| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1904067 | 37 | M | TX | 11/27/2021 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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C-reactive protein, Echocardiogram, Electrocardiogram, Pericarditis, Troponin; B...
C-reactive protein, Echocardiogram, Electrocardiogram, Pericarditis, Troponin; Blood test, Cardiac failure, Cardiac ventricular thrombosis, Echocardiogram, Myocarditis; Pericarditis, Stress echocardiogram, Troponin increased
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Pericarditis
Pericarditis
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| 2860612 | 5 | M | CA | 09/22/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y004545 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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No symptoms reported at the time of the call. No additional AE; HCP called to report an expired dose...
No symptoms reported at the time of the call. No additional AE; HCP called to report an expired dose of PROQUAD was administered to a patient on 8/21/2025. HCP reported that PROQUAD expired 8/19/2025; This spontaneous report was received from a physician assistant (reported as medical assistant) and refers to a 5-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 21-Aug-2025, the patient was vaccinated with an expiry dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA [recombinant human albumin]) (PROQUAD), Injection, at a dose of 0.5 milliliter (mL), administered as prophylaxis (Lot No. Y004545 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 19-Aug-2025) (strength, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (Lot No., expiration date, route and indication were not provided) (expired product administered). No adverse event was reported (no adverse event). Follow-up information was received from the physician assistant (reported as medical assistant) on 17-Sep-2025. It was reported that the suspect expired vaccine was administered in the left deltoid.
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| 2860613 | 1 | F | KS | 09/22/2025 |
MMR |
MERCK & CO. INC. |
X026330 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; temperature excursion; This spontaneous report was received from a nurse on 11-Sep...
No additional AE; temperature excursion; This spontaneous report was received from a nurse on 11-Sep-2025, referring to a 1-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX UPGRADE), Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) and HAVRIX (Hepatitis a vaccine inact). On 08-Sep-2025, the patient was vaccinated with first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X026330, expiration date: 07-Nov-2025), 1 dosage form administered by Subcutaneous route in left upper arm, which was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT), (lot # and expiration date were not reported) as prophylaxis after temperature excursion (product storage error). No additional AE (no adverse event). The medication error occurred at the point of storage in clinical practice. Preliminary of by VFC consult. The vaccine was resumed on 03-Sep-2025. The vaccine was used according to the instruction leaflet. Operator of vaccine was reported as healthcare professional. Temperature excursion occurred as a result of a reading from a digital data logger. Temperature excursions outside of manufacturer-recommended storage ranges. The refrigerator unit DDLs experienced temperature fluctuations outside of the recommended storage ranges due to the doors being open for brief periods of time; during each event the unit doors were kept closed until temperatures stabilized to normal storage ranges. Each event was reported to the VFC program, and approval for use was given for vaccines each time. After 2 excursions occurring within a short timeframe, It was requested inspection and maintenance services for the unit. An inspection found an issue with the thermostat sensor of the refrigerator, leading to over connection of temperature changes. The unit was repaired and the thermostat calibrated along with DDL to ensure accurate readings. No further issues with temperatures. Due to subsequent excursions, it was told to perform stability analysis on the vaccines in the refrigerator based on the cumulative times and temperature of all temperature fluctuations. Although it was previously informed that vaccines can be continued to use, it was told to wait for stability analysis.; Reporter's Comments: Keywords : MUL; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02869093-02869059 , CLIC number : , ESTAR number : , IRMS number : 500UW00000kzgvzYAA|11092025230033|1237 , Central date : 2025-09-12 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2327758 , MNSC case number : 02869093 , MNSC interaction number : 02869059 , Integration log UniqueID : 500UW00000kzgvzYAA|11092025230033|1237 , Service cloud CaseID : 500UW00000kzgvzYAA
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| 2860614 | F | WI | 09/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
2M7GR |
Product preparation issue
Product preparation issue
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suspect they got two vials of the liquid part of the shingrix vaccine; suspect they got two vials of...
suspect they got two vials of the liquid part of the shingrix vaccine; suspect they got two vials of the liquid part of the shingrix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 2M7GR, expiry date 31-JAN-2027) for prophylaxis. On 22-AUG-2025, the patient received Shingrix. On 22-AUG-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: suspect they got two vials of the liquid part of the shingrix vaccine) and inappropriate dose of vaccine administered (Verbatim: suspect they got two vials of the liquid part of the shingrix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 26-AUG-2025 and 27-AUG-2025 Pharmacist contacted that had a patient who received a vaccine with another pharmacist. However they suspect they got two vials of the liquid part of the Shingrix vaccine. Instead of reconstitution of the vaccine with one liquid and one powder Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The administration of the 2 diluents only of Shingrix was last Friday on 22 Aug 2025.
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| 2860615 | F | FL | 09/22/2025 |
COVID19 |
MODERNA |
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Cerebrovascular accident
Cerebrovascular accident
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at some point that his wife, that should also get a booster vaccine for Covid, had in the past a str...
at some point that his wife, that should also get a booster vaccine for Covid, had in the past a stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (at some point that his wife, that should also get a booster vaccine for Covid, had in the past a stroke) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for an unknown indication. The patient's past medical history included Stroke. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (at some point that his wife, that should also get a booster vaccine for Covid, had in the past a stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (at some point that his wife, that should also get a booster vaccine for Covid, had in the past a stroke) outcome was unknown. No concomitant medication was reported. The customer mentioned at some point that his wife, who should also get a booster vaccine for Covid, had a stroke in the past. After that, an AE was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. Reporter did not allow further contact; Reporter's Comments: Very limited information to assess a meaninfull assessment. The benefit-risk relationship of product is not affected by this report.
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| 2860616 | 83 | F | MD | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0590 |
COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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COVID after COVID Vaccine shots/ I have never had COVID before. I was got it.; COVID after COVID Vac...
COVID after COVID Vaccine shots/ I have never had COVID before. I was got it.; COVID after COVID Vaccine shots/ I have never had COVID before. I was got it.; This is a spontaneous report received from a Consumer or other non HCP. An 84-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 17Oct2024 as dose 1, single (Lot number: LN0590, Expiration Date: 07May2025) at the age of 83 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer taking a little cancer pill. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2021, when the patient was 81 years old, for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 2022, when the patient was 82 years old, for Covid-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 15Sep2025, outcome "unknown" and all described as "COVID after COVID Vaccine shots/ I have never had COVID before. I was got it.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Sep2025) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical information: Consumer stated, "It was Moderna (Later vaccine name clarified as Pfizer COVID-19 Vaccine). On here, it is Pfizer, in 2023 it's Pfizer. That was 2023, I have been taken of whatever it is for me to take. I have been taking, and I always get the same thing. It is Pfizer and it is 2021, 21, 21, 22, so I have been taking them the whole time." Consumer stated, "I take a little cancer pill. I had breast cancer. I take little cancer pill, very small, it's a pill." Consumer stated, "No, because this is what happened. My husband was in the hospital, and he came home and then he went to see his primary care doctor on 09Sep but while he was in the hospital, the hospital was very cold, and he caught a cold. So, when he came home and he went to see his primary care doctor, they did not anything about, he was coughing but he was not coughing real bad but that Wednesday he started coughing really bad, this was last Wednesday. So, I called his doctor, and they told me to give him some cough medicine and some this and some that and then I started coughing and I thought what was this. I said I caught his cold, so I called my doctor yesterday morning she said come to the office I want to evaluate you because I just need to see you, and this is what and when she came in. When I went to my doctor, she gave me a test, and she came back and she says you have the COVID and how can I have that when I have not had this shot a year yet. She said but you have it, and this is when she prescribed this medication for me. Other than that, I have only taken cough medicine because I did not know any better. I took the cough medicine because I thought it was a cold and had coughing and runny nose."
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| 2860618 | 23 | F | OR | 09/22/2025 |
COVID19 COVID19 FLU3 FLU3 MENB MENB |
PFIZER\BIONTECH PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH |
NA0738 NA0738 F4A7R F4A7R LL0637 LL0637 |
Injection site rash, Night sweats, Pain, Pyrexia, Rash erythematous; Rash prurit...
Injection site rash, Night sweats, Pain, Pyrexia, Rash erythematous; Rash pruritic; Injection site rash, Night sweats, Pain, Pyrexia, Rash erythematous; Rash pruritic; Injection site rash, Night sweats, Pain, Pyrexia, Rash erythematous; Rash pruritic
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itchy red circular rash at injection site, that grew ~1/2 inch a day. At time of report diameter of ...
itchy red circular rash at injection site, that grew ~1/2 inch a day. At time of report diameter of rash was ~3 inches. Body aches, low grade fever (range from 99-102), night sweats. Instructed to take oral antihistamine, apply hydrocortisone cream, apply cool compress, OTC pain medication.
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| 2860619 | 36 | M | TX | 09/22/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
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Chest pain, Dyspnoea, Fatigue, Inflammation, Muscle fatigue; Peripheral swelling...
Chest pain, Dyspnoea, Fatigue, Inflammation, Muscle fatigue; Peripheral swelling, Thyroid disorder, Tremor
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immediately after vaccine within 6 hours had swelling in my legs, tremors and extreme chain pains wi...
immediately after vaccine within 6 hours had swelling in my legs, tremors and extreme chain pains with shortness of breathe. Over the last few years i have continued to have an onset of blood pressure, thyroid, muscle fatigue and short windedness that I have never experienced which immediately followed and have never truly subsided. Many more issues with extreme fatigue as well as inflammation. I did not want to get the vaccine, but the boss that we worked for made comments to the effect that it would affect our careers and we where stopped from traveling at that time without vaccine.
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| 2860620 | 76 | F | SC | 09/22/2025 |
PNC20 |
PFIZER\WYETH |
lx4483 |
Erythema, Fatigue, Swelling
Erythema, Fatigue, Swelling
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Patient came back to pharmacy on the 22nd, stated she had got her vaccine a week ago. Stated that it...
Patient came back to pharmacy on the 22nd, stated she had got her vaccine a week ago. Stated that it swelled up, was red and hot to the touch, and is having fatigue. No fever, no swelling of face, tongue, or throat. Stated this had happened to her in the past, when she had taken the Boostrix vaccine, and she went to the ER a few days later. Had been told by ER doctor that she was having an allergic reaction. Came to the pharmacy because she was concerned that she was still having swelling and symptoms a week later, and asked if she should consult her prescriber. Got two vaccines on the same day in the same arm, but she has had a flu shot in the past without incident, so believes to be Prevnar 20. Says she will contact her MD right away, and will take Diphenhydramine before bed to see if that causes an improvement. Patient knows if conditions to go to ER like she has in the past.
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| 2860621 | 58 | F | CA | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Injection site rash, Injection site swelling, Supraventricular extrasystoles, Su...
Injection site rash, Injection site swelling, Supraventricular extrasystoles, Supraventricular tachycardia
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Rash and swelling at injection sight, irregular heart rate PACS SVT
Rash and swelling at injection sight, irregular heart rate PACS SVT
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| 2860622 | 1.08 | M | OR | 09/22/2025 |
UNK UNK UNK VARCEL |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. |
S016871 R010474 AT5497 R018780 |
Decreased eye contact, Speech disorder developmental; Decreased eye contact, Spe...
Decreased eye contact, Speech disorder developmental; Decreased eye contact, Speech disorder developmental; Decreased eye contact, Speech disorder developmental; Decreased eye contact, Speech disorder developmental
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Avoiding eye contact, complete regression of speech, decline in ASQ questionnaire (when he was previ...
Avoiding eye contact, complete regression of speech, decline in ASQ questionnaire (when he was previously ahead), etc.
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| 2860623 | 3 | M | CA | 09/22/2025 |
COVID19 |
MODERNA |
3046979 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Not applicable. There was no adverse event. Vaccine was given after FDA's EUA for the vaccine a...
Not applicable. There was no adverse event. Vaccine was given after FDA's EUA for the vaccine administration was revoked.
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| 2860624 | 67 | F | AZ | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Unevaluable event
Unevaluable event
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My dermatologist put me on th topical steroid Clobetasol propionate three days after my Covid 19 vac...
My dermatologist put me on th topical steroid Clobetasol propionate three days after my Covid 19 vaccine. I put the steroid on my entire right forearm. Can this interfere with the effectiveness of my Covid shot? I am to use the topical steroid for two weeks. Should I get another Covid shot. I am a diabetic over 65 and with diabetes and my mother who I see daily is currently doing her chemotherapy for breast cancer. Thank you for your help. Sincerely,
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| 2860625 | 1 | F | WA | 09/22/2025 |
DTAP |
SANOFI PASTEUR |
3CA25C1 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The vaccine was administered one month earlier than scheduled. Vaccine wasn't due until 10/11/2...
The vaccine was administered one month earlier than scheduled. Vaccine wasn't due until 10/11/25
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| 2860626 | 1 | F | CA | 09/22/2025 |
COVID19 |
MODERNA |
3046979 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Not applicable. There was no adverse event. Vaccine was given after FDA's EUA for the vaccine a...
Not applicable. There was no adverse event. Vaccine was given after FDA's EUA for the vaccine administration was revoked.
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| 2860627 | 29 | F | PA | 09/22/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
MY9548 407007 |
Loss of consciousness, Seizure; Loss of consciousness, Seizure
Loss of consciousness, Seizure; Loss of consciousness, Seizure
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Patient received immunizations at onsite clinic and passed out. She went into convusions for about ...
Patient received immunizations at onsite clinic and passed out. She went into convusions for about 20 seconds. HCP opened an ammonia inhalant to revive patient and closely observed her for 10 minutes. Patient was offered water and cool towels which she refused. Emergency services was contacted and patient refused. Patient's family member was contacted and patient was supervised to their car and released to their care.
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| 2860628 | 60 | F | MA | 09/22/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4B22T |
Lymphadenopathy, Pain, Pain in extremity, Pruritus
Lymphadenopathy, Pain, Pain in extremity, Pruritus
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body aches, sore left arm, itchiness in left arm, swelling in lymph nodes near collar bone
body aches, sore left arm, itchiness in left arm, swelling in lymph nodes near collar bone
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| 2860629 | 54 | F | WI | 09/22/2025 |
PPV PPV PPV |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y016291 Y016291 Y016291 |
Arthralgia, Bursitis, Exercise tolerance decreased, Injection site pain, Magneti...
Arthralgia, Bursitis, Exercise tolerance decreased, Injection site pain, Magnetic resonance imaging abnormal; Magnetic resonance imaging joint, Muscle strain, Osteoarthritis, Pain, Pain in extremity; Product administered at inappropriate site, Scan with contrast abnormal, X-ray limb normal
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9/8/2025 3:15 Vaccine given. Shoulder and arm started to hurt about 3 hours after vaccine was given ...
9/8/2025 3:15 Vaccine given. Shoulder and arm started to hurt about 3 hours after vaccine was given (6:15pm), by 3am I was in so much pain I needed to go to the Urgent Care. Was given 600mg of Ibuprofen and Hydrocodone for pain. Arm proceeded to hurt and unable to move it without severe pain at times. Another follow up on 9/15. By 9/17 feeling a little better but not great range of motion. Pain comes and goes. By 9/20, the pain was so bad I needed to take the hydrocodone. As of today, 9/22 it still aches, I can not work out, lift anything heavy and certain movements make the pain much worse. At times I will feel a surge of pain down my arm. I can feel one particular area where the injection was that hurts to put pressure on. ** Injection area was so high it was basically at my shoulder. It appears she did not even get it in the muscle.
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| 2860630 | 17 | M | MA | 09/22/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052671 U8790AA |
Feeling cold, Hyperhidrosis, Hypotonia, Loss of consciousness, Pallor; Feeling c...
Feeling cold, Hyperhidrosis, Hypotonia, Loss of consciousness, Pallor; Feeling cold, Hyperhidrosis, Hypotonia, Loss of consciousness, Pallor
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After recieving both vaccines patient sat down with the rest of his family and within minutes he slu...
After recieving both vaccines patient sat down with the rest of his family and within minutes he slumped over in his seat and seemed to loose consciousness. When his mother called for assistance, in the seconds in took for me to leave the pharmacy and get to him his eyes were open again but his mother seemed to be holding him up. His mother stated this has happened multiple times before due to his severe anxiety. They had warned us of his dislike for needles and how anxious he was previously. She said there was no issues with allergies. While we waited for EMTs to arrive and a technician spoke with EMS, we layed patient down on the ground and elevated his legs. He stated he was cold but seemed to be sweating so he was given an ice pack which mom placed behind his neck. He was extremely pale but was able to keep his eyes open and tell us how he was feeling. When the EMTs arrived he was able to stand on his own and they helped him onto the stretcher. This all took place over the course of about 15 mins time.
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| 2860640 | 0.75 | M | CA | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
LN7305 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Not applicable. There was no adverse event. Vaccine was given after FDA's EUA for the vaccine a...
Not applicable. There was no adverse event. Vaccine was given after FDA's EUA for the vaccine administration was revoked.
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| 2860641 | 83 | M | CA | 09/22/2025 |
COVID19 FLU3 RSV VARZOS |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
NA0589 U8764CB J9493 23AH2 |
Fluid retention, Joint swelling, Peripheral swelling, Scab, Wound; Fluid retenti...
Fluid retention, Joint swelling, Peripheral swelling, Scab, Wound; Fluid retention, Joint swelling, Peripheral swelling, Scab, Wound; Fluid retention, Joint swelling, Peripheral swelling, Scab, Wound; Fluid retention, Joint swelling, Peripheral swelling, Scab, Wound
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Swelling of left ankle and open wound (now scabbing), swelling water retention of left leg, Swelling...
Swelling of left ankle and open wound (now scabbing), swelling water retention of left leg, Swelling of right elbow (quickly went away).
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| 2860642 | 18 | F | WA | 09/22/2025 |
COVID19 COVID19 COVID19 FLU3 FLU3 FLU3 |
MODERNA MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
80777011296 80777011296 80777011296 70461065503 70461065503 70461065503 |
Asthenia, Dizziness, Dyspnoea, Fatigue, Feeling cold; Headache, Hyperaesthesia, ...
Asthenia, Dizziness, Dyspnoea, Fatigue, Feeling cold; Headache, Hyperaesthesia, Pain, Paraesthesia, Presyncope; Pyrexia, Speech disorder, Visual brightness; Asthenia, Dizziness, Dyspnoea, Fatigue, Feeling cold; Headache, Hyperaesthesia, Pain, Paraesthesia, Presyncope; Pyrexia, Speech disorder, Visual brightness
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At 09:00 am 09/21/2025 experienced extreme headache, body ache, fatigue, fever, sensitivity to touch...
At 09:00 am 09/21/2025 experienced extreme headache, body ache, fatigue, fever, sensitivity to touch until around 08:00 am 09/22/2025. At 05:45 pm 09/22/2025, after spending most of the day resting in bed, stood up and walked around for 5+ minutes, experiencing symptoms comparable to being about to pass out, ie: lights getting bright, light headedness, shortness of breath, tingling in the extremities, extreme cold, weakness of the entire body, limitations in speaking capability. This is out of the norm for me and I feel cause for concern.
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| 2860643 | 21 | M | TX | 09/22/2025 |
COVID19 COVID19 |
NOVAVAX NOVAVAX |
FF 2587 FF 2587 |
Biopsy, Chills, Malaise, Mobility decreased, Pharyngeal swelling; Thyroid mass
Biopsy, Chills, Malaise, Mobility decreased, Pharyngeal swelling; Thyroid mass
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Possible link to Thyroid Nodule (Did not have it before). Additionally, the second shot made me feel...
Possible link to Thyroid Nodule (Did not have it before). Additionally, the second shot made me feel absolutely horrible for about a full week basically bed ridden with chills and throat swelling.
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| 2860644 | 82 | F | CA | 09/22/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3052583 3052583 |
Gait inability, Mobility decreased, Muscle disorder, Muscular weakness, Oxygen s...
Gait inability, Mobility decreased, Muscle disorder, Muscular weakness, Oxygen saturation decreased; Peripheral swelling, Swelling
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patient was taken to hospital post 1 day from injection. Patient got vaccine 9/19 and symptoms star...
patient was taken to hospital post 1 day from injection. Patient got vaccine 9/19 and symptoms started to present the following day. patient presented with loss of body muscle control in that she couldnt hold anything and couldnt move very well, she also could not walk, she ended up with decreased oxygen intake and was rushed to hospital, patient also had swelling on body including fingers
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| 2860645 | 53 | F | 09/22/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Z006889 Z006889 |
Headache, Injection site erythema, Injection site warmth, Neuralgia, Pain in ext...
Headache, Injection site erythema, Injection site warmth, Neuralgia, Pain in extremity; Pyrexia
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Patient experienced a sore arm at first about 2 hours after the dose was given, started to get a red...
Patient experienced a sore arm at first about 2 hours after the dose was given, started to get a red spot at the site of injection. Patient the started to get headache, fever, neuropathic pain, the area was hot to the touch, all happened after dose was given. At day 3 patient is feeling better and is going to start taking benadryl cream and tablets.
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| 2860646 | 47 | F | IA | 09/22/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
MY9550 3F7A5 |
Injection site erythema, Injection site inflammation, Injection site pain, Injec...
Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth; Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
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Patient states site is red, inflamed, warm to touch, and sore. No fever, no other symptoms. Inject...
Patient states site is red, inflamed, warm to touch, and sore. No fever, no other symptoms. Injection site of flu shot is fine.
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| 2860647 | 44 | M | IL | 09/22/2025 |
FLU3 |
SEQIRUS, INC. |
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Erythema, Peripheral swelling, Pruritus, Skin discolouration
Erythema, Peripheral swelling, Pruritus, Skin discolouration
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Overnight while sleeping (Saturday) woke up and felt like there was a bug bite/itching. Next day (S...
Overnight while sleeping (Saturday) woke up and felt like there was a bug bite/itching. Next day (Sunday) noticed three red raised areas under the arm (not at injection site). Took loratadine with no effect. As day progressed raised areas became yellowish and looked more closely like poisen ivy. Put on clear calamine lotion to no effect. Itchiness continued. Monday raised areas continue to be discolored and continue to get bigger. Itching has continued. Went to pharmacy where I got the injection to ask what to do and they said I should file this report.
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| 2860648 | 61 | F | IL | 09/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
MY9547 MY9547 |
Erythema, Induration, Peripheral swelling, Rash, Rash pruritic; Skin warm, Tende...
Erythema, Induration, Peripheral swelling, Rash, Rash pruritic; Skin warm, Tenderness
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Arm got really swollen, red, hot, very hard and painful to the touch few hours after the shot. It s...
Arm got really swollen, red, hot, very hard and painful to the touch few hours after the shot. It slowly getting better now after 3 days, rash is spreading down the arm and starts becoming itchy.
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| 2860649 | 78 | M | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Headache, Somnolence
Chills, Headache, Somnolence
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chills, headache, drowsiness
chills, headache, drowsiness
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| 2860650 | 52 | F | NC | 09/22/2025 |
COVID19 FLU3 VARZOS |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
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Hypoaesthesia, Paraesthesia; Hypoaesthesia, Paraesthesia; Hypoaesthesia, Paraest...
Hypoaesthesia, Paraesthesia; Hypoaesthesia, Paraesthesia; Hypoaesthesia, Paraesthesia
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PT CALLED AND INFORMED THAT SHE HAD SOME TINGING IN BOTH THE PALMS OF HER HANDS A FEW HOURS AFTER TH...
PT CALLED AND INFORMED THAT SHE HAD SOME TINGING IN BOTH THE PALMS OF HER HANDS A FEW HOURS AFTER THE VACCINES THAT SHE RECEIVED ON 9/15/25. ON 9/17/25, PATIENT STATED SHE HAS TINGLING AND SOME NUMBNESS IN SOME OF HER FINGERS AND BOTH FEET.
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| 2860651 | 64 | M | TX | 09/22/2025 |
COVID19 |
PFIZER\BIONTECH |
my9550 |
Dizziness
Dizziness
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Patient received a flucelvax and a comirnaty imz at roughly 6:15pm. He began to feel dizzy after I g...
Patient received a flucelvax and a comirnaty imz at roughly 6:15pm. He began to feel dizzy after I gave his wife her IMZs and he was sitting down on our bench. I had him lay down on the concrete to avoid him fainting and falling. took his bp at 6:19pm and it was 101/65.....I then ask him if it would be ok to give him some benadryl and he agreed and I gave him 10cc of 12.5mg/5cc liquid. I continued to take his bp 6:20pm 115/76 and 6:21pm 119/79. Patient wanted to try to sit up on the bench so helped him do that but he again felt dizzy and got back down flat on the concreate floor. I was then informed that he had given plasma earlier that day and had not eaten for a bit and I already new he was a diabetic. I had offered glucose tabs earlier but he said he did not need them and took the benadryl. So when he got back on the floor I gave him a glucose tablet and he immediately began to feel better and bp came up more. At 6:26 bp was 126/82. He took the glucose tablet at 6:29pm and given water to sip on. bp at 6:32 127/89 and 133/85 at 6:36. He again wanted to sit up on the bench and said he felt a lot better and wanted to leave with his wife. I had offered also to call EMS but he did not want to do that.. At 6;40pm patient stood up felt steady and left with his wife. I/we will call tomorrow to check on him and see how he is doing. In my opinion reaction seemed more about his blood sugar possibly being too low along with his giving plasma eariler today than a reaction to the imzx
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| 2860652 | 23 | F | OR | 09/22/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
8146670 8146670 |
Gaze palsy, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Seizure; Syncope
Gaze palsy, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Seizure; Syncope
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Patient fainted about 15 seconds after vaccine administration. About 5 seconds after fainting, patie...
Patient fainted about 15 seconds after vaccine administration. About 5 seconds after fainting, patient experienced seizure involving stiffening of muscles and eyes rolling back. Seizure lasted about 5 seconds. Patient quickly recovered, but was very pale and sweaty. Notably, the patient had a strong phobia of needles, had not had anything to eat the day of vaccine administration, and the vaccination room was quite hot.
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| 2860653 | 82 | F | CO | 09/22/2025 |
PNC21 |
MERCK & CO. INC. |
Z004302 |
Contusion, Erythema, Inflammation, Peripheral swelling
Contusion, Erythema, Inflammation, Peripheral swelling
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Pt said day of vaccination arm (9/17) was starting to get red and swell and went below elbow on the ...
Pt said day of vaccination arm (9/17) was starting to get red and swell and went below elbow on the inside. Tried arnica (for bruising) and nothing by mouth. Patient tried to contact PCP but was unable to get in touch with office. Advised patient to seek care at Urgent Clinic. Patient called back later during day (9/22) and says urgent care said it is not an infection but inflammation or her body responding to the vaccination and to continue to monitor for a few more days. Did not recommend any oral medications like ibuprofen or Tylenol.
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| 2860654 | 0.08 | M | CA | 09/22/2025 |
FLU3 |
SANOFI PASTEUR |
U8830AA |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Fluzone High-Dose single dose for 65 years & Up was administered to patient who is 62 years old....
Fluzone High-Dose single dose for 65 years & Up was administered to patient who is 62 years old. No adverse reactions noted.
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| 2860655 | 94 | M | FL | 09/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3T74X |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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GIVEN A THIRD DOSE OF SHINGRIX BY MISTAKE DUE TO A DUPLICATE REPORT ON THE SYSTEM. THE REPORT USED W...
GIVEN A THIRD DOSE OF SHINGRIX BY MISTAKE DUE TO A DUPLICATE REPORT ON THE SYSTEM. THE REPORT USED WAS THE ONE IN WHICH THE PATIENT WAS DUE FOR FIRST DOSE OF SHINGRIX. THE OTHER REPORT WAS FOUND WITH HIS MIDDLE NAME AND SHOWED A 2 DOSES GIVEN ON 11/24/2020 AND 07/29/2021. NO ADVERSE EVENT AT THE TIME OF PROCEDURE. INFORMED THE PATIENT TO CONTACT US IF ANY ADVERSE EVENT DEVELOP ON THE NEXT FEW DAYS AFTER TODAY.
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| 2860656 | 68 | F | FL | 09/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
H4K3S |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient feels fine with no adverse effects. Patient received another dose of Tdap in 07/14/2025. Thi...
Patient feels fine with no adverse effects. Patient received another dose of Tdap in 07/14/2025. This dose was not appropriate for patient.
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| 2860657 | 24 | M | 09/22/2025 |
HPV9 |
MERCK & CO. INC. |
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Vomiting
Vomiting
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no complications during vaccine or after the 15 min waiting period. Pt reported vomiting after HPV a...
no complications during vaccine or after the 15 min waiting period. Pt reported vomiting after HPV administration. Resolved on own.
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| 2860669 | 18 | F | NC | 09/22/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
3R33K |
Generalised tonic-clonic seizure, Loss of consciousness
Generalised tonic-clonic seizure, Loss of consciousness
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Pt passed out on her chair after receiving her vaccine, while positiong the patient on a flat surfac...
Pt passed out on her chair after receiving her vaccine, while positiong the patient on a flat surfaced while other staff calls EMS, pt had a grand mal seizure upon positioning her on a flat surface, head was protected, safety and privacy provided at this time. Vitals signs in HD are as follows: BP-128/81, HR-105, O2 Sat on RA 99%. When EMS arrives pt is already conscious and coherent, was able to provide her Name, DOB and provided her mother's number. Pt states refusal to go to ER, howerver EMS stated she has to be in the EMS car for assessment and evaluation while waiting for her parents. Patient and parent declined to go to ER and opted to go home. This RN called number provided on file to follow up, mom states pt is terrified of needles, just like the other siblings, mom also states is that another reason why she passed out is because of her constant practice for cheerleading. Pt mom was instructed that if patient had another episode of seizure or if any throat swelling and DOB, she has to go to ED, pt mom voices understanding.
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| 2860171 | 77 | M | IA | 09/21/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
LM1211 LM1211 |
Acute myocardial infarction, Chest pain, Condition aggravated, Echocardiogram ab...
Acute myocardial infarction, Chest pain, Condition aggravated, Echocardiogram abnormal, Ejection fraction decreased; Electrocardiogram ST segment depression, Hypotension, Ischaemia, Troponin increased, Ventricular hypokinesia
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Within 24 hours of receiving RSV and flu shot on same day, patient presented with chest pain and ele...
Within 24 hours of receiving RSV and flu shot on same day, patient presented with chest pain and elevated troponin consistent with non STEMI and acutely worsening reduced EF 30% with hypotension.
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| 2860172 | 71 | F | UT | 09/21/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Fatigue, Loss of personal independence in daily activities
Fatigue, Loss of personal independence in daily activities
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Severe fatigue beginning shortly after receiving influenza and hep B vaccines. Not sure of the name ...
Severe fatigue beginning shortly after receiving influenza and hep B vaccines. Not sure of the name etc of the vaccines. It was not the flu vaccine for seniors. I've had the flu vaccine many times with no problem. I don't recall ever having the hep B vaccine before. The fatigue is severe enough to severely limit my activities although I can perform basic daily activities to cate for myself. I have not seen my physician yet but I may do so if it doesn't improve soon. I only just associated the fatigue with the vaccines.
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| 2860173 | 55 | F | MD | 09/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
Fj1614 Fj1614 |
Axillary mass, Axillary pain, Chest pain, Lymphadenitis, Neck pain; Oedema perip...
Axillary mass, Axillary pain, Chest pain, Lymphadenitis, Neck pain; Oedema peripheral, Pain in extremity
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Knot in left arm pit pain and swelling in armpit pain in chest above left breast pain running down l...
Knot in left arm pit pain and swelling in armpit pain in chest above left breast pain running down left arm into hand and fingers pain left side neck
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| 2860174 | 36 | F | AL | 09/21/2025 |
COVID19 |
MODERNA |
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Chest discomfort, Pericarditis
Chest discomfort, Pericarditis
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pericarditis - pressure and tightness in chest when laying down. Relieved when sitting up or leaning...
pericarditis - pressure and tightness in chest when laying down. Relieved when sitting up or leaning forward. Symptoms lasted about 2 weeks
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| 2860175 | 46 | F | NV | 09/21/2025 |
COVID19 |
MODERNA |
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Loss of consciousness
Loss of consciousness
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About 14 hours after vaccine I passed out
About 14 hours after vaccine I passed out
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| 2860176 | 40 | F | NY | 09/21/2025 |
TDAP |
SANOFI PASTEUR |
1 |
Eye swelling
Eye swelling
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left eye swollen
left eye swollen
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| 2860177 | 65 | F | FL | 09/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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COVID-19, Cough, Influenza, Influenza virus test, Nasopharyngitis; SARS-CoV-2 te...
COVID-19, Cough, Influenza, Influenza virus test, Nasopharyngitis; SARS-CoV-2 test
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Three months after getting vaccination, I got a cold from my little niece, this cold lasted months a...
Three months after getting vaccination, I got a cold from my little niece, this cold lasted months and a cough that lingered for 3 months. (mind you I had not had a cold in years, I might have gotten a cold once every 10 years). Then I got the covid, then I got a cold again (2022). Then I got the flu (had never had the flu). Between 2021 - 2025 I have had many colds throughout year, covid 3 times, flu 2 times and flu A. This year alone I have had 4 colds lasting weeks with lingering cough for months.
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| 2860178 | 16 | F | AR | 09/21/2025 |
MNQ |
SANOFI PASTEUR |
U8562AA |
Fall, Presyncope, Syncope
Fall, Presyncope, Syncope
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Patient fainted after receiving vaccine. Some observers thought they might have had a seizure. Fell ...
Patient fainted after receiving vaccine. Some observers thought they might have had a seizure. Fell from chair outside of health services room. EMT was called and took her to hospital. Spoke with mom next day and it was determined patient did not have a seizure, had a vasovagal response.
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| 2860180 | 68 | M | NY | 09/21/2025 |
COVID19 |
MODERNA |
3052133 |
Dizziness
Dizziness
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Patient called on Sunday 9/21/25 at 9:10am to complain that on the evening of Saturday 9/20/25 (day ...
Patient called on Sunday 9/21/25 at 9:10am to complain that on the evening of Saturday 9/20/25 (day of vaccination of mnexspike 0.2ml) he started to feel faint then it subsided. He wanted to report to it the pharmacy as he states this is not a common reaction to the vaccine. We informed him that it is a known adverse reaction and it can happen after any vaccination. He reported feeling fine this morning.
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| 2860181 | 37 | M | KS | 09/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FL3197 FL3197 |
Cardiac monitoring, Chest pain, Echocardiogram, Electrocardiogram, Heart rate in...
Cardiac monitoring, Chest pain, Echocardiogram, Electrocardiogram, Heart rate increased; Laboratory test, Ultrasound scan, Ventricular extrasystoles, Ventricular tachycardia
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Intermittent Chest pain first noted when sitting or laying down; regularly occurring; has continued ...
Intermittent Chest pain first noted when sitting or laying down; regularly occurring; has continued to develop into rapid heart rate at rest, rapid increase of heart rate during minimum exertion conducting activities of daily living; continued intermittent chest pain, PVVs followed by vtach until heart converts itself
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| 2860182 | 16 | M | 09/21/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
3s54k |
Inappropriate schedule of product administration, Pain in extremity
Inappropriate schedule of product administration, Pain in extremity
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Patient given Harvix as second dose in the series but age was not appropriate. Pharmacist notified p...
Patient given Harvix as second dose in the series but age was not appropriate. Pharmacist notified patient and discussed of potential side effects; patient was having sore arm afterwards but no severe side effects.
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| 2860183 | 82 | F | NC | 09/21/2025 |
FLU3 |
SANOFI PASTEUR |
u8855ca |
Injection site pain, Lymphadenopathy, Ophthalmoplegia, Oral discomfort
Injection site pain, Lymphadenopathy, Ophthalmoplegia, Oral discomfort
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Patient called the pharmacy on Saturday and reported swollen lymph nodes in her right neck. No other...
Patient called the pharmacy on Saturday and reported swollen lymph nodes in her right neck. No other pain or concerns. She called back on Sunday and said her lymph node was still swollen, her arm at the injection side was a little sore, her mouth felt like she had burned the inside, and her eyes felt weak. Advised to use Tylenol if needed. She said she will call her medical doctor Monday morning.
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