| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2865568 | F | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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Still got infected; Still got infected; The initial case was missing the following minimum criteria:...
Still got infected; Still got infected; The initial case was missing the following minimum criteria: specific number of patients. Upon receipt of follow-up information on 09Oct2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a consumer, Program ID. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Still got infected". After 4 or 5 vaccines, the patient and her husband still got infected. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500119969 Same reporter, product, and event; different patient;
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| 2865569 | 10/13/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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COVID-19, Drug ineffective; COVID-19, Drug ineffective
COVID-19, Drug ineffective; COVID-19, Drug ineffective
|
got Covid about 2 years ago; got Covid about 2 years ago; This is a spontaneous report received from...
got Covid about 2 years ago; got Covid about 2 years ago; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789858 (Moderna Clinical Safety and Pharmacovigilance). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; elasomeran (SPIKEVAX), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Respiratory disorder" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "got Covid about 2 years ago". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: it was reported that patient got COVID about 2 years ago after having multiple vaccines. Patient had COVID for 3 weeks though had treatment medication of Paxlovid. It was interpreted that got COVID because always had Moderna vaccines and had gotten Pfizer which was premature. The patient was unable to take penicillin but it was not explained the reason. It was unknown if the patient experienced any additional symptoms or events. Moderna comment: The benefit-risk relationship of the product (Spikevax) is not affected by this report. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2865570 | 10/13/2025 |
FLU3 |
SANOFI PASTEUR |
|
Influenza like illness
Influenza like illness
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their reaction as flu-like; Initial information received on 08-Oct-2025 regarding an unsolicited val...
their reaction as flu-like; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who had their reaction as flu-like after receiving Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot number, strength, expiry date-unknown) via unknown route in unknown administration site for Suspension for injection in pre-filled syringe (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date the patient developed a their reaction as flu-like (influenza like illness) (unknown latency). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.
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| 2865571 | 5 | F | OH | 10/13/2025 |
DTP |
UNKNOWN MANUFACTURER |
|
Anaphylactic reaction
Anaphylactic reaction
|
anaphylactic reaction to a vaccine" from Sanofi 19 years ago due to their allergic reaction to ...
anaphylactic reaction to a vaccine" from Sanofi 19 years ago due to their allergic reaction to dairy; Initial information received on 08-Oct-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 5 years old female patient who had anaphylactic reaction to a vaccine from sanofi 19 years ago due to their allergic reaction to dairy after receiving Diphtheria, Tetanus And Nos Pertussis Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Dairy intolerance. On an unknown date, the patient received an unknown dose of suspect Diphtheria, Tetanus And Nos Pertussis Vaccine produced by unknown manufacturer (lot number, expiry date, formulation and strength not reported) via unknown route in unknown administration site for Immunisation. Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date, the patient developed anaphylactic reaction to a vaccine from sanofi 19 years ago due to their allergic reaction to dairy (anaphylactic reaction) (latency unknown) following the administration of Diphtheria And Tetanus And Nos Pertussis Vaccine. Reportedly, they stated that their daughter was five years old at time of onset and has an allergic reaction to dairy. They also noted that the adverse reaction has already passed and that their daughter is studying for her masters in genetics at the time of the call. They could no longer recall the brand name, lot number, and expiration date of the product nor any other details surrounding the adverse event. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event. Seriousness criteria- The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 08-Oct-2025: This case involves a 5 years old female patient who had anaphylactic reaction to a vaccine from sanofi 19 years ago due to their allergic reaction to dairy after receiving Diphtheria, Tetanus And Nos Pertussis Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. At the time of the event, the patient had ongoing Dairy intolerance. Lack of information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
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| 2865572 | 7 | M | ID | 10/13/2025 |
FLU3 |
SANOFI PASTEUR |
U8827AA |
No adverse event, Product storage error
No adverse event, Product storage error
|
Max temperature reached: 25.7F Duration: 4 h17 min Previous Excursion? No Human error? YES Administe...
Max temperature reached: 25.7F Duration: 4 h17 min Previous Excursion? No Human error? YES Administered post-excursion? Yes Does extended stability data cover the excursion? No with no ae; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 years old male patient and product had temperature excursion: max temperature reached: 25.7f duration: 4 h17 min previous excursion? no human error? yes administered post-excursion? yes does extended stability data cover the excursion? no with no ae for vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (lot U8827AA, Expiry date: 30-Jun-2026) via intramuscular route in the left arm as immunization and product had temperature excursion: max temperature reached: 25.7f duration: 4 h17 min previous excursion? no human error? yes administered post-excursion? yes does extended stability data cover the excursion? no with no ae (product storage error; latency: same day) . Reportedly, that was administered post temperature excursion that left the product not suitable for use. Vaccine was used at a flu clinic post excursion. Reason: refrigerator temperature knob was accidentality turned down Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2865573 | 9 | M | ID | 10/13/2025 |
FLU3 |
SANOFI PASTEUR |
U8827AA |
No adverse event, Product storage error
No adverse event, Product storage error
|
patient received Fluzone which was exposed to temperature excursion due to refrigerator temperature ...
patient received Fluzone which was exposed to temperature excursion due to refrigerator temperature knob was accidentality turned down and Max temperature reached: 25.7 degree Fahrenheit for 4 hours and 17 minutes with no adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA- 2025SA303414. This case involves a 9 years old male patient who received Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] which was exposed to temperature excursion due to refrigerator temperature knob was accidentality turned down and maximum temperature reached was 25.7 degree Fahrenheit for 4 hours and 17 minutes with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (once), Suspension for injection, Strength Standard, lot U8827AA and expiry date 30-Jun-2026 in left arm for immunisation, which was exposed to temperature excursion due to refrigerator temperature knob was accidentality turned down and maximum temperature reached was 25.7 degree Fahrenheit for 4 hours and 17 minutes with no adverse event (product storage error) (Latency Same day). Reportedly, this excursion occurred due to a human error, extended stability data did not cover the excursion. Vaccine did not had any previous excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA303414:
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| 2865574 | 6 | M | ID | 10/13/2025 |
FLU3 |
SANOFI PASTEUR |
U8827AA |
No adverse event, Product storage error
No adverse event, Product storage error
|
FLUZONE TRIVALENT(UNOPENED) exposed to temp excursion due to refrigerator temperature knob was accid...
FLUZONE TRIVALENT(UNOPENED) exposed to temp excursion due to refrigerator temperature knob was accidentality turned down Max temperature reached: 25.7F DEGREES Duration: 4 hours and 17 minutes with no reported adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with US-SA-2025SA301769 (master case). This case involves a 6 years old male patient who received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] (unopened) post temperature excursion; the temperature excursion was due to refrigerator temperature knob was accidentality turned down where max temperature reached: 25.7f degrees for the duration: 4 hours and 17 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- standard, expiry date- 30-JUN-2026 and lot U8827AA) via unknown route in the left arm for Immunization post temperature excursion and the temperature excursion was due to refrigerator temperature knob was accidentality turned down where max temperature reached: 25.7f degrees for the duration: 4 hours and 17 minutes with no reported adverse event (product storage error) (unknown latency). Reportedly, there was no previous excursion. Human error was involved. The producr was administered post-excursion. The extended stability data did not cover the excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA301769:master case
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| 2865578 | 79 | F | AZ | 10/13/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052835 407268 |
Nausea, Pyrexia; Nausea, Pyrexia
Nausea, Pyrexia; Nausea, Pyrexia
|
Patient experienced nausea and fever the same night she received the vaccine (10/3/25). Patient felt...
Patient experienced nausea and fever the same night she received the vaccine (10/3/25). Patient felt a little better the next morning on 10/4. We recommended her to stay hydrated, rest, and take Tylenol as needed. We also recommended patient to seek care immediately should the symptoms got worse.
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| 2865579 | 60 | F | NC | 10/13/2025 |
FLU3 FLU3 FLU3 PNC20 PNC20 PNC20 VARZOS VARZOS VARZOS |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
U8832AA U8832AA U8832AA MA2488 MA2488 MA2488 3T74X 3T74X 3T74X |
Asthenia, Blood test, Chest X-ray, Chest discomfort, Chills; Electrocardiogram, ...
Asthenia, Blood test, Chest X-ray, Chest discomfort, Chills; Electrocardiogram, Erythema, Myalgia, Nausea, Pain in extremity; Peripheral swelling, Pyrexia, Vomiting; Asthenia, Blood test, Chest X-ray, Chest discomfort, Chills; Electrocardiogram, Erythema, Myalgia, Nausea, Pain in extremity; Peripheral swelling, Pyrexia, Vomiting; Asthenia, Blood test, Chest X-ray, Chest discomfort, Chills; Electrocardiogram, Erythema, Myalgia, Nausea, Pain in extremity; Peripheral swelling, Pyrexia, Vomiting
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10/09 - 10/10 CHILLS/SHIVERING, FEVER, NAUSEA/THROWING UP, WEAKNESS, Advil (ibuprofen/Tylenol); Feve...
10/09 - 10/10 CHILLS/SHIVERING, FEVER, NAUSEA/THROWING UP, WEAKNESS, Advil (ibuprofen/Tylenol); Fever broke 10/10 in the evening. 10/10-10/11 Nausea, muscle soreness, weakness; 10/11 i- n evening arm soreness, swelling and large red patch appeared on arm with extreme pain, took more Advil (ibuprofen/Tylenol). 10/12 - Arm red patch continued to spread and arm swollen, chest discomfort began under left arm into left side of chest.
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| 2865580 | 75 | F | NC | 10/13/2025 |
COVID19 FLU3 PNC21 |
MODERNA SANOFI PASTEUR MERCK & CO. INC. |
3052549 u8859ba z006076 |
Eyelid injury, Syncope; Eyelid injury, Syncope; Eyelid injury, Syncope
Eyelid injury, Syncope; Eyelid injury, Syncope; Eyelid injury, Syncope
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Wednesday night she fainted in the bathroom. Laceration to her right eye lid.
Wednesday night she fainted in the bathroom. Laceration to her right eye lid.
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| 2865581 | 22 | F | 10/13/2025 |
FLU3 |
SEQIRUS, INC. |
|
Rash
Rash
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she called and said she had developed a rash on her right cheek after getting her flu shot
she called and said she had developed a rash on her right cheek after getting her flu shot
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| 2865582 | 56 | F | CA | 10/13/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
JS74H |
Dysphonia, Influenza virus test negative, Pyrexia, Respiratory syncytial virus t...
Dysphonia, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
More
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fever starting after vaccine lasting 4 days. dysphonia started on 9/12/25.
fever starting after vaccine lasting 4 days. dysphonia started on 9/12/25.
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| 2865585 | 66 | F | IL | 10/13/2025 |
COVID19 RSV |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3051995 5A457 |
Injection site erythema, Peripheral swelling; Injection site erythema, Periphera...
Injection site erythema, Peripheral swelling; Injection site erythema, Peripheral swelling
More
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Patient got the RSV shot on her right deltoid on 10-12-2025 around 11 AM. She came to the pharmacy t...
Patient got the RSV shot on her right deltoid on 10-12-2025 around 11 AM. She came to the pharmacy the next day and said her arm last night was very swollen. When I looked at it, it was red, with a diameter of about 2 inches. It did not appear swollen. Informed her it was most likely an injection site reaction and to put ice on it. She states that the technician who gave her the vaccine did clean the site with alcohol prior to the injection. Her left deltoid, which had the covid vaccine administered on the same date and time, did not have any of these syhmptoms.
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| 2865586 | 64 | F | NV | 10/13/2025 |
FLU3 |
SEQIRUS, INC. |
407266 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient received flu shot indicated for 65 and older before patient turned 65. Patient reports no ad...
Patient received flu shot indicated for 65 and older before patient turned 65. Patient reports no adverse effects, feels great. Noticed on the day after as that is when the shot was processed
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| 2865594 | 61 | F | GA | 10/13/2025 |
PNC21 |
MERCK & CO. INC. |
Y013009 |
Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
Injection site reaction, Injection site warmth, Rash erythematous, Rash pruritic
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Patient presented to pharmacy with complaint of itchy rash spreading at site of vaccination that was...
Patient presented to pharmacy with complaint of itchy rash spreading at site of vaccination that was administered 5 days previous (October 8, 2025). RPh on duty invited patient into counseling room so that RPh could assess her condition. RPh noted red rash approximately 3in X 6in size. Rash was very hot to touch. Assessment - patient was experiencing an active reaction at the site of vaccine administration. RPh reviewed SCT and profile to confirm vaccine and location of administration. RPh reviewed actions to be performed by RPh which included reporting to VAERS and contacting her PCP. Patient was advised to seed immediate medical attention by her PCP or Emergency medical facility.
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| 2865595 | 74 | M | TX | 10/13/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75D3A |
Injected limb mobility decreased, Injection site erythema, Injection site pain, ...
Injected limb mobility decreased, Injection site erythema, Injection site pain, Pain in extremity
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Patient came to the pharmacy and told us after he received his 2nd dose Shingrix vaccine in May 7, h...
Patient came to the pharmacy and told us after he received his 2nd dose Shingrix vaccine in May 7, he has been having trouble lifting his left arm up above the shoulder (limit on range of motion and pain). Initial side effect was redness and soreness at the injection site but it has recovered now. Recommended pt to follow up and discuss if any treatment is needed.
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| 2865596 | 66 | F | NY | 10/13/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
|
Asthenia, Myalgia, Pyrexia; Asthenia, Myalgia, Pyrexia
Asthenia, Myalgia, Pyrexia; Asthenia, Myalgia, Pyrexia
|
High fever 103.7 and weakness, muscle aches for 1 1/2 days
High fever 103.7 and weakness, muscle aches for 1 1/2 days
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| 2865598 | 67 | F | SD | 10/13/2025 |
COVID19 |
MODERNA |
3053253 |
No adverse event, Underdose
No adverse event, Underdose
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Patient was mistakenly administered the pediatric dose of Moderna's Spikevax instead of the adu...
Patient was mistakenly administered the pediatric dose of Moderna's Spikevax instead of the adult dose. After contacting the patient, they complained of no symptoms or reactions.
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| 2865599 | 70 | F | AZ | 10/13/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9550 U8832BA |
Pain in extremity; Pain in extremity
Pain in extremity; Pain in extremity
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Patient presented to pharmacy on 10/13/25 reporting that she was still experiencing arm pain on her ...
Patient presented to pharmacy on 10/13/25 reporting that she was still experiencing arm pain on her left arm since date of administration (9/28/25). She states the arm pain is noticeable as she conducts day to day activities and has persisted since the administration. She has not sought medical help for the matter, but states she discussed it with her physical therapist at her most recent visit. The physical therapist provided her with exercises to attempt to help with the pain. Patient reports not having taken any medications to attempt to help with the pain. There was a visible mark (small red spot) still apparent where vaccine had been administered - it was not in a high location that would cause concern for SIRVA. Patient reports that she has a complex medical history including fibromyalgia and she believes the arm pain may be coincidental or caused by an aggravation of her underlying conditions. She agreed to contact pharmacy if pain continues/worsens or if she does ultimately seek medical attention or receive a diagnosis/determination from a provider of the cause of the persistent arm pain.
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| 2865600 | 89 | M | NC | 10/13/2025 |
FLU3 |
SANOFI PASTEUR |
U8862EA |
Dyspnoea, Throat tightness, Tremor
Dyspnoea, Throat tightness, Tremor
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PATIENT HAS TROUBLE BREATHING AND SAID HIS THROAT IS CLOSING UP. PATIENT WAS SHAKING AFTER THE VACCI...
PATIENT HAS TROUBLE BREATHING AND SAID HIS THROAT IS CLOSING UP. PATIENT WAS SHAKING AFTER THE VACCINE. ONE DOSE OF EPINEPHRINE WAS GIVEN TO THE PATIENT AT THE PHARMACY AND CALLED 911 IMMEDIATELY; FOLLOWED INSTRUCTIONS PROVIDED BY THEM AND PATIENT WAS TRANSPORTED TO THE HOSPITAL BY EMS.
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| 2865601 | 60 | M | SD | 10/13/2025 |
COVID19 |
MODERNA |
3053253 |
No adverse event, Underdose
No adverse event, Underdose
|
Patient was mistakenly administered the pediatric dose of Moderna's Spikevax instead of the adu...
Patient was mistakenly administered the pediatric dose of Moderna's Spikevax instead of the adult dose. After contacting the patient, they complained of no symptoms or reactions.
More
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| 2865603 | 95 | F | CO | 10/13/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Erythema, Peripheral swelling
Erythema, Peripheral swelling
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Swelling and redness from shoulder to elbow
Swelling and redness from shoulder to elbow
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| 2865604 | 25 | F | MO | 10/13/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site indurati...
Chills, Fatigue, Hyperhidrosis, Injection site erythema, Injection site induration; Injection site pain, Injection site swelling, Pyrexia
More
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Chills, sweating, fatigue, swelling of injection site, redness of injection site, upper arm within s...
Chills, sweating, fatigue, swelling of injection site, redness of injection site, upper arm within several inches of injection is very sensitive to touch, red area around injection site is harder than the rest of the arm. Have been treating by applying alternating ice and heat to the injection site, as well as taking Tylenol to help treat mild fever causing chills/sweats and pain. Been sleeping when possible to help with fatigue.
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| 2865605 | 9 | M | CA | 10/13/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8779LA UT8779LA |
Arthralgia, Back pain, Dysgraphia, Headache, Joint swelling; Mobility decreased,...
Arthralgia, Back pain, Dysgraphia, Headache, Joint swelling; Mobility decreased, Pain in extremity, Pyrexia, Rhinorrhoea, Serum sickness
More
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ON 9/13 PT HAD A FEVER AND RUNNY NOSE HEADACHE. HE WENT TO SCHOOL AND ON THE 15 HE COMPLAINED OF PAI...
ON 9/13 PT HAD A FEVER AND RUNNY NOSE HEADACHE. HE WENT TO SCHOOL AND ON THE 15 HE COMPLAINED OF PAIN IN HIS LOWER LIMBS AND KNEES, BACK PAIN, WRIST PAIN AND SWELLING WITH DIFFICULTY MOVING SAME ON HE CAME INTO CLINIC ON 9/23/2025 WITH THE ABOVE COMPLIANTS, DX SERUM SICKNESS BY URGENT CARE PROVIDER
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| 2865606 | 60 | F | TX | 10/13/2025 |
FLU3 |
SANOFI PASTEUR |
U8832BA |
Erythema, Rash, Swelling
Erythema, Rash, Swelling
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Patient stated she had swelling, redness and bumps that have been occurring daily since receiving th...
Patient stated she had swelling, redness and bumps that have been occurring daily since receiving the vaccine. Goes away after taking Benadryl.
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| 2865607 | 71 | M | 10/13/2025 |
FLU3 |
SEQIRUS, INC. |
407252 |
Hypoaesthesia, Limb injury, Mobility decreased, Pain in extremity
Hypoaesthesia, Limb injury, Mobility decreased, Pain in extremity
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Patient is reporting shoulder injury (limited mobility) as well as numbness/pain in bicep and forear...
Patient is reporting shoulder injury (limited mobility) as well as numbness/pain in bicep and forearm. Patient states he believes vaccine was given too high. Patient used ice and acetaminophen and consulted a DR and started physical therapy. Still experiencing symptoms at 4 weeks post vaccination.
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| 2865608 | 81 | F | MO | 10/13/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
NA0589 407270 |
Injection site bruising, Injection site mass; Injection site bruising, Injection...
Injection site bruising, Injection site mass; Injection site bruising, Injection site mass
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Patient states that she had a knot under her skin after receiving her Covid Vaccine and her arm brui...
Patient states that she had a knot under her skin after receiving her Covid Vaccine and her arm bruised. She still can feel the knot and her arm is still bruised and the bruise has travelled down her arm
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| 2865609 | 90 | F | PA | 10/13/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NDC:00069-2528- NDC:49281-01256 |
Asthenia, Gait disturbance, Wheelchair user; Asthenia, Gait disturbance, Wheelch...
Asthenia, Gait disturbance, Wheelchair user; Asthenia, Gait disturbance, Wheelchair user
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Day after the injection he was Extremely weak? could hardly walk even with his walker? needed to use...
Day after the injection he was Extremely weak? could hardly walk even with his walker? needed to use wheelchair to help get him in house? this weakness lasted all day. Needed 2 people to help get him out of the car . These symptoms lasted all day following day of injection. By the following day he was back to normal.
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| 2865610 | 63 | F | AZ | 10/13/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
TFAA2538 TFAA2538 |
Injection site bruising, Injection site discolouration, Injection site erythema,...
Injection site bruising, Injection site discolouration, Injection site erythema, Injection site mass, Injection site pain; Injection site swelling, Injection site warmth
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Was swollen two days later with a lump you could feel under the skin. Pt stated it was warm to the ...
Was swollen two days later with a lump you could feel under the skin. Pt stated it was warm to the touch. It has now developed a very large bruise in the area about 1 inch in diameter. It is purple, blue, and red. Pt states it is tender to the touch, she can move her arm.
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| 2865611 | 73 | F | CA | 10/13/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794CA |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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FRONTAL HALF OF UPPER RIGHT ARM IS SWOLLEN AND RED.
FRONTAL HALF OF UPPER RIGHT ARM IS SWOLLEN AND RED.
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| 2867318 | 53 | F | NC | 10/13/2025 |
FLU3 |
SANOFI PASTEUR |
ut8770ja |
Headache, Loss of personal independence in daily activities, Paraesthesia
Headache, Loss of personal independence in daily activities, Paraesthesia
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Experienced a debilitating headache unable to do normal daily functions requiring constant over the ...
Experienced a debilitating headache unable to do normal daily functions requiring constant over the counter medications which only decreased symptoms approximately 50%. The headache Still Remains 72 hours after the inoculation. I still have a tingling in my arm for the inoculation.
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| 2865156 | 79 | F | CA | 10/12/2025 |
COVID19 FLU3 VARZOS |
PFIZER\BIONTECH SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
NA0739 407241 55KB9 |
Eye irritation, Herpes zoster, Pain, Rash; Eye irritation, Herpes zoster, Pain, ...
Eye irritation, Herpes zoster, Pain, Rash; Eye irritation, Herpes zoster, Pain, Rash; Eye irritation, Herpes zoster, Pain, Rash
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Patient went to the Urgent Care (Name, address, phone, city, state- withheld) on Sunday, 5 October, ...
Patient went to the Urgent Care (Name, address, phone, city, state- withheld) on Sunday, 5 October, in the morning due to severe rashes, Pain, and burning. She was diagnosed with Shingles. She was treated with antiviral medication (valacyclovir) for 7 days and then extended for 7 more days, and gabapentin due to her severe symptoms.
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| 2865157 | 77 | M | TN | 10/12/2025 |
COVID19 |
PFIZER\BIONTECH |
Na4452 |
Atrial fibrillation
Atrial fibrillation
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Fib. Have not had it in over a year.
Fib. Have not had it in over a year.
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| 2865158 | 38 | F | NM | 10/12/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9JC49 |
Headache, Musculoskeletal stiffness, Nausea, Neck pain, Tinnitus
Headache, Musculoskeletal stiffness, Nausea, Neck pain, Tinnitus
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Patient presented to ER complaining of intermittent right ear tinnitus, headache, nausea, right side...
Patient presented to ER complaining of intermittent right ear tinnitus, headache, nausea, right sided neck pain/stiffness worse with turning neck. Patient states headache has resolved, states other symptoms remain.
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| 2865159 | 11 | F | NM | 10/12/2025 |
FLU3 HPV9 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
9JC49 Y013407 |
Tinnitus; Tinnitus
Tinnitus; Tinnitus
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Patient presented to ER complaining of intermittent bilateral tinnitus. Symptom started immediately ...
Patient presented to ER complaining of intermittent bilateral tinnitus. Symptom started immediately after administration, but resolved shortly after and was attributed as anxiety in clinic. Tinnitus has been intermittent since, last episode 10/11/2025 @ 1700. Patient received both Fluarix and Gardasil at same time, however patient's mother received only Fluarix on this date and exhibited similar symptoms. Therefore, reaction is believed to be attributed to Fluarix.
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| 2865160 | 32 | F | WA | 10/12/2025 |
RSV |
PFIZER\WYETH |
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Exposure during pregnancy, Premature delivery
Exposure during pregnancy, Premature delivery
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Preterm birth, first baby, 10/XX/2025, 6lb6oz.
Preterm birth, first baby, 10/XX/2025, 6lb6oz.
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| 2865161 | 64 | F | FL | 10/12/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9CC9K |
Oral herpes
Oral herpes
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Received flu vaccine on Thursday 10/2/ 25 and woke up Saturday 10 /4/25 with cold sore on my lip.
Received flu vaccine on Thursday 10/2/ 25 and woke up Saturday 10 /4/25 with cold sore on my lip.
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| 2865162 | 63 | F | AL | 10/12/2025 |
FLU3 VARZOS |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
U8823AA 3T74X |
Dysstasia, Gait disturbance, Mobility decreased, Vertigo; Dysstasia, Gait distur...
Dysstasia, Gait disturbance, Mobility decreased, Vertigo; Dysstasia, Gait disturbance, Mobility decreased, Vertigo
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Severe vertigo lasting three weeks. Days 1-5: Unable to stand, walk or sit up without assistance. On...
Severe vertigo lasting three weeks. Days 1-5: Unable to stand, walk or sit up without assistance. Onset: 6:30 p.m., approx 1.5 hours after vaccine(s). Performed Epley maneuver, took Meclizine 25 mg, but no improvement. Next day: visit to urgent care (Sunday). Given Dexamethasone IM plus a Methylprednisolone dosepak (4 mg/6 day). Very slight improvement. Two days later (Tuesday): PCP visit. Prescribed Levocetirizine and Montelukast. Recommendation to reduce sodium in diet. Gradual improvement over several days. Day 10: Relapse to severe vertigo, unable to sit up, stand, or walk without assistance. Continued same regimen. Slow improvement over next week to normal orientation.
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| 2865164 | 72 | M | NJ | 10/12/2025 |
ADEN_4_7 COVID19 |
TEVA PHARMACEUTICALS MODERNA |
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Hallucination, visual; Hallucination, visual
Hallucination, visual; Hallucination, visual
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Had a visual hallucination of seeing a bird in my house; flying around trying to escape; Tried to ge...
Had a visual hallucination of seeing a bird in my house; flying around trying to escape; Tried to get him out and when I realized I couldn?t I called my wife to help; then he disappeared; She did not see him
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| 2865165 | 66 | F | IL | 10/12/2025 |
FLU3 |
SANOFI PASTEUR |
UT8763EA |
Needle issue, Underdose
Needle issue, Underdose
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PROBLEM WITH NEEDLE SO ALL OF VACCINE WAS NOT ADMINSTERED
PROBLEM WITH NEEDLE SO ALL OF VACCINE WAS NOT ADMINSTERED
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| 2865166 | 53 | F | MD | 10/12/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Cough, Dizziness, Hyperhidrosis, Malaise, Pyrexia; Retching, Tinnitus, Vomiting
Cough, Dizziness, Hyperhidrosis, Malaise, Pyrexia; Retching, Tinnitus, Vomiting
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I don't know which Moderna vaccine (Mnexspike or Spikevax) I got but it was the mRNA Moderna CO...
I don't know which Moderna vaccine (Mnexspike or Spikevax) I got but it was the mRNA Moderna COVID-19 vaccine. I have my vaccine card if you need it. I got the first shot on 4/20/21 and the second shot on 5/18/21, and a booster shot on 1/2/22. The ringing in my right ear started in the late fall of 2022 and I still have it. It comes and goes but lasts all day when I have it. I also get dizzy sometimes. This has reduced the quality of my life. Also, I felt like I was going to die right after the 2nd shot. For about 24 hours I had constant vomiting, fever, sweating, and heaving, We were warned there could be a bad reaction but that it was normal so we didn't call 911. Looking back at it though I probably almost died. It was that bad. I've also had persistent coughing since the COVID vaccine. It comes out of the blue and lasts for about 5 minutes at a time.
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| 2865167 | 68 | M | WV | 10/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
NR4T5 |
Injection site rash, Rash, Rash macular, Rash pruritic
Injection site rash, Rash, Rash macular, Rash pruritic
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Patient received a Shingrix vaccine on 10/6/2025. He came to pharmacy on 10/12/25 to pick up some ot...
Patient received a Shingrix vaccine on 10/6/2025. He came to pharmacy on 10/12/25 to pick up some other prescriptions and reported that he had an itchy rash surrounding the injection site and other rash patches all over his body. Stated he was taking Benadryl to help with it. Advised him to use a different antihistamine or topical Benadryl if the oral Benadryl wasn't helping and hydrocortisone cream to help relieve itch. Advised that if the rash did not improve in the next day to consult his doctor for further evaluation.
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| 2865168 | 74 | F | 10/12/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
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Chills, Fatigue, Injection site pain, Nausea, Pain; Pyrexia
Chills, Fatigue, Injection site pain, Nausea, Pain; Pyrexia
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Soreness at injection site-immediate; approximately 12-14 hours later: nausea, fatigue, body aches, ...
Soreness at injection site-immediate; approximately 12-14 hours later: nausea, fatigue, body aches, slight fever, chills. Resolved after approximately 16 hours.
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| 2865169 | 78 | M | IL | 10/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Injection site swelling, Nausea, Pyrexia, Rash
Arthralgia, Injection site swelling, Nausea, Pyrexia, Rash
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swelling at site, nauseau, rash on chest and back, fever for 3 days, sore joints.
swelling at site, nauseau, rash on chest and back, fever for 3 days, sore joints.
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| 2865170 | 50 | F | CO | 10/12/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
35A77 |
Neurological symptom
Neurological symptom
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Pt reported symptoms of guillain-Barre syndrom shortly (the following week) to the pharmacy. However...
Pt reported symptoms of guillain-Barre syndrom shortly (the following week) to the pharmacy. However, she was unsure and went to MD to confirm. We tried multiple times to contact pt. When she came in following month it was confirmed that pt had this reaction (per pt). She states she is going to be seeing a neurologist. They also believe it may have been brought on by an already weakened immunity and Possible MS.
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| 2865171 | 80 | F | KY | 10/12/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052731 U8859BA |
Injected limb mobility decreased, Pain in extremity; Injected limb mobility decr...
Injected limb mobility decreased, Pain in extremity; Injected limb mobility decreased, Pain in extremity
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Patient reports arm pain (she can barely lift her arm) in her right arm (where she received flu shot...
Patient reports arm pain (she can barely lift her arm) in her right arm (where she received flu shot) for weeks post administration. She is experiencing frequent pain and does not think she will take vaccines moving forward due to length of arm pain, as she has never experienced this before. She mentioned it to her PCP and they recommended Tylenol, ice, and time to which pharmacy also recommended.
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| 2865172 | 16 | M | VA | 10/12/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
JE74J |
Dizziness, Loss of consciousness, Syncope, Thirst, Vision blurred
Dizziness, Loss of consciousness, Syncope, Thirst, Vision blurred
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Patient felt lightheaded immediately after the inoculation, and fainted after sitting down. He regai...
Patient felt lightheaded immediately after the inoculation, and fainted after sitting down. He regained consciousness in 10-20 seconds. Afterwards he felt thirsty, dizzy and start having blurry vision. Upon advice of the medical staff he lied down with his legs up on the chair which helped him feel better.
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| 2865173 | 71 | M | OH | 10/12/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3052735 3052735 |
Chills, Gait inability, Incoherent, Mobility decreased, Pain; Pyrexia, Speech di...
Chills, Gait inability, Incoherent, Mobility decreased, Pain; Pyrexia, Speech disorder
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Fever, body aches, chills, "unable to move/couldn't walk", "babbling incoherentl...
Fever, body aches, chills, "unable to move/couldn't walk", "babbling incoherently"
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| 2865174 | 68 | M | TN | 10/12/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
BG5J4 |
Extra dose administered
Extra dose administered
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THE PATIENT HAD PREVIOUSLY RECEIVED THIS VACCINE ON 10/11/2024 AND WE DIDN'T CATCH IT BEFORE AD...
THE PATIENT HAD PREVIOUSLY RECEIVED THIS VACCINE ON 10/11/2024 AND WE DIDN'T CATCH IT BEFORE ADMINISTERING THE VACCINE ON 10/12/2025
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| 2865175 | 62 | F | FL | 10/12/2025 |
PNC20 RSV |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
MA2523 BG5J4 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Pt received a dose of Arexvy previously on 10/08/2023 so this vaccination was given outside of recom...
Pt received a dose of Arexvy previously on 10/08/2023 so this vaccination was given outside of recommended number of doses. Pt received a dose of Prevnar 20 previously on 03/10/2024 so this vaccination was given outside of recommended number of doses.
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