicting information: patient also reported completing the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) vaccination series when she was younger but did not elaborate further). On an unknown date, the patient got the flu after receiving her second dose of the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) vaccine. On an unknown date, the patient completed a Varicella titer for nursing school, it showed no immunity towards Varicella after the titer and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) vaccination series. At the reporting time, the outcome of events flu and Varicella titer showed no immunity was not provided. Action taken with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was not applicable. The causal relationship between the events and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) with reconstituted sterile diluent (MERCK STERILE DILUENT) was not provided. Lot# is being requested and will be submitted if received.
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| 2846477 | 11 | F | CA | 06/18/2025 |
HPV9 HPV9 MNQ MNQ TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
Z002580 Z002580 U8494AA U8494AA U8232aa U8232aa |
Blood glucose normal, Dizziness, Fall, Head injury, Headache; Swelling face; Blo...
Blood glucose normal, Dizziness, Fall, Head injury, Headache; Swelling face; Blood glucose normal, Dizziness, Fall, Head injury, Headache; Swelling face; Blood glucose normal, Dizziness, Fall, Head injury, Headache; Swelling face
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Per mother patient fell and hit her head on the wall. Noted patient had bump on forehead on the left...
Per mother patient fell and hit her head on the wall. Noted patient had bump on forehead on the left side. C/O dizziness and headache. Ice pack applied to patient forehead. Vital: BP: 145/94, pulse: 97, O2 98%, BG: 110mg/dl. Patient alert and oriented X4. Patient received HPV, Tdap and MCV vaccines. Stated she didn't had any breakfast. Rechecked vitals after 5 mins BP:127/85. MD assessed patient and advice sent patent out to ER for further evaluation for headache and dizziness. Call 9-1-1 patient sent to ER approx at 11:21am. Family will follow the ambulance.
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| 2846478 | 64 | F | WI | 06/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3334Y |
Pain in extremity
Pain in extremity
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Patient reports severe pain starting two days after vaccination in the arm of vaccination. She "...
Patient reports severe pain starting two days after vaccination in the arm of vaccination. She "just dealt with it". It has since subsided to an ache, but she still experiences the pain a month and a half later. I advised her to be seen so she can be evaluated for SIRVA.
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| 2846479 | 55 | M | MA | 06/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Brain fog, Fatigue
Brain fog, Fatigue
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Pt developed brain fog and generalized fatigue about 8hrs after the administration of shingrix vacci...
Pt developed brain fog and generalized fatigue about 8hrs after the administration of shingrix vaccine.
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