| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2856251 | 57 | F | MD | 09/01/2025 |
HEP HEP HEP VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK UNK UNK UNK |
Abdominal discomfort, Blood electrolytes decreased, Blood test abnormal, Cardiac...
Abdominal discomfort, Blood electrolytes decreased, Blood test abnormal, Cardiac disorder, Computerised tomogram normal; Dyspnoea, Inappropriate schedule of product administration, Respiratory tract congestion, Scan with contrast normal, Thyroid hormones test; Urine analysis abnormal; Abdominal discomfort, Blood electrolytes decreased, Blood test abnormal, Cardiac disorder, Computerised tomogram normal; Dyspnoea, Inappropriate schedule of product administration, Respiratory tract congestion, Scan with contrast normal, Thyroid hormones test; Urine analysis abnormal
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heart deviation; Thyroid up; thyroid down; congested chest; abdominal discomfort; Urine abnormal; Sh...
heart deviation; Thyroid up; thyroid down; congested chest; abdominal discomfort; Urine abnormal; Short of breath; low electrolytes; drug dose administration interval too long; This non-serious case was reported by a consumer via call center representative and described the occurrence of urine analysis abnormal in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. Previously administered products included Shingrix with an associated reaction of oral herpes (received first dose on 12-DEC-2024). On 30-JUL-2025, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient received Hepatitis B vaccine. On 30-JUL-2025, an unknown time after receiving Shingrix and not applicable after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: drug dose administration interval too long). On 15-AUG-2025, the patient experienced urine analysis abnormal (Verbatim: Urine abnormal), shortness of breath (Verbatim: Short of breath), blood electrolytes decreased (Verbatim: low electrolytes), chest fullness (Verbatim: congested chest) and abdominal discomfort (Verbatim: abdominal discomfort). On an unknown date, the patient experienced heart disorder (Verbatim: heart deviation), thyroid hormones decreased (Verbatim: Thyroid up) and thyroid hormones decreased (Verbatim: thyroid down). The outcome of the urine analysis abnormal, shortness of breath, blood electrolytes decreased, chest fullness and abdominal discomfort were unknown and the outcome of the heart disorder, thyroid hormones decreased and thyroid hormones decreased were not resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the urine analysis abnormal, shortness of breath, blood electrolytes decreased, heart disorder, thyroid hormones decreased, thyroid hormones decreased, chest fullness and abdominal discomfort to be related to Shingrix and Hepatitis B vaccine. It was unknown if the company considered the urine analysis abnormal, shortness of breath, blood electrolytes decreased, heart disorder, thyroid hormones decreased, thyroid hormones decreased, chest fullness and abdominal discomfort to be related to Shingrix and Hepatitis B vaccine. Additional Information: GSK Receipt Date: 22-AUG-2025 The patient reported that she had to visit the ER for several complaints. She was not hospitalized, and the CT with contrast was within normal limits, she was told that she has abnormal blood, abnormal urine, low electrolytes, a deviation with her heart and her thyroid was going up and down. She had difficulty providing the history, the details and dates of the vaccinations and the dates of the miscellaneous disorders. The outcome date of events Urine analysis abnormal, Shortness of breath, Blood electrolytes decreased, Chest fullness and abdominal discomfort was provided as 15-AUG-2025.
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| 2856252 | 09/01/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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I had a moderate to severe case; I had a moderate to severe case; This serious case was reported by ...
I had a moderate to severe case; I had a moderate to severe case; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had a moderate to severe case) (serious criteria GSK medically significant) and shingles (Verbatim: I had a moderate to severe case). The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 1 month). It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-AUG-2025 This case was reported by a patient via interactive digital media. Patient stated that if you do not get the 2nd dose the effectiveness is not high and vaccines can cause mild side effects but to him/her it was worth it to not get shingles. Also stated that Shingles are horrible and to treat it with anti-virals and meds to prevent nerve damage are expensive with no insurance. Patient was put on Valtrex and Gabapentin, as had a moderate to severe case and it lasts about 1 month to clear up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2856254 | 09/01/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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I had the 2nd one yesterday and except for slightly sore arm; This non-serious case was reported by...
I had the 2nd one yesterday and except for slightly sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 21-AUG-2025, the patient received the 2nd dose of Shingles vaccine. In AUG-2025, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: I had the 2nd one yesterday and except for slightly sore arm). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a patient via interactive digital media. The patient had the 2nd one dose one day before the reporting date and except for slightly sore arm, no side effects was there. The patient mentioned that a new study says that vaccine might lower dementia risk by 20 percent.
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| 2856255 | M | 09/01/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; got it twice; This serious case was reported by a consumer via intera...
Suspected vaccination failure; got it twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Family history included dementia (patient's sister took Gabapentin, and which causes dementia did not touch it), c-section (patient's sister had a C section with no anesthesia; it was worse than that) and shingles (patient's sister had it for close to two years and did a Des bio detox and kicked it). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got it twice). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: SK receipt date: 24-AUG-2025 This case was reported by a patient's sister via interactive digital media. The reporter reported that CBD gummies with THC provided relief and comfrey cream ended up saving her. Her brother, who was a surgeon, got vaccinated and got it twice. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2856256 | 09/01/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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I got so sick with first vaccine even worse with second shot; This non-serious case was reported by ...
I got so sick with first vaccine even worse with second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine with an associated reaction of illness (received 1st dose on an unknown date, For tolerance to 1st dose, refer case US2025AMR110631.). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I got so sick with first vaccine even worse with second shot). Rechallenge with Shingles vaccine was positive. The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR110631 Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a patient via interactive digital media. The patient got so sick with first vaccine even worse with second shot. This case is linked with US2025AMR110631, reported by same reporter.
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| 2856257 | 09/01/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; have shingles right now; This serious case was reported by a consumer...
Suspected vaccination failure; have shingles right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 79-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have shingles right now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-AUG-2025 This case was reported by a patient via interactive digital media. The patient had shingles right now. Most horrible experience ever had. The patient had the shot years ago and would gladly get another one when patient well. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2856258 | F | 09/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Influenza like illness
Influenza like illness
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1st dose of Shingrix that was flu like symptoms; This non-serious case was reported by a nurse via s...
1st dose of Shingrix that was flu like symptoms; This non-serious case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in a 50-year-old female 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: 1st dose of Shingrix that was flu like symptoms). The outcome of the influenza-like symptoms was resolved (duration 2 days). It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR111186 Additional Information: GSK Receipt Date: 22-AUG-2025 The nurse reported that patient had a reaction to the 1st dose of Shingrix that was flu like symptoms for about 2 days.; Sender's Comments: US-GSK-US2025AMR111186:Shingrix dose 2
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| 2856259 | F | HI | 09/01/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB056A |
Product preparation issue
Product preparation issue
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Incorrect preparation; Inappropriate dose of vaccine administered; This non-serious case was reporte...
Incorrect preparation; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Incorrect preparation) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 19-AUG-2025 The reporter had question regarding Menveo, specifically the Menveo kids so, they have a kind of a situation right now where while they were doing their monthly inventory of vaccines they ended up with one powder vial which told that group of five did not get fully vaccinated. So, the question was, because they did not wanted to revaccinate all five patients because they did not know which of the five received the incomplete vaccine, so, what was the timeframe for them to revaccinate a 12 years old.
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| 2856260 | 1 | M | NC | 09/01/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4SB5S |
Product storage error
Product storage error
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Dose administered after a temperature excursion; This non-serious case was reported by a other healt...
Dose administered after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received MMR (Priorix) (batch number 4SB5S, expiry date 01-MAR-2027) for prophylaxis. On 11-AUG-2025, the patient received Priorix (subcutaneous). On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Dose administered after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 20-AUG-2025 Reporter stated that one patient received Priorix after the vaccine was stored in the freezer at a lowest temperature of minus 20 degree Celsius, which led to incorrect of storage of drug. Also stated that the vaccine was thawed before it was administered.
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| 2856261 | 70 | F | 09/01/2025 |
COVID19 |
MODERNA |
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Feeling abnormal
Feeling abnormal
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feel like crap; This spontaneous case was reported by a consumer and describes the occurrence of FEE...
feel like crap; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel like crap) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel like crap). At the time of the report, FEELING ABNORMAL (feel like crap) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications provided by the reporter. It was reported that vaccine did not prevent from to get Covid, but it prevented people from deathly ill. Patient received Moderna vaccination and patient felt like crap post vaccination, but later patient felt it was Oki. Patient thought vaccination helped people to prevent from COVID or if people had vaccine, then they may have a mild case and may not ended up in a hospital. It was unknown if the patient experienced any additional symptoms or events. No treatment medications provided by the reporter.
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| 2856262 | 50 | F | 09/01/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ...
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 50-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included 1st degree heart block (2 to 3 years ago). Concurrent medical conditions included Allergy. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that she wanted to confirm if the mNEXSPIKE booster was safe for her and if it was going to give her a hard time with age. Her healthcare provider assured her that it was safe to take. She explained that she had a first-degree heart block and, 2 to 3 years ago, had to postpone her COVID-19 booster due to a scheduled breast ultrasound. During that time, she contracted COVID-19 and subsequently received the vaccine later. Her entire department at work also contracted the virus around the same time, which she attributed to being outdoors without masks and being in the wrong place at the wrong time. She noted that she couldn't distinguish between her allergy symptoms and COVID-19. However, she confirmed that she did not contract COVID-19 from the vaccine, and she believed that timely vaccination could prevented some of the issues she experienced. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. Reporter did not allow further contact
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| 2856263 | 31 | F | PA | 09/01/2025 |
COVID19 |
MODERNA |
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Fatigue, Pain in extremity
Fatigue, Pain in extremity
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sore arm; felt tired for about 24 hours; This spontaneous case was reported by a consumer and descri...
sore arm; felt tired for about 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired for about 24 hours) in a 31-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired for about 24 hours). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (felt tired for about 24 hours) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications provided by the reporter. It was reported that post vaccination patient had sore arm and felt tired for about 24 hours. It was unknown if the patient experienced any additional symptoms or events. No treatment medications provided by the reporter.
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| 2856264 | 18 | F | NY | 09/01/2025 |
MEN MNQ |
UNKNOWN MANUFACTURER SANOFI PASTEUR |
U8361AA |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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patient's vaccination history indicated receiving 1 dose of MENACTRA in 2018 and another dose i...
patient's vaccination history indicated receiving 1 dose of MENACTRA in 2018 and another dose in 2023 was given MENQUADFI yesterday, 26-Aug-2025 with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 18 years old female patient with vaccination history indicated receiving 1 dose of Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] in 2018 and another dose in 2023, was given Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] yesterday, 26-aug-2025 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 in 2018, the patient received dose 1 of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine Solution for injection via unknown route in unknown administration site and on an unknown date in 2023 she again received dose 2 of Menactra via unknown route in unknown administration site for immunization (strength, dose, batch and expiry date unknown for both the doses). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. On 26-AUG-2025, the patient received a Booster dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine dose 0.5 ml 1x(once) Solution for injection (strength standard) lot U8361AA expiry date-31-Mar-2028 via intramuscular route in the right deltoid for immunization with no reported adverse event (Extra dose administered) (same day latency) for Menquadfi. Reportedly, since the patient was going to college this weekend, a booster of MENQUADFI was provided. Then, they found out that the patient had a booster in 2023 Action taken- not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2856265 | 66 | M | CO | 09/01/2025 |
COVID19 |
MODERNA |
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Blood test, Polymyalgia rheumatica
Blood test, Polymyalgia rheumatica
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Inflammatory arthritis and PMR
Inflammatory arthritis and PMR
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| 2856266 | 72 | F | VA | 09/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
nr4t5 |
Abdominal pain upper, Diarrhoea
Abdominal pain upper, Diarrhoea
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pt states that they started having started having stomach cramping on Friday and have been having di...
pt states that they started having started having stomach cramping on Friday and have been having diarrhea since then. Taking immodium
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| 2856267 | 68 | M | GA | 09/01/2025 |
PNC21 |
MERCK & CO. INC. |
Z002626 |
Heart rate increased, Injection site erythema, Injection site inflammation, Inje...
Heart rate increased, Injection site erythema, Injection site inflammation, Injection site warmth, Malaise
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PATIENT REPORTED TO ER WITH INCREASED HEART RATE AND GENERAL MALAISE. INJECTION SITE: RED, HOT, AND...
PATIENT REPORTED TO ER WITH INCREASED HEART RATE AND GENERAL MALAISE. INJECTION SITE: RED, HOT, AND INFLAMMED. PHYSICIAN EXAMINED PT AND SENT HOME. PT ADVISED TO FOLLOW UP WITH PCP.
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| 2856268 | 59 | M | TX | 09/01/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FH8030 FH8030 |
Acantholysis, Biopsy skin abnormal, Blister, Immunoassay, Impaired healing; Lip ...
Acantholysis, Biopsy skin abnormal, Blister, Immunoassay, Impaired healing; Lip blister, Pemphigus, Scab, Stomatitis
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BLISTER SORE ON HEAD DEC 2021, BLISTER AND SORE WILL NOT HEAL, JAN OR FEB 2022 BLISTER AND SORE IN M...
BLISTER SORE ON HEAD DEC 2021, BLISTER AND SORE WILL NOT HEAL, JAN OR FEB 2022 BLISTER AND SORE IN MOUTH FOR FIRST TIME
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| 2856269 | 0.25 | F | FL | 09/01/2025 |
IPV |
SANOFI PASTEUR |
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Crohn's disease, Food aversion, Fungal infection, Gastrooesophageal reflux ...
Crohn's disease, Food aversion, Fungal infection, Gastrooesophageal reflux disease, Vomiting projectile
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Severe projectile vomiting within 1 hour of the vaccine being given and for weeks following she had ...
Severe projectile vomiting within 1 hour of the vaccine being given and for weeks following she had vomiting and severe reflux. We had to see a pediatric GI specialist who prescribed medication(Zantac) to help treat the issue, however the issue is still currently ongoing following the vaccine and in addition to reflux she had chronic yeast that caused severe food aversions and allergies(peanut, other nuts etc and ultimately a few years ago she was diagnosed with Crohn's disease we believe is caused by the vaccine that caused years of gut issues she never recovered from.
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| 2856270 | 30 | M | CA | 09/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Computerised tomogram, Diverticulitis
Computerised tomogram, Diverticulitis
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Less than a month later, was hospitalized with acute diverticulitis. I?ve never had a history of GI...
Less than a month later, was hospitalized with acute diverticulitis. I?ve never had a history of GI issues, and had no family history of diverticulitis.
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| 2856271 | 36 | F | HI | 09/01/2025 |
TDAP TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
H4279 H4279 H4279 |
Arthralgia, Computerised tomogram, Impaired work ability, Injected limb mobility...
Arthralgia, Computerised tomogram, Impaired work ability, Injected limb mobility decreased, Injection site pain; Loss of personal independence in daily activities, Pain, Pain in extremity, Quality of life decreased, Scan with contrast; Sleep disorder
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Adverse Reaction Description: Following administration of the TDAP vaccine (Boostrix) in the left de...
Adverse Reaction Description: Following administration of the TDAP vaccine (Boostrix) in the left deltoid on 08/13/2025, I developed severe, persistent pain and loss of function in my left arm. Symptoms began 08/13/2025 shortly after the injection and have continued without improvement. Symptoms: ~ Constant, severe pain in the left deltoid and shoulder region, worsened by palpation or movement. ~ Pain radiates down the arm into the carpal region (wrist) and phalanges (fingers). ~ Inability to raise or rotate the left arm due to pain and restricted mobility. ~Difficulty or inability to perform everyday activities (lifting, reaching, dressing, work tasks). ~ Inability to sleep on the left side due to pain. ~Pain remains constant and has not improved over time. Functional Impact: ~Limited range of motion in the shoulder and arm. ~ Reduced ability to work and carry out activities of daily living. ~Persistent discomfort affecting rest, sleep, work and quality of life. Attempts at Follow-Up: I attempted to schedule a follow-up evaluation with the administering clinic soon after symptoms began. The clinic refused to provide an appointment, instead advising me to seek care at urgent care. I went to Urgent Care on 08/18/2025. At urgent care, I was informed that I should really be following up with the original administering clinic for evaluation and responsibility. I was only prescribed cyclobenzaprine, which I cannot take and safely work or drive as it gives me a hangover. When I eventually returned to the administering clinic, my concerns were dismissed without proper evaluation. Denial of Records: When I requested a copy of my Tdap vaccination record, the clinic staff refused to provide it to me, despite my explanation that it is part of my medical record and my legal right under HIPAA. Patients are entitled to full access to their own health records, and withholding this information not only violates my rights but also creates additional barriers to my ability to seek appropriate follow-up care and report my adverse reaction. I only received my vaccination record once I came to my scheduled follow-up exam on 08/27/2025 and threatened legal recourse if I was not given a copy of my vaccination record. Clinic Follow-Up: on 08/27/2025 ~Reported the pain and the loss of function of my left arm to the administering clinic. ~ My symptoms were not investigated, diagnosed, or properly documented. My concerns were completely disregarded ~No specialist referral was offered. I had to "beg" for imaging service, which they were reluctant to make for me; I quote they stated "this is not a normal request" ~The only prescription offered was pain medication (Gabapentin 100MG), which I cannot take safely while working or driving. I also did not want to take Gabapentin as it is just a nerve block and I wanted a diagnosis as to why I was experiencing such extreme pain and constant discomfort.. ~No guidance was given about reporting the adverse reaction or further evaluation. ~Concerns were dismissed without explanation of possible vaccine administration injury. A quote from Dr was " if the vaccine was wrongfully administered, what do you want me to do about it?"
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| 2856272 | 57 | M | OK | 09/01/2025 |
COVID19 |
MODERNA |
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Computerised tomogram, Headache, Magnetic resonance imaging
Computerised tomogram, Headache, Magnetic resonance imaging
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Have had a Headace now for 3 years 9 months it never goes away it started the day after the shot mos...
Have had a Headace now for 3 years 9 months it never goes away it started the day after the shot most times it ranges between a 5 and a 9
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| 2856273 | 52 | F | WA | 09/01/2025 |
FLU3 |
SANOFI PASTEUR |
ut8779ka |
Neuralgia
Neuralgia
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10 minutes after vaccination pt said that she felt nerve pain to her collar bone. Correct vaccine si...
10 minutes after vaccination pt said that she felt nerve pain to her collar bone. Correct vaccine site and technique used. Pt not concerned, but had a virtual doctor call and doctor said nerve must have been inadvertently hit and was unconcerned with lasting effects. Pt applied heat to site. Spoke with pt on 09/01/25 and she said pain had resolved.
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| 2856274 | 79 | M | FL | 09/01/2025 |
COVID19 |
MODERNA |
011L20A |
Arrhythmia, Cardiac disorder, Cardioversion, Loss of consciousness
Arrhythmia, Cardiac disorder, Cardioversion, Loss of consciousness
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Arrythmias, heart issues, passing out, cardioversion
Arrythmias, heart issues, passing out, cardioversion
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โ | |||||
| 2856275 | 34 | M | 09/01/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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Additional dose
Additional dose
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| 2856282 | 54 | F | SC | 09/01/2025 |
COVID19-2 COVID19-2 |
MODERNA MODERNA |
3046734 3046734 |
Chest discomfort, Chest pain, Dysgeusia, Flushing, Hyperhidrosis; Injection site...
Chest discomfort, Chest pain, Dysgeusia, Flushing, Hyperhidrosis; Injection site pain
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Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Meta...
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Metallic taste-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: PT complained of metallic taste. They also complained of sweating, flushing, and very mild chest tightness. We monitored pt and took her blood pressure(around 150/90) every 3 minutes for 30 minutes post vaccination. We did offer to call EMS, but pt declined. She left after those 30 minutes., Other Vaccines: VaccineTypeBrand: Moderna Spikevax; Manufacturer: Moderna; LotNumber: 3046734; Route: IM; BodySite: Left arm (deltoid); Dose: ; VaxDate: UNKNOWN
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| 2856283 | 78 | F | CA | 09/01/2025 |
COVID19 |
MODERNA |
3046714 |
Injected limb mobility decreased, Injection site pain
Injected limb mobility decreased, Injection site pain
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Site: Pain at Injection Site-Medium, Additional Details: After patient received vaccine, they descri...
Site: Pain at Injection Site-Medium, Additional Details: After patient received vaccine, they described a "burning" pain from below their shoulder area to around the elbow area which lasted around up to a day after injection. Patient says still difficult to lift arm or move around their arm currently.
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| 2856284 | 66 | F | CA | 09/01/2025 |
PNC21 |
MERCK & CO. INC. |
z003579 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: Fluzone High-dose; Manufacturer: Sanofi; LotNumber: u8764cb; Route: IM; BodySite: left arm; Dose: 1; VaxDate: 08/13/2025
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| 2856285 | 50 | M | AL | 09/01/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946889 |
Headache, Injection site pain, Malaise, Pain in extremity, Pyrexia
Headache, Injection site pain, Malaise, Pain in extremity, Pyrexia
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Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Additional Details...
Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Additional Details: pt said arm hurt and felt sick for 3 days. said he recovered and will only do 1 shot at a time in the future., Other Vaccines: VaccineTypeBrand: boostrix; Manufacturer: glaxosmithkline; LotNumber: pg3rp; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: shingrix; Manufacturer: glaxosmithkline; LotNumber: 5y4tl; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: capvaxive; Manufacturer: merck; LotNumber: z004301; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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| 2856287 | 38 | F | CT | 09/01/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Z008195 Z008195 |
Injection site abscess, Injection site erythema, Injection site pain, Injection ...
Injection site abscess, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction; Injection site swelling, Urticaria
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient contacted pharmacy to report redness, swelling, warmth and itching at injection site after administration of Varivax subcutaneously on 8/12/25. Asked patient to come into pharmacy to observe. Patient came into pharmacy and arm was visibly red, swollen, appeared to have welts at the injection site. Recommended patient go to Urgent care for further follow-up, intervention. Pt was not experiencing any difficulty breathing, etc. Explained to patient that Pharmacist would fill out VAERS.
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| 2856288 | 72 | M | NJ | 09/01/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3046734 3046734 |
Abdominal pain, Colonoscopy normal, Culture stool, Frequent bowel movements, Inf...
Abdominal pain, Colonoscopy normal, Culture stool, Frequent bowel movements, Inflammation; Injection site erythema
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Site: Redness at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: gut inflammation, c...
Site: Redness at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: gut inflammation, cramping,frequent bm with cramps,-Medium, Additional Details: no changes in diet, colonoscopy showed no inflammation noted on 06-25, fecal test was performed after vaccination
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| 2856289 | 33 | M | NC | 09/01/2025 |
FLUC4 |
SEQIRUS, INC. |
406981 |
Injection site bruising, Injection site haemorrhage, Injection site swelling
Injection site bruising, Injection site haemorrhage, Injection site swelling
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Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Af...
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: After receiving the flu shot, patient had blood come out of his arm, and then a blue bruise formed. I checked again, after giving vaccines to his family member, and the bruising seemed to have gone down some. I told the patient sometimes this can occur, and I told him to monitor his arm. , Other Vaccines: VaccineTypeBrand: pfizer covid; Manufacturer: pfizer; LotNumber: mr6639; Route: IM; BodySite: left arm; Dose: ; VaxDate: 08/16/2025
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| 2856290 | 59 | M | AL | 09/01/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
not known not known |
Arthralgia, Fatigue, Feeding disorder, Lethargy, Malaise; Pain
Arthralgia, Fatigue, Feeding disorder, Lethargy, Malaise; Pain
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Systemic: Exhaustion / Lethargy-Mild, Systemic: Joint Pain-Mild, Additional Details: pt was asked if...
Systemic: Exhaustion / Lethargy-Mild, Systemic: Joint Pain-Mild, Additional Details: pt was asked if wanted a vaccine. he said last time he took two shots here was sick for 7 days. had aches and pain, could not eat. shot is so old i cannot pull up anything, but pt wanted it documented., Other Vaccines: VaccineTypeBrand: flucelvax; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2856291 | 50 | F | CT | 09/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
99d52 |
Herpes zoster, Rash
Herpes zoster, Rash
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Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient reports shingles outbreak f...
Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient reports shingles outbreak following administration
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| 2856292 | 28 | F | WA | 09/01/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
4T93R |
Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flus...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
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| 2856294 | 73 | M | GA | 09/01/2025 |
FLU4 |
SANOFI PASTEUR |
ut8763ga |
Injection site erythema, Injection site pain, Injection site pruritus
Injection site erythema, Injection site pain, Injection site pruritus
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
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| 2856295 | 68 | F | FL | 09/01/2025 |
FLU4 |
SANOFI PASTEUR |
UT8763GA |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: The...
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: The patient said that she has had redness/swelling before with different vaccines but never with the flu shot before. This redness/swelling was also over a larger area (moved down her arm towards her elbow). She happened to be seeing the doctor after the vaccination and the doctor noticed it. She thought there might be an infection present so the doctor prescribed cephalexin and told the patient to notify the pharmacy of the reaction., Other Vaccines: VaccineTypeBrand: Moderna COVID Spikevax; Manufacturer: Moderna; LotNumber: 3045224; Route: IM; BodySite: R Arm; Dose: 1; VaxDate: 07/16/2025, VaccineTypeBrand: Prevnar 20; Manufacturer: Wyeth/Pfizer; LotNumber: LK6655; Route: IM; BodySite: L Arm; Dose: 1; VaxDate: 07/16/2025
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| 2856296 | 54 | F | CA | 09/01/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
946907 946907 |
Asthenia, Confusional state, Dizziness, Fatigue, Headache; Injection site pain, ...
Asthenia, Confusional state, Dizziness, Fatigue, Headache; Injection site pain, Lethargy, Nausea, Pyrexia, Vomiting
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Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-S...
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Medium, Systemic: Weakness-Severe, Additional Details: patient had administered wegovy prior to coming in for the appointment where she received both capvaxive and heplisa b. Pt had never had any reactions from vaccines or wegovy individually, but believes the combo of all three injections on the same day caused side effects of wegovy to manifest. Patient is still recovering, still very weak. , Other Vaccines: VaccineTypeBrand: CAPVAXIVE; Manufacturer: ; LotNumber: Y019158; Route: IM; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: WEGOGY; Manufacturer: ; LotNumber: ; Route: SC; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2856298 | 19 | F | VA | 09/01/2025 |
FLUC4 |
SEQIRUS, INC. |
406983 |
Fatigue, Syncope, Unresponsive to stimuli
Fatigue, Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Medium, Additional Details: Vaccine administered per (name withhel...
Systemic: Fainting / Unresponsive-Medium, Additional Details: Vaccine administered per (name withheld) Clinic protocol by staff. Patient felt well prior to leaving examination room after appropriate waiting period. Patient ambulated to lobby and reported to her mother she felt "tired." Patient's family member notified staff; Staff and provider responded to patient and upon arriving in lobby, patient sitting in the chair and patient was assisted to ground as patient appeared pale. Ptexperienced no injury. VSS throughout. Recovered well within 1 minute and monitored
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| 2856299 | 83 | F | IL | 09/01/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5F5XK |
Injection site erythema, Injection site pain, Injection site swelling, Rash
Injection site erythema, Injection site pain, Injection site swelling, Rash
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Additional Details: Patient presented in pharmacy following visit at md with swelling and redness on arm where injection occured. MD gave patient prescription for antibiotic.
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| 2856300 | 65 | F | MD | 09/01/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3046714 3046714 |
Fatigue, Injection site bruising, Injection site erythema, Injection site pain, ...
Fatigue, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus; Lethargy, Rash
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Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection...
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Exhaustion / Lethargy-Severe, Other Vaccines: VaccineTypeBrand: AREXVY (10-PK) KIT; Manufacturer: GLAXOSMITHKLINE; LotNumber: 957DA; Route: IM; BodySite: RIGHT ARM; Dose: 1; VaxDate: 08/12/2025
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| 2856301 | 48 | M | MD | 09/01/2025 |
FLUC4 |
SEQIRUS, INC. |
406982 |
Injection site bruising, Injection site swelling
Injection site bruising, Injection site swelling
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Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines: Vacci...
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: BOOSTRIX TDAP VACCINE SYRINGE BOOSTER SYRINGE; Manufacturer: GLAXOSMITHKLINE; LotNumber: 37F34; Route: IM; BodySite: LEFT ARM; Dose: 1; VaxDate: 08/17/2025, VaccineTypeBrand: HEPLISAV-B 20 MCG/0.5 ML SYRINGE MULTI DOSE; Manufacturer: DYNAVAX TECH CORP; LotNumber: 946908; Route: IM; BodySite: LEFT ARM; Dose: 2; VaxDate: 08/17/2025
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| 2856302 | 63 | M | FL | 09/01/2025 |
RSV |
PFIZER\WYETH |
me5461 |
Joint injury
Joint injury
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines: VaccineTypeBrand: sh...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines: VaccineTypeBrand: shingrix ( rx#withheld); Manufacturer: glaxosmitjkline; LotNumber: 990d52; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
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| 2856303 | 71 | F | NC | 09/01/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
99D52 |
Injection site swelling, Pruritus, Rash, Urticaria, Visual impairment
Injection site swelling, Pruritus, Rash, Urticaria, Visual impairment
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Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic:...
Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Severe, Systemic: HIVES FROM HANDS TO ARMS-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: PATIENT CALLED A FEW DAYS AFTER RECEIVING VACCINE WITH COMPLAINT OF HIVES ON ARMS AND CALLED AGAIN ON 08/15/25 WITH CONTINUED REACTION OF HIVES SPREADING ON ARMS, Other Vaccines: VaccineTypeBrand: SHINGRIX; Manufacturer: GLAXOSMITHKLINE; LotNumber: 99D52; Route: INTRAMUSCULAR; BodySite: RIGHT DELTOID; Dose: 2; VaxDate: 07/24/2025
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| 2856304 | 32 | F | CA | 09/01/2025 |
HPV9 |
MERCK & CO. INC. |
Y020464 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: Flucelvax; Manufacturer: ...
Systemic: Fainting / Unresponsive-Mild, Other Vaccines: VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus, Inc.; LotNumber: 406984; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 08/16/2025
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| 2856305 | 44 | F | CA | 09/01/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
946908 |
Dizziness
Dizziness
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Systemic: Dizziness / Lightheadness-Medium
Systemic: Dizziness / Lightheadness-Medium
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| 2856309 | 46 | F | MA | 09/01/2025 |
FLUC4 |
SEQIRUS, INC. |
406982 |
Erythema, Pruritus, Rash, Skin warm, Urticaria
Erythema, Pruritus, Rash, Skin warm, Urticaria
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Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (speci...
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: several hours after vaccine patient experienced itchy, red, hot, large hives all over legs and ankles. resolves mostly with benedryl use.
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| 2856310 | 64 | F | SC | 09/01/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
K73J3 K73J3 |
Injection site bruising, Injection site erythema, Injection site induration, Inj...
Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus; Injection site swelling, Joint injury, Product administered at inappropriate site
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Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injec...
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Spouse stated that vaccine was given below deltoid, closer to elbow of the right arm; area was bulging, red, hard, and itching; spouse took patient to ER on 8/17/25; Vaccine given on 8/14/25
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| 2856311 | 50 | F | TX | 09/01/2025 |
PNC20 |
PFIZER\WYETH |
lx4486 |
Injection site swelling
Injection site swelling
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Site: Swelling at Injection Site-Mild, Systemic: Raised bump that looks like a burn at injection sit...
Site: Swelling at Injection Site-Mild, Systemic: Raised bump that looks like a burn at injection site.-Mild
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| 2856312 | 65 | F | NC | 09/01/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
957d4 |
Injection site bruising, Injection site cellulitis, Injection site erythema, Inj...
Injection site bruising, Injection site cellulitis, Injection site erythema, Injection site swelling
More
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Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at I...
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient had signifcant bruising and redness at injection site, MD gave her antibiotic for cellulitis
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| 2856313 | 54 | F | NV | 09/01/2025 |
FLUC4 |
SEQIRUS, INC. |
406984 |
Heart rate decreased, Loss of consciousness, Syncope, Unresponsive to stimuli
Heart rate decreased, Loss of consciousness, Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Medium, Additional Details: After the Flu shot was given, the Pati...
Systemic: Fainting / Unresponsive-Medium, Additional Details: After the Flu shot was given, the Patient sprung back arching their back over the back of the chair and then fainted, sliding down to the floor. Patient was unconscious for about 5 seconds, then came back to alert and responsive. Her heart rate was low after the shot, no history of any heart conditions, does have a history of hypoglycemia. Paramedics came and found all her vitals normalized and recommended she see her pcp. , Other Vaccines: VaccineTypeBrand: Tdap, Boostrix; Manufacturer: GLAXOSMITHKLINE; LotNumber: h4279; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
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