| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2865718 | 87 | F | GA | 10/14/2025 |
PNC21 |
MERCK & CO. INC. |
Z004301 |
Feeling jittery, Posture abnormal
Feeling jittery, Posture abnormal
|
Patient received vaccination and stated that she was going to sit here for a little while. She star...
Patient received vaccination and stated that she was going to sit here for a little while. She started to feel like she felt jittery and asked for water. Gave her sip of water and went to get blood pressure monitor. Upon returning she was slumped over in the chair, but we were able to arouse her. We called 911 and checked her BP (62/38 and 58/42). This took place over 15 minutes.
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| 2865719 | 19 | M | CO | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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Hypersomnia, Laboratory test
Hypersomnia, Laboratory test
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Idiopathic hypersonic
Idiopathic hypersonic
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| 2865720 | 77 | F | CO | 10/14/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8874AA U8874AA |
Blood culture negative, Blood test normal, Chest X-ray abnormal, Depressed level...
Blood culture negative, Blood test normal, Chest X-ray abnormal, Depressed level of consciousness, Metabolic function test normal; Oxygen saturation decreased, Pulmonary mass, Pyrexia, Urine analysis normal, White blood cell count normal
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Fever of 104.7, semiconscious; transported to ER
Fever of 104.7, semiconscious; transported to ER
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โ | |||||
| 2865721 | 63 | M | MI | 10/14/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
ZE423 ZE423 |
Injection site erythema, Injection site induration, Injection site oedema, Injec...
Injection site erythema, Injection site induration, Injection site oedema, Injection site swelling, Injection site warmth; Local reaction, Malaise, Nausea
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I received an influenza vaccination and had a significant local reaction with some systemic side eff...
I received an influenza vaccination and had a significant local reaction with some systemic side effects as well. The deltoid area was extremely edematous/swollen/hard, hot to the touch and had a reddish in color. I had a low grade fever of 100.3 degrees F with significant nausea and a malaise feeling. I was icing the injection site and started taking acetaminophen 1000mg and diphenhydramine 50mg ATC for the next following days.
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| 2865722 | 69 | F | MO | 10/14/2025 |
FLU3 |
SEQIRUS, INC. |
70461-0025-03 |
Gait inability, Myalgia
Gait inability, Myalgia
|
About 2 hours after my injection, I experienced severe left leg muscle pain. I was unable to walk. ...
About 2 hours after my injection, I experienced severe left leg muscle pain. I was unable to walk. I had mild muscle pain in my right leg. I elevated my left leg, iced it and took ibuprofen. My leg pain resolved by morning.
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| 2865723 | 79 | F | KS | 10/14/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
U8859BA Z009681 |
Erythema, Limb discomfort, Peripheral swelling, Pruritus, Skin warm; Erythema, L...
Erythema, Limb discomfort, Peripheral swelling, Pruritus, Skin warm; Erythema, Limb discomfort, Peripheral swelling, Pruritus, Skin warm
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Patient received the Capvaxive IMZ in her right arm and the fluzone HD in her left arm on 10/8/2025 ...
Patient received the Capvaxive IMZ in her right arm and the fluzone HD in her left arm on 10/8/2025 aboud 3:57 pm. She reports first noticing a reaction on her right arm on Monday October 13 around 5:30 pm. It started off with a small red area. Then today the pt. noticed the arm was more red over a larger area. There is swelling and it feels warm to the touch. She reports it is uncomfortable feeling and itches.
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| 2865724 | 83 | F | OH | 10/14/2025 |
COVID19 |
MODERNA |
3052736 |
Diarrhoea, Erythema, Nausea, Pain in extremity, Peripheral swelling
Diarrhoea, Erythema, Nausea, Pain in extremity, Peripheral swelling
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Patient had full upper arm swelling, deep redness also around whole upper arm, with pain. Also GI s...
Patient had full upper arm swelling, deep redness also around whole upper arm, with pain. Also GI symptoms including diarrhea/nausea. Came on later that evening after getting the vaccine.
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| 2865725 | 50 | F | WI | 10/14/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
FH4YR |
Arthralgia, Hypoaesthesia, Paraesthesia
Arthralgia, Hypoaesthesia, Paraesthesia
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Patient developed pain in shoulder which was still present 8 days after receiving the vaccine. Patie...
Patient developed pain in shoulder which was still present 8 days after receiving the vaccine. Patient also developed numbness and tingling into forearm and arm after receiving the vaccine.
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| 2865728 | 69 | F | FL | 10/14/2025 |
PNC20 |
PFIZER\WYETH |
MA2488 |
Extra dose administered
Extra dose administered
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Patient received additional dose when no additional doses are recommended. Doses received 11/2023 an...
Patient received additional dose when no additional doses are recommended. Doses received 11/2023 and 10/2025.
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| 2865729 | 61 | F | MA | 10/14/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
T9DX2 |
Paraesthesia oral, Urticaria
Paraesthesia oral, Urticaria
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Developed hives and tongue tingling with in 15 min of receiving vaccine. 50 mg of Benadryl given, no...
Developed hives and tongue tingling with in 15 min of receiving vaccine. 50 mg of Benadryl given, no SOB
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| 2865730 | 74 | M | NJ | 10/14/2025 |
FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
407255 407255 407255 |
Areflexia, Arteriogram carotid, Computerised tomogram abdomen, Computerised tomo...
Areflexia, Arteriogram carotid, Computerised tomogram abdomen, Computerised tomogram head normal, Computerised tomogram normal; Computerised tomogram thorax, Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Laboratory test normal; Magnetic resonance imaging spinal normal, Muscular weakness, Paraesthesia, Respiratory failure, Scan with contrast normal
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Guillian Barre Syndrome. Pt started to have upper extremity finger tip tingling in both arms at 1am...
Guillian Barre Syndrome. Pt started to have upper extremity finger tip tingling in both arms at 1am on 10/10, progressed to weakness in the arms then legs, got acutely worse in ER. No reflexes. No other explanation for weakness. Scans negative, admitted to ICU, intubated for respiratory failure on 10/12.
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โ | โ | ||||
| 2865731 | 68 | F | OH | 10/14/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Arthralgia, Limb injury
Arthralgia, Limb injury
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Shoulder injury, pain and limited range of motion. Symptoms started later that evening. Symptoms per...
Shoulder injury, pain and limited range of motion. Symptoms started later that evening. Symptoms persisting for the past 12 days.
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| 2865732 | F | 10/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Death, Encephalitis viral, Vaccination failure
Death, Encephalitis viral, Vaccination failure
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patient got the shot and died from the virus migrating to her brain.; Suspected vaccination failure;...
patient got the shot and died from the virus migrating to her brain.; Suspected vaccination failure; patient got the shot and died from the virus migrating to her brain.; This serious case was reported by a consumer via interactive digital media and described the occurrence of encephalitis herpes in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced encephalitis herpes (Verbatim: patient got the shot and died from the virus migrating to her brain.) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: patient got the shot and died from the virus migrating to her brain.). The outcome of the vaccination failure and shingles were not reported. The reported cause of death was encephalitis herpes. It was unknown if the reporter considered the encephalitis herpes, vaccination failure and shingles to be related to Shingrix. The company considered the encephalitis herpes and vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 09-SEP-2025 Reporter indicated to weigh the risks carefully as his/her friend got the shot and died from the virus migrating to her brain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Encephalitis herpes, on an unknown date, an unknown time after receiving Shingrix, in an adult female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.; Reported Cause(s) of Death: Encephalitis herpes
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| 2865734 | 73 | F | OH | 10/14/2025 |
FLU3 |
SEQIRUS, INC. |
407259 |
Wrong product administered
Wrong product administered
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Patient was expecting a covid vaccine and we gave her a flu shot.
Patient was expecting a covid vaccine and we gave her a flu shot.
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| 2865735 | 9 | M | OH | 10/14/2025 |
FLUN3 HEP |
MEDIMMUNE VACCINES, INC. MERCK & CO. INC. |
YF3413B |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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No adverse events were noted.
No adverse events were noted.
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| 2865736 | 53 | M | TX | 10/14/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
027A21A 027A21A 027A21A 027A21A 027A21A 027A21A |
Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Antinuclear an...
Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Antinuclear antibody negative, Blood cholesterol, Blood cortisol; Blood homocysteine, Blood iron increased, Blood testosterone decreased, Brain fog, C-reactive protein; Erectile dysfunction, Eye haemorrhage, Fatigue, Frustration tolerance decreased, Impaired work ability; Insulin-like growth factor, Laboratory test normal, Metabolic function test, Prostatic specific antigen, Psoriatic arthropathy; Rheumatoid factor increased, Serum ferritin, Sleep apnoea syndrome, Tenolysis, Thyroid function test; Trigger finger, Vertigo, Vitamin B12, Vitamin D
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Took two Moderna vaccine injections in 2022. Developed Psoriatic Arthritis, trigger finger, sleep ap...
Took two Moderna vaccine injections in 2022. Developed Psoriatic Arthritis, trigger finger, sleep apnea, vertigo, erectile dysfunction, chronic fatigue, low testosterone, increased rheumatoid factor, brain fog. Trigger finger surgery was done on three fingers. From patient, "I had not missed a day of work since 11/1983 until I took the vaccine. After the vaccine, blood vessels on the exterior of both eyes burst, developed severe vertigo, chronic fatigue, psoriatic arthritis, trigger finger in all 10 fingers (surgery on three fingers 8/8/25), erectile dysfunction, sleep apnea. I have been tested for sjogren's disease and lupus with negative results. Brain fog is my worst culprit. I work in healthcare and my memory/brain fog is extremely frustrating."
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โ | |||||
| 2865737 | 86 | M | CA | 10/14/2025 |
COVID19 |
MODERNA |
3052579 |
Underdose
Underdose
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patient received 2025-2026 COVID 19- Moderna Spikevax 6mo-11 yo 0.25 mL instead of the 2025-2026 COV...
patient received 2025-2026 COVID 19- Moderna Spikevax 6mo-11 yo 0.25 mL instead of the 2025-2026 COVID 19- Moderna Spikevax 12+ 0.5 mL dose.
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| 2865738 | 43 | F | OH | 10/14/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Seizure
Seizure
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Pt reported she had seizure after getting a covid vaccine.
Pt reported she had seizure after getting a covid vaccine.
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| 2865739 | 64 | M | ND | 10/14/2025 |
FLU3 PNC21 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4D255 Z006889 |
Injection site erythema, Injection site pruritus, Injection site rash, Injection...
Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth; Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
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Was reported that (R) arm/deltoid, became red, warm, itchy. "Looks like a rash around the arm&q...
Was reported that (R) arm/deltoid, became red, warm, itchy. "Looks like a rash around the arm".
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| 2865740 | 84 | F | CA | 10/14/2025 |
COVID19 |
MODERNA |
3052579 |
Underdose
Underdose
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patient received 2025-2026 COVID 19 MODERNA SPIKEVAX 6mo-11yo 0.25 mL instead of COVID 19 MODERNA SP...
patient received 2025-2026 COVID 19 MODERNA SPIKEVAX 6mo-11yo 0.25 mL instead of COVID 19 MODERNA SPIKEVAX 12+ 0.5 mL.
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| 2865741 | 11 | M | PR | 10/14/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
N4TY2 94KG2 |
Injection site erythema, Injection site inflammation, Injection site warmth; Inj...
Injection site erythema, Injection site inflammation, Injection site warmth; Injection site erythema, Injection site inflammation, Injection site warmth
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MOTHER REPORTS "THE MINOR'S AREA WHERE HE WAS VACCINATED STARTED TO TURN RED, HOT, AND INF...
MOTHER REPORTS "THE MINOR'S AREA WHERE HE WAS VACCINATED STARTED TO TURN RED, HOT, AND INFLAMED."
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| 2865742 | 4 | M | NY | 10/14/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4L454 Z008221 |
Cyanosis, Erythema, Urticaria, Vomiting; Cyanosis, Erythema, Urticaria, Vomiting
Cyanosis, Erythema, Urticaria, Vomiting; Cyanosis, Erythema, Urticaria, Vomiting
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Vaccines given at 1159. Mother called on her way to the car, spoke with RN stating red cheeks. Ret...
Vaccines given at 1159. Mother called on her way to the car, spoke with RN stating red cheeks. Returned to office at 1240. Patient with erythematous cheeks and urticaria on face spreading downward. No swelling noted. Good air entry. Sats >97%. Tachy from 150-160. 17mg PO diphenhydramine given at 1300. At 1308- started with NB, NB emesis and perioral cyanosis. 0.15mg epipen given @ 1309. Vitals monitored. HR improved, erythema resolved with residual urticaria noted in abdomen. Perioral cyanosis improved. Patient stated feeling better. 911 called. Patient sent to [withheld name] ED for further monitoring.
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| 2865743 | 17 | M | LA | 10/14/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
CD44A |
Asthenia, Dizziness, Headache, Vision blurred
Asthenia, Dizziness, Headache, Vision blurred
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blurred vision, light-headedness, headache, weakness
blurred vision, light-headedness, headache, weakness
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| 2865744 | 77 | F | GA | 10/14/2025 |
COVID19 |
MODERNA |
3052731 |
Dry throat, Dysphonia, Speech disorder, Throat tightness
Dry throat, Dysphonia, Speech disorder, Throat tightness
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Pt received vaccine at 12:15. After the vaccine was administered patient was asked to wait in the st...
Pt received vaccine at 12:15. After the vaccine was administered patient was asked to wait in the store for 15 to 30 mins. Pt stated she might have an allergic reaction so she would stay. At 12:23 the patient walked up to the window and stated her throat was dry and she was hoarse with difficulty speaking. She asked for us to provide her with Benadryl and water. I asked if I needed to call 911 or get the Epipen ready the patient stated no call to 911 and she was unable to receive an Epipen due to her heart. She stated she has so many allergies she is aware of the best way to handle them and the bendaryl should work fine. We gave her Benadryl and water at this time store management (name withheld) was also with us in the waiting room. At 12:35 the patient stated she was feeling better and she could speak, her throat was no longer tight. I requested she wait for another 15 minutes. (name withheld) Store manager asked her if we needed to call someone and she stated she was fine and feeling better. At 12:51 we asked her if she was driving herself she stated she was and she felt fine to drive and she was ready to leave.
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| 2865745 | 78 | F | IN | 10/14/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
8146743 8146743 |
Arthralgia, Brain fog, Confusional state, Dizziness, Fatigue; Injection site ery...
Arthralgia, Brain fog, Confusional state, Dizziness, Fatigue; Injection site erythema, Injection site warmth, Nausea, Pruritus, Pyrexia
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pt woke up the morning after vaccine with red, warm area at injection site, some itching all down le...
pt woke up the morning after vaccine with red, warm area at injection site, some itching all down legs, she had some nausea, dizziness, fatigue and joint pain. Said she also noted a slight fever. today 10/14/25 she also reported some brainfog and confusion. She went to the ER on 10/11/25 due to the symptoms.
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| 2865746 | 72 | M | NJ | 10/14/2025 |
COVID19 |
MODERNA |
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Back pain, Burning sensation, Paraesthesia
Back pain, Burning sensation, Paraesthesia
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Back.pain, right side , just to right of spine. Pain spreads out every 30-60 minutes to a tingling ...
Back.pain, right side , just to right of spine. Pain spreads out every 30-60 minutes to a tingling and burning feeling over entire right side over all my ribs.
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| 2865747 | 30 | F | FL | 10/14/2025 |
FLU3 TD |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
2L353 U80218A |
No adverse event; No adverse event
No adverse event; No adverse event
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No adverse events reported or noted.
No adverse events reported or noted.
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| 2865748 | 41 | F | VA | 10/14/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
AH2G4 |
Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Injected limb mobility decreased, Pain in extremity, Peripheral swelling
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States pain going down arm, swelling, Still decreased range of motion in left arm. Vaccine was give...
States pain going down arm, swelling, Still decreased range of motion in left arm. Vaccine was given in muscle at correct location.
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| 2865749 | 70 | F | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
my9550 |
Injection site erythema, Injection site paraesthesia
Injection site erythema, Injection site paraesthesia
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left arm in vicinity of vaccination site slightly redder than other arm and pt report of tingling se...
left arm in vicinity of vaccination site slightly redder than other arm and pt report of tingling sensation around site
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| 2865750 | 73 | M | UT | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9550 |
Arthralgia, Neck pain, Pain, Pain in extremity
Arthralgia, Neck pain, Pain, Pain in extremity
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2 DAYS AFTER INJECTION, PATIENT DESCRIBES DULL PAIN RADIATING FROM SHOULDER/ARM UP TO NECK. HAS GOTT...
2 DAYS AFTER INJECTION, PATIENT DESCRIBES DULL PAIN RADIATING FROM SHOULDER/ARM UP TO NECK. HAS GOTTEN WORSE IN THE LAST WEEK. I ADVISED PATIENT TO TREAT WITH ORAL ANTI-INFLAMMATORIES FOR 2 TO 3 DAYS AROUND THE CLOCK TO HELP EASE ANY INFLAMMATION AND IF NOT RESOLVED, SEEK MEDICAL ADVISE FROM PHYSICIAN.
More
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| 2865751 | 58 | F | CA | 10/14/2025 |
COVID19 COVID19 COVID19 COVID19 FLU3 FLU3 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
00069-2528-10 00069-2528-10 00069-2528-10 00069-2528-10 49281-0725-10 49281-0725-10 49281-0725-10 49281-0725-10 |
Aphasia, Blood cholesterol, Cerebral ischaemia, Coagulation test normal, Compute...
Aphasia, Blood cholesterol, Cerebral ischaemia, Coagulation test normal, Computerised tomogram head abnormal; Computerised tomogram normal, Confusional state, Echocardiogram normal, Electrocardiogram ambulatory, Electrocardiogram normal; Electroencephalogram normal, Facial paralysis, Gait inability, Glycosylated haemoglobin, Magnetic resonance imaging normal; Scan with contrast normal, Troponin normal; Aphasia, Blood cholesterol, Cerebral ischaemia, Coagulation test normal, Computerised tomogram head abnormal; Computerised tomogram normal, Confusional state, Echocardiogram normal, Electrocardiogram ambulatory, Electrocardiogram normal; Electroencephalogram normal, Facial paralysis, Gait inability, Glycosylated haemoglobin, Magnetic resonance imaging normal; Scan with contrast normal, Troponin normal
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Acute onset of confusion, inability to talk or walk, left sided facial drooping.. CT showed tempora...
Acute onset of confusion, inability to talk or walk, left sided facial drooping.. CT showed temporal lobe ischemia, CT angiogram showed clear arteries, MRI normal. EEG, EKG and cardiac echo all normal as well. Normal troponin. Admitted to the hospital for 24 hours. Took a full 24 hours before symptoms resolved.
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โ | โ | ||||
| 2865752 | 63 | F | MN | 10/14/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052864 948402 |
Hallucination, auditory; Hallucination, auditory
Hallucination, auditory; Hallucination, auditory
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Client received vaccine 10/13, site contact called our office 10/14. (withheld name) Director of Cli...
Client received vaccine 10/13, site contact called our office 10/14. (withheld name) Director of Clinical Operations, took this call. Reported client having auditory hallucinations similar to getting the vaccine last year, which was attributed to the flu vaccine. Unsure if the client's POA (who completed the consent form) was aware of this allergy (communicated that this should be included on consent form for future vaccines). The client was noted to be on a balcony last night - there was fear she may harm herself. Instructed to call PCP / POA and seek care if not improved.
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| 2865753 | 10/14/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Increased viscosity of bronchial secretion, Sputum discoloured, Upper respirator...
Increased viscosity of bronchial secretion, Sputum discoloured, Upper respiratory tract infection
More
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Clinic called it pre curser to pneumonia; got upper respiratory end Dec; Green thick mucus thought i...
Clinic called it pre curser to pneumonia; got upper respiratory end Dec; Green thick mucus thought it was the end; Green thick mucus thought it was the end.; This serious case was reported by a consumer via interactive digital media and described the occurrence of pneumonia in a elderly patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pneumonia (Verbatim: Clinic called it pre curser to pneumonia) (serious criteria GSK medically significant), upper respiratory tract infection (Verbatim: got upper respiratory end Dec), mucous membrane disorder (Verbatim: Green thick mucus thought it was the end) and sputum viscosity increased (Verbatim: Green thick mucus thought it was the end.). The outcome of the pneumonia, upper respiratory tract infection, mucous membrane disorder and sputum viscosity increased were not reported. It was unknown if the reporter considered the pneumonia, upper respiratory tract infection, mucous membrane disorder and sputum viscosity increased to be related to RSV vaccine. The company considered the pneumonia to be unrelated to RSV vaccine. It was unknown if the company considered the upper respiratory tract infection, mucous membrane disorder and sputum viscosity increased to be related to RSV vaccine. Additional Information: GSK receipt date 3 Oct 2025 This case was reported by a consumer via interactive digital media. The patient had rsv shot mid-November. The patient got upper respiratory at the end of December. The patient had Green thick mucus thought it was the end and clinic called it as pre curser to pneumonia. The patient recently saw a warning if over 60 should talk to your doctor before getting rsv vaccine if you had certain other conditions.; Sender's Comments: A case of Pneumonia, Unknown time after receiving RSV vaccine, in a elderly patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2865754 | 30 | F | ID | 10/14/2025 |
HPV9 |
MERCK & CO. INC. |
Y014510 |
Pharyngeal swelling, Urticaria
Pharyngeal swelling, Urticaria
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Hives developed at home after vaccine. Benadryl given , 2 days later developed swelling in throat w...
Hives developed at home after vaccine. Benadryl given , 2 days later developed swelling in throat with hives . Sought care at an Urgent Care.
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| 2865755 | 30 | F | PA | 10/14/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
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Injection site reaction, Injection site vesicles, Myalgia, Pyrexia; Injection si...
Injection site reaction, Injection site vesicles, Myalgia, Pyrexia; Injection site reaction, Injection site vesicles, Myalgia, Pyrexia
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Felt feverish and had muscle aches after getting vaccines on 10/11/2025. On 10/14/2025, she saw 2 ve...
Felt feverish and had muscle aches after getting vaccines on 10/11/2025. On 10/14/2025, she saw 2 vesicles with fluid inside at sites on L arm where received the flu and COVID-19 vaccines.
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| 2865756 | 57 | F | 10/14/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0738 |
Injection site bruising, Injection site discolouration
Injection site bruising, Injection site discolouration
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Vaccine administration site turned almost completely black, continued bruising noted one week later ...
Vaccine administration site turned almost completely black, continued bruising noted one week later but less severe than initially noted
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| 2865757 | 36 | F | TX | 10/14/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
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Exposure during pregnancy, No adverse event, Wrong product administered
Exposure during pregnancy, No adverse event, Wrong product administered
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36 yo G2P0010 at 30 weeks 5 days estimated gestational age with EDD 12/7/2025 presented to routine O...
36 yo G2P0010 at 30 weeks 5 days estimated gestational age with EDD 12/7/2025 presented to routine OB appointment. She was given the Vaxelis vaccine instead of the Tdap vaccine. No immediate adverse side effects noted.
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| 2865758 | 24 | M | KS | 10/14/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052034 u8864ca |
Injection site erythema, Injection site warmth; Injection site erythema, Injecti...
Injection site erythema, Injection site warmth; Injection site erythema, Injection site warmth
More
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Patient presents to pharmacy concerned about redness and warmth on left arm where he received two IM...
Patient presents to pharmacy concerned about redness and warmth on left arm where he received two IMZ 10/12/2025. He received mNexspike and Flublok. I reviewed the normal ADRs with him, including erythema at injection site, pain at injection site, and swelling at injection site. Redness appeared to be a normal reaction to me-- approximately 2.5-3" wide in a band below the bicep. I reviewed literature and explained that I suspected the COVID vaccine to be responsible and that literature suggests resolution after a median duration of 4 to 6 days (range: 2 to 11 days). Patient is going to take cetirizine, apap/ibu as needed for discomfort and we will follow-up with him in 2 days to ensure complete resolution.
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| 2865759 | 39 | F | TX | 10/14/2025 |
FLU3 |
SEQIRUS, INC. |
AX4606A |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Employee Health RN (reporter) asked employee if she needed a flu shot this year. Employee consented ...
Employee Health RN (reporter) asked employee if she needed a flu shot this year. Employee consented to receive flu shot. Flu shot was administered without issue. Post flu administration (30 minutes later) employee notified nurse that she forgot she had already been given the flu vaccine in September. No signs or symptoms of adverse reaction.
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| 2865760 | 1.17 | F | 10/14/2025 |
HPV9 |
MERCK & CO. INC. |
Y013407 |
Dermatitis diaper, Diarrhoea, Gastroenteritis viral, Product administered to pat...
Dermatitis diaper, Diarrhoea, Gastroenteritis viral, Product administered to patient of inappropriate age
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HPV was given to this baby in error. The mistake was not identified till 3 days later. Mother denied...
HPV was given to this baby in error. The mistake was not identified till 3 days later. Mother denied any complications, abnormal symptoms, or concerns at time of disclosure 3 days after event. Patient was seen 7 days after for loose stool, which was deemed most likely related to viral gastroenteritis that became prolonged in to osmotic diarrhea by excessive juice consumption. Noted previous diaper rash which was improving at that time. No other abnormal findings.
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| 2865761 | 80 | F | MI | 10/14/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8862CA C9X3R |
Asthenia, Dysarthria, Facial paralysis, Laboratory test normal; Asthenia, Dysart...
Asthenia, Dysarthria, Facial paralysis, Laboratory test normal; Asthenia, Dysarthria, Facial paralysis, Laboratory test normal
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on Friday 10/10 patient experienced weakness, drooping of chin, slurred speech. She was taken to eme...
on Friday 10/10 patient experienced weakness, drooping of chin, slurred speech. She was taken to emergency room and multiple tests were done and they were negative for stroke. The physician said it could be a rare side effect of shingles vaccine. She received fluzone HD the same time but she has had history of receiving the flu shot but not the shingles vaccine
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| 2865762 | 42 | F | 10/14/2025 |
COVID19 |
MODERNA |
8146545 |
Pruritus
Pruritus
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Pt had c/o itchy skin within the 15 minute waiting period. Pt stated they felt itchy at scalp line o...
Pt had c/o itchy skin within the 15 minute waiting period. Pt stated they felt itchy at scalp line of head and on cheeks of face. Immediately Hydro cortisone 1% was offered and accepted by pt. Pt applied the cream to forehead at scalp line and to cheeks. Also applied a small amount on L forearm. Pt stated she felt relief immediately. Pt had other stops to make and stated she had an appointment with her PCP within the next 30 minutes. Pt stated they felt well and good drive, so she left.
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| 2865763 | 77 | F | TX | 10/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
G2HA7 |
Hypersensitivity
Hypersensitivity
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DR DESCRIBED AS ALLERGIC REACTION, PATIENT STATES SHE WAS TOLD TO TAKE BENADRYL
DR DESCRIBED AS ALLERGIC REACTION, PATIENT STATES SHE WAS TOLD TO TAKE BENADRYL
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| 2865764 | 52 | F | NJ | 10/14/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9fg5m |
Dyspnoea, Palpitations, Pruritus, Sensation of foreign body, Urticaria
Dyspnoea, Palpitations, Pruritus, Sensation of foreign body, Urticaria
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shot @ 1:30pm by 1:45pm difficulty breathing, lump in throat, racing heartbeat, itching all over, hi...
shot @ 1:30pm by 1:45pm difficulty breathing, lump in throat, racing heartbeat, itching all over, hives . took 3 Benadryl and asthma pump to help breathing immediately. I continued to take 4 Benadryl and asthma pump every 4 hours until Saturday night 10/11/25, when the symptoms weakened enough not to need medication.
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| 2865766 | 61 | F | AZ | 10/14/2025 |
PNC21 PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Z006076 Z006076 Z006076 |
Decreased appetite, Disorganised speech, Erythema, Fatigue, Hallucination; Migra...
Decreased appetite, Disorganised speech, Erythema, Fatigue, Hallucination; Migraine, Nausea, Pain, Peripheral swelling, Pruritus; Pyrexia
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Facial itching, migraine headache, fever, swelling and redness to entire left arm, extreme fatigue, ...
Facial itching, migraine headache, fever, swelling and redness to entire left arm, extreme fatigue, loss of appetite, hallucinations, "word salad", body aches, nausea
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| 2865767 | 9 | F | TN | 10/14/2025 |
HPV9 |
MERCK & CO. INC. |
y012864 |
Syncope
Syncope
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Fainting 5 minutes following administration
Fainting 5 minutes following administration
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| 2865768 | 8 | M | MA | 10/14/2025 |
FLU3 |
SANOFI PASTEUR |
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Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Patient received the wrong flu vaccine. Patient was given Flublok at time of administration. Patient...
Patient received the wrong flu vaccine. Patient was given Flublok at time of administration. Patient is under the age of appropiate vaccination that should have been given which should have been Afluria.
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| 2865770 | 59 | F | MI | 10/14/2025 |
FLU3 FLU3 FLU3 FLU3 PNC21 PNC21 PNC21 PNC21 PPV PPV PPV PPV PPV PPV PPV PPV |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
409415 409415 409415 409415 Z004302 Z004302 Z004302 Z004302 Z004302 Z004302 Z004302 Z004302 Z004302 Z004302 Z004302 Z004302 |
Erythema, Inflammation, Pyrexia, Staphylococcal infection, Streptococcal infecti...
Erythema, Inflammation, Pyrexia, Staphylococcal infection, Streptococcal infection; Cellulitis, Erythema, Fatigue, Lymphadenopathy, Magnetic resonance imaging; Nausea, Pain, Peripheral swelling, Pyrexia, Skin warm; Tenderness; Erythema, Inflammation, Pyrexia, Staphylococcal infection, Streptococcal infection; Cellulitis, Erythema, Fatigue, Lymphadenopathy, Magnetic resonance imaging; Nausea, Pain, Peripheral swelling, Pyrexia, Skin warm; Tenderness; Erythema, Inflammation, Pyrexia, Staphylococcal infection, Streptococcal infection; Cellulitis, Erythema, Fatigue, Lymphadenopathy, Magnetic resonance imaging; Nausea, Pain, Peripheral swelling, Pyrexia, Skin warm; Tenderness; Erythema, Inflammation, Pyrexia, Staphylococcal infection, Streptococcal infection; Cellulitis, Erythema, Fatigue, Lymphadenopathy, Magnetic resonance imaging; Nausea, Pain, Peripheral swelling, Pyrexia, Skin warm; Tenderness
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Patient was given 2 vaccines on 10/10/2025. Patient started experiencing redness, inflammation, and ...
Patient was given 2 vaccines on 10/10/2025. Patient started experiencing redness, inflammation, and fevers that wouldn't go away after a few days as expected with typical vaccine side effects. Patient visited the hospital where she received IV antibiotics. The doctors there diagnosed her with a staph/strep infection due to vaccine injury. Patient was released after one night in the hospital after improvement in her condition.
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| 2865771 | 49 | F | MN | 10/14/2025 |
COVID19 |
NOVAVAX |
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Haemorrhage, Scab, Skin exfoliation, Skin lesion
Haemorrhage, Scab, Skin exfoliation, Skin lesion
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patches of skin on the back of my hands (particularly right hand, although also three visible ones o...
patches of skin on the back of my hands (particularly right hand, although also three visible ones on left) started flaking off 1 or 2 days after vaccine. Three patches on backs of first three fingers on right hand bad enough to bleed and scab, although raw area about half the size of the peeled-off skin. Largest lesion is 1cm diameter. Peeling continued for over a week, as did bleeding, although now appears to be stabilizing (after a week of application of protopic).
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| 2865772 | F | 10/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site erythema, Injection site swelling, Injection site warmth, Malaise...
Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Pyrexia
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Hot at injection site; red at injection site; swollen at injection site; overall did not feel well; ...
Hot at injection site; red at injection site; swollen at injection site; overall did not feel well; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included in the past prior to vaccination with Shingrix taken 2 injections of medication for osteoporosis prevention were taken. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: Hot at injection site), injection site erythema (Verbatim: red at injection site), injection site swelling (Verbatim: swollen at injection site), feeling unwell (Verbatim: overall did not feel well) and fever (Verbatim: Fever). The outcome of the injection site warmth, injection site erythema, injection site swelling, feeling unwell and fever were resolved. It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site swelling, feeling unwell and fever to be related to Shingrix. It was unknown if the company considered the injection site warmth, injection site erythema, injection site swelling, feeling unwell and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 16-SEP-2025 The consumer was the reporter. The consumer reported that after receiving her first dose of Shingrix the injection site was hot, swollen and red. The consumer reported she may have had a bit of a fever that only lasted a couple of days. The consumer stated that overall she did not feel well. The consumer stated the dose was administered in her left arm and it took several weeks for the red, hot, swollen area to resolve. The consumer stated that her feeling of not feeling well overall resolved in a few days after the vaccination. Consumer stated she was healthy with no significant past history of health concerns. Consumer was unable to provide the date of the first Shingrix vaccination and stated if the lot number for the vaccine was provided to her that she would have discarded that information. The batch number was not provided, and we are unable to contact the reporter.
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