| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2861050 | 68 | F | NY | 09/24/2025 |
COVID19 |
MODERNA |
3052549 |
Erythema, Swelling
Erythema, Swelling
|
Pt developed a large red bump
Pt developed a large red bump
|
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| 2861051 | 77 | F | FL | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Asthenia, Chills, Lymphadenopathy, Pain, Pyrexia
Asthenia, Chills, Lymphadenopathy, Pain, Pyrexia
|
Fever, chills, pains & aches, swollen glands, weakness
Fever, chills, pains & aches, swollen glands, weakness
|
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| 2861052 | 4 | F | WV | 09/24/2025 |
MMRV |
MERCK & CO. INC. |
z002990 |
Immediate post-injection reaction, Injection site erythema, Injection site warmt...
Immediate post-injection reaction, Injection site erythema, Injection site warmth, Local reaction
More
|
Immediate local reaction to vaccine. Redness and warmth-circular area around injection sight 4 cm a...
Immediate local reaction to vaccine. Redness and warmth-circular area around injection sight 4 cm across with injection site in center. No reaction to alcohol prep or vaccine given in opposing thigh
More
|
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| 2861053 | 45 | M | CO | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Rash
Rash
|
rash up arm, started day after injection. pt said was improving.
rash up arm, started day after injection. pt said was improving.
|
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| 2861054 | 54 | F | MI | 09/24/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946064 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
|
no adverse event; dose #2 was given at wrong interval. Dose 2 administered 1 week after Dose 1 inste...
no adverse event; dose #2 was given at wrong interval. Dose 2 administered 1 week after Dose 1 instead of 1 month apart
More
|
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| 2861055 | 53 | F | MD | 09/24/2025 |
FLU3 |
SEQIRUS, INC. |
406984 |
Rash, Rash erythematous, Rash pruritic, Urticaria
Rash, Rash erythematous, Rash pruritic, Urticaria
|
After about 6 hours from vaccination, areas around collarbone, left trunk and left tummy was itchy. ...
After about 6 hours from vaccination, areas around collarbone, left trunk and left tummy was itchy. The next morning, left collarbone area and left tummy showed small rash. In the evening, more rashes and hives around left side of trunk, collarbone, and tummy appeared. They were itchy and red. There were no rashes or hives in the left arm. The following day, today, the rashes and hives calmed down with red marks.
More
|
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| 2861056 | 28 | F | CA | 09/24/2025 |
FLU3 |
SANOFI PASTEUR |
UT8802NA |
Dizziness, Headache, Nausea, Pruritus, Urticaria
Dizziness, Headache, Nausea, Pruritus, Urticaria
|
Employee complained of hives to her mid-belly area and itching to her entire body, especially her le...
Employee complained of hives to her mid-belly area and itching to her entire body, especially her legs. Employee noticed onset of symptoms about 30 minutes after receiving Fluzone during annual employee health screening. She also complained of an intense headache, 8/10 pain scale, and dizziness, accompanied by nausea. Denied shortness of breath, no evidence of airway compromise. Vitals were stable throughout monitoring. Onsite physician ordered diphenhydramine 50mg/mL, which was administered IM to right deltoid. Treatment was tolerated well. After continuous monitoring order was discontinued, employee was deemed stable for discharge home with her partner. ED precautions were given along with Rx for diphenhydramine, by mouth, and an EpiPen and instructions provided for medication frequency with f/u to ED for any further symptoms.
More
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| 2861057 | 11 | F | WV | 09/24/2025 |
HPV9 |
MERCK & CO. INC. |
Y019751 |
Wrong product administered
Wrong product administered
|
The child presented for her Flu vaccination but received an HPV in error.
The child presented for her Flu vaccination but received an HPV in error.
|
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| 2861058 | 69 | F | NH | 09/24/2025 |
FLU3 |
SANOFI PASTEUR |
|
Arthralgia, Joint swelling, Pain, Sleep disorder
Arthralgia, Joint swelling, Pain, Sleep disorder
|
She received a flu shot on Monday at the pharmacy and began experiencing soreness in her left should...
She received a flu shot on Monday at the pharmacy and began experiencing soreness in her left shoulder that evening. The soreness was more intense than usual, as she typically does not have any reaction to flu shots. By the evening, she experienced significant pain and swelling, which led to difficulty sleeping. She visited urgent care the following morning due to the persistent pain and swelling. She was advise to rest and ice the shoulder. She was prescribed antibiotics, but She has not taken the prescribed antibiotic as there is no redness or signs of infection. She has no fever, chills, or other systemic symptoms. The pain is primarily located in the front of the shoulder and is associated with swelling. She has pain with range of motion which has limited her movement, although she can still move the shoulder. She has not experienced any numbness, weakness or tingling.
More
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| 2861059 | 40 | F | CO | 09/24/2025 |
COVID19 |
MODERNA |
3052579 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
There were no adverse events, but the incorrect vaccine was given. We had received the pediatric (6 ...
There were no adverse events, but the incorrect vaccine was given. We had received the pediatric (6 months to 11 years) doses of Moderna Spikevax earlier that day and the tech that unpacked them didn't realize they were pediatric shots, so she didn't label them as such and put the bag of syringes next to the adult doses of Spikevax. The syringes of peds Spikevax DO NOT say pediatric or 6m-11y or anything to distinguish that they are for kids. The only difference is the syringe shows 0.25ml instead of 0.5ml. The lot number of the adult 0.5ml dose that we were using was 3052549 (exp 5/8/26) and the lot number of the 0.25ml dose that we accidentally gave was 3052579 (exp 5/10/26). As you can see, the lot numbers were off by only one number, so we thought it was just a typo on our end. Again, the sticker that comes off the syringe DOES NOT say 0.25ml or peds dose or anything to distinguish it from the adult dose. We realized what had happened the next day when another pharmacist (who had seen the peds syringes at a different pharmacy) noticed the syringe was a pediatric dose. We went back and checked our shots given, and this was the only one that we found was done in error. The patient has been contacted and we are going to give her one more 0.25ml dose to bring her up to the full dose of 0.5ml.
More
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| 2861060 | 70 | F | FL | 09/24/2025 |
FLU3 |
SANOFI PASTEUR |
ut8829ba |
Erythema, Peripheral swelling, Pruritus
Erythema, Peripheral swelling, Pruritus
|
arm swelling, redness and itching
arm swelling, redness and itching
|
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| 2861061 | 32 | M | MD | 09/24/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
|
Anxiety, Chest discomfort, Dizziness, Palpitations, Panic attack; Supraventricul...
Anxiety, Chest discomfort, Dizziness, Palpitations, Panic attack; Supraventricular extrasystoles, Ventricular extrasystoles; Anxiety, Chest discomfort, Dizziness, Palpitations, Panic attack; Supraventricular extrasystoles, Ventricular extrasystoles
More
|
Palpitations, premature atrial contractions, premature ventricle contractions, chest tightness, dizz...
Palpitations, premature atrial contractions, premature ventricle contractions, chest tightness, dizziness, panic, anxiety
More
|
โ | |||||
| 2861062 | 19 | F | MI | 09/24/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
MD9SL |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Outside of FDA age range. Patient received the Engerix indicated for age 20 and above but patient is...
Outside of FDA age range. Patient received the Engerix indicated for age 20 and above but patient is age 19.
More
|
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| 2861063 | 9 | F | MA | 09/24/2025 |
HPV9 |
MERCK & CO. INC. |
|
Vaccination error
Vaccination error
|
The seal of the pre-filled syringe was broken on 9/19 and a capped needle was attached, the syringe ...
The seal of the pre-filled syringe was broken on 9/19 and a capped needle was attached, the syringe should have been discarded at the end of the workday, because it was not used. The vaccine was administered to the patient on 9/22.
More
|
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| 2861064 | 68 | F | SC | 09/24/2025 |
COVID19 FLU3 HEPAB |
MODERNA SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
3052583 U88T9BA AZ2A3 |
Limb mass, Mass, Pain in extremity, Skin warm; Limb mass, Mass, Pain in extremit...
Limb mass, Mass, Pain in extremity, Skin warm; Limb mass, Mass, Pain in extremity, Skin warm; Limb mass, Mass, Pain in extremity, Skin warm
More
|
Patient states that her Right arm is very sore, very hot to the touch, and has a knot in it. She sa...
Patient states that her Right arm is very sore, very hot to the touch, and has a knot in it. She says this is from the flu/covid shots.
More
|
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| 2861065 | 20 | F | VA | 09/24/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
KM5GK |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
patient was given expired vaccine, no adverse reaction to date
patient was given expired vaccine, no adverse reaction to date
|
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| 2861066 | 70 | M | OH | 09/24/2025 |
PNC21 |
MERCK & CO. INC. |
Y019158 |
Muscular weakness, Neuralgia
Muscular weakness, Neuralgia
|
Patient presents with nerve pain, and arm weakness (difficult to raise arm). Patient was given Gabap...
Patient presents with nerve pain, and arm weakness (difficult to raise arm). Patient was given Gabapentin 300 mg at bedtime, and a Medrol dose pack on 9/9 with moderate improvement in symptoms. Unsure if this was already reported, so reporting when patient first notified me of incident post evaluation.
More
|
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| 2861067 | 75 | F | IN | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Nausea, Pyrexia, Vertigo, Vomiting
Nausea, Pyrexia, Vertigo, Vomiting
|
About 6 hr after the vaccination awoke with vertigo. Then nausea and vomiting which lasted 30 hrs. F...
About 6 hr after the vaccination awoke with vertigo. Then nausea and vomiting which lasted 30 hrs. Feverish. No lower GI problems
More
|
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| 2861068 | 54 | F | GA | 09/24/2025 |
PNC20 PNC20 PNC20 PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
LN4927 LN4927 LN4927 |
Injection site pain, Injection site swelling, Pain in extremity; Axillary pain, ...
Injection site pain, Injection site swelling, Pain in extremity; Axillary pain, Back pain, Breast pain, Injection site pain, Neuralgia; Sleep disorder; Injection site pain, Injection site swelling, Pain in extremity; Axillary pain, Back pain, Breast pain, Injection site pain, Neuralgia; Sleep disorder
More
|
Arm soreness/pain and swelling at injection site
Arm soreness/pain and swelling at injection site
|
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| 2861069 | 17 | M | TX | 09/24/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Arthralgia, Injection site pruritus, Oedema peripheral
Arthralgia, Injection site pruritus, Oedema peripheral
|
Sore shoulder, itching at site, swollen armpit on the vaccinated aide
Sore shoulder, itching at site, swollen armpit on the vaccinated aide
|
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| 2861070 | 0.42 | F | SD | 09/24/2025 |
RSV |
MODERNA |
|
Incorrect dose administered
Incorrect dose administered
|
pediatric patient was given an adult version of RSV vaccine
pediatric patient was given an adult version of RSV vaccine
|
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| 2861071 | 69 | F | NM | 09/24/2025 |
COVID19 |
MODERNA |
3052583 |
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
|
She has redness, swelling and it itched at the vaccine site starting the day after the vaccine. It h...
She has redness, swelling and it itched at the vaccine site starting the day after the vaccine. It had been keeping her awake at night.
More
|
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| 2861072 | 66 | F | GA | 09/24/2025 |
MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
|
Rash; Rash
Rash; Rash
|
Patient stated that the night of receiving the mmr and varicella vaccines, she broke out in a rash o...
Patient stated that the night of receiving the mmr and varicella vaccines, she broke out in a rash on her torso. Patient states it happened hours after vaccine. She contacted after hours nurse line and was advised to take an antihistamine. Patient states rash resolved after taking medication.
More
|
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| 2861073 | 15 | F | CA | 09/24/2025 |
HPV9 |
MERCK & CO. INC. |
U037064 |
Muscular weakness
Muscular weakness
|
Weakness in arm for 2-3 months that has since resolved. Wasn't reported to physician until over...
Weakness in arm for 2-3 months that has since resolved. Wasn't reported to physician until over 2 years later.
More
|
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| 2861074 | 40 | F | CA | 09/24/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
|
Immediate post-injection reaction, Injection site erythema, Injection site indur...
Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus; Injection site swelling
More
|
Almost immediate redness, swelling, itching, pain, firmness at injection sight
Almost immediate redness, swelling, itching, pain, firmness at injection sight
|
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| 2861075 | 32 | M | CO | 09/24/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9548 U8790AA |
Cough, Tremor; Cough, Tremor
Cough, Tremor; Cough, Tremor
|
Patient was speaking and stopped abruptly - seeming like he was about to faint but started shaking s...
Patient was speaking and stopped abruptly - seeming like he was about to faint but started shaking slightly and making sounds. Seemed more like a seizure afterwards. Stayed that way for at least 5 minutes. Coughed/shook his head forward twice and was back to normal.
More
|
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| 2861076 | 9 | F | NE | 09/24/2025 |
TYP |
SANOFI PASTEUR |
Y2A04P1 |
Cough, Pyrexia
Cough, Pyrexia
|
fever cough
fever cough
|
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| 2861077 | 42 | F | ME | 09/24/2025 |
FLU3 VARZOS |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
406982 2HJ99 |
Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased,...
Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain; Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
More
|
Pain at injection site immediately, after a few days pain was still present but mostly in my shoulde...
Pain at injection site immediately, after a few days pain was still present but mostly in my shoulder joint, and is still present with limited range of motion and joint pain.
More
|
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| 2861078 | 32 | F | NE | 09/24/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Migraine
Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, Migraine
|
Hormone issues such as extreme increase in menstrual pain and flow, irregular periods after being re...
Hormone issues such as extreme increase in menstrual pain and flow, irregular periods after being regular for years, migraines
More
|
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| 2861079 | 82 | F | 09/24/2025 |
COVID19 |
MODERNA |
|
Headache, Hyperhidrosis, Pyrexia
Headache, Hyperhidrosis, Pyrexia
|
patient reported headache, mild fever and sweatiness. she is resting at home
patient reported headache, mild fever and sweatiness. she is resting at home
|
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| 2861080 | 78 | M | WA | 09/24/2025 |
COVID19 |
MODERNA |
|
Rash, Rash macular, Rash pruritic
Rash, Rash macular, Rash pruritic
|
Development of macular pruritic rash to anterior and posterior torso. No respiratory involvement.
Development of macular pruritic rash to anterior and posterior torso. No respiratory involvement.
|
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| 2861081 | 46 | F | VT | 09/24/2025 |
FLU3 |
SEQIRUS, INC. |
|
Chills, Headache, Pain, Pyrexia
Chills, Headache, Pain, Pyrexia
|
12 hours later: headache, body aches, mild fever, chills
12 hours later: headache, body aches, mild fever, chills
|
||||||
| 2861082 | 0.17 | M | WI | 09/24/2025 |
RSV |
PFIZER\WYETH |
LL8398 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Adult RSV vaccine given inadvertently. No apparent adverse effects observed.
Adult RSV vaccine given inadvertently. No apparent adverse effects observed.
|
||||||
| 2861083 | 53 | F | MI | 09/24/2025 |
PNC21 |
MERCK & CO. INC. |
z006889 |
Erythema, Pain in extremity, Rash
Erythema, Pain in extremity, Rash
|
Rash, Red sore arm the same day, ER visit prescriber in er wanted patient on Antibiotics
Rash, Red sore arm the same day, ER visit prescriber in er wanted patient on Antibiotics
|
||||||
| 2861084 | 49 | F | 09/24/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
NA0589 NA0589 U8790AA U8790AA |
Diarrhoea, Dizziness, Laboratory test, Malaise, Nausea; Vomiting; Diarrhoea, Diz...
Diarrhoea, Dizziness, Laboratory test, Malaise, Nausea; Vomiting; Diarrhoea, Dizziness, Laboratory test, Malaise, Nausea; Vomiting
More
|
Patient came back to the pharmacy and stated that she didn't feel good after getting her FLU an...
Patient came back to the pharmacy and stated that she didn't feel good after getting her FLU and COVID vaccines at the same time. It was a delayed reaction, and did not start until the next day. Said for 3 days she was dizzy, nausea, vomiting and diarrhea. That resolved after 3 days and the diarrhea continued for a week. She did go get seen at the hospital and they ran all sorts of tests. She said they released her and to her knowledge everything was ok but she is unable to access her online portal from the visit.
More
|
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| 2861085 | 65 | F | PA | 09/24/2025 |
FLU3 |
SEQIRUS, INC. |
407246 |
Pain, Pain in extremity
Pain, Pain in extremity
|
Patient states she is experiencing pain in her right arm since receiving her flu shot. She has pain ...
Patient states she is experiencing pain in her right arm since receiving her flu shot. She has pain when the arm is in motion and when she rests the arm on the arm rest of her couch/chair. She is going to wait to contact her doctor for a few more days. If it does not feel any better by next week, she will contact her doctor.
More
|
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| 2861086 | 20 | F | AK | 09/24/2025 |
FLU3 |
SANOFI PASTEUR |
U8848BA |
Chest discomfort, Electrocardiogram, Pharyngeal swelling
Chest discomfort, Electrocardiogram, Pharyngeal swelling
|
Symptoms of chest tightness and throat swelling. There were no objective airway swelling and no hive...
Symptoms of chest tightness and throat swelling. There were no objective airway swelling and no hives. Pt was observed at the ER and discharged home later.
More
|
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| 2861087 | 69 | F | FL | 09/24/2025 |
COVID19 |
MODERNA |
014C21A |
Blood test, Full blood count, Headache, Hypoaesthesia, Magnetic resonance imagin...
Blood test, Full blood count, Headache, Hypoaesthesia, Magnetic resonance imaging head
More
|
Headaches and numbness in legs and feet. Headaches have different levels. Headaches are non stop, on...
Headaches and numbness in legs and feet. Headaches have different levels. Headaches are non stop, only different levels of headaches. When headaches are on high level, I cannot do any daily activities. Treatments for headaches: Ajovy Autoinjector 225 mg/1.5 mL subcutaneous solution Date Started On: Sep 16, 2025 Ubrelvy 100 mg oral tablet Date Started On: Sep 16, 2025 propranolol 20 mg oral tablet Date Started On: Sep 16, 2025 Xiidra 5% ophthalmic solution Apr 28, 2025 Creon 36,000 units oral delayed release capsule Apr 28, 2025 latanoprost 0.005% ophthalmic emulsion Date Started On: Apr 28, 2025 Qulipta 60 mg oral tablet Date Started On: Feb 28, 2025 Maxalt 10 mg oral tablet Date Started On: Nov 19, 2024 Aimovig SureClick 140 mg/mL subcutaneous solution Date Started On: Nov 19, 2024 Ordered By: Emgality Prefilled Syringe 120 mg/mL subcutaneous solution Date Started On: Jul 23, 2024 Ordered By: ibuprofen 600 mg oral tablet Date Started On: Jul 17, 2024 Effexor XR 75 mg oral capsule, extended release Date Started On: Jun 18, 2024 Effexor XR 37.5 mg oral capsule, extended release Date Started On: Jun 18, 2024 Effexor XR 75 mg oral capsule, extended release Date Started On: Jun 04, 2024 sumatriptan 100 mg oral tablet Date Started On: May 29, 2024 venlafaxine 75 mg oral tablet, extended release Date Started On: May 29, 2024 venlafaxine 37.5 mg oral tablet, extended release Date Started On: May 29, 2024 Misc Medication Date Started On: May 29, 2024 Vitamin B12 Date Started On: May 29, 2024 Prolia 60 mg/mL subcutaneous solution Date Started On: May 29, 2024 Vitamin D3 Date Started On: May 29, 2024 calcium (as carbonate) 600 mg oral tablet Date Started On: May 29, 2024 Lumigan 0.01% ophthalmic solution Date Started On: May 29, 2024 timolol maleate 0.5% ophthalmic solution Date Started On: May 29, 2024 famotidine 20 mg oral tablet Date Started On: May 29, 2024 ibuprofen 600 mg oral tablet Date Started On: May 29, 2024
More
|
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| 2861088 | 60 | F | CA | 09/24/2025 |
COVID19 |
MODERNA |
|
Tinnitus
Tinnitus
|
I have been experiencing symptoms of tinnitus after the last booster , which I hear cricket noise i...
I have been experiencing symptoms of tinnitus after the last booster , which I hear cricket noise in my right side of my brain. Initially it bothered me only during the night when it was quiet. Now. It is so loud and I can feel all day long. I thought it would probably go away after sometime. However, it is only getting worse. One of my friends experienced similar symptoms after the last booster of Covid vaccine. He went to see doctor and was told to wear hearing aid, which is ridiculous since his hearing ability is perfectly fine. I tried herbal remedies this year and none of them reduced the symptoms. I noticed the similar outcome after Covid vaccine have been reported before. Since my symptom is not going away, I am encouraged to report mine!
More
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| 2861089 | 18 | F | AL | 09/24/2025 |
MENB |
PFIZER\WYETH |
GF4143 |
Expired product administered
Expired product administered
|
injection was expired
injection was expired
|
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| 2861090 | 17 | F | MA | 09/24/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
3R33K 3R33K |
Erythema, Fatigue, Hypoaesthesia, Pain, Pain in extremity; Paraesthesia, Periphe...
Erythema, Fatigue, Hypoaesthesia, Pain, Pain in extremity; Paraesthesia, Peripheral swelling
More
|
She states that since the afternoon of 9/22/25 she has had temperatures around 100.0. Denies fever o...
She states that since the afternoon of 9/22/25 she has had temperatures around 100.0. Denies fever of 100.4 or higher. Reaction occurred within a few hours of being home after getting the vaccine Arm has been swollen, red and painful There was pain and numbness down the arm Numbness and tingling has decreased today Denies sore throat, cough, congestion Reports generalized body aches and fatigue Temp up to 100 yesterday
More
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| 2861091 | 26 | M | AZ | 09/24/2025 |
FLU3 |
SEQIRUS, INC. |
AX4604A |
Blood glucose normal, Dizziness, Loss of consciousness, Presyncope
Blood glucose normal, Dizziness, Loss of consciousness, Presyncope
|
Patient was in for a fasting blood draw appointment and requested to have his flu shot done as well....
Patient was in for a fasting blood draw appointment and requested to have his flu shot done as well. I asked patient if he does well with blood draws and or shots. Asked if he has ever had any incidents and he answered no. I then Administered age appropriate vaccine - Afluria . Patient appeared well. Proceeded to do blood work. Venipuncture and specimen collection was completed successfully. Patient then told me he felt dizzy. I rushed to his side and he experienced a vasovagal episode. I called for a doctor while holding patient to prevent injury or fall and then patient's PCP Dr. (withheld) came on site. Patient regained consciousness a few seconds later. And was then evaluated by the provider. Dr. (withheld) asked patient questions and he responded and appeared coherent. Patient explained to the provider that this had never happened to him. I checked patient's bp and did a fingerstick glucose per Dr. (withheld) request , both came back normal. Entered them into chart. Patient was given water. Patient then told Dr. (withheld) what his preparation was prior to the appointment Dr. recommended patient does not do a flu shot along with a blood draw again. He advised patient on fasting window and guidelines. He also recommends patient be drawn lying down at least for the next draw. Patient rested in office until he was feeling completely recovered and Dr. agreed he was clear to go home.
More
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| 2861092 | 73 | M | 09/24/2025 |
RSV |
PFIZER\WYETH |
MM9159 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
PT RECEIVED A SECOND DOSE OF RSV. PT IS FINE BUT SECOND DOSE NOT RECOMMENDED
PT RECEIVED A SECOND DOSE OF RSV. PT IS FINE BUT SECOND DOSE NOT RECOMMENDED
|
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| 2861094 | 25 | M | 09/24/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
|
Confusional state, Diarrhoea, Headache, Lymphadenopathy, Malaise; Nausea
Confusional state, Diarrhoea, Headache, Lymphadenopathy, Malaise; Nausea
|
nausea, diarrhea, lymphadenopathy, malaise, confusion, headache,
nausea, diarrhea, lymphadenopathy, malaise, confusion, headache,
|
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| 2861095 | 76 | F | TN | 09/24/2025 |
FLU3 |
SANOFI PASTEUR |
UT8820AA |
Injection site induration, Injection site pruritus, Injection site swelling, Inj...
Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
More
|
Patient described itching initially, then moderate swelling ("golf ball sized area") aroun...
Patient described itching initially, then moderate swelling ("golf ball sized area") around the injection site. Described area as firm and warm, but no redness or other symptoms noticed. Described it as similar to a "knot in the muscle". Advised patient to treat with ice, OTC medications and to continue to monitor for any changes and seek further medical asssistance if any other symptoms develop or worsen.
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| 2861096 | 45 | F | MT | 09/24/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Biopsy skin abnormal, Dermatitis, Rash, Rash macular, Rash pruritic; Transient a...
Biopsy skin abnormal, Dermatitis, Rash, Rash macular, Rash pruritic; Transient acantholytic dermatosis
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I had my first Moderna shot on 7/27/2021 with no reactions. 2 weeks(ish) after my second Moderna sh...
I had my first Moderna shot on 7/27/2021 with no reactions. 2 weeks(ish) after my second Moderna shot I started getting an itchy, splotchy rash on my torso, upper arms and thighs. I pointed it out to my dermatologist at an appointment on 10/12/2021. They said it was an unspecified dermatitis and treated with a cream. The cream didn't make a difference, and we revisited it a year later on 10/14/2022. Same diagnosis (unspecified dermatitis), but I had read about Grover's Disease brought on by the Moderna Covid 19 shot. Research says Grover's Disease is generally found in middle aged men and "usually" clears itself up in 3-5 years. We decided to wait another year and see how things progressed.
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| 2861097 | 57 | F | CA | 09/24/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
K4K3S |
Arthralgia, Differential white blood cell count, Full blood count, Red blood cel...
Arthralgia, Differential white blood cell count, Full blood count, Red blood cell sedimentation rate, Ultrasound scan
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57-year-old female complains of right shoulder pain since receiving tetanus booster.
57-year-old female complains of right shoulder pain since receiving tetanus booster.
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| 2861098 | 48 | M | NY | 09/24/2025 |
UNK |
UNKNOWN MANUFACTURER |
04zaz1a |
Bursa injury, Magnetic resonance imaging abnormal, Magnetic resonance imaging jo...
Bursa injury, Magnetic resonance imaging abnormal, Magnetic resonance imaging joint, Periarthritis
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Frozen sholder went to therapy a few times. Went to orthopedic and got an MRI that show a bursa tea...
Frozen sholder went to therapy a few times. Went to orthopedic and got an MRI that show a bursa tear.
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| 2861104 | CO | 09/24/2025 |
HIBV |
MERCK & CO. INC. |
Y006392 |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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No additional adverse event reported; Medical assistant called to report that another medical assist...
No additional adverse event reported; Medical assistant called to report that another medical assistant in the facility administered PEDVAX HIB subcutaneously rather than intramuscularly. The caller reports that the documentation states it was administered intramuscularly; however, a pic; Information has been received from Business Partner/CRO on 10-Sep-2025. This spontaneous report was received from a other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 08-Sep-2025, the patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y006392, expiration date: 08-Nov-2026) for an unknown indication. On 08-Sep-2025, the vaccine was administered subcutaneously rather than intramuscularly (Intramuscular formulation administered by other route). No additional adverse event was reported.
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| 2861105 | TX | 09/24/2025 |
MMRV |
MERCK & CO. INC. |
Z008867 |
Product storage error
Product storage error
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HCP reported vaccine was administered after temperature excursion. No other information provided. ...
HCP reported vaccine was administered after temperature excursion. No other information provided. See additional AEs 02872616, 02872668, 02872694. No PQC reported. ? Names of vaccines involved (including lot/exp) PROQUAD Z008867 11/10/2026; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On 08-SEP-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z008867, expiration date: 10-NOV-2026) 0.5 mL, administered by Subcutaneous route (dose not reported) as prophylaxis after temperature excursion. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date not reported). No other information provided. Additionally, it was reported that the temperature was 32 farenheit (F), with time frame 4 hours 30 minute with no previous temperature excursion. The operator of device was a healthcare professional.
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