| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2862339 | 1 | M | OK | 09/30/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
NDC #58160-821- NDC #58160-821- |
Aggression, Aphasia, Autism spectrum disorder, Developmental regression, Inconti...
Aggression, Aphasia, Autism spectrum disorder, Developmental regression, Incontinence; Loss of personal independence in daily activities, Self-destructive behaviour
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Following vaccination on September 30, 2015, with his vaccines my son showed no immediate issues exc...
Following vaccination on September 30, 2015, with his vaccines my son showed no immediate issues except that he lost his life essence. Approximately two years later, around October 2017, he began displaying signs of developmental regression, including loss of previously acquired verbal skills, leading to nonverbal status. Concurrently, he started self-harming behaviors (e.g., head-banging, scratching) and occasional aggression toward others, alongside persistent incontinence requiring diapers. These symptoms intensified over the next several months,where a diagnosis of autism spectrum disorder was confirmed, potentially linked to the vaccination timeline. He received occupational therapy to address self-injury and aggression, and speech therapy to attempt communication restoration, though progress has been limited. Medications such as risperidone were prescribed to manage behaviors, with ongoing adjustments. As of September 2025, he continues to need constant supervision. The outcome has been a permanent nonverbal autistic condition, necessitating lifelong diaper use and ongoing management of self-injurious and aggressive behaviors. This has significantly impacted his daily functioning, requiring special education support and restricting his ability to interact safely with peers.
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| 2862340 | 37 | F | FL | 09/30/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
025J20-2A 046c21a |
Muscle mass; Muscle mass
Muscle mass; Muscle mass
|
Adverse event occurred approximately 2 weeks after he first injection/shot was received on 6 Jan 202...
Adverse event occurred approximately 2 weeks after he first injection/shot was received on 6 Jan 2021. My right arm developed a large lump around the bicep area. The lump is the size of a tennis ball. It has been 4 years, and the lump still has not gone away. Physican Assistants have said they were not concerned because the lump was soft and not hard. Therefore, they said it wasn't concerning for them to do further testing. I would have to pay out of pocket to have surgery to have it removed as a cosmetic procedure to get rid of the adverse reaction caused by the shot. They said if you had Covid prior to the shot, and then got the Moderna vaccine, it was called Covid Arm when you got a lump growth.
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| 2862341 | 60 | F | SC | 09/30/2025 |
COVID19 TDAP VARZOS |
PFIZER\BIONTECH SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
na0587 4ca28c1 55kb9 |
Rash, Rash pruritic; Rash, Rash pruritic; Rash, Rash pruritic
Rash, Rash pruritic; Rash, Rash pruritic; Rash, Rash pruritic
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The morning of 9/28/25 the patient experienced a rash on her abdominal area with intense itching. La...
The morning of 9/28/25 the patient experienced a rash on her abdominal area with intense itching. Later patients arms appeared to be slightly swollen with a fine rash. Patient did not experience any difficulty breathing , increased heart rate, etc. The patient came to the pharmacy on 9/29/25 and pharmacist looked at the areas and recommended hydrocortisone 1% cream and benadryl 25mg minitabs. Patient was counseled on the benadryl causing drowsiness and not to drive or operate heavy machinery. Spoke with patient this morning 9/30/25 and patient seems fine.
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| 2862342 | 11 | M | WA | 09/30/2025 |
FLU3 HPV9 MNQ TDAP |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
5EF45 Y015760 U8573AA 37R35 |
Dyskinesia, Loss of consciousness, Posture abnormal, Syncope; Dyskinesia, Loss o...
Dyskinesia, Loss of consciousness, Posture abnormal, Syncope; Dyskinesia, Loss of consciousness, Posture abnormal, Syncope; Dyskinesia, Loss of consciousness, Posture abnormal, Syncope; Dyskinesia, Loss of consciousness, Posture abnormal, Syncope
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Patient received all four vaccines and then once the last one (HPV) was given, he fainted for 1-2 se...
Patient received all four vaccines and then once the last one (HPV) was given, he fainted for 1-2 seconds. He slumped forward and mom and I helped lay him backwards, he did jerk a little bit. Parents and I helped him lay down completely once he gained consciousnesses. While laying, his vitals were taken and they were normal. Provided patient with water and goldfish crackers. Patient states that he did not eat any breakfast this morning and was extremely anxious prior to receiving the vaccines. He was stable before leaving the clinic.
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| 2862343 | 13 | M | WI | 09/30/2025 |
FLU3 |
SEQIRUS, INC. |
406984 |
Fall, Staring
Fall, Staring
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Patient was the first of 4 people he was with receiving the flu vaccine. He appeared well until aft...
Patient was the first of 4 people he was with receiving the flu vaccine. He appeared well until after the fourth person received the vaccine, about 10 minutes later. He was standing against the wall and he began staring and then falling. The vaccinator noticed and caught him as he was falling before he hit the floor or anything else. He was sat down on the floor and instructed by the vaccinator to place his head between his legs and breathe in through the nose and out through the mouth. He was also given a Sprite, which he drank, and a cold pack which he placed on the back of his neck and was monitored for another 10-15 minutes. He was with his parents. He left them after returning to baseline.
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| 2862344 | 51 | M | NV | 09/30/2025 |
COVID19 |
MODERNA |
041C21A |
Nausea, Vomiting
Nausea, Vomiting
|
Nausea and Vomiting
Nausea and Vomiting
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โ | โ | โ | |||
| 2862345 | 47 | F | CO | 09/30/2025 |
FLU3 |
SANOFI PASTEUR |
ut8779na |
Rash, Rash pruritic
Rash, Rash pruritic
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Patient has rash forming down the arm that is itchy. They find it to be relieved by benadryl and co...
Patient has rash forming down the arm that is itchy. They find it to be relieved by benadryl and cortisone cream
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| 2862347 | 86 | M | GA | 09/30/2025 |
FLU3 |
SANOFI PASTEUR |
u8855ca |
Contusion
Contusion
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bruising over entire forearm
bruising over entire forearm
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| 2862348 | 72 | F | AZ | 09/30/2025 |
FLU3 FLU3 FLU3 PNC21 PNC21 PNC21 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
u8764cb u8764cb u8764cb y019157 y019157 y019157 |
Arthralgia, Erythema, Fatigue, Headache, Induration; Myalgia, Oral herpes, Pain ...
Arthralgia, Erythema, Fatigue, Headache, Induration; Myalgia, Oral herpes, Pain in extremity, Palpitations, Peripheral swelling; Skin warm; Arthralgia, Erythema, Fatigue, Headache, Induration; Myalgia, Oral herpes, Pain in extremity, Palpitations, Peripheral swelling; Skin warm
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Patient reported: Heart palpitations for 3 days after injection, severe pain in arm, 24 hours later ...
Patient reported: Heart palpitations for 3 days after injection, severe pain in arm, 24 hours later the upper arm turned bright red, swollen, hot and hard. Arm reported as still pink on 9/30/25. Patient reported sore muscles and joints for 4 days. Headache, fatigue also reported. Cold sore outbreak occurred after several days. Patient typically fine with flu shot but thinks it is likely related to the combination of immunizations received.
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| 2862349 | 63 | M | MA | 09/30/2025 |
FLU3 |
SEQIRUS, INC. |
AX6151A |
Asthenia, Nausea, Vertigo, Vomiting
Asthenia, Nausea, Vertigo, Vomiting
|
vertigo, nausea, vomiting. Vomiting frequently over a period of at least 2 hours and generalized wea...
vertigo, nausea, vomiting. Vomiting frequently over a period of at least 2 hours and generalized weakness.
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| 2862350 | 67 | F | CA | 09/30/2025 |
MNP PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LP7146 MA2519 |
Cold sweat, Headache, Pain, Pyrexia, Skin warm; Cold sweat, Headache, Pain, Pyre...
Cold sweat, Headache, Pain, Pyrexia, Skin warm; Cold sweat, Headache, Pain, Pyrexia, Skin warm
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After the patient was administered the vaccines as part of our Program, patient advised their health...
After the patient was administered the vaccines as part of our Program, patient advised their healthcare provider that they experienced the following Adverse Events: fever (unknown temperature but skin was hot to the touch), body aches, cold sweats, and bad headaches following her vaccine visit on 9/26/25. The headaches were the patient's largest complaint. Treatment and outcome is unknown.
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| 2862351 | 72 | M | MD | 09/30/2025 |
COVID19 |
MODERNA |
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Periarthritis
Periarthritis
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frozen shoulder/last Spikevax that may have caused the frozen shoulder/arm's usually a little s...
frozen shoulder/last Spikevax that may have caused the frozen shoulder/arm's usually a little stiff after you get a shot and stuff, but it never kind of went away, and it kind of built up; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (frozen shoulder/last Spikevax that may have caused the frozen shoulder/arm's usually a little stiff after you get a shot and stuff, but it never kind of went away, and it kind of built up) in a 72-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Frozen shoulder (back in 2012) in 2012. Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 1) on 19-Oct-2023 and Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax and Spikevax NOS. On 04-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In October 2024, the patient experienced PERIARTHRITIS (frozen shoulder/last Spikevax that may have caused the frozen shoulder/arm's usually a little stiff after you get a shot and stuff, but it never kind of went away, and it kind of built up). At the time of the report, PERIARTHRITIS (frozen shoulder/last Spikevax that may have caused the frozen shoulder/arm's usually a little stiff after you get a shot and stuff, but it never kind of went away, and it kind of built up) was resolving. No concomitant medication was reported. The patient had Moderna shots ever since 23-Feb-2021. When he got his last shot on 4-Oct-2024, it was Moderna Spikevax. He had frozen shoulder after he got the shot. He thought it was the same shot as the 19-Oct-2023. He took Moderna shots whenever required, ever since 2021. And this was the second time he took the Spikevax, he had no trouble with the first Spikevax on 19-Oct-2023. But on 4-Oct-2024, when he took it that time, he had trouble. And it kind of builds up gradually. He had the vaccine on 4-Oct-2024, and arms were usually a little stiff after getting a shot and stuff, but it never kind of went away, and it kind of built up. He had frozen shoulders in the past, like back in 2012, but it kind of built up over time. He tried to combat it with exercises and stuff, and it just built up, so he did physiotherapist on it this year. It improved a little bit with physiotherapists. He wanted to get another shot. He was wondering if he should switch to Pfizer vs. Moderna because he did not know if there was something different in the last Spikevax that might cause the frozen shoulder in terms of formulation/ingredients. He never had any trouble with any of the previous Moderna shots. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported.; Reporter's Comments: Patients medical history of Frozen shoulder is a confounder for the event Periarthritis. The benefit-risk relationship of product is not affected by this report.
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| 2862352 | 16 | F | AR | 09/30/2025 |
MNQ |
SANOFI PASTEUR |
U8573AA |
Dizziness, Dyspnoea, Loss of consciousness
Dizziness, Dyspnoea, Loss of consciousness
|
After administering a dose of Menquadfi to a 16 year old female, I asked the patient to stay seated ...
After administering a dose of Menquadfi to a 16 year old female, I asked the patient to stay seated for a few mintues to monitor for adverse events of the vaccination. While monitoring the patient, she stated that she started feeling a little dizzy. Two minutes later, the patient's head rolled back as she passed out in the chair. I immediately stabalized her head and kept her from falling from the chair. While continually checking pulse, her arms started to draw up and body slumped. I continued to keep the patient from falling out of the chair. Approximately 1 minute after the event started, the patient opened her eyes while breathing heavily. She did not remember passing out. I stayed with the patient and her step mother for 15-20 additional minutes in the clinical services room. Before the patient left the pharmacy, I made sure the dizziness had passed. She stated that she felt back to normal and felt comfortable leaving. Her step mother was present during the administration of the vaccine and throughout the event.
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| 2862353 | 73 | F | PA | 09/30/2025 |
COVID19 |
MODERNA |
3052736 |
Arthralgia, Injected limb mobility decreased, Injection site reaction, Nervous s...
Arthralgia, Injected limb mobility decreased, Injection site reaction, Nervous system disorder
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Right shoulder pain, difficulty raising arm, seen in hospital evening of shot and kept for 3 days, s...
Right shoulder pain, difficulty raising arm, seen in hospital evening of shot and kept for 3 days, saw three neurologists while in hospital, ruled out stroke, determined nerve/muscle reaction at injection site. Pt to have additional testing outpatient. To follow up with neurologist.
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| 2862354 | 52 | M | NC | 09/30/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LX4486 PJ353 |
Burning sensation, Hypoaesthesia, Impaired work ability, Mobility decreased, Pai...
Burning sensation, Hypoaesthesia, Impaired work ability, Mobility decreased, Pain in extremity; Burning sensation, Hypoaesthesia, Impaired work ability, Mobility decreased, Pain in extremity
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Arm pain, both arms started after vaccine on 9/12/25. The patient indicated that the arms were "...
Arm pain, both arms started after vaccine on 9/12/25. The patient indicated that the arms were "hurting so bad, could not move them and had to miss work due to inability to drive." The Shringix site in left arm was the worst. He experienced numbness in arms and hand. Right arm symptoms resolved prior to 9/18/25. Left arm persisted until 9/18/25, but patient continued to experience burning pain and numbness from spine to shoulder and down to 1st three fingers. The patient has been a pack a day smoker since age 18. Complained of left side being swollen prior to vaccine administration since earlier in 2025.
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| 2862355 | 75 | M | GA | 09/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
342XP |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient did not complain of any side effects other than sore arm. Pt realized his second dose was to...
Patient did not complain of any side effects other than sore arm. Pt realized his second dose was too early when he tried to update his records of his vaccination history at home. His physician's office was contacted to inform them of early 2nd dose administered
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| 2862357 | 49 | F | WA | 09/30/2025 |
FLU3 |
SANOFI PASTEUR |
U8823CA |
Bell's palsy, Ear pain, Eyelid function disorder, Facial paralysis, Hypoaes...
Bell's palsy, Ear pain, Eyelid function disorder, Facial paralysis, Hypoaesthesia oral
More
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Patient stated started with ear pain Sunday (09/28/2025) following with tongue numbness, face droopi...
Patient stated started with ear pain Sunday (09/28/2025) following with tongue numbness, face drooping, eyes not blinking Monday (09/29/2025); went to ER and diagnosed with Bell's palsy. Patient is feeling better but not 100 % recovered yet.
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| 2862358 | 76 | F | NE | 09/30/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052671 u8859ba |
Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic
Rash, Rash erythematous, Rash pruritic; Rash, Rash erythematous, Rash pruritic
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hours after recieving vaccines she got a bright red itchy rash on her arm from the top of her should...
hours after recieving vaccines she got a bright red itchy rash on her arm from the top of her shoulder to her elbow, she rubbed aloe vera cream on which helped with itching, redness and itching resolved after about 72 hours.
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| 2862359 | 46 | F | GA | 09/30/2025 |
EBZR |
MERCK & CO. INC. |
H23P16A1AC |
Anxiety, Cold sweat, Eye movement disorder, Flushing, Syncope
Anxiety, Cold sweat, Eye movement disorder, Flushing, Syncope
|
Ebola vaccine to left deltoid at 1427. She fainted for less than 30 seconds. eyes rolled to back of ...
Ebola vaccine to left deltoid at 1427. She fainted for less than 30 seconds. eyes rolled to back of head. Flushed face. clammy. started to fan her and she woke back up. Says she felt like she was "going to sleep". Called for assistance and RN and PhD, RN came to assist. Took vitals in chair at 1434 (100/64 BP, 64 HR, 22 RR, 96% RA). Moved to bed table with assistance from RN and Dr. Took vitals on bed table. (115/78 BP, 68 HR, 20 RR, 98% on room air.) FNP in room shortly after. Employee states she was anxious after getting the vaccine. Continued to monitor her for 30 minutes after the vaccine. Given cold compress on forehead for comfort along with cranberry juice. At 1443, moved back to chair. She was fine for the rest of the time and walked out by Dr at around 1515 to 1520 for her clinic discharge.
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| 2862360 | 37 | M | TX | 09/30/2025 |
HPV9 |
MERCK & CO. INC. |
Z009260 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient received 3 dose series in 2023 however they received their 3rd dose 4 months after receiving...
Patient received 3 dose series in 2023 however they received their 3rd dose 4 months after receiving the second dose. This caused them to not have full protection and thus the third dose needed to be repeated. Today we administered their fourth dose of Gardasil.
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| 2862361 | 70 | F | NJ | 09/30/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
|
Chills, Dizziness, Fatigue, Hyperhidrosis, Incontinence; Mobility decreased, Nau...
Chills, Dizziness, Fatigue, Hyperhidrosis, Incontinence; Mobility decreased, Nausea, Rhinorrhoea, Vertigo, Vomiting
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pt says she had sniffles, runny nose, and was tired. She had a good night sleep. When she woke up th...
pt says she had sniffles, runny nose, and was tired. She had a good night sleep. When she woke up the next day she had some dizziness. She took an Advil and felt better. The following day she went to the gym but after an hour she became dizzy and nauseas. She had chills and perspiration coming from her forehead. When returning home she started vomiting and could not hold anything down. Not even ginger ale. She then became incontinent Since she was dizzy and her head was spinning, she had to stay in bed. She took Dramamine with ginger to help. These symptoms lasted a couple of days. By Saturday she was able to eat very lightly but was still not able to do anything physical. She no longer has these symptoms at this time.
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| 2862362 | 36 | F | NC | 09/30/2025 |
COVID19 TDAP |
MODERNA SANOFI PASTEUR |
|
Injection site swelling; Injection site swelling
Injection site swelling; Injection site swelling
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with both vaccines, patient arm swelled below the injection site down to her wrist. reaction happene...
with both vaccines, patient arm swelled below the injection site down to her wrist. reaction happened roughly 2 days post vaccination per patient.
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| 2862363 | 68 | F | TX | 09/30/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0738 |
Contusion, Rash
Contusion, Rash
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Rise on arm and bruise
Rise on arm and bruise
|
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| 2862364 | 16 | M | TX | 09/30/2025 |
FLU3 HEP IPV MMR TD VARCEL |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. |
UT8792MA 3N2ND Y1A201M Y013131 U8492BA Y017061 |
Cold sweat, Pallor, Syncope; Cold sweat, Pallor, Syncope; Cold sweat, Pallor, Sy...
Cold sweat, Pallor, Syncope; Cold sweat, Pallor, Syncope; Cold sweat, Pallor, Syncope; Cold sweat, Pallor, Syncope; Cold sweat, Pallor, Syncope; Cold sweat, Pallor, Syncope
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9/30/25 12:12 pm - 17 year old male received 6 vaccines and had an episode of syncope. Patient did n...
9/30/25 12:12 pm - 17 year old male received 6 vaccines and had an episode of syncope. Patient did not eat anything before receiving vaccines. Patient was pale, clammy so legs were elevated and he was given graham crackers and Gatorade. 12:18 pm - Patient blood pressure 106/64 and Pulse 68. 12:21 pm - Notified provider and manager of incident. 12:30 pm - reassess blood pressure 110/66 and Pulse 72. 12:38 pm - Patient feeling better and left ambulatory with relative. 3:09 pm - Called to follow up on patient. Father stated that patient went back to school and patient has not notified him of being unwell. Advised father if patient had any other symptoms to take him to Emergency Room.
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| 2862365 | 75 | F | NY | 09/30/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0738 |
Arthralgia, Blood test, Lymphadenopathy, Muscular weakness, Myalgia
Arthralgia, Blood test, Lymphadenopathy, Muscular weakness, Myalgia
|
3 weeks of thigh weakness and muscle pain, unresolved, swollen gland back of neck x 1 week, resolve...
3 weeks of thigh weakness and muscle pain, unresolved, swollen gland back of neck x 1 week, resolved, bilateral shoulder pain, unresolved. Saw medical provider today. Referred to neuro
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| 2862366 | 68 | F | WV | 09/30/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946062 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No adverse event. Reporting because unnecessary vaccine was given. Pt had already received and com...
No adverse event. Reporting because unnecessary vaccine was given. Pt had already received and completed the hep a/hep b series in 2019, so this dose of heplisav was not indicated.
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| 2862367 | 90 | F | VA | 09/30/2025 |
FLU3 |
SANOFI PASTEUR |
U8855AA |
Malaise, Pyrexia
Malaise, Pyrexia
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Fever, Not feeling well
Fever, Not feeling well
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| 2862368 | 35 | F | CA | 09/30/2025 |
FLU3 |
SANOFI PASTEUR |
UT8770KA |
No adverse event, Product storage error
No adverse event, Product storage error
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Refrigerator had a temperature excursion that was discovered after the patient received the injectio...
Refrigerator had a temperature excursion that was discovered after the patient received the injection. After running the report on the data reader, it was discovered that the temperature had been out of range in the previous 24 hours as low as 1.1 degrees Celsius for 2.48 minutes and as high as 45.2 degrees Celsius for 13.36 minutes. The manufacturer said if the vaccine is over 25degrees at any time it is no longer viable. Patient was notified of the event. Patient did not report any symptoms related to this event.
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| 2862369 | F | 09/30/2025 |
COVID19 |
MODERNA |
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COVID-19, Vertigo
COVID-19, Vertigo
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vertigo; covid; This spontaneous case was reported by an other health care professional and describe...
vertigo; covid; This spontaneous case was reported by an other health care professional and describes the occurrence of VERTIGO (vertigo) and COVID-19 (covid) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo) and COVID-19 (covid). At the time of the report, VERTIGO (vertigo) and COVID-19 (covid) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. It was reported that patient was frustrated. Patient said her doctor specifically told caller not to get a covid-19 vaccine because caller had some pretty severe side effects. Patient's ENT and her regular GP said to caller she had one, she's had covid, she cannot get it anymore because caller had vertigo and she was in bed for a month. Patient said that she already reported this side effect to VAERS years ago. It was after the first covid-19 vaccine. She was fine, she just doesn't get them anymore. Patient was told don't get the vaccines anymore. At the time, caller reported it with the lot number. Patient did not know when it was administered, she got the vaccine from their pharmacy, she would have to go into the pharmacy computer, and she was working from home. Caller had vertigo after the shot. It was unknown if the patient experienced any additional symptoms/events. Treatment medication details were not reported by the reporter.
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| 2862370 | 33 | F | PR | 09/30/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
036c21A 036c21A 036c21A |
Dyspnoea, Feeling abnormal, Hallucinations, mixed, Headache, Immediate post-inje...
Dyspnoea, Feeling abnormal, Hallucinations, mixed, Headache, Immediate post-injection reaction; Impaired work ability, Mania, Nightmare, Psychotic disorder, Pyrexia; Rash, Schizoaffective disorder bipolar type, Sensory disturbance
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On Monday June 7 of 2021 I went to a pharmacy to take the second shot of the COVID 19 vaccine from M...
On Monday June 7 of 2021 I went to a pharmacy to take the second shot of the COVID 19 vaccine from Moderna. Immediately after I developed a Schizophrenic disorder. I began hearing voices and feeling strange sensations on my body with the illusion that I was being observed. I noticed immediately that something was possessing my body. Two weeks after I ended up at the Psychiatric Hospital due to all the psychotic episodes accompanied by non-stop voices in my head, visions, headaches, fevers, nightmares, skin rashes and feelings of being touched or grabbed on in my body. Since then I have been diagnosed with Schizoaffective disorder, bipolar type. I have been hospitalized several times throughout the years and have to deal with the symptoms every day. After trying with multiple pharmaceuticals I am finally treating myself with a medication called InVega. It helps to some extent with the symptoms but it doesn't take them away. Due to my condition I haven?t been able to work as normal and had to quit my latest jobs. Still sometimes the manic episodes turn to be as strong as it was in the beginning, and these days it is difficult to even breathe. Other days are more manageable.
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| 2862371 | 1.17 | M | NC | 09/30/2025 |
HIBV MMR PNC20 VARCEL |
SANOFI PASTEUR MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
UK227AC Y011711 LP4946 Y019319 |
No adverse event, Product preparation issue; No adverse event, Product preparati...
No adverse event, Product preparation issue; No adverse event, Product preparation issue; No adverse event, Product preparation issue; No adverse event, Product preparation issue
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HIB Mixed with incorrect Diluent - Used 0.7 Sterile Water instead of 0.6 of Sodium Chloride that is ...
HIB Mixed with incorrect Diluent - Used 0.7 Sterile Water instead of 0.6 of Sodium Chloride that is provided with vaccine No known reaction
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| 2862372 | 1 | F | CA | 09/30/2025 |
HEPA HEPA HIBV HIBV MMR MMR PNC20 PNC20 VARCEL VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
MB599 MB599 Y020468 Y020468 Y014095 Y014095 LX2496 LX2496 Z008083 Z008083 |
Decreased appetite, Diarrhoea, Pyrexia, Rash, Rash papular; Rash pruritic, Sleep...
Decreased appetite, Diarrhoea, Pyrexia, Rash, Rash papular; Rash pruritic, Sleep disorder; Decreased appetite, Diarrhoea, Pyrexia, Rash, Rash papular; Rash pruritic, Sleep disorder; Decreased appetite, Diarrhoea, Pyrexia, Rash, Rash papular; Rash pruritic, Sleep disorder; Decreased appetite, Diarrhoea, Pyrexia, Rash, Rash papular; Rash pruritic, Sleep disorder; Decreased appetite, Diarrhoea, Pyrexia, Rash, Rash papular; Rash pruritic, Sleep disorder
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About a week after receiving routine vaccines at 12 month well child visit, pt developed red papular...
About a week after receiving routine vaccines at 12 month well child visit, pt developed red papular rash all over body. Rash started on face first and then spread to arms, chest, abdomen, back and legs. Rash is somewhat itchy as pt scratched at them. Pt was having difficulty sleeping at night due to the rash. Rash improved gradually after a week. Mom used OTC cream for itching relief (calmoseptine) and it helped. Pt did have slight fever (Tm 100), loose stools and decreased appetite for few days.
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| 2862373 | 33 | F | NC | 09/30/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
93NL9 93NL9 |
Flushing, Immediate post-injection reaction, Injection site erythema, Injection ...
Flushing, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling; Injection site warmth, Pruritus
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Immediate burning, redness, heat in area, swollen, expansion down entire upper arm, intense itching,...
Immediate burning, redness, heat in area, swollen, expansion down entire upper arm, intense itching, and becoming flush
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| 2862375 | 0.5 | M | CT | 09/30/2025 |
FLU3 |
SEQIRUS, INC. |
406989 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Patient was scheduled for flu clinic in office. Patient was here with parents and sister who was als...
Patient was scheduled for flu clinic in office. Patient was here with parents and sister who was also receiving flu vaccine. Patients' sisters flu vaccine was administered. Conversation was being had with patient's parents. Immunization was administered. Flu vaccine was then scanned which was discovered flu vaccine was due to be given after 10/06/2025, as this is patients booster. Mother was made aware that vaccine was given 6 days too early. Mother states that she was under the understanding that flu vaccine requires two weeks in between, confirmed with mother that vaccine is to be given a month apart. Mother understanding. Mother made aware patient may receive booster at patients 9 month appointment. No adverse reactions noted by parent at this time.
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| 2862376 | 69 | F | WY | 09/30/2025 |
FLU3 |
SANOFI PASTEUR |
U8764CB |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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Pt developed an injection site reaction. A red itchy area (6"x4") developed at the site ...
Pt developed an injection site reaction. A red itchy area (6"x4") developed at the site of administration. Pt took benadryl and the reaction is improving.
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| 2862377 | 68 | F | VA | 09/30/2025 |
COVID19 FLU3 PNC20 VARZOS |
PFIZER\BIONTECH SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
MY9547 U8855AA LC1281 93N4J |
Extra dose administered; Extra dose administered; Extra dose administered; Extra...
Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered
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WE ADMINISTERED AN EXTRA DOSE OF SHINGRIX AS WE HAVE BEEN NOT NOTIFIED UNTIL SHE WAS BEEN ADMINISTE...
WE ADMINISTERED AN EXTRA DOSE OF SHINGRIX AS WE HAVE BEEN NOT NOTIFIED UNTIL SHE WAS BEEN ADMINISTERED SERIES OF SHINGRIX IN THE YEAR OF 2020.
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| 2862379 | 67 | F | IL | 09/30/2025 |
COVID19 |
PFIZER\BIONTECH |
3052583 |
Pruritus, Urticaria
Pruritus, Urticaria
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Patient reports intense itching starting evening after administration, localized, with welt.
Patient reports intense itching starting evening after administration, localized, with welt.
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| 2862380 | 70 | F | NJ | 09/30/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
Lot#3052155 Lot#3052155 |
Dizziness, Headache, Influenza virus test negative, Pain, Peripheral coldness; S...
Dizziness, Headache, Influenza virus test negative, Pain, Peripheral coldness; SARS-CoV-2 test negative
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Extreme dizziness, Severe, pounding headache not solved with analgesia (like Aleve or Tylenol or Mot...
Extreme dizziness, Severe, pounding headache not solved with analgesia (like Aleve or Tylenol or Motrin) body ache all over, perspiring, and then freezing cold to my extremities. Unrelenting symptoms. 5th day of these issues today. I never have any headaches at all, never mind this. It's excruciating.
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| 2862381 | 31 | M | TX | 09/30/2025 |
FLU3 |
SANOFI PASTEUR |
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Ageusia, Anosmia
Ageusia, Anosmia
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Loss of taste and smell
Loss of taste and smell
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| 2862382 | 60 | M | CA | 09/30/2025 |
COVID19 |
MODERNA |
3052549 |
Dyspnoea, Fatigue
Dyspnoea, Fatigue
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Patient states he began experiencing fatigue and shortness of breath the day after receiving the vac...
Patient states he began experiencing fatigue and shortness of breath the day after receiving the vaccination (in the evening).
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| 2862383 | 11 | M | CA | 09/30/2025 |
HEP HEPA HPV9 MNQ TDAP |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
9N9PY Z010429 Y018297 9549B 37F34 |
No adverse event, Vaccination error; No adverse event, Vaccination error; No adv...
No adverse event, Vaccination error; No adverse event, Vaccination error; No adverse event, Vaccination error; No adverse event, Vaccination error; No adverse event, Vaccination error
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HEP A (Vaqta) given in error when no further doses were needed by MA ( clinic staff person). Presen...
HEP A (Vaqta) given in error when no further doses were needed by MA ( clinic staff person). Presently no adverse reaction to this additional not needed vaccine.
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| 2862385 | 65 | F | AK | 09/30/2025 |
FLU3 |
SANOFI PASTEUR |
U8827AA |
Injection site reaction, Neck pain, Pain
Injection site reaction, Neck pain, Pain
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Left arm throbbing pain that radiates from deltoid to lateral neck. I am seeing the provider today.
Left arm throbbing pain that radiates from deltoid to lateral neck. I am seeing the provider today.
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| 2862386 | 9 | F | OR | 09/30/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9550 |
Incorrect dose administered
Incorrect dose administered
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Pt was given higher dose of Covid vaccine than recommended. Pt was given the 12+ Covid vaccine.
Pt was given higher dose of Covid vaccine than recommended. Pt was given the 12+ Covid vaccine.
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| 2862387 | 9 | F | CA | 09/30/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
es4h5 |
Fall, Loss of consciousness
Fall, Loss of consciousness
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Patient passed out and fell down a little after the vaccine was administered , was unconscious for ...
Patient passed out and fell down a little after the vaccine was administered , was unconscious for few seconds. Pharmacist did administer any treatment but call 911 and observed the patient till the paramedic comes in and took over.
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| 2862388 | 37 | F | MO | 09/30/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NA0738 52TM4 |
Blood pressure increased, Headache; Blood pressure increased, Headache
Blood pressure increased, Headache; Blood pressure increased, Headache
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Approximately 2 - 2.5 hours after receiving both vaccines, patient reported to have: Blood pressure ...
Approximately 2 - 2.5 hours after receiving both vaccines, patient reported to have: Blood pressure elevated around 160/100 mmHg and a significant headache that is worse than her normal headaches but not the worst headache she has ever had. Patient reported taking Tylenol; however, it had yet to have a meaningful effect at the time of reporting.
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| 2862389 | 64 | M | TN | 09/30/2025 |
FLU3 |
SEQIRUS, INC. |
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Diarrhoea
Diarrhoea
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Diarrhea, for three days.
Diarrhea, for three days.
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| 2862390 | 60 | F | PA | 09/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7532J |
Headache, Herpes zoster, Pyrexia, Rash
Headache, Herpes zoster, Pyrexia, Rash
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Acute shingles: fever, painful rash, headache
Acute shingles: fever, painful rash, headache
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| 2862391 | 28 | F | MO | 09/30/2025 |
COVID19 COVID19 FLUX FLUX |
MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Blood thyroid stimulating hormone, C-reactive protein, Electrocardiogram, N-term...
Blood thyroid stimulating hormone, C-reactive protein, Electrocardiogram, N-terminal prohormone brain natriuretic peptide, Red blood cell sedimentation rate; Supraventricular extrasystoles, Troponin I; Blood thyroid stimulating hormone, C-reactive protein, Electrocardiogram, N-terminal prohormone brain natriuretic peptide, Red blood cell sedimentation rate; Supraventricular extrasystoles, Troponin I
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NSR w/ frequent PAC's sometimes in couplets and triplets; This spontaneous case was reported by...
NSR w/ frequent PAC's sometimes in couplets and triplets; This spontaneous case was reported by a consumer and describes the occurrence of SUPRAVENTRICULAR EXTRASYSTOLES (NSR w/ frequent PAC's sometimes in couplets and triplets) in a 28-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 13-Sep-2025 at 12:00 PM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On 13-Sep-2025, the patient experienced SUPRAVENTRICULAR EXTRASYSTOLES (NSR w/ frequent PAC's sometimes in couplets and triplets). The patient was treated with Ibuprofen at an unspecified dose and frequency. At the time of the report, SUPRAVENTRICULAR EXTRASYSTOLES (NSR w/ frequent PAC's sometimes in couplets and triplets) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2025, Electrocardiogram: palpitations. On 17-Sep-2025, Electrocardiogram: Normal Sinus Rhythm (NSR) with frequent Premature Atrial Complexes (PACs), sometimes in couplets and triplets. On an unknown date, Blood thyroid stimulating hormone: 1.38. On an unknown date, C-reactive protein: 6.5. On an unknown date, N-terminal prohormone brain natriuretic peptide: 113. On an unknown date, Red blood cell sedimentation rate: 15. On an unknown date, Troponin I: <4. No concomitant medications were reported. On 13-Sep-2025, at 12:00pm. Around 8pm the patient experienced heart palpitations that would resolve on and off for 20 min at a time. On 14-Sep-2025, around 7pm, heart palpitations resumed, again for about 20 minutes at a time, but would self-resolve. The patient went to urgent care on 15-Sep-2025 and got an EKG which captured the palpitations. Follow-up with Cardiologist on 17-Sep-2025, the EKG showed NSR w/ frequent PAC's sometimes in couplets and triplets. The patient did not experience any additional symptoms or events.
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| 2862392 | 82 | F | VA | 09/30/2025 |
COVID19 |
MODERNA |
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Rash
Rash
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Red rash over all body, lighter on arms and legs, not red day later but still pale; This spontaneous...
Red rash over all body, lighter on arms and legs, not red day later but still pale; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Red rash over all body, lighter on arms and legs, not red day later but still pale) in an 82-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 22-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 milliliter. On 24-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced RASH (Red rash over all body, lighter on arms and legs, not red day later but still pale). At the time of the report, RASH (Red rash over all body, lighter on arms and legs, not red day later but still pale) was resolving. The concomitant medication was not reported by the reporter. The patient had a red rash all over the body, which was lighter on the arms and legs. A day later, it was not red but still pale. The patient did not have welts or hives. She did not call the doctor as it was resolving. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.
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| 2862393 | 66 | M | PA | 09/30/2025 |
COVID19 |
MODERNA |
3052586 |
Asthenia, Diarrhoea, Headache, Hyperhidrosis, Nausea
Asthenia, Diarrhoea, Headache, Hyperhidrosis, Nausea
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weakness; sweating; diarrhea; headache; nausea; This spontaneous case was reported by a consumer and...
weakness; sweating; diarrhea; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nausea) in a 66-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052586) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 25-Sep-2025, the patient experienced ASTHENIA (weakness), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, ASTHENIA (weakness), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), HEADACHE (headache) and NAUSEA (nausea) had resolved. The concomitant medication was not reported by the reporter. On the evening of 25-Sep-2025, the patient experienced severe weakness, headache, diarrhea, sweating and severe nausea that lasted for 6 hours. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.
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