| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843203 | 41 | M | WA | 05/29/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946888 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Staff made vaccination error on a 2nd dose of a hep B vaccine. The 2nd vaccine of the Heplisev vacc...
Staff made vaccination error on a 2nd dose of a hep B vaccine. The 2nd vaccine of the Heplisev vaccine was given too early, the patient will need to be re-vaccinated. The first dose was given 5/14/2025. The second vaccine should have been given at least 4 weeks apart according to the CDC. I was working too fast and did not pay enough attention to the vaccination dates. This was my error. The patient will need to return to the clinic for his 2nd Hep B vaccine. The patient will be contacted. The patient's pcp has already been contacted as well for safety. CDC was contacted, the vaccine preformed on 5/16/2025 does not count as completing the series. The patient will need to return to the clinic for his 2nd Hep B vaccine.
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| 2843204 | 61 | F | 05/29/2025 |
PNC20 |
PFIZER\WYETH |
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Swelling face
Swelling face
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pt stated that her right jaw was swollen for 2 day and she could not eat anything until swelling res...
pt stated that her right jaw was swollen for 2 day and she could not eat anything until swelling resolved 2 days later
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| 2843205 | 12 | F | OH | 05/29/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y014510 3E99M KR7FK |
Blood glucose normal, Syncope; Blood glucose normal, Syncope; Blood glucose norm...
Blood glucose normal, Syncope; Blood glucose normal, Syncope; Blood glucose normal, Syncope
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Patient experienced Syncope after receiving vaccinations. Vaccines were administered in both arms in...
Patient experienced Syncope after receiving vaccinations. Vaccines were administered in both arms intramuscular. Tdap and Menveo given first in the left arm, then HPV in the second arm. Patient was sitting on the exam table while the vaccines were being administered. As the vaccines were being disposed of in the sharps container Patient lost consciousness and fell off the exam table to the right. Patient was still sitting on the exam table when she experienced the syncope. Event happened approximately 30 seconds to a minute after the administration of the HPV vaccine which was done last. Patient hit the right side of her head and regained consciousness in 15 to 30 seconds. After regaining consciousness Patient appeared to be fine and was re-examined by the Doctor. Repeat blood pressure was done after the event. Blood pressure was 110/60. Blood sugar was also taken after the event. Blood sugar was 105. Mother stated Patient had not eaten anything before the vaccines were administered.
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| 2843206 | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Blood glucose, Blood glucose increased
Blood glucose, Blood glucose increased
|
got the same glucose spike; This is a spontaneous report received from a Consumer or other non HCP f...
got the same glucose spike; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) 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: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "got the same glucose spike". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated 3 other friends got the same glucose spike that he just talked to. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500109801 Same reporter/product/event; different patient;US-PFIZER INC-202500109803 Same reporter/product/event; different patient;
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| 2843207 | 6 | M | MA | 05/29/2025 |
MMRV |
MERCK & CO. INC. |
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Anxiety, Cognitive disorder, Depressed mood
Anxiety, Cognitive disorder, Depressed mood
|
After my son got the vaccine his cognitive ability declined. He was good in math and could no longer...
After my son got the vaccine his cognitive ability declined. He was good in math and could no longer do math work anymore. His anxiety went up and he was not as happy as he use to be. He had a very sharp decline in his ability to critical think. He no longer can pick up on social cues it was like it got autism and we are looking to get him tested for it. The court order at the time for our parenting plan stated that i had joint medical decision making and this was done illegally with out my consent and the doctors did not call to speak with me about the decision. My son has been with his dad a victim of abuse.
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| 2843208 | 64 | F | KS | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75GZ7 |
Dizziness, Erythema, Feeling hot, Muscle spasms
Dizziness, Erythema, Feeling hot, Muscle spasms
|
The patient and I were sitting discussing something and she suddenly got very dizzy about one minute...
The patient and I were sitting discussing something and she suddenly got very dizzy about one minute after receiving the second dose of the vaccine. She immediately turned bright red and said she was hot when asked. I checked the site of administration and besides a little blood for which a band-aid was applied, nothing looked abnormal. The patient was given water and fanned for a couple of minutes. Then she developed cramps in her back and then her legs. I stepped out to verify if this sort of reaction had been reported. Temperature was checked on both arms and they were both warm. She started to regain normal color in her face, so she was given time to sit alone and relax. She was checked on after about 7 minutes and her color was back to normal and the cramps had gone away. She stated before the vaccine that she had had no reaction to the first dose.
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| 2843209 | 12 | M | MA | 05/29/2025 |
TD TD TD TD |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
SKB575HC SKB575HC |
Cognitive disorder, Depression, Illiteracy, Loss of personal independence in dai...
Cognitive disorder, Depression, Illiteracy, Loss of personal independence in daily activities, Reading disorder; Social anxiety disorder, Thinking abnormal; Cognitive disorder, Depression, Illiteracy, Loss of personal independence in daily activities, Reading disorder; Social anxiety disorder, Thinking abnormal
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I was not there not there and again current court order, Mother did not consent and it was against m...
I was not there not there and again current court order, Mother did not consent and it was against my will the father and doctor did not call me. I filed a police report. As soon as my son got this shot he became even worse he can barley critically think he can not live on his on. And it was obvious after the first round that he was acting more immature. And then when we got to this last round of vaccine my son was starting to fail school he almost had to stay back. He lost all motivation to really be active and social. He currently has a high level social anxiety and was diagnosed with depression and i think the mild autism that he had is even worse. He has verbal issues and what he wants to say the opposite comes out of his mouth. He is having issues with reading. And when you speak to him at a normal pass he will ask you to slow down. He is not able to speak with you at a normal pass his congnivate ability has gone down. Now at this time he was living with his dad. But his dad moved back and my son wanted to try to live with his dad full time. Against my better judgement. And i didn't not find out about this vaccine for a year or two after he got it. And i just got this report and looked at it for the first time. When i filed the police report it was the same day that i found out - 03/14/2025. I just moved a month before. My son had said something but didn't know what vaccine it was and the dad did not tell me. He is currently visiting friends for the summer that where he dad lives but he is not in contact with him or have a relationship with him. I have 2 cases. His last Dr, states we need to get him neurologically tested.
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| 2843210 | 55 | F | TX | 05/29/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 |
Cough, Discomfort, Injection site pain, Injection site rash, Injection site swel...
Cough, Discomfort, Injection site pain, Injection site rash, Injection site swelling; Nasopharyngitis, Pain, Rhinorrhoea
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Rash on arm slightly down arm from injection site , patient says painful to touch and beneath skin,...
Rash on arm slightly down arm from injection site , patient says painful to touch and beneath skin, slightly swollen,. Patient feels like she has covidlike symptoms of achy all over , feels heaviness all over, with runny nose and cough
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| 2843211 | 0.25 | F | UT | 05/29/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
3Z34X |
Erythema, Irritability
Erythema, Irritability
|
Patient's mom stated she has not noticed any redness, irritability, or any other symptoms on pa...
Patient's mom stated she has not noticed any redness, irritability, or any other symptoms on patient.
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| 2843212 | 82 | F | NC | 05/29/2025 |
PNC20 PNC20 PNC20 PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
GW7965 GW7965 GW7965 GW7965 GW7965 GW7965 |
Balance disorder, Condition aggravated, Eye infection, Facial pain, Fall; Fatigu...
Balance disorder, Condition aggravated, Eye infection, Facial pain, Fall; Fatigue, Headache, Laboratory test, Pain, Sinusitis; Balance disorder, Dysstasia, Laboratory test, Malaise, Middle ear effusion; Balance disorder, Condition aggravated, Eye infection, Facial pain, Fall; Fatigue, Headache, Laboratory test, Pain, Sinusitis; Balance disorder, Dysstasia, Laboratory test, Malaise, Middle ear effusion
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pt states her severe chronic fatigue was triggered and her sinuses became infected. She had eye infe...
pt states her severe chronic fatigue was triggered and her sinuses became infected. She had eye infection in her right eye and severe headache. Her equilibrium is not the same. She went to ER due to the pain and she was falling. They were going to admit her but they ended up sending her home because there were a lot of covid patients there. She is going clinic seeing Dr. He has her antibiotics for the sinus infection but she continues to have a terrible headache and now her entire face hurts. She also has pain from her waist down. She feels like these symptoms were all brought on or made worse by the pneumonia vaccine.
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| 2843214 | 19 | F | OH | 05/29/2025 |
IPV IPV TDAP TDAP TYP TYP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
X1C891M X1C891M U8352AA U8352AA W1A991M W1A991M |
Dizziness, Erythema, Fall, Head injury, Pallor; Skin abrasion, Syncope; Dizzines...
Dizziness, Erythema, Fall, Head injury, Pallor; Skin abrasion, Syncope; Dizziness, Erythema, Fall, Head injury, Pallor; Skin abrasion, Syncope; Dizziness, Erythema, Fall, Head injury, Pallor; Skin abrasion, Syncope
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After vaccines were administered client c/o feeling dizzy while sitting in office chair. Clients col...
After vaccines were administered client c/o feeling dizzy while sitting in office chair. Clients color became very pale and as this nurse was walking to client around the desk the client fainted and fell to the floor striking right side of face and head. Client was turned over on back and was awake but confused about where she was at. Client was reoriented and legs elevated. Vital signs were 102/68 BP, 74HR, 16R, 99% O2 sat. Client was clammy and shaky. Client assisted to sitting position on floor and cool ice pack placed to back of neck. Client was able to move all extremities and state her name and todays date. Abrasions to right cheek were noted. Small redness present underneath right lower eyelid. Second larger abrasion to mid cheek approximately 2 inches long and third abrasion to jaw area round and approximately 2 inches. Scant amount of blood coming from jaw abrasion. All areas cleaned with soap and water and ice pack applied to area. Client c/o of mild pain in abrasion area but no other pain elsewhere. Client spoke with parents and declined calling 911. Advised client to have family member pick her up. Grandfather picked client up and client left office in stable condition. Client advised to follow up with PCP and call 911 if experiencing any dizziness, increase pain, or excessive tiredness.
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| 2843215 | 64 | F | AK | 05/29/2025 |
RSV TDAP |
PFIZER\WYETH SANOFI PASTEUR |
|
Angioedema; Angioedema
Angioedema; Angioedema
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Angioedema, has had the Tdap vaccine before
Angioedema, has had the Tdap vaccine before
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| 2843216 | 22 | F | IN | 05/29/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
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Blood test, Computerised tomogram, Hypoaesthesia, Lumbar puncture, Magnetic reso...
Blood test, Computerised tomogram, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging; Multiple sclerosis, Peroneal nerve palsy, X-ray; Blood test, Computerised tomogram, Hypoaesthesia, Lumbar puncture, Magnetic resonance imaging; Multiple sclerosis, Peroneal nerve palsy, X-ray
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Multiple sclerosis, Diagnosed a year and a half later, left sided numbness, drop foot
Multiple sclerosis, Diagnosed a year and a half later, left sided numbness, drop foot
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โ | โ | ||||
| 2843217 | 47 | M | MA | 05/29/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
945665 945665 |
Anaphylactic reaction, Chest pain, Dysphagia, Pharyngeal swelling, Urticaria; Vo...
Anaphylactic reaction, Chest pain, Dysphagia, Pharyngeal swelling, Urticaria; Vomiting
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Pt complained of chest pain, vomiting, started to feel throat swelling, difficulty swallowing, hives...
Pt complained of chest pain, vomiting, started to feel throat swelling, difficulty swallowing, hives on face consistent with anaphylactic reaction. 911 was called. Prior to EMS arrival, patient was given epinephrine 0.3 mg IM R arm and 25 mg liquid benadryl which he vomited up.
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| 2843218 | 0.5 | F | IN | 05/29/2025 |
DTAPIPVHIB HEP PNC20 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
UK228AB 4D333 MF0415 |
Swelling face; Swelling face; Swelling face
Swelling face; Swelling face; Swelling face
|
mom reports swollen face 30 min after leaving the office, patient sent to ER. At hospital mom repor...
mom reports swollen face 30 min after leaving the office, patient sent to ER. At hospital mom reports right side of patient face swelled 20 min after vaccine administration. mom reports giving the patient Motrin after vaccinations. but swelling largely resolved by the time patient seen at ER. seen at ER f/u on 5/29/2025: no facial swelling noticed by provider and patient overall in good health.
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| 2843219 | 0.17 | F | CO | 05/29/2025 |
DTAPIPVHIB HEP PNC15 RV5 |
SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
UK110AA Y015924 Y017360 2096663 |
Altered state of consciousness, Listless, Pallor; Altered state of consciousness...
Altered state of consciousness, Listless, Pallor; Altered state of consciousness, Listless, Pallor; Altered state of consciousness, Listless, Pallor; Altered state of consciousness, Listless, Pallor
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BRUE that afternoon. Became pale and listless, turned blue. Altered consciousness for up to 2 minut...
BRUE that afternoon. Became pale and listless, turned blue. Altered consciousness for up to 2 minutes, then returned to baseline.
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| 2843220 | 45 | F | UT | 05/29/2025 |
ADEN_4_7 |
TEVA PHARMACEUTICALS |
PG3RP |
Cellulitis, Erythema, Injection site induration, Peripheral swelling
Cellulitis, Erythema, Injection site induration, Peripheral swelling
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Patient came in to the pharmacy on 05/29/25 to pick up antibiotics and report the adverse event. She...
Patient came in to the pharmacy on 05/29/25 to pick up antibiotics and report the adverse event. She received Boostrix on 05/22/25 and approx. 36 hours later her arm was red and puffy with a hard lump around injection site. She was seen by a MD and was diagnosed with cellulitis. She also reported red streaks on her arm. Patient received antibiotic on 05/29/25.
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| 2843221 | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood glucose, Blood glucose increased
Blood glucose, Blood glucose increased
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got the same glucose spike; This is a spontaneous report received from a Consumer or other non HCP f...
got the same glucose spike; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) 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: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "got the same glucose spike". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter stated 3 other friends got the same glucose spike that he just talked to. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500109801 Same reporter/product/event; different patient;US-PFIZER INC-202500109802 Same reporter/product/event; different patient;
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| 2843222 | 1.83 | M | MI | 05/29/2025 |
DTAPIPV |
SANOFI PASTEUR |
|
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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N/A
N/A
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| 2843223 | 2 | F | MI | 05/29/2025 |
DTAPIPV |
SANOFI PASTEUR |
U7931AB |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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None
None
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| 2843224 | 17 | F | CO | 05/29/2025 |
YF |
SANOFI PASTEUR |
UK134AA |
Head injury, Loss of consciousness
Head injury, Loss of consciousness
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Yellow fever vaccine administered subcutaneously in patient's left arm while she was seated on ...
Yellow fever vaccine administered subcutaneously in patient's left arm while she was seated on exam table. About three minutes later, patient lost consciousness, slid off exam table, and hit head on floor. Patient regained consciousness within a few minutes and was alert and oriented x4.
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| 2843225 | 0.83 | F | MI | 05/29/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
|
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
No adverse events reported. Kinrix given instead of separate DTaP / Polio.
No adverse events reported. Kinrix given instead of separate DTaP / Polio.
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| 2843226 | 26 | F | NC | 05/29/2025 |
HPV9 |
MERCK & CO. INC. |
yo15180 |
Erythema, Pain in extremity, Peripheral swelling
Erythema, Pain in extremity, Peripheral swelling
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ptnt did not come in but called. Arm stated to be red and swollen at site and hurting.
ptnt did not come in but called. Arm stated to be red and swollen at site and hurting.
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| 2843227 | 73 | F | MI | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
33FD3 |
Rash, Rash erythematous
Rash, Rash erythematous
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Patient developed Red rash on arm after receiving her immunizations. 8 days after receiving the imm...
Patient developed Red rash on arm after receiving her immunizations. 8 days after receiving the immunization patient still has the rash patient.
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| 2843228 | 51 | F | SC | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
E754F |
Injection site swelling, Injection site warmth
Injection site swelling, Injection site warmth
|
Patient showed her doctor the injection site which was bigger than normal and she described it as ho...
Patient showed her doctor the injection site which was bigger than normal and she described it as hot. He asked her to come back to the pharmacy for us to report the potential issue to VAERS. She was advised that it should go down significantly in the next day or two and if it got any bigger or did not go down to go back to her doctors office
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| 2843229 | 91 | F | NY | 05/29/2025 |
COVID19 |
MODERNA |
3042879 |
Erythema, Pain in extremity
Erythema, Pain in extremity
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Patient came in on May 29, 2025, and said within 24 hours her arm was red and hurt for about a week....
Patient came in on May 29, 2025, and said within 24 hours her arm was red and hurt for about a week. It resolved on its own and she didn't seek medical help.
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| 2843230 | 22 | F | TN | 05/29/2025 |
VARCEL |
MERCK & CO. INC. |
Y011015 |
Anxiety, Dizziness, Headache, Loss of consciousness, Malaise
Anxiety, Dizziness, Headache, Loss of consciousness, Malaise
|
Before getting the vaccine she warned me that she has issues with needles so I told her to remain se...
Before getting the vaccine she warned me that she has issues with needles so I told her to remain seated after the vaccine until she felt like she sure she would not have any issues from the injection. I couple minutes after the injection she said she did not feel well: dizzy and headache. I offered her water but before I could go get it she starting feeling worse and she started to lean back in the chair and passed out for just a few moments. I was holding her up to make sure she didn't fall then I had a tech help me lower her to the floor. We called a code white and an ambulance was called. The EMS team checked her out and determined she had an anxiety attack when I gave her the vaccine. She stabilized and refused transport to hospital and left with family member.
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| 2843231 | 59 | F | LA | 05/29/2025 |
YF YF |
SANOFI PASTEUR SANOFI PASTEUR |
UK133AB UK133AB |
Blood creatinine increased, C-reactive protein increased, Decreased appetite, He...
Blood creatinine increased, C-reactive protein increased, Decreased appetite, Hepatic enzyme increased, Rash; Vomiting
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Client reported rash to face, neck and torso along with loss of appetite and one episode of vomiting...
Client reported rash to face, neck and torso along with loss of appetite and one episode of vomiting. Denied fever and/or chills. She was seen by Urgent Care and given Pepcid and Claritin. She was instructed to follow up with her PCP the following day. On 5/23/25, she saw NP at Clinic where her CRP, creatinine and liver enzymes were elevated. She given one liter IV fluids and instructed to hydrate at home and to return to clinic on 5/26/25. She was seen most recently on 5/26/25, where repeat liver and renal lab results were improved. Potassium was still elevated. Client still reported fatigue but rash was improved. She was instructed to return for labs again on 5/29/25.
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| 2843232 | 0.5 | F | PA | 05/29/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
9359N |
Injection site erythema, Injection site warmth, Pyrexia
Injection site erythema, Injection site warmth, Pyrexia
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pt has red warm area on right this where vaccines was given. she also has a reported fever from mom ...
pt has red warm area on right this where vaccines was given. she also has a reported fever from mom of 100.9
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| 2843233 | 42 | M | TX | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
59267100002 |
Cerebrovascular accident
Cerebrovascular accident
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Stroke
Stroke
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โ | โ | ||||
| 2843234 | 72 | F | MN | 05/29/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Chills, Cough, Diarrhoea, Fatigue, Headache; Mobility decreased, Nausea, Pyrexia...
Chills, Cough, Diarrhoea, Fatigue, Headache; Mobility decreased, Nausea, Pyrexia, Wheezing
More
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Incessant dry coughing, wheezing, raging headache, diarrhea, nausea, intermittent fever, chills, fat...
Incessant dry coughing, wheezing, raging headache, diarrhea, nausea, intermittent fever, chills, fatigue. Most symptoms disappeared after 24 hrs, but coughing, wheezing, headache, and fatigue lasted 2+ days. I was bed-ridden for 2 full days. I have NEVER had a reaction remotely like this to any vaccine. The shot site on my arm may be sensitive and my muscles may ache a bit, but this was significantly more intense. Something in the 2025 COVID vaccine formulation was problematic for me.
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| 2843235 | 75 | F | PA | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93N4J |
Injection site bruising, Injection site rash, Rash erythematous
Injection site bruising, Injection site rash, Rash erythematous
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Patient stated the day after receiving the vaccine, she developed a red rash at the injection site a...
Patient stated the day after receiving the vaccine, she developed a red rash at the injection site and also a bruise on her arm below where she received the injection. She still has a rash and bruise 6 days later.
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| 2843236 | F | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Pulmonary sarcoidosis, Sarcoidosis
Pulmonary sarcoidosis, Sarcoidosis
|
Sarcoidosis in her lungs, 1.7cm nodules in her lungs; 1.7cm nodules around her spleen and in her leg...
Sarcoidosis in her lungs, 1.7cm nodules in her lungs; 1.7cm nodules around her spleen and in her legs; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 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: PULMONARY SARCOIDOSIS (medically significant), outcome "unknown", described as "Sarcoidosis in her lungs, 1.7cm nodules in her lungs"; SARCOIDOSIS (non-serious), outcome "unknown", described as "1.7cm nodules around her spleen and in her legs". The events "sarcoidosis in her lungs, 1.7cm nodules in her lungs" and "1.7cm nodules around her spleen and in her legs" required physician office visit. Clinical course: The reporter stated his wife got Sarcoidosis in her lungs, 1.7cm nodules in her lungs, around her spleen and in her legs. Reporter stated about 9 months after the Pfizer Covid Vaccine she went to her doctor and was told she has nodules all in her lungs. His wife was never by chemicals and never by anything. Doctor said initially they didn't know what it was from, but now it is listed as a side effect that it could cause Sarcoidosis. Reporter stated that the vaccine causes nothing but harm. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2843237 | 50 | F | OH | 05/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
PJ353 |
Erythema, Mobility decreased, Pain in extremity
Erythema, Mobility decreased, Pain in extremity
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Patient received vaccination approximately 4:30pm on 5/24. Seemed to be ok at that time. Patient cal...
Patient received vaccination approximately 4:30pm on 5/24. Seemed to be ok at that time. Patient called on 5/26 maybe around noon and stated that her arm hurt and it was difficult to move. At that time (since I personally have had a sore arm for several days) I advised to use cold compresses and take tylenol or ibuprofen. Patient was still having issues with her arm being sore/red and difficult to move by 5/28 so she made appointment with primary care MD. He stated that it appeared that she had infection and proceeded to prescribe an antibiotic (cephalexin). Patient called pharmacy around 5:35 pm on 5/29 to let us know what had happened.
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| 2843238 | 68 | F | NY | 05/29/2025 |
PNC21 |
MERCK & CO. INC. |
Z002626 |
Injection site erythema, Injection site induration, Injection site warmth, Malai...
Injection site erythema, Injection site induration, Injection site warmth, Malaise
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ON 5/26/25- PATIENT STARTED WITH MALAISE & PATIENT TOOK THERAFLU AND FELT BETTER. THE FOLLOWING...
ON 5/26/25- PATIENT STARTED WITH MALAISE & PATIENT TOOK THERAFLU AND FELT BETTER. THE FOLLOWING DAY THE PATIENT NOTICED THE AREA ON THE RIGHT ARM WAS HARD, HOT TO THE TOUCH AND RED.. THE PATIENT THEN CAME TO THE PHARMACY WHERE SHE WAS INSTRUCTED TO START A PAIN RELIEVER, ANTIHISTAMINE, AND WARM COMPRESS TO THE AFFECTED AREA.
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| 2843239 | F | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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died 6 Days after getting the Pfizer Covid 19 Vaccine; This is a spontaneous report received from a ...
died 6 Days after getting the Pfizer Covid 19 Vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 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: DEATH (death, medically significant), outcome "fatal", described as "died 6 Days after getting the Pfizer Covid 19 Vaccine". The date and cause of death for the patient were unknown. Clinical course: Reporter stated his Mother in Law died 6 Days after getting the Pfizer Covid 19 Vaccine and she was perfectly fine and they listed the vaccine as the cause on her death certificate. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: Unknown cause of death
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| 2843240 | F | TX | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID After Pfizer Shots; COVID After Pfizer Shots; This is a spontaneous report received from a Con...
COVID After Pfizer Shots; COVID After Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 66-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. Vaccination history included: Bnt162b2 (Primary immunization completed), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID After Pfizer Shots". Patient got the booster then still got COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient used Paxlovid. The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
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| 2843241 | M | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dermatitis atopic, Headache, Nasal congestion
Dermatitis atopic, Headache, Nasal congestion
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headache and congestion; headache and congestion; having flare ups symptoms; This is a spontaneous r...
headache and congestion; headache and congestion; having flare ups symptoms; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019422 (Biontech SE), 2025SA123612 (Sanofi), AE-019425 (Biontech SE). A 53-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Mar2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Dec2024) at 300 mg (strength: 300 mg/2ml at a dose of 300 mg qow) for dermatitis atopic, eczema. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "headache and congestion"; DERMATITIS ATOPIC (non-serious), outcome "recovered" (2025), described as "having flare ups symptoms". The action taken for dupilumab was unknown. Additional information: This case involved a 53-year-old male patient who experienced burning at the injection site when dupilumab [Dupixent] was initially administered while still cold at the doctor's office, reported headaches, congestion, and flare-up symptoms while being treated with dupilumab delivered via pre-filled pen, as well as receiving COVID-19 vaccine, Pneumonia, Shingles, and Hepatitis vaccines (INNs unspecified). Patient did not receive a loading dose at start of therapy with no ae (adverse event) directly linked to incorrect dose administered. The DUPIXENT SINGLEDOSE PRE-FILLED PEN component of the combination product DUPIXENT (Single-entity for initial use) has been identified with a device issue. The product was not stored or used properly. The device was operated by the Health Care Professional. The patient's past medical history, medical treatment(s), concomitant medication(s), diseases or risk factors, vaccination(s) and family history was not provided. In Dec-2024, the patient started taking DUPIXENT (DUPILUMAB) solution for injection via pre-filled pen (strength: 300 mg/2ml) at a dose of 300 mg QOW with no loading dose (incorrect dose administered) (same day latency) (unknown batch number and expiry date) subcutaneously for dermatitis atopic and eczema. In Dec-2024 the patient developed a non-serious event "when he first began dupixent, md office administered dupixent while it was still cold, burning to injection site" (injection site pain and product preparation error) (same day latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB. In Mar-2025, the patient started taking Hepatitis, COVID-19, pneumonia and shingles vaccines with unknown formulation, dosage, route, strength, frequency, device and indication. In Mar-2025 the patient developed a non-serious event "having flare ups symptoms" (dermatitis atopic) (latency: 03 months approximately) following the first dose intake (unknown batch number and batch number) of DUPILUMAB, (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE, Hepatitis, pneumonia and shingles vaccines. In 2025 the patient developed a non-serious event "headache and congestion" (nasal congestion and headache) (latency: more than 01 month approximately) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB, (unknown latency) following the first dose intake (unknown batch number and expiry date) of COVID-19 VACCINE, Hepatitis, pneumonia and shingles vaccines. Information regarding batch number and expiry date corresponding to the one at time of event occurrence was requested. It was reported "Patient reported over the past month, having flare ups symptoms. He states he keeps in touch with medical doctor regularly. Flare has since subsided with dose of Dupixent. No dates were reported. patient states he did not receive a loading dose at start of therapy, patient states he received 1-300 mg injection on day 1 (Dec-2024), manufacturer recommends a loading dose of 2-300 mg injections on day 1 for atopic dermatitis, unknown if md (Doctor of medicines) aware. Patient states around 6-8 weeks ago (patient unable to provide exact date) he had covid, hepatitis, pneumonia and shingles vaccines administered (unknown if all vaccines administered the same date), patient states after receiving vaccines, he developed headache and congestion, patient unable to provide date and duration of ill effects, md unaware, no further details provided. Patient states when he first began dupixent, md office administered dupixent while it was still cold, patient reports he had burning to injection site, (exact date of occurrence is unknown) unknown if md aware, no further details provided". Action taken: unknown for incorrect dose administered, product preparation error and no action taken for rest of the events. Action taken with COVID-19 VACCINE, Hepatitis, pneumonia and shingles vaccines: unknown for all the events. Corrective treatment: Not reported for dermatitis atopic, injection site pain. Outcome: Recovered in 2025 for dermatitis atopic and unknown for injection site pain. 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. Additional information was received on 29-Apr-2025 from the patient. New suspects (COVID-19 VACCINE, Hepatitis, pneumonia and shingles vaccines), events of injection site pain, incorrect dose administered, product preparation error, nasal congestion and headache were added. Text amended accordingly.
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| 2843242 | 05/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pyrexia
Pyrexia
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fever; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and g...
fever; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) 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: PYREXIA (non-serious), outcome "recovered", described as "fever". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2843243 | M | PA | 05/29/2025 |
PPV |
UNKNOWN MANUFACTURER |
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Peripheral swelling, Rash
Peripheral swelling, Rash
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arm swelling and rash; arm swelling and rash; This is a spontaneous report received from a Consumer ...
arm swelling and rash; arm swelling and rash; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), in 2020 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), RASH (non-serious), outcome "recovered" and all described as "arm swelling and rash". 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. Additional Information: The patient developed a reaction after receiving the PCV13 pneumococcal vaccine in 2020. The reaction included arm swelling and rash that lasted for a few weeks. Their provider was recommending that he receive Prevnar20 but the patient was concerned about the risks as he does not want to experience another bad reaction.
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| 2843244 | 05/29/2025 |
FLUX |
UNKNOWN MANUFACTURER |
388494 |
Lung disorder
Lung disorder
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Patient had a severe reaction, which has continued since patient received flu vaccine, It has attach...
Patient had a severe reaction, which has continued since patient received flu vaccine, It has attached patient lungs; This spontaneous case, initially received on 22-May-2025, with additional information received on 26-May-2025 (being process together), was reported by a non-health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On 29-Jan-2025, the patient received INN Flu Vaccine Seasonal for Indication not reported, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 388494. No additional suspect drugs. Adverse reactions/events and outcomes: On 29-Jan-2025, the Patient had a severe reaction, which has continued since patient received flu vaccine, It has attached patient lungs (outcome: Not Reported). Patient had a severe reaction, which has continued since patient received flu vaccine on 29-Jan-2025. Lot 388494. It has attached patient lungs. It happened within few hours after shot. Patient still have trouble which was never there before. 2 weeks before receiving shot patient had a complete check up with patient's cardiologist. All was fine. INN Flu Vaccine Seasonal action taken: Not Applicable Reporter's assessment: The reporter did not provide the seriousness and causality assessment of event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the event is considered related for reporting purposes. Considered related due to plausible temporal relationship (same day within few hours after suspect).
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| 2843245 | 64 | F | CA | 05/29/2025 |
PNC21 |
MERCK & CO. INC. |
Z002626 |
Injection site discolouration, Injection site pruritus, Injection site reaction,...
Injection site discolouration, Injection site pruritus, Injection site reaction, Injection site warmth
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Injection site reaction: warmth, discoloration, mild itchiness, no pain, no noticeable swelling. Sym...
Injection site reaction: warmth, discoloration, mild itchiness, no pain, no noticeable swelling. Symptoms improving.
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| 2843246 | 15 | F | CA | 05/29/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y017513 Y015100 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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15/ Female, received ProQuad MMR V and Varicella Vaccine.
15/ Female, received ProQuad MMR V and Varicella Vaccine.
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| 2843263 | 18 | F | TX | 05/29/2025 |
MENB |
PFIZER\WYETH |
LL0637 |
Confusional state, Dizziness, Pallor
Confusional state, Dizziness, Pallor
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Dizziness. Confusion. Lips turning white. Unconsciousness.
Dizziness. Confusion. Lips turning white. Unconsciousness.
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| 2843264 | 27 | M | CA | 05/29/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
013B22A 013B22A 061B22A 061B22A |
Abdominal X-ray, Chest pain, Computerised tomogram abdomen, Computerised tomogra...
Abdominal X-ray, Chest pain, Computerised tomogram abdomen, Computerised tomogram thorax, Dyspnoea; Dyspnoea exertional, Exercise tolerance decreased, Gastrointestinal sounds abnormal, Tachycardia; Abdominal X-ray, Chest pain, Computerised tomogram abdomen, Computerised tomogram thorax, Dyspnoea; Dyspnoea exertional, Exercise tolerance decreased, Gastrointestinal sounds abnormal, Tachycardia
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After the Covid vaccine was administered I went home and attempted to work out I was never told not...
After the Covid vaccine was administered I went home and attempted to work out I was never told not to I got shortness of breath and chest pain. I rested and developed shortness of breath through the years. Last year I was working out and I heard a pop in my left abdomen and can bo longer work out as I get shortness of breath. I attempted to go to a jacuzzi to see if I got relief but the pressure makes me feel like something is going to pop.
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| 2843265 | 16 | F | KS | 05/29/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FP7137 FP7137 FP7137 |
Anxiety, Autoantibody test, Chest X-ray normal, Condition aggravated, Echocardio...
Anxiety, Autoantibody test, Chest X-ray normal, Condition aggravated, Echocardiogram; Electrocardiogram, Laboratory test normal, Loss of consciousness, Magnetic resonance imaging head, Postural orthostatic tachycardia syndrome; Sinus operation
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Passing out, POTS flare up and anxiety attack. Went to hospital. Labs and chest X-ray were normal...
Passing out, POTS flare up and anxiety attack. Went to hospital. Labs and chest X-ray were normal at the time. Afterwards established care with cardiologist, neurologist, ENT, rheumatologist and working on getting a gastrologist.
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| 2843266 | 65 | F | 05/29/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Erythema, Pain, Pruritus, Rash
Erythema, Pain, Pruritus, Rash
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redness, rash, sore and itch
redness, rash, sore and itch
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| 2843267 | 12 | F | KS | 05/29/2025 |
RAB |
SANOFI PASTEUR |
L7L55 |
Injection site urticaria, Urticaria
Injection site urticaria, Urticaria
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Urticaria involving 2/3 of affected upper arm on date of admission. Recurrent hives ever since at i...
Urticaria involving 2/3 of affected upper arm on date of admission. Recurrent hives ever since at injection site
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| 2843268 | 65 | M | CA | 05/29/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Trigger finger
Trigger finger
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Immediate onset of trigger finger, middle finger of right hand. Never had symptoms previously.
Immediate onset of trigger finger, middle finger of right hand. Never had symptoms previously.
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| 2843285 | 81 | F | IL | 05/29/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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PATIENT RECEIVED CAPVAXIVE ON 5/16/25. A FEW DAYS PRIOR SHE INQUIRED ABOUT GETTING THE VACCINE AND T...
PATIENT RECEIVED CAPVAXIVE ON 5/16/25. A FEW DAYS PRIOR SHE INQUIRED ABOUT GETTING THE VACCINE AND THE PATIENT WAS UNSURE IF SHE'S GOTTEN A PREVIOUS DOSE OF PNEUMONIA. WE TOLD HER TO FOLLOW-UP WITH HER DOCTOR. THE PHARMACY ALSO PUT IN A CALL TO THE DOCTOR ASKING WHICH VACCINE WE SHOULD ADMINISTERED. THE NEXT TIME THE PATIENT CAME IN SHE SAID THAT HER DOCTOR GAVE HER THE OKAY TO GET THE VACCINE BECAUSE SHE DID NOT GET ANY PREVIOUS SHOT. WE ADMINISTERED THE SHOT ON 5/16/25. A FEW DAYS LATER THE DOCTOR CALLED BACK TO RETURN OUR CALL ONLY TO BE TOLD BY THE DOCTOR'S OFFICE THAT THE PATIENT ALREADY RECEIVED PREVNAR 20 A FEW DAYS BEFORE 5/16/25. PATIENT HAS NOT REPORTED ANY SIDE EFFECTS.
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