| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2846791 | 81 | M | ME | 06/21/2025 |
COVID19 |
MODERNA |
3043259 |
Expired product administered
Expired product administered
|
patient was given expired vaccine
patient was given expired vaccine
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| 2846792 | 80 | F | ME | 06/21/2025 |
COVID19 |
PFIZER\BIONTECH |
lp1776 |
Expired product administered
Expired product administered
|
patient was given expire vaccine
patient was given expire vaccine
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| 2846793 | 79 | M | ME | 06/21/2025 |
COVID19 |
PFIZER\BIONTECH |
lp1776 |
Expired product administered
Expired product administered
|
patient was given expire vaccine
patient was given expire vaccine
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| 2846794 | 59 | F | VA | 06/21/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site erythema, Injection site warmth, Joint stiffness, Mobility decrea...
Injection site erythema, Injection site warmth, Joint stiffness, Mobility decreased, Musculoskeletal stiffness; Pain in extremity
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After receiving the vaccine, my arm was very sore and I could not raise it above shoulder height (no...
After receiving the vaccine, my arm was very sore and I could not raise it above shoulder height (not too unexpected). The injection site (left arm) has remained red and tender for 2 days. The worst (and reason I wanted to report) was the morning after the shot (Friday 6/20/25) my whole body (shoulders, arms, legs joints, etc.) was STIFF so much so that I remained in bed for about 2.5 hours after my normal wake up time (7:30am). I got up and too two Aleve (noproxen sodium 220mg) liquid gel caps and I felt much better within about one hour of taking the meds. I just wanted to report this because I didn't read "muscle stiffness" as a possible side effect. Thank you.
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| 2846795 | 16 | F | NY | 06/21/2025 |
CHIK |
BAVARIAN NORDIC |
FDP00691 |
Syncope
Syncope
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IXIARO (LOT: JEV24B20E) WAS ADMINISTERED TO PATIENT'S LEFT DELTOID. FOLLOWING IXIARO DOSE VIMK...
IXIARO (LOT: JEV24B20E) WAS ADMINISTERED TO PATIENT'S LEFT DELTOID. FOLLOWING IXIARO DOSE VIMKUNYA INJECTION WAS ADMINISTERED INTO LEFT DELTOID BELOW IXIARO ADMINISTRATION SITE. WITHIN ONE MINUTE OF VIMKUNYA DOSE PATIENT EXPEIRENCED VASOVAGAL SYNCOPE EPISODE . SYNCOPE EPISODE LASTED LESS THAN ONE MINUTE AND PATIENT WAS GIVEN SODA AND WATER AND REMAINED SEATED INTO SHOT ROOM FOR 30 MINUTES. PATIENT RECOVERED WITH SODA AND WATER.
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| 2846796 | 69 | F | AZ | 06/21/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
80777-0110-96 80777-0110-96 |
Abdominal pain upper, Chills, Diarrhoea, Dyspnoea, Tremor; Vomiting
Abdominal pain upper, Chills, Diarrhoea, Dyspnoea, Tremor; Vomiting
|
On Saturday night, June 14, 2025, 30 hours after receiving the vaccine, I had terrible stomach cramp...
On Saturday night, June 14, 2025, 30 hours after receiving the vaccine, I had terrible stomach cramps, vomiting, diarrhea and the most violent shivering that lasted 30 minutes. I almost called the emergency room. The shivering was like a seizure in that I could not control my limbs (arms and legs) which were moving very quickly and violently. I also had difficulty breathing in that my throat seized up and I could breathe only shallowly and rapidly in an effort to control the violet shivering.
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| 2846797 | 64 | F | AL | 06/21/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
No adverse events pt just had already received vaccine in 2023
No adverse events pt just had already received vaccine in 2023
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| 2846798 | 50 | F | FL | 06/21/2025 |
HEP VARZOS |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
|
Fatigue, Paraesthesia; Fatigue, Paraesthesia
Fatigue, Paraesthesia; Fatigue, Paraesthesia
|
PATIENT COMPAINT OF TINGLING WITHOUT ANY RESPIRATORY DISTRESS. PT CAN'T DESCRIBE SYMPTOMS BUT S...
PATIENT COMPAINT OF TINGLING WITHOUT ANY RESPIRATORY DISTRESS. PT CAN'T DESCRIBE SYMPTOMS BUT SAYS TIRED AND TINGLING FEELING
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| 2846799 | 58 | F | CA | 06/21/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946063 |
Dizziness, Dyspnoea, Feeling jittery, Nasopharyngitis
Dizziness, Dyspnoea, Feeling jittery, Nasopharyngitis
|
PT CAME BACK IN 5 MINUTES LATER AFTER VACCINATION. PT EXPERIENCE JITTERY, COLD SYMPTOMS, DIZZINESS....
PT CAME BACK IN 5 MINUTES LATER AFTER VACCINATION. PT EXPERIENCE JITTERY, COLD SYMPTOMS, DIZZINESS. 5 MINUTES LATER, PT TOLD ME THAT SHE COULDN'T BREATH. CALL 911 . PT HAD TAKEN TO THE ER
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| 2846800 | 76 | F | MS | 06/21/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y019158 MG5S9 |
Injection site dryness, Pain in extremity; Injection site dryness, Pain in extre...
Injection site dryness, Pain in extremity; Injection site dryness, Pain in extremity
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per patient, the day after immunization, her arms were sore and then a small area of dry, patchy ski...
per patient, the day after immunization, her arms were sore and then a small area of dry, patchy skin appeared in the same spot she got the two immunizations on each arm. She described it as having a raised, dry feeling when touched. She is dark skinned so the spot is not visible, can just tell by touch. It is not painful to the touch. The spots are still present 2 months after administration. She uses non-scented soap. She applies moisturizing lotion to the places every night after taking a bath. Patient has an upcoming appointment with her provider for routine check up, advised her to get her provider to look at those areas of skin.
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| 2846801 | 53 | M | AL | 06/21/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
d5934 |
Condition aggravated, Rheumatic disorder
Condition aggravated, Rheumatic disorder
|
Patient described the symptoms similar to rheumatic flares with extreme total body involvement.
Patient described the symptoms similar to rheumatic flares with extreme total body involvement.
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| 2846617 | F | 06/20/2025 |
MMR |
MERCK & CO. INC. |
X008385 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No additional AE/No PQC; an expired dose of MMR II was administered to a 4-year-old female patient o...
No additional AE/No PQC; an expired dose of MMR II was administered to a 4-year-old female patient on 6/16/2025.; This spontaneous report was received from an Other health professional and referres to a 4-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 16-Jun-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X008385, expiration date: 21-Mar-2025) 0.5 mL, for prophylaxis (Expired vaccine used). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). No additional AE.
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| 2846618 | IA | 06/20/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB030A |
Product preparation issue
Product preparation issue
|
one of our patients they were not sure which of the four others had only the diluent; one of our pat...
one of our patients they were not sure which of the four others had only the diluent; one of our patients they were not sure which of the four others had only the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB030A, expiry date 30-APR-2025) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: one of our patients they were not sure which of the four others had only the diluent) and inappropriate dose of vaccine administered (Verbatim: one of our patients they were not sure which of the four others had only the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 10-JUN-2025 and 11-JUN-2025 The reporter was Clinic Administrator and was looking for some guidance. They had a box of Menveo vaccine and when, he/she had a clinical staff nurse that went to administered the last dose and noticed there were 2 vials of the concentrate, if they would and only one bottle of the diluent in there. So, it appeared that one of our patients they were not sure which of the four others had only the diluent and not the full dosing of the Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. So, he/she was just wondering what recommendations for those four patients and asked if they had to re-vaccinate or what. The reporter did not know the patients information nor when did the patients received the vaccine. 4 Suspected patients. He only provided the lot number of the vaccine. The reporter consented to follow up.
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| 2846629 | 06/20/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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Shingles; This non-serious case was reported by a consumer via interactive digital media and describ...
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included shingles vaccine (received first dose of vaccine on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-JUN-2025 Patient had done it and still got it. He/she had received two vaccines and got it right afterward.
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| 2846630 | TX | 06/20/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Unapproved age; This non-serious case was reported by a nurse via call center representative and des...
Unapproved age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa (Infanrix) for prophylaxis. On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age). The outcome of the inappropriate age at vaccine administration was 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: 13-JUN-2025 One of the medical assistants had administered a DTaP vaccine to a 49 year old patient, which led to Inappropriate age at vaccine administration
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| 2846631 | F | 06/20/2025 |
COVID19 |
MODERNA |
|
Vision blurred
Vision blurred
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Blurry visions; This spontaneous case was reported by a consumer and describes the occurrence of VIS...
Blurry visions; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry visions) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurry visions). At the time of the report, VISION BLURRED (Blurry visions) outcome was unknown. Concomitant medication was not provided. Patient reported same symptoms as reporter. The patient had eye examination one month prior to vaccination and had no issues with eyes. She experienced symptoms approximately two weeks post-vaccination. Her doctor attributed the condition to the moderna vaccine. She felt like Moderna was responsible for her issue as they were not given any warning, and it was Moderna responsibility to report those side effects to the public. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787613 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787613:Master case (Patient 1)
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| 2846633 | 43 | F | AZ | 06/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
KK75K |
Lymph node pain, Lymphadenopathy
Lymph node pain, Lymphadenopathy
|
Swollen lymph nodes on left side, neck and axillary Pt referred to Allergy and Immunology Tender lym...
Swollen lymph nodes on left side, neck and axillary Pt referred to Allergy and Immunology Tender lymph node area and swelling
More
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| 2846634 | 79 | F | WA | 06/20/2025 |
COVID19 RSV |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
MD3414 3M9DS |
Muscle spasms, Pain, Pain in extremity; Muscle spasms, Pain, Pain in extremity
Muscle spasms, Pain, Pain in extremity; Muscle spasms, Pain, Pain in extremity
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Pt reported being awakened in the middle of the night the evening after receiving the vaccines by a ...
Pt reported being awakened in the middle of the night the evening after receiving the vaccines by a shooting pain that traveled down the left side of the body down to the foot, with the big toe of that side spasming in a painful upright position. This lasted about 5 minutes, then resolved on its own. This occurred on the same side of the body that the RSV shot had been administered. She was initially concerned about a potential cardiac event until it passed.
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| 2846635 | 9 | M | IL | 06/20/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y012864 Y012864 |
Allergy to arthropod bite, Arthralgia, Borrelia test negative, Joint swelling, R...
Allergy to arthropod bite, Arthralgia, Borrelia test negative, Joint swelling, Rash; Streptococcus test negative, Urticaria
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Left ankle swelling 6/3/25 and then on 6/14/25 seemed to get some insect bites and then developed hi...
Left ankle swelling 6/3/25 and then on 6/14/25 seemed to get some insect bites and then developed hive like break out and seemed to worsen - ankle swollen and painful - seen in ER steroids given - lyme titer done - negative. Improved fast. Currently no issues. Dx with urticaria due to insect bites or post viral infection or post hpv reaction.
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| 2846642 | M | WA | 06/20/2025 |
SMALLMNK |
BAVARIAN NORDIC |
Unknown |
Atrial fibrillation
Atrial fibrillation
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Atrial fibrillation; Case reference number AU-BN-2025-000487 initially downloaded from Department of...
Atrial fibrillation; Case reference number AU-BN-2025-000487 initially downloaded from Department of Health and Aged Care, Regulatory Authority is a spontaneous case received from consumer via Health Authority (TGA ID: AU-TGA-0000775733) and concerns a *59-year-old*, male patient. The patient's relevant medical history and concomitant medication details were not provided. On *17-Sep-2022*, the patient was vaccinated with a dose of Jynneos (batch number: unknown) at an unknown dose, route or site of administration for unknown indication. On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient developed atrial fibrillation. *The event management of atrial fibrillation was conducted through the hospital emergency department. * Patient had no previous vaccine reactions. At the time of initial report, it was unknown if the patient recovered from event atrial fibrillation. The reporter *assessed the event atrial fibrillation as non-serious and as possibly related to Jynneos*, however the event of atrial fibrillation was assessed serious due to seriousness criteria of medically significance. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up downloaded from RA received from consumer via Health authority (TGA ID: AU-TGA-0000775733) on 05-Jun-2025: New information included patient details, event management, onset date of vaccination, seriousness and causality assessment.; Reporter's Comments: A 59-year-old male patient experienced a serious event of atrial fibrillation (medical significance) on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Atrial fibrillation is unlisted and unexpected for Jynneos per CCDS v7, Product Monograph and USPI. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. The report lacks critical information necessary for a meaningful causality assessment. Specifically, the timing of onset relative to vaccination, patient's relevant medical history, concomitant medications, and clinical course are not provided which renders the causality as not assessable. This case is considered as serious due to medical significance.; Sender's Comments: A 59-year-old male patient experienced a serious event of atrial fibrillation (medical significance) on an unspecified date, an unknown amount of time after the patient was vaccinated with Jynneos for unknown indication. Atrial fibrillation is unlisted and unexpected for Jynneos per CCDS v7, Product Monograph and USPI. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. The report lacks critical information necessary for a meaningful causality assessment. Specifically, the timing of onset relative to vaccination, patient's relevant medical history, concomitant medications, and clinical course are not provided which renders the causality as not assessable. This case is considered as serious due to medical significance.
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| 2846684 | 58 | M | OK | 06/20/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
|
Anxiety, Condition aggravated, Coronary arterial stent insertion, Deep vein thro...
Anxiety, Condition aggravated, Coronary arterial stent insertion, Deep vein thrombosis, Depression; Electric shock sensation, Electromyogram abnormal, Haematoma, Hypertension, Laboratory test; Myocardial infarction, Nerve injury, Pain in extremity, Pneumonia
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pt states that when he shows up for work that Monday morning, he had electrical shocking pain down h...
pt states that when he shows up for work that Monday morning, he had electrical shocking pain down his right leg that was causing terrible pain. He continued to work while hurting but ended up in an ambulance to the ER (redacted) Hospital in (redacted state). He was admitted and spent 3 days in there because his BP was so high but was not treated for the pain in his leg. After being discharged he was told to see his PCP. He went to Medical. Dr. ran some test and given an EMG. The nerve was dead in his right leg from a blood clot. The hematoma hit his sciatic nerve and killed his leg and his leg is dead today. He is on blood thinner now for the clots. and has DVT. Had to go to the hospital in (redacted) for a heart attack. Dr. placed 4 stints in his heart. No further treatment. On Jan 19th, 2025, He had to take an ambulance to Hospital in (redacted) for pneumonia. He had a z-pack and sedative. After being released, he couldn't fill meds because pharmacy was closed so he went back to the ER. They wanted to give him another sedative and send him home. He told them he was not going home. They sent him security vehicle to (redacted) Hospital and is now on mood stabilizers for his mental state from anxiety and depression. He is currently being treated with physicians through (redacted) Health. Currents medications. buspirone 10mg 3x daily, Hydroxyz 25 mg prn x 3 daily, lisinopril 10mg x 1 daily, propranolol 20 mg x 2 daily, mirtazapine 15mg x1 tab daily, abilify 5 mg x1 daily, Lipitor 20mg x 1 daily, Plavix 75mg, Lexapro 20mg x1 daily, depico 500 mg x 2 daily, gabapentin 300 mg x 3 daily, Flomax .4 mg 1 daily.
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โ | โ | โ | |||
| 2846685 | 67 | F | 06/20/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
7MN4C |
Tremor
Tremor
|
Patient experienced shaking 3hrs after vaccine was administered
Patient experienced shaking 3hrs after vaccine was administered
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| 2846686 | 28 | M | MI | 06/20/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
030H21B 030H21B |
Abdominal pain, Diarrhoea, Gastritis, Imaging procedure abnormal, Large intestin...
Abdominal pain, Diarrhoea, Gastritis, Imaging procedure abnormal, Large intestinal obstruction; Nausea, Splenic lesion
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1/6/22 extreme diarrhea, nausea, abdominal pain. Reported to ER. Imaging revealed hundreds of spleni...
1/6/22 extreme diarrhea, nausea, abdominal pain. Reported to ER. Imaging revealed hundreds of splenic lesions. Admitted and placed on liquid diet. Diarrhea subsided, nausea and abdominal pain remained. Ultimate diagnosis for cause of abdominal pain and nausea was gastritis. No history of gastritis prior. Treated with PPIs, symptoms continue today when stopping medication. GI issues continue including blocked colon during 20204.
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โ | |||||
| 2846687 | 79 | F | 06/20/2025 |
RSV VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
94cc4 PJ353 |
Injection site erythema, Injection site pain, Injection site swelling; Injection...
Injection site erythema, Injection site pain, Injection site swelling; Injection site erythema, Injection site pain, Injection site swelling
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Swollen, pain, redness of injection site. Told pt they could use IBU for pain and ice for swelling ...
Swollen, pain, redness of injection site. Told pt they could use IBU for pain and ice for swelling but if it got worse or did not get better they need to go be seen by HCP.
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| 2846688 | 11 | F | KS | 06/20/2025 |
HPV9 |
MERCK & CO. INC. |
Y012776 |
Dyspnoea, Eye movement disorder, Muscle rigidity
Dyspnoea, Eye movement disorder, Muscle rigidity
|
During observation period, patient family member called out for help. Patient was found leaning rigi...
During observation period, patient family member called out for help. Patient was found leaning rigidly next to exam bed while being supported by family member. Patient's eyes were rolled back and body was tense and legs were unable to be straightened. After approximately 5 seconds patient opened eyes wide and was heavily breathing. Symptoms resolved but 10 minutes later, patient's left arm was flexed with wrist also flexed in, right arm was semi-flexed, patients head was bent forward, and patient was very stiff and not responding to commands. This lasted approximately 10 seconds. Symptoms completed resolved after 10 minutes and patient was discharged later in stable condition.
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| 2846689 | 1.5 | F | NM | 06/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
M7YY5 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Pt was due to receive dose #4 of DTaP series, but instead received a dose of TDaP. Provider, managem...
Pt was due to receive dose #4 of DTaP series, but instead received a dose of TDaP. Provider, management and pt's mother were all informed. Per CDC guidelines, this TDaP dose DOES count for #4 in DTaP series. No adverse reactions have occurred/been reported
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| 2846690 | 2 | M | CA | 06/20/2025 |
COVID19 |
MODERNA |
3046979 |
Expired product administered
Expired product administered
|
Vaccine was given after the expiration date which was 04/25/2025. Vaccine was given on 04/28/2025
Vaccine was given after the expiration date which was 04/25/2025. Vaccine was given on 04/28/2025
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| 2846691 | 10 | F | CA | 06/20/2025 |
COVID19 |
MODERNA |
3046979 |
Expired product administered
Expired product administered
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Vaccine was given after it was expired on 04/25/2025. Vaccine given on 04/30/2025
Vaccine was given after it was expired on 04/25/2025. Vaccine given on 04/30/2025
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| 2846692 | 63 | F | FL | 06/20/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Extra dose administered
Extra dose administered
|
Patient had already received the RSV vaccine on 2/22/2024 and no other doses were required. An addit...
Patient had already received the RSV vaccine on 2/22/2024 and no other doses were required. An additional dose was administered on 6/18/2025
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| 2846693 | 1 | F | 06/20/2025 |
HEPA MMR |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
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Erythema, Irritability, Papule, Pyrexia, Rash; Erythema, Irritability, Papule, P...
Erythema, Irritability, Papule, Pyrexia, Rash; Erythema, Irritability, Papule, Pyrexia, Rash
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Rash of face and trunk. Disseminated 1 mm erythematous papules. Increased fussiness, subjective feve...
Rash of face and trunk. Disseminated 1 mm erythematous papules. Increased fussiness, subjective fever per mother. Otherwise well.
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| 2846694 | 11 | M | CA | 06/20/2025 |
IPV |
SANOFI PASTEUR |
W1B511M |
Erythema, Hypersensitivity, Pruritus, Rash, Urticaria
Erythema, Hypersensitivity, Pruritus, Rash, Urticaria
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On May 11, he got an allergic reaction all over his body around 6PM. He complained of being itchy. H...
On May 11, he got an allergic reaction all over his body around 6PM. He complained of being itchy. His skin was red with rash and hives covering his face, neck, torso, arms and legs. Took an antihistamine, which brought the itch down a bit, but had no effect on the rash/hives. On May 12, he saw Dr. who recommended Zyrtec. He took the Zyrtec and symptoms were 90% decreased by that evening. May 13, he was fatigued and continued the Zyrtec. May 14, was fully recovered and continued the Zyrtec. May 15 discontinued Zyrtec. Symptoms did not return.
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| 2846695 | 26 | M | MA | 06/20/2025 |
YF YF YF YF YF |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
UK134AA UK134AA UK134AA UK134AA UK134AA |
Autologous blood patching, Borrelia test negative, Brain fog, CSF lymphocyte cou...
Autologous blood patching, Borrelia test negative, Brain fog, CSF lymphocyte count increased, CSF protein normal; CSF white blood cell count increased, Dizziness, Drug screen negative, Fatigue, HIV test negative; Headache, Impaired work ability, Inflammation, Injection site reaction, Laboratory test normal; Lymphadenopathy, Magnetic resonance imaging head normal, Musculoskeletal stiffness, Neurological symptom, Pleocytosis; Presyncope, Scan with contrast normal, Syphilis test negative
More
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Initially had local injection site reaction (common reaction) with regional lymphadenopathy but hen ...
Initially had local injection site reaction (common reaction) with regional lymphadenopathy but hen developed what patient described as brain fog and non-vertiginous, one episode of pre-syncopal dizziness followed by non-specific, non-presyncopal, dizziness. His symptoms persisted although he tried to work, it was interfering with his desk job and was very tired. There were no definite fevers or focal neurological symptoms or headache at time. His arm inflammation responded very nicely to moderate doses of ibuprofen. He got significantly worse with activity. I followed him closely by phone then saw him in office 5/21 and the arm and regional nodes were essentially resolved back to normal. His exam was reassuring and seemed like a viral syndrome with encephalopathy from YF vaccination. He called 2 days later that he now had headache and I referred to ED for MRI and LP. He looked too well to the ED staff with a normal physical exam and only non-contrast MRI was done which was normal. He was sent home. He felt worse and family encouraged ED visit and this time to another hospital 5/28/25. His exam was reassuring but had LP and revealed CSF pleocytosis. He was seen by Neurology and Inf Dis consultation services and monitored for 24 hrs. CDC was consulted regarding YEL-AND and CSF was sent to CDC. Other tests were done and negative including syphilis. He had worse headache that was due to lumbar puncture and was sent home on analgesics. After DC to home he called complaining of ongoing symptoms and HA was not improved and had new back stiffness. I arranged for blood patch and this resolved those symptoms. His dizziness and brain fog persisted and had new peripheral sensory and motor symptoms and I worried about ADEM and GBS vs anxiety. He went back to our ED and was admitted for ruled out. He had another neurology consult and contrast brain MRI which was reassuringly normal. There was no meningismus or hallucinations and there were no seizure-like symptoms. Drug screen was negative and EEG was not done. He was discharged home and since has improved
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| 2846696 | 36 | F | GA | 06/20/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
945663 945663 |
Dizziness, Erythema, Flushing, Pruritus, Rash; Urticaria
Dizziness, Erythema, Flushing, Pruritus, Rash; Urticaria
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Patient reported back to the clinic after 45 minutes of being vaccinated. Facial flushing, itching, ...
Patient reported back to the clinic after 45 minutes of being vaccinated. Facial flushing, itching, localized rash, hives and redness, slight dizziness. Patient A/O x10;NKA; stable, and no breathing difficulties. Cold compress implemented on the face to reduce inflammation and pain; cetirizine 10mg administered, and blood pressure monitored. Patient monitored for 45 minutes, was stable, swelling, itching, hives, and redness reduced, pt. voiced "I feel better, thank you" Patient educated and encourage to monitor flushing and itching and report to urgent care if needed.
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| 2846697 | 31 | F | CO | 06/20/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Z005469 Z005469 |
Blood iron, Fatigue, Full blood count, Lipase, Metabolic function test; Nausea, ...
Blood iron, Fatigue, Full blood count, Lipase, Metabolic function test; Nausea, Vomiting
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She had nausea, vomiting and extreme fatigue starting a few days after the vaccine was given
She had nausea, vomiting and extreme fatigue starting a few days after the vaccine was given
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| 2846698 | 22 | F | VT | 06/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945659 |
Anxiety, Dizziness, Fatigue, Nausea
Anxiety, Dizziness, Fatigue, Nausea
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After vaccination patient experienced dizziness, fatigue, and intermittent nausea and anxiety relate...
After vaccination patient experienced dizziness, fatigue, and intermittent nausea and anxiety related to these symptoms. She denied trouble breathing, trouble swallowing, rash, or itchiness. She says this started about 15 minutes following vaccination but was not reported to anyone until about an hour following vaccination.
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| 2846699 | 11 | F | GA | 06/20/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
K009482 U5058AA U4870BA |
Affect lability, Anxiety, Crying, Personality change; Affect lability, Anxiety, ...
Affect lability, Anxiety, Crying, Personality change; Affect lability, Anxiety, Crying, Personality change; Affect lability, Anxiety, Crying, Personality change
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Per Mom eight hours after the vaccines were administered the patient started crying, which continued...
Per Mom eight hours after the vaccines were administered the patient started crying, which continued for another 3 weeks. The parents also noticed abrupt changes in her personality, there was a significant emotional liability and severe anxiety that was not present prior to the vaccines. This required multiple therapy appointments and has recently been prescribed medication to help with the mental changes.
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| 2846700 | 1.25 | F | TN | 06/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
LX494 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Pt was supposed to get Dtap and was given Tdap. Parents notified right after event and told to watch...
Pt was supposed to get Dtap and was given Tdap. Parents notified right after event and told to watch for fever or other concerns. Nurse spoke with patient about 30 minutes after immunization and no adverse side effects noted.
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| 2846701 | 28 | F | ID | 06/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Injection site erythema, Injection site pruritus, Injection site swelling, Pruri...
Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
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EE contacted this nurse to report she experienced post Hep B vaccine arm swelling to injection site ...
EE contacted this nurse to report she experienced post Hep B vaccine arm swelling to injection site and had red and itchiness to site. States she got the itching to her whole body for a couple of days. Reports she took benadryl and that helped clear it up on 6/14/25.
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| 2846702 | 82 | F | ID | 06/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
F95YS |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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A patient came by this am on 6/20/2025 to show me her arm from a shingles shot she got on 6/12/25. ...
A patient came by this am on 6/20/2025 to show me her arm from a shingles shot she got on 6/12/25. There was a 6 inch pinkish patch from the mid-deltoid halfway to her elbow that started the evening of 6/12/2025 and next morning. She said it was itching but otherwise not bothersome. Patient was advised that the second shot was not advisable and that she might try Benadryl and a itch cream like Benadryl cream or hydrocortisone. She said she's been putting Cerave on it and that helped the itching.
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| 2846703 | 20 | F | CA | 06/20/2025 |
DTAP DTAP MNQ MNQ |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
PD324 PD324 Z92L4 Z92L4 |
Confusional state, Disorientation, Dizziness, Gaze palsy, Laboratory test; Seizu...
Confusional state, Disorientation, Dizziness, Gaze palsy, Laboratory test; Seizure; Confusional state, Disorientation, Dizziness, Gaze palsy, Laboratory test; Seizure
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Patient stood up from the vaccine administration area, walked to the counter to obtain the paperwork...
Patient stood up from the vaccine administration area, walked to the counter to obtain the paperwork and then looked at me and said, ?am I pale? I think I?m going to pass out.? She then crumpled into my arms. I took her to the ground ? her eyes were rolled back in her head. I tried to wake her. She then had a small convulsion/seizure. When she awoke she was confused and disoriented.
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| 2846705 | 12 | M | NV | 06/20/2025 |
DTAP |
SANOFI PASTEUR |
3CA55C1 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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The medical assistant administered Dtap instead of Tdap. Corrective action has been taken. Education...
The medical assistant administered Dtap instead of Tdap. Corrective action has been taken. Education provided.
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| 2846706 | 67 | M | PA | 06/20/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793PT |
Asthenia, Headache, Immediate post-injection reaction
Asthenia, Headache, Immediate post-injection reaction
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Patient stated immediately after the vaccine he developed a headache and later felt a little weak. H...
Patient stated immediately after the vaccine he developed a headache and later felt a little weak. He denied dizziness, feeling faint, shortness of breath, difficulty breathing. Patient's BP was 135/77 and HR 77 taken by pharmacist. Patient refused to lie down and refused ambulance. He was planning to go back to urgent care who directed him to receive vaccine, stated as soon as he got to his car was already feeling better.
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| 2846707 | 62 | F | 06/20/2025 |
TDAP |
SANOFI PASTEUR |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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3rd Tdap was given too early. No known adverse effects.
3rd Tdap was given too early. No known adverse effects.
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| 2846708 | 12 | F | MI | 06/20/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
ES49H |
Wrong product administered
Wrong product administered
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Patient administered Bexsero at well child check in February. Mother informed office in June she not...
Patient administered Bexsero at well child check in February. Mother informed office in June she noticed on patients medical records that the patient was administered Bexsero instead of Menveo.
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| 2846709 | 40 | F | NM | 06/20/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FA7485 FA7485 FC3183 FC3183 |
Blood electrolytes decreased, Blood glucose increased, Fatigue, Gastrooesophagea...
Blood electrolytes decreased, Blood glucose increased, Fatigue, Gastrooesophageal reflux disease, Glycosylated haemoglobin increased; Thirst, Type 1 diabetes mellitus, Vision blurred, Weight decreased; Blood electrolytes decreased, Blood glucose increased, Fatigue, Gastrooesophageal reflux disease, Glycosylated haemoglobin increased; Thirst, Type 1 diabetes mellitus, Vision blurred, Weight decreased
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Blurred vision, increased thirst. Followed two months later by weight loss, exhaustion and acid refl...
Blurred vision, increased thirst. Followed two months later by weight loss, exhaustion and acid reflux. Followed three months later by increased weight loss, unquenchable thirst, constant exhaustion and severe acid reflux. Urgent care visit showed BG level of 600+. immediate hospitalization determined depleted electrolytes and A1C of 14. Test results determined diagnosis of type 1 diabetes.
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| 2846710 | 45 | F | TN | 06/20/2025 |
TYP |
SANOFI PASTEUR |
X2A231M |
Arthralgia, Headache, Neck pain, Pain, Pyrexia
Arthralgia, Headache, Neck pain, Pain, Pyrexia
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She reported on 06/18/2025 that a few hours after she received the Typhoid vaccine during her travel...
She reported on 06/18/2025 that a few hours after she received the Typhoid vaccine during her travel medicine appt. she developed a headache, 101 fever, body aches and shoulder/neck pain that was bilateral but worse on her left side. Pt states she took Tylenol and the symptoms resolved within a few hours. Pt reports she has had Typhoid vaccine several times in the past and has never had a reaction before this. She reports all symptoms resolved and have not returned.
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| 2846711 | 67 | M | NV | 06/20/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Arthralgia, Asthenia, Fatigue, Gait inability, Joint swelling; Peripheral swelli...
Arthralgia, Asthenia, Fatigue, Gait inability, Joint swelling; Peripheral swelling, Thrombosis, Ultrasound Doppler abnormal
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Soreness in arm for several days after shot. Approximately 6 or 7 months after the shot l was feeli...
Soreness in arm for several days after shot. Approximately 6 or 7 months after the shot l was feeling very fatique and simply had no energy. I noticed l had swelling in my left calf and ankle but it wasn't really causing much pain until one night l woke up with pain and swelling and couldn't walk. Contacted Dr. at that point. Dr. sent me to get an Ultrasound and a 23 inch blood clot was confirmed. Been on 20 MG Xarelto ever since.
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| 2846712 | 11 | F | AL | 06/20/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Y019459 U8494AA U8232AA |
Dizziness, Syncope; Dizziness, Syncope; Dizziness, Syncope
Dizziness, Syncope; Dizziness, Syncope; Dizziness, Syncope
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AFTER RECEIVING THE VACCINES, SHE WAS DIZZY AND LIGHT-HEADED. SHE FAINTED IN THE WAITING ROOM. THE E...
AFTER RECEIVING THE VACCINES, SHE WAS DIZZY AND LIGHT-HEADED. SHE FAINTED IN THE WAITING ROOM. THE EPISODE LASTED ABOUT 60 SECONDS.
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| 2846713 | 67 | F | NY | 06/20/2025 |
COVID19 |
PFIZER\BIONTECH |
I do not know |
Dizziness, Laboratory test normal
Dizziness, Laboratory test normal
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I became very dizzy and I'm never dizzy. I waited from Sunday to Wednesday and then went to ...
I became very dizzy and I'm never dizzy. I waited from Sunday to Wednesday and then went to urgent care--MD who did a full neurological work up. They said that they couldn't be sure it was from the vaccine though I read several studies indicating that it was a lesser known side-effect. It would have been helpful to be aware of that as it is not on the main sheets of information
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| 2846714 | 77 | F | IL | 06/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
47N37Y |
Arthralgia, Injected limb mobility decreased, Product administered at inappropri...
Arthralgia, Injected limb mobility decreased, Product administered at inappropriate site
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PATIENT RECIVED THE VACCINE SO HIGH IN THE SHOULDE THAT SHE COULDNT MOVE HER ARM FOR 2 DAYS AND SHE ...
PATIENT RECIVED THE VACCINE SO HIGH IN THE SHOULDE THAT SHE COULDNT MOVE HER ARM FOR 2 DAYS AND SHE STILL HAVE SHOULDER PAIN
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