| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2859910 | M | 09/19/2025 |
RVX VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Malaise, Medical induction of coma; Malaise, Medical induction of coma
Malaise, Medical induction of coma; Malaise, Medical induction of coma
|
He does not know much because he was in an induced coma; Sickness; This serious case was reported by...
He does not know much because he was in an induced coma; Sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of artificial coma in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving RSV vaccine and Shingles vaccine, the patient experienced artificial coma (Verbatim: He does not know much because he was in an induced coma) (serious criteria GSK medically significant) and sickness (Verbatim: Sickness). The outcome of the artificial coma was resolved and the outcome of the sickness was not reported. It was unknown if the reporter considered the artificial coma to be related to RSV vaccine and Shingles vaccine. The reporter considered the sickness to be unrelated to RSV vaccine. The reporter considered the sickness to be related to Shingles vaccine. The company considered the artificial coma and sickness to be unrelated to RSV vaccine. The company considered the artificial coma to be unrelated to Shingles vaccine. The company considered the sickness to be related to Shingles vaccine. Additional Information: This case was reported by a patient via interactive digital media. The reporter stated that RSV was not what had made patient sick, it was shingles. The patient had been flown to the hospital as well. The patient did not think that he had be interested in talking about it and had not known much because he had been in an induced coma.; Sender's Comments: A case of Medical induction of coma, unknown time after receiving RSV vaccine and Shingles vaccine in a male patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
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| 2859911 | 09/19/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Cardiac failure congestive, Chronic obstructive pulmonary disease
Cardiac failure congestive, Chronic obstructive pulmonary disease
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CHF; COPD; This serious case was reported by a consumer via interactive digital media and described...
CHF; COPD; This serious case was reported by a consumer via interactive digital media and described the occurrence of congestive heart failure in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced congestive heart failure (Verbatim: CHF) (serious criteria GSK medically significant) and chronic obstructive pulmonary disease (Verbatim: COPD). The outcome of the congestive heart failure and chronic obstructive pulmonary disease were not reported. It was unknown if the reporter considered the congestive heart failure and chronic obstructive pulmonary disease to be related to Arexvy. The company considered the congestive heart failure to be unrelated to Arexvy. It was unknown if the company considered the chronic obstructive pulmonary disease to be related to Arexvy. Additional Information: GSK Receipt Date: 05-SEP-2025 This case was reported by a patient via interactive digital media. Patient had two conditions, chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF).; Sender's Comments: A case of Cardiac failure congestive, unknown time after receiving Arexvy in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (concurrent chronic obstrutive pulmonary disease).
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| 2859912 | F | 09/19/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
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Pain; This non-serious case was reported by a consumer via interactive digital media and described t...
Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced pain (Verbatim: Pain). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Herpes Zoster vaccine. It was unknown if the company considered the pain to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 20-AUG-2025 This case was reported by a patient via interactive digital media. Patient had pain but not often. There were no signs if a rash.
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| 2859913 | 75 | F | 09/19/2025 |
COVID19 |
MODERNA |
|
COVID-19
COVID-19
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Last year, in 2024, she got COVID; This spontaneous case was reported by a consumer and describes th...
Last year, in 2024, she got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Last year, in 2024, she got COVID) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Concurrent medical conditions included COPD (chronic stage 3) and Emphysema (chronic). On 02-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2024, the patient experienced COVID-19 (Last year, in 2024, she got COVID). At the time of the report, COVID-19 (Last year, in 2024, she got COVID) outcome was unknown. No concomitant medication was reported. She had terrible lungs. She stated that if she gets sick again, she probably won't make it. Her lung doctor advised her to take the COVID-19 vaccine, but her family doctor was completely against it. She mentioned that she had been taking the vaccines since they became available. She received her 4th vaccine on 2-Nov-2023. In 2024, she got COVID before she could get the vaccine, so she did not receive it and was very sick. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2021-237423 (Patient Link).
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| 2859914 | PA | 09/19/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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use of Flublok influenza vaccine off-label as dosing twice yearly, with no reported adverse event; I...
use of Flublok influenza vaccine off-label as dosing twice yearly, with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who took Influenza Trivalent Recombinant Vaccine [Flublok TIV] twice yearly, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, an unknown age and unknown gender patient who received an unknown dose of suspect Influenza Trivalent Recombinant Vaccine (lot number, strength and expiry date-unknown) via intramuscular route in unknown administration site for Influenza vaccination (Influenza immunisation) twice yearly, with no reported adverse event (off label use) (latency-1 day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable.
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| 2859915 | 56 | M | CA | 09/19/2025 |
COVID19 |
JANSSEN |
|
Blood test, Electromyogram, Magnetic resonance imaging, Muscular weakness
Blood test, Electromyogram, Magnetic resonance imaging, Muscular weakness
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Weakness in the left hip 2 months after first vaccination and weak left foot after second . There is...
Weakness in the left hip 2 months after first vaccination and weak left foot after second . There is no treatment for ALS.
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โ | โ | ||||
| 2859951 | F | CO | 09/19/2025 |
PNC15 |
MERCK & CO. INC. |
Z008265 |
Accident at work, Skin laceration, Syringe issue
Accident at work, Skin laceration, Syringe issue
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A medical assistant reported that one VAXNEUVANCE syringe was found to be broken in the tray. She w...
A medical assistant reported that one VAXNEUVANCE syringe was found to be broken in the tray. She will send photos and return the tray which has the one broken syringe. AE was also filed because one of the other medical assistants "poked" her finge; other medical assistants "poked" her finger on the broken glass; injury associated with device; Information has been received from Business Partner on 27-Aug-2025, 03-Sep-2025, and 09-Sep-2025. This spontaneous report was received from a Other health professional and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Pneumococcal 15-valent Conjugate Vaccine (lot #Z008265, expiration date: 21-Jul-2027) for an unknown indication. On an unknown date, a medical assistant reported that one VAXNEUVANCE syringe was found to be broken in the tray. She will send photos and return the tray which has the one broken syringe. AE was also filed because one of the other medical assistants "poked" her finger on the broken glass (injury associated with device and syringe broken). The patient recovered/resolved from the event of other medical assistants "poked" her finger on the broken glass on an unspecified date. The action taken with Pneumococcal 15-valent Conjugate Vaccine was reported as not applicable. The causal relationship between the event of other medical assistants "poked" her finger on the broken glass and Pneumococcal 15-valent Conjugate Vaccine was unknown/not reported/not provided.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-08-28 , number : , number : , number : , number : 02863296 , Central date : 2025-08-27 , Classification : , Attachment description : Post Marketing Basic , Safety case number :
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| 2859952 | TN | 09/19/2025 |
HPV9 |
MERCK & CO. INC. |
Z002437 |
Device connection issue, Syringe issue
Device connection issue, Syringe issue
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No AE/PQC; poor quality device administered; syringe broke off on the Luer Lock area; This spontaneo...
No AE/PQC; poor quality device administered; syringe broke off on the Luer Lock area; This spontaneous report was received from a/an Pharmacist and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-Sep-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Z002437, expiration date: 11-Aug-2027) 1 dosage form (exact dose, anatomical location and route of administration were not reported) as prophylaxis. On the same date, syringe broke off on the Luer Lock area (Syringe broken) (Poor quality device administered). At the reporting time, the outcome of syringe broke off on the Luer Lock area and poor quality device administered was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as not applicable. This is an invalid case due to lack of patient's identifier. Follow-up information was received from the reporter on 15-Sep-2025. There was no adverse event. Reporter sent pictures associated with this case. No additional information.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02871963-02871960 , CLIC number : , ESTAR number : , IRMS number : 500UW00000lPYmdYAG|16092025230034|2948 , Central date : 2025-09-17 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2329675 , MNSC case number : 02871963 , MNSC interaction number : 02871960 , Integration log UniqueID : 500UW00000lPYmdYAG|16092025230034|2948 , Service cloud CaseID : 500UW00000lPYmdYAG
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| 2859953 | 85 | M | MO | 09/19/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
544SD |
Product preparation issue
Product preparation issue
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administered only the adjuvant component of Arexvy to a patient; administered only the adjuvant comp...
administered only the adjuvant component of Arexvy to a patient; administered only the adjuvant component of Arexvy to a patient; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 85-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 544SD, expiry date 19-NOV-2025) for prophylaxis. On 18-AUG-2025, the patient received Arexvy (intramuscular, left deltoid). On 18-AUG-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered only the adjuvant component of Arexvy to a patient) and inappropriate dose of vaccine administered (Verbatim: administered only the adjuvant component of Arexvy to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-AUG-2025 The pharmacy technician reported that a pharmacist at his retail location administered only the adjuvant component of Arexvy to a patient and did not reconstitute the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
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| 2859954 | 43 | M | 09/19/2025 |
COVID19 |
MODERNA |
044A21A |
Cardiac disorder, Chest pain, Discomfort, Laboratory test
Cardiac disorder, Chest pain, Discomfort, Laboratory test
|
Pain in my chest near my heart; nurse line recommended I go to ER when I received full checkup. Sec...
Pain in my chest near my heart; nurse line recommended I go to ER when I received full checkup. Second time, I think I was also referred. Third time it happened, I just didn?t report it as it was a waste of time. Attempted to claim on disability due to known heart issues, it was denied.
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| 2859955 | 24 | F | FL | 09/19/2025 |
COVID19 |
JANSSEN |
202A219 |
Adenomyosis, Endometriosis, Menstruation irregular
Adenomyosis, Endometriosis, Menstruation irregular
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In 2021, I noticed a month after I got the shot, I had issues with my periods. I had one in Septembe...
In 2021, I noticed a month after I got the shot, I had issues with my periods. I had one in September for 5 days and then it stopped for a week and then started again. I?ve never had that issue before until I took the shot.
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โ | โ | ||||
| 2859956 | 21 | M | IN | 09/19/2025 |
COVID19 |
JANSSEN |
|
Asthenia, Brain fog, Cognitive test, Dyspnoea, Malaise
Asthenia, Brain fog, Cognitive test, Dyspnoea, Malaise
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Very bad Covid symptoms and brain fog and weakness/shortness of breat that has lasted until present ...
Very bad Covid symptoms and brain fog and weakness/shortness of breat that has lasted until present day
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| 2859957 | 29 | M | CA | 09/19/2025 |
FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
407002 407002 407002 |
Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase incre...
Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Burning sensation, Discomfort; Dizziness, Full blood count, International normalised ratio normal, Metabolic function test normal, Monocyte percentage increased; Pain in extremity, Paraesthesia, Peripheral swelling, Prothrombin time normal, Ultrasound Doppler normal
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Lightheadedness and dizziness at time of vaccination around 2:30am. Around 3:45am I noticed swelling...
Lightheadedness and dizziness at time of vaccination around 2:30am. Around 3:45am I noticed swelling of my right forearm and upper arm with tingling in my fingertips. This was accompanied with various types of pain in the arm including burning pain, pressure pain, and an aching pain in and around the elbow. I did NOT have any itching, difficulty breathing, or color changes. No medications were given during emergency department visit, but I was prescribed a 6-day supply of methylprednisone. No outcome available yet as this occurred yesterday and I still have symptoms.
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| 2859958 | 38 | M | MN | 09/19/2025 |
COVID19 |
JANSSEN |
|
Palpitations, Pulmonary embolism
Palpitations, Pulmonary embolism
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Pulmonary embolism that was unexplainable and cause unknown.
Pulmonary embolism that was unexplainable and cause unknown.
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โ | |||||
| 2859959 | 19 | F | SC | 09/19/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Delivery, Foetal cardiac disorder, Maternal exposure before pregnancy
Delivery, Foetal cardiac disorder, Maternal exposure before pregnancy
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Congenital heart block in fetus while pregnant, will affect child for the rest of their life. Prescr...
Congenital heart block in fetus while pregnant, will affect child for the rest of their life. Prescribed hydroxychloroquine to help prevent and minimize heart problems. Child still has heart block and will need pacemaker by age 18.
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| 2859960 | 22 | F | 09/19/2025 |
COVID19 |
JANSSEN |
|
Infertility female
Infertility female
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We can?t directly tie it to the COVID vaccine, but my husband and I have ?unexplained infertility.? ...
We can?t directly tie it to the COVID vaccine, but my husband and I have ?unexplained infertility.? We?ve been trying to get pregnant for almost 4 years now. We paid out of pocket for 5 rounds of IUI with each one being unsuccessful. We?ve done most, if not all of the fertility tests and everything came back normal. I heard back in 2021, after I got the shot, that these shots were leading to fertility and pregnancy issues.
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| 2859963 | 25 | M | TX | 09/19/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Depressed level of consciousness, Electrocardiogram, Heart rate decreased, Nause...
Depressed level of consciousness, Electrocardiogram, Heart rate decreased, Nausea, Syncope; Tunnel vision
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Had 3 fainting spells where I felt very nauseous had tunnel vision and was struggling to stay consci...
Had 3 fainting spells where I felt very nauseous had tunnel vision and was struggling to stay conscious as my HR plummeted; was told it was vasovagal syncope
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| 2859964 | 30 | M | GA | 09/19/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Central venous catheterisation, Death, Dialysis, Dyspnoea, Endotracheal intubati...
Central venous catheterisation, Death, Dialysis, Dyspnoea, Endotracheal intubation; Lung assist device therapy, Oxygen saturation decreased, Pneumothorax, Tracheostomy
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Couldn?t breathe, 02 dropped below 60. Had to get med flight to facility. He had to get ecmo, trach,...
Couldn?t breathe, 02 dropped below 60. Had to get med flight to facility. He had to get ecmo, trach, dialysis pick lines tubes for collapsed lungs hand up passing away on November 26, 2021.
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โ | โ | โ | |||
| 2859965 | 35 | M | FL | 09/19/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Catheterisation cardiac normal, Cerebral infarction, Chest pain, Echocardiogram ...
Catheterisation cardiac normal, Cerebral infarction, Chest pain, Echocardiogram normal, Myocarditis; Troponin increased
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myocarditis infarction , separate from that may 4th of this year 2025 had a cerebrovascular acute i...
myocarditis infarction , separate from that may 4th of this year 2025 had a cerebrovascular acute infarct
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โ | โ | โ | |||
| 2859966 | M | 09/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Magnetic resonance imaging head normal, Malaise, Tinnitus
Magnetic resonance imaging head normal, Malaise, Tinnitus
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that made him feel unwell for a few days; the patient developed ringing in the ears or tinnitus; Thi...
that made him feel unwell for a few days; the patient developed ringing in the ears or tinnitus; This non-serious case was reported by a other health professional via sales rep and described the occurrence of feeling unwell in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose in SEP-2020 and dose made him felt unwell, refer case US2025AMR107961). Concurrent medical conditions included prostatic disorder (pre-existing prostate problems). In FEB-2021, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: that made him feel unwell for a few days) and tinnitus (Verbatim: the patient developed ringing in the ears or tinnitus). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved and the outcome of the tinnitus was not resolved. It was unknown if the reporter considered the feeling unwell to be related to Shingrix. The reporter considered the tinnitus to be possibly related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. The company considered the tinnitus to be possibly related to Shingrix. Linked case(s) involving the same patient: US2025AMR107961 Additional Information: GSK Receipt Date: 20-AUG-2025 The patient took dose 2 of Shingrix and also had side effects that made him feel unwell for a few days. Within a month of taking the 2nd dose of the Shingrix vaccine the patient developed ringing in the ears or tinnitus. He saw an ENT physician who ordered a magnetic resonance imaging and the findings did not identify the cause or reason for the tinnitus. The patient still experienced almost daily episodes of ringing in the ears as this form of tinnitus was not debilitating, but annoying and still persisted from 2020 through 2025. The patient's ENT physician was suspicious that the tinnitus was somehow related to the Shingrix vaccine since it developed within a few weeks of taking dose 2 of Shingrix.; Sender's Comments: US-GSK-US2025AMR107961:same patient
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| 2859967 | 30 | M | NC | 09/19/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
011A21A 011A21A 011A21A 011A21A 011A21A 011A21A 011A21A 011A21A 011A21A |
Alanine aminotransferase normal, Albumin globulin ratio increased, Aspartate ami...
Alanine aminotransferase normal, Albumin globulin ratio increased, Aspartate aminotransferase normal, Basophil percentage decreased, Blood albumin normal; Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine increased; Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal; Carbon dioxide, Chills, Dizziness, Dyspnoea, Eosinophil count decreased; Eosinophil percentage decreased, Full blood count, Haematocrit decreased, Haemoglobin decreased, Immature granulocyte count; Lymphocyte count decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell haemoglobin normal, Mean platelet volume increased; Monocyte count normal, Monocyte percentage, Nausea, Neutrophil count increased, Neutrophil percentage increased; Platelet count normal, Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cell nucleated morphology; Red cell distribution width increased, Vomiting, White blood cell count increased
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Fever, Chills, Nausea, vomiting, dizziness, and shortness of breath
Fever, Chills, Nausea, vomiting, dizziness, and shortness of breath
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| 2859968 | 54 | M | NH | 09/19/2025 |
FLU3 PNC21 |
SEQIRUS, INC. MERCK & CO. INC. |
AX4143A Z006889 |
Back pain, Chills, Dizziness, Erythema, Pyrexia; Back pain, Chills, Dizziness, E...
Back pain, Chills, Dizziness, Erythema, Pyrexia; Back pain, Chills, Dizziness, Erythema, Pyrexia
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Patient received the vaccines on 09/16/2025. When he got home, he developed back pain, chills and di...
Patient received the vaccines on 09/16/2025. When he got home, he developed back pain, chills and dizziness. The next day patient developed fevers around 101-102. Patient went to MD and they ruled out COVID/Flu. Patient developed redness to his left arm on 09/19/2025. Patient's wife who is an MD, advised that the patient is stable at this time.
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| 2859969 | 35 | M | MT | 09/19/2025 |
COVID19 |
PFIZER\BIONTECH |
Ew0178 |
Chest discomfort, Chest pain, Lethargy, Magnetic resonance imaging heart, Myoper...
Chest discomfort, Chest pain, Lethargy, Magnetic resonance imaging heart, Myopericarditis
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Lethargic and chest pain/tightness. Diagnosed with myopericarditis
Lethargic and chest pain/tightness. Diagnosed with myopericarditis
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| 2859970 | 38 | F | NY | 09/19/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
MY9550 MY9550 MY9550 MY9550 |
Heart rate increased, Rash, Tremor; Anaphylactic reaction, Blood test, Chest pai...
Heart rate increased, Rash, Tremor; Anaphylactic reaction, Blood test, Chest pain, Computerised tomogram, Dizziness; Electrocardiogram, Erythema, Flushing, Nausea, Swelling; Tachycardia, Tremor; Heart rate increased, Rash, Tremor; Anaphylactic reaction, Blood test, Chest pain, Computerised tomogram, Dizziness; Electrocardiogram, Erythema, Flushing, Nausea, Swelling; Tachycardia, Tremor
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The patient had a mild rash, shaking and increase heart rate
The patient had a mild rash, shaking and increase heart rate
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| 2859971 | 25 | F | 09/19/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
Unkown Unkown |
Abortion spontaneous, Blood pressure increased, Blood test, Dizziness, Haematocr...
Abortion spontaneous, Blood pressure increased, Blood test, Dizziness, Haematocrit; Headache, Infertility female
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About a week after my first dose of the vaccine I started having extreme headaches and dizziness. I...
About a week after my first dose of the vaccine I started having extreme headaches and dizziness. I was seen by my primary care physician and my blood pressure was extremely elevated. It was bad enough that they called the ambulance to send me to the hospital. After a week of monitoring my blood pressure it was decided that I needed to go on blood pressure medication. I have been on an off the medication since then. I also have since suffered two first trimester miscarriages and have not been able to get pregnant after a year of trying.
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| 2859972 | 60 | F | ME | 09/19/2025 |
COVID19 |
MODERNA |
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Injection site cellulitis
Injection site cellulitis
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Cellulitis at injection site
Cellulitis at injection site
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| 2859973 | 25 | M | PA | 09/19/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
003B21A 003B21A 006D21A 006D21A |
Cardiac stress test normal, Chest pain, Dizziness, Dyspnoea, Electrocardiogram a...
Cardiac stress test normal, Chest pain, Dizziness, Dyspnoea, Electrocardiogram ambulatory normal; Endoscopy normal, Nausea; Cardiac stress test normal, Chest pain, Dizziness, Dyspnoea, Electrocardiogram ambulatory normal; Endoscopy normal, Nausea
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After receiving second dose, patient began to experience severe chest pain throughout the day. After...
After receiving second dose, patient began to experience severe chest pain throughout the day. After going to medical regarding the issue a log was started to track the pain. Patient learned over time the chest pain was most frequent and severe when under excess stress and after operating on a lack of sleep or a lack of quality sleep. 1/19/2022, 10:08 chest pain while sitting at computer lasted approx. 1 minute 1/19/2022 11:37 pain while driving, approx. 2 minutes 1/19/2022 14:50 pain while sitting at desk, 1 minute 1/20/2022 14:21 pain while standing near engine, 1 minute 1/20/2022 20:40 pain at desk, 2 minutes 1/21/2022 9:08 pain while pushing engine, 2 minutes 1/21/2022 12:31 pain while working on engine, 1 minute 1/21/2022 13:24 pain while standing, 1 minute 1/21/2022 15:07 pain while driving, 1 minute 1/21/2022 23:12 pain at bar, 4 minutes, stopped drinking after 1 drank water from then on 1/22/2022 20:28 pain at desk, 2 minutes 1/22/2022 20:59 pain at dinner, 2 minutes 1/24/2022 08:12 pain standing at work, 1 minute 1/24/2022 13:32 pain while pushing engine, 4 minutes 1/25/2022 14:34 pain while at desk, 2 minutes 1/25/2022 18:53 pain at desk, 2 minutes 1/26/2022 14:16 pain at desk 2 minutes 1/27/2022 7:30 pain at all call, 1 minute 1/27/2022 11:05 pain while working on engine, 1 minute 1/29/2022 22:17 pain at desk, 1 minute 1/31/2022 10:19 pain working on engine, 1 minute 1/31/2022 10:22 lesser pain working on engine, 2 minutes 1/31/2022 11:00 pain while standing up, 2 minutes 2/1/2022 8:10 sharper pain while on fod walk, 3 minutes 2/1/2022 8:55 pain while on computer, 1 minute 2/2/2022 right arm muscle and right knee joint pain 2/5/2022 22:43 heart pain while on computer, had two drinks, 2 minutes 2/7/2022 07:52 pain while on computer, 1 minute 2/8/2022 9:20 pain while working, 1 minute 2/9/2022 07:53 pain standing while working, 2 minutes 2/9/2022 08:30 pain while working, 1 minute 2/9/2022 multiple long pains from 16:00-1800, at home angry 2/10/2022 9:09 pain while working, 2 minutes 2/14/2022 07:52 pain while sitting at computer, 1 minute 2/15/2022 06:38 pain while driving, 1 minute 2/16/2022 11:10 pain while lifting stages, 2 minutes 2/16/2022 11:54 pain while lifting stages 2 minutes 2/28/2022 06:47 pain while driving, 1 minute 3/02/2022 08:07: pain while working on engine, 1 minute 3/02/2022 11:00 pain while driving, 1 minute 3/02/2022 12:33 pain while waiting for meeting, 1 minute 3/02/2022 13:10 pain after meeting, angry, 5 minutes 3/12/2022 11:56 pain while playing video games, 1 minute 3/13/2022 12:54 pain while playing video games, 2 minutes 3/16/2022 5:45- intermittent heart pain each lasting a few seconds, light headed, shortness of breath, and nausea
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| 2859974 | 42 | F | NM | 09/19/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Unevaluable event
Unevaluable event
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None stated.
None stated.
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| 2859975 | 77 | F | GA | 09/19/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9550 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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ADMINISTERED AFTER 3 WEEKS OF THE LAST COVID VACCINE DOSE INSTEAD OF AFTER 8 WEEKS.
ADMINISTERED AFTER 3 WEEKS OF THE LAST COVID VACCINE DOSE INSTEAD OF AFTER 8 WEEKS.
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| 2859976 | 37 | M | OH | 09/19/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8779NA UT8779NA |
Feeling hot, Injection site reaction, Lethargy, Rash erythematous, Rash papular;...
Feeling hot, Injection site reaction, Lethargy, Rash erythematous, Rash papular; Throat irritation
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rash, red raised area around injection site about the size of an orange, itchy throat, lethargic, &q...
rash, red raised area around injection site about the size of an orange, itchy throat, lethargic, "feeling hot", itchy throat (has seasonal allergies had not yet taken his allergy medication (patient reported this, wanted it included). Patient stayed in office for an hour during reaction. The rash stayed the same, zero breathing issues developed, patient advised as soon as he arrived home (1 minute) to take Benadryl, by doctor on site. Physician described symptoms to patient in which he should give the ems a call to be taken to hospital, and to take Benadryl as soon as he arrived home (1 minute away). Patient verbalized understanding
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| 2859977 | 17 | M | CT | 09/19/2025 |
HPV9 |
MERCK & CO. INC. |
Y018297 |
Dizziness, Hyperhidrosis, Nervousness, Tunnel vision
Dizziness, Hyperhidrosis, Nervousness, Tunnel vision
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Administered State: HPV immunization(s) as ordered. Patient initially tolerated procedure/injectio...
Administered State: HPV immunization(s) as ordered. Patient initially tolerated procedure/injection fine. While patient was waiting in the room for the required 15 minutes following HPV administration mother alerted staff that pt started feeling dizzy and diaphoretic. This RN and RN at bedside. Pt reported feeling dizzy, shaky and had tunnel vision. Pt was helped to a supine position and MD called to room. Vitals monitored and pt assessed by Dr. Shortly after lying down sx resolved, VSS and pt able to tolerate po. After further observation pt back to baseline and able to ambulate w/o difficulties. Dr. cleared pt to leave office and advised to call office with any further questions or concerns. Mom and pt verbalized an understanding. Patient denies any questions or concerns at this time.
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| 2859978 | 29 | M | CA | 09/19/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
032H20A 032H20A 012M20A 012M20A |
Chest pain, Fibromyalgia, Hallucination, visual, Inflammation, Neuropathy periph...
Chest pain, Fibromyalgia, Hallucination, visual, Inflammation, Neuropathy peripheral; Pain; Chest pain, Fibromyalgia, Hallucination, visual, Inflammation, Neuropathy peripheral; Pain
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Developed chest pain, neuropathy's in both arms. Developed inflammatory response to all require...
Developed chest pain, neuropathy's in both arms. Developed inflammatory response to all required annual flu shots. Patient has since developed chronic pain syndrome, fibromyalgia, and visual hallucinations/visual alterations/Persistive Positive Visual Phenomena.
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| 2859979 | 60 | F | MI | 09/19/2025 |
PNC20 |
PFIZER\WYETH |
LN4931 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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None- incorrect vaccine given.
None- incorrect vaccine given.
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| 2859980 | 61 | M | PA | 09/19/2025 |
COVID19 |
MODERNA |
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Rash, Rash papular
Rash, Rash papular
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pt says he about a week after being vaccinated he woke up at night with raised dots under his right...
pt says he about a week after being vaccinated he woke up at night with raised dots under his right arm. They were spread out under the arm around the chest and under the arm around the back. They were kind of like bug bites. By the next day when he woke up these red dots had completely disappeared. This continued for the next 3 nights. Only at night these dots were on and around the right elbow and by the morning they were gone. On the 3rd night these dots were like hives on his right arm and on his lower body. They were mostly gone by the next morning they were mostly gone with the exception of a few. He reported this to his pharmacist and saw his PCP on the 17th. He was prescribed cortisone cream and told to take antihistamine meds. He took Claritin and did not have any red dots at night after taking this medication.
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| 2859981 | 0.33 | M | 09/19/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK194AA |
Product preparation issue
Product preparation issue
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Pentacel was not mixed correctly. The 2 vials were not mixed and only vial #1 was given.
Pentacel was not mixed correctly. The 2 vials were not mixed and only vial #1 was given.
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| 2859982 | 19 | M | TX | 09/19/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EP7533 EN6207 |
Chest X-ray abnormal, Chest scan abnormal, Dyspnoea, Mediastinal cyst; Chest X-r...
Chest X-ray abnormal, Chest scan abnormal, Dyspnoea, Mediastinal cyst; Chest X-ray abnormal, Chest scan abnormal, Dyspnoea, Mediastinal cyst
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Cyst developed between heart and lung after receiving COVID-19 shot around summer-fall 2021. Patient...
Cyst developed between heart and lung after receiving COVID-19 shot around summer-fall 2021. Patient and doctor noted unusual shortness of breath and prescribed an inhaler. Waiver to commission was granted by doctor given that I could still pass a fitness test.
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| 2859983 | 32 | M | TX | 09/19/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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COVID-19, Cardiac stress test normal, Chest discomfort, Chest pain, Dizziness; D...
COVID-19, Cardiac stress test normal, Chest discomfort, Chest pain, Dizziness; Dyspnoea, Fatigue, Gastrooesophageal reflux disease, Myocarditis
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My symptoms were: chest pain and pressure, shortness of breath, lightheadedness, and fatigue. These ...
My symptoms were: chest pain and pressure, shortness of breath, lightheadedness, and fatigue. These symptoms started around 24 hours after my first and only COVID booster shot (third shot overall). In response to this event, I took a big dose of ibuprofen, rested, and prayed that I would survive. After a couple days, I felt normal. However, I had another event with the same symptoms on September 3rd, 2024. This event was not preceded by a vaccine, but likely in response to my having COVID. This time, I went to the ER and was treated with fluids and ibuprofen, and monitored for improvement. They ruled out heart attack, stroke, and collapsed lung, but said further diagnosis must come from my PCM. After the ER visit, it took five and a half weeks to be seen by my PCM. My PCM said that it was likely caused by myocarditis or GERD, but my GERD has been managed with medication.
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| 2859984 | 09/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Influenza like illness, Malaise
Influenza like illness, Malaise
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I was very sick; I had a 3-day flu type reaction to the 1st vaccine; This non-serious case was repor...
I was very sick; I had a 3-day flu type reaction to the 1st vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: I had a 3-day flu type reaction to the 1st vaccine) and sickness (Verbatim: I was very sick). The outcome of the influenza-like symptoms was resolved (duration 3 days) and the outcome of the sickness was not reported. It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms and sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 09-SEP-2025 Consumer reported that will not be get the 2nd vaccine.
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| 2859985 | 0.33 | M | AR | 09/19/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK194AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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Pentacel is 2 vials mixed together, a liquid and a powder. The vials were not mixed together and on...
Pentacel is 2 vials mixed together, a liquid and a powder. The vials were not mixed together and only the vial #1 with the liquid was given. Patient had no reaction to this vaccine given in error.
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| 2859986 | 26 | M | TX | 09/19/2025 |
COVID19 |
PFIZER\BIONTECH |
unknown |
Ageusia, Anosmia, Malaise, Nausea, Vomiting
Ageusia, Anosmia, Malaise, Nausea, Vomiting
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general sickness, nausea, loss of sense of smell and taste, vomiting
general sickness, nausea, loss of sense of smell and taste, vomiting
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| 2859987 | 35 | F | OH | 09/19/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Arthralgia, Injected limb mobility decreased, Product administered at inappropri...
Arthralgia, Injected limb mobility decreased, Product administered at inappropriate site
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Extremely painful shoulder, limited range or motion. Vaccine given too high up on the shoulder.
Extremely painful shoulder, limited range or motion. Vaccine given too high up on the shoulder.
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| 2859988 | 16 | F | TX | 09/19/2025 |
HPV9 MENB MNQ |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
Y015179 K7JY2 2JS53 |
Pruritus, Rash, Rash maculo-papular; Pruritus, Rash, Rash maculo-papular; Prurit...
Pruritus, Rash, Rash maculo-papular; Pruritus, Rash, Rash maculo-papular; Pruritus, Rash, Rash maculo-papular
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Diffuse macular papular rash across body starting approx one day after receiving vaccines. Reports i...
Diffuse macular papular rash across body starting approx one day after receiving vaccines. Reports itching. Denial of any tongue or lip swelling or trouble breathing. Denies introduction of any new foods or detergents.
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| 2859989 | 5 | F | CA | 09/19/2025 |
COVID19 |
MODERNA |
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Pyrexia, Vomiting
Pyrexia, Vomiting
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Fever, vomiting
Fever, vomiting
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| 2859990 | 50 | F | IL | 09/19/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL8982 EL8982 EL9269 EL9269 |
Antiphospholipid antibodies, Arthralgia, C-reactive protein increased, Feeling a...
Antiphospholipid antibodies, Arthralgia, C-reactive protein increased, Feeling abnormal, Joint swelling; Pain, Pyrexia, Rheumatoid arthritis, Rheumatoid factor; Antiphospholipid antibodies, Arthralgia, C-reactive protein increased, Feeling abnormal, Joint swelling; Pain, Pyrexia, Rheumatoid arthritis, Rheumatoid factor
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Shortly after my second vaccine-I developed high fever, body aches, generally feeling awful. After ...
Shortly after my second vaccine-I developed high fever, body aches, generally feeling awful. After these symptoms went away, I developed joint problems-swelling and pain in my joints that never went away. I eventually went to my dr who did blood work and my CRP was so very high. I was diagnosed with rheumatoid arthritis from my covid vaccine.
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| 2859991 | 45 | M | AL | 09/19/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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B-cell small lymphocytic lymphoma, Brain fog, Chronic lymphocytic leukaemia, Con...
B-cell small lymphocytic lymphoma, Brain fog, Chronic lymphocytic leukaemia, Confusional state, Deafness; Dysarthria, Hemiparesis, Hypoaesthesia, Meniere's disease, Muscle spasms; Palpitations, Tinnitus; B-cell small lymphocytic lymphoma, Brain fog, Chronic lymphocytic leukaemia, Confusional state, Deafness; Dysarthria, Hemiparesis, Hypoaesthesia, Meniere's disease, Muscle spasms; Palpitations, Tinnitus
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1st shot: Hearing loss, Tinnitus, Heart palpitations within 14 days 2nd Shot: Heart palpitations, mu...
1st shot: Hearing loss, Tinnitus, Heart palpitations within 14 days 2nd Shot: Heart palpitations, muscle weakness left side, slurred speech, involuntary muscle spasms, brain fog, confusion, numbness left side from head to toe
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| 2859992 | 32 | M | FL | 09/19/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
040C21A 040C21A 040C21A |
COVID-19, Chills, Dizziness, Dyspnoea, Eye irritation; Headache, Hyperhidrosis, ...
COVID-19, Chills, Dizziness, Dyspnoea, Eye irritation; Headache, Hyperhidrosis, Laboratory test normal, Pain in jaw, SARS-CoV-2 test positive; Tooth fracture, Tremor
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A few hours after I received my first COVID shot, I started to feel very lightheaded and shaky aroun...
A few hours after I received my first COVID shot, I started to feel very lightheaded and shaky around 2 in the afternoon. I finished my work and went home at 4pm. My side effects were gradually getting worse fast. I was getting chills, my eyes burned like they were on fire, I had a pounding headache, and I was shaking uncontrollably. Later that night around 8pm, my wife brought me to the ER because she thought I was dying. She dragged me into the ER and told them what was going on. They ran some tests on me, told me "This is normal for the first shot. You do not have COVID, I promise." I sat in wheelchair with a blanket in the waiting room for approximately 4-6 hours. At this point everything kept getting worse. It was very hard to breathe, I couldn't speak to ask for help, I couldn't move, and I was shivering so much that I got a chip in my front tooth, and my jaw was on fire. Eventually I got hooked up to some machine where they tested the oxygen level in my blood (I think that's what they were doing), and then they told me I was good to go home. That I would be fine in the morning. I still could not control my movements, I was sweating and shivering, I really thought I was going to die that night. The weekend went by and by Monday I was feeling a little bit better, but not much. I called the base clinic and told them that I wanted to get tested and seen, as I thought I just had a severe reaction to the vaccine. I drove on Monday morning and took a COVID test and I was told that I had COVID. Again, I had gone this whole time never contracting COVID, until the day I received the shot.
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| 2859993 | 64 | F | KY | 09/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
94J5E |
Rash, Rash erythematous, Rash pruritic
Rash, Rash erythematous, Rash pruritic
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Red itchy rash on right arm. Pt going to MD.
Red itchy rash on right arm. Pt going to MD.
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| 2859994 | 5 | F | NJ | 09/19/2025 |
FLU3 |
SANOFI PASTEUR |
U8863BA |
Headache, Vomiting
Headache, Vomiting
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On the way home from from the doctor's office complained of headache. Once home vomited several...
On the way home from from the doctor's office complained of headache. Once home vomited several times.
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| 2859995 | 11 | M | NY | 09/19/2025 |
FLU3 HPV9 |
SEQIRUS, INC. MERCK & CO. INC. |
406959 Y012776 |
Fall, Presyncope, Skin laceration, Unresponsive to stimuli; Fall, Presyncope, Sk...
Fall, Presyncope, Skin laceration, Unresponsive to stimuli; Fall, Presyncope, Skin laceration, Unresponsive to stimuli
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Within 10 minutes of vaccination the patient had a vasovagal response falling forward from the exam ...
Within 10 minutes of vaccination the patient had a vasovagal response falling forward from the exam table. The episode was witnessed by the nurse and the patients father. He was responsive again within 3 minutes. He sustained a small cut above his right eye.
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| 2859996 | 45 | M | MD | 09/19/2025 |
FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
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Anxiety, Arteriogram carotid, Blood electrolytes normal, Blood glucose normal, B...
Anxiety, Arteriogram carotid, Blood electrolytes normal, Blood glucose normal, Blood pressure increased; Defaecation urgency, Dysgeusia, Eating disorder, Electrocardiogram normal, Exercise tolerance decreased; Glycosylated haemoglobin normal, High density lipoprotein normal, Hyperhidrosis, Hypoaesthesia, Hypoaesthesia oral; Loss of personal independence in daily activities, Low density lipoprotein increased, Magnetic resonance imaging head normal, Magnetic resonance imaging neck normal, Metabolic function test normal; Micturition urgency, Palpitations, Paraesthesia, Sleep disorder, Troponin normal; Weight decreased
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On 9/9/25- 6 hours after vaccine administration, started having metallic taste in mouth, tingling in...
On 9/9/25- 6 hours after vaccine administration, started having metallic taste in mouth, tingling in both feet and left hand. On 9/10/25- developed left cheek and left upper gums numbness, on top of the symptoms from day before. Started having exercise intolerance, unable to climb a flight of stairs. Eating triggered an episode of blood pressure of 160/90, palpitations, and sense of doom. These episodes would come and go, triggered by exertion, food, getting out of bed- always finished with urgent urination and/or defecation. Episodes would last 20-30 minutes. On 9/12/2025 the facial numbness worsened accompanied by another episode of high blood pressure and sense of impending doom- in ED initial blood pressure was 180/90, HR 117. MRI and MRA head and neck normal, troponins normal, EKG normal, CMP normal, electrolytes normal. Was initiated on amlodipine 5mg daily. Exercise intolerance worsened over next few days, was unable to walk kids from car to school. Stopped showering, could eat only blueberries and oatmeal as everything else triggered the episodes. Lost 10 pounds in a week. Had severe, drenching night sweats, disrupted sleep, waking up every 2 hours. Symptoms were persistent until 9/18/2025 when the exercise intolerance significantly improved. On 9/19/2025 the left cheek and gum paresthesias resolved and was back to baseline.
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