| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2862131 | 80 | F | MN | 09/29/2025 |
COVID19 |
PFIZER\BIONTECH |
na0587 |
Throat tightness
Throat tightness
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Patient states after returning home following vaccination she felt throat tightening. Husband broug...
Patient states after returning home following vaccination she felt throat tightening. Husband brought her to hospital where she was treated
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| 2862132 | 41 | F | IL | 09/29/2025 |
TDAP TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
PD324 PD324 PD324 |
Arthralgia, Asthenia, Balance disorder, Cough, Headache; Injection site swelling...
Arthralgia, Asthenia, Balance disorder, Cough, Headache; Injection site swelling, Malaise, Neck pain, Pain in jaw, Pallor; Somnolence, Vomiting
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About 10 minutes after the vaccine the patient began to cough a little bit. I (Senior Clinic Directo...
About 10 minutes after the vaccine the patient began to cough a little bit. I (Senior Clinic Director and an RN) was observing the patient and asked if she was okay. She said she was fine. In another 10-15 minutes the patient vomited and walked up to me appearing weak and unstable. Pt was assisted to the closest exam table and lay down. She stated her head hurt and she pointed to her collarbone, neck and jaw and stated she had pain. The doctor was called in to see assess the patient and vitals were taken. It was difficult to get a blood pressure reading while sitting up. In supine position BP 110/70, BS 12 and pulse ox 100% RA, HR 78. She was alert, site of vaccine had minimal swelling. After observing her for 20 min and having her drinking fluid she started vomiting again and was not feeling better, she remained very pale and drowsy. It was then decided to have her go to the ER.
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| 2862133 | 64 | F | PA | 09/29/2025 |
FLU3 |
SEQIRUS, INC. |
407245 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient was given a vaccination for those over 65 years of age, despite not being 65 years of age. ...
Patient was given a vaccination for those over 65 years of age, despite not being 65 years of age. No adverse events actually reported
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| 2862134 | 12 | M | TN | 09/29/2025 |
HPV9 MNQ |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
Z007847 AMVB079A |
Erythema, Skin warm; Erythema, Skin warm
Erythema, Skin warm; Erythema, Skin warm
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This is the patient's first Meningococcal vaccination and second HPV vaccination. The Meningoco...
This is the patient's first Meningococcal vaccination and second HPV vaccination. The Meningococcal vaccination was given in the left arm. The HPV vaccination was given in the right arm. Patient had vaccinations on 09/25/2025 after 03:30PM. Patient noticed left arm getting red, and hot to the touch on 09/26/2025 around 09:00AM. The patient's mother contacted the clinic at 03:05PM. LPN informed Dr. of the symptoms occurring. The nurse informed the patient's mom to give 200 mg ibuprofen and a Claritin 10 mg or Zyrtec 5 mg. If he gets super itchy, then you can give him 12.5 mg of Benadryl on top of that. Mother also applied hydrocortisone cream for itchiness. The patient's mother then noticed the right arm on 09/28/2025 around 09:00AM. The right has been red and hot. The patient's mother continued with course of treatment as recommended.
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| 2862135 | 09/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Eye swelling, Herpes zoster, Pain, Vaccination failure
Eye swelling, Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; I have shingles now in the right side of my face and head; eye swolle...
Suspected vaccination failure; I have shingles now in the right side of my face and head; eye swollen; head hurts like crazy; 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: Suspected vaccination failure) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: I have shingles now in the right side of my face and head), eye swelling (Verbatim: eye swollen) and headache (Verbatim: head hurts like crazy). The outcome of the vaccination failure, eye swelling and headache were not reported and the outcome of the facial herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure, facial herpes zoster, eye swelling and headache 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 facial herpes zoster, eye swelling and headache to be related to Shingles vaccine. Additional Information: GSK receipt date :19-SEP-2025 and 20-SEP-2025 The case was received from the patient via interactive digital media. The patient had shingles now in the right side of face and head and had the vaccines, it did not help to him/her. The patient reported that the way mine was eye swollen head hurts like crazy he/she The patient did not know to get the new singles shot or not. The patient wants to be asked could get shingles two time. 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: A case of Vaccination failure, unknown time after receiving Shingles vaccine in patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2862136 | 09/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
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Herpes zoster
Herpes zoster
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Shingles; This non-serious case was reported by a consumer via interactive digital media and describ...
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-SEP-2025 The patient received Shingles vaccine and had a case of shingles within 2 weeks, but went ahead and had the 2nd vaccine of Shingles 2 months later.
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| 2862137 | 74 | F | CO | 09/29/2025 |
COVID19 |
MODERNA |
024M20A |
Hodgkin's disease, Underdose
Hodgkin's disease, Underdose
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Received booster dose (0.25 ml) instead of 3rd primary series dose (0.5 ml).; Hodgkin's lymphom...
Received booster dose (0.25 ml) instead of 3rd primary series dose (0.5 ml).; Hodgkin's lymphoma; This spontaneous case was reported by a consumer and describes the occurrence of HODGKIN'S DISEASE (Hodgkin's lymphoma) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .25 milliliter. On 25-Mar-2021, the patient experienced HODGKIN'S DISEASE (Hodgkin's lymphoma) (seriousness criterion medically significant). On 18-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced UNDERDOSE (Received booster dose (0.25 ml) instead of 3rd primary series dose (0.5 ml).). At the time of the report, HODGKIN'S DISEASE (Hodgkin's lymphoma) was resolving and UNDERDOSE (Received booster dose (0.25 ml) instead of 3rd primary series dose (0.5 ml).) outcome was unknown. Concomitant drugs were not reported. Treatment details included chemotherapy. The patient stated she was diagnosed with Hodgkin's lymphoma on 25Mar2021. She reported she started chemotherapy treatment in April 2021. Her last chemotherapy treatment was either in June or July 2021. She stated that her cancer went into remission after the chemotherapy treatments. The patient reported she considered herself immunocompromised at the time when she received her Moderna booster dose on 18Aug2021 due to the cancer diagnosis and chemotherapy treatments. The patient stated that the adverse events were not due to any of three doses. This case was linked to MOD-2022-511169 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2022: Upon internal review significant corrections were performed on 29-Aug-2025 after which the case was reassessed and determined to be valid. On 06-Apr-2022: Follow up received information added to I narrative supplement; Reporter's Comments: Hodgkin's lymphoma was assessed as not related to Moderna COVID vaccine due to very short latency. Company causality for underdose is not applicable. The benefit-risk relationship of product is not affected by this report.
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| 2862138 | 67 | M | 09/29/2025 |
COVID19-2 |
MODERNA |
057F22A |
COVID-19, Circumstance or information capable of leading to medication error
COVID-19, Circumstance or information capable of leading to medication error
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he "gets COVID like its nothing and in spite of all of the vaccinations; He says on his app it ...
he "gets COVID like its nothing and in spite of all of the vaccinations; He says on his app it says 999 mL but that doesn't make sense. "That's impossible, 999 mil milliliters that, that cannot be the dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he "gets COVID like its nothing and in spite of all of the vaccinations) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He says on his app it says 999 mL but that doesn't make sense. "That's impossible, 999 mil milliliters that, that cannot be the dose) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (he "gets COVID like its nothing and in spite of all of the vaccinations) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He says on his app it says 999 mL but that doesn't make sense. "That's impossible, 999 mil milliliters that, that cannot be the dose). At the time of the report, COVID-19 (he "gets COVID like its nothing and in spite of all of the vaccinations) had resolved and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He says on his app it says 999 mL but that doesn't make sense. "That's impossible, 999 mil milliliters that, that cannot be the dose) outcome was unknown. No concomitant drug was reported. The patient had no relevant medical conditions and that he was kind of healthy. The patient got COVID like it was nothing and despite all of the vaccinations, he always gets it. He was fully boosted last time he got COVID. He presented a paper at a conference and by the time he was on the plane, he was shaking, he got COVID. It hit him for 2-3 days bad and after that, it was very quick. He stated that most people who got lucky with COVID, right, when get it, hits hard, lasts a day or two, and then goes away very quickly, and that was exactly how it happened to him. He plays a lot of sports, so he noticed that he had a little bit of shortness of breath for a month or two. It was a long time ago and everything was recovered at the time of reporting. It was unknown if the patient experienced any additional symptoms/events. No treatment drug was reported. This case was linked to MOD-2025-789627 (Patient Link).
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| 2862139 | 62 | F | 09/29/2025 |
COVID19 |
MODERNA |
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Headache
Headache
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having a headache since the day after she received the vaccine/Headache is ongoing/constant; This sp...
having a headache since the day after she received the vaccine/Headache is ongoing/constant; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (having a headache since the day after she received the vaccine/Headache is ongoing/constant) in a 62-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer; for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included Headache with Pfizer and Spikevax NOS. On 17-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 18-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced HEADACHE (having a headache since the day after she received the vaccine/Headache is ongoing/constant). The patient was treated with Paracetamol (Tylenol) in September 2025 for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (having a headache since the day after she received the vaccine/Headache is ongoing/constant) had not resolved. No concomitant medication was reported. The patient had a variety of Moderna and Pfizer in the past and had a headache that's just not stopping. She had been having a headache since the day after she received the vaccine. She was pretty laid out, thought she had a migraine, took migraine medicine, and it didn't work like it always works, though it was probably a reaction to the vaccine. Headache was ongoing/constant, and patient was taking Tylenol and NSAIDs. It was almost as if the patient ever had the flu, where the head felt heavy, and it hurt. Headache was also described as unrelenting. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789597, US-MODERNATX, INC.-MOD-2025-789603 (E2B Linked Report). This case was linked to MOD-2025-789596 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789597:Husband's case US-MODERNATX, INC.-MOD-2025-789603:Husband case
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| 2862140 | 82 | F | MA | 09/29/2025 |
COVID19 |
MODERNA |
3052036 |
Electrocardiogram, Urticaria
Electrocardiogram, Urticaria
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2 inch round bright pink harder lump on her arm from it/to itch a little the night of the shot; This...
2 inch round bright pink harder lump on her arm from it/to itch a little the night of the shot; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (2 inch round bright pink harder lump on her arm from it/to itch a little the night of the shot) in an 82-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052036) for COVID-19 prophylaxis. Concurrent medical conditions included Iritis, Arthritis, Spinal stenosis, Allergy to animal (dog and cat), Grass allergy (various grasses), IBD and Colitis. On 17-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 17-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced URTICARIA (2 inch round bright pink harder lump on her arm from it/to itch a little the night of the shot). At the time of the report, URTICARIA (2 inch round bright pink harder lump on her arm from it/to itch a little the night of the shot) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: EKG showed something with the left ventricle possible causes. The Patient received allergy shot to avoid allergic reaction from dog, cat and various grasses as concomitant medication on Sep-2025 and she received the allergy shot two and half week prior to vaccination. It was reported that patient has iritis so she must take ketorolac. The patient had another scheduled for allergy shot week after vaccination. The patient should have a stress test because the EKG showed for the patient something with the left ventricle possible causes. But the patient avoided stress test because she thought that there was a 1 in 5000 risk of dying from the test. The patient got a 2 inch round bright pink harder lump on her arm from the MNEXSPIKE PFS vaccination, and she did not have that symptom with other covid-19 vaccines. The patient still had a semi-hard 2 inch by 1- and 1/2-inch allergic bright pink thing swelling on her upper arm. It was reported that the patient did not have those symptoms before, and it was interpreted that this shot must have added something different. It was reported that post vaccination swelling on her upper arm started to itch a little the night of the shot and there was about a 1-inch pink thing there, but then the next day it was 2 inches, and it turned as itchier and harder, but not soft. It was now finally got a little less hard, but it was still firm and still bright pink. The Patient put off her allergy shot for another week due to the symptom. No treatment medications provided by the reporter. This case was linked to MOD-2025-789602 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2025: Live significant follow-up received in which suspect product lot number was added and new reference number was added.; Reporter's Comments: Concurrent medical condition several allergies are confounders for the event. The benefit -risk relationship of product is not affected by this report.
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| 2862141 | 67 | M | 09/29/2025 |
COVID19 |
MODERNA |
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COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
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shaking/shortness of breath/ got COVID; This spontaneous case was reported by a consumer and describ...
shaking/shortness of breath/ got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (shaking/shortness of breath/ got COVID) in a 67-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (shaking/shortness of breath/ got COVID). At the time of the report, COVID-19 (shaking/shortness of breath/ got COVID) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2025, SARS-CoV-2 test: he swabbed his nostrils and plugged it back in and the line appeared immediately - in 2-3 seconds it became a red line. This was in either February or March of 2025. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant drug was reported. The patient had no relevant medical conditions, and he was kind of healthy. The patient got COVID like it was nothing and despite all of the vaccinations, he always gets it. He was fully boosted last time he got COVID. He presented a paper at a conference and by the time he was on the plane, he was shaking, he got COVID. It hit him for 2-3 days bad and after that, it was very quick. He plays a lot of sports, so he noticed that he had a little bit of shortness of breath for a month or two. It was a long time ago and everything was recovered at the time of reporting. It was unknown if the patient experienced any additional symptoms/events. No treatment drug was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789629 (E2B Linked Report). This case was linked to MOD-2025-789648 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789629:Mother case
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| 2862142 | 75 | F | 09/29/2025 |
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 75-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. In 2025, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. The concomitant medication was not reported by the reporter. The patient had COVID at the end of July and the beginning of August this year. She mentioned that she had received all her COVID-19 vaccines. She said the first ones were Moderna, and then subsequently she got whatever was available at the pharmacy. She added that it was the first time she had ever had COVID since it came out, so she was surprised to get it. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.
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| 2862144 | 09/29/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Atlantoaxial instability, Dizziness, Eagle's syndrome, Gastrointestinal dis...
Atlantoaxial instability, Dizziness, Eagle's syndrome, Gastrointestinal disorder, Head discomfort; Laboratory test, May-Thurner syndrome, Paraesthesia, Visual impairment
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head pressure; visual orbs; tingling; dizzy; gi issues; cci; vascular eagles; may thurner; This is a...
head pressure; visual orbs; tingling; dizzy; gi issues; cci; vascular eagles; may thurner; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "have chiari" (ongoing), notes: was decompressed in 2018; "chiari was decompressed", start date: 2018, stop date: 2018, notes: was decompressed in 2018. The patient's concomitant medications were not reported. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "head pressure"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "visual orbs"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "gi issues"; ATLANTOAXIAL INSTABILITY (non-serious), outcome "unknown", described as "cci"; EAGLE'S SYNDROME (non-serious), outcome "unknown", described as "vascular eagles"; MAY-THURNER SYNDROME (non-serious), outcome "unknown", described as "may thurner". The events "head pressure", "visual orbs", "tingling", "dizzy" and "gi issues" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Chat question Verbatim 1: Patients neck and shoulders had been killing so much more lately. More head pressure, visual orbs, tingling, dizzy, gi issues, etc. felt like patient getting worse but have exhausted ERs as all labs are "normal". Nights and mornings are the worst. Tonight keep jolting awake, it feels like patients neck slips Chat question Verbatim 2: full history, had chiari, was decompressed in 2018. After the covid vaccine and each covid infection making patient worse had found cci, vascular eagles, may thurner, pots or similar, mcas or similar, anaplasmosis, reactivated mono, small vessel on brainstem, loss of lordotic curve, me/cfs. Mo Chat question Verbatim 3: Doctor recommendations, anyone that truly understands these issues: Patient getting worse rapidly. Chat question Verbatim 4: Any tips to get sleep tonight with all the symptoms patient having Chat question Verbatim 5: All of this is too much and terrifying. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2862145 | F | 09/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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She has covid from her shot; She has covid from her shot; This is a spontaneous report received from...
She has covid from her shot; She has covid from her shot; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She has covid from her shot". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2862146 | M | 09/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Genital infection fungal, Investigation, Penis disorder
Genital infection fungal, Investigation, Penis disorder
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Extremely heavy genital yeast infections; Stinky penis head; This is a spontaneous report received f...
Extremely heavy genital yeast infections; Stinky penis head; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENITAL INFECTION FUNGAL (non-serious), outcome "unknown", described as "Extremely heavy genital yeast infections"; PENIS DISORDER (non-serious), outcome "unknown", described as "Stinky penis head". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: When again requested adverse event, consumer stated, "Yes and then I will explain what my Doctor said. So, a couple of days after receiving the COVID Vaccine., I started to deal with extremely heavy genital yeast infections." Further consumer stated, "Okay, so when I saw my Doctor she saw that it was necessary to do a genital examination. During the genital examination she had noticed that I was uncircumcised and she was also concerned because she did not think I so any sort of cleaning and she was also concerned because the foreskin need to go all the way back. She was telling me that I have very stinky penis head." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2862147 | 09/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Genital infection fungal
Genital infection fungal
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Extremely heavy genital yeast infections; This is a spontaneous report received from a Consumer or o...
Extremely heavy genital yeast infections; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENITAL INFECTION FUNGAL (non-serious), outcome "unknown", described as "Extremely heavy genital yeast infections". The event "extremely heavy genital yeast infections" required physician office visit. Additional information: Consumer stated, before I explain that I just want like to let you know that I had been to my doctor about it and she wanted me to provide some information that she gathered. Do you want me to explain the adverse event that what she said. So, I started to experience like extremely heavy genital yeast infections and a lot of redness and irritation and itchiness. Do you want me to provide the information that my doctor provided with me. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2862148 | 56 | M | 09/29/2025 |
PNC20 |
PFIZER\WYETH |
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Fatigue, Headache, Pain in extremity, Somnolence
Fatigue, Headache, Pain in extremity, Somnolence
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minor headache; pain in arm; drowsiness; fatigue; This is a spontaneous report received from a Consu...
minor headache; pain in arm; drowsiness; fatigue; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 23Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left deltoid for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NAPROXEN, start date: 14Sep2025, stop date: 14Sep2025. The following information was reported: SOMNOLENCE (non-serious) with onset 23Sep2025 at 19:00, outcome "not recovered", described as "drowsiness"; FATIGUE (non-serious) with onset 23Sep2025 at 19:00, outcome "not recovered"; HEADACHE (non-serious) with onset 23Sep2025 at 19:00, outcome "not recovered", described as "minor headache"; PAIN IN EXTREMITY (non-serious) with onset 23Sep2025 at 19:00, outcome "not recovered", described as "pain in arm". Therapeutic measures were not taken as a result of headache, pain in extremity, somnolence, fatigue. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2862149 | F | 09/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Headache
Chills, Headache
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The patient had lots of chills and a headache. She reported she felt bad for 36 hours; The patient h...
The patient had lots of chills and a headache. She reported she felt bad for 36 hours; The patient had lots of chills and a headache. She reported she felt bad for 36 hours; This is a spontaneous report received from a Consumer or other non HCP. A 37-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in Sep2025 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), HEADACHE (non-serious) all with onset Sep2025, outcome "recovered" (Sep2025) and all described as "The patient had lots of chills and a headache. She reported she felt bad for 36 hours". It was unknown if therapeutic measures were taken as a result of chills, headache. Additional information: The hospitalization Prolonged was reported as no. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2862151 | F | 09/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Erythema, Flushing, Rash, Urticaria
Erythema, Flushing, Rash, Urticaria
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flush; hives; rash; redness; This is a spontaneous report received from a Consumer or other non HCP....
flush; hives; rash; redness; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19Sep2025 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergic to hornets" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Allergy". The following information was reported: FLUSHING (non-serious) with onset 20Sep2025 at 19:00, outcome "recovered" (25Sep2025), described as "flush"; URTICARIA (non-serious) with onset 20Sep2025 at 19:00, outcome "recovered" (25Sep2025), described as "hives"; RASH (non-serious) with onset 20Sep2025 at 19:00, outcome "recovered" (25Sep2025); ERYTHEMA (non-serious) with onset 20Sep2025 at 19:00, outcome "recovered" (25Sep2025), described as "redness". Therapeutic measures were not taken as a result of flushing, urticaria, rash, erythema. Additional information: Reason why batch/lot was unknown: Unable to locate or read the details; facility where vaccine was administered: Doctor's office/urgent care; the patient did not receive any other vaccines on the same date as the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not taking any other medications within 2 weeks of the event starting. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2862152 | 68 | F | KS | 09/29/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Asthenia, Fatigue, Headache, Pain, Pyrexia; Thirst, Vaccination site pain
Asthenia, Fatigue, Headache, Pain, Pyrexia; Thirst, Vaccination site pain
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Fever; weakness; fatigue; headache; soreness at injection sight; general all-over body aches; extrem...
Fever; weakness; fatigue; headache; soreness at injection sight; general all-over body aches; extreme thirst; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 24Sep2025 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "obesity" (unspecified if ongoing); "gastric reflux" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; OMEPRAZOLE; SEMAGLUTIDE, start date: 19Apr2025. The following information was reported: PYREXIA (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "Fever"; THIRST (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "extreme thirst"; FATIGUE (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered"; PAIN (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "general all-over body aches"; HEADACHE (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered"; VACCINATION SITE PAIN (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "soreness at injection sight"; ASTHENIA (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "weakness". Therapeutic measures were taken as a result of pyrexia, asthenia, fatigue, headache, vaccination site pain, pain, thirst. Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. The patient was taking any other medications within 2 weeks of the event starting. The Pt was received treatment Advil for the adverse events. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2862154 | 59 | M | OR | 09/29/2025 |
FLU3 |
SANOFI PASTEUR |
UT8858KA |
Diarrhoea, Myalgia, Pyrexia
Diarrhoea, Myalgia, Pyrexia
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watery stool, fever, myalgia, within 36hrs of administration of vaccine, symptoms lasting 48hrs. tyl...
watery stool, fever, myalgia, within 36hrs of administration of vaccine, symptoms lasting 48hrs. tylenol and ibuprofen
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| 2862155 | 46 | M | AR | 09/29/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
2Y393 |
Immediate post-injection reaction, Injection site pain, Pain
Immediate post-injection reaction, Injection site pain, Pain
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Immediate pain at injection site, which got worse over the next 20 days. Patient would feel signific...
Immediate pain at injection site, which got worse over the next 20 days. Patient would feel significant pain when exercising, walking, running, or any type of movement. Patient states it did not feel like normal injection site pain following other immunizations. Pain was constant, not waning or throbbing. Patient's pain resolved after about 3 weeks.
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| 2862156 | 32 | F | 09/29/2025 |
VARCEL |
MERCK & CO. INC. |
X004246 |
Dyspnoea, Injection site haemorrhage
Dyspnoea, Injection site haemorrhage
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Bleeding at site administration> resolved with direct pressure and band-aide. Moderate local reac...
Bleeding at site administration> resolved with direct pressure and band-aide. Moderate local reaction several hours later. Responded to Benadryl. A couple of days later, called clinic and reported that she felt SOB at times. Advised to seek medical care at Urgent Care. Returned to work per supervisor.
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| 2862157 | 88 | F | PA | 09/29/2025 |
RSV |
PFIZER\WYETH |
MG2195 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No adverse reaction reported. Vaccine was administered. Upon billing the claim, we reviewed a rejec...
No adverse reaction reported. Vaccine was administered. Upon billing the claim, we reviewed a rejection stating that vaccine was already billed on 12/19/2023.
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| 2862158 | 4 | F | WI | 09/29/2025 |
VARCEL |
MERCK & CO. INC. |
X025846 |
Immediate post-injection reaction, Injection site erythema, Injection site infla...
Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Pruritus
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pt complained of itching immediately following the vaccine. Site became red and inflamed. Provider...
pt complained of itching immediately following the vaccine. Site became red and inflamed. Provider was notified immediately and evaluated pt. Pt was given 10ml of Zyrtec which mother had along with her. Inflammation was traced in skin marker, ice pack applied. Pt remained in clinic for over 30 minutes, closely monitored. Redness subsided quickly and pt was no longer complaining of itching. No breathing or cardiac concerns. Pt sent home with parent with no ongoing complications
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| 2862159 | 51 | M | WI | 09/29/2025 |
FLU3 |
SANOFI PASTEUR |
U8832AA |
Hyperhidrosis, Somnolence
Hyperhidrosis, Somnolence
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Asked for Covid Vaccine. Was given Flublok. Patient had stated anaphylaxis to flu vaccine. Assessed....
Asked for Covid Vaccine. Was given Flublok. Patient had stated anaphylaxis to flu vaccine. Assessed. Became sleepy and sweaty. Lungs clear no itching of throat, lungs clear, vss. Not able to check blood glucose of db pt. EMS called and transported. Benadryl given in ER as well as Pepcid.
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| 2862160 | 56 | F | AZ | 09/29/2025 |
FLU3 HEP PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
4F2AJ 42B22 MA2502 |
Underdose; Underdose; Underdose
Underdose; Underdose; Underdose
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Patient was given pediatric Hep B dose instead of adult dose.
Patient was given pediatric Hep B dose instead of adult dose.
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| 2862161 | 73 | F | FL | 09/29/2025 |
PNC20 |
PFIZER\WYETH |
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Peripheral swelling
Peripheral swelling
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arm swelling
arm swelling
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| 2862162 | 67 | F | WI | 09/29/2025 |
COVID19 VARZOS |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
NA0738 9L944 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient asked for SHINGLES vaccine. Administered SHINGLES vaccine. Found out she already completed...
Patient asked for SHINGLES vaccine. Administered SHINGLES vaccine. Found out she already completed series. No reaction reported.
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| 2862163 | 0.5 | F | CA | 09/29/2025 |
DTAPHEPBIP PNC20 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH |
TE499 LP4946 |
Rash, Urticaria; Rash, Urticaria
Rash, Urticaria; Rash, Urticaria
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Few minutes post-vaccination patient developed an urticarial rash on the upper nape, Rt side of face...
Few minutes post-vaccination patient developed an urticarial rash on the upper nape, Rt side of face and back. This reaction occurred within minutes of the administration of vaccines. The rash resolved within the 20 minutes of observation. Provider ordered Cetirizine PRN.
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| 2862164 | 49 | F | WI | 09/29/2025 |
FLU3 |
SANOFI PASTEUR |
U8832AA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Requested Covid Vaccine. Flublok given. History of high temps post Flu vaccine as a child so she doe...
Requested Covid Vaccine. Flublok given. History of high temps post Flu vaccine as a child so she doesn't receive them anymore. Notified primary care physican. PCP stated will follow up. Teaching done. Husband in ER for his Flu shot see (name withheld) and she accompanied him. Follow up call at 15:07 Patient stated no temperature increase and that she is feeling good.
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| 2862165 | 73 | F | TX | 09/29/2025 |
FLU3 |
SANOFI PASTEUR |
U8800AA |
Peripheral swelling, Urticaria
Peripheral swelling, Urticaria
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Patient reported swelling of the arm and hives on the left arm where shot was given
Patient reported swelling of the arm and hives on the left arm where shot was given
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| 2862182 | 12 | F | UT | 09/29/2025 |
HPV9 |
MERCK & CO. INC. |
ZOO7940 |
Extra dose administered
Extra dose administered
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CLIENT ALREADY HAD 2 HPV VACCINES. DIDN'T NEED A THIRD DOSE.
CLIENT ALREADY HAD 2 HPV VACCINES. DIDN'T NEED A THIRD DOSE.
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| 2862183 | 33 | F | WY | 09/29/2025 |
COVID19 |
MODERNA |
8146545 |
Influenza like illness, Tachycardia
Influenza like illness, Tachycardia
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Pt woke up with flu-like symptoms the next day and then had tachycardia requiring labetalol treatmen...
Pt woke up with flu-like symptoms the next day and then had tachycardia requiring labetalol treatment on 9/28
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| 2862184 | 18 | F | TX | 09/29/2025 |
MNQ MNQ MNQ |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
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Epstein-Barr virus antibody positive, Epstein-Barr virus infection, Exercise tol...
Epstein-Barr virus antibody positive, Epstein-Barr virus infection, Exercise tolerance decreased, Headache, Hepatic enzyme abnormal; Lymphocyte count increased, Malaise, Pain, Paraesthesia, Pyrexia; Splenomegaly, Transferrin saturation decreased
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Within 24 hours she had a headache, body aches and fever. Whithin a couple days she developed an exe...
Within 24 hours she had a headache, body aches and fever. Whithin a couple days she developed an exercise intolerance and body tingles. We had her checked out a bout 10 days later when things weren't getting any better. They did labs and it showed her liver enzymes off, her iron saturation low, and a high lymphocyte count. That led the doctor to test her EBV antibodies and it was discovered she had a reactivation of EBV as well as an enlarged spleen. Once she recovered from the EBV reactivation, she is getting sick every couple weeks with something new. I fully believe this vaccine has weakened her immunity to other things. She went from rarely being sick to being sick every couple weeks. As a college athlete this is completely derailing her playing future.
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| 2862185 | 52 | F | PA | 09/29/2025 |
COVID19 FLU3 PNC20 |
PFIZER\BIONTECH SEQIRUS, INC. PFIZER\WYETH |
my9548 407003 ln4930 |
Extra dose administered, Injection site pain; Extra dose administered, Injection...
Extra dose administered, Injection site pain; Extra dose administered, Injection site pain; Extra dose administered, Injection site pain
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Patient attended flu/covid vaccine clinic and reported having no pneumonia vaccine history at time o...
Patient attended flu/covid vaccine clinic and reported having no pneumonia vaccine history at time of clinic. Patient was administered 1 dose of Prevnar 20 along with seasonal influenza vaccine and dose of COVID vaccine. Upon viewing of patient prescription profile following clinic, patient was found to have been administered prevnar20 in 2024, making most recent injection of prevnar20 unnecessary. Patient reports having injection site pain that has subsided.
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| 2862186 | 69 | F | NM | 09/29/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Wrong technique in product usage process
Wrong technique in product usage process
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Patient called the following day after a vaccination to report a concern about the technique used. S...
Patient called the following day after a vaccination to report a concern about the technique used. She told me that the technician who administered the vaccine "bunched up the skin" of the arm and administered into the deltoid. She reported being shocked at the administration technique and stating that she knows this is contraindiated with the covid vaccine. I then asked her if she was a medical professional, and she stated that she was not, but is a medical writer who has done a lot of reading into the injection technique of vaccines. I let her know that this is a common way to administer vaccine. She stated that no, it should not be that way, that there is literature in the CDC and Pfizer to support this. I then looked into while on the phone with her, and again after we had stopped talking. I saw no mention of contraindication in pinching the muscle during vaccination on the CDC website or other vaccine sites. I let her know again that it is a common method and that no site I referenced mentioned a contraindication to the specific vaccine technique. She says that she did not believe me and that she felt the need to report this to the Board of Pharmacy. I then gave her my name and manager's name. We then got off the phone. Afterward, I was able to locate a study indicating that it may not be preferred, but did not see any changes to administration technique. Some sites also suggested flattening the skin, but again, no mention of a contraindication to pinching the skin.
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| 2862187 | 78 | M | AZ | 09/29/2025 |
FLU3 |
SANOFI PASTEUR |
U8764BB |
Pain, Pain in extremity, X-ray limb, X-ray normal
Pain, Pain in extremity, X-ray limb, X-ray normal
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Patient reports still having pain in arm. Patient originally had sore arm that was improving with n...
Patient reports still having pain in arm. Patient originally had sore arm that was improving with no reports of range of motion limitations. However, pain has since continued and now patient reporting increased pain with certain movements.
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| 2862188 | 76 | F | CA | 09/29/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Eye irritation, Headache, Heart rate irregular, Sputum discoloured, Vision blurr...
Eye irritation, Headache, Heart rate irregular, Sputum discoloured, Vision blurred
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Had Flu vaccine not sure which one. Has eyes burning, red with white mucus, irregular heart beat, he...
Had Flu vaccine not sure which one. Has eyes burning, red with white mucus, irregular heart beat, headache, blurry vision
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| 2862189 | 64 | M | PA | 09/29/2025 |
COVID19 FLU3 PNC20 |
MODERNA SEQIRUS, INC. PFIZER\WYETH |
ln4931 407003 ln4931 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Patient attended flu/covid vaccine clinic and reported having no pneumonia vaccine history at time o...
Patient attended flu/covid vaccine clinic and reported having no pneumonia vaccine history at time of clinic. Patient was administered 1 dose of Prevnar 20 along with seasonal influenza vaccine and dose of COVID vaccine. Upon viewing of patient prescription profile following clinic, patient was found to have been administered prevnar20 in 2024, making most recent injection of prevnar20 unnecessary. Patient reports no side effects.
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| 2862190 | 26 | F | OH | 09/29/2025 |
TDAP |
SANOFI PASTEUR |
U8620AA |
Dizziness
Dizziness
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Donor received a Tdap vaccine following plasma donation. Donor was talking from medical office to ch...
Donor received a Tdap vaccine following plasma donation. Donor was talking from medical office to chairs and became dizzy. Donor gently lowered herself to the floor. Nurse used a wheelchair to get donor to a bed to complete treatment. Donor was provided 20 ounces of Powerade and became asymptomatic within 10 minutes.
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| 2862191 | 77 | F | FL | 09/29/2025 |
COVID19 VARZOS |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
na4452 7523j |
Extra dose administered, Wrong product administered; Extra dose administered, Wr...
Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered
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patient was given shingrix in error when she was supposed to have covid vaccine. patient has already...
patient was given shingrix in error when she was supposed to have covid vaccine. patient has already received 2 doses of shingrix.
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| 2862192 | 68 | M | OK | 09/29/2025 |
COVID19 PNC21 |
MODERNA MERCK & CO. INC. |
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Injection site swelling, Injection site urticaria, Injection site warmth, Pyrexi...
Injection site swelling, Injection site urticaria, Injection site warmth, Pyrexia; Injection site swelling, Injection site urticaria, Injection site warmth, Pyrexia
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Pt describes swelling and fever at site of injection. Broke out in hives locally at site of injectio...
Pt describes swelling and fever at site of injection. Broke out in hives locally at site of injection. Had bodily fever which subsided after 1 day. Pt reports swelling reducing 5 days after injection
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| 2862193 | 84 | M | AZ | 09/29/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Arthralgia, Blood test, Deep vein thrombosis, Electrocardiogram, Pain in extremi...
Arthralgia, Blood test, Deep vein thrombosis, Electrocardiogram, Pain in extremity; Peripheral swelling, Ultrasound Doppler abnormal, X-ray
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Within 10 minutes of being given vaccine, patient expressed having pain in his left knee. For the ne...
Within 10 minutes of being given vaccine, patient expressed having pain in his left knee. For the next 3 days, he had pain and swelling in left thigh. I took him to urgent care at that point, they sent him to ER for an ultrasound which showed a DVT. He was put on heparin, and flown (by helicopter) to a vascular surgeon for immediate care.
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| 2862194 | 22 | F | TN | 09/29/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
H4K3S H4K3S |
Burning sensation, Fatigue, Injected limb mobility decreased, Limb discomfort, M...
Burning sensation, Fatigue, Injected limb mobility decreased, Limb discomfort, Muscular weakness; Pain, Pain in extremity
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Left Arm became extremely sore and heavy about an hour after receiving the shot. My arm is still sor...
Left Arm became extremely sore and heavy about an hour after receiving the shot. My arm is still sore 3 weeks later and I have trouble lifting my arm all the way up as well as lifting objects in general. My arm has felt weak and aches all day long every day since getting the shot, and sometimes I have a burning and shooting pain in my arm. I have also been extremely fatigued and have not felt at all like myself since receiving the
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| 2862195 | 72 | M | WA | 09/29/2025 |
FLU3 |
SEQIRUS, INC. |
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Condition aggravated, Hypoacusis, Tinnitus
Condition aggravated, Hypoacusis, Tinnitus
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Increased intensity of tinnitus, first noticed at early morning bathroom break. Very loud all day l...
Increased intensity of tinnitus, first noticed at early morning bathroom break. Very loud all day long interfering with hearing normal conversation, had to increase volume on television in evening and on radio at bedtime. Self-checked blood pressure; normal. Still louder than usual at bedtime but used radio to allow sleep. Intensity back to what I am used to by morning 09/29/2025. So, about a 24-hour time course.
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| 2862196 | 36 | F | LA | 09/29/2025 |
HPV9 |
MERCK & CO. INC. |
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Arthralgia, Hypoaesthesia, Pain, Product administered at inappropriate site
Arthralgia, Hypoaesthesia, Pain, Product administered at inappropriate site
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Immediate onset of neurologic symptoms following vaccine administration on 09/25/2025. Symptoms incl...
Immediate onset of neurologic symptoms following vaccine administration on 09/25/2025. Symptoms included numbness involving the left axilla, forearm, and fingers, which resolved spontaneously within 48 hours. However, the patient continues to experience persistent, sharp, and intense pain in the left shoulder since the time of injection. The pain is exacerbated by shoulder movement. It is noted that the vaccine was administered in a location that was abnormally high and posterior on the upper arm. Photographic documentation of the injection site has been obtained for reference.
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| 2862197 | 72 | M | GA | 09/29/2025 |
FLU3 PNC20 RSV |
SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
UT8781DA LX4486 F4AC3 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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The patient had already received arexvy and prevnar 20 in 2023 and did not need to get them again.
The patient had already received arexvy and prevnar 20 in 2023 and did not need to get them again.
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| 2862198 | 74 | F | FL | 09/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
7yd42 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
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injection site reaction: 4 X 2 inch area on arm presents as red and swollen. Patient reports soren...
injection site reaction: 4 X 2 inch area on arm presents as red and swollen. Patient reports soreness and itching.
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| 2862199 | 62 | F | GA | 09/29/2025 |
FLU3 |
SANOFI PASTEUR |
u8823aa |
Anxiety, Injection site erythema, Injection site swelling
Anxiety, Injection site erythema, Injection site swelling
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Patient states redness and swollen where vaccine was given; expressed concerns t was to low on arm a...
Patient states redness and swollen where vaccine was given; expressed concerns t was to low on arm and was worried she may not get effect of vaccine. I assured patient that vaccine was still given in therapeutic area and she was having a local area injection site reaction; counseled on ibuprofen and cold compress
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