| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2866325 | 10/16/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA SANOFI PASTEUR SANOFI PASTEUR |
3043160 3043160 |
Balance disorder, Deafness unilateral, Gait disturbance, Nausea, Vertigo; Vision...
Balance disorder, Deafness unilateral, Gait disturbance, Nausea, Vertigo; Vision blurred; Balance disorder, Deafness unilateral, Gait disturbance, Nausea, Vertigo; Vision blurred
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loss of hearing in one ear/deafness in one ear; blurred vision; extreme vertigo/vertigo so bad; naus...
loss of hearing in one ear/deafness in one ear; blurred vision; extreme vertigo/vertigo so bad; nausea/sick with nausea/became very nauseated; difficulty walking/could not walk across the room/barely able to walk; balance issues/unbalanced; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of DEAFNESS UNILATERAL (loss of hearing in one ear/deafness in one ear), GAIT DISTURBANCE (difficulty walking/could not walk across the room/barely able to walk), BALANCE DISORDER (balance issues/unbalanced), VISION BLURRED (blurred vision), VERTIGO (extreme vertigo/vertigo so bad) and NAUSEA (nausea/sick with nausea/became very nauseated) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043160) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluzone high dose) for Prophylactic vaccination. Previously administered products included for Drug use for unknown indication: Penicillin and Sulphur. Past adverse reactions to the above products included Drug allergy with Sulphur; and Penicillin allergy with Penicillin. Concurrent medical conditions included Drug hypersensitivity, Drug allergy (Sulphur) and Penicillin allergy. Concomitant products included Metoprolol tartrate and Levothyroxine sodium (Synthroid) for an unknown indication. On 20-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine inact split 3v (Fluzone high dose) (unknown route) 1 dosage form. In 2024, the patient experienced BALANCE DISORDER (balance issues/unbalanced) (seriousness criterion hospitalization). On 21-Sep-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced GAIT DISTURBANCE (difficulty walking/could not walk across the room/barely able to walk) (seriousness criterion hospitalization). On 23-Sep-2024, the patient experienced DEAFNESS UNILATERAL (loss of hearing in one ear/deafness in one ear) (seriousness criteria hospitalization and medically significant), VISION BLURRED (blurred vision) (seriousness criterion hospitalization), VERTIGO (extreme vertigo/vertigo so bad) (seriousness criterion hospitalization) and NAUSEA (nausea/sick with nausea/became very nauseated) (seriousness criterion hospitalization). The patient was hospitalized from 24-Sep-2024 to 30-Sep-2024 due to BALANCE DISORDER, DEAFNESS UNILATERAL, GAIT DISTURBANCE, NAUSEA, VERTIGO and VISION BLURRED. At the time of the report, DEAFNESS UNILATERAL (loss of hearing in one ear/deafness in one ear), GAIT DISTURBANCE (difficulty walking/could not walk across the room/barely able to walk), BALANCE DISORDER (balance issues/unbalanced), VISION BLURRED (blurred vision), VERTIGO (extreme vertigo/vertigo so bad) and NAUSEA (nausea/sick with nausea/became very nauseated) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. The patient's past medical history, medical treatment (s), vaccination (s) and family history were not provided. Action taken with Fluzone high dose was reported as not applicable. An unknown corrective treatment was received for all the events. It was not reported if the patient received corrective treatment for all the events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2866326 | 83 | 10/16/2025 |
COVID19 |
MODERNA |
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Eczema
Eczema
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eczema outbreak; This spontaneous case was reported by a consumer and describes the occurrence of EC...
eczema outbreak; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (eczema outbreak) in an 83-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Eczema. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema outbreak). At the time of the report, ECZEMA (eczema outbreak) had resolved. No concomitant medication was reported. Although each time patient got a booster, experienced eczema outbreak for about a month. Patient asked guidance on receiving new vaccine given tolerability of eczema versus risk of COVID. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790141 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790141:Same patient with different suspect (Moderna COVID-19 Vaccine)
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| 2866327 | M | CA | 10/16/2025 |
COVID19 |
MODERNA |
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Vaccination site pain
Vaccination site pain
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Felt pain at the injection site every time; This spontaneous case was reported by a consumer and des...
Felt pain at the injection site every time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Felt pain at the injection site every time) in an elderly male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Felt pain at the injection site every time). At the time of the report, VACCINATION SITE PAIN (Felt pain at the injection site every time) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. The current age of the patient was reported as 79-Year-old. The patient received millions of shots and had a reaction to Moderna before. After each vaccine, the body changed each time. It was reported that for millions of people, if the arm hurts, it means the vaccine had worked. The patient had pain from past vaccines, but right now, it was early, it did not feel like the arm hurts yet. It had only been about an hour or so. The patient had 10 shots of Moderna and felt pain at the injection site every time. Before (referencing previous shots), it hurt, and they said that it was because of the immune response at the shot site. This time, it was not quite hurting yet. Based on research, sometimes it hurts, sometimes it did not, depending on the shot and the person. It was reported that in terms of human death, in the history of the world, over the last 6000-7000 years, the largest number of people were killed by COVID-19. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-790155 (Patient Link).
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| 2866328 | 77 | F | GA | 10/16/2025 |
COVID19 |
MODERNA |
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Dizziness, Headache, Illness, Nausea, Pain
Dizziness, Headache, Illness, Nausea, Pain
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achy for a whole day; she had always gotten real sick afterwards; dizzy; bad headache; nausea; This ...
achy for a whole day; she had always gotten real sick afterwards; dizzy; bad headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy for a whole day), ILLNESS (she had always gotten real sick afterwards), DIZZINESS (dizzy), HEADACHE (bad headache) and NAUSEA (nausea) in a 77-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Arthritis. Concomitant products included Apixaban (Eliquis) for Anticoagulant therapy, Paracetamol (Tylenol) for Arthritis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (achy for a whole day), ILLNESS (she had always gotten real sick afterwards), DIZZINESS (dizzy), HEADACHE (bad headache) and NAUSEA (nausea). At the time of the report, PAIN (achy for a whole day) had resolved and ILLNESS (she had always gotten real sick afterwards), DIZZINESS (dizzy), HEADACHE (bad headache) and NAUSEA (nausea) outcome was unknown. The patient was interested in knowing if mNEXSPIKE was available everywhere because she saw the add on TV and last Saturday, she went to have a Covid 19 vaccine thinking she would have a choice, but then they gave her a general one, not mNEXSPIKE. The patient was 77 and that when the vaccines became available at the pharmacies like that it would be an automatic choice for elderly people. She got upset when she found out she was just going to receive a general Covid shot because she was expecting a special shot for over 65, specifically mNEXSPIKE. As per the ad on TV she was led to believe that all the places in the (withheld country) would have it. However, it was not the case. The patient expressed concern regarding other elderly people like herself that might be seeking to get this new shot, they needed to know that they have to ask the pharmacy first if they have it. The patient was worried because she did not even know if it was an up-to-date shot that they gave her. She was happy not to have any side effects from this last shot, but she was unable to say which vaccine they gave her. She did not have any written documentation regarding it. She thought they might have said Pfizer, but she was not sure. The patient explained that in the past when she had the COVID shots, she had always gotten real sick afterwards, and she did after this one too but not quite as bad as the last three that she had. In the past, she had not been prepared, and it always threw her off guard, because she was waking up with the nausea, achy for a whole day and nauseated and dizzy. But, once, she did not remember which time it was, but she got it at pharmacy, and she got the sickest the nausea bad to throwing up and a super bad headache. And then she was achy for a couple of days. That one was the worst. No treatment medication was provided. But this time, she only got nauseated and she did not get the headache. Only when she got up in the night, she felt nausea. She did not have any problems until then. The patient referred having had a nausea pill and having laid down for a time and then she took two Tylenols of the extra straight for arthritis. The patient reported that she could not take Advil or Aleve because she was on Eliquis which was a blood thinner. This case was linked to MOD-2025-790216 (Patient Link). Reporter did not allow further contact
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| 2866329 | 85 | F | MA | 10/16/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8830BA U8830BA |
Chills, Fatigue, Immediate post-injection reaction, Injected limb mobility decre...
Chills, Fatigue, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain; Pain, Pain in extremity, Pyrexia, Sensory disturbance
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Immediate: pain and unusual sensation at injection site - described as "feeling of fluid moving...
Immediate: pain and unusual sensation at injection site - described as "feeling of fluid moving across my chest". Later that evening: severe fatigue, fever, chills, bodyaches. Persistently over past 3 weeks - severe right arm pain and ROM limitation
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| 2866330 | 70 | F | FL | 10/16/2025 |
COVID19 VARZOS |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NA0590 7523J |
Extra dose administered, No adverse event, Wrong product administered; Extra dos...
Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered
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two patients came into get vaccines together (family or friends unsure relation). The man wanted a c...
two patients came into get vaccines together (family or friends unsure relation). The man wanted a covid vaccine while patient wanted a Shingrix vaccine. Both vaccines were typed, prepared, and verified correctly. during administration however the gentleman's covid vaccine was given to patient on accident. Immunizing technician immediately informed me of the event and I spoke with patient. She was not upset or angry and was actually happy to get a second thinking this will give her added benefit. She reported no signs of symptoms when she got her first 2025/2026 dose from two weeks prior. I informed her of the risk of reaction and she confirmed and consented to still get this Shingrix vaccine. Patient had no immediate reaction following administration. Patient remained in the store for 15 minute observation period before leaving.
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| 2866331 | 62 | F | MO | 10/16/2025 |
FLU3 |
SEQIRUS, INC. |
AW1616A |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient received dose of Afluria from the 2024-2025 batch. Patient was notified upon discovery. Seqi...
Patient received dose of Afluria from the 2024-2025 batch. Patient was notified upon discovery. Seqirus was contacted for guidance about need for additional care. Seqirus instructed that no additional action was needed. Patient did not report any side effects or adverse events.
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| 2866332 | 75 | M | OH | 10/16/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Ataxia, Blood alcohol increased, Carotid artery stenosis, Cerebrovascular accide...
Ataxia, Blood alcohol increased, Carotid artery stenosis, Cerebrovascular accident, Computerised tomogram head abnormal; Computerised tomogram neck abnormal, Drug screen negative, Magnetic resonance imaging head abnormal, Muscular weakness, Scan with contrast abnormal; Troponin normal
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Stroke of left frontoparietal region complicated by left internal carotid stenosis with right arm an...
Stroke of left frontoparietal region complicated by left internal carotid stenosis with right arm and leg weakness and ataxia
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| 2866333 | 12 | M | CT | 10/16/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7NT95 |
Flushing, Urticaria
Flushing, Urticaria
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Pt began with full body hives and flushing approximately 3-4 hours after administration of vaccine. ...
Pt began with full body hives and flushing approximately 3-4 hours after administration of vaccine. Pt was no longer in school at that time and was home under the care of his mother, who reported that pt did not have any coughing/SOB/tongue/lip swelling. Mom gave Zrytec 10 mg and continued to administer Zrytec daily for 4 days with full resolution of rash. Pt was not seen by any medical provider during that time, but does have documented cell phone pictures of rash.
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| 2866334 | 10 | M | MI | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
U8767BA |
Injection site erythema
Injection site erythema
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Redness around injection site, pt was given benadryl by mother. Mother stated that redness went away...
Redness around injection site, pt was given benadryl by mother. Mother stated that redness went away after benadryl was given. Pt was given 50mg by mother
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| 2866335 | 63 | F | OH | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
u8832aa |
Injection site bruising, Injection site swelling, Injection site warmth
Injection site bruising, Injection site swelling, Injection site warmth
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Patient returned to the store today due to a reaction experienced from a vaccine given here on 10/10...
Patient returned to the store today due to a reaction experienced from a vaccine given here on 10/10/2025. swelling, bruising, warmth at injection site
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| 2866336 | 48 | F | MO | 10/16/2025 |
FLU3 FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
AH2G4 AH2G4 AH2G4 |
Fatigue, Headache, Injected limb mobility decreased, Injection site pain, Loss o...
Fatigue, Headache, Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities; Neck pain, Pain, Pain in extremity, Product administered to patient of inappropriate age, Rhinorrhoea; Sleep disorder
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Adverse reactions: Instant pain at injection site, inability to move arm that injection was placed i...
Adverse reactions: Instant pain at injection site, inability to move arm that injection was placed in, inability to sleep due to pain despite taking over the counter medications, severe headache impeding normal daily functioning, constant nasal drainage, extreme fatigue impeding normal daily functioning, pain radiating up neck to head and down arm to wrist. Adverse treatment: I was erroneously given the high dose flu vaccine , I am not immunocompromised, I am not over the age of 65.
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| 2866337 | 12 | M | FL | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
UT8770NA |
Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope
Immediate post-injection reaction, Loss of consciousness, Nausea, Syncope
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The patient fainted immediately after receiving the flu vaccine. He was in a sitting position. Aft...
The patient fainted immediately after receiving the flu vaccine. He was in a sitting position. After several seconds, he regained consciousness and was feeling very nauseous. He was given pedialyte and monitored for 30 minutes afterwards. Once fully recovered, he left the medical office with his mother.
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| 2866338 | 17 | M | GA | 10/16/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS PFIZER\WYETH |
7mn4c ma2515 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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Dr. ordered Meningococcal vaccine and Men B vaccine, Trumenba and Bexsero were pulled by mistake, in...
Dr. ordered Meningococcal vaccine and Men B vaccine, Trumenba and Bexsero were pulled by mistake, instead of MCV and Men B. Dr. verified the vaccines pulled and gave me the okay. Once I started to enter the vaccines into the chart myself and someone caught the error. I then went and told Dr. what was realized when entering the vaccines and explained the patient had received 2 doses of Men B. I then called my manager and reported the mistake to her.
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| 2866339 | 60 | M | OH | 10/16/2025 |
COVID19 |
MODERNA |
8146545 |
Vomiting
Vomiting
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Patient has been vomiting since late last night 10/15/25 into 10/16/25, recommended fluids. If unabl...
Patient has been vomiting since late last night 10/15/25 into 10/16/25, recommended fluids. If unable to keep down fluids seek medical attention as dehydration can lead to complications. Recommended to go to urgent care if symptoms don't improve, will be following up with patient regarding his reaction.
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| 2866340 | 75 | M | IL | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
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Diarrhoea, Dysuria, Pyrexia, Urinary tract infection
Diarrhoea, Dysuria, Pyrexia, Urinary tract infection
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On sunday i got diherra and i went 4 times in a row and it was real bad. I took something and the ne...
On sunday i got diherra and i went 4 times in a row and it was real bad. I took something and the next day i got fever its 101.4. I went to the doctors offier and the practiner nurse saw me and they told me my temp 98.1 and i dont think it went down that last, They checked and i have a UTI and they put on an antibodic and after 4 days its been a real struggle just to pee and I still have a fever.
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| 2866341 | 63 | M | MA | 10/16/2025 |
COVID19 |
MODERNA |
3052741 |
Injection site rash, Injection site warmth, Rash erythematous, Rash papular
Injection site rash, Injection site warmth, Rash erythematous, Rash papular
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Raised, hot, red rash over left deltoid at injection site
Raised, hot, red rash over left deltoid at injection site
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| 2866342 | 9 | F | TX | 10/16/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
33CM4 |
Chest pain, Dizziness, Dyspnoea, Eye pain, Headache
Chest pain, Dizziness, Dyspnoea, Eye pain, Headache
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2 days post vaccine, child complaining of severe chest pain, headache, shortness of breath, dizzines...
2 days post vaccine, child complaining of severe chest pain, headache, shortness of breath, dizziness, and eye pain. Patient referred to ER.
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| 2866343 | 77 | F | IA | 10/16/2025 |
PNC21 |
MERCK & CO. INC. |
Z006076 |
Injection site rash, Injection site warmth, Rash erythematous
Injection site rash, Injection site warmth, Rash erythematous
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2 INCH CIRCULAR RED RASH AT SITE OF INJECTION 6 DAYS AFTER INJECTION. RASH WAS WARM TO THE TOUCH. PA...
2 INCH CIRCULAR RED RASH AT SITE OF INJECTION 6 DAYS AFTER INJECTION. RASH WAS WARM TO THE TOUCH. PATIENT WAS ADVISED TO GO TO A DOCTOR. PATIENT WENT TO URGENT CARE AND WAS PRESCRIBED A 7 DAY COURSE OF ANTIBIOTICS.
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| 2866344 | 10/16/2025 |
COVID19 |
MODERNA |
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Pain in extremity
Pain in extremity
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only a very sore arm; This spontaneous case was reported by a consumer and describes the occurrence ...
only a very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (only a very sore arm) in a patient of an unknown age and gender who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Concurrent medical conditions included General physical health deterioration (other health issues). In 2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) 1 dosage form. In 2025, the patient experienced PAIN IN EXTREMITY (only a very sore arm). At the time of the report, PAIN IN EXTREMITY (only a very sore arm) outcome was unknown. No concomitant medications were reported. It was reported that the patient took Moderna Covid-19 vaccine for first time in 2020 and had many reactions. But with newest Moderna vaccine, the patient described the reactions as virtually none but only a very sore arm. The patient waited for this time for the reaction to hit the patient. It was reported that patient was not a young person and had other health issues, so the patient needed to get an update for Covid. No treatment medications were reported. This case was linked to MOD-2025-790237 (Patient Link).
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| 2866345 | 77 | M | IL | 10/16/2025 |
FLU3 PNC20 |
SEQIRUS, INC. PFIZER\WYETH |
407266 MN2505 |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
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None noted at this time
None noted at this time
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| 2866346 | 79 | F | OH | 10/16/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
3052732 my9550 |
Extra dose administered, Injection site pain; Extra dose administered, Injection...
Extra dose administered, Injection site pain; Extra dose administered, Injection site pain
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Patient's daughter called the pharmacy to state she received the COVID vaccine twice. She came ...
Patient's daughter called the pharmacy to state she received the COVID vaccine twice. She came to the pharmacy counter and stated she had not received the vaccine before and was willing to receive it. She has only stated injection site soreness -- no additional symptoms at this time.
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| 2866348 | 16 | F | FL | 10/16/2025 |
HPV9 HPV9 MNP MNP |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH |
Y015599 Y015599 LX5014 LX5014 |
Cough, Erythema, Lip swelling, Pain in extremity, Peripheral swelling; Skin warm...
Cough, Erythema, Lip swelling, Pain in extremity, Peripheral swelling; Skin warm, Throat irritation, Urticaria; Cough, Erythema, Lip swelling, Pain in extremity, Peripheral swelling; Skin warm, Throat irritation, Urticaria
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Patient reports that shortly after she was given the vaccines (on 10/11/2025) , her left arm, in wh...
Patient reports that shortly after she was given the vaccines (on 10/11/2025) , her left arm, in which Pembraya was administered, became swollen, red, hot, and painful. The next day it slowly improved. However, o a few days after on 10/14/2025, she started with generalized hives over her body. Also, she had an itchy throat, lower lip swelling, some coughing, but no difficulty in breathing. Patient did not go to emergency room for further evaluation, but was seen in the office the next day on 10/15/2025. On examination, Patient still had hives and was still very itchy. On the left arm, there was no redness, or swelling, but still had some mild tenderness at the site.
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| 2866349 | 73 | M | MD | 10/16/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
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Chills, Headache, Injection site pain, Loss of personal independence in daily ac...
Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Mobility decreased; Pain, Somnolence, Vomiting; Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Mobility decreased; Pain, Somnolence, Vomiting
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Vaccines were administered about 2:20 Pm on 10/14/25. Patient noted sore injection sites right &...
Vaccines were administered about 2:20 Pm on 10/14/25. Patient noted sore injection sites right & left arms around 11pm. Patient was achey and sleepy and did not get out of bed on 10/15/25. At 10am on 10/16/25 patient has chills and headache and vomited during the night. Patient is expected to stay in bed and will miss a scheduled wound care doctor appointment.
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| 2866350 | 0.75 | F | 10/16/2025 |
FLU3 |
SEQIRUS, INC. |
406997 |
Urticaria
Urticaria
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Development of hives about 2 hours after administration. Symptoms resolved following dose of Zyrtec.
Development of hives about 2 hours after administration. Symptoms resolved following dose of Zyrtec.
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| 2866351 | 61 | F | GA | 10/16/2025 |
PNC21 |
MERCK & CO. INC. |
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Injection site rash, Injection site warmth, Rash erythematous, Rash pruritic
Injection site rash, Injection site warmth, Rash erythematous, Rash pruritic
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Delayed injection site reaction - red, itchy rash with warmth on in vicinity of previous injection s...
Delayed injection site reaction - red, itchy rash with warmth on in vicinity of previous injection site 5 days previously
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| 2866352 | 69 | F | FL | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Muscle discomfort, Myalgia, Sleep disorder
Muscle discomfort, Myalgia, Sleep disorder
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Severe pain in muscle under left arm and across chest. Felt like the muscle was being stretched to t...
Severe pain in muscle under left arm and across chest. Felt like the muscle was being stretched to the point of ripping. Could not sleep due to pain. One week later better but still uncomfortable
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| 2866354 | 57 | F | CT | 10/16/2025 |
FLU3 |
SEQIRUS, INC. |
407006 |
Injection site hypoaesthesia, Injection site swelling
Injection site hypoaesthesia, Injection site swelling
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Numbess to right arm beneath injection site. States swelling noted at injection site. Numbess and sw...
Numbess to right arm beneath injection site. States swelling noted at injection site. Numbess and swelling and numbess resolved after taking 600mg ibuprofen.
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| 2866355 | 31 | F | DC | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dizziness, Fatigue, Headache, Nausea
Dizziness, Fatigue, Headache, Nausea
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Severe headache, nausea, dizziness, fatigue over the course of 10 days
Severe headache, nausea, dizziness, fatigue over the course of 10 days
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| 2866356 | 77 | F | CO | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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patient signed up for the flu vaccine online and completed the consent to receive it. She had recei...
patient signed up for the flu vaccine online and completed the consent to receive it. She had received the same vaccine in September 2025. The verifying pharmacist did not catch the duplicate and the high dose flu vaccine (for > 65 yo) was administered. Patient was counseled (as well as husband) on the possible side effects. Pharmacist manager followed up 48 hours later and patient stated she did not experience any adverse effects from the vaccine and was "doing well"
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| 2866357 | 1.25 | M | VA | 10/16/2025 |
DTPPVHBHPB MMR PNC20 VARCEL |
MSP VACCINE COMPANY MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
U7536AA Y000224 LC5484 Z005232 |
Expired product administered; Expired product administered; Expired product admi...
Expired product administered; Expired product administered; Expired product administered; Expired product administered
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the vaccine was expired with a date of 9/30/2025.
the vaccine was expired with a date of 9/30/2025.
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| 2866358 | 55 | F | VA | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4457 |
Blood pressure increased, Cold sweat, Dizziness, Hyperhidrosis, Nausea
Blood pressure increased, Cold sweat, Dizziness, Hyperhidrosis, Nausea
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I got the vaccine on Monday afternoon. When I arrived in the parking lot at work around 7:45 Wed mo...
I got the vaccine on Monday afternoon. When I arrived in the parking lot at work around 7:45 Wed morning, I started feeling queasy and sweaty. I thought I might try to drive home, but it would have taken too long and I was afraid I would have to vomit. I got out of the car and about halfway to the office door, I had to sit down because I was so lightheaded. I was in a cold sweat and still felt like I would vomit. After about 5 min of sitting on the curb, my coworkers helped me to walk into the building. Once inside, I sat at my desk and the symptoms resolved after about 15 minutes. A friend took my BP around 1 p.m. and it was 159/86. At 5 p.m. it was 160/82. I normally have BP around 110/70. At bedtime, it had gone down to 140/84. The next morning as soon as I woke up, it was back to normal - 113/74. The only thing different in my routine was the vaccine administration.
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| 2866359 | 86 | F | OH | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794BA |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Erythematous and swollen injection site. Started occurring about 36 hours post injection. Ice pack ...
Erythematous and swollen injection site. Started occurring about 36 hours post injection. Ice pack and tylenol administered per facility orders.
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| 2866360 | 79 | F | TX | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
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Atrial fibrillation, Condition aggravated, Laboratory test normal
Atrial fibrillation, Condition aggravated, Laboratory test normal
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About 2 hours after receiving the vaccine, I had about a 30 minute episode of A-Fib.
About 2 hours after receiving the vaccine, I had about a 30 minute episode of A-Fib.
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| 2866362 | 64 | F | AZ | 10/16/2025 |
COVID19 |
MODERNA |
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Vaccination site pain
Vaccination site pain
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arm-injection site soreness for a day or two; This spontaneous case was reported by a consumer and d...
arm-injection site soreness for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm-injection site soreness for a day or two) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced VACCINATION SITE PAIN (arm-injection site soreness for a day or two). At the time of the report, VACCINATION SITE PAIN (arm-injection site soreness for a day or two) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided by the reporter. It was reported that the patient never had any reactions to Covid vaccinations since late 2020. It was reported that post vaccination, the patient experienced arm-injection site soreness which had lasted for a day or two. No treatment medications provided by the reporter. This case was linked to MOD-2025-789998 (Patient Link).
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| 2866363 | 54 | F | IL | 10/16/2025 |
UNK |
UNKNOWN MANUFACTURER |
52TM4 |
Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased
Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased
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Immediately after injection she felt left shoulder pain. Pain has persisted and she has decreased RO...
Immediately after injection she felt left shoulder pain. Pain has persisted and she has decreased ROM in her left arm
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| 2866364 | 75 | M | MN | 10/16/2025 |
COVID19 |
MODERNA |
3052671 |
Arthralgia, Depressed level of consciousness, Malaise, Vomiting
Arthralgia, Depressed level of consciousness, Malaise, Vomiting
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Called patient and discussed reaction to Covid shot. He stated last year that he got both the infl...
Called patient and discussed reaction to Covid shot. He stated last year that he got both the influenza and covid the same day, and the following day he fainted and passed out the following day of getting the vaccine. This year he stated that he received the flu shot 2 days ago, and had no reaction so came in yesterday to get the Covid vaccine. He stated during the night he didn't feel good, shoulder hurt and this am, he stated he loss consciousness, vomited and feels good now. He stated his wife is a nurse and was there to witness the episode. Discuss any other symptoms concerns and he stated he feels good. Encouraged them to call their primary provider or to come in to be evaluated. They stated they will call their PCP first and then come in to office if needed.
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| 2866365 | 73 | F | 10/16/2025 |
COVID19 HEPAB VARZOS |
MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site pain, Injection site swelling; Injection...
Injection site erythema, Injection site pain, Injection site swelling; Injection site erythema, Injection site pain, Injection site swelling; Injection site erythema, Injection site pain, Injection site swelling
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redness soreness at injection site some swelling too lasting 2 days starting to improve now
redness soreness at injection site some swelling too lasting 2 days starting to improve now
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| 2866367 | 81 | F | TN | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
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Injection site haematoma
Injection site haematoma
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7-8 cm hematoma at inj site
7-8 cm hematoma at inj site
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| 2866368 | 55 | F | NY | 10/16/2025 |
PNC20 |
PFIZER\WYETH |
MA2505 |
Rash, Rash erythematous, Rash papular, Skin warm
Rash, Rash erythematous, Rash papular, Skin warm
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Red, raised and warm rash to L arm.
Red, raised and warm rash to L arm.
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| 2866369 | 0.5 | F | OH | 10/16/2025 |
DTPPVHBHPB FLU3 PNC20 |
MSP VACCINE COMPANY SANOFI PASTEUR PFIZER\WYETH |
U8265AA UT8792MA LP4946 |
Inappropriate schedule of product administration; Inappropriate schedule of prod...
Inappropriate schedule of product administration; Inappropriate schedule of product administration; Inappropriate schedule of product administration
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none
none
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| 2866370 | 51 | F | ND | 10/16/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
946064 946064 |
Arthralgia, Diplopia, Fatigue, Headache, Nausea; Vomiting
Arthralgia, Diplopia, Fatigue, Headache, Nausea; Vomiting
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Headache, nausea, vomiting, joint aches, fatigue, double-vision. Symptoms lasted approximately 72 h...
Headache, nausea, vomiting, joint aches, fatigue, double-vision. Symptoms lasted approximately 72 hours.
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| 2866371 | 74 | M | MN | 10/16/2025 |
FLU3 |
SEQIRUS, INC. |
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Extra dose administered
Extra dose administered
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patient was given a second flu vaccine this season
patient was given a second flu vaccine this season
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| 2866373 | 5 | F | MA | 10/16/2025 |
FLU3 |
SEQIRUS, INC. |
406995 |
Injection site swelling
Injection site swelling
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Patient had an swollen arm 2 days after flu shot. Entire upper arm swelled up . Patient's mom g...
Patient had an swollen arm 2 days after flu shot. Entire upper arm swelled up . Patient's mom gave benadryl that night after the reaction as well as applied hydrocortisone and ice packs to the area. Swelling lasted a few days with repeated hydrocortisone and ice packs
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| 2866374 | 62 | F | IL | 10/16/2025 |
COVID19 |
MODERNA |
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Pain
Pain
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couple days after having vaccine had a little soreness which is normal. use rubbing alcohol. Tuesday...
couple days after having vaccine had a little soreness which is normal. use rubbing alcohol. Tuesday put some cream on it. Unable to lift arm over head without extreme pain.
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| 2866375 | 74 | F | NC | 10/16/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
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Asthenia, Chills, Influenza like illness, Nausea, Pain; Pyrexia
Asthenia, Chills, Influenza like illness, Nausea, Pain; Pyrexia
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approximately 6 hours after administration started having severe flu like symptoms - fever, aches, c...
approximately 6 hours after administration started having severe flu like symptoms - fever, aches, chills, nausea, weakness that lasted ~48 hours with gradual lessening the second day. By day 3 was weak but back to normal.
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| 2866376 | 31 | F | MA | 10/16/2025 |
COVID19 |
PFIZER\BIONTECH |
NA4452 |
Angiogram, Magnetic resonance imaging, Occipital lobe stroke
Angiogram, Magnetic resonance imaging, Occipital lobe stroke
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Acute occipital stroke
Acute occipital stroke
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โ | โ | ||||
| 2866377 | 38 | M | NV | 10/16/2025 |
COVID19 |
MODERNA |
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Nausea, Oedema peripheral, Pain in extremity, Vomiting
Nausea, Oedema peripheral, Pain in extremity, Vomiting
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nausea, vomiting, and arm pain and edema
nausea, vomiting, and arm pain and edema
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| 2866378 | 71 | F | WA | 10/16/2025 |
FLU3 |
SANOFI PASTEUR |
|
Lip swelling, Oral discomfort
Lip swelling, Oral discomfort
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Felt fine after shot. Nothing unusual till next morning when woke up. Then I noticed my lips were sw...
Felt fine after shot. Nothing unusual till next morning when woke up. Then I noticed my lips were swollen and burning. Lasted about 4 to 5 days. Now they started to feel better with lots of ChapStick. I was not sick or feeling ill, so the only thing I can attribute my lip swelling is the high dose Flu shot. Just wanted to let you know.
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| 2866379 | 59 | F | TX | 10/16/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
73BN2 73BN2 |
Bell's palsy, Blood test normal, Computerised tomogram normal, Ear pain, Fa...
Bell's palsy, Blood test normal, Computerised tomogram normal, Ear pain, Facial pain; Facial paralysis, Magnetic resonance imaging normal
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Bell's Palsy; facial paralysis to right side, pain to right ear and right side of face. sympto...
Bell's Palsy; facial paralysis to right side, pain to right ear and right side of face. symptoms started approximately 48 hours after vaccination
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