| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2844358 | 72 | F | TN | 06/09/2025 |
COVID19 |
MODERNA |
3043153 |
Headache
Headache
|
Systemic: Headache-Severe, Additional Details: Patient says she has a prior history of headaches fro...
Systemic: Headache-Severe, Additional Details: Patient says she has a prior history of headaches from a couple of years ago, but the headaches have gotten worse. Patient is unsure if the COVID vaccine is the cause, but says it is getting worse.
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| 2844359 | 75 | F | TX | 06/09/2025 |
COVID19 |
MODERNA |
3043366 |
Dyspnoea
Dyspnoea
|
Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Patient says she had COVID in 2...
Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Patient says she had COVID in 2020 and continues to experience breathing issues and has remained on oxygen 24/7.
More
|
โ | |||||
| 2844360 | 73 | M | CA | 06/09/2025 |
COVID19 |
MODERNA |
7654321 |
Arthralgia, Malaise, Vomiting
Arthralgia, Malaise, Vomiting
|
Site: Pain at Injection Site-Mild, Systemic: Vomiting-Medium, Additional Details: The vomiting laste...
Site: Pain at Injection Site-Mild, Systemic: Vomiting-Medium, Additional Details: The vomiting lasted the same day that the vaccine was administered, however, the patient stated that he didn't feel well for at least a week following the injection.
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| 2844361 | 74 | F | FL | 06/09/2025 |
COVID19 |
MODERNA |
3046731 |
Headache, Injection site erythema, Injection site pain
Headache, Injection site erythema, Injection site pain
|
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Systemic: Headache-Medi...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Systemic: Headache-Medium
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| 2844362 | 18 | F | TX | 06/09/2025 |
MNQ |
SANOFI PASTEUR |
U8256AB |
Head injury, Hypotension, Syncope, Unresponsive to stimuli
Head injury, Hypotension, Syncope, Unresponsive to stimuli
|
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient ...
Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient accompanied to MC by Mom to get a Meningococcal vaccine required for college admission. After patient received vaccine while sitting in bed, noted to have a Syncopal episode. She hit her head on the wall while leaned backwards with eyes closed. Assisted to lay in bed, checked for pulse, called 911 and checked vital signs. Pulse was present and vital signs stable. Became AAO x 4 after about 2 minutes. EMT responded and assessed patient. Bp 91/54. Transferred to ED by EMT and Mom.
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| 2844363 | 80 | M | PA | 06/09/2025 |
COVID19 |
MODERNA |
3042560 |
Chills, Headache, Influenza like illness, Pain
Chills, Headache, Influenza like illness, Pain
|
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Other Flu-Like Symptoms-...
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Other Flu-Like Symptoms-Medium, Systemic: Headache-Medium
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| 2844364 | 35 | F | TX | 06/09/2025 |
COVID19 |
MODERNA |
3043837 |
Dermatitis bullous, Injection site erythema, Injection site pain, Injection site...
Dermatitis bullous, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
|
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection ...
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient saw her doctor today 6/4/25. Dr. stated it is a local reaction on the left arm. Doctor described it as a bullous. Patient was advised to ice, take zyrtec, and benadryl and use hydrocortisone cream.
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| 2844365 | 23 | F | CA | 06/09/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945661 |
Injection site pain, Pain in extremity, Sleep disorder
Injection site pain, Pain in extremity, Sleep disorder
|
Site: Pain at Injection Site-Severe, Additional Details: Patient had pain after two injections in on...
Site: Pain at Injection Site-Severe, Additional Details: Patient had pain after two injections in one arm. The pain has lasted several months and is now causing her to not sleep.
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| 2844367 | 45 | F | IN | 06/09/2025 |
HPV9 |
MERCK & CO. INC. |
y020531 |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pa...
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated that she is experiencing pain and swelling at the injection site. It has impacted her ability to sleep on arm
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|
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| 2844368 | 68 | F | IN | 06/09/2025 |
COVID19 |
MODERNA |
3042560 |
Injection site erythema, Injection site pain, Injection site warmth
Injection site erythema, Injection site pain, Injection site warmth
|
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient reported that she experienced a big red circle at the injection side that was associated with a hot and achy feeling that lasted for a week. She also mentioned that this happened the last two times you received the COVID vaccine., Other Vaccines: VaccineTypeBrand: FLUAD TRIVALENT 2024-2025; Manufacturer: ; LotNumber: 388461; Route: intramuscular; BodySite: Right Arm; Dose: ; VaxDate: UNKNOWN
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| 2844369 | 61 | F | LA | 06/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55TH4 |
Injection site erythema
Injection site erythema
|
Site: Redness at Injection Site-Mild, Additional Details: Patient was administered five vaccines (Sh...
Site: Redness at Injection Site-Mild, Additional Details: Patient was administered five vaccines (Shingrix, Boostrix, Moderna, Capvaxive and Arexvy) at pharmacy on 06/04/2025. Pharmacy was made aware that patient was being seen in the ER on 06/05/2025 by ER staff. , Other Vaccines: VaccineTypeBrand: Boostrix; Manufacturer: ; LotNumber: 793PT; Route: unknown; BodySite: unknown; Dose: unknown; VaxDate: 06/04/2025, VaccineTypeBrand: Moderna; Manufacturer: ; LotNumber: 3046732; Route: unknown; BodySite: unknown; Dose: unknown; VaxDate: 06/04/2025, VaccineTypeBrand: Capvaxive/ and arexvy; Manufacturer: ; LotNumber: Z002626/ and 4B22T; Route: unknown; BodySite: unknown; Dose: unknown; VaxDate: 06/04/2025
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|
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| 2844370 | 53 | F | NV | 06/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7349L |
Dermatitis, Rash
Dermatitis, Rash
|
Systemic: Allergic: Rash Generalized-Mild, Additional Details: Potential Resurgence of skin inflamma...
Systemic: Allergic: Rash Generalized-Mild, Additional Details: Potential Resurgence of skin inflammation processes on abdominal area from previous shingles infection
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| 2844371 | 66 | F | NJ | 06/09/2025 |
COVID19 |
MODERNA |
3043029 |
COVID-19
COVID-19
|
Systemic: Patient got COVID in October 2024 (a month after COVID vaccine)-Mild, Additional Details: ...
Systemic: Patient got COVID in October 2024 (a month after COVID vaccine)-Mild, Additional Details: Patient got COVID in October 2024 (a month after COVID vaccine)
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| 2844372 | 65 | F | FL | 06/09/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 |
Arthralgia, Influenza like illness, Injection site pain, Pain, Rash; Rash macula...
Arthralgia, Influenza like illness, Injection site pain, Pain, Rash; Rash macular
More
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Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Ach...
Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient reports later in day after Capvaxive immunization, felt flu like body/joint aches as well as develpoed splotchy rash down arm of vaccine. Day after vaccine was the worst then started to improve somewwhat day after that. Still achy and splotch rash although improved.
More
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| 2844373 | 69 | F | NV | 06/09/2025 |
COVID19 |
MODERNA |
3042914 |
Fatigue, Lethargy, Pain, Pyrexia
Fatigue, Lethargy, Pain, Pyrexia
|
Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, A...
Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Additional Details: Patient stated that she experienced the usual achiness and mild fever. She did not feel like doing anything and all symptoms only lasted for 1 day
More
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| 2844374 | 69 | F | FL | 06/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
99D52 |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
More
|
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injec...
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Pt reported infection at injection site, described having a large pustule with green fluid that burst, pain and redness and fluid leakage. Pt did see doctor in-person during a follow up in which no antibiotics were prescribed at the time, per patient the doctor believes it is healing on its own.
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| 2844375 | 53 | F | FL | 06/09/2025 |
COVID19 |
MODERNA |
8080803 |
Aphonia, Asthenia, Headache, Oropharyngeal pain, Pyrexia
Aphonia, Asthenia, Headache, Oropharyngeal pain, Pyrexia
|
Systemic: Fever-Medium, Systemic: Sore Throat/Loss of voice-Medium, Systemic: Headache-Medium, Syste...
Systemic: Fever-Medium, Systemic: Sore Throat/Loss of voice-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium
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| 2844376 | 64 | M | VA | 06/09/2025 |
FLU3 FLU3 UNK UNK |
SANOFI PASTEUR SANOFI PASTEUR UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Aphasia, Ear discomfort, Headache, Memory impairment, Skin discolouration; Skin ...
Aphasia, Ear discomfort, Headache, Memory impairment, Skin discolouration; Skin exfoliation, Sleep disorder, Swollen tongue, Tendon pain; Aphasia, Ear discomfort, Headache, Memory impairment, Skin discolouration; Skin exfoliation, Sleep disorder, Swollen tongue, Tendon pain
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|
About 10 later my tongue started swelling up and i was talking funny. I then noticed a piece of skin...
About 10 later my tongue started swelling up and i was talking funny. I then noticed a piece of skin on it that turned grey and it came right off. And i was looking in the mirror at my tongue and it was about as round as my little finger and it was deep. And they told me to gargle with that water and peroxide after a couple of days it started to go away. I stopped doing it for a couple of days and then it started coming back. So i did it again and made sure i did it right and it went away. I found that my short term memory was really bad and i couldn't remember what in front of me. I even forgot my doctor where he was located and what he looked liked. I looked at his card and knew it was my doctor but couldn't remember anything else, I had to go to the store and had them look up his address and gave me directions to the doctor and i went down there but it was a Saturday and it wasn't open. I did sleep for more than 3 days and told me he couldn't given me anything because of the medications I am on. But i told him i need something now i haven't slept, something is wrong. He did end up getting me a prescription for Quietin or something like that and i had to take 2. I tried to take one but i hated how it made me feel. Then all around my eyes went black and they stay black now and it looks someone punched me in both eyes. The top of my head was bothering me and it wasnt like a headache but it hurt. And thats when i had to go get some aspirin. My tendons in my fingers began to hurt and they felt tight and they would sting when i would try and move my fingers. I have trouble in conversation to find the words i need to speak. My right ear feels like its infected.
More
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| 2844377 | 52 | F | CT | 06/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site pain, Pain in extremity
Injection site pain, Pain in extremity
|
I woke up and showered the morning after vaccine. My arm was understandably sore as expected. When...
I woke up and showered the morning after vaccine. My arm was understandably sore as expected. When I got out of shower and put deodorant on, I recognized that my whole arm pit, extending down and toward left breast, felt like a bruise, and it was overly sore to apply deodorant. I think it's lymph node involvement? I took some naproxen and also drinking lots of water to try to flush my system. Today, 2 days after injection, I'm still sore but not as bad. i'm not sure if this is considered "recovered"- being less sore.
More
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| 2844378 | 2 | F | GA | 06/09/2025 |
DTAP HEPA MENB MNQ |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
Y7JC3 YD2C5 ES49H X4T99 |
Injection site bruising, Injection site induration, Irritability, Product admini...
Injection site bruising, Injection site induration, Irritability, Product administered to patient of inappropriate age, Pyrexia; Injection site bruising, Injection site induration, Irritability, Product administered to patient of inappropriate age, Pyrexia; Injection site bruising, Injection site induration, Irritability, Product administered to patient of inappropriate age, Pyrexia; Injection site bruising, Injection site induration, Irritability, Product administered to patient of inappropriate age, Pyrexia
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|
PT RECEIVED MCV AND MBB PRIOR TO RECOMMENDED AGE IN THE LEFT DELTOID IN ERROR. PT ALSO RECEIVED DTAP...
PT RECEIVED MCV AND MBB PRIOR TO RECOMMENDED AGE IN THE LEFT DELTOID IN ERROR. PT ALSO RECEIVED DTAP AND HEP A IN LEFT THIGH VASTUS LATERALUS APPROPRIATE FOR AGE ON 05/13/2025. NO SYMPTOMS AT TIME OF VISIT. PHONE CALL F/U THE NEXT DAY UNABLE TO REACH BY PHONE. PT'S MOTHER CALLS TODAY 06/09/25 TO REPORTS BRUISING AND HARD KNOT TYPE SWOLLEN AREA TO RIGHT THIGH THAT DEVELOPED 2-3 DAYS POST VACCINATION. RAN FEVER 1 DAY AFTER VACCINATION. REPORTS CHILD HAS BEEN FUSSIER SINCE VACCINATIONS AND THE KNOT HAS GOTTEN SMALLER BUT IS STILL ABLE TO BE FELT.
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| 2844379 | 4 | M | 06/09/2025 |
DTAPIPV DTAPIPV MMR MMR VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
|
Diarrhoea, Feeling abnormal, Headache, Nausea, Pain in extremity; Pallor; Diarrh...
Diarrhoea, Feeling abnormal, Headache, Nausea, Pain in extremity; Pallor; Diarrhoea, Feeling abnormal, Headache, Nausea, Pain in extremity; Pallor; Diarrhoea, Feeling abnormal, Headache, Nausea, Pain in extremity; Pallor
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patient stated he had leg pain then head pain and then felt fuzzy he turned white in color felt naus...
patient stated he had leg pain then head pain and then felt fuzzy he turned white in color felt nausea and had diarrhea within 10 minutes of vaccines
More
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| 2844380 | 41 | F | NM | 06/09/2025 |
MMR |
MERCK & CO. INC. |
Y004114 |
Extra dose administered
Extra dose administered
|
Client provided vaccine history showing last MMR injection in 04/25 and no recent live virus immuniz...
Client provided vaccine history showing last MMR injection in 04/25 and no recent live virus immuniz. Client stated on Part B form, no vaccines received in past 4 wks. After client left and I was charting, I saw a varicella vaccine had been given 05/22/25, becoming invalid since I administered MMR. Client had no reactions to any vaccines including MMR received. Varicella vaccine is considered invalid since another live vaccine (MMR on 06/05/25) was given prior to 28 days from varicella vaccine (05/22/25).
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| 2844381 | 75 | F | NV | 06/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5A4XG |
Rash, Rash erythematous
Rash, Rash erythematous
|
Per patient, an hour after she left the pharmacy her right arm developed red rash & it became so...
Per patient, an hour after she left the pharmacy her right arm developed red rash & it became sore that got bigger over the weekend. I informed the patient to take an antihistamine & apply Benadryl cream and she informed me now rash is getting better.
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| 2844382 | 34 | F | VA | 06/09/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
|
Blood pressure increased, Malaise
Blood pressure increased, Malaise
|
MALAISE, ELEVATED BLOOD PRESSURE
MALAISE, ELEVATED BLOOD PRESSURE
|
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| 2844383 | 71 | F | WA | 06/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
F95YS |
Injection site pain, Injection site swelling, Injection site warmth
Injection site pain, Injection site swelling, Injection site warmth
|
Patient reported her left arm ( injection site) started swelling, warm to touch and painful two day...
Patient reported her left arm ( injection site) started swelling, warm to touch and painful two days after the shot. Patient uses ice pack, ibuprofen and/or tylenol, benadyl after counseled to the pharmacist
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| 2844384 | 11 | M | 06/09/2025 |
PNC20 |
PFIZER\WYETH |
lj5282 |
Unevaluable event
Unevaluable event
|
none
none
|
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| 2844385 | 0.5 | F | TX | 06/09/2025 |
DTPPVHBHPB DTPPVHBHPB PNC20 PNC20 RV5 RV5 |
MSP VACCINE COMPANY MSP VACCINE COMPANY PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
U7767AA U7767AA LN4931 LN4931 Y015018 Y015018 |
Condition aggravated, Eczema, Erythema, Pyrexia, Rhinorrhoea; Swelling face; Con...
Condition aggravated, Eczema, Erythema, Pyrexia, Rhinorrhoea; Swelling face; Condition aggravated, Eczema, Erythema, Pyrexia, Rhinorrhoea; Swelling face; Condition aggravated, Eczema, Erythema, Pyrexia, Rhinorrhoea; Swelling face
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Had fever to 103 about 4.5 hours after receiving vaccine and runny nose, and then facial redness an...
Had fever to 103 about 4.5 hours after receiving vaccine and runny nose, and then facial redness and swelling that lasted 4 hours and then had flare up of eczema for 1 day.
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| 2844386 | 06/09/2025 |
PNC13 |
PFIZER\WYETH |
|
Antibody test abnormal, Illness
Antibody test abnormal, Illness
|
repeated illnesses; This is a spontaneous report received from a Nurse from medical information team...
repeated illnesses; This is a spontaneous report received from a Nurse from medical information team. A patient (age and gender not provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "repeated illnesses". Additional information: Pediatric patient received 4 doses of PCV13. Had visit with immunologist after repeated illnesses and received report pneumococcal titers were low. Patients insurance will not cover PCV23. Given this specific situation, is there any data that supports patient use of PCV20. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2844387 | M | WI | 06/09/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood test, COVID-19, Drug ineffective, Investigation, Respiratory syncytial vir...
Blood test, COVID-19, Drug ineffective, Investigation, Respiratory syncytial virus test; SARS-CoV-2 test
More
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covid; covid/bad cough, secretions, nasal drippings; This is a spontaneous report received from a Ph...
covid; covid/bad cough, secretions, nasal drippings; This is a spontaneous report received from a Physician from medical information team, Program ID. An 82-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cardiac disease" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "valvular artery disease" (unspecified if ongoing); "heart failure" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "renal induced gout" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing); "Kidney failure" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "airways disease" (unspecified if ongoing), notes: always before exercise and it is for airway disease. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; FEBUXOSTAT taken for gout; APIXABAN taken for anticoagulant therapy; LASIX [FUROSEMIDE] taken for renal failure; ATORVASTATIN taken for hypercholesterolaemia; LISINOPRIL taken for hypertension; FARXIGA; LEVALBUTEROL [LEVOSALBUTAMOL] taken for bronchial hyperreactivity. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "covid"; COVID-19 (medically significant), outcome "not recovered", described as "covid/bad cough, secretions, nasal drippings". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Flu A: Unknown results; Unknown results; Respiratory syncytial virus test: Unknown results; SARS-CoV-2 test: Positive, notes: 3rd or 4th day tested; Positive, notes: 3rd or 4th day tested. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : The caller is retired doctor, calling in to ask why they only got 5 days for taking the Paxlovid. Wanted to know the typical reaction for it and also had a shot for Pfizer Covid-19 vaccine but there was a case that he had a bad cough, had secretions and nasal drippings. Got better almost immediately for 3-5 days and on the 5th they stopped taking it and came back in spades and much worse than the beginning. As per transferring agent caller is a patient in this situation but caller is also a retired physician, transferring agent provided HCP contact information verbally per HCP (both him and his wife) came down with covid, 3rd or 4th day tested positive day were put on Paxlovid (both him and his wife) and symptoms went absolutely away progressively 5 days when they were on it, nasal drainage was much less, and it was putrid and coughing started to clear quite a bit after 5th day it was like a reticence of the disease and it was worse that we have ever had and next 2 or 3 days it was progressively worse and worse and worse we are now week after that and we seem to be doing well how many people get a rebound. The caller is a retired university doctor professor and a patient, took a course of Paxlovid and first time had Covid since the beginning of the year. They got a good dose about 3-4 days into it. Wanted to know if that is a typical reaction had a bad cough, had secretions in his nasal drippings and took it. He got better almost immediately and was incredible for about 3-5 days. They stopped taking it on the 5th day and disease came back in spades and much worse than in the beginning. He's also fully vaccinated and was a Pfizer vaccine and got worse because of Paxlovid, awful taste in his mouth and wanted to talk with somebody as to why they only get 5 days.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 omicron (kp.2) cannot be excluded for the reported LOE events.
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| 2844389 | F | NY | 06/09/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
|
prescribed Paxlovid; prescribed Paxlovid; This is a spontaneous report received from a Consumer or o...
prescribed Paxlovid; prescribed Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "prescribed Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: During an inbound call the patient, (name withheld), stated, "I was prescribed Paxlovid and in the past when I've taken it, I've never paid anything." Later, she said, "the only medication that I do out of Pfizer is just this COVID medication, Paxlovid and the other Pfizer thing is, when I get vaccinated I I only do the Pfizer vaccine, that's it." Towards the end of the call she states, "It's very frustrating cause I feel sick right now and I really don't want to be going through this but it's terrible." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2844390 | M | 06/09/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Pyrexia
Pyrexia
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fever; This is a spontaneous report received from a Consumer or other non HCP from License Party. Ot...
fever; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019548 (BioNTech SE), 2024SA035670 (SANOFI). A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since Oct2023) at 600 mg (600 mg, once) and second regimen since Oct2023 (ongoing)) at 300 mg (300 mg, every other week), all subcutaneous for eczema, urticaria. The patient's relevant medical history was not reported. Concomitant medication(s) included: XOLAIR (ongoing). The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever". The action taken for dupilumab was dosage not changed. Additional information: This case involves a patient who developing fever about 2.5 days after covid injection and dupixent for urticaria with no reported adverse event while being treated with dupilumab (Dupixent) with the use of medical device prefilled syringe and covid-19 vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant nedications included OMALIZUMAB (XOLAIR). In October 2023, the patient started treatment with initial loading dose of dupilum ab solution for injection 600 mg once subcutaneous followed by maintenance dose of 300 mg every other week subcutaneous (with an unknown batch number and expiration date) for Eczema and Urticaria(product use in unapproved indication) (latency: same day). Information regarding batch number and expiration date were requested. On an unknown date, patient stared treatment with covid-19 vaccine injection (with an unknown strength, dose, route, frequency, batch number and expiration date) for Prophylactic vaccination On an unknown date the patient developed a non-serious event "developing fever about 2.5 days after covid injection" (pyrexia) (unknown latency). It was reported "patient reported current xolair and dupixent therapy, patient reports xolair therapy was being slowly weaned off and will continue with dupixent therapy, dupixent therapy started beginning of oct-2023 with samples from md office, unknown xolair therapy start date or estimated end date, currently taking xolair every 6 weeks, unknown xolair dose, no new or worsening eczema symptoms reported by patient, patient reported feeling more energy and "younger", unknown if prescribing md was same for both medications, unknown if md (Doctor of medicine) aware. patient reported received covid injection afte: start of dupixent therapy, palient reported developing fever about 2.5 days after covid injection, unknown date, patient reports no missed doses, md aware, md recommends a slower wean off of xolair." DUPILUMAB (DUPIXENT) was continued for dupilumab and Not applicable for covid-19 vaccine. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Unknown Batch/lot number is not provided, and it cannot be obtained.
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| 2844392 | 40 | M | PA | 06/09/2025 |
TDAP |
SANOFI PASTEUR |
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Biopsy skin abnormal, Eczema, Pruritus, Rash, Skin burning sensation
Biopsy skin abnormal, Eczema, Pruritus, Rash, Skin burning sensation
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itching; Chronic burning eczema rash all over body; Chronic burning eczema rash all over body; Initi...
itching; Chronic burning eczema rash all over body; Chronic burning eczema rash all over body; Initial information received on 01-Jun-2025 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional. This case involves a 43-year-old male patient who had chronic burning eczema rash all over body and itching after receiving Diphtheria-2/Tetanus/5 AC pertussis Vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Prednisone; and Tacrolimus for Rash and Pruritus. On 12-Jul-2022, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 AC pertussis Vaccine Suspension for injection (lot number, strength and expiry date-unknown) via subdermal route in unknown administration site for Tetanus. Information on the batch number was requested corresponding to the one at time of event occurrence. On 01-Se-2024 the patient developed chronic burning eczema rash all over body (skin burning sensation), chronic burning eczema rash all over body (eczema) 2 years 1 month 20 days). On an unknown date the patient developed itching (pruritus) (unknown latency). Relevant laboratory test results included: Biopsy skin - On an unknown date: [Lab test (biopsy) on skin condition came back positive for chronic excema] Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events. Seriousness Criteria- Skin burning sensation and eczema was leading to disability.; Sender's Comments: Sanofi company comment dated 04-JUN-2025: This case involves a 43-year-old male patient who had chronic burning eczema rash all over body and itching after receiving Diphtheria-2/Tetanus/5 AC pertussis Vaccine [Adacel]. Further information regarding regarding allergic history, medical history, and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
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| 2844393 | 1.25 | F | KY | 06/09/2025 |
HIBV |
SANOFI PASTEUR |
UJ614AB |
Expired product administered, No adverse event
Expired product administered, No adverse event
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administered of expired ACT-HIB with no reported Adverse event; Initial information received on 05-J...
administered of expired ACT-HIB with no reported Adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves 3 years and 6 months old female patient who administered expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Infanrix) and pneumococcal vaccine conj 13 V (CRM 197) (Prevnar 13) both for prophylactic vaccination (Immunisation). On 16-Mar-2023, the patient received a dose of 0.5 ml of expired suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot UJ614AB and expiry date 12-Mar-2023) (strength : standard and frequency: once) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (Latency: same day). Reportedly, Nurse reported that patients were administered expired two years ago. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2844394 | PA | 06/09/2025 |
HIBV |
SANOFI PASTEUR |
UK169AB |
No adverse event, Product preparation error
No adverse event, Product preparation error
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administering ACTHIB that was not reconstituted with the packaged diluent and instead used sterile w...
administering ACTHIB that was not reconstituted with the packaged diluent and instead used sterile water with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] that was not reconstituted with the packaged diluent and instead used sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date, the patient received unknown of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (unknown strength) with lot UK169AB and expiry date 20-Feb-2026 via unknown route in unknown administration site for Immunization that was not reconstituted with the packaged diluent and instead used sterile water with no reported adverse event (product preparation error) (Latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2844395 | 35 | F | KY | 06/09/2025 |
DTAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
3CA25C1 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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35-year-old patient was supposed to receive ADACEL but instead was administered DAPTACEL in error wi...
35-year-old patient was supposed to receive ADACEL but instead was administered DAPTACEL in error with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 35 years old female patient who was supposed to receive diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] but instead was administered diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] in error with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis B vaccine (HEP B VAX) for Immunisation. On 04-Jun-2025, 35 years old patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (lot 3CA25C1, expiry date Apr-2026, frequency: once and strength: standard) via intramuscular route in unknown administration site in error and was supposed to receive diphtheria-15/tetanus/5 AC pertussis vaccine (formulation Suspension for injection) with no reported adverse event (wrong product administered) (Latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2844397 | 24 | F | WI | 06/09/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
943187 |
Dizziness, Fatigue
Dizziness, Fatigue
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Donor felt dizzy and tired 3 hours after vaccine
Donor felt dizzy and tired 3 hours after vaccine
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| 2844398 | 52 | F | FL | 06/09/2025 |
HEPAB PNC20 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
P2443 LX4482 |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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PATIENT EXPERIENCED RED, WARM, PAINFUL, SWOLLEN LEFT ARM ABOVE THE ELBOW STARTING 2 DAYS AFTER INJEC...
PATIENT EXPERIENCED RED, WARM, PAINFUL, SWOLLEN LEFT ARM ABOVE THE ELBOW STARTING 2 DAYS AFTER INJECTION. SHE HAS BEEN EXPERIENCING THE SYMPTOMS 5 DAYS LATER AND WENT TO HER PHYSICIAN. THE PRESCRIBER TOLD HER TO TAKE DOXYCYCLINE 100MG FOR 10 DAYS.
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| 2844403 | 18 | F | OH | 06/09/2025 |
IPV MMR |
SANOFI PASTEUR MERCK & CO. INC. |
W1C751M X027902 |
Loss of consciousness, Nausea, Syncope; Loss of consciousness, Nausea, Syncope
Loss of consciousness, Nausea, Syncope; Loss of consciousness, Nausea, Syncope
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syncope episode, brief LOC. last 1-2 mins, nausea. improved with laying supine with legs elevated.
syncope episode, brief LOC. last 1-2 mins, nausea. improved with laying supine with legs elevated.
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| 2844404 | 50 | F | IN | 06/09/2025 |
PNC20 |
PFIZER\WYETH |
LJ5281 |
Erythema, Swelling
Erythema, Swelling
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PT HAD REDNESS AND SWELLING POST VACCINATION. SHE HAS TAKEN BENADRYL TO MINIMIZE DISCOMFORT.
PT HAD REDNESS AND SWELLING POST VACCINATION. SHE HAS TAKEN BENADRYL TO MINIMIZE DISCOMFORT.
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| 2844405 | 67 | F | PA | 06/09/2025 |
COVID19 |
PFIZER\BIONTECH |
5WO171 |
Leg amputation, Thrombosis
Leg amputation, Thrombosis
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Blood clots, loss of right limb, above knee amputation.
Blood clots, loss of right limb, above knee amputation.
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| 2844406 | 47 | F | 06/09/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Arthralgia, Dizziness, Ear pain, Nausea, Pyrexia; Respiratory tract congestion, ...
Arthralgia, Dizziness, Ear pain, Nausea, Pyrexia; Respiratory tract congestion, Upper-airway cough syndrome, Vomiting
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Patient reports nausea, arthralgia, fever, otalgia, chest congestion, intermittent dizziness, postna...
Patient reports nausea, arthralgia, fever, otalgia, chest congestion, intermittent dizziness, postnasal drip, vomiting (once) since receiving chikungunya vaccination. She took her emgality injection at the time of symptom onset and is unsure if this exacerbated symptoms. She is also unsure if she has a viral illness as she was recently on vacation, although no known sick contacts. No vaccination site reaction. Treated with supportive measures, zofran, flonase, adequate hydration. Motrin/tylenol as needed.
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| 2844407 | 0.17 | M | PA | 06/09/2025 |
DTAPHEPBIP HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
9359N UK113AB LX4482 2117042 |
Crying; Crying; Crying; Crying
Crying; Crying; Crying; Crying
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crying inconsolably for several hours, no fever
crying inconsolably for several hours, no fever
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| 2844408 | 64 | M | TX | 06/09/2025 |
MMR PNC21 TDAP VARZOS |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y013131 Y011819 39LB7 E754F |
Arthropod bite, Product preparation issue, Rash erythematous, Rash pruritic; Art...
Arthropod bite, Product preparation issue, Rash erythematous, Rash pruritic; Arthropod bite, Product preparation issue, Rash erythematous, Rash pruritic; Arthropod bite, Product preparation issue, Rash erythematous, Rash pruritic; Arthropod bite, Product preparation issue, Rash erythematous, Rash pruritic
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MMR II vaccine was incorrectly reconstituted with a syringe of Moderna Spikevax covid vaccine. Patie...
MMR II vaccine was incorrectly reconstituted with a syringe of Moderna Spikevax covid vaccine. Patient returned to pharmacy 2 days later with itchy red rash. He had gone to the ER and was prescribed prednisone with a diagnosis of severe reaction to flea bites. It is unknown if this rash was related to vaccinations, but reporting just in case.
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| 2844409 | 71 | F | MO | 06/09/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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I received the Prevnar 20 vaccine on April 30, 2025. The following day my arm began to be red and it...
I received the Prevnar 20 vaccine on April 30, 2025. The following day my arm began to be red and itchy around the injection site. The redness area and itchiness increased for 5 days, then began to subside. It was at its largest on May 5, and measured approximately 5 inches in length and 3 inches in width on that day and itched a lot. The reaction slowly subsided over the following week and was completely gone by two weeks.
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| 2844410 | 27 | M | CA | 06/09/2025 |
COVID19 |
MODERNA |
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Autoimmune thyroiditis, Blood glucose increased, Type 1 diabetes mellitus
Autoimmune thyroiditis, Blood glucose increased, Type 1 diabetes mellitus
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Type 1 diabetes diagnosis after ER visit found blood sugar over 500 roughly 20 hours after receiving...
Type 1 diabetes diagnosis after ER visit found blood sugar over 500 roughly 20 hours after receiving first dose. Hashimotos diagnosis 1 month after
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| 2844411 | 4 | F | VA | 06/09/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U8383AB Z006282 |
Cough, Pain in extremity, Streptococcus test; Cough, Pain in extremity, Streptoc...
Cough, Pain in extremity, Streptococcus test; Cough, Pain in extremity, Streptococcus test
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Rt. arm soveness croupy cough
Rt. arm soveness croupy cough
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| 2844412 | 61 | F | 06/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Injected limb mobility decreased, Pain in extremity
Injected limb mobility decreased, Pain in extremity
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PATIENT COMPLAINED OF A VERY SORE ARM. SHE FELT THAT THE VACCINE ADMINISTRATION HIT A BONE. SHE COUL...
PATIENT COMPLAINED OF A VERY SORE ARM. SHE FELT THAT THE VACCINE ADMINISTRATION HIT A BONE. SHE COULDN'T LIFT HER ARM AND WAS IN PAIN SO WENT TO URGENT CARE. THEY THOUGHT IT HIT A NERVE. SHE WENT TO EMERGENCY AND THEY COULDN'T HELP HER. TOLD HER TO REST. IN 2 WEEKS SHE FELT BETTER.
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| 2844413 | 52 | F | NJ | 06/09/2025 |
COVID19 |
MODERNA |
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Arthralgia, Injection site indentation, Myalgia, Vitiligo
Arthralgia, Injection site indentation, Myalgia, Vitiligo
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I?ve been getting Covid shots since they started. My 2nd and 3rd shots gave me Covid arm in my left...
I?ve been getting Covid shots since they started. My 2nd and 3rd shots gave me Covid arm in my left arm. I switched to right arm and was fine until now. I noticed the last week in May that I now have an indentation and vitiligo where I have been given the shot on my right arm. I also have the feeling of pain (joint and muscle) in same arm.
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| 2844264 | 5 | M | CA | 06/08/2025 |
MMR |
MERCK & CO. INC. |
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Pyrexia
Pyrexia
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fever of 103 9 days after shot. for over 24 hours, Motrin didn't take it down so we had to give...
fever of 103 9 days after shot. for over 24 hours, Motrin didn't take it down so we had to give Tylenol too
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| 2844265 | 63 | F | OK | 06/08/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Cardiac disorder
Cardiac disorder
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paracardia-micardia
paracardia-micardia
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โ | โ |