| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2848170 | 73 | F | 07/02/2025 |
COVID19 COVID19 PNC21 PNC21 |
MODERNA MODERNA MERCK & CO. INC. MERCK & CO. INC. |
8080748 8080748 Y013009 Y013009 |
Amnesia, Body temperature, Confusional state, Illness, Malaise; Neurological sym...
Amnesia, Body temperature, Confusional state, Illness, Malaise; Neurological symptom, Pyrexia, Suspected COVID-19; Amnesia, Body temperature, Confusional state, Illness, Malaise; Neurological symptom, Pyrexia, Suspected COVID-19
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exhibiting symptoms of a stroke/ confusion; very sick; PYREXIA/ 104-degree fever; symptoms of COVID-...
exhibiting symptoms of a stroke/ confusion; very sick; PYREXIA/ 104-degree fever; symptoms of COVID-19; NEUROLOGICAL SYMPTOM; very little recollection of the series of events; MALAISE; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (exhibiting symptoms of a stroke/ confusion), ILLNESS (very sick), PYREXIA (PYREXIA/ 104-degree fever) and SUSPECTED COVID-19 (symptoms of COVID-19) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080748) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. Previously administered products included for Drug use for unknown indication: penicillin (penicillin) and meperidine (meperidine). Past adverse reactions to the above products included Allergic reaction NOS with meperidine and penicillin. Concurrent medical conditions included Hypertension, Dry eye, Migraine, Hyperlipidemia, Hypokalemia, Urge incontinence, Dementia, Drug allergy (meperidine allergy), Penicillin allergy (penicillin allergy) and Allergy to antibiotic (sulfa antibiotics allergy). Concomitant products included Amitriptyline hydrochloride (Amitriptyline), Amlodipine besilate (Amlodipine), Galcanezumab gnlm (Emgality), Ezetimibe, Hydroxyzine hydrochloride (Hydroxyzine HCL), Potassium chloride (Klor-con/ef), Losartan potassium (Losartan), Mirabegron, Rizatriptan benzoate (Rizatriptan), Rosuvastatin calcium (Rosuvastatin), Topiramate and Lifitegrast (Xiidra) for an unknown indication. On 03-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 03-Apr-2025, the patient experienced CONFUSIONAL STATE (exhibiting symptoms of a stroke/ confusion) (seriousness criteria hospitalization and medically significant), ILLNESS (very sick) (seriousness criterion hospitalization), PYREXIA (PYREXIA/ 104-degree fever) (seriousness criterion hospitalization), SUSPECTED COVID-19 (symptoms of COVID-19) (seriousness criterion hospitalization), NEUROLOGICAL SYMPTOM (NEUROLOGICAL SYMPTOM), AMNESIA (very little recollection of the series of events) and MALAISE (MALAISE). At the time of the report, CONFUSIONAL STATE (exhibiting symptoms of a stroke/ confusion), ILLNESS (very sick), PYREXIA (PYREXIA/ 104-degree fever), SUSPECTED COVID-19 (symptoms of COVID-19), NEUROLOGICAL SYMPTOM (NEUROLOGICAL SYMPTOM), AMNESIA (very little recollection of the series of events) and MALAISE (MALAISE) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2025, Body temperature: 104 degree fever. It was reported that the patient received two vaccines. Several hours later, she was taken to the Emergency Department, and she had exhibited symptoms of a stroke, including confusion. She also had a 104-degree fever and felt very sick when she was taken to the hospital. She had very little recollection of the series of events. The physician reported that she exhibited symptoms of COVID-19 exposure, but no test was done to confirm this. On 04-Apr-2025, the patient felt well enough to discuss the incident and appeared to be coherent and in good spirits. She was discharged home, and no further treatments were apparent at that time. No treatment medications were reported.; Reporter's Comments: Co-suspect product included non-company product Pneumococcal vaccine. The benefit -risk relationship of product is not affected by this report.
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| 2848171 | M | NE | 07/02/2025 |
COVID19 |
MODERNA |
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Deafness
Deafness
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he ran into a fellow physician that had the vaccine and he lost his hearing in his ear; This spontan...
he ran into a fellow physician that had the vaccine and he lost his hearing in his ear; This spontaneous case was reported by a physician and describes the occurrence of DEAFNESS (he ran into a fellow physician that had the vaccine and he lost his hearing in his ear) in a male 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 DEAFNESS (he ran into a fellow physician that had the vaccine and he lost his hearing in his ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (he ran into a fellow physician that had the vaccine and he lost his hearing in his ear) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-270609 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-270609:Master case (Same reporter, different patient)
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| 2848172 | F | 07/02/2025 |
COVID19 |
MODERNA |
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Emotional distress, Fatigue, Gait inability, Heart rate
Emotional distress, Fatigue, Gait inability, Heart rate
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emotional trauma/distress; She cannot even walk around the house or perform simple household tasks w...
emotional trauma/distress; She cannot even walk around the house or perform simple household tasks without distress.; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (emotional trauma/distress), GAIT INABILITY (She cannot even walk around the house or perform simple household tasks without distress.) and FATIGUE (extreme fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EMOTIONAL DISTRESS (emotional trauma/distress), GAIT INABILITY (She cannot even walk around the house or perform simple household tasks without distress.) and FATIGUE (extreme fatigue). At the time of the report, EMOTIONAL DISTRESS (emotional trauma/distress), GAIT INABILITY (She cannot even walk around the house or perform simple household tasks without distress.) and FATIGUE (extreme fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: Elevated dangerously. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. The patient was a physician and, as a frontline healthcare provider during the pandemic, she selflessly cared for COVID-19 patients and took the vaccine in good faith, trusting it was safe and effective. She suffered severe long-term health consequences following her Moderna COVID-19 vaccination nearly four years ago. Since then, she faced unrelenting health problems including a dangerously elevated heart rate with even minimal exertion, extreme fatigue, and an inability to function normally in her daily life. She could not even walk around the house or perform simple household tasks without distress. Over the four years that followed, she endured not only profound physical challenges but also emotional trauma, financial strain from ongoing medical care, and countless hours spent searching for answers. Despite consultations with specialists and trying numerous treatments, she continued to suffer with no clear resolution in sight. The reporter wanted to advocate for recognition, support, and action for individuals like her whose lives had been drastically altered. They hoped Moderna would show compassion and responsibility by helping those rare but real cases who trusted in science and stepped forward to protect the greater community only to be left behind when things went wrong.
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| 2848173 | 75 | M | CA | 07/02/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3046714 3046714 |
Atrial fibrillation, Body temperature, Chest discomfort, Chest pain, Electrocard...
Atrial fibrillation, Body temperature, Chest discomfort, Chest pain, Electrocardiogram; Headache, Lethargy, Pain, Pyrexia, Type 2 diabetes mellitus
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was a slight rise in temperature last night, it was 101.5F; little bit of headache; significant ches...
was a slight rise in temperature last night, it was 101.5F; little bit of headache; significant chest pain tightening and burning; significant chest pain tightening and burning; achy; lethargy; AFib; type 2 diabetes; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) and TYPE 2 DIABETES MELLITUS (type 2 diabetes) in a 75-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046714) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In June 2025, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criterion medically significant), TYPE 2 DIABETES MELLITUS (type 2 diabetes) (seriousness criterion medically significant) and LETHARGY (lethargy). On 21-Jun-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced CHEST DISCOMFORT (significant chest pain tightening and burning), CHEST PAIN (significant chest pain tightening and burning), PAIN (achy) and HEADACHE (little bit of headache). On 24-Jun-2025, the patient experienced PYREXIA (was a slight rise in temperature last night, it was 101.5F). The patient was treated with Tirzepatide (Mounjaro) in June 2025 for Type 2 diabetes mellitus, at an unspecified dose and frequency; Apixaban (Eliquis) in June 2025 for AFib, at a dose of 5 milligram twice a day; Ibuprofen (Advil) in June 2025 at a dose of UNK, qid and Famotidine (Pepcid) in June 2025 at a dose of UNK, bid. At the time of the report, ATRIAL FIBRILLATION (AFib), TYPE 2 DIABETES MELLITUS (type 2 diabetes), CHEST DISCOMFORT (significant chest pain tightening and burning), CHEST PAIN (significant chest pain tightening and burning), PAIN (achy), LETHARGY (lethargy), PYREXIA (was a slight rise in temperature last night, it was 101.5F) and HEADACHE (little bit of headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2025, Electrocardiogram: proved that there had been no change to a prior EKG that took place just 45 days ago. On 24-Jun-2025, Body temperature: there was a slight rise in temperature last night, it was 101.5 F.. No concomitant medications provided by the reporter. Patient was received Moderna Covid-19 vaccine since outbreak of Covid and post vaccination patient used to shake it off in 1 or 2 days. This was probably his 7th or 8th booster on 20-Jun-2025. It was reported that patient symptoms were now on day five. Post booster dose of vaccination he experienced a significant chest pain tightening and burning. Cardiologist thought that he might have experienced myocarditis. He received treatment medication of a couple of Advil 4 times a day and to add on top of that some Pepcid 2 times a day. The symptoms started on Saturday, 21-Jun-2025. Patient had the normal reaction, a little bit of headache, achy. He took a couple Advil. Saturday afternoon it started coming in, and it was pretty intense. He went to see the cardiologist. The cardiologist took an EKG on Monday at 2 o'clock. The symptoms had not resolved. The intensity of the pain/the heat around his heart has subsided significantly, like by 80%, but in the evening, there was a slight rise in temperature last night, it was 101.5F. He took a couple Advil and sweat it out, etc. But the symptom of aches and lethargy were continued for patient. It was also reported that, following vaccination with Moderna covid-19, the patient was prescribed Eliquis 5 mg twice daily for AFib and Mounjaro for type 2 diabetes. This case was linked to MOD-2025-787797 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2025: Live non-significant follow-up information received in which new reference number was added. On 25-Jun-2025: Live significant follow-up received in which suspect product lot/batch number was added, new treatment medication Mounjaro and Eliquis was added, new event of Atrial fibrillation and Type 2 diabetes mellitus was added. Case narrative was updated, and new reference number was added.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
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| 2848174 | 16 | F | OH | 07/02/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
77KA5 |
Wrong technique in product usage process
Wrong technique in product usage process
|
IM injection with subcutaneous needle with subq technique. After visit it was discovered that the Me...
IM injection with subcutaneous needle with subq technique. After visit it was discovered that the Men B vaccine was given with at subcutaneous needle so would not have gotten into the muscle bed. Parent contacted and informed of the error and that it will not be effective and will need to get the vaccine again.
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| 2848175 | 0.17 | M | NC | 07/02/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
47788AA LN4929 Z007575 |
Full blood count normal, Irritability; Full blood count normal, Irritability; Fu...
Full blood count normal, Irritability; Full blood count normal, Irritability; Full blood count normal, Irritability
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extreme irritability, started shortly after administration and continued for 4 days
extreme irritability, started shortly after administration and continued for 4 days
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| 2848176 | 1.25 | M | TX | 07/02/2025 |
DTAP HIBV PNC20 |
SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH |
3CA20C1 UK148AA LN4929 |
Product preparation error; Product preparation error; Product preparation error
Product preparation error; Product preparation error; Product preparation error
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Patient received ACTHIB but it was not mixed with the diluent that came in the box. Instead it was ...
Patient received ACTHIB but it was not mixed with the diluent that came in the box. Instead it was mixed with diluent used to mix MMR, Varicella and Proquad. Sterile diluent used was from MERCK manufacturing company. Lot # 2053179 exp. 5/2/2027.
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| 2848177 | 9 | F | 07/02/2025 |
HPV9 |
MERCK & CO. INC. |
Y013407 |
Arthralgia, Fall, Head injury, Headache, Limb injury
Arthralgia, Fall, Head injury, Headache, Limb injury
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Administered first dose of HPV vaccine to patient after confirming no prior hx of syncope with blood...
Administered first dose of HPV vaccine to patient after confirming no prior hx of syncope with blood draws or vaccines. Approximately 1-2 minutes post-vaccination I observed the patient just before she hit the floor, landing on her left shoulder and then hitting head - fall partially witnessed. Emergency cord pulled. Patient appeared unresponsive for approximately 30-45 seconds. Responded to verbal stimuli gradually. Two nurses and the provider arrived immediately to assist. Vitals assessed - BP 120/68, HR 66, RR unlabored, airway patent. She reported left shoulder pain and HA upon gaining full consciousness. Ice pack applied to left shoulder; water provided. Patient was slowly assisted into a sitting position on the floor, and then safely transferred to wheelchair. Provider spoke with mom about needing further evaluation in UC for xray. Patient was A/O, and stable at the time of transfer and was escorted to UC via wheelchair by self for further assessment.
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| 2848178 | 40 | F | VA | 07/02/2025 |
TDAP VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
H4279 Y011019 |
Mass, Pain, Tenderness; Mass, Pain, Tenderness
Mass, Pain, Tenderness; Mass, Pain, Tenderness
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Client called was directed to my phone and client left a voicemail on Tuesday 07/01/2025 at 11:45am ...
Client called was directed to my phone and client left a voicemail on Tuesday 07/01/2025 at 11:45am stating "I believe that I'm having a severe allergic reaction to the vaccinations" and asked for a call back from a nurse. I returned the call on Tuesday 07/01/2025 at 12:31pm. Client confirmed the two vaccinations listed above were administered on Tuesday 06/24/2025 at her 9:15am appointment, both to her left arm. She confirmed an allergy to sulfa, no previous reactions/problems with receiving vaccinations, no past/current health history and no sick symptoms the day of vaccination. She reported left arm soreness/pain after the vaccinations which she stated she expected to happen and that the injection site discomfort lasted through approximately Saturday 06/28/2025. She also stated she had developed a "knot on my collarbone" and when asked to describe the knot she said It was a knot on the left side of her collarbone that had constant pain associated with it until approximately Saturday 06/28/2025 when the pain changed to only being when the knot was touched. She noted that she looked up vaccine reactions on the Internet. She was concerned that the knot might turn into a more severe problem and/or "travel" to another part of her body. When asked if she had experienced any rash, hives, swelling to the face/mouth/neck/airway, trouble eating/drinking/swallowing or difficulty breathing since the vaccinations and/or while this knot existed, she responded with no. When asked if she had tried any at home treatments, such as a cold/heat compresses, she stated she intended to do some self-care but life events happened and time got away from her. When asked if she had taken any over the counter medications to alleviate any discomfort/soreness/pain, she stated yes but did not specify medication/dose/frequency. When asked if she had gone to a physician/urgent care center/hospital emergency department, she answered no and replied that she wanted to give it a few days to see if it would go away on its own and that she was concerned if she did go somewhere for treatment, that it wouldn't necessarily be treated but would be told to give it time and be asked to follow-up multiple times; she stated she does not have health insurance and that the financial aspect of those visits would be a concern. She asked if the health department offered any physician follow-up services for post vaccination/general medical issues and was told unfortunately not. I recommended that if she was unable or unwilling to seek medical attention, she could try cold compresses for about 10 minutes at a time about three times a day and that she could take over-the-counter medication, such as ibuprofen, as directed on the instructions as ibuprofen has an anti-inflammatory component to it in addition to pain reliever. I did recommend that she seek medical attention in general, but especially if her knot/pain does not go away and absolutely if she experiences any symptoms including rash, hives, swelling to the face/mouth/neck/airway, trouble eating/drinking/swallowing or difficulty breathing as they are serious health complications. She stated that she hoped the phone conversation was documented so it was known that "you tried to help me." I let her know that I would be reporting the event to VAERS which is official documentation and she would receive a copy of the submitted report within 24 hours. She thanked me for my assistance and call back.
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| 2848179 | 100 | F | IA | 07/02/2025 |
COVID19 |
MODERNA |
3046731 |
Death
Death
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Resident passed away.
Resident passed away.
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| 2848180 | F | 07/02/2025 |
DTAPHEPBIP HIBV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH |
9359N UK229AA LG5578 |
Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Vaccine error, given at the wrong age
Vaccine error, given at the wrong age
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| 2848181 | 62 | F | NM | 07/02/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Chest X-ray normal, Chills, Diarrhoea, Dyspnoea, Electrocardiogram normal; Nause...
Chest X-ray normal, Chills, Diarrhoea, Dyspnoea, Electrocardiogram normal; Nausea, Pyrexia
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Patient developed chills, nausea, fever, diarrhea, shortness of breath the day after the vaccination...
Patient developed chills, nausea, fever, diarrhea, shortness of breath the day after the vaccination. Now a week later seeing me she feels better.
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| 2848182 | 2 | F | AR | 07/02/2025 |
HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Product administered to patient of inappropriate age, Wrong product administered...
Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age; Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age
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My 2 year old daughter was supposed to receive a HEP A vaccination. The doctor's office contact...
My 2 year old daughter was supposed to receive a HEP A vaccination. The doctor's office contacted us after leaving to let us know that they had given her an HPV vaccination in error.
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| 2848183 | 1.25 | F | OH | 07/02/2025 |
DTPPVHBHPB PNC15 |
MSP VACCINE COMPANY MERCK & CO. INC. |
U8313AA Y010032 |
Injection site bruising, Pyrexia; Injection site bruising, Pyrexia
Injection site bruising, Pyrexia; Injection site bruising, Pyrexia
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FEVER, LARGE BRUISE AT INJECTION SITE 5 INCHES IN SIZE.
FEVER, LARGE BRUISE AT INJECTION SITE 5 INCHES IN SIZE.
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| 2848184 | 15 | F | PA | 07/02/2025 |
HPV9 |
MERCK & CO. INC. |
Y012508 |
Dizziness, Syncope
Dizziness, Syncope
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After receiving the vaccine pt became lightheaded and fainted. she was lain down on exam table and h...
After receiving the vaccine pt became lightheaded and fainted. she was lain down on exam table and her feet were elevated. was assessed by provider. water and snack were provided. she was monitored for 20 minutes and was back at her baseline and was feeling fine when she left the office
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| 2848185 | 6 | M | 07/02/2025 |
DTAP IPV |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
5KR3R Y1A201M |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
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None
None
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| 2848186 | 33 | F | WI | 07/02/2025 |
PNC20 |
PFIZER\WYETH |
ln4930 |
Injection site erythema, Injection site mass, Injection site pain, Injection sit...
Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
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Injection site reaction reported by patient noted to be redness, hardened lump area, swelling, tende...
Injection site reaction reported by patient noted to be redness, hardened lump area, swelling, tender to touch, warm to touch. patient did send photos via mychart
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| 2848187 | CO | 07/02/2025 |
PNC20 |
PFIZER\WYETH |
LN4930 |
Liquid product physical issue
Liquid product physical issue
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There was a growth of some sort in the vial, in the prefilled syringe; A tan color substance; This i...
There was a growth of some sort in the vial, in the prefilled syringe; A tan color substance; This is a spontaneous report received from an Other HCP from product quality group. No patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), (Lot number: LN4930, Expiration Date: 31Jul2026) for immunisation. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "There was a growth of some sort in the vial, in the prefilled syringe; A tan color substance". Additional information: the reporter stated that they have Prevnar 20, a couple boxes of it. Confirmed that the product was not administered to patient. Noticed that there was a growth of some sort in the vial in the prefilled syringe. It was like a tan color substance. Causality for "there was a growth of some sort in the vial, in the prefilled syringe; a tan color substance" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
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| 2848188 | 60 | M | MI | 07/02/2025 |
COVID19 HEP HEPA MMR |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
ME6072 4BX39 EY57A Y004115 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Patient was given an extra dose of Comirnaty. Doses 20 days apart. No treatment. Patient states he i...
Patient was given an extra dose of Comirnaty. Doses 20 days apart. No treatment. Patient states he is doing just fine. No problems.
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| 2848189 | 0.5 | F | NM | 07/02/2025 |
DTAPHEPBIP DTAPIPVHIB PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
5YB7L UK167AA MF0425 2091232 |
Extra dose administered, Wrong product administered; Extra dose administered, Wr...
Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered
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Pentacel was administered instead of giving ActHIB by itself. Consequently patient ended up receivin...
Pentacel was administered instead of giving ActHIB by itself. Consequently patient ended up receiving pediarix and pentacel the same day.
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| 2848190 | 25 | F | AZ | 07/02/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chest X-ray, Pneumonia
Chest X-ray, Pneumonia
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Within one week, I had pneumonia
Within one week, I had pneumonia
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| 2848191 | 16 | F | CA | 07/02/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
99g34 |
Product storage error
Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
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| 2848192 | 11 | F | CA | 07/02/2025 |
HPV9 |
MERCK & CO. INC. |
y007197 |
Product storage error
Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
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| 2848193 | 0.5 | F | CA | 07/02/2025 |
DTPPVHBHPB PNC20 |
MSP VACCINE COMPANY PFIZER\WYETH |
U8313AA MF0425 |
Erythema, Swelling; Erythema, Swelling
Erythema, Swelling; Erythema, Swelling
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Redness and Swelling
Redness and Swelling
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| 2848194 | 16 | F | CA | 07/02/2025 |
HPV9 MENB |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
y007197 99g34 |
Product storage error; Product storage error
Product storage error; Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
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| 2848195 | 11 | F | WI | 07/02/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y012921 9X7CD 9JT4S |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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Patient received a second dose of 11 year old vaccines (Tdap, Meningococcal, HPV). Previously receiv...
Patient received a second dose of 11 year old vaccines (Tdap, Meningococcal, HPV). Previously received these vaccines in February 2025.
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| 2848196 | 46 | M | TN | 07/02/2025 |
IPV TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
Y1D03P1 PD324 |
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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This nurse administered patient's second dose of polio vaccine too soon. Dose should have been ...
This nurse administered patient's second dose of polio vaccine too soon. Dose should have been administered on or after 6/27/25, this nurse administered on 6/5/25. Patient required no treatment or negative outcomes. Patient will need to have a total of 4 doses to be considered complete with series.
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| 2848197 | 14 | M | CA | 07/02/2025 |
HPV9 |
MERCK & CO. INC. |
y007197 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
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| 2848198 | 4 | M | CA | 07/02/2025 |
COVID19 COVID19 DTAPIPV DTAPIPV MMRV MMRV |
MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
3046979 3046979 4L454 4L454 Z003307 Z003307 |
Blood test normal, Computerised tomogram head normal, Electroencephalogram abnor...
Blood test normal, Computerised tomogram head normal, Electroencephalogram abnormal, Febrile convulsion, Intensive care; Magnetic resonance imaging head normal, Postictal state, Pyrexia, Urine analysis normal; Blood test normal, Computerised tomogram head normal, Electroencephalogram abnormal, Febrile convulsion, Intensive care; Magnetic resonance imaging head normal, Postictal state, Pyrexia, Urine analysis normal; Blood test normal, Computerised tomogram head normal, Electroencephalogram abnormal, Febrile convulsion, Intensive care; Magnetic resonance imaging head normal, Postictal state, Pyrexia, Urine analysis normal
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fever and then complex febrile seizure resulting in 911 call and to ER and then admission to pediatr...
fever and then complex febrile seizure resulting in 911 call and to ER and then admission to pediatric ICU
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| 2848199 | 4 | F | CA | 07/02/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
42y93 |
No adverse event, Product storage error
No adverse event, Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per authority directions.
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| 2848200 | 37 | F | ID | 07/02/2025 |
RAB RAB |
SANOFI PASTEUR SANOFI PASTEUR |
Y1B401M Y1B401M |
C-reactive protein normal, Full blood count normal, Lip swelling, Metabolic func...
C-reactive protein normal, Full blood count normal, Lip swelling, Metabolic function test normal, Red blood cell sedimentation rate normal; Swelling face, Urticaria
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On 23 Jun 25, the patient received 3rd Rabies vaccine (Imovax). On 25 Jun 25 at around 8 pm she deve...
On 23 Jun 25, the patient received 3rd Rabies vaccine (Imovax). On 25 Jun 25 at around 8 pm she developed hives on left arm and neck. Upon waking on 26 Jun 25 entire body was covered in hives. She was given Benadryl 50mg in the morning. Around 3:45 pm face and lips began to swell. She reported to the local Emergency Room for treatment. She received IV Benadryl, IV Pepcid and IV solumedrol in the ER. She then took Prednisone 60mg for 4 days along with Zyrtec at home.
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| 2848201 | 14 | F | PA | 07/02/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y013565 Y013565 |
Fall, Head injury, Loss of consciousness, Muscle contractions involuntary, Muscl...
Fall, Head injury, Loss of consciousness, Muscle contractions involuntary, Muscle rigidity; Syncope, Urinary incontinence
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RN administered vaccine to patient. Patient reported feeling fine and appeared well. Moments after l...
RN administered vaccine to patient. Patient reported feeling fine and appeared well. Moments after leaving the room patient fainted and fell from exam table, injuring her head. RN quickly returned to room to find patient was unconscious on the floor. Patient then became rigid, had muscle contractions, and urinary incontinence during the event. Vital signs were obtained, and patient was assessed by nursing and providers. Ice applied to head injury.
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| 2848202 | 17 | F | CA | 07/02/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
99g34 |
Product storage error
Product storage error
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Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during invent...
Vaccine experienced excursion temperature change of 29.2 degrees Fahrenheit for 30mins during inventory check, no symptoms reported, patient will be called back for revaccination per agency directions.
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| 2848203 | 37 | F | ID | 07/02/2025 |
RAB |
NOVARTIS VACCINES AND DIAGNOSTICS |
SDP00543 |
Urticaria
Urticaria
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On 30 Jun 25, she received the 4th vaccine (RabAvert) at 09:45 am. By 11:30 am hives developed on le...
On 30 Jun 25, she received the 4th vaccine (RabAvert) at 09:45 am. By 11:30 am hives developed on left arm, chest, neck and face. That morning she had already taken 60mg of Prednisone. She took an additional 30mg of prednisone along with Pepcid 20mg PO and Benadryl 25mg.
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| 2848204 | 81 | F | AZ | 07/02/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
3046732 3046732 03215 21A 03215 21A 017B22A 017B22A 032M20A 032M20A 030M20A 030M20A |
Blood pressure increased, Blood test normal, Computerised tomogram normal, Condi...
Blood pressure increased, Blood test normal, Computerised tomogram normal, Condition aggravated, Electrocardiogram normal; Headache, Pain, Pyrexia, Vertigo, Vomiting; Blood pressure increased, Blood test normal, Computerised tomogram normal, Condition aggravated, Electrocardiogram normal; Headache, Pain, Pyrexia, Vertigo, Vomiting; Blood pressure increased, Blood test normal, Computerised tomogram normal, Condition aggravated, Electrocardiogram normal; Headache, Pain, Pyrexia, Vertigo, Vomiting; Blood pressure increased, Blood test normal, Computerised tomogram normal, Condition aggravated, Electrocardiogram normal; Headache, Pain, Pyrexia, Vertigo, Vomiting; Blood pressure increased, Blood test normal, Computerised tomogram normal, Condition aggravated, Electrocardiogram normal; Headache, Pain, Pyrexia, Vertigo, Vomiting
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Fever 100, extreme body aches for 24 hrs, 1 week later vertigo, followed in less than a week with ra...
Fever 100, extreme body aches for 24 hrs, 1 week later vertigo, followed in less than a week with raise in BP, (which had been very stable for two years) and headache. BP med changed. A week later BP still unstable. Now June 30-appt made with primary for July 1. Daughter driving, vertigo worse. Had to stop on way- vomiting. Primary rerouted us to ER
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| 2848205 | 64 | F | FL | 07/02/2025 |
PNC20 |
PFIZER\WYETH |
LX4482 |
Extra dose administered, Fatigue
Extra dose administered, Fatigue
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Patient got Prevnar 20 on April 02, 2025. Then she was calling us and want pneumonia shot. We were...
Patient got Prevnar 20 on April 02, 2025. Then she was calling us and want pneumonia shot. We were so busy to check on database ...we gave her Prevnar again on June 29, 25. I called her on Monday and Tuesday June 30 and July 1. I talked to her about this . She said she ok ..on Monday she was so tired but Tuesday she is back to normal.
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| 2848206 | 1 | F | IN | 07/02/2025 |
HPV9 |
MERCK & CO. INC. |
Y007991 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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HPV vaccine was administered to a one year old patient. No adverse reactions to report. Only vacci...
HPV vaccine was administered to a one year old patient. No adverse reactions to report. Only vaccine error. Parents were notified by physician.
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| 2848207 | 43 | F | IL | 07/02/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
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Breath sounds abnormal, Computerised tomogram head, Computerised tomogram neck, ...
Breath sounds abnormal, Computerised tomogram head, Computerised tomogram neck, Fall, Foaming at mouth; Generalised tonic-clonic seizure, Tongue biting, Tremor
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Grand mal seizure that lasted about 5 minutes according to witnesses. Fell straight backwards, tremb...
Grand mal seizure that lasted about 5 minutes according to witnesses. Fell straight backwards, trembled, gurgled, foamed at mouth, bit tongue, bled, took to ED via ambulance CT scan of head and neck, saw neurologist
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| 2848208 | 79 | M | FL | 07/02/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
BG5J4 |
Extra dose administered
Extra dose administered
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Was notified by my corporate pharmacy that the patient has received this vaccine twice in error. On ...
Was notified by my corporate pharmacy that the patient has received this vaccine twice in error. On 07/01/2005 and 02/16/2024. Patient has been notified.
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| 2848209 | 35 | M | TN | 07/02/2025 |
VARCEL |
MERCK & CO. INC. |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Pt came in for vaccines for immigration, needed a Varicella vaccine. Nurse did not realize that he h...
Pt came in for vaccines for immigration, needed a Varicella vaccine. Nurse did not realize that he had a MMR (live vaccine) 2 days prior at other facility. Live vaccines are not allowed to be given within 28 days if not given together.
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| 2848210 | 75 | M | IA | 07/02/2025 |
COVID19 |
MODERNA |
3046731 |
Death
Death
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Resident passed away
Resident passed away
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| 2848211 | 3 | M | OK | 07/02/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
YC239 |
Injection site erythema, Injection site rash, Injection site swelling, Injection...
Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
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Returned to our clinic 2 days following vaccine with rash, redness, swelling and warmth at the injec...
Returned to our clinic 2 days following vaccine with rash, redness, swelling and warmth at the injection site.
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| 2848212 | 60 | F | TX | 07/02/2025 |
PNC21 |
MERCK & CO. INC. |
z004302 |
Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swell...
Dyspnoea, Injection site erythema, Injection site pruritus, Injection site swelling, Swelling face
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patient was weak and had difficulty breathing for a few days. then immunization site was red, swolle...
patient was weak and had difficulty breathing for a few days. then immunization site was red, swollen and very itchy. patient took Tylenol for a few days, is still using ice and hydrocortisone 5 days later. patient today had swelling on face near jawline, patient saw PCP today and was informed to take benadryl and ice. if swelling on face does not go down to followup with doctor in one week
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| 2848213 | 0.42 | F | OK | 07/02/2025 |
DTAPHEPBIP HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
9C295 UK198AA LN4928 2124039 |
Body temperature increased, Heart rate increased; Body temperature increased, He...
Body temperature increased, Heart rate increased; Body temperature increased, Heart rate increased; Body temperature increased, Heart rate increased; Body temperature increased, Heart rate increased
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Owlet pulse oximeter alerted parents of critical high heart rate. Patient was observed to have 15-20...
Owlet pulse oximeter alerted parents of critical high heart rate. Patient was observed to have 15-20 minutes of elevated heart rate 220-240BPM while at rest/asleep. Minimal temperature of 100.5 at the time. HR remained at about 165-170 for an additional 30 minutes before returning to her baseline of 130's. No symptoms of tachycardia since incident occured.
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| 2848214 | 76 | F | FL | 07/02/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3273H |
Injection site pain, Injection site rash, Rash papular
Injection site pain, Injection site rash, Rash papular
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Patient had a red rash at injection site that was raised. Stated that it was a burning pain sensatio...
Patient had a red rash at injection site that was raised. Stated that it was a burning pain sensation. Told patient to keep an eye on the reaction if it gets bigger are swells to go to the doctor. In the meantime she can take ibuprofen or Tylenol to help with pain
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| 2848215 | 33 | F | HI | 07/02/2025 |
DTAP DTAP |
SANOFI PASTEUR SANOFI PASTEUR |
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Blister, Discomfort, Exposure during pregnancy, Inflammation, Pruritus; Rash, Sk...
Blister, Discomfort, Exposure during pregnancy, Inflammation, Pruritus; Rash, Skin irritation
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On June 20, 2025 I took the DTap shot. I was 30 weeks pregnant then. Currently I?m 32 weeks pregnant...
On June 20, 2025 I took the DTap shot. I was 30 weeks pregnant then. Currently I?m 32 weeks pregnant. A day after taking the shot my right thigh was itchy. Never usually have any rashes thought it was odd figure it?d go away. A couple days later it was in my left thigh, running down both legs. My right arm was completely covered in these bumps. I had allergy medicine I had from early on in my pregnancy for congestion which I started taking Fexofenadine 180mg. No success w/that medicine. They were extremely uncomfortable, itchy, irritated, inflamed, I was afraid so I messaged my doctors on my app on my phone and sent photos attached. No one responded for days. I ALSO ATTACHED MY MATERNITY LEAVE DOCUMENTS at this time to a seperate department??no one responded?.I checked into the ER because I was so uncomfortable AND I?m pregnant. They didn?t run any blood work and just google searched what skin allergy pregnancy safe medication to send me home with?literally searched this in front of me. I went to hospital. This doctor also recorded our conversation which I was fine with, they sent me home with Cetirizine 10mg tabs 2x daily. A couple days later I had a phone call from a lady asking about my Maternaty leave documents. I asked her if anyone will be getting back to me regarding my skin reaction to the vaccine?.i got a PCP appointment right away finally, doc gave me Trimcinolone Acetonide and a weekly regimen steroid pill. W/o success again, I went back to the emergency room the rash spread behind my neck and started blistering on my cheeks (not puss blistering just welting blisters) the only place uncovered was my belly feet and hands at this point. They took blood work and said everything looks ok? I am still itchy and going through this. Still pregnant concerned though and etc
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| 2848216 | 75 | F | KY | 07/02/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5f5xk |
Pain in extremity
Pain in extremity
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Patient experienced pain in left arm beginning after the shot. The pain has not gone away since time...
Patient experienced pain in left arm beginning after the shot. The pain has not gone away since time of injection.
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| 2848218 | 11 | F | GA | 07/02/2025 |
MNQ |
SANOFI PASTEUR |
PMCU8375AA |
Nausea, Pallor, Tinnitus, Vision blurred, Vomiting
Nausea, Pallor, Tinnitus, Vision blurred, Vomiting
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Patient reported her ears were ringing, her vision was blurry, she was nauseous and vomited a small ...
Patient reported her ears were ringing, her vision was blurry, she was nauseous and vomited a small amount, she became pale in the face this happened about 2 minutes after the vaccine was given. A coke was provided, she declined peanut butter crackers. A fan was placed on patient, cold cloth on her neck and head. BP was taken twice, patient reported about 10 minutes after the vaccine she felt better. 4:15 blood pressure was 93/61 heart rate was 62, 4:19 blood pressure 96/73 heart rate 58. Patients color returned to her face and she was able to ambulate out of clinic with mom on her own.
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| 2848219 | 56 | F | TX | 07/02/2025 |
PNC20 |
PFIZER\WYETH |
LJ5280 |
Erythema, Skin warm
Erythema, Skin warm
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PATIENT SAID HER ARM IS RED AND WARM TO THE TOUCH
PATIENT SAID HER ARM IS RED AND WARM TO THE TOUCH
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| 2848220 | 10 | F | UT | 07/02/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
Y015599 Y015599 |
Abdominal pain, Erythema, Influenza virus test negative, Peripheral swelling, Re...
Abdominal pain, Erythema, Influenza virus test negative, Peripheral swelling, Respiratory syncytial virus test negative; SARS-CoV-2 test negative, Streptococcus test negative, Urine analysis normal
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Patient developed severe abdominal pain that started 3 days after vaccine that has not improved. Sh...
Patient developed severe abdominal pain that started 3 days after vaccine that has not improved. She also had redness and swelling of her arm that resolved after 1 week.
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