| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2862994 | 72 | F | WA | 10/03/2025 |
COVID19 |
MODERNA |
3052732 |
Dizziness, Fear, Gait disturbance, Vertigo
Dizziness, Fear, Gait disturbance, Vertigo
|
Dizzy early AM next morning (9/30/2035) after vaccine. 1 event severe. I was fine the rest of day...
Dizzy early AM next morning (9/30/2035) after vaccine. 1 event severe. I was fine the rest of day. 10/1/2025 woke up during night very dizzy, had trouble walking to bathroom. Vertigo continue most of the morning. Subsided in afternoon. totally gone by evening. Started again the next night (10/1/25) not as bad but I was still unsteady. Improved throughout the day. 10/2/2025 had vertigo when lying down on bed. It continued off and continues the next morning, 10/3/2025. I fear it will not resolve.
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| 2862996 | 4 | F | NE | 10/03/2025 |
FLU3 |
SANOFI PASTEUR |
UT8826KA |
Injection site reaction, Injection site swelling, Injection site warmth, Rash ma...
Injection site reaction, Injection site swelling, Injection site warmth, Rash macular
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Blotchiness to left thigh, warmth to the touch, and swelling noted, larger scale than localized at s...
Blotchiness to left thigh, warmth to the touch, and swelling noted, larger scale than localized at site of injection.
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| 2862997 | 1 | M | SC | 10/03/2025 |
VARCEL |
MERCK & CO. INC. |
|
Chemotherapy, Leukaemia, Varicella zoster virus infection
Chemotherapy, Leukaemia, Varicella zoster virus infection
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Varicella infection requiring antiviral treatment
Varicella infection requiring antiviral treatment
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โ | |||||
| 2862999 | 14 | F | AZ | 10/03/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
Y015760 U8573AA |
Fear, Syncope; Fear, Syncope
Fear, Syncope; Fear, Syncope
|
at the time of administration of the HPV 9 vaccine, after administering Medquafi. pt. stated she was...
at the time of administration of the HPV 9 vaccine, after administering Medquafi. pt. stated she was feeling scared, and she fainted. MA made sure she was safe and breathing and conscious. instructed parents to stay by her side while she ran to find provider. Provider was in another room which he quickly left to attend to pt. He performed an exam to confirm pt was ok, pt then stated she has a history of syncope with vaccines. pt waited 15 mins after provider was done examining her to confirm she was okay. after which MA confirmed she was not having any more symptoms.
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| 2863000 | 50 | F | 10/03/2025 |
COVID19 FLU3 RSV |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site bruising, Injection site discolouration, Injection site erythema,...
Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain; Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain; Injection site bruising, Injection site discolouration, Injection site erythema, Injection site pain
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Delayed reaction. Severe, large red spots, pain, bruising, discoloration. It?s on the RSV injectio...
Delayed reaction. Severe, large red spots, pain, bruising, discoloration. It?s on the RSV injection site.
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| 2863001 | 86 | F | 10/03/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Burning sensation, Circulatory collapse, Diabetes mellitus, Hypoaesthesia, Nerve...
Burning sensation, Circulatory collapse, Diabetes mellitus, Hypoaesthesia, Nerve injury; Neuropathy peripheral, Paraesthesia, Rash
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burning neuropathy from knees down; diabetes; blood vessels in my hands and my feet have been damage...
burning neuropathy from knees down; diabetes; blood vessels in my hands and my feet have been damaged; numbness; terrible nerve damage; terrible burning/ burning neuropathy from knees down; tingling; rash; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (burning neuropathy from knees down), DIABETES MELLITUS (diabetes) and CIRCULATORY COLLAPSE (blood vessels in my hands and my feet have been damaged) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (burning neuropathy from knees down) (seriousness criterion medically significant), DIABETES MELLITUS (diabetes) (seriousness criterion medically significant), CIRCULATORY COLLAPSE (blood vessels in my hands and my feet have been damaged) (seriousness criterion medically significant), HYPOAESTHESIA (numbness), NERVE INJURY (terrible nerve damage), BURNING SENSATION (terrible burning/ burning neuropathy from knees down), PARAESTHESIA (tingling) and RASH (rash). At the time of the report, NEUROPATHY PERIPHERAL (burning neuropathy from knees down), DIABETES MELLITUS (diabetes), CIRCULATORY COLLAPSE (blood vessels in my hands and my feet have been damaged), HYPOAESTHESIA (numbness), NERVE INJURY (terrible nerve damage), BURNING SENSATION (terrible burning/ burning neuropathy from knees down), PARAESTHESIA (tingling) and RASH (rash) outcome was unknown. No concomitant medications were reported. It was reported that patient experienced symptom of burning neuropathy from knees down, and was tested for diabetes, and had rash post 3rd Moderna vaccine. The patient also experienced symptom of terrible nerve damage, terrible burning, tingling, numbness and nerve damage. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2021-248000 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2025: Live follow-up received which contained no new information. On 24-Sep-2025: Upon internal review on 24-Sep-2025, it was identified that the case MOD-2025-789559 was created inadvertently as a duplicate of case MOD-2025-789561. Hence, all the information from the duplicate case MOD-2025-789559 has been added and merged into the retained case MOD-2025-789561. The duplicate case MOD-2025-789559 will be deleted from the safety database. On 25-Sep-2025: Live follow-up received which contained no new information.; Reporter's Comments: The age is a confounder for the events. The events neuropathy peripheral hypoaesthesia, nerve injury, burning sensation and paraesthesia are likely an associated consequence of diabetes event. The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-248000:Case for female patient (reporter's daugther case)
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| 2863002 | 67 | M | FL | 10/03/2025 |
RSV |
PFIZER\WYETH |
MF2187 |
Extra dose administered
Extra dose administered
|
Patient had already received a dose of RSV vaccine (Arexvy) in 2023, but he requested another RSV va...
Patient had already received a dose of RSV vaccine (Arexvy) in 2023, but he requested another RSV vaccine on 10/2/25 and was mistakenly given another dose of RSV vaccine (Abrysvo) outside of ACIP recommendations.
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| 2863003 | 83 | F | 10/03/2025 |
FLU3 |
SEQIRUS, INC. |
407247 |
Hot flush, Immediate post-injection reaction
Hot flush, Immediate post-injection reaction
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Pt reports new onset daily hot flashes that began immediately after receiving flu vaccine. Otherwise...
Pt reports new onset daily hot flashes that began immediately after receiving flu vaccine. Otherwise no new symptoms and feeling well.
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| 2863004 | 77 | F | MA | 10/03/2025 |
HEPAB PNC21 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
p2443 z003579 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
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Swelling, redness, heat on right arm, below injection site, patient came in to pharmacy 2 days after...
Swelling, redness, heat on right arm, below injection site, patient came in to pharmacy 2 days after receiving. Injection site looks normal. Referred pt to md for follow up, especially if redness spreads or doesn't improve in next few days
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| 2863005 | 66 | F | GA | 10/03/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
1009681 1009681 |
Arthralgia, Chills, Headache, Influenza, Lethargy; Nausea, Pain, Pain in extremi...
Arthralgia, Chills, Headache, Influenza, Lethargy; Nausea, Pain, Pain in extremity, Pyrexia
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chills, fever, aches, joint pain, very sore arm, headache, lethargy, nausea. I feel like I have a ba...
chills, fever, aches, joint pain, very sore arm, headache, lethargy, nausea. I feel like I have a bad case of the flu. Treating at home with bed rest, liquids, Tylenol and cool compresses.
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| 2863006 | 80 | F | NC | 10/03/2025 |
COVID19 |
MODERNA |
3052579 |
Underdose
Underdose
|
The patient was accidently given the children's version of the vaccine instead of the adult ver...
The patient was accidently given the children's version of the vaccine instead of the adult version.
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| 2863007 | 16 | M | OR | 10/03/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
47KS7 |
Abdominal pain lower, Vomiting
Abdominal pain lower, Vomiting
|
patient received 2 meningitis vaccines at office visit today: Bexsero & Menveo Was fine in offic...
patient received 2 meningitis vaccines at office visit today: Bexsero & Menveo Was fine in office & when he got home About 2 hours after being home he ate & then started having terrible low L abdominal pain & vomiting Has been vomiting every 5 minutes since Has not checked temp No SOB, wheezing Pain in abdomen not easing up & continues to vomit every 5 min mom worried & wondering if he should be seen at ER, advised yes & she agrees to take him now. Mom called back to let his pediatrician know that he started gradually feeling better. So they opted not to take him to the ER. When we called to check on him the next day he was totally back to normal. No complaints or concerns. His pediatrician then asked we file this report.
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| 2863008 | 75 | F | NC | 10/03/2025 |
COVID19 |
MODERNA |
3052579 |
Underdose
Underdose
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Patient was given the children's version of the vaccine instead of the adult version.
Patient was given the children's version of the vaccine instead of the adult version.
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| 2863009 | 69 | F | KS | 10/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
E754F E754F |
Anaphylactic reaction, Anaphylaxis treatment, Dysphagia, Pruritus, Pustule; Rash...
Anaphylactic reaction, Anaphylaxis treatment, Dysphagia, Pruritus, Pustule; Rash, Swelling face, Trismus
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On 9/30/25, Patient reported an anaphylaxis reaction to the 2nd dose of Shingrix she received from u...
On 9/30/25, Patient reported an anaphylaxis reaction to the 2nd dose of Shingrix she received from us on 9/22. Two days after receiving the vaccine, she woke up and could not open her mouth, with a rash and facial swelling. She also reports weeping pus pockets in ears, nose, hairline, neck, both arms, and entire belly. She also had a hard time swallowing. This resulted in her receiving and epinephrine injection and a hospitalization duration of four days. When reported to our pharmacy, she stated she is feeling better but still incredibly itchy. Her primary care physician has been made aware of the reaction.
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โ | |||||
| 2863010 | 63 | M | PA | 10/03/2025 |
FLU3 |
SANOFI PASTEUR |
ut8804aa |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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resident is under 65 y/o and received a high dose flu vaccine
resident is under 65 y/o and received a high dose flu vaccine
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| 2863011 | 1.25 | F | IA | 10/03/2025 |
UNK |
UNKNOWN MANUFACTURER |
Z010730 |
Wrong product administered
Wrong product administered
|
MMRV (proquad) was provided instead of the ordered med MMR II. Patient was also separately given the...
MMRV (proquad) was provided instead of the ordered med MMR II. Patient was also separately given the varivax shot in the oposite leg on the same day.
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| 2863012 | 4 | F | 10/03/2025 |
COVID19 |
MODERNA |
3052586 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
|
Adult dosage (0.5mL) administered to pediatric patient. No acute adverse reaction. Error recognized...
Adult dosage (0.5mL) administered to pediatric patient. No acute adverse reaction. Error recognized later in the day after patient left appointment. Parent contacted by department manager and made aware.
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| 2863014 | 65 | F | IN | 10/03/2025 |
PNC21 |
MERCK & CO. INC. |
Z009681 |
Induration, Peripheral swelling, Rash
Induration, Peripheral swelling, Rash
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Patient came to pharmacy 4 days later reporting a rash between her breasts. She stated the rash star...
Patient came to pharmacy 4 days later reporting a rash between her breasts. She stated the rash started 10 minutes after receiving vaccine, but was unable to come back as car would not start and had to be towed. She said her arm was swollen and felt hard. The arm did not look red or otherwise compromised with visual inspection. I recommended that she get checked out by a healthcare representative.
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| 2863015 | 4 | M | VA | 10/03/2025 |
COVID19 DTAPIPV FLU3 MMRV |
MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Erythema, Urticaria; Erythema, Urticaria; Erythema, Urticaria; Erythema, Urticar...
Erythema, Urticaria; Erythema, Urticaria; Erythema, Urticaria; Erythema, Urticaria
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Diffuse body redness and hives
Diffuse body redness and hives
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| 2863016 | 75 | F | 10/03/2025 |
COVID19 |
PFIZER\BIONTECH |
hm7010 |
Peripheral swelling
Peripheral swelling
|
Pt had swelling in the right arm after vaccine with Comirnaty. Pt did not have and redness ,fever , ...
Pt had swelling in the right arm after vaccine with Comirnaty. Pt did not have and redness ,fever , or soreness. Is causing no problems to her but is about the size of a golf ball. Is not hard but has a defined shape. Has been there for almost 2 years now and pt come in today to get another vaccine and wanted to make sure that it was reported. this was not her first pfizer covid vaccine we think around doe 3-5
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| 2863017 | 0.67 | F | MN | 10/03/2025 |
DTAPIPV FLU3 PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR PFIZER\WYETH MERCK & CO. INC. |
3RT93 U8889DA MA2502 2088619 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered
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nurse administered Kinrix instead of the ordered vaccine Vaxelis
nurse administered Kinrix instead of the ordered vaccine Vaxelis
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| 2863018 | 84 | F | CA | 10/03/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8794CA UT8794CA |
Abdominal pain upper, Dizziness, Headache, Injection site pain, Neck pain; Pain,...
Abdominal pain upper, Dizziness, Headache, Injection site pain, Neck pain; Pain, Pain in extremity
More
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Pt experienced pain in the injection site of the left arm radiating to the neck and stomach, dizzine...
Pt experienced pain in the injection site of the left arm radiating to the neck and stomach, dizziness, and headache the night of she received the injection. Pt went to the hospital and was informed by ER doctor that the reactions were more than likely from the flu vaccine. Most symptoms have resovled however she complains of soreness in her arm.
More
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| 2863019 | 46 | F | MI | 10/03/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3052586 3052586 |
Back pain, Headache, Injection site erythema, Injection site warmth, Neck pain; ...
Back pain, Headache, Injection site erythema, Injection site warmth, Neck pain; Pain in extremity, Peripheral swelling
More
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redness and heat at injection site. Upper and lower arm swelling. Arm, hand, neck, back, and head pa...
redness and heat at injection site. Upper and lower arm swelling. Arm, hand, neck, back, and head pain. Benadryl given with symptom improvement. Continuing to monitor.
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| 2863021 | 59 | F | IN | 10/03/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9548 U8830BA |
Incorrect dose administered, No adverse event; Incorrect dose administered, No a...
Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event
More
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Patient received high-dose vaccine instead of regular dose. Notified immediately. No immediate repor...
Patient received high-dose vaccine instead of regular dose. Notified immediately. No immediate reports of side effects
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| 2863022 | 73 | F | CA | 10/03/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL8982 EL8982 EN6200 EN6200 FG3527 FG3527 |
Anal prolapse, Death, Depression, Laboratory test abnormal, Renal failure; Trans...
Anal prolapse, Death, Depression, Laboratory test abnormal, Renal failure; Transfusion; Anal prolapse, Death, Depression, Laboratory test abnormal, Renal failure; Transfusion; Anal prolapse, Death, Depression, Laboratory test abnormal, Renal failure; Transfusion
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*Depression- Xanax -continued to get worse *Kidney failure- diuretics, weekly shots, blood transfu...
*Depression- Xanax -continued to get worse *Kidney failure- diuretics, weekly shots, blood transfusions *Prolapsed anus Then she died on Jan 1, 2024.
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โ | โ | โ | โ | ||
| 2863023 | 38 | F | IL | 10/03/2025 |
FLU3 |
SANOFI PASTEUR |
N9CS2 |
Arthralgia, Joint range of motion decreased, Pain, Rotator cuff syndrome
Arthralgia, Joint range of motion decreased, Pain, Rotator cuff syndrome
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Shoulder pain/impingement following administration. Seen in office today with persistent pain and li...
Shoulder pain/impingement following administration. Seen in office today with persistent pain and limited ROM
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| 2863024 | F | 10/03/2025 |
COVID19 COVID19 COVID19 |
JANSSEN MODERNA PFIZER\BIONTECH |
|
Organ failure; Organ failure; Organ failure
Organ failure; Organ failure; Organ failure
|
All her organs shut down/Due to the vaccination, her whole body went down; This spontaneous case was...
All her organs shut down/Due to the vaccination, her whole body went down; This spontaneous case was reported by a consumer and describes the occurrence of ORGAN FAILURE (All her organs shut down/Due to the vaccination, her whole body went down) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and COVID-19 vaccine NRVV Ad26 (JNJ 78436735) (Janssen COVID-19 vaccine) for an unknown indication. Concurrent medical conditions included Diabetes. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form and dose of COVID-19 vaccine NRVV Ad26 (JNJ 78436735) (Janssen COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORGAN FAILURE (All her organs shut down/Due to the vaccination, her whole body went down) (seriousness criterion death). The patient died on 08-Feb-2022. The reported cause of death was all her organs shut down/due to the vaccination, her whole body went down. It is unknown if an autopsy was performed. No concomitant medications were reported. It was reported that, the patient was diabetic. She got vaccinated and all her organs shut down, and she died, on 08-Feb-2022. Due to the vaccination, her whole body went down. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-310582 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2025: Live non-significant follow-up received included reporter phone number and reference numbers were added. On 26-Sep-2025: Live non-significant follow-up received included reference numbers were added.; Reporter's Comments: Patient๏ฟฝs condition of diabetes mellitus and co-suspect products Tozinameran and Janssen COVID-19 vaccines, remain as confounding factors. The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-310582:Reporter case (Master case); Reported Cause(s) of Death: All her organs shut down/Due to the vaccination, her whole body went down
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| 2863025 | 62 | F | CO | 10/03/2025 |
FLU3 |
SANOFI PASTEUR |
U8848AA |
Throat irritation, Tongue disorder
Throat irritation, Tongue disorder
|
Client started complaining of feeling bumps on her tongue, and itchy throat. approx 20 minutes after...
Client started complaining of feeling bumps on her tongue, and itchy throat. approx 20 minutes after she received the flu vaccine. She was given 25 mg of Benadryl and then was taken to the ER for evaluation. When the client was in the ER, she stated the Benadryl , her tongue was better but the itching had not changes She was given hydroxyzine in the ER. She was monitored and discharged from the ER at 1232.
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| 2863029 | 47 | F | WV | 10/03/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
my9548 407001 |
Dizziness; Dizziness
Dizziness; Dizziness
|
patient felt light headed because she was having 2 shots on same day but she was fine after a few m...
patient felt light headed because she was having 2 shots on same day but she was fine after a few minutes of sitting
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| 2863031 | 50 | F | CO | 10/03/2025 |
FLU3 RSV VARZOS |
SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
ubb32ba md5462 55kb9 and dilue |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
More
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pt made an appointment for flu and shingles vaccine - it was typed in as flu and rsv and administere...
pt made an appointment for flu and shingles vaccine - it was typed in as flu and rsv and administered as such. When the patient asked when to return for the second shingles vaccine - the error was discovered. The pt was not upset and agreed that the RSV vaccine was ok to have but wanted to also get a shingles vaccine - The shingles vaccine was then input into the system an administered to the patient
More
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| 2863032 | 65 | F | NC | 10/03/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
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Chest discomfort, Cough, Head discomfort, Injection site pain, Injection site wa...
Chest discomfort, Cough, Head discomfort, Injection site pain, Injection site warmth; Palpitations, Respiratory tract congestion, Tachycardia
More
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Around 10:20 PM I experienced a sudden episode of tachycardia. I took my blood pressure and it was 1...
Around 10:20 PM I experienced a sudden episode of tachycardia. I took my blood pressure and it was 145/140 my pulse rate was 165 bpm. I experienced pressure in my chest and in my head. I did the vasal Vegus maneuver several times and the blood pressure dropped to. 119/69 with a pulse of 70 bpm. I also experienced intermittent cardiac palpitations and congestion in my chest and a cough. My arm was very painful and hot to the touch around the vaccination site.
More
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| 2863034 | 75 | M | CA | 10/03/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EN6201 ER2613 FG3527 |
Death, Laboratory test, Myocardial infarction, Surgery; Death, Laboratory test, ...
Death, Laboratory test, Myocardial infarction, Surgery; Death, Laboratory test, Myocardial infarction, Surgery; Death, Laboratory test, Myocardial infarction, Surgery
More
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Heart attack -surgery -rehab -hospice -death
Heart attack -surgery -rehab -hospice -death
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โ | โ | โ | โ | ||
| 2863035 | 11 | F | AL | 10/03/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Z007940 Z453D ZE4N7 |
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa...
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm
More
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Left arm started swelling with redness and warm to the touch the night after getting the vaccines th...
Left arm started swelling with redness and warm to the touch the night after getting the vaccines that day, patient instructed to take Ibuprofen if needed and do compresses and return to clinic if symptoms worsen
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| 2863036 | 64 | F | CA | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
D942J_HD249 |
Fatigue, Pain, Pain in extremity, Pyrexia
Fatigue, Pain, Pain in extremity, Pyrexia
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fever, body aches, left arm pain, and fatigue.
fever, body aches, left arm pain, and fatigue.
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| 2863037 | 62 | F | IN | 10/03/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0738 U8830BA |
Incorrect dose administered, No adverse event; Incorrect dose administered, No a...
Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event
More
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No adverse event. Patient was given high dose Fluzone for patients 65 and older and the patient was ...
No adverse event. Patient was given high dose Fluzone for patients 65 and older and the patient was 62.
More
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| 2863038 | 20 | F | NC | 10/03/2025 |
HPV9 HPV9 TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
1957407 1957407 KR75K KR75K |
Dizziness, Fall, Feeling hot, Hypotonia, Loss of consciousness; Pallor, Skin lac...
Dizziness, Fall, Feeling hot, Hypotonia, Loss of consciousness; Pallor, Skin laceration; Dizziness, Fall, Feeling hot, Hypotonia, Loss of consciousness; Pallor, Skin laceration
More
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Patient received 2 vaccines. One was Gardasil and the other was Boostrix. I put the band-aid on and...
Patient received 2 vaccines. One was Gardasil and the other was Boostrix. I put the band-aid on and was taking off my gloves. I saw her quickly go limp and fall over from the chair and onto the floor. She was out for about 30 seconds to 1 minute. We called 911 and paramedics came out to check her out. She said she felt okay but her skin was white and she said she was hot and dizzy a few seconds before she passed out. She had hit her brow on the floor and there were a couple drops of blood but no swelling or bruising. She did not want to go to the hospital and when she felt okay I walked her out to the car. She is going to follow up with a doctor today. I called this morning to check on her and she said she is feeling okay but is still going to get checked by her doctor.
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| 2863039 | 50 | F | FL | 10/03/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
00000 00000 00000 |
Arthralgia, Computerised tomogram, Injection site mass, Injection site pain, Mob...
Arthralgia, Computerised tomogram, Injection site mass, Injection site pain, Mobility decreased; Pain, Pain in extremity; Injection site pain, Joint injury; Arthralgia, Computerised tomogram, Injection site mass, Injection site pain, Mobility decreased; Pain, Pain in extremity; Injection site pain, Joint injury
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2 days after vaccine could not lift my arm over my head. Upper arm/ shoulder throbbing pain and ach...
2 days after vaccine could not lift my arm over my head. Upper arm/ shoulder throbbing pain and ache. There is a knot under the injection site. The injection site still hurts 2 months after the vaccine. I still have pain when moving my arm in certain scenarios.
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| 2863040 | 87 | F | DE | 10/03/2025 |
COVID19 |
MODERNA |
3052671 |
Arthralgia, Product administered at inappropriate site
Arthralgia, Product administered at inappropriate site
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A patient states she was given a covid shot in the top front of her shoulder bone. She reports shou...
A patient states she was given a covid shot in the top front of her shoulder bone. She reports shoulder pain started the next morning. She cannot move or use her right arm as a result. She went to an urgent care for the pain and was given a Medrol dose pack and over the counter Voltaren gel for the pain. She is on the second day of the medrol pack and reports no improvement.
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| 2863041 | 77 | F | MO | 10/03/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8800BA U8800BA |
Fatigue, Feeling abnormal, Glossodynia, Loss of consciousness, Pain in extremity...
Fatigue, Feeling abnormal, Glossodynia, Loss of consciousness, Pain in extremity; Swollen tongue
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Patient reported feeling strange a couple hours after immunization, she then felt her tongue was swo...
Patient reported feeling strange a couple hours after immunization, she then felt her tongue was swollen and very painful, she rested the rest of the day, the following morning she reported passing out and her arm was very sore, she felt fatigued the whole second day, she did report to her doctor
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| 2863042 | 4 | F | NC | 10/03/2025 |
DTAP FLU3 IPV |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR |
JP227 UT8779LA Y1A212M |
Injection site discolouration, Injection site erythema; Injection site discolour...
Injection site discolouration, Injection site erythema; Injection site discolouration, Injection site erythema; Injection site discolouration, Injection site erythema
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Developed erythema and purplish coloration of thigh on medial anterior area about 12 cm by 6cm. No f...
Developed erythema and purplish coloration of thigh on medial anterior area about 12 cm by 6cm. No fevers, tenderness
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| 2863043 | 82 | F | TX | 10/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Rash
Rash
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Patient received 3 vaccines: HD-Flu, mNexspike and Arexvy. She waited the mandatory 15 minutes aft...
Patient received 3 vaccines: HD-Flu, mNexspike and Arexvy. She waited the mandatory 15 minutes after the vaccines and left without incident. She called 2 hours later and noticed a rash on her face. Advised her to take Benadryl, and if it didn't help or gets worse to call her doctor. Arexvy is the only new vaccine to her.
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| 2863044 | 18 | M | NC | 10/03/2025 |
MNQ TDAP VARCEL |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. |
U8599AA U8620BA Z005455 |
Syncope; Syncope; Syncope
Syncope; Syncope; Syncope
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Patient experienced fainting about ten minutes after receiving the vaccines. Comfort measures provid...
Patient experienced fainting about ten minutes after receiving the vaccines. Comfort measures provided. Patient regain normalcy a few seconds after the episode. Patient was observed for about 20 minutes before leaving. Patient was conscious, oriented, and denied any other symptoms before leaving the facility. Patient refused evaluation by medic. Patient was educated on signs and symptoms and to contact 911 if experiencing any medical emergency. Vital signs were BP: 108/64 and HR: 77 before leaving.
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| 2863045 | 79 | F | 10/03/2025 |
COVID19 |
MODERNA |
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Lethargy, Pain in extremity, Rash
Lethargy, Pain in extremity, Rash
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rash that stayed for about a week; 2 days of general lethargy; 2 days of achy legs; This spontaneous...
rash that stayed for about a week; 2 days of general lethargy; 2 days of achy legs; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (2 days of general lethargy), PAIN IN EXTREMITY (2 days of achy legs) and RASH (rash that stayed for about a week) in a 79-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. In September 2023, the patient received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced LETHARGY (2 days of general lethargy), PAIN IN EXTREMITY (2 days of achy legs) and RASH (rash that stayed for about a week). At the time of the report, LETHARGY (2 days of general lethargy), PAIN IN EXTREMITY (2 days of achy legs) and RASH (rash that stayed for about a week) had resolved. Concomitant medication was not provided. It was unknown if the patient experienced any additional symptoms/events. Treatment medication information was not reported. This case was linked to MOD-2025-789700 (Patient Link).
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| 2863046 | 54 | F | OH | 10/03/2025 |
FLU3 |
SEQIRUS, INC. |
AX4143C |
Chills, Feeling cold, Heart rate increased, Pain, Tremor
Chills, Feeling cold, Heart rate increased, Pain, Tremor
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Client reported "I received my flu shot this morning at 10:00am at facility and have since expe...
Client reported "I received my flu shot this morning at 10:00am at facility and have since experienced symptoms that I have never received before: I started to receive body aches in the afternoon, which is usual, but usually happens the next day and are mild. When I left work at 4:45pm, the body aches began to increase and within the next 30 minutes, I was trembling, and my teeth were chattering. I was freezing and had to lay in the bed with a winter blanket over me. I eventually went to the recliner and layed on a heating pad on low. I continued to tremble/chatter for about an hour then that stopped. I was still achy. Then about an hour later, my watch started to indicate that my heart rate was rising. 126 7:59pm, 124 at 9:04pm, 136 at 9:24."
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| 2863047 | 94 | M | AZ | 10/03/2025 |
FLU3 |
SEQIRUS, INC. |
407255 |
Injection site bruising
Injection site bruising
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PER PT, AFTER THE VACCINATION HE WAS OK, BUT THE DAY AFTERWARD, HE DEVELOPED A LARGE DARK BRUISING A...
PER PT, AFTER THE VACCINATION HE WAS OK, BUT THE DAY AFTERWARD, HE DEVELOPED A LARGE DARK BRUISING ABOUT 3-4 INCHES UNDERNEATH THE INJECTION SITE. IT SEEMS TO BE AROUND 5-7 INCHES OF BRUISING, YELLOWING AT THE EDGE AT THE TIME OF REPORTING.
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| 2863048 | 75 | F | 10/03/2025 |
FLU3 |
SANOFI PASTEUR |
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Extra dose administered
Extra dose administered
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Pt received a second dose of a flu vaccine by mistake within a month.
Pt received a second dose of a flu vaccine by mistake within a month.
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| 2863049 | 85 | F | WV | 10/03/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Brain fog, Confusional state, Feeling abnormal, Headache, Injection site pain; M...
Brain fog, Confusional state, Feeling abnormal, Headache, Injection site pain; Malaise, Memory impairment
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pt says she has a large red spot right below the injection site that is tender. The day following af...
pt says she has a large red spot right below the injection site that is tender. The day following after the vaccine she was in her kitchen when she had a feeling of confusion and was not feeling well. She felt as she was having a mini-stroke and her memory was fuzzy. She had brain fog and headache. She was having the same feeling as she did when she had trauma in the past. She became confused when dispensing her medication and a feeling of confusion about everything as nothing feels right. She would forget where she was going and what she was doing. She wasn't able to remember how to do her normal routine. She went to bed but when she woke up she had the same symptoms. She would nap longer than usual and continues to feel confused. She spoke with her pharmacist and he felt she had brain fog from the vaccine and was told these symptoms would improve after a period of time. She feels some better but is still having brain fog.
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| 2863050 | 51 | F | MI | 10/03/2025 |
COVID19 |
MODERNA |
3052549 |
Condition aggravated, Tinnitus
Condition aggravated, Tinnitus
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Much increased ringing in right ear
Much increased ringing in right ear
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| 2863051 | 87 | F | PA | 10/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
GJ952 |
Bone pain, Fatigue, Influenza like illness, Injection site reaction
Bone pain, Fatigue, Influenza like illness, Injection site reaction
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Pt called and said she has bone pain at inj site and is feeling tired and like she has the flu
Pt called and said she has bone pain at inj site and is feeling tired and like she has the flu
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| 2863052 | 62 | F | 10/03/2025 |
PNC20 |
PFIZER\WYETH |
LX2498 |
Erythema, Oedema, Pain
Erythema, Oedema, Pain
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Unexpected adverse reaction to a vaccine, erythema, edema and pain. Patient requires antibiotics (or...
Unexpected adverse reaction to a vaccine, erythema, edema and pain. Patient requires antibiotics (oral).
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