| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2823573 | U | 01/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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sick; This non-serious case was reported by a consumer via interactive digital media and described t...
sick; 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. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick). 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: US2025AMR010378 Additional Information: GSK Receipt Date: 11-JAN-2025 This case was reported by a patient via interactive digital media. Patient got two of the shots and they both made him/her sick. For tolerance of the 2nd dose, refer linked case US2025AMR010378, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR010378:same patient
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| 2823574 | U | 01/29/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Herpes zoster oticus, Paralysis, Post herpetic neuralgia, Vaccina...
Herpes zoster, Herpes zoster oticus, Paralysis, Post herpetic neuralgia, Vaccination failure; Herpes zoster, Herpes zoster oticus, Paralysis, Post herpetic neuralgia, Vaccination failure
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Suspected vaccination failure; Ramsey Hunt Syndrome; paralysis; post herpetic nerve damage; shingles...
Suspected vaccination failure; Ramsey Hunt Syndrome; paralysis; post herpetic nerve damage; shingles right side of face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ramsay-hunt syndrome (Verbatim: Ramsey Hunt Syndrome) (serious criteria GSK medically significant), paralysis (Verbatim: paralysis) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: post herpetic nerve damage) and facial herpes zoster (Verbatim: shingles right side of face). The outcome of the vaccination failure, ramsay-hunt syndrome and facial herpes zoster were not reported and the outcome of the paralysis and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome, paralysis, post herpetic neuralgia and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, ramsay-hunt syndrome and paralysis to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the post herpetic neuralgia and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the shingles shot and booster as soon as turned 50, still developed shingles on the right side of face which developed to Ramsey Hunt Syndrome. Still suffered from post herpetic nerve damage and paralysis. The reporter would still recommend the shots though because who know if it would have been worst. This case was considered as suspected vaccination failure as details regarding 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. Herpes zoster oticus and Paralysis are unlisted events which are considered unrelated to GSK Shingles vaccine.
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| 2823575 | U | 01/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspceted vaccination failure; had the vaccine and still got them; This serious case was reported by...
Suspceted vaccination failure; had the vaccine and still got them; 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: Suspceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine and still got them). 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: GSK Receipt Date: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine and still got shingles and asked do he/she need another. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination 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 vaccine Shingles vaccine.
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| 2823576 | U | 01/29/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; Shingles about every two months on torso; This serious case was repor...
Suspected vaccination failure; Shingles about every two months on torso; 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) and shingles (Verbatim: Shingles about every two months on torso). 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: GSK Receipt Date: 16-JAN-2025 This case was reported by a patient via interactive digital media. The patient have had the vaccine and still get shingles about every two months on torso but well, the patient's were painful just an annoyance. 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 vaccine Shingles vaccine.
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| 2823577 | 49 | M | LA | 01/29/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
4KF75 |
Abdominal pain upper
Abdominal pain upper
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Right upper quadrant pain; This non-serious case was reported by a physician via call center represe...
Right upper quadrant pain; This non-serious case was reported by a physician via call center representative and described the occurrence of upper abdominal pain in a adult male patient who received HAB (Twinrix) (batch number 4KF75) for prophylaxis. On 02-JUL-2024, the patient received the 1st dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced upper abdominal pain (Verbatim: Right upper quadrant pain). The outcome of the upper abdominal pain was resolved. It was unknown if the reporter considered the upper abdominal pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the upper abdominal pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: Follow-up information received on 31-DEC-2024. The reporter contacted Medical Information call Center and provided additional information on case AE-117102 about side effects after Twinrix vaccination. The patient experienced right upper quadrant pain after Twinrix and it ran away. Follow up by Safety Team was accepted to his personal email. Summary of changes: Patient tab, product tab, event tab and narrative was updated.; Sender's Comments: US-GSK-US2024AMR166318:For dose 2nd
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| 2823580 | F | NV | 01/29/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Fatigue, Loss of personal independence in daily activities, Mobility decreased
Fatigue, Loss of personal independence in daily activities, Mobility decreased
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absolute fatigue, it started after I got the RSV shot; I couldn't even walk my dogs; Couldn...
absolute fatigue, it started after I got the RSV shot; I couldn't even walk my dogs; Couldn't get out of bed for a week; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: absolute fatigue, it started after I got the RSV shot), activities of daily living impaired (Verbatim: I couldn't even walk my dogs) and bedridden (Verbatim: Couldn't get out of bed for a week). The outcome of the fatigue, activities of daily living impaired and bedridden were not resolved. It was unknown if the reporter considered the fatigue, activities of daily living impaired and bedridden to be related to Arexvy. It was unknown if the company considered the fatigue, activities of daily living impaired and bedridden to be related to Arexvy. Additional Information: GSK Receipt Date: 01-JAN-2025 Consumer reported that her problem was a absolute fatigue, it started after she got the RSV shot, at the and she couldn't get out of bed for a week, except to just you know go to bathroom, and essentials like that. She couldn't even walk her dogs, and then it has just continued on. Here it was a year and half latter, and she talk to the doctor, she went to rheumatologist, she talk to the pharmacist and it just doesn't let up. She was wondering is there is anything you know and asked for help.
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| 2823581 | 16 | F | TX | 01/29/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
EK7DG |
Incorrect dose administered, Product preparation error
Incorrect dose administered, Product preparation error
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reconstituted with sterile water; Inappropriate dose of vaccine administered; 1mL was administered t...
reconstituted with sterile water; Inappropriate dose of vaccine administered; 1mL was administered to the patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number EK7DG, expiry date 31-DEC-2025) for prophylaxis. On 02-JAN-2025, the patient received Menveo. On 02-JAN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water), inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered) and overdose (Verbatim: 1mL was administered to the patient). The outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and overdose were unknown. It was unknown if the reporter considered the overdose to be related to Menveo. It was unknown if the company considered the overdose to be related to Menveo. Additional Information: GSK Receipt Date: 03-JAN-2025 The Healthcare Professional reported that Menveo 1 vial was reconstituted with sterile water from the MMR vaccine and 1ml was administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
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| 2823582 | 52 | F | GA | 01/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Acne, Blister rupture, Rash, Rash vesicular
Acne, Blister rupture, Rash, Rash vesicular
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The patient states "it is maybe a mild shingles; an acne like break out; they popped when I sho...
The patient states "it is maybe a mild shingles; an acne like break out; they popped when I showered; is creeping to the upper part of the back; bumpy blistery rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included The patient was red haired person. On 08-DEC-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 13-DEC-2024, 5 days after receiving Shingrix, the patient experienced rash (Verbatim: is creeping to the upper part of the back) and blistery rash (Verbatim: bumpy blistery rash). On an unknown date, the patient experienced shingles (Verbatim: The patient states "it is maybe a mild shingles), acne (Verbatim: an acne like break out) and blister (Verbatim: they popped when I showered). The patient was treated with hydrocortisone (Cortaid). The outcome of the shingles was unknown and the outcome of the rash was not resolved and the outcome of the blistery rash and blister were resolved and the outcome of the acne was not reported. It was unknown if the reporter considered the shingles, rash, blistery rash, acne and blister to be related to Shingrix. It was unknown if the company considered the shingles, rash, blistery rash, acne and blister to be related to Shingrix. Additional Information: GSK Receipt Date: 03-JAN-2025 The reporter reported that the patient received Shingrix and had a rash as a bumpy blistery rash on patient back, with very small blisters. The reporter describes it as an acne like break out. The reporter reported about the blisters as they popped when patient showered. The blisters went away but not the rash. The reporter states the rash was creeping to the upper part of the back. It was maybe a mild shingles. The rash first appeared on the right section of the back, and it has moved to the upper left part of the back, near the neck and the shoulder. It has moved from right to left. The patient will see a dermatologist next week but states that the nurse recommended to take an oral antihistamine and to apply Cortaid topical cream. The patient has used this for a week and states it has helped. The reporter wanted to share the fact that she was a red-haired person. The reporter states red-haired people react differently to medications, and it was a real thing, it was crazy. The reporter stated we can overreact to medications, and with anesthesia they give less or more depending on the patient, and the patient always overreact to medications.
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| 2823583 | F | FL | 01/29/2025 |
RSV VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Respiratory disorder; Respiratory disorder
Respiratory disorder; Respiratory disorder
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respiratory issues; the patient had received two total doses of Arexvy; This non-serious case was re...
respiratory issues; the patient had received two total doses of Arexvy; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of respiratory disorder in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on unknown date) and Arexvy (received 1st dose of Arexvy vaccine in 2023). On an unknown date, the patient received the 2nd dose of Shingrix and the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Shingrix and Arexvy, the patient experienced respiratory disorder (Verbatim: respiratory issues) and extra dose administered (Verbatim: the patient had received two total doses of Arexvy). The outcome of the respiratory disorder and extra dose administered were unknown. It was unknown if the reporter considered the respiratory disorder to be related to Shingrix and Arexvy. It was unknown if the company considered the respiratory disorder to be related to Shingrix and Arexvy. Additional Information: GSK Receipt Date: 15-JAN-2025 Pharmacist reported that the patient was vaccinated with Shingrix at the same time as receiving her second dose of Arexvy which led to extra dose administered. After vaccination the patient had respiratory issues and was transported to the emergency department by personnel was made aware of the the vaccinations administered to the patient, however, was not informed the patient had received two total doses of Arexvy. No further information was known such as medical history of patient, demographics of patient, dates of administration for both doses of Arexvy and the dose of Shingrix, or the patient was admitted into the hospital or released from the emergency department. This case was linked with case US2025005052, reported by the same reporter for different patient.; Sender's Comments: US-GSK-US2025005052:Same reporter/Different Patient
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| 2823584 | 74 | U | 01/29/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Chills, Decreased appetite, Dizziness, Erythema, Headache; Hypersomnia, Limb mas...
Chills, Decreased appetite, Dizziness, Erythema, Headache; Hypersomnia, Limb mass, Muscular weakness, Nausea, Pyrexia; Urinary incontinence
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lose all muscle control in arms, legs; loose of control bladder; lots of sleeping most of the day; d...
lose all muscle control in arms, legs; loose of control bladder; lots of sleeping most of the day; dizzy; fever; chills; nausea; terrific headache; loss of appetite; redness and lump on my arm are flaming; redness and lump on my arm are flaming; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming) and DECREASED APPETITE (loss of appetite) in a 74-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concomitant products included Levothyroxine sodium, Rosuvastatin calcium (Rosuvastatin) and Ezetimibe for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 23-Nov-2024, the patient experienced LIMB MASS (redness and lump on my arm are flaming) and ERYTHEMA (redness and lump on my arm are flaming). On an unknown date, the patient experienced MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), DECREASED APPETITE (loss of appetite), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache). At the time of the report, MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming), DECREASED APPETITE (loss of appetite), ERYTHEMA (redness and lump on my arm are flaming), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache) had not resolved. Patient had received Moderna Covid vaccines and their booster doses every year since their availability. Patient had reactions to vaccine which caused patient to be bedridden for a few days. Patient had reactions which included losing all muscle control in arms, legs, and bladder; lots of sleeping most of the day; fever, chills, nausea, dizzy, terrific headache, and loss of appetite. It was like a nightmare for the patient. Since 23-Nov-2024, the patient had redness and lump on the arm. It was reported that patient researched online for side affects, but could not find anything close to what patient continued to experience. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2024: Live non-significant follow up received with no new information. On 17-Dec-2024: Live non-significant follow up received with no new information.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
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| 2823585 | 79 | M | 01/29/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Blood pressure measurement, Culture, Gastritis viral, Heart rate, Heart rate dec...
Blood pressure measurement, Culture, Gastritis viral, Heart rate, Heart rate decreased; Hypotension, Laboratory test, Pain in extremity
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low blood pressure and pulse; low blood pressure and pulse; viral gastritis//vomiting; Calf pain; Th...
low blood pressure and pulse; low blood pressure and pulse; viral gastritis//vomiting; Calf pain; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE DECREASED (low blood pressure and pulse), HYPOTENSION (low blood pressure and pulse) and GASTRITIS VIRAL (viral gastritis//vomiting) in a 79-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: High dose flu vaccine (High dose) on 27-Dec-2024. Past adverse reactions to the above products included No adverse effect with High dose flu vaccine. On 15-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In January 2025, the patient experienced GASTRITIS VIRAL (viral gastritis//vomiting) (seriousness criterion hospitalization). On 16-Jan-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY (Calf pain). On 18-Jan-2025, the patient experienced HEART RATE DECREASED (low blood pressure and pulse) (seriousness criterion hospitalization) and HYPOTENSION (low blood pressure and pulse) (seriousness criterion hospitalization). The patient was hospitalized on 18-Jan-2025 due to GASTRITIS VIRAL, HEART RATE DECREASED and HYPOTENSION. On 19-Jan-2025, HEART RATE DECREASED (low blood pressure and pulse) and HYPOTENSION (low blood pressure and pulse) was resolving. On 20-Jan-2025, PAIN IN EXTREMITY (Calf pain) had resolved. At the time of the report, GASTRITIS VIRAL (viral gastritis//vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Culture: Negative. On an unknown date, Heart rate: Low. On an unknown date, Laboratory test: normal. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. On 18-Jan-2025, patient started vomiting and admitted to the hospital due to low blood pressure and pulse. Blood clots were ruled out. Vomiting stopped. Patient would be released from hospital on 21-Jan-2025. The final diagnosis was viral gastritis. No treatment medications were reported.; Reporter's Comments: Company comment: Causality of event gastritis viral was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
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| 2823586 | 75 | M | SC | 01/29/2025 |
COVID19 |
MODERNA |
D71F21A |
COVID-19
COVID-19
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Patient contracted COVID in April of 22; This spontaneous case was reported by a patient and describ...
Patient contracted COVID in April of 22; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient contracted COVID in April of 22) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D71F21A, 028A21A and D121A21A) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (Patient contracted COVID in April of 22). At the time of the report, COVID-19 (Patient contracted COVID in April of 22) had resolved. No concomitant medication was reported. On 13-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Patient received 5h dose of Spikevax vaccine on OCT-2024. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
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| 2823587 | F | NV | 01/29/2025 |
COVID19 COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
5683MF012 5683MF012 5683MF012 |
Adverse event, Brain fog, COVID-19, Fatigue, Malaise; Nasopharyngitis, Nervous s...
Adverse event, Brain fog, COVID-19, Fatigue, Malaise; Nasopharyngitis, Nervous system disorder, Oropharyngeal pain, Pain in extremity, Post-acute COVID-19 syndrome; SARS-CoV-2 antibody test, Tremor, Vaccination failure
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I start shaking; Got a light case of Covid 19; I took a test and it was positive; I felt like little...
I start shaking; Got a light case of Covid 19; I took a test and it was positive; I felt like little cold like symptoms and with a little sore throat; I felt like little cold like symptoms and with a little sore throat; I still have the fatigue and some brain symptoms; The next day I can do almost nothing; In the middle of exercising, I need to stop and sit down; I still have the fatigue and some brain symptoms; I start shaking; The next day I can do almost nothing; In the middle of exercising, I need to stop and sit down; I still have the fatigue and some brain symptoms; Feeling a little under the weather; Sore arm; I had minimal side effects; Brain fog; I still have long covid symptoms; This serious initial spontaneous safety report was received by Novavax on 09-Oct-2024 from a consumer via Novavax Medical Information (NOV24-00567 and NOV24-00609). A female of unspecified age was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula)(Intramuscular) (Lot number was not provided in the report) in 2023. The following medical history was reported: ALLERGIC ASTHMA. No concomitant medications were reported. On an unspecified date after vaccination the patient experienced Feeling a little under the weather (Malaise) and Sore arm (Pain in extremity). In Nov-2023 the patient experienced I felt like little cold like symptoms and with a little sore throat (Nasopharyngitis) (Oropharyngeal pain), I took a test and it was positive (Vaccination failure) (Serious: Other Medically Important Condition), Got a light case of Covid 19 (COVID-19), I still have long covid symptoms (Post-acute COVID-19 syndrome), I still have the fatigue and some brain symptoms (fatigue) (Nervous system disorder). Treatment for COVID-19 included Paxlovid. Relevant lab tests included: COVID-19 TEST(Result: Positive, Test Date: Nov-2023). At the time of reporting, the event outcome of Fatigue and Nervous system disorder was Recovering/Resolving; the event outcome of Malaise, Pain in extremity, COVID-19 was Unknown; the event outcome of Post-acute COVID-19 syndrome was Not Recovered/Not Resolved/Ongoing, the event outcome of Nasopharyngitis, Oropharyngeal pain and Vaccination failure was Recovered/Resolved. On 15-Oct-2024, significant information was received from PQC via a follow-up query - added 2 new reporters, updated therapy start and end date from --2023 to 29-Oct-2023, and lot number to 5683MF012, vaccination facility telephone, added 1 new event: I had minimal side effects (PT: Adverse event) with the outcome as Recovered/Resolved. Patient's past therapy was added: Nuvaxovid COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) administered on 15-Oct-2024, with associated events Pain, Headache and Fever. On 14-Nov-2024, significant information was received from a consumer via a query response: Added reporter's middle name Added 1 new patient past therapy (Moderna in 2021 with reported event: Severe reaction to my 2nd Moderna shot). Added 2 new events in the patient past therapy for Nuvaxovid received in 2024: Not nearly as bad as my severe reaction to my 2nd Moderna shot in 2021, but definitely uncomfortable (PT: Adverse event), Worse since my booster (PT: Condition aggravated) Added body temperature increased in patient medical history Updated COVID test date from -Nov-2023 to 23-Nov-2023 Updated event onset date of I took a test and it was positive (PT: Vaccination failure) to 23-Nov-2023, added Paxlovid as treatment started on 23-Nov-2023. Added 2 new events - On an unknown date, the patient experienced Brain fog (PT: Brain fog); On an unknown date in Nov-2023, the patient experienced I start shaking (Tremor). The outcome of the events Brain fog and Tremor were Not Recovered/Not Resolved/Ongoing. The reported term for the event PT: Fatigue was updated from "I still have the fatigue and some brain symptoms" to "I still have the fatigue and some brain symptoms; The next day I can do almost nothing; In the middle of exercising, I need to stop and sit down". Updated event outcome of PT: Fatigue to Not recovered/Not resolved/Ongoing. On 21-Nov-2024, the product quality complaint (PQC) investigation results were received. Per the investigation summary, the vaccine was expected ti meet all critical quality attributes at the time of vaccine administration. PQC was added as Report classification. On 20-Dec-2024, non-significant information was received from a consumer - No new information was received. On 25-Jan-2025, significant information was received from a consumer via a query response: History of Allergic asthma estimated start was provided as 25 years ago, and classified as current condition as response to whether condition is ongoing was "unknown/sometimes". Added Flu vaccine to past therapy. Other COVID-19 vaccines site of administration for Moderna and Johnson & Johnson received in 2022 was updated to left arm. Dose number in series of two moderna doses received in 2022 was confirmed as Doses 1 and 2 while dose of Johnson & Johnson was in 2022 was confirmed as booster dose. The following events were upgraded to serious: fatigue (serious: disability), Nervous system disorder (serious: disability), COVID-19 (serious: disability), Adverse event (serious: disability), brain fog (serious: disability), Onset date of the event of PT: COVID-19 was updated to 23-Nov-2023 and outcome was updated recovered/resolved with sequelae. Onset date of the event of PT: Nasopharyngitis was updated to 23-Nov-2023 and outcome was updated recovered/resolved. Onset date of the event of PT: Oropharyngeal pain was updated to 23-Nov-2023 and outcome was updated recovered/resolved. Onset date of the event of PT: Malaise was updated to 23-Nov-2023 and outcome was updated recovered/resolved. Onset date of the event of PT: Pain in extremity was updated to 23-Nov-2023 and outcome was updated to recovered/resolved. Onset date of the event of PT: Adverse event was updated to 23-Nov-2023, and outcome was updated to recovered/resolved with sequelae. Onset date of the event of PT: Brain fog was updated to 23-Nov-2023. Onset date of the event of PTs: Fatigue and Nervous system disorder was updated to 23-Nov-2023, and outcome of the events were updated to not recovered/not resolved. Start date of the event of PT: Tremor was updated to 15-Dec-2023. Discrepancies were identified in the source document - Flu vaccine was reported as concomitant medication, but it was also stated that it was received a few weeks - 45 days, thus not captured as concomitant medication as it was beyond 30 days in the structured field. This was instead captured as past therapy. Start dates captured as 23-Nov-2023 as no month corresponds to 23 if the format of DD/MMM/YYYY is followed. Patient's age was reported as 70 years, however age at the time of the event was retained (69 years).; Sender's Comments: This 69 years old female experienced Malaise, Pain in extremity, Adverse event, Brain fog, Tremor, COVID-19, Post-acute COVID-19 syndrome, Nasopharyngitis, Oropharyngeal pain, Nervous system disorder, Fatigue and Vaccination failure after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (4). The event Vaccination failure was assessed as serious. The events of Fatigue, Nervous system disorder, COVID-19, Adverse event, and brain fog were reported as serious. The event Malaise, Pain in extremity, Tremor, Post-acute COVID-19 syndrome, Nasopharyngitis, Oropharyngeal pain were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and COVID-19, Post-acute COVID-19 syndrome, Tremor, Nasopharyngitis, Oropharyngeal pain, Nervous system disorder, Fatigue, Malaise, Pain in extremity, Adverse event and Brain fog is considered Possible; and the event of Vaccination failure is considered Related.
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| 2823588 | U | SC | 01/29/2025 |
RSV |
PFIZER\WYETH |
KC7884 |
Device breakage
Device breakage
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the device broke and the solution fell everywhere/solution fell all over the ground; This is a spont...
the device broke and the solution fell everywhere/solution fell all over the ground; This is a spontaneous report received from a Pharmacist from product quality group, Program ID:. A patient should have received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: KC7884, Expiration Date: Oct2025) for immunisation, Device Lot Number: HM8389, Device Expiration Date: Sep2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the device broke and the solution fell everywhere/solution fell all over the ground". NDC Number: 0069034401. UPC Number: 300690344010. The reporter considered "the device broke and the solution fell everywhere/solution fell all over the ground" not related to rsv vaccine prot.subunit pref 2v. Causality for "the device broke and the solution fell everywhere/solution fell all over the ground" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
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| 2823590 | F | 01/29/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Asthenia, Cardiac flutter, Dyspnoea, Fatigue, Pyrexia; Tremor
Asthenia, Cardiac flutter, Dyspnoea, Fatigue, Pyrexia; Tremor
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heart fluttering; fatigue; fever; weakness; very shaky; had to concentrate to be able to breath; Thi...
heart fluttering; fatigue; fever; weakness; very shaky; had to concentrate to be able to breath; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 75-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stage III Endometrial cancer" (not ongoing), notes: she beat it, she's in health now. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Comirnaty (2023-2024 formula) (DOSE 3 (BOOSTER), SINGLE), administration date: Oct2023, for Covid-19 Immunization, reaction(s): "severe reaction". The following information was reported: CARDIAC FLUTTER (medically significant), 10 hrs after the suspect product(s) administration, outcome "not recovered", described as "heart fluttering"; FATIGUE (non-serious), 10 hrs after the suspect product(s) administration, outcome "not recovered"; PYREXIA (non-serious), outcome "not recovered", described as "fever"; ASTHENIA (non-serious), 10 hrs after the suspect product(s) administration, outcome "not recovered", described as "weakness"; TREMOR (non-serious), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "very shaky"; DYSPNOEA (non-serious), 10 hrs after the suspect product(s) administration, outcome "unknown", described as "had to concentrate to be able to breath". Clinical course: Caller had all her Pfizer COVID-19 doses, first, second, third and the most recent one, but on the last one, she started experiencing fever, weakness, heart fluttering, fatigue, and she's wondering what to do now. She wanted to know whether to get the new vaccine or not. She mentioned she's afraid to get another vaccination, but she's also afraid of getting covid and not surviving. She doesn't know what to do. She added that she's 75 years old, and not in an age to fight. She also had a cancer diagnosis few years ago, it was Stage III Endometrial, and she beat it, she's in health now, but her body is been through a lot. She mentioned her reaction was so bad, she really thought she was going to die. She stated that the fatigue went through weeks and weeks, and she went to the ER several times, and nobody knew what to do. Caller mentioned her previous dose was about a year ago, Oct2023, she mentioned it might have been the "bi-variant". Caller also wanted to know if having a previous history of side effects to the other Pfizer COVID-19 Vaccine formulations would cause her to get a reaction again. Caller then spoke about "preveset" or "prevesid", which is a medication given by doctors to make a milder case of covid if you take this medication within the first days of getting COVID, but she added her doctor told her that their site is not using that medication as it has too many complications, too many reactions. Caller finally stated that she will either try to get lucky, or maybe switch to Moderna to avoid reaction with our vaccine again. Consumer stated, "So, I had a several of the Pfizer COVID shot (Later clarified as Pfizer COVID-19 Shot) the 1st, the 2nd, the 3rd and the last one I had, I had terrible reaction from it that lasted, the most severe reaction was, I had it 11 O'clock in the morning and at 09:30 that evening the reaction was extremely severe, I suddenly got very weak, very shaky, my heart was kind of fluttering, I had to concentrate to be able to breath and I had extreme fatigue for weeks and weeks afterwards. So, I am wondering, what do I do now to not die from COVID because I am worried about it." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2823591 | F | 01/29/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
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I had the covid shot the vaccination shot and i got really sick from the shot.; Caller had the covid...
I had the covid shot the vaccination shot and i got really sick from the shot.; Caller had the covid virus and they gave her Paxlovid to take; Caller had the covid virus and they gave her Paxlovid to take; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "My kidneys are a little bit low" (unspecified if ongoing); "I also has a heart problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2025, outcome "unknown" and all described as "Caller had the covid virus and they gave her Paxlovid to take"; ILLNESS (non-serious), outcome "unknown", described as "I had the covid shot the vaccination shot and i got really sick from the shot". It was reported that the patient had the covid shot the vaccination shot and she got really sick from the shot. Caller had the covid virus. Patient had fever. They gave her Paxlovid to take. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2025) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2823592 | F | TN | 01/29/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
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Asthenia, Balance disorder, Bone pain, Condition aggravated, Eye disorder; Limb ...
Asthenia, Balance disorder, Bone pain, Condition aggravated, Eye disorder; Limb discomfort, Malaise, Systemic lupus erythematosus
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affected balance, eyes, hands; affected balance, eyes, hands; affected balance, eyes, hands; every b...
affected balance, eyes, hands; affected balance, eyes, hands; affected balance, eyes, hands; every bone in body hurts; triggered an attack on lupus; triggered an attack on lupus; This is a spontaneous report received from a Consumer or other non HCP. A 91-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 29Nov2024 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Lupus", start date: 2023 (ongoing), notes: under the care of a dermatologist, doing fine; "Covid-19", start date: 2023 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (medically significant, disability) with onset 2024, outcome "not recovered", SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant, disability), outcome "not recovered" and all described as "triggered an attack on lupus"; BALANCE DISORDER (disability), EYE DISORDER (disability), LIMB DISCOMFORT (disability), outcome "not recovered" and all described as "affected balance, eyes, hands"; BONE PAIN (disability), outcome "not recovered", described as "every bone in body hurts". Clinical course: The patient got lupus 2 years ago (2023) when got covid (2023), but she has been under the care of a dermatologist. The patient was doing fine and the day after thanksgiving she got RSV vaccination shot, and patient has been sick ever since. The RSV shot triggered an attack on lupus, the shot also affected her balance, eyes, hands and every bone in body hurts. Patient stated that Pfizer was going to say the age, 91, had a lot to do with it but that's not true. Now patient was suffering from these debilitating side effects. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
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| 2823593 | U | AZ | 01/29/2025 |
COVID19 |
PFIZER\BIONTECH |
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Therapeutic response unexpected
Therapeutic response unexpected
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After received second Pfizer Covid shot patient flareups with FMF stopped. Patient used to get at le...
After received second Pfizer Covid shot patient flareups with FMF stopped. Patient used to get at least four attacks per year.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Familia Mediterranean Fever (FMF)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "After received second Pfizer Covid shot patient flareups with FMF stopped. Patient used to get at least four attacks per year.". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2823594 | F | 01/29/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Injection site erythema, Injection site induration, Injection site mass, Pyrexia
Injection site erythema, Injection site induration, Injection site mass, Pyrexia
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Patient experience fever; site reaction ( bump); site reaction (red ); site reaction ( hard); This s...
Patient experience fever; site reaction ( bump); site reaction (red ); site reaction ( hard); This spontaneous case, initially received on 12-Jan-2025, was reported by a non health professional and concerns a(n) Other child female patient. Past medical history included Immunization. Administration of company suspect drug(s): On an unknown date, the patient received INN Flu Vaccine Seasonal for Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On 12-Jan-2025, the patient experienced Patient experience fever (outcome: Recovered / Resolved, stop date: Jan-2025), site reaction ( bump) (outcome: Recovered / Resolved), site reaction (red ) (outcome: Recovered / Resolved), site reaction ( hard) (outcome: Recovered / Resolved). Non-drug treatment/Other action taken: INN Flu Vaccine Seasonal action taken: Not Applicable; Reporter's Comments: The events were considered related
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| 2823595 | F | MA | 01/29/2025 |
UNK |
UNKNOWN MANUFACTURER |
946618 |
Influenza, Influenza A virus test positive
Influenza, Influenza A virus test positive
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Influenza A; Influenza A; This spontaneous case, initially received on 20-Jan-2025, was reported by ...
Influenza A; Influenza A; This spontaneous case, initially received on 20-Jan-2025, was reported by a non health professional and concerns a female patient with unknown age. Medical history and concomitant medications were unknown. Administration of company suspect drug: On 10-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, dose regimen: 0.5 ml, route of administration and anatomical location: not reported, Lot number: 946618. No additional suspect drugs. Adverse reactions/events and outcomes: On 06-Jan-2025, the patient experienced Influenza A (Medically Significant, outcome: Unknown), Influenza A (outcome: Not reported). The patient reported that was administered Flucelvax 2024-2025 (Lot #946618) on 10-Oct-2024 at Pharmacy. On Monday 06-Jan-2025 the patient was diagnosed with Influenza A (by point-of-care testing Influenza A rapid) at Urgent Care. It was unknown if patient was hospitalized. Treatment measures associated with event: Unknown Flucelvax (TIV) action taken: Not Applicable Reporter assessment: The reporter considered the events as non serious and did not provide a causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. A lack of effect/vaccination failure can generally be expected for any medicinal/drug product/vaccine as a 100% success rate cannot be reasonably assumed in every patient treated.
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| 2823596 | M | 01/29/2025 |
UNK |
UNKNOWN MANUFACTURER |
No batch number |
Fatigue, Influenza, Influenza virus test positive, Pain, Pyrexia
Fatigue, Influenza, Influenza virus test positive, Pain, Pyrexia
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Diagnosed with flu; Tested positive for the flu on Sunday 19-Jan-2025/ received a Flucelvax vaccine ...
Diagnosed with flu; Tested positive for the flu on Sunday 19-Jan-2025/ received a Flucelvax vaccine on 29-Oct-2024; Fever; Aches and pains; Fatigue; This spontaneous case, initially received on 21-Jan-2025, was reported by a non health professional and concerns a male patient of unknown age. Concomitant Medications: Unknown Medical History: Unknown Administration of company suspect drug: On 29-Oct-2024, the patient received Flucelvax (TIV) for an indication not reported, Dose regimen: 0.5 ml, route of administration and anatomical location: not reported. Lot number: not reported but will be requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On 19-Jan-2025, the patient experienced Tested positive for the flu on Sunday 19-Jan-2025/ received a Flucelvax vaccine on 29-Oct-2024 (Medically Significant, outcome: Unknown). On 19-Jan-2025, the patient experienced Diagnosed with flu (Medically Significant, outcome: Unknown). Associated symptoms included: Fever, Aches and pains, Fatigue. The patient reported that had tested positive for the flu on Sunday 19-Jan-2025. He received a Flucelvax vaccine on 29-Oct-2024. Side effects he had had were fever, aches and pains and fatigue. Patient reported that he was diagnosed with flu (influenza) after taking Flucelvax. Flucelvax (TIV) action taken: Not Applicable Reporter assessment: The reporter considered the events as non serious and did not provide a causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. A lack of effect can generally be expected for any medicinal/drug product as a 100% success rate cannot be reasonably assumed in every patient treated.
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| 2823612 | 16 | F | MN | 01/29/2025 |
HIBV |
MERCK & CO. INC. |
Y003145 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Patient incorrectly received HIB in place of ordered Menveo vaccine. No adverse outcome noted. Patie...
Patient incorrectly received HIB in place of ordered Menveo vaccine. No adverse outcome noted. Patient remains stable with no medical intervention required.
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| 2823613 | 49 | F | VA | 01/29/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8366AA U8366AA |
Fatigue, Feeling abnormal, Headache, Oropharyngeal pain, Pyrexia; Rhinorrhoea, S...
Fatigue, Feeling abnormal, Headache, Oropharyngeal pain, Pyrexia; Rhinorrhoea, Sneezing
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Headache, fever, sore throat, sneezing, runny nose, tiredness, overall feeling bad.
Headache, fever, sore throat, sneezing, runny nose, tiredness, overall feeling bad.
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| 2823614 | 74 | F | FL | 01/29/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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the pt did not have an adverse event, however, this medication was given a dose that was not indicat...
the pt did not have an adverse event, however, this medication was given a dose that was not indicated or considered necessary. Pt received an Arexvy vaccine on 01/27/2025, however, the pt had received a previous Arexvy vaccine on 11/14/2023 as well.
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| 2823615 | 11 | F | CA | 01/29/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y007991 LB93L F4T5L |
Dizziness, Presyncope; Dizziness, Presyncope; Dizziness, Presyncope
Dizziness, Presyncope; Dizziness, Presyncope; Dizziness, Presyncope
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had lightheadedness on way out of clinic and had vasovagal event
had lightheadedness on way out of clinic and had vasovagal event
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| 2823616 | 30 | F | PA | 01/29/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Swelling face, Urticaria
Swelling face, Urticaria
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Hives on opposite arm a couple hours after injection, followed by outbreak of hives and swelling in ...
Hives on opposite arm a couple hours after injection, followed by outbreak of hives and swelling in forehead that have lasted more than 24 hours.
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| 2823617 | 71 | F | MI | 01/29/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
U8519CA Y013009 |
Limb mass, Peripheral swelling; Limb mass, Peripheral swelling
Limb mass, Peripheral swelling; Limb mass, Peripheral swelling
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Patient stated that her arm swelled up with a lump like a golf ball. Did not seek medical treatment...
Patient stated that her arm swelled up with a lump like a golf ball. Did not seek medical treatment.
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| 2823618 | 1 | F | AR | 01/29/2025 |
HEPA HEPA PNC20 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH |
22gp3 22gp3 lj5284 lj5284 |
Breath holding, Computerised tomogram head normal, Crying, Haemoglobin decreased...
Breath holding, Computerised tomogram head normal, Crying, Haemoglobin decreased, Human rhinovirus test positive; Immediate post-injection reaction, Seizure, Tonic clonic movements; Breath holding, Computerised tomogram head normal, Crying, Haemoglobin decreased, Human rhinovirus test positive; Immediate post-injection reaction, Seizure, Tonic clonic movements
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Patient presented to the clinic for 12 month well child exam. After the exam she was given the firs...
Patient presented to the clinic for 12 month well child exam. After the exam she was given the first two vaccines (Hep A and Prevnar.) She immediately started crying and appeared to have a breath holding spell. MOm picked her up off of the exam table when she would not catch her breath and then the patient started seizing. The patient had generalized tonic clonic movements for about 15 minutes after the vaccines. An ambulance was called but the infant stopped seizing without medication by the time that paramedics arrived. She was transferred to a local emergency room for evaluation. She had a normal CT scan and tested positive for rhinovirus. She will be evaluated by Neurology as an outpatient. She was sent home with Diastat in the case that she has more seizure activity.
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| 2823619 | 64 | F | NC | 01/29/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
4m472 |
Product preparation issue
Product preparation issue
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After patient was vaccinated it was realized that pt had just been vaccinated with just the diluent....
After patient was vaccinated it was realized that pt had just been vaccinated with just the diluent. the shingrix vaccine was never reconstituted
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| 2823620 | 64 | F | TX | 01/29/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
|
Injection site induration, Injection site pain, Injection site swelling, Injecti...
Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
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Firm, painful swelling at the injection site, notably warm to the touch. Noticed within the first ...
Firm, painful swelling at the injection site, notably warm to the touch. Noticed within the first 48 hours after receiving the vaccine. Slowly enlarged in size until approximately 1.5 cm in diameter. It has been 20 days since the vaccination was administered. Both the size of the swelling and the pain level have decreased, but are still present.
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| 2823621 | 81 | M | VA | 01/29/2025 |
RSV |
PFIZER\WYETH |
LN5460 |
Pruritus, Urticaria
Pruritus, Urticaria
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1 day after vaccine developed pruritic hives on his chest and arms. Seen in clinic the next day and...
1 day after vaccine developed pruritic hives on his chest and arms. Seen in clinic the next day and hives were covering 90% of his arms, chest, back, buttocks and thighs.
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| 2823622 | 56 | F | OR | 01/29/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
|
Arrhythmia, Headache, Hypoaesthesia, Paraesthesia
Arrhythmia, Headache, Hypoaesthesia, Paraesthesia
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I'm filling this out the same day of the shot. Within two minutes of the shot, I notices prick...
I'm filling this out the same day of the shot. Within two minutes of the shot, I notices prickly feelings in my left arm, hand, and fingers. I sat in my car for about 20 minutes after the shot. When I was driving away from the pharamcy, within the first hour of the shot, I felt two arrhythmia feelings: one at about 1/4 mile from the pharmacy where I got the shot, and one a bit further as I was entering the grocery parking lot (named for timing/distance from the pharmacy). It's within 8 hours of receiving the shot, and I'm feeling prickly, needle-like feelings still in my left arm in various places, including under my arm, as well. I'm also feeling the prickly and numb sensations on both sides of my neck, on my ears, as well as my temples, up to the top of my head where I also have a headache sensation. It seems the prickly feeling is spreading to more than my arm and hand throughout the day.
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| 2823631 | 12 | F | CA | 01/29/2025 |
FLU3 FLU3 HPV4 HPV4 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
AE257 AE257 Y007197 Y007197 |
Blood glucose, Electrocardiogram, Fall, Head injury, Loss of consciousness; Pain...
Blood glucose, Electrocardiogram, Fall, Head injury, Loss of consciousness; Pain, Syncope; Blood glucose, Electrocardiogram, Fall, Head injury, Loss of consciousness; Pain, Syncope
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after HPV vaccine administration, patient had syncope episode. Patient had LOC for about a minute, f...
after HPV vaccine administration, patient had syncope episode. Patient had LOC for about a minute, fell on floor and hit head. Patient regained consciousness. Vital signs monitored, blood sugar taken. Patient taken to ER, observed, EKG done. Patient had a follow up appointment the next day at the clinic patient reported feeling well, ambulating normal, and pain.
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| 2823633 | 63 | F | IL | 01/29/2025 |
PNC20 |
PFIZER\WYETH |
LK6650 |
Injected limb mobility decreased, Pain in extremity
Injected limb mobility decreased, Pain in extremity
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Pain in arm (Left) Limited motion in left arm - patient states she can't lift arm above shoulde...
Pain in arm (Left) Limited motion in left arm - patient states she can't lift arm above shoulder
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| 2823128 | 30 | F | TN | 01/28/2025 |
HPV4 HPV4 HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Abdominal pain, Antinuclear antibody increased, Arthralgia, Asthenia, Dizziness;...
Abdominal pain, Antinuclear antibody increased, Arthralgia, Asthenia, Dizziness; Dyskinesia, Fibromyalgia, Gastrointestinal inflammation, Impaired work ability, Inappropriate schedule of product administration; Joint range of motion decreased, Loss of personal independence in daily activities, Muscle disorder, Orthostatic hypotension, Pain; Postural orthostatic tachycardia syndrome, Psoriatic arthropathy, Pyrexia, Tachycardia
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abdominal pain; bowel inflammation; low-grade fevers; psoriatic arthritis, joint pain,loss of range ...
abdominal pain; bowel inflammation; low-grade fevers; psoriatic arthritis, joint pain,loss of range of motion/lack of control of some muscles and fingers; second dose 22-APR-2022; fibromyalgia, severe chronic pain,weakness/joint pain; POTS-like symptoms/tachycardia/postural hypotesion/elevated antinuclear antibodies/dizziness; Information has been received from a lawyer regarding a case in litigation, concerning an adult female patient (pt) of unknown age. The pt's medical history, concurrent conditions, and concomitant medications were not provided. On 23-APR-2021 (when she was 30-years old), the pt was inoculated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection as prevention of cervical cancer (dose, route of administration, anatomical location, lot number, and expiration date were not provided). Subsequently on 22-APR-2022, she received the second dose of the vaccine (Inappropriate schedule of product administration), both vaccines were administered under her physician's recommendation. On approximately 30-APR-2021 (reported as "within approximately a week from receiving the first Gardasil injection"), the pt began experiencing unusual joint pain. The pain began at the knees and progressed to the pt's shoulder joints and smaller joints. In addition, she began experiencing daily POTS-like (postural orthostatic tachycardia syndrome) symptoms, including tachycardia, dizziness, postural hypotension, and abdominal pain. Due to the abdominal pain, she made reoccurring visits to the hospital. As well as relied on medications such as hydroxychloroquine (PLAQUENIL) and various over-the-counter pain relief items like heat wraps, lidocaine patches, NSAID creams, and more. Unfortunately, none of these remedied the pain. Moreover, on an unknown date, the pt was diagnosed with elevated antinuclear antibodies, low-grade fevers, severe chronic pain, loss of range of motion, weakness, and lack of control of some muscles and fingers, and bowel inflammation. Post vaccination, the pt visited numerous specialists to evaluate her symptoms, such as an orthopedist, gastroenterologist, rheumatologist, and the emergency room. Thus, she was diagnosed with psoriatic arthritis and fibromyalgia. As the months progressed, so did the pt's injuries. She was seen by multiple physicians and specialists for her complaints which now included: joint pain, tachycardia dizziness, POTS-like symptoms, postural hypotension, abdominal pain, low-grade fevers, chronic pain, loss of range of motion, weakness, muscle function loss, bowel inflammation, and elevated antinuclear antibodies levels. As a result of her post Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, the pt has been unable to engage in activities that a normal young person would enjoy. As the sole caregiver and a healthcare professional, her career has been significantly impacted by the physical limitations caused by these symptoms. She was no longer able to complete a full shift without experiencing considerable pain and now depended on lidocaine patches for relief. Additionally, the medications that help her manage these symptoms have severely restricted her ability to pursue her personal aspirations, such as traveling, making such goals nearly impossible to achieve. Furthermore, the medication prescribed to manage her symptoms carries the risk of causing blindness, instilling a profound fear for the long-term quality of her life and future. Based upon her chronic and severe symptoms, the pt has been diagnosed with various medical conditions, including but not limited to, psoriatic arthritis, fibromyalgia, and POTS-like symptoms. In addition, the pt contended that her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune and autonomic injuries, including but not limited to psoriatic arthritis, fibromyalgia, and POTS-like symptoms, as well as a constellation of adverse events symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or otherwise linked to her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)-induced autoimmune and autonomic disorder. Moreover, the pt sustained that The Company's negligence was the proximate cause of the injuries, harm, and economic losses that she suffered, and will continue to suffer, as described herein. Additionally, as a direct and proximate result of her vaccine-induced injuries the pt has suffered considerable non-economic and economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and will continue to incur. The patient had not recovered from the adverse events, and it was considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Upon internal review the event psoriatic arthropathy was considered to be medically significant. Lot numbers are being requested and will be submitted if received.
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| 2823129 | U | IL | 01/28/2025 |
MMRV |
MERCK & CO. INC. |
Y013574 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE; HCP called to report a Temperature Excursion on case number 02740636. The case is...
No additional AE; HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROQUAD was inadvertently administered after suffering from a Te; This spontaneous report has been received from a Nurse referring to a patient of an unknown age and gender. The patient's concomitant medications included sterile diluent (MERCK STERILE DILUENT). The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On 11-NOV-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA[recombinant human albumin]) (PROQUAD) injection, 0.5 milliliter, administered as prophylaxis (Lot No. Y013574 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date was not reported but upon internal validation established as 03-FEB-2026) (dose number, route of administration, anatomical location of administration and vaccination scheme frequency were not provided) (product storage error), after a temperature excursion of -11.6 degree Celsius (C) during a time frame of 3 hours, 5 minutes and 0 seconds. Previous temperature excursions could not be confirmed. No additional adverse event (AE) was reported (no adverse event). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2501USA007066: US-009507513-2501USA008866: US-009507513-2501USA008885: US-009507513-2501USA009045: US-009507513-2501USA008880: US-009507513-2501USA008935: US-009507513-2501USA008877: US-009507513-2501USA008882: US-009507513-2501USA007047: US-009507513-2501USA007446: US-009507513-2501USA008861:
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| 2823140 | 69 | M | OR | 01/28/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2406 |
Injection site paraesthesia, Injection site reaction
Injection site paraesthesia, Injection site reaction
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PATIENT STATES THAT INJECTION SITE FELT FINE FOR A FEW DAYS AFTER THE VACCINE WAS GIVEN. AS TIME WE...
PATIENT STATES THAT INJECTION SITE FELT FINE FOR A FEW DAYS AFTER THE VACCINE WAS GIVEN. AS TIME WENT ON NOTICED TINGLING AT THE INJECTION SITE AND FEELING LIKE MUSCLES WERE MOVING (DESCRIBED LIKE THE MUSCLE WAS A BED OF WORMS). PATIENT FEELS LIKE THE SENSATION IS GETTING MORE INTENSE AS TIME GOES ON.
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| 2823141 | 50 | F | OR | 01/28/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
GA99K GA99K |
Abdominal discomfort, Arthralgia, Chest discomfort, Chills, Cough; Myalgia, Pyre...
Abdominal discomfort, Arthralgia, Chest discomfort, Chills, Cough; Myalgia, Pyrexia, Rash
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Approximately 12 hours after administration, pt reported rigors, chills, GI discomfort. Progressed t...
Approximately 12 hours after administration, pt reported rigors, chills, GI discomfort. Progressed to myalgias, arthralgias, chest discomfort, cough, rash. Fever in office on 1/28/2025 of 103.1 (no fever management prior to visit.)
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| 2823145 | 41 | M | AZ | 01/28/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Bacterial test negative, Breakthrough COVID-19, CSF protein increased, CSF virus...
Bacterial test negative, Breakthrough COVID-19, CSF protein increased, CSF virus no organisms observed, Chills; Computerised tomogram head normal, Cough, Diplopia, Headache, Magnetic resonance imaging head normal; Myalgia, Pyrexia, SARS-CoV-2 test positive, X-ray
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient is a 43-year-old male (F->M) with a history of asthma, GAD, mood disorder, PTSD, Htn, anxiety, depression, headache, neck pain diabetes hyperlipidemia who presented with cough, myalgias, and headache. He is a nursing student who has had recent exposure to COVID, flu,and meningitis. He reports double vision that is worse in the left eye. His COVID test came back positive and the patient was admitted on 9/26 for further workup and meningitis rule out. Imaging including CT head, MRI brain were negative for acute process. On 9/27 he underwent a fluoro guided LP by IR to r/o meningitis. His sx were improving at this time. CSF studies showed marginally elevated protein, no other significant findings and biofire resulted as normal for all viral and bacterial pathologies. Pt experienced fever, myalgia, and chills and also received remdesivir treatment He was cleared for d/c on 9/28. Other Relevant HX: 1. Posttraumatic stress disorder (SNOMED CT 47505003) 2. Intervertebral Disk Displacement * 3. LBP * 4. Hyperkinetic Synd Nos 5. Acne 6. Mastectomy 7. Seizure (SNOMED CT 91175000) 8. Mood Disorder due to a General Medical Condition 9. Asthma (SNOMED CT 195967001) 10. Headache (SNOMED CT 25064002) 11. Neck Pain 12. Hypothyroidism (SNOMED CT 40930008) 13. Hyperlipidemia 14. Cholecystectomy 15. Diarrhea * 16. Vision, Subnormal * 17. Colonoscopy through Stoma 18. Pulp Necrosis 19. Acute apical periodontitis of pulpal origin 20. Seizure (SNOMED CT 91175000)
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| 2823146 | 75 | M | AZ | 01/28/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
GJ3275 GJ3275 GJ3275 |
Acute respiratory failure, Anaemia, Asthenia, Breakthrough COVID-19, Chronic obs...
Acute respiratory failure, Anaemia, Asthenia, Breakthrough COVID-19, Chronic obstructive pulmonary disease; Condition aggravated, Cough, Dyspnoea, Faeces discoloured, Malaise; SARS-CoV-2 test positive
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: 77yo male w/ PMh sig for Prostate CA, Barrett's esophagus, h/o esophageal stricture, COPD, and dysarthria admitted to hospital on 09/26 for evaluation/management of Acute hypoxemic respiratory failure thought to be due to an exacerbation of COPD triggered by COVID infection after presenting to hospital w/ 1-2d h/o worsening cough, malaise, weakness, and dyspnea in the setting of COVID19 infection. Patient subsequently noted to have black stools and anemia with concern for UGI bleeding. Pt became medically stable and was discharged on October 3rd, 2024. Other Relevant HX: 1. Asthma (195967001) 2. History of malignant neoplasm of prostate (428262008) 3. Hypertensive heart disease (64715009) 4. Barrett's esophagus (302914006) 5. Abnormal gait (22325002) 6. Chronic low back pain 7. Morbid obesity 8. Osteopenia 9. Primary malignant neoplasm of prostate 10. Arthritis 11. Chronic back pain 12. Degeneration of lumbosacral intervertebral disc 13. Impacted cerumen 14. Arthritis of knee 15. Allergic rhinitis 16. Acute exacerbation of chronic obstructive airways disease 17. Arthropathy of knee joint 18. Chronic obstructive lung disease 19. Nocturia 20. Edema 21. Contact dermatitis 22. At moderate risk of venous thromboembolism 23. Osteoporosis 24. Iron deficiency anemia 25. Gastroesophageal reflux disease 26. Exposure to potentially hazardous substance (133261000119105) Other: Hospitalization
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| 2823147 | 75 | M | AZ | 01/28/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EN6207 EN6207 EN6207 |
Asthenia, Breakthrough COVID-19, Chest pain, Chills, Deep vein thrombosis; Diarr...
Asthenia, Breakthrough COVID-19, Chest pain, Chills, Deep vein thrombosis; Diarrhoea, Feeding disorder, Oropharyngeal pain, Painful respiration, Productive cough; Pulmonary embolism, SARS-CoV-2 test positive, Urinary tract infection, Vomiting
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was admitted on October 3rd, 2024 Patient is 79 year old MALE with PMHx of chronic back pain, HTN, HLD, CAD, HFrEF (40-45%), OSA, DM, prostate cancer with suprapubic catheter, hypothyroidism, mood disorder, parkinson's disease, restless leg syndrome, with recent hospitalization (9/27-10/1) for segmental PE with LE DVT and found to be COVID positive during hospital stay has returned to the ED one day after discharge for severe throat pain preventing him from eating or drinking. He feels he is just too weak and his daughter brought him to the ER because she was concerned with his inability to eat or drink anything. The sore throat started the day he was tested for COVID in his last admission and has gotten progressively worse. He doese endorse chest pain in the center of his chest when he takes a deep breathe. He has been compliant with his new medications including the apixaban for his known PE. He also notes a cough with some sputum but he cannot comment on what the sputum looks like. He reports subjective chills but no recorded temperature at home. He did vomit upon arrival to the ED and believes he has been having diarrhea. He denies headache, difficulty breathing, palpitations, leg swelling, abdominal pain, or constipation. Patient also found to have a UTI during prior hospitalization. Denies any dysuria. Upon admission, patient was started on IV remdesivir course for COVID-19 infection, which was continued for
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| 2823148 | 57 | M | AZ | 01/28/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
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Breakthrough COVID-19, Dyspnoea, Dyspnoea exertional, Fatigue, Orthopnoea; SARS-...
Breakthrough COVID-19, Dyspnoea, Dyspnoea exertional, Fatigue, Orthopnoea; SARS-CoV-2 test positive, Sleep disorder
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Pt was admitted October 3rd, 2024. Patient is a 60 year old MALE who was admitted to the ED due to 3 days of shortness of breath. Pmhx of hypertension, substance use disorder, alcohol use disorder (abstinent for > 1 year) and tobacco use (last use 1 month ago). Pt states that his SOB has been persistent for the past three days. Nothing has relieved it, and it is worsened with exercise and laying down flat while trying to sleep. He has never had these symptoms before. Pt states that while he has been tired, he does get woken up multiple times by it, and ends up gasping for breath. Pt stated that he had no illness before leading up to his SOB. He denies systemic symptoms, no fevers, chills. Patient was also found to be Covid positive in the ED and he recieved remdesivir 200mg once and 2 days of 100mg for symptoms. Symptomatic treatment was continued during hospitalization. Pt became medically stable was discharged on October 5th, 2024 Other Relevant HX: 1. gerd 2. hypertension 3. h/o cocaine and etoh abuse 4. s/p right bunionectomy 2001 5. Major-Recurernt 6. Dupuytren's disease of palm of bilateral hands (16314671000119104) 7. Inguinal hernia, without mention of obstruction or gangrene 8. Hypertension (38341003) 9. Sciatica * 10. Chronic back pain (134407002) 11. Esophageal Reflux 12. Polysubstance dependence 13. Plantar fibromatosis * 14. Bipolar affective disorder (13746004) 15. Pain in left knee
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| 2823149 | 77 | M | AZ | 01/28/2025 |
COVID19-2 |
PFIZER\BIONTECH |
GL0447 |
Breakthrough COVID-19, SARS-CoV-2 test positive
Breakthrough COVID-19, SARS-CoV-2 test positive
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was admitted on 7/23 and discharged back to group home on 7/27. Other Relevant HX: Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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| 2823150 | 73 | M | AZ | 01/28/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FH8030 FH8030 |
Breakthrough COVID-19, Chest X-ray abnormal, Dyspnoea, Lung infiltration, Malais...
Breakthrough COVID-19, Chest X-ray abnormal, Dyspnoea, Lung infiltration, Malaise; Pulmonary fibrosis, SARS-CoV-2 test positive
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Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient is a 76 year old MALE with PMH of COPD on 4L home 02, previous PE on apixaban, and recent COVID + status who presents to the ED with increased difficulty breathing and worsening dyspnea. He was admitted 08/28/2024. Patient was recently seen in the ED on 08/23 for complaint of feeling unwell and increased shortness of breath with increased 02 requirements and was diagnosed with COVID 19 at that time, and started on molnupiravir. Over the weekend patient states that he did not get any better despite therapy, and today he feels subjectively worse than previous so decided to seek care. He denies any chest pain, palpitations, vomiting, diarrhea, headache. Pt was admitted and then after being medically stabilized he was discharged 09/02/2024. Patient was encouraged to seek out his pulmonologist for follow up appointment and to get prescription for specific at home oxygen usage. Other Relevant HX: PMH of Gout, BPH, Essential hypertension, Chronic obstructive lung disease, Vitamin B12 deficiency, Obesity, Gastroesophageal reflux disease, Pulmonary embolism, and Raised prostate specific antigen. Other: : Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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| 2823151 | 84 | F | AZ | 01/28/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Asthenia, Breakthrough COVID-19, Decreased activity, Hyponatraemia, Hypophagia; ...
Asthenia, Breakthrough COVID-19, Decreased activity, Hyponatraemia, Hypophagia; Inappropriate antidiuretic hormone secretion, Migraine, SARS-CoV-2 test positive, Viral infection
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: 88-year-old female with past medical history significant for hypertension, hyperlipidemia, hypothyroidism, fibromyalgia. HOSPITAL COURSE: #COVID-19 infection #Migrainous headache likely secondary to above #Fibromyalgia - No respiratory symptoms - Remdesivir x 3 days completed #Generalized Weakness due to COVID-19 and inactivity - PT/OT evaluations and recommendation for home safety evaluation - additionally will provide home health PT for follow up on discharge. - Patient and Daughter at bedside in agreement with plan #Hyponatremia likely secondary to poor oral intake from acute viral illness. - No significant change in the sodium level with NS IV - seems hypoosmolar, UNa > 20, suspect SIADH in the setting COVID. - Would not aggressively fluid restrict, continue PO intake at home Pt recovered, became stable at discharge, and discharged to home on 09/04/2024 Other Relevant HX: PROBLEM 1. Hypothyroidism 2. Osteoporosis 3. Cataract 4. Benign essential hypertension 5. Hyperlipidemia 6. Low Back Pain 7. Shoulder Pain 8. Pain in both hip joints 9. Urinary Incontinence 10. Fibromyalgia 11. Osteoarthritis 12. Benign neoplasm of larynx 13. Dysphagia 14. Perforation of nasal septum Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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| 2823152 | 76 | M | AZ | 01/28/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Acute myocardial infarction, Acute respiratory failure, Breakthrough COVID-19, C...
Acute myocardial infarction, Acute respiratory failure, Breakthrough COVID-19, Cardiac failure, Catheterisation cardiac; Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Intensive care, Left ventricular failure; Positive airway pressure therapy, SARS-CoV-2 test positive
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: 77 year old MALE with PMH significant for recent NSTEMI (6/30/2024 sp LHC (no intervention), recent covid infection (1 mtn ago), Afib (on eliquis), severe COPD Gold Grade 4(FEV<30%), GroupD on 3-4L O2 NC at home, dilated cardiomyopathy (EtOH?) LVEF 55-60%, HTN, HLD, chronic cystitis, severe spinal stenosis, sacral wounds (follows with wound care) and previous smoker presented to hospital with dyspnea from his living facility. Patient admitted to the MICU for acute hypoxic respiratory failure requiring bipap secondary to concern for COPD exacerbation and decompensated diastolic heart failure exacerbation. Patient underwent treatment with steroids and azithromycin for COPD exacerbation and decompensated diastolic heart failure. He was downgraded to the medicine team on 9/2. Patient became stable and was discharged on 9/6. Other Relevant HX: PMH significant for NSTEMI, sp LHC, covid infection, Afib, severe COPD Gold Grade 4(FEV<30%),GroupD on 3-4L O2 NC at home, dilated cardiomyopathy, LVEF 55-60%, HTN, HLD, chronic cystitis, severe spinal stenosis, sacral wounds, and previous smoker. Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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| 2823153 | 75 | F | AZ | 01/28/2025 |
COVID19 |
PFIZER\BIONTECH |
EM9809 |
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
Breakthrough COVID-19, Chest X-ray, SARS-CoV-2 test positive
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Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054115:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient was admitted to the hospital on 7/31 and was discharged to home on 8/1/24. Other Relevant HX: PMH: T2DM, HTN, HLD, osteomyelitis; hx of hip fracture, hx of CABG, atrial flutter, BPH Other: Hospitalization due to Covid-19 infection after having received Covid-19 Vaccination
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| 2823154 | 92 | M | AZ | 01/28/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Arthralgia, Asthenia, Breakthrough COVID-19, Confusional state, Cough; Dyspnoea,...
Arthralgia, Asthenia, Breakthrough COVID-19, Confusional state, Cough; Dyspnoea, Fatigue, Feeling of body temperature change, Muscle spasms, Myalgia; Nasal congestion, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
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Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID...
Reported Symptoms: 10054112:HOSPITALISATION; 10067923:VACCINE BREAKTHROUGH INFECTION; 10084268:COVID-19; Narrative: Patient is a 96 year old MALE presents this evening with shortness of breath with nasal congestion and chest congestion. Symptoms started earlier 09/14/2024. He states he had a fever but does not know how high. He has hot and cold sensations. He has had a sore throat. He does have a cough but no sputum production. No diarrhea. Eating and drinking normally. No chest pain or palpitations. He has been weak, tired and fatigued more than usual. No vision changes. Positive myalgias and arthralgias out of the ordinary. No leg swelling or pain out of the ordinary. No abdominal pain. No diarrhea. No dysuria. No rashes. No headache. Patient did nothing at home to improve his symptoms. Time seems to be worsening things. As the day went on his weakness persisted and got worse as the day progressed. Some mild confusion that waxes and wanes. He is taking his medications and no recent changes in medications. Occasional muscle cramping. HOSPITAL COURSE: Found to have COVID19, treated as noted below. Issues with disposition initially but step son agreed to take home. COVID-19 infection, resolved, on room air, s/p dex, azithro, remdesivir 3 day course. Pt became stable and was discharged 09/20/2024 Other Relevant HX: PROBLEM 1. Hyperlipidemia (55822004) 2. Obesity (414916001) 3. Elevated PSA (396152005) 4. Benign prostatic hyperplasia (266569009) 5. Dermatitis/Eczema 6. Intermittent
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| 2823155 | 41 | F | MI | 01/28/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3042648 3042648 |
Angina pectoris, Atrial flutter, Electrocardiogram QRS complex shortened, Myocar...
Angina pectoris, Atrial flutter, Electrocardiogram QRS complex shortened, Myocardial ischaemia, Palpitations; Tachycardia, Troponin increased
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Reported Symptoms: 10043071:TACHYCARDIA; Narrative: Patient presented to the urgent care on 10/21/2...
Reported Symptoms: 10043071:TACHYCARDIA; Narrative: Patient presented to the urgent care on 10/21/24 with cold and flu symptoms following strep throat exposure. While being in urgent care the patient was given a covid and influenza vaccine. Patient presented to her local emergency department on 10/21/24 with angina and feeling like her heart was racing. EKG showed narrow complex tachycardia with maximum heart rate of 211. Patient was given adenosine with no resolution so she was started on heparin and diltiazem continuous infusions for atrial flutter with RVR. Troponin inreased to 170 from 51 showing demand ischemia. Patient was transferred to a highter acuity facility and the patient spontaneously converted to a normal sinus rhythm . Patient was transitioned to metoprolol and apixaban on discharge. Patient was discharged on 10/23/24. Follow-up ECG from 12/4/24 showed normal function of the left ventricle. Facility physician suspected the cause of this event was the Covid vaccine. Patient had no previous cardiac diagnoses. Patient has no other vaccine reactions listed. Other Relevant HX; Other: TACHYCARDIA
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| 2823156 | 39 | M | MI | 01/28/2025 |
COVID19 |
MODERNA |
3043156 |
Rash
Rash
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Reported Symptoms: 10037844:RASH; Narrative: Patient received the Spikevax vaccine on 9/24/24. Patie...
Reported Symptoms: 10037844:RASH; Narrative: Patient received the Spikevax vaccine on 9/24/24. Patient called on 10/9/24 complaining of a pruritic rash x2-3 days. He stated that he forgot that this had happened the last time he had received a Covid vaccine on 1/26/22. Patient was seen by a local urgent care following the 1/26/22 reaction and there are no records of this in the electronic record. Patient stated that he was treated with steroids in 2022. Patient was called back on 10/10/24 and he stated that he self treated with steroids that he had at his house and diphenhydramine and was doing so much better. He was instructed to not receive the Covid vaccine again, patient said he will still continue to get the annual Covid vaccine again, patient said he will still continue to get the annual Covid vaccine despite having the reaction. Other Relevant HX: Other: RASH
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