| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2850300 | 70 | F | FL | 07/18/2025 |
RSV |
PFIZER\WYETH |
md5462 |
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-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
More
|
||||||
| 2850301 | 58 | F | NJ | 07/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55th4 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
More
|
||||||
| 2850302 | 58 | F | CT | 07/18/2025 |
PNC21 |
MERCK & CO. INC. |
z004301 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia
More
|
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Medium, Other Vaccines: VaccineTypeBrand: heplisav; Manufacturer: dynavax tech; LotNumber: 946064; Route: im; BodySite: left deltoid; Dose: 1; VaxDate: 06/28/2025
More
|
||||||
| 2850304 | 64 | M | SC | 07/18/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
h4279 |
Dizziness
Dizziness
|
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient states that he felt like he wa...
Systemic: Dizziness / Lightheadness-Mild, Additional Details: patient states that he felt like he was going to pass out.
More
|
||||||
| 2850305 | 53 | F | NE | 07/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
TS525 |
Injection site erythema, Injection site pain
Injection site erythema, Injection site pain
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
|
||||||
| 2850307 | 65 | F | FL | 07/18/2025 |
PNC20 |
PFIZER\WYETH |
ln4928 |
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-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection...
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
More
|
||||||
| 2850308 | 28 | F | MA | 07/18/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
h4279 |
Joint injury
Joint injury
|
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
|
||||||
| 2850309 | 70 | M | FL | 07/18/2025 |
COVID19 |
PFIZER\BIONTECH |
me6072 |
Asthenia, Hypoaesthesia, Injection site bruising, Injection site erythema, Parae...
Asthenia, Hypoaesthesia, Injection site bruising, Injection site erythema, Paraesthesia
More
|
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: arm/finge...
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: arm/finger numbness/tingling especially in wrist-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: numbness/tingling arm/hand/wrist
More
|
||||||
| 2850310 | 55 | F | CA | 07/18/2025 |
PNC21 |
MERCK & CO. INC. |
z003579 |
Heart rate increased, Injection site erythema, Injection site pain, Palpitations
Heart rate increased, Injection site erythema, Injection site pain, Palpitations
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: fast heart be...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: fast heart beat/ palpitations-Mild, Other Vaccines: VaccineTypeBrand: boostrix; Manufacturer: glaxosmithkline; LotNumber: h4279; Route: im; BodySite: right deltoid; Dose: 1; VaxDate: UNKNOWN
More
|
||||||
| 2850311 | 29 | M | TX | 07/18/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
946064 946064 |
Chest discomfort, Chest pain, Eye swelling, Mouth swelling, Pruritus; Swelling f...
Chest discomfort, Chest pain, Eye swelling, Mouth swelling, Pruritus; Swelling face, Swollen tongue
More
|
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / T...
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: pt developed symptoms 15 min after injection, he rushed to ER and was given benadryl and medrol dose pack. Symptoms has subside after medication
More
|
||||||
| 2850312 | 50 | M | GA | 07/18/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5Y4TL 5Y4TL |
Dizziness, Flushing, Hyperhidrosis, Injection site pain, Loss of consciousness; ...
Dizziness, Flushing, Hyperhidrosis, Injection site pain, Loss of consciousness; Pallor, Syncope, Tremor, Unresponsive to stimuli
More
|
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Un...
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: AFTER VACCINE ADMNISTRATION, PATIENT BECAME LIGHT HEADED DIZZY, PASSED OUT 5-10 SECONDS, SHAKING, THEN BECAME ALERT. THEN, SWEATY, FLUSH, PALE. NO FALLS, BLOOD PRESSUE ~10 MINS AFTER EVEN 104/72 PULSE 80, ~25 MINS AFTER 124/80
More
|
||||||
| 2850313 | 42 | M | CA | 07/18/2025 |
TDAP TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
h4279 h4279 h4279 |
Chills, Dizziness, Fatigue, Hypoaesthesia, Hypotension; Injection site erythema,...
Chills, Dizziness, Fatigue, Hypoaesthesia, Hypotension; Injection site erythema, Injection site pain, Injection site swelling, Lethargy, Pain; Pyrexia, Tremor, Vomiting
More
|
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Medium, Systemic: Vomiting-Mild
More
|
||||||
| 2850315 | 65 | F | TX | 07/18/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
lm2215 lm2215 |
Asthenia, Fatigue, Injection site pain, Lethargy, Pain; Pyrexia
Asthenia, Fatigue, Injection site pain, Lethargy, Pain; Pyrexia
|
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion /...
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Weakness-Severe, Additional Details: pt came after a month complaining she has take pain management course probably some kind of injection and was in mergency for few days, Other Vaccines: VaccineTypeBrand: shingles; Manufacturer: glaxosmith; LotNumber: 3273h; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: covid; Manufacturer: pfizer; LotNumber: md3414; Route: im; BodySite: right; Dose: ; VaxDate: UNKNOWN
More
|
||||||
| 2850316 | 72 | F | NJ | 07/18/2025 |
COVID19 |
PFIZER\BIONTECH |
ME6072 |
Epistaxis, Headache, Injection site erythema, Injection site pain
Epistaxis, Headache, Injection site erythema, Injection site pain
|
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Reported bloody n...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Reported bloody nose-Medium, Systemic: Headache-Medium, Additional Details: Patient came to pharmacy in-person on 07/08/25 and reported that she had these side effects after receiving the vaccine on 06/24/25.
More
|
||||||
| 2850317 | 77 | F | CA | 07/18/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
a2b72 |
No adverse event
No adverse event
|
Site: Redness at Injection Site-Mild, Systemic: Weakness-Mild, Additional Details: pt is on radiatio...
Site: Redness at Injection Site-Mild, Systemic: Weakness-Mild, Additional Details: pt is on radiation told the pharmacist after vaccine was given and mentioned egg allergy told after vaccination pt follow up she was doing good no side effects after vaccination advised to seek er if any side effects , note: no pain or redness or weekness or side effects at the site of injection when contacted the pt ( just on the report have to choose an option )
More
|
||||||
| 2850318 | 65 | F | TX | 07/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55th4 |
Injection site erythema, Injection site pain, Injection site swelling, Product a...
Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
More
|
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient visited doctor after pain/swelling/redness in injection site did not subside. Doctor mentioned that the injection appeared to be given too low on the arm. Redness and swelling are better, but patient is still experiencing pain.
More
|
||||||
| 2850319 | 79 | F | KS | 07/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
TS525 |
Tachycardia
Tachycardia
|
Systemic: tachycardia-Mild, Systemic: Tachycardia-Mild
Systemic: tachycardia-Mild, Systemic: Tachycardia-Mild
|
||||||
| 2850320 | 55 | F | CT | 07/18/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Injection site pain
Injection site pain
|
Site: Pain at Injection Site-Medium, Additional Details: Patient reported event via email. Patient ...
Site: Pain at Injection Site-Medium, Additional Details: Patient reported event via email. Patient unable to be reached by phone after multiple attempts.
More
|
||||||
| 2850321 | 34 | F | FL | 07/18/2025 |
HPV9 |
MERCK & CO. INC. |
y008640 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: heplisav; Manufacturer: dynavax; LotNumber: 946060; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
More
|
||||||
| 2850322 | 17 | M | NV | 07/18/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
57h54 57h54 |
Dizziness, Eye movement disorder, Injection site erythema, Loss of consciousness...
Dizziness, Eye movement disorder, Injection site erythema, Loss of consciousness, Pallor; Syncope, Unresponsive to stimuli, Vomiting
More
|
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: ...
Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Immunizer gave Menveo Injection IM Left Arm and after the injection patient said he felt light headed and then his eyes rolled back and he passed out. immunizer Immediately called me over and he regained consciousness once I got there. His face was very pale and threw up. I gave him water and OJ. We called 911. His mom was in the room the whole time EMT took his vitals and said he looked good. After about 20 min or so he felt fine and left with his mom.
More
|
||||||
| 2850323 | 73 | F | OH | 07/18/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793pt |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
|
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injec...
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Other Vaccines: VaccineTypeBrand: Shingles (Shingrix); Manufacturer: GSK; LotNumber: 2M7GR; Route: IM; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
More
|
||||||
| 2850324 | 72 | F | AZ | 07/18/2025 |
PNC21 |
MERCK & CO. INC. |
y019158 |
Injection site erythema, Injection site pruritus, Injection site rash, Injection...
Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
More
|
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at In...
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: patient present on 7/10 with rash at injection site and is itchy/warm to the touch. recommended pt to try topical ice and hydrocortisone cream. and to let us know if it gets any worse.
More
|
||||||
| 2850325 | 41 | M | FL | 07/18/2025 |
HPV9 |
MERCK & CO. INC. |
z002903 |
Hypoaesthesia, Paraesthesia, Pruritus
Hypoaesthesia, Paraesthesia, Pruritus
|
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: fa...
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient waiting to see if symptoms subside prior to doctor visit if symptoms persist patient will proceed with doctor visit within 72 hours. Will followup with patient in 24 hours from vaccine administration.
More
|
||||||
| 2850326 | 65 | F | CA | 07/18/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
xa534 |
Injection site bruising, Injection site erythema, Injection site pain
Injection site bruising, Injection site erythema, Injection site pain
|
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
More
|
||||||
| 2850327 | 60 | F | CA | 07/18/2025 |
PNC21 |
MERCK & CO. INC. |
z003579 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: arexvy; Manufacturer: ; LotNumber: xa53y; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 07/07/2025
More
|
||||||
| 2850328 | 82 | F | FL | 07/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
39h2s |
Injection site erythema, Injection site pain, Injection site pruritus, Skin exfo...
Injection site erythema, Injection site pain, Injection site pruritus, Skin exfoliation
More
|
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient came in on 07/10/2025 at 5:08pm stating the vaccine she had received on 06/20/25 had caused her to have current reddness, injection site pain and peeling of skin around the injection site. Stated when she had the injection on 06/20/25, she had experienced some arm pain and it had continued to worsen. Advised patient to seek medical attention as soon as she can to look at the condition. Patient denied that she is unable to breathe and is able to continue with her daily activities
More
|
||||||
| 2850329 | 61 | F | CA | 07/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
33fd3 |
Injection site erythema
Injection site erythema
|
Site: Redness at Injection Site-Medium, Additional Details: pt stopped by the pharmacy and complaine...
Site: Redness at Injection Site-Medium, Additional Details: pt stopped by the pharmacy and complained of skin redness that developed a day after receiving shingrix vaccine at the pharmacy. Skin redness described as ( 4x6 in) area on the left lateral arm, right beneath her deltoid region where she received the injection. Smooth looking skin with no raised lesions or hives observed at the redness area. Pt said she has been applying ice to the area. Recommended her to take benadryl to control the allergic rxn sx and advised her to go to urgent care
More
|
||||||
| 2850330 | 16 | F | GA | 07/18/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
57H54 |
Seizure
Seizure
|
Systemic: Seizure-Medium, Other Vaccines: VaccineTypeBrand: HPV (GARDASIL 9); Manufacturer: Merck; ...
Systemic: Seizure-Medium, Other Vaccines: VaccineTypeBrand: HPV (GARDASIL 9); Manufacturer: Merck; LotNumber: Z005055; Route: IM; BodySite: Right Arm; Dose: 2 of 3; VaxDate: 07/12/2025
More
|
||||||
| 2850331 | 29 | F | KY | 07/18/2025 |
COVID19-2 COVID19-2 |
PFIZER\BIONTECH PFIZER\BIONTECH |
ME6072 ME6072 |
Anaphylactic reaction, Cough, Dysphagia, Dyspnoea, Flushing; Hyperhidrosis, Thro...
Anaphylactic reaction, Cough, Dysphagia, Dyspnoea, Flushing; Hyperhidrosis, Throat tightness
More
|
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A...
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: She began coughing within 5 minutes of the vaccine and started grabbing her throat. By the time I got out to her, she was in extreme distress.
More
|
||||||
| 2850332 | 54 | M | OH | 07/18/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
0175541842 0175541842 |
Erythema, Headache, Injection site erythema, Injection site pain, Injection site...
Erythema, Headache, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Pain in extremity, Peripheral swelling, Pyrexia
More
|
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Severe, Systemic: Headache-Medium, Additional Details: pain, swelling, redness traveled from injection site down to the hand over a week after the vaccine
More
|
||||||
| 2850333 | 61 | M | AL | 07/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
x5t42 |
Arthralgia, Injection site pain, Mobility decreased, Pain in extremity
Arthralgia, Injection site pain, Mobility decreased, Pain in extremity
|
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: patient said h...
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: patient said her arm hurt and she cannot lift it above her shoulder. she does not wantt to go to md since she has high deductible, Other Vaccines: VaccineTypeBrand: boostrix; Manufacturer: ; LotNumber: kr75k; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
More
|
||||||
| 2850334 | 76 | F | FL | 07/18/2025 |
PNC20 |
PFIZER\WYETH |
ln4930 |
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
|
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Inject...
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Pt came in on 07/14/25 at 9:05 am and displayed her arm with slight redness and swelling from when she got a prevnar 20 and covid 19 (pfizer) vaccine together on the same day. Pt has gotten a covid vaccine before and suspects it to be from prevnar. Advised pt to seek professional help for check up and pt confirmed no limitations to daily activities, Other Vaccines: VaccineTypeBrand: covid; Manufacturer: pfizer; LotNumber: me6072; Route: intramuscular; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
More
|
||||||
| 2850335 | 4 | M | MA | 07/18/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U8383AB Z007853 |
Posture abnormal, Seizure, Tremor; Posture abnormal, Seizure, Tremor
Posture abnormal, Seizure, Tremor; Posture abnormal, Seizure, Tremor
|
Mom was lying next to him in bed and noticed that he was shaking. Mom thought he might be cold and ...
Mom was lying next to him in bed and noticed that he was shaking. Mom thought he might be cold and pulled a blanket on him. Lasted 6 seconds in total. Patient was sleeping at naptime later in day and started convulsing. Lasted less than 10 seconds. Legs were extended and upper arms were flexed. Eyes were closed. Did not pick him up or touch him until the shaking stopped. Patient was conversant with them immediately after the episode. By the time mom arrived, patient was in a chair. Seemed a little out of it, but that is normal when he wakes from a nap.
More
|
||||||
| 2850336 | 14 | M | ID | 07/18/2025 |
HPV9 MENB MNQ |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
Y007991 G334J U8438AA |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration
More
|
Patient given Men A and Men B too early. Parents notified that patient will need imms again at late...
Patient given Men A and Men B too early. Parents notified that patient will need imms again at later date.
More
|
||||||
| 2850337 | F | TX | 07/18/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Alanine aminotransferase, Antineutrophil cytoplasmic antibody, Aspartate aminotr...
Alanine aminotransferase, Antineutrophil cytoplasmic antibody, Aspartate aminotransferase, Biopsy muscle, Blood bilirubin; Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood thyroid stimulating hormone, CSF glucose, CSF protein; CSF red blood cell count, CSF test, CSF white blood cell count, Chest X-ray, Glycosylated haemoglobin; HLA marker study, Magnetic resonance imaging spinal, Physical examination, Renal function test, Rhabdomyolysis; Rheumatoid factor, Smooth muscle antibody, Thyroxine free, White blood cell count
More
|
Vaccine-Induced Rhabdomyolysis; This is a literature report . A 53-year-old female patient received...
Vaccine-Induced Rhabdomyolysis; This is a literature report . A 53-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The following information was reported: RHABDOMYOLYSIS (caused hospitalization) with onset 2021, 45 days after the suspect product(s) administration, outcome "recovered", described as "Vaccine-Induced Rhabdomyolysis". The patient was hospitalized and prolonged hospitalization for rhabdomyolysis (hospitalization duration: 43 day(s)). The patient's medical history, historical vaccinations, concomitant medications, and clinical course was reported as follows: The patient initially presented to the hospital after 3 weeks of progressive proximal extremity weakness. The patient reported bilateral proximal upper and lower extremities pain, which started with the left lower extremity and progressed to the right lower extremity. One week later, the patient reported right upper extremity pain followed by left extremity pain. She noted a decrease in exercise capacity, from 30 minutes on the treadmill to 10-15 minutes. She denied prior similar symptoms. The pain was described as muscle soreness from a workout that occurred predominantly with movement. Neck and lower back pain were endorsed but the patient attributed these findings to a sedentary job. The patient received the second dose of COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine), in early 2021, with both vaccines given in the left arm. Adverse effects reported from the vaccine included nausea and vomiting that resolved after 2 weeks. Presentation of symptoms occurred about 45 days after the second dose. The patient denied fever, chills, headache, recent trauma, shortness of breath, recent upper respiratory infections, gastrointestinal infections, pain in extremities, chest pain, rashes, recent travels, camping, new diet/foods (honey), medication changes, family history or cancers personally or in family. The patient had a past medical history of diabetes mellitus and dyslipidemia. Medications included atorvastatin 80 mg which was decreased to 40 mg, due to left extremity soreness, about 45 days after the second dose, and metformin 500 mg. Of note, the patient had been on atorvastatin for over 3 years. Surgical history included ectopic pregnancy status post laparoscopy. She had no known drug allergies. The patient reported she consumed alcoholic beverages on occasion but denied smoking or recreational drug use. Physical exam showed the patient had bilateral proximal weakness in the upper and lower extremities, which was specifically pronounced bilaterally in the thighs. She was also noted to have pronounced tenderness on passive and active movements of bilateral upper and lower extremities. Initial labs included creatine kinase of 7800 U/L initially, which trended down during hospitalization. Other labs included, aspartate aminotransferase 241 U/L, alanine aminotransferase 384 U/L, total bilirubin 1.2 mg/ dL, white blood cell (WBC) count 10.4 x 109/L , thyroid-stimulating hormone 7.18 uUI/mL with free T4 1.15 ng/dL, creatine kinase MB 292.3 U/L, HbA1c 6.3%, rheumatoid factor less than 10 IU/ mL, cytoplasmic anti-neutrophil cytoplasmic antibody less than 0.2 IU/mL, and anti-smooth muscle antibody of 14 units. Cerebrospinal fluid (CSF) analysis was obtained, which showed colorless fluid with CSF protein of 24.7 mg/dl, CSF WBC 0 x 109/L, CSF RBC 1, CSF glucose 66 mg/ dL. The CSF results were not consistent with Guillain-Barre syndrome. Imaging consisted of chest x-ray which demonstrated no abnormalities. A magnetic resonance image without contrast of cervical spine/ lumbar spine/extremities demonstrated mild degenerative changes in the discs throughout the region with mild diffuse annular disc bulging and spondylosis at C5-6 and C6-7. Lumbar region findings included mild degenerative changes in discs, otherwise, with no other acute abnormality. Extremities were noted to have no significant abnormality. A right thigh skeletal muscle biopsy was ordered, which was consistent with necrotizing myopathy, without specific diagnostic features and without features of chronic myopathic disorder. HLA class I immunohistochemistry was negative which provided support for nonimmune myopathy. Atorvastatin was discontinued on day 1 of hospitalization. The patient received aggressive intravenous hydration consisting of normal saline at 150 cc/hr, increased to 200 cc/hr on day 2 of hospitalization, and sustained at 200 cc/hr until day 41. Kidney function was monitored throughout the hospitalization and reοΏ½mained within normal limits. Strict intake and output were documented along with volume status evaluation. The patient also received prednisone from day 1 to day 42 of hospitalization (30-40 mg PO daily) due to suspicion of an autoimmune process. She was also given intra-venous immunoglobulin from day 37 to day 42 and was monitored for possible improvement in creatine kinase. The patient symptomatically improved throughout the hospitalization and was discharged home on Day 43 with close follow-up. Therapeutic measures were taken as a result of rhabdomyolysis. Per the author's discussion: There are few published cases of similar symptoms with COVID-19 vaccine. Unlike prior similar cases, our patient demonstrated a delayed adverse effect, approximately 5 weeks after injection of the second vaccine dose. This could be attributed to the efficacy of the second dose of vaccine with age, cellular, and humoral immune responses as contributing factors, with studies demonstrating peak IgA/ IgG approximately 5 weeks. Rhabdomyolysis secondary to vaccines has been previously described with the influenza vaccine. These cases displayed similar histopathological features on biopsy as our patient: a small number of lymphocytes, almost exclusively associated with necrotic and regenerating myofibers; minimal inflammation, with negative HLA Class I immunohistochemistry, supporting a non-immune (non-inflammatory) myopathy.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event Rhabdomyolysis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
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| 2850338 | 52 | F | PA | 07/18/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3273H |
Back pain, Injection site pain, Muscle spasms, Pain in extremity
Back pain, Injection site pain, Muscle spasms, Pain in extremity
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Soreness at the injection site, lower back spasms, and pain on the left side from lower back to leg.
Soreness at the injection site, lower back spasms, and pain on the left side from lower back to leg.
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| 2850339 | 48 | F | GA | 07/18/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
EB499 |
Pain, Pain in extremity
Pain, Pain in extremity
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Patient was treated in our office due to a needlestick. She received a TDAP vaccine at that time. A ...
Patient was treated in our office due to a needlestick. She received a TDAP vaccine at that time. A few days following the event patient began to have extreme pain from her upper arm to mainly just below her elbow. She reports the pain as pulsating. She reports difficulty describing the pain as it can almost feel numb at times. We have recommended cold compress and OTC pain medications
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| 2850340 | 0.67 | F | VA | 07/18/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
YN2x2 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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An 8-month-old patient was brought in by the mother for routine vaccinations. The mother prefers to ...
An 8-month-old patient was brought in by the mother for routine vaccinations. The mother prefers to space out vaccines. To accommodate the parent s request, Kinrix a combination vaccine for DTaP and IPV was chosen instead of administering two separate shots. Kinrix is specifically for ages 4 years and older. This age-related description was not discussed with the parent during the visit. The parent was not informed that Kinrix, a vaccine intended for older children, was being administered. No adverse reactions reported or occurred.
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| 2850341 | 53 | M | MN | 07/18/2025 |
COVID19 |
MODERNA |
021C21A |
Burning sensation, Fatigue, Nervous system disorder, Tinnitus
Burning sensation, Fatigue, Nervous system disorder, Tinnitus
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Fatigue, tinnitus, burning sensations, other nervous system events,
Fatigue, tinnitus, burning sensations, other nervous system events,
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| 2850343 | 28 | F | WY | 07/18/2025 |
TDAP |
SANOFI PASTEUR |
3CA34C1 |
Contusion, Pain, X-ray normal
Contusion, Pain, X-ray normal
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Around 10 days following the injection, patient noted bruising, worsening pain, and increasing pain ...
Around 10 days following the injection, patient noted bruising, worsening pain, and increasing pain with push/pull motions
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| 2850344 | 88 | F | MN | 07/18/2025 |
MMR PNC20 VARZOS |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
GE974 LX4483 GJ952 |
Dizziness, Dysstasia; Dizziness, Dysstasia; Dizziness, Dysstasia
Dizziness, Dysstasia; Dizziness, Dysstasia; Dizziness, Dysstasia
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Patient started feeling very dizzy about 15 minutes post immunizations. He couldn't stand and ...
Patient started feeling very dizzy about 15 minutes post immunizations. He couldn't stand and had to put his head between his legs. He eventually felt well enough to drive. He refused an ambulance.
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| 2850345 | 40 | F | ID | 07/18/2025 |
TDAP TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8353BA U8353BA U8353BA |
Abdominal distension, Axillary pain, Chills, Dizziness, Erythema; Fatigue, Flush...
Abdominal distension, Axillary pain, Chills, Dizziness, Erythema; Fatigue, Flushing, Headache, Injection site mass, Injection site pain; Injection site warmth, Myalgia, Nausea, Pain, Palpitations
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Today she states overall feeling a bit worse than date of injury. States on 7/15 localized symptoms ...
Today she states overall feeling a bit worse than date of injury. States on 7/15 localized symptoms started and towards the end of the night she began to have muscle soreness, fatigue. The following day she developed more soreness, body aches/chills, facial flushing, and a hard lump at the injection site. The following day, 7/17 she developed deep, burning pain into her axilla, nausea, increased erythema, the injection site became hot, tender to touch, fatigue and headaches, dizziness, palpations, epigastric fullness. Today she woke with worsening pain at the injection site, worsening fatigue, headache, body aches. Does endorse the epigastric fullness, palpitations, dizziness are resolved now. States touch is painful, clothing rubbing on the injection site is painful and continues to be warm and tender to touch. Current treatments: - Benadryl - Hydrocortisone cream - Tylenol - Pepcid - Zyrtec - Ice - Tramadol - Zofran - Anti-Inflammatories
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| 2850346 | 11 | F | CA | 07/18/2025 |
COVID19 HPV9 MNQ TDAP |
PFIZER\BIONTECH MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
LN7302 Y015179 3E99M L5229 |
Product storage error; Product storage error; Product storage error; Product sto...
Product storage error; Product storage error; Product storage error; Product storage error
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Covid vaccine was administered outside the recommended 10 weeks after taken from the ultra cold env...
Covid vaccine was administered outside the recommended 10 weeks after taken from the ultra cold environment.
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| 2850347 | 6 | F | CA | 07/18/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN7302 CZ47E |
Product storage error; Product storage error
Product storage error; Product storage error
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Covid vaccine was administered outside the recommended 10 weeks after taken from the ultra cold env...
Covid vaccine was administered outside the recommended 10 weeks after taken from the ultra cold environment.
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| 2850348 | 8 | F | MO | 07/18/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4L454 Z003308 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient had received all recommended doses of these vaccinations. These additional doses were admini...
Patient had received all recommended doses of these vaccinations. These additional doses were administered in error. Discussed with parents. Advised of possible side effects of sore arm, fever, pain and rash at the injection site. Discussed interventions such as administration of acetaminophen or ibuprofen for pain or fever, apply cold compress as needed. Consult physician if child develops more severe or prolonged symptoms.
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| 2850349 | 12 | F | 07/18/2025 |
COVID19 TYP |
PFIZER\BIONTECH SANOFI PASTEUR |
ME6072 Y2A031M |
Laboratory test, Palpitations; Laboratory test, Palpitations
Laboratory test, Palpitations; Laboratory test, Palpitations
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Per patient's mother, patient had gone to the ER the night of 7/17/25 due to palpitations. Base...
Per patient's mother, patient had gone to the ER the night of 7/17/25 due to palpitations. Based on the encounter, the medical staff had run tests and sent the patient home with instructions to continue monitoring heartrate.
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| 2850350 | 78 | F | CA | 07/18/2025 |
COVID19 PNC20 |
PFIZER\BIONTECH PFIZER\WYETH |
ME6072 LN4929 |
Dizziness, Dizziness postural, Headache, Rash erythematous, Rash pruritic; Dizzi...
Dizziness, Dizziness postural, Headache, Rash erythematous, Rash pruritic; Dizziness, Dizziness postural, Headache, Rash erythematous, Rash pruritic
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Patient came to pharmacy 7/18/25 @ 09:20 reporting a left-arm circumferential pink rash 3 inches bel...
Patient came to pharmacy 7/18/25 @ 09:20 reporting a left-arm circumferential pink rash 3 inches below vaccination site (and 1 inch above elbow bend). States it started the morning after injection of both Prevnar 20 and Comirnaty. Patient states she felt dizzy spells and tingles in her head at night with some headache. She also reported mild orthostasis/dizziness upon rising from a reclined or lying position. She says the rash it a little itchy. I recommended she speak to her MD immediately (she states she did and has an appointment this Monday, 7/21/25). I recommended some 1% hydrocortisone to help reduce the pinkness and itchiness from the rash and to report to her MD immediately if her dizzy spells continue. I advised her not to drive (she did drive to the pharmacy today to report her adverse events).
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| 2850351 | 17 | F | TN | 07/18/2025 |
MENB |
PFIZER\WYETH |
LW8911 |
Pharyngeal swelling, Swelling face, Throat irritation, Urticaria
Pharyngeal swelling, Swelling face, Throat irritation, Urticaria
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Two days following immunization she developed facial swelling, hives, throat itching/swelling. No ot...
Two days following immunization she developed facial swelling, hives, throat itching/swelling. No other symptoms of illness and no medications taken in the last month.
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| 2850352 | 0.5 | M | FL | 07/18/2025 |
DTAPIPVHIB PNC20 RV5 |
SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
UK194AA LK6655 Y015019 |
Drooling, Lip swelling, Pyrexia; Drooling, Lip swelling, Pyrexia; Drooling, Lip ...
Drooling, Lip swelling, Pyrexia; Drooling, Lip swelling, Pyrexia; Drooling, Lip swelling, Pyrexia
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The morning after receiving vaccinations, patient presented to the ED for swelling of the lower lip,...
The morning after receiving vaccinations, patient presented to the ED for swelling of the lower lip, mild drooling, and fever. Patient was observed at ED without any increase in swelling or evidence of angioedema or anaphylaxis.
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| 2850353 | 07/18/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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took the Pfizer vaccine and passed away after it; This is a spontaneous report received from a Consu...
took the Pfizer vaccine and passed away after it; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-788038 (Moderna). 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: DEATH (death), outcome "fatal", described as "took the Pfizer vaccine and passed away after it". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Caller stated knew of a that took the Pfizer vaccine and passed away after it. It is unknown if the patient experienced any additional symptoms/events. 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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