| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2866915 | 78 | F | WA | 10/19/2025 |
FLU3 |
SANOFI PASTEUR |
UT8820BA |
Injection site rash
Injection site rash
|
Pt reported rash spreading down the arm from injection site which was resolving after a few days.
Pt reported rash spreading down the arm from injection site which was resolving after a few days.
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| 1407965 | 15 | M | NY | 10/18/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8736 ER8736 EW0177 EW0177 ER 8736 |
Blood test, Cardiac stress test, Chest pain, Echocardiogram, Electrocardiogram a...
Blood test, Cardiac stress test, Chest pain, Echocardiogram, Electrocardiogram ambulatory; Headache, Magnetic resonance imaging heart, Pyrexia, Troponin increased; Blood test, Cardiac stress test, Chest pain, Echocardiogram, Electrocardiogram ambulatory; Headache, Magnetic resonance imaging heart, Pyrexia, Troponin increased; Myocarditis, Troponin increased
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On 6/8/21, three days after the second dose of Pfizer Covid-19 vaccine, patient experienced severe h...
On 6/8/21, three days after the second dose of Pfizer Covid-19 vaccine, patient experienced severe headache, fever, and intermittent chest pain. An appointment was scheduled for the following day, 6/9/21, with his pediatrician. Patient was referred to pediatric cardiologist, and seen the next day, on 6/10/21. Immediate bloodwork was ordered by the cardiologist, resulting in elevated Troponin and possibly other abnormalities. Patient was admitted to hospital. He was under the care of pediatric cardiologist. Patient was monitored with repeat blood work, cardiac testing, cardiac echo, cardiac sonogram, and restricted physical activity. Patient was discharged from the hospital on 6/13/25
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โ | โ | ||||
| 2866734 | M | NY | 10/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
2A3HY |
Product preparation error
Product preparation error
|
pharmacy intern failed to swab / cleanse the stopper of the adjuvant component to Shingrix and adjuv...
pharmacy intern failed to swab / cleanse the stopper of the adjuvant component to Shingrix and adjuvant was not administered; pharmacy intern failed to swab / cleanse the stopper of the adjuvant component to Shingrix and adjuvant was not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 2A3HY, expiry date 26-APR-2027) and (batch number 2XB45, expiry date 26-APR-2027) for prophylaxis. On 30-SEP-2025, the patient received Shingrix. On 30-SEP-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: pharmacy intern failed to swab / cleanse the stopper of the adjuvant component to Shingrix and adjuvant was not administered) and inappropriate dose of vaccine administered (Verbatim: pharmacy intern failed to swab / cleanse the stopper of the adjuvant component to Shingrix and adjuvant was not administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date 01-OCT-2025 A pharmacist reported that on 30th September 2025, a pharmacy intern failed to properly swab or cleanse the stopper of the adjuvant component of Shingrix, resulting in an inappropriate reconstitution technique. The adjuvant was not used to administer the vaccine to a patient. The lot number of the adjuvant was 2XB45, with an expiration date of 26 April 2027. The lot number of the antigen was 2A3HY.
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| 2866735 | 70 | F | AZ | 10/18/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Injection site discomfort, Injection site erythema, Injection site pain, Injecti...
Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Pain; Pain in extremity
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injection site was raised, red, uncomfortable, and sore; injection site was raised, red, uncomfortab...
injection site was raised, red, uncomfortable, and sore; injection site was raised, red, uncomfortable, and sore; injection site was raised, red, uncomfortable, and sore; injection site was raised, red, uncomfortable, and sore; left arm ached and was painful to lift or move for a week; left arm ached and was painful to lift or move for a week; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included iodine allergy. Concomitant products included metformin hydrochloride (Metformin), hydrochlorothiazide, lisinopril dihydrate (Lisinopril) and atorvastatin calcium propylene glycol solvate (Atorvastatin). On 16-APR-2025, the patient received Shingrix (intramuscular, left arm). On 16-APR-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: left arm ached and was painful to lift or move for a week) and mobility decreased (Verbatim: left arm ached and was painful to lift or move for a week). On an unknown date, the patient experienced injection site swelling (Verbatim: injection site was raised, red, uncomfortable, and sore), injection site erythema (Verbatim: injection site was raised, red, uncomfortable, and sore), injection site discomfort (Verbatim: injection site was raised, red, uncomfortable, and sore) and injection site pain (Verbatim: injection site was raised, red, uncomfortable, and sore). The outcome of the injection site swelling, injection site erythema, injection site discomfort, injection site pain, pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site discomfort, injection site pain, pain in arm and mobility decreased to be related to Shingrix. It was unknown if the company considered the injection site swelling, injection site erythema, injection site discomfort, injection site pain, pain in arm and mobility decreased to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR127373 Additional Information: GSK Receipt Date: 02-OCT-2025 The reporter/patient is a female that received her first dose of Shingrix and experienced that her left arm ached and was painful to lift or move for a week. This started the same day as receiving the vaccine on 16 APR 2025. The patient reported that the injection site was raised, red, uncomfortable, and sore but did not prevent her from doing anything. The patient stated she was allergic to Povidone (pre-existing Shingrix) and her first reaction to Povidone was in her early 20 years of age.; Sender's Comments: US-GSK-US2025AMR127373:Same patient/Dose 2
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| 2866736 | 10/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site pain, Injection site warmth, Malaise
Injection site pain, Injection site warmth, Malaise
|
Injection site hot; injection site pain; sick first fay; This non-serious case was reported by a con...
Injection site hot; injection site pain; sick first fay; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site warmth (Verbatim: Injection site hot), injection site pain (Verbatim: injection site pain) and sickness (Verbatim: sick first fay). The outcome of the injection site warmth, injection site pain and sickness were not reported. It was unknown if the reporter considered the injection site warmth, injection site pain and sickness to be related to Shingrix. It was unknown if the company considered the injection site warmth, injection site pain and sickness to be related to Shingrix. Additional Information: GSK receipt date: 06-OCT-2025 This case was reported by a patient via interactive digital media. The batch number was not provided, and we are unable to contact the reporter.
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| 2866737 | 10/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
received 1st dose 4 years ago; This non-serious case was reported by a consumer via interactive digi...
received 1st dose 4 years ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 4 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received 1st dose 4 years ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 03-OCT-2025 This case was reported by a patient via interactive digital media. The batch number was not provided, and we are unable to contact the reporter.
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| 2866738 | F | 10/18/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Inappropriate schedule of product administration, Vaccination site erythema, Vac...
Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site pruritus
More
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mild Itching and redness at the covtd shot Injection site; mild Itching and redness at the covtd sho...
mild Itching and redness at the covtd shot Injection site; mild Itching and redness at the covtd shot Injection site; being about 2 days late and about 2 days early for several doses over the summer with no adverse event; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-021146 (BioNTech SE), 2025SA138951 (SANOFI). Initial information received on 08May2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 74 years old female patient who reported about 2 days before every injection her itching and bumpy skin starts to return and mild itching and redness at the covid shot injection site while being treated with DUPILUMAB (DUPIXENT) via pre-filled syringe and COVID-19 vaccine, being about 2 days late and about 2 days early for several doses over the summer with no adverse event directly linked to inappropriate schedule of product administration. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In Apr2025, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 600 mg 1X followed by 300 mg QOW since 2025 (strength: 300mg/2ml) subcutaneous for atopic dermatitis via pre filled syringe. On an unknown date, the patient started taking COVID-19 vaccine (with unknown vaccine, strength, frequency, route and indication). In 2025 the patient developed a non-serious event: "about 2 days before every injection her itching and bumpy skin starts to return" (pruritus) (skin swelling) (therapeutic response shortened) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB.In 2025 the patient developed a non-serious event: "mild itching and redness at the covid shot injection site" (injection site pruritus) (injection site erythema) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 vaccine. In 2025 the patient developed a non-serious event "being about 2 days late and about 2 days early for several doses over the summer with no adverse event" (Inappropriate schedule of product administration) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and COVID-19 vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "about 2 days before every injection her itching and bumpy skin starts to return (last occurrence started 06May2025, dose taken 08May2025, unknown if still ongoing; dates and duration of other occurrences unknown). Reports of pruritus (moderate) mild acne. No injection site reactions reported. Patient reports mild itching and redness at the covid shot injection site (date, onset from dose, and duration unknown). Reports similar reactions with previous covid vaccines (unknown timing and duration of therapy). Also reports being about 2 days late and about 2 days early for several doses over the summer (dates unknown) due to travel, unknown if still ongoing. No issues reported from occasional early or late dosing." Action taken with DUPILUMAB (DUPIXENT) was continued for pruritus, skin swelling; unknown for rest of the events. Action taken with COVID-19 vaccine (COVID-19 vaccine) was not applicable for pruritus, skin swelling; unknown for rest of the events. It was not reported if the patient received a corrective treatment for the events (pruritus) (skin swelling, injection site pruritus, injection site erythema). At time of reporting, the outcome was Unknown for the event pruritus, skin swelling. This suspected adverse reaction report is submitted and classified as a medically confirmed case solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification and its wording is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to blame for the occurrence of this transaction error. Additional information was received on 22Sep2025 from patient: Event injection site pruritus, injection site erythema, inappropriate schedule of product administration and co suspect was added; Text amended accordingly.
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| 2866759 | 28 | M | CA | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
U8847CA |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
No known adverse effects reported.
No known adverse effects reported.
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| 2866760 | 64 | M | CA | 10/18/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Chills, Fatigue, Gait inability, Injection site pain, Malaise; Myalgia, Nausea, ...
Chills, Fatigue, Gait inability, Injection site pain, Malaise; Myalgia, Nausea, Pain, Pain in extremity
More
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Approximately 16 hours after the injection along with symptoms of chills, muscle and body aches, nau...
Approximately 16 hours after the injection along with symptoms of chills, muscle and body aches, nausea, injections site pain, malaise and fatigue, I woke up the same morning with moderate hip pain that developed into more intense hip pain with periodic debilitating almost severe (9) pain particularly in my right hip, but with both hips chronically painful. When severe pain onsets periodically, I am unable to walk. If this pain continues the next 24 hours I plan to seek urgent care. I have reported the condition to my doctor via a medical patient record portal.
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| 2866762 | 32 | F | CA | 10/18/2025 |
RSV |
PFIZER\WYETH |
|
Diarrhoea, Headache, Musculoskeletal stiffness, Oropharyngeal pain
Diarrhoea, Headache, Musculoskeletal stiffness, Oropharyngeal pain
|
Headache, neck stiffness, diarrhea, sore throat. G2P1, EDD 12/5/25
Headache, neck stiffness, diarrhea, sore throat. G2P1, EDD 12/5/25
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| 2866763 | 48 | F | PA | 10/18/2025 |
FLUN3 FLUN3 |
MEDIMMUNE VACCINES, INC. MEDIMMUNE VACCINES, INC. |
|
Asthenia, Fatigue, Headache, Lethargy, Oropharyngeal pain; Respiratory tract con...
Asthenia, Fatigue, Headache, Lethargy, Oropharyngeal pain; Respiratory tract congestion
More
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Lethargic, tired/weak, sore throat, congestion, headache
Lethargic, tired/weak, sore throat, congestion, headache
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| 2866768 | 4 | M | FL | 10/18/2025 |
MMR MMR UNK UNK UNK UNK VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. |
|
Blood test normal, Gait disturbance, Injection site movement impairment, Injecti...
Blood test normal, Gait disturbance, Injection site movement impairment, Injection site pain, Joint effusion; Pain in extremity, Pyrexia, Synovitis, Ultrasound joint abnormal, X-ray normal; Blood test normal, Gait disturbance, Injection site movement impairment, Injection site pain, Joint effusion; Pain in extremity, Pyrexia, Synovitis, Ultrasound joint abnormal, X-ray normal; Blood test normal, Gait disturbance, Injection site movement impairment, Injection site pain, Joint effusion; Pain in extremity, Pyrexia, Synovitis, Ultrasound joint abnormal, X-ray normal; Blood test normal, Gait disturbance, Injection site movement impairment, Injection site pain, Joint effusion; Pain in extremity, Pyrexia, Synovitis, Ultrasound joint abnormal, X-ray normal
More
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The same day of the shot my sons arm was extremely sore and he didn't want to move it at all. T...
The same day of the shot my sons arm was extremely sore and he didn't want to move it at all. The next morning at 7:30 a.m. when he woke up he said his leg hurt him and pointed to his hip, he told me he didn't want to walk and asked me to carry him out of bed. He had a low-grade fever and I gave him Mortin. later that day he seemed to get a little bit better and was walking around. The next morning, he told me he could not walk and needed me to carry him. This time I could see a visible difference in his face, and I could tell he was feeling a lot of pain. He did not want to walk and sat in a chair for over an hour. I called the nurses line ( it was a Sunday so I could not speak to the pediatrician) they advised me to take him to ER since the shots were in his arm and not in his leg. When we got to ER he tries walking and was walking with a visible limp and walked very slow.
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| 2866769 | 83 | M | PA | 10/18/2025 |
COVID19 |
MODERNA |
8146545 |
Balance disorder, Diplopia
Balance disorder, Diplopia
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24 hours after the vaccine was given, double vision and balance issues. As of 10/18/25 - it still h...
24 hours after the vaccine was given, double vision and balance issues. As of 10/18/25 - it still has not resolved
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| 2866770 | 67 | M | OH | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
49281-0125-65 |
Ear pain, Headache, Lacrimation increased, Vision blurred
Ear pain, Headache, Lacrimation increased, Vision blurred
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Severe eye pain. Excessive eye watering. Blurred vision, headache
Severe eye pain. Excessive eye watering. Blurred vision, headache
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| 2866772 | 70 | F | PA | 10/18/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
8146367 407259 |
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity; Mobility decreased, Pain in extremity
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Patient reported she is 2 weeks out from vaccination and is still experiencing severe arm pain and c...
Patient reported she is 2 weeks out from vaccination and is still experiencing severe arm pain and cannot lift her arm.
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| 2866773 | 26 | F | GA | 10/18/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Dizziness, Fatigue, Gait disturbance, Mental status changes
Dizziness, Fatigue, Gait disturbance, Mental status changes
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given Boostrix 8/19 and returned to ER 8/31 w/ AMS, gait problem, dizziness, and fatigues
given Boostrix 8/19 and returned to ER 8/31 w/ AMS, gait problem, dizziness, and fatigues
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โ | |||||
| 2866774 | 79 | F | OH | 10/18/2025 |
COVID19 |
MODERNA |
3052669 |
Arthralgia, Joint swelling
Arthralgia, Joint swelling
|
Customer called pharmacy to inform staff that she had an adverse reaction to covid vaccine administe...
Customer called pharmacy to inform staff that she had an adverse reaction to covid vaccine administered 9/24/25. Was informed that she had no adverse reaction to previous 6 covid vaccine immunizations. Adverse reaction was swollen shoulder with pain and she went to ER where she was prescribed oxycodone
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| 2866775 | 54 | F | MA | 10/18/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
58160-0823-11 58160-0823-11 |
Fatigue, Headache, Injection site pain, Myalgia, Nausea; Pyrexia
Fatigue, Headache, Injection site pain, Myalgia, Nausea; Pyrexia
|
Starting the following morning (10/15), I started experiencing a fever of just over 101, extensive ...
Starting the following morning (10/15), I started experiencing a fever of just over 101, extensive arm pain at the site of the injection including the top half of that arm, headache, muscle pains and fatigue. We checked with the pharmacy who said these reactions were normal, but that if they worsened to go to Urgent Care/ER. 10/16, I was still feverish with all the symptoms but they started to lessen throughout the day. By the end of the day my fever was down to 100. The following day 10/17, I was fever free but nauseous and had a headache all day. The site of the injection hurts less, but the point of the injection has become swollen and itchy- it is about the size of a baseball. I've been itchy all day but no rash. By the day's end I had hives on the back of my neck and upper back. Called the pharmacist again who said that although hives are not a common reaction, I did not need to go to the ER/Emergency Room unless I experienced difficulty breathing. They suggested Benadryl which did help resolve the hives. 10/18 Headache is still present but less. Left armis still painful, injection site is still swollen and itchy. Hives are present on my stomach. Called Pharmacy again who said I could take Benadryl a couple times a day and if not getting better by Monday, should consult with my doctor and that I may want to talk to them about what to do regarding the second injection.
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| 2866776 | 13 | M | WI | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
U8881DA |
Extra dose administered
Extra dose administered
|
PATIENT WAS VACCINATED AT MASS FLU CLINIC ON 10/18/2025. PARENT SIGNED UP PATIENT. ONCE FACILITY W...
PATIENT WAS VACCINATED AT MASS FLU CLINIC ON 10/18/2025. PARENT SIGNED UP PATIENT. ONCE FACILITY WENT TO ENTER VACCINE INTO IMMUNIZATION REGISTERY FOUND THAT CHILD WAS ALREADY VACCINATED WITH FLU VACCINE ON 09/09/2025. PARENT WAS MADE AWARE CHILD RECEIVED TWO DOSES THIS SEASON VIA PHONE CALL FROM NURSE. MOTHER REPORTS FATHER TOOK CHILD TO ANNUAL VISIT ON 09/09/2025 AND DID NOT MENTION CHILD ALREADY RECEIVED FLU VACCINE THERE.
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| 2866777 | 60 | F | WI | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
U8832BA |
Injection site pain, Mobility decreased, Neck pain, Pain
Injection site pain, Mobility decreased, Neck pain, Pain
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The patient felt a stabbing pain as soon as the vaccine was administered. As the evening progressed...
The patient felt a stabbing pain as soon as the vaccine was administered. As the evening progressed, the pain got worse. She was not able to move her arm above her head for 5 days and was still in pain at the time of reporting . She describes the pain as a constant stabbing pain in the upper arm at the site of injection radiating to her neck. She will be visiting her doctor for further care.
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| 2866778 | 3 | F | MA | 10/18/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9548 |
Incorrect dose administered
Incorrect dose administered
|
The patient was erroneously immunized with Comirnaty (12+) 0.3ml vaccine
The patient was erroneously immunized with Comirnaty (12+) 0.3ml vaccine
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| 2866779 | 9 | F | MA | 10/18/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9548 |
Incorrect dose administered
Incorrect dose administered
|
The patient was erroneously immunized with Comirnaty (12+) 0.3ml vaccine
The patient was erroneously immunized with Comirnaty (12+) 0.3ml vaccine
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| 2866780 | 77 | M | TN | 10/18/2025 |
FLU3 |
SEQIRUS, INC. |
407268 |
Erythema, Pain
Erythema, Pain
|
redness and painful
redness and painful
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| 2866781 | 65 | F | IN | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
NA4452 |
Chills, Pain, Pyrexia
Chills, Pain, Pyrexia
|
7:35 am got shot. 10:30 am arm getting sore. 3:30 chills start with worsening fever
7:35 am got shot. 10:30 am arm getting sore. 3:30 chills start with worsening fever
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| 2866782 | 80 | F | MN | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
U8862EA |
Rash
Rash
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Patient called us stating that she has a rash on her upper body... no throat swelling or anaphylacti...
Patient called us stating that she has a rash on her upper body... no throat swelling or anaphylactic symptoms but just has a rash. She has not previously had this with prior years vaccinations.
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| 2866783 | 3 | F | TX | 10/18/2025 |
DTAPHEPBIP DTAPHEPBIP FLU3 FLU3 HEPA HEPA PNC20 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH |
K25M3 K25M3 UT8826JA UT8826JA 3255P 3255P LX2498 LX2498 |
Contusion, Injection site erythema, Injection site induration, Injection site pa...
Contusion, Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles; Injection site warmth, Pyrexia; Contusion, Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles; Injection site warmth, Pyrexia; Contusion, Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles; Injection site warmth, Pyrexia; Contusion, Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles; Injection site warmth, Pyrexia
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Per mom patient had fever to 100.5F the day following the vaccines and noticed the redness and bruis...
Per mom patient had fever to 100.5F the day following the vaccines and noticed the redness and bruising with left being worse than the right. On he 2nd day post-vaccines noticed left leg was worse and she was scratching the site so decided to make an appointment. Saw her in office on 10/17 with my assessment being: "Left lateral upper leg with localized erythema and mild tenderness upon palpation. Right upper leg with diffuse erythema and tenderness upon palpation with mild induration and warmth near injection site. Injection site with few vesicles. Injection site noted to be more to medial part of leg in subcutaneous tissue. Ecchymosis and warmth localized. Patient moving legs and kicking throughout the exam. No fever in office."
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| 2866784 | 77 | F | OK | 10/18/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EM9009 |
Death, Dyspnoea, Headache; Death, Dyspnoea, Headache
Death, Dyspnoea, Headache; Death, Dyspnoea, Headache
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Headache, shortness of breath, death.
Headache, shortness of breath, death.
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โ | |||||
| 2866785 | 72 | F | NY | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
u8855da |
Injection site erythema, Injection site pain, Injection site warmth
Injection site erythema, Injection site pain, Injection site warmth
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patient experience redness pain and warmth several inches below the injection site on her arm. start...
patient experience redness pain and warmth several inches below the injection site on her arm. started next morning and she took only acetaminophen as of the time of reporting.
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| 2866787 | OH | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
u8823ba |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Flublok was given to the patient. Flublok is intended for patients over the age of 9. This patient...
Flublok was given to the patient. Flublok is intended for patients over the age of 9. This patient is 6.
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| 2866788 | 7 | F | MO | 10/18/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0590 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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NO ADVERSE REACTION REPORTED PER MOM AFTER THE IMMUNIZING PHARMACIST ADMINISTERED ADULT PFIZER COVID...
NO ADVERSE REACTION REPORTED PER MOM AFTER THE IMMUNIZING PHARMACIST ADMINISTERED ADULT PFIZER COVID VACCINE TO PEDIATRIC PATIENT. PHARMACIST CONTACTED MOM AND ADVISED HER TO MONITOR FOR ANY UNUSUAL SIGNS/SYMPTOMS
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| 2866789 | 8 | M | OH | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
u8823ba |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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The patient was given flublok vaccine. Flublok is intended for children over the age of 9. The pat...
The patient was given flublok vaccine. Flublok is intended for children over the age of 9. The patient is 8.
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| 2866790 | 45 | F | OR | 10/18/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Urticaria; Urticaria
Urticaria; Urticaria
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Hives. Started out as just a couple spots, but by 2 weeks hives were covering most of my low back/l...
Hives. Started out as just a couple spots, but by 2 weeks hives were covering most of my low back/lower abdomen, under my breasts, my lower arms and behind my knees.
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| 2866791 | 47 | F | CA | 10/18/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER2613 ER2613 ER2613 ER2613 |
Angiogram cerebral abnormal, Anxiety, Anxiety disorder, Asthma exercise induced,...
Angiogram cerebral abnormal, Anxiety, Anxiety disorder, Asthma exercise induced, Blood glucose decreased; Blood glucose increased, Cerebrovascular accident, Computerised tomogram head, Diabetes mellitus, Dyspnoea; Fear, Impaired driving ability, Intensive care, Loss of consciousness, Postprandial hypoglycaemia; Postural orthostatic tachycardia syndrome, Syncope, Transient ischaemic attack, Troponin increased
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within 10-12 days of 2nd shot , was in a spin class at my gym -suddenly couldn't breathe while ...
within 10-12 days of 2nd shot , was in a spin class at my gym -suddenly couldn't breathe while driving home -went to urgent care and had to go to Er due to High troponin. Since have been to the ER numerous times more . urgent care almost monthly . Developed diabetes , and to go to the ER had a blood sugar of 350 . POTS - lost consciousness , had to take ambulance to E R, Mini stroke , had to go to E R and stay in ICU for a night (given TPA. The List goes on - Asthma attacks when exercising , debilitating anxiety disorder . Can't drive . went to clinic for long haul and vaccine injury -tried biofeedback (to no avail)see my cardio who helps me with the PoTs - have tried many meds -clonodine ,fludrocortisone, have been prescribed Ativan for the anxiety attacks-i take metformin and wear a CGMfor my blood sugars. have real lows at night -in the low 50's . I do therapy now to work on my fear of driving and passing out , because I faint often . for asthma , I use an inhaler. For psoriasis , I take otezla . For anxiety , I take trintellix and buspar. for mini strokes , I take aspirin daily . I also have MTHfR homozygous , so I have to be careful with that
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| 2866792 | 31 | F | TX | 10/18/2025 |
TDAP |
SANOFI PASTEUR |
U8620BA |
Arthralgia, Exposure during pregnancy, Mobility decreased, Rotator cuff syndrome...
Arthralgia, Exposure during pregnancy, Mobility decreased, Rotator cuff syndrome, Shoulder injury related to vaccine administration
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SIRVA/Tendonitis - seen in ER on 10/10 and visit orthopedics 10/16 - unable to move arm unassisted -...
SIRVA/Tendonitis - seen in ER on 10/10 and visit orthopedics 10/16 - unable to move arm unassisted - joint pain
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| 2866793 | 70 | M | AZ | 10/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55KB9 |
Rash
Rash
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patient states he developed a rash a week or 2 after the immunization was administered. He was seen...
patient states he developed a rash a week or 2 after the immunization was administered. He was seen by a dermatologists on 9/30/25 and the prescriber sent prescriptions in for Permethrin with dx code B86-Scabies and for Clobetasol. Patient states dermotologist did not know what the rash was. He also states he has a follow up appointment with same dermatologist, on 10/22/25. Rash is still present.
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| 2866794 | 5 | F | MO | 10/18/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0590 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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NO ADVERSE REACTIONS REPORTED AFTER (NAME WITHHELD) ( IMMUNIZING PHARMACIST ) CONTACTED PATIENT'...
NO ADVERSE REACTIONS REPORTED AFTER (NAME WITHHELD) ( IMMUNIZING PHARMACIST ) CONTACTED PATIENT'S MOTHER EXPLAINING THAT ADULT PFIZER COVID VACCINE WAS ADMINISTERED TO CHILD. MOM WAS INSTRUCTED TO MONITOR FOR ANY UNUSUAL SIGNS/SYMPTOMS AND TO LET US KNOW.
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| 2866795 | 16 | F | IL | 10/18/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2CA5M |
Blood glucose, Hypertension, Loss of consciousness
Blood glucose, Hypertension, Loss of consciousness
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Pharmacy technician administered fluarix in left deltoid. Patient passed out and slid on the chair a...
Pharmacy technician administered fluarix in left deltoid. Patient passed out and slid on the chair and regained consciousness right away. No injuries occurred and 911 was called by the parents. Patient declined hospitalization and went home with her parents.
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| 2866796 | 85 | F | SC | 10/18/2025 |
PNC21 |
MERCK & CO. INC. |
Z010762 |
Injection site erythema, Injection site warmth
Injection site erythema, Injection site warmth
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Area around the injection site is red and warm to touch.
Area around the injection site is red and warm to touch.
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| 2866797 | 82 | F | UT | 10/18/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Lymph node pain, Lymphadenitis; Lymph node pain, Lymphadenitis
Lymph node pain, Lymphadenitis; Lymph node pain, Lymphadenitis
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PT REPORTS RIGHT LYMPH NODES IN HER NECK FEELING TENDER AND INFLAMED. SHE REPORTS THAT LAST NIGHT T...
PT REPORTS RIGHT LYMPH NODES IN HER NECK FEELING TENDER AND INFLAMED. SHE REPORTS THAT LAST NIGHT THERE WAS ALMOST NO SYMPTOMS BUT THIS MORNING THE TENDERNESS WAS THERE AGAIN.
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| 2866798 | 82 | F | IN | 10/18/2025 |
FLU3 RSV |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8837AA 7HZ93 |
Pruritus; Pruritus
Pruritus; Pruritus
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Patient reported severe skin itching across entire body that started a few days after vaccination
Patient reported severe skin itching across entire body that started a few days after vaccination
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| 2866799 | 68 | F | NM | 10/18/2025 |
COVID19 |
MODERNA |
3052034 |
No adverse event, Vaccination error
No adverse event, Vaccination error
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No adverse events as of yet patient did recieve vaccine in error.
No adverse events as of yet patient did recieve vaccine in error.
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| 2866800 | 86 | M | FL | 10/18/2025 |
FLU3 PNC20 |
SEQIRUS, INC. PFIZER\WYETH |
407272 L65579 |
Asthenia, Chills, Immunosuppression, Pyrexia, Tremor; Asthenia, Chills, Immunosu...
Asthenia, Chills, Immunosuppression, Pyrexia, Tremor; Asthenia, Chills, Immunosuppression, Pyrexia, Tremor
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Extreme chills, fever, extreme shaking with chills, weakness
Extreme chills, fever, extreme shaking with chills, weakness
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| 2866801 | 82 | F | AZ | 10/18/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9548 |
Dizziness, Fall, Feeling cold, Tremor
Dizziness, Fall, Feeling cold, Tremor
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Pt came in today 10/18 to report an adverse rection to the COVID shot she received on 10//25. She sa...
Pt came in today 10/18 to report an adverse rection to the COVID shot she received on 10//25. She said the next day she became cold, was shaking all over, arms and legs flailing around, she flailed off the couch and off the bed, and was dizzy, and it lasted for 3 days. She called her doctor and he said that it was because people are getting too many COVID shots and told her not to get any more.
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| 2866802 | 56 | F | TX | 10/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Pain in extremity, Rash, Rash erythematous, Urticaria
Arthralgia, Pain in extremity, Rash, Rash erythematous, Urticaria
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The 1st day after shingles vaccine-slight rash of small red dots on right arm; arm and shoulder sore...
The 1st day after shingles vaccine-slight rash of small red dots on right arm; arm and shoulder soreness. The 2nd day, rash spread about 3 inches across and 4-5 inches long as one solid pink hive in appearance, significant right arm and shoulder pain. I called my doctor and was prescribed a prednisone pill, but was permitted to try Benadryl by mouth first. I also consulted a pharmacist who said the prednisone will make the vaccine less effective, so I passed on the prednisone. By the 4th day after the vaccine, the rash seemed to lessen, although the itchiness and discomfort seemed to come and go throughout the day. On the morning of the 7th day after the vaccine, the rash/hives returned. I called my doctor again and asked for an appointment, although they said they couldn't see me until 5 days later (12th day after vaccine). I consulted another pharmacist who apologized for the reaction, informed me that 1/16 people have this reaction, and that the rash tends to come and go. Today is the 10th day after the vaccine and the arm appears not to be red, although where the rash was seems darker, discolored, and it is still itchy. The arm and shoulder soreness are still present.
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| 2866803 | 67 | M | OH | 10/18/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052133 409166 |
Pulmonary embolism; Pulmonary embolism
Pulmonary embolism; Pulmonary embolism
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PATIENTS WIFE REPORTED THAT ON 10/10/2025 THE PATIENT WAS ADMITTED TO THE ER WITH PULMONARY EMBOLISM...
PATIENTS WIFE REPORTED THAT ON 10/10/2025 THE PATIENT WAS ADMITTED TO THE ER WITH PULMONARY EMBOLISMS IN BOTH LUNGS
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| 2866804 | 14 | M | MI | 10/18/2025 |
COVID19 |
MODERNA |
3053669 |
Pain, Pain in extremity, Paraesthesia
Pain, Pain in extremity, Paraesthesia
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Patient stated pain, tingling, sharp pain running down from shoulder to hand.
Patient stated pain, tingling, sharp pain running down from shoulder to hand.
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| 2866805 | 83 | F | WA | 10/18/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794CA |
Erythema, Peripheral swelling, Skin warm
Erythema, Peripheral swelling, Skin warm
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swelling, redness and warmth down arm. Still having some effects 3 days later. Has had HD shot mul...
swelling, redness and warmth down arm. Still having some effects 3 days later. Has had HD shot multiple years prior
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| 2866806 | 60 | F | MI | 10/18/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3053669 407265 |
Incorrect dose administered; Incorrect dose administered
Incorrect dose administered; Incorrect dose administered
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Influenza vaccine intended for patients 65 years and older was given in error to a patient aged less...
Influenza vaccine intended for patients 65 years and older was given in error to a patient aged less than 65.
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| 2866807 | 63 | F | FL | 10/18/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
TFAA2502 7523J |
Burning sensation, Guillain-Barre syndrome, Paraesthesia; Burning sensation, Gui...
Burning sensation, Guillain-Barre syndrome, Paraesthesia; Burning sensation, Guillain-Barre syndrome, Paraesthesia
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PT REPORTED TODAY THAT SHE GOT SEVERE TINGLING AND BURNING 2-3 DAYS AFTER GETTING THE SHOTS ON AUGUS...
PT REPORTED TODAY THAT SHE GOT SEVERE TINGLING AND BURNING 2-3 DAYS AFTER GETTING THE SHOTS ON AUGUST ,4TH, 2025 --- AS PER THE PATIENT SHE WAS REPORTED TO EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH GUILLAIN BARRE SYNDROME WITH ER DOCTOR
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| 2866808 | 85 | M | FL | 10/18/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0590 |
Pyrexia, Tremor
Pyrexia, Tremor
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PATIENT COMPLAINS OF FEVER 102 AND SHAKES FOR MORE THAN 1 DAY
PATIENT COMPLAINS OF FEVER 102 AND SHAKES FOR MORE THAN 1 DAY
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