| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2828879 | 1 | F | OK | 02/28/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
3RT93 |
Inappropriate schedule of product administration, Product administered to patien...
Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
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patient was supposed to receive a hepatitis A vaccine, but was inadvertently administered a dose of ...
patient was supposed to receive a hepatitis A vaccine, but was inadvertently administered a dose of Kinrix instead; 12 month old female patient received kinrix; The Kinrix made the patient's fourth DTaP; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis. Co-suspect products included Hepatitis A vaccine for prophylaxis. On 31-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Hepatitis A vaccine. On 31-JAN-2025, immediately after receiving Kinrix and not applicable after receiving Hepatitis A vaccine, the patient experienced wrong vaccine administered (Verbatim: patient was supposed to receive a hepatitis A vaccine, but was inadvertently administered a dose of Kinrix instead), inappropriate age at vaccine administration (Verbatim: 12 month old female patient received kinrix) and inappropriate schedule of vaccine administered (Verbatim: The Kinrix made the patient's fourth DTaP). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter reported that a 12 month old female patient had been supposed to receive a hepatitis A vaccine, but was inadvertently administered a dose of Kinrix instead on 31st January 2025, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Kinrix had made the patient's fourth DTaP and IPV dose, with most recent prior dose in August 2024, which led to inappropriate schedule of vaccine administered. The patient had been due for 15 month old DTaP in April 2025. The Kinrix dose had been administered from lot number 3RT93 and expiration date 03th April 2026. The patient had left with plans to come back another day to receive the hepatitis A dose.
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| 2828880 | M | WV | 02/28/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
CX4HL |
Extra dose administered
Extra dose administered
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A twelve year old patient received a first dose of BOOSTRIX on August eight twenty-twenty four and a...
A twelve year old patient received a first dose of BOOSTRIX on August eight twenty-twenty four and a second dose today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number CX4HL, expiry date 09-NOV-2026) for prophylaxis. Previously administered products included Boostrix (received 1st dose on 08-AUG-2024). On 11-FEB-2025, the patient received the 2nd dose of Boostrix. On 11-FEB-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: A twelve year old patient received a first dose of BOOSTRIX on August eight twenty-twenty four and a second dose today). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-FEB-2025 The reporter gave a Boostrix vaccine that was not needed. A patient received a first dose of Boostrix and received second dose on the day of reporting which led to extra dose administered. Licensed practice nurse inquired about any advice on this situation. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.
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| 2828881 | 60 | M | FL | 02/28/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
3L339 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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administer to 60 year old patient"; This non-serious case was reported by a pharmacist via call...
administer to 60 year old patient"; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 60-year-old male patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 03-SEP-2027) for prophylaxis. On 11-FEB-2025, the patient received the 1st dose of Bexsero. On 11-FEB-2025, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: administer to 60 year old patient"). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-FEB-2025 The reporter reported that there was a vaccine, the Bexsero vaccine that it was administered at our pharmacy on 11th February 2025, it said that the ages was between 10 to 25 years of age for administration, and the pharmacist that worked that day did not see that and administer to 60 year old patient. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional mentioned that this was the 1st Bexsero dose that the patient received which led to inappropriate age at vaccine administration.
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| 2828882 | CT | 02/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call cente...
Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine 2 years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 19-FEB-2025 The reporter asked that if a person who dosed their first dose of Shingrix more than 2 years ago, what would be the anticipated percentage of coverage for, so they dosed their first dose more than 2 years ago and want another dose now. Do they need to restart altogether or do they have 80% coverage, 60% coverage. If you could please give me a call back, I would greatly appreciate it. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2828883 | 52 | F | FL | 02/28/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Twinrix late third dose; Twinrix late second dose; This non-serious case was reported by a pharmacis...
Twinrix late third dose; Twinrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. On 20-FEB-2025, the patient received the 3rd dose of Twinrix. On 19-FEB-2025, the patient received the 2nd dose of Twinrix. On 19-FEB-2025, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). On 20-FEB-2025, the patient experienced drug dose administration interval too short (Verbatim: Twinrix late third dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 20-FEB-2025 Other HCP reported that she could give a third dose of Twinrix to a patient who received the second dose on 19th February 2025 and the first dose six months ago. Third dose has not been given. Patient received 2nd dose of Twinrix,?later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) Patient received 3rd dose of Twinrix,?earlier than the recommended interval, which led to shortening of vaccinations schedule. (Drug dose administration interval too short)
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| 2828884 | F | FL | 02/28/2025 |
COVID19 |
JANSSEN |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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Covid; lack of effect; This spontaneous report received from a consumer concerned a female patient o...
Covid; lack of effect; This spontaneous report received from a consumer concerned a female patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. The patient's concurrent conditions included: non smoker. The patient was previously treated with janssen covid-19 vaccine for covid-19 prophylaxis. (dose series 1) The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 2, for covid-19 prophylaxis. 0.50 mL. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid and lack of effect. (dose series 2). It was reported that the Johnson and Johnson vaccines were of the poorest quality and they did not work. Patient had her second vaccine with Johnson and Johnson 2 years ago before Christmas or 3 years ago in November and in January, she died of COVID. And she was perfectly healthy. She had no problems. She didn't have any diabetes, cancer, or what have you. And she was a nonsmoker, and she died of it. The action taken with janssen covid-19 vaccine was not applicable. It was unknown if an autopsy was performed. Reported cause of death was covid. The patient died of covid on an unspecified date. The outcome of lack of effect was not reported. This report was associated with a product quality complaint: Product Complaint 90000353174. Investigation Results: 90000353174:Void:N:Product identification information and/or physical evidence, including field sample or photograph to conduct a root cause investigation was not available at the time of this assessment. Root cause and disposition determinations were assessed based on available information.. This report was serious (death and other medically important condition).; Sender's Comments: V0: COVID-19: The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: NATURE OF THE EVENT . Therefore, these events are considered not related. Drug ineffective: The event is a special reporting situation and owing to its own nature, it is not possible to attribute this occurrence to the suspect drug. Hence, the causality is considered as not related.; Reported Cause(s) of Death: Covid
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| 2828885 | F | 02/28/2025 |
COVID19 |
MODERNA |
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COVID-19, Pain, Vaccination failure
COVID-19, Pain, Vaccination failure
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pain and suffering; has the COVID virus for 3 times; Moderna sold a product that doesn't work; ...
pain and suffering; has the COVID virus for 3 times; Moderna sold a product that doesn't work; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (pain and suffering), COVID-19 (has the COVID virus for 3 times) and VACCINATION FAILURE (Moderna sold a product that doesn't work) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain and suffering), COVID-19 (has the COVID virus for 3 times) and VACCINATION FAILURE (Moderna sold a product that doesn't work). At the time of the report, PAIN (pain and suffering), COVID-19 (has the COVID virus for 3 times) and VACCINATION FAILURE (Moderna sold a product that doesn't work) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient had the COVID virus for 3 times since having the Moderna vaccine. She experienced pain and suffering. Moderna sold a product that doesn't work. Investigation Summary & Conclusion with Root Cause Details: On 19FEB2025, a consumer contacted Moderna regarding concerns about the effectiveness of the Spikevax (COVID-19 Vaccine, mRNA). The caller reported that his wife had contracted COVID-19 three times despite receiving the Moderna vaccine, questioning its efficacy. The individual alleged that the vaccine was not properly tested and claimed that it did not prevent COVID-19 as expected. However, no specific product details, such as batch numbers or administration history, were provided, and the caller declined consent for follow-up. The case was forwarded to the Drug Safety team for adverse event reporting, and the regulatory product disclosure was provided. Given that no batch information or additional details were made available, further investigation into the perceived lack of effectiveness was not feasible. It is important to note that while Spikevax is indicated for the prevention of COVID-19, breakthrough infections can still occur due to various factors, including individual immune response and circulating virus variants. No treatment medication was reported. Reporter causality was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2025: Live non-significant information received: reference number added. On 21-Feb-2025: Live significant information received: Closed PQC report received, QC comment and narrative updated.
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| 2828886 | 68 | F | 02/28/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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COVID-19, Chest pain, Ear pain, Malaise, SARS-CoV-2 test; Taste disorder
COVID-19, Chest pain, Ear pain, Malaise, SARS-CoV-2 test; Taste disorder
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tested positive with Covid (home test) on 12FEB2025; Awful taste in the mouth; still feel unwell; ea...
tested positive with Covid (home test) on 12FEB2025; Awful taste in the mouth; still feel unwell; ears hurt; chest hurts; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive with Covid (home test) on 12FEB2025), TASTE DISORDER (Awful taste in the mouth), MALAISE (still feel unwell), EAR PAIN (ears hurt) and CHEST PAIN (chest hurts) in a 68-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Ex-smoker (Smoked for 30 years, quit 15 years ago). Previously administered products included for Product used for unknown indication: Covid-19 vaccine (Dose 7) on 21-Nov-2023, Covid-19 vaccine (Dose 8) on 13-May-2024 and Flu (Always receives a flu shot annually in November.). Past adverse reactions to the above products included No adverse effect with Covid-19 vaccine, Covid-19 vaccine and Flu. On 23-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 12-Feb-2025, the patient experienced COVID-19 (tested positive with Covid (home test) on 12FEB2025), TASTE DISORDER (Awful taste in the mouth), MALAISE (still feel unwell), EAR PAIN (ears hurt) and CHEST PAIN (chest hurts). At the time of the report, COVID-19 (tested positive with Covid (home test) on 12FEB2025), MALAISE (still feel unwell), EAR PAIN (ears hurt) and CHEST PAIN (chest hurts) was resolving and TASTE DISORDER (Awful taste in the mouth) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2025, SARS-CoV-2 test: (Positive) Covid (home test). On 19-Feb-2025, SARS-CoV-2 test: Negative. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. On 08-Mar-2021, The patient received first dose of moderna COVID-19 vaccine (Lot: 036A21A). On 05-Apr-2021, The patient received second dose of moderna COVID-19 vaccine (Lot: 025B21A). On 01-Nov-2021, The patient received 1st booster of moderna COVID-19 vaccine (Lot: 004 F21A). On 02-May-2022, The patient received 2nd booster of moderna COVID-19 vaccine (Lot: 002M21A). On 12-Sep-2022, The patient received Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot: AS7143C On 25-Jul-2023, The patient received Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Lot: AS7645B. Patient never had a fever but due to an "Awful taste in the mouth", decided to test for Covid. Patient had an appointment with HCP on Monday i.e., 24-FEB-2025. No vaccines were received in the 4 weeks prior to last vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-660956 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2022-660956:Same patient with different moderna product
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| 2828887 | 67 | M | CA | 02/28/2025 |
COVID19 |
MODERNA |
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Seizure
Seizure
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seizure; This spontaneous case was reported by a pharmacist and describes the occurrence of SEIZURE ...
seizure; This spontaneous case was reported by a pharmacist and describes the occurrence of SEIZURE (seizure) in a 68-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Falling (history of falling), Major depressive disorder, Metabolic encephalopathy and Unspecified protein-calorie malnutrition. Concurrent medical conditions included Dementia (unspecified dementia), Adult failure to thrive, Bradycardia, Schizophrenia, Epilepsy, Anemia, Hyperlipidemia, Essential hypertension and Generalized osteoarthritis. In October 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In December 2024, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter considered SEIZURE (seizure) to be related. Patient had no known allergies. All the historical condition was as of 16-May-2024 according to the resident's face sheet. It was unknown if the patient had any additional medical history, concomitant disease or risk factor. Concomitant product use was not provided by the reporter. It was reported that patient was in a skilled nursing facility at the time of vaccination. There were no lab data or results were available. Treatment information was not provided. It was reported that seizure was risk from COVID vaccines.; Reporter's Comments: The medical history of Metabolic encephalopathy, concurrent medical conditions dementia, Schizophrenia and Epilepsy are confounders for the event. In view of the long non-suggestive onset latency the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
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| 2828888 | 60 | M | 02/28/2025 |
COVID19 |
MODERNA |
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Herpes virus infection, Herpes virus test, Respiratory disorder
Herpes virus infection, Herpes virus test, Respiratory disorder
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Moderna vaccine caused herpes, and respiratory issues / he now has both; Moderna vaccine caused herp...
Moderna vaccine caused herpes, and respiratory issues / he now has both; Moderna vaccine caused herpes, and respiratory issues / he now has both; This spontaneous case was reported by a patient and describes the occurrence of HERPES VIRUS INFECTION (Moderna vaccine caused herpes, and respiratory issues / he now has both) and RESPIRATORY DISORDER (Moderna vaccine caused herpes, and respiratory issues / he now has both) in a 60-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (Moderna vaccine caused herpes, and respiratory issues / he now has both) and RESPIRATORY DISORDER (Moderna vaccine caused herpes, and respiratory issues / he now has both). At the time of the report, HERPES VIRUS INFECTION (Moderna vaccine caused herpes, and respiratory issues / he now has both) and RESPIRATORY DISORDER (Moderna vaccine caused herpes, and respiratory issues / he now has both) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Herpes virus test: Positive. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. Patient had read reports suggesting that the moderna vaccine was linked to herpes and respiratory issues, and he now experiences both conditions. He discovered that moderna planned to release a herpes cure in June 2025, raised questions about accessibility and affordability for average workers, especially since he had limited financial resources. He was inactive sexually for over 20 years, he underwent a physical in 2019 that included herpes testing, which returned negative results. However, after receiving the moderna vaccine and boosters during the covid pandemic, he tested positive for herpes in a 2024 physical, a result he found shocking. Despite retesting twice with the same positive outcome, he felt devastated. Now in his 60s and eager to started dating, he was hesitant to pursue relationships due to the fear of unintentionally transmitting the virus, even with protection. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.
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| 2828889 | M | 02/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Memory impairment
Memory impairment
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lost all sense of recognition as to me were we live anything that was familiar to him; This is a spo...
lost all sense of recognition as to me were we live anything that was familiar to him; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Feb2025 as dose 1, 30 ug single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious) with onset 24Feb2025, outcome "unknown", described as "lost all sense of recognition as to me were we live anything that was familiar to him". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500043877 same reporter/event, different patient;
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| 2828891 | 82 | M | MA | 02/28/2025 |
RSV RSV RSV RSV |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\WYETH PFIZER\WYETH |
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Hypoaesthesia, Laboratory test; Hypoaesthesia; Hypoaesthesia, Laboratory test; H...
Hypoaesthesia, Laboratory test; Hypoaesthesia; Hypoaesthesia, Laboratory test; Hypoaesthesia
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much like Guillain Barre Syndrome; Numbness in my extremities/Numbness in my feet and hands; This is...
much like Guillain Barre Syndrome; Numbness in my extremities/Numbness in my feet and hands; This is a spontaneous report received from a Consumer or other non HCP. An 82-year-old male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 18Feb2025 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years intramuscular (left shoulder) for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPOAESTHESIA (hospitalization) with onset 21Feb2025 at 06:30, outcome "unknown", described as "Numbness in my extremities/Numbness in my feet and hands"; GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset 21Feb2025 at 06:30, outcome "unknown", described as "much like Guillain Barre Syndrome". The patient was hospitalized for guillain-barre syndrome, hypoaesthesia (start date: 22Feb2025). The patient underwent the following laboratory tests and procedures: Lab work: Unknown results. 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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| 2828892 | F | CA | 02/28/2025 |
PNC20 |
PFIZER\WYETH |
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Arthritis, Mouth swelling, Pain in extremity, Pain in jaw, Peripheral swelling
Arthritis, Mouth swelling, Pain in extremity, Pain in jaw, Peripheral swelling
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Her arm was very/really sore for many days and swollen at the the same time; It's on the right...
Her arm was very/really sore for many days and swollen at the the same time; It's on the right side of mouth where she is having issues, it was swollen; Her jaw hurts a lot.; TMJ joint is inflamed; TMJ joint is inflamed; Her arm was very/really sore for many days and swollen at the the same time; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Feb2025 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Feb2025, outcome "recovered" (26Feb2025), PERIPHERAL SWELLING (non-serious), outcome "recovered" (26Feb2025) and all described as "Her arm was very/really sore for many days and swollen at the the same time"; PAIN IN JAW (non-serious) with onset 23Feb2025, outcome "not recovered", described as "Her jaw hurts a lot."; TEMPOROMANDIBULAR PAIN AND DYSFUNCTION SYNDROME (non-serious), ARTHRITIS (non-serious) all with onset 23Feb2025, outcome "not recovered" and all described as "TMJ joint is inflamed"; MOUTH SWELLING (non-serious), outcome "unknown", described as "It's on the right side of mouth where she is having issues, it was swollen". Therapeutic measures were taken as a result of pain in jaw, temporomandibular pain and dysfunction syndrome, arthritis. Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling. Additional information: TMJ joint is inflamed: She further explained it hurts when drink hot and cold. She cannot pin point a tooth whole, whole side is sore. Patient took Ibuprofen once or twice a day for TMJ joint is inflamed. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2828893 | F | LA | 02/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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first time ever getting Covid; first time ever getting Covid; This is a spontaneous report received ...
first time ever getting Covid; first time ever getting Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as does 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series complete.), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "first time ever getting Covid". The event "first time ever getting covid" required emergency room visit. Clinical details: the patient stated that out of all the times, this was her first time ever getting Covid, she never had it. She got all her Covid shots.
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| 2828894 | F | NC | 02/28/2025 |
COVID19 |
PFIZER\BIONTECH |
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Fatigue, Lichenoid keratosis
Fatigue, Lichenoid keratosis
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lichenoid dermatitis; long term fatigue; This is a spontaneous report received from a Consumer or ot...
lichenoid dermatitis; long term fatigue; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "Chronic fatigue/long hauler covid" (unspecified if ongoing); "Chronic fatigue/long hauler covid" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "L ventricular regurgitation/coronary artery disease" (unspecified if ongoing); "L ventricular regurgitation/coronary artery disease" (unspecified if ongoing); "mild copd" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; WELLBUTRIN taken for depression; TRINTELLIX taken for depression; ADDERALL taken for fatigue, post-acute covid-19 syndrome; CLONAZEPAN taken for insomnia; ASA taken for coronary artery disease, mitral valve incompetence. Past drug history included: Codeine for Drug allergy; Talwin for Drug allergy; Augmentin for Drug allergy; Zpak for Drug allergy; Erythromycin for Drug allergy; Lunesta for Drug allergy; Seroquel for Drug allergy. The following information was reported: LICHENOID KERATOSIS (non-serious), outcome "unknown", described as "lichenoid dermatitis"; FATIGUE (non-serious), outcome "unknown", described as "long term fatigue". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500007634 same patient, product, event; different dose;
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| 2828895 | M | FL | 02/28/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
946583 946583 |
Facial paralysis, Gait disturbance, Guillain-Barre syndrome, Paraesthesia, Presy...
Facial paralysis, Gait disturbance, Guillain-Barre syndrome, Paraesthesia, Presyncope; Syncope, Walking aid user
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Guillain-Barre Syndrome; Facial paralysis is still pretty significant.; Patient still can't wal...
Guillain-Barre Syndrome; Facial paralysis is still pretty significant.; Patient still can't walk without walker; Syncope; Presyncope; Paresthesia; This spontaneous case, initially received on 20-Feb-2025, was reported by a health professional and concerns an adult male patient. Concomitant medication were reported as unknown and patient has no medical history. There was no allergy information reported. There was no product complaint associated with this case. Administration of company suspect drug: On 01-Jan-2025, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: not reported, Lot number: 946583. No additional suspect drugs. Adverse reactions/events and outcomes: On 14-Feb-2025, the patient experienced Guillain-Barre Syndrome (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved), Facial paralysis is still pretty significant (Medically Significant, Hospitalized, outcome: Not recovered / Not resolved), Patient still can't walk without walker (Hospitalized, outcome: Not recovered / Not resolved). On an unknown date, the patient experienced Syncope (Medically Significant, outcome: Not Reported), presyncope (outcome: Not Reported), paresthesia (outcome: Not Reported). The following additional adverse events had been identified during post-approval use of FLUCELVAX or FLUCELVAX QUADRIVALENT. Because these events were reported voluntarily from a population of uncertain size, it was not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. Nervous systems disorders: Syncope, presyncope, paresthesia, Guillain-Barr๏ฟฝ syndrome." Patient received Flucelvax and experienced Guillain-Barr๏ฟฝ Syndrome. Patient still could not walk without walker and facial paralysis was still pretty significant. Patient never experienced an adverse reaction to the vaccine. It was prescribed to patient 5 days of hemoglobulin therapy infusion. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Hemoglobin Reporter's assessment: The reporter assessed the events Guillain-Barre Syndrome, Facial paralysis is still pretty significant, and Patient still can't walk without walker as serious (Hospitalization) and did not provide the causality assessment. The reporter did not provide the seriousness and causality assessment for the rest of the events.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Causal association could not be completely ruled out in view of insufficient information, hence causality assessed as related.(onset latency/temporality, medical history, concomitant drugs,diagnostic reports). Brighton collaboration criteria assessed as Level 4 (insufficient information to meet any level of certainty) for Guillain Barre Syndrome and facial paralysis .
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โ | ||||||
| 2828896 | 83 | F | 02/28/2025 |
COVID19 COVID19 UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
6024MF020 6024MF020 388489 388489 |
Acute respiratory failure, Areflexia, CSF glucose, CSF protein, CSF red blood ce...
Acute respiratory failure, Areflexia, CSF glucose, CSF protein, CSF red blood cell count; CSF white blood cell count, Guillain-Barre syndrome, Muscular weakness, Quadriplegia, Toxic encephalopathy; Acute respiratory failure, Areflexia, CSF glucose, CSF protein, CSF red blood cell count; CSF white blood cell count, Guillain-Barre syndrome, Muscular weakness, Quadriplegia, Toxic encephalopathy
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Acute respiratory failure; Guillain-Barre syndrome; Acute toxic metabolic encephalopathy; Quadripleg...
Acute respiratory failure; Guillain-Barre syndrome; Acute toxic metabolic encephalopathy; Quadriplegia; Areflexia; Muscular weakness; This spontaneous case, initially received on 21-Feb-2025, was reported by a non health professional and concerns an elderly female patient. Drug history included cefaclor (Reaction: allergy), erithromycin (Reaction: allergy). At the time of the event the patient had hypothyroidism, osteoporosis, hypertension, hypercholesterolemia, cerebrovascular small vessel disease, sciatica, osteoarthritis. On an unknown date, the patient had clotting factor transfusion and endotracheal intubation. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 03-Dec-2024, the patient received Fluad (TIV) for Drug use for unknown indication, Dose regimen and anatomical location: not reported, Route of administration: Unknown, Lot number: 388489. Non-company suspect drugs: Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373)), Indication: COVID-19 immunisation. Patient received 0.5 ml, intramuscular, anatomical location: not reported on 03-Dec-2024. Adverse reactions/events and outcomes: On 25-Dec-2024, the patient experienced Acute respiratory failure (Medically Significant, Hospitalized, outcome: Unknown), Acute toxic metabolic encephalopathy (Medically Significant, Hospitalized, outcome: Unknown) and Guillain-Barre syndrome (Medically Significant, Hospitalized, outcome: Unknown) Associated symptoms included, Quadriplegia, Muscular weakness, Areflexia. An elderly female with relevant past medical history of hypertension, hyperlipidemia and hypothyroidism presented to an OSH (outside hospital) on 26-Dec-2024 with complaint of significant lower extremity weakness. Patient was found to have AIDP (Acute inflammatory demyelinating polyneuropathy), acute respiratory failure (extubated 05-Jan-2025), and acute toxic metabolic encephalopathy, now sip plasmapheresis (completed on 15-Jan-2025) and cryoprecipitate (16-Jan-2025) now presenting with incomplete tetraplegia with LE (lower extremity) much more affected than UE (upper extremity). Admitted to for AIDP on 17-Jan-2025. AIDP -consistent with GBS, especially given elevated CSF protein, absent DTRs and recent influenza and COVID vaccines about 1 month ago -CSF studies to date reviewed: Protein 124.6, glucose 101 -Lactic acid 2.2 -WBC 1, RBC 1 -Gram stain no organisms, Cx NGTD -VDRL not detected -VZV, HSV, CMV, WNV, enterovirus PCR negative -KOH prep reveals no mycelia or yeast forms; ABF smear negative -Cytology revealed increased white cells with a few neutrophils, lymphocytes and many monocytes -Completed 5 sessions of plasmapheresis last on 15-Jan-2205. Relevant lab tests included: CSF CULTURE NEGATIVE (Result: Negative, Test Date: Unknown), CSF GLUCOSE INCREASED (Result: INCREASED, Test Date: Unknown), CSF LACTATE DECREASED (Result: DECREASED, Test Date: Unknown), CSF PROTEIN INCREASED (Result: INCREASED, Test Date: Unknown), CSF RED BLOOD CELL COUNT POSITIVE (Result: Positive, Test Date: Unknown), CSF WHITE BLOOD CELL COUNT NEGATIVE (Result: Negative, Test Date: Unknown), CYTOLOGY ABNORMAL (Result: ABNORMAL, Test Date: Unknown) (increased white cells with a few neutrophils, lymphocytes and many monocytes), CYTOMEGALO VIRUS TEST NEGATIVE(Result: Negative, Test Date: Unknown), ENTERO VIRUS TEST NEGATIVE (Result: Negative, Test Date: Unknown), GRAM STAIN NEGATIVE (Result: Negative, Test Date: Unknown), HERPES SIMPLEX TEST NEGATIVE (Result: Negative, Test Date: Unknown), MYCOBACTERIUM TEST NEGATIVE (Result: Negative, Test Date: Unknown), POTASSIUM HYDROXIDE PREPARATION NEGATIVE (Result: Negative, Test Date: Unknown), TREPONEMA TEST NEGATIVE ( Result: Negative, Test Date: Unknown), VARJCELLA VIRUS TEST NEGATIVE (Result: Negative, Test Date: Unknown) and WEST NILE VIRUS TEST NEGATIVE (Result: Negative, Test Date: Unknown). At the time of reporting, the event outcome of Acute respiratory failure was Unknown, Areflexia was Unknown, CSF glucose increased was Unknown, CSF red blood cell count positive was Unknown, CSF lactate decreased was Unknown, Guillain-Barre syndrome was Unknown, Quadriplegia was Unknown, CSF protein increased was Unknown, Cytology abnormal was Unknown, Toxic encephalopathy was Unknown and Muscular weakness was Unknown. Fluad (TIV) action taken: Not Applicable Reporter's causality: The reporter did not provide causality assessment and all events considered as serious (Hospitalization and medically significant).; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes. Related for Guillain-Barre syndrome due to pharmacological plausibility. Guillain-Barre syndrome and Toxic encephalopathy are assessed as contributing factors for acute respiratory failure. Of note, co-suspect Novavax vaccine is considered as confounder for the events. The case meets Level 4 (due to insufficient information) Brighton Collaboration diagnostic certainty for the event of Guillain-Barre syndrome.
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โ | ||||||
| 2828902 | M | 02/28/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Myocardial infarction, Ventricular fibrillation; Myocardial infarction, Ventricu...
Myocardial infarction, Ventricular fibrillation; Myocardial infarction, Ventricular fibrillation; COVID-19, Drug ineffective; Myocardial infarction, Ventricular fibrillation; Myocardial infarction, Ventricular fibrillation; COVID-19, Drug ineffective; Myocardial infarction, Ventricular fibrillation; Myocardial infarction, Ventricular fibrillation; COVID-19, Drug ineffective
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Vfib heart attack; Vfib heart attack; This is a spontaneous report received from a Consumer or other...
Vfib heart attack; Vfib heart attack; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: VENTRICULAR FIBRILLATION (death), MYOCARDIAL INFARCTION (death) all with onset Jan2022, outcome "fatal" and all described as "Vfib heart attack". The patient date of death was Jan2022. Reported cause of death: "Vfib heart attack", "heart attack". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202500024499 Same patient and suspect product different dose/AE;; Reported Cause(s) of Death: Vfib heart attack; heart attack
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โ | |||||||
| 2828903 | F | NV | 02/28/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Alopecia
Alopecia
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The nurse told her she was losing her hair as well; This is a spontaneous report received from a Con...
The nurse told her she was losing her hair as well; 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 and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "The nurse told her she was losing her hair as well". Additional information: Reporter stated she was talking to a lady in the store, and they were comparing Pfizer covid vaccine things. She was a nurse and stated that 15,000 people had same reaction as she did with Pfizer Covid vaccine. The nurse told her she was losing her hair as well after the Pfizer Covid vaccine. The lady said she had the same and at least 15,000 had the same reaction she did. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2828904 | VA | 02/28/2025 |
PNC20 |
PFIZER\WYETH |
LK6655 |
Device breakage
Device breakage
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one of the 10 vials in the box was cracked; This is a spontaneous report received from an Other HCP ...
one of the 10 vials in the box was cracked; This is a spontaneous report received from an Other HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown., single (Lot number: LK6655, Expiration Date: 30Jun2026) for immunisation, Device Lot Number: LK6655, Device Expiration Date: 30Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PHYSICAL ISSUE (non-serious), outcome "unknown", described as "one of the 10 vials in the box was cracked". The reporter considered "one of the 10 vials in the box was cracked" not related to pneumococcal 20- valent conjugate vaccine (diphtheria CRM197 protein). Causality for "one of the 10 vials in the box was cracked" was determined associated to device constituent of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (malfunction).
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| 2828906 | 34 | F | MA | 02/28/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
53Ky2 |
CSF test, Headache, Imaging procedure, Laboratory test, Neurodegenerative disord...
CSF test, Headache, Imaging procedure, Laboratory test, Neurodegenerative disorder
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Vaccine given on 11/1/24. Headache lasting 5 days that started on 11/4/24. On 11/15 started with neu...
Vaccine given on 11/1/24. Headache lasting 5 days that started on 11/4/24. On 11/15 started with neurologic findings that would lead to diagnosis of autoimmune cerebellar degeneration.
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โ | โ | ||||
| 2828907 | 64 | F | 02/28/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
m4b34 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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No adverse effect 3rd dose of twinrix gives less than 6 months from first (shot given 2/26/25 instea...
No adverse effect 3rd dose of twinrix gives less than 6 months from first (shot given 2/26/25 instead of 3/13/2025)
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| 2828908 | 53 | F | FL | 02/28/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Red localized swelling at administration site
Red localized swelling at administration site
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| 2828919 | 57 | F | TX | 02/28/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93kk4 |
Unevaluable event
Unevaluable event
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Patient stated she experience 100 degree fever.
Patient stated she experience 100 degree fever.
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| 2828920 | 57 | M | NV | 02/28/2025 |
PNC20 |
PFIZER\WYETH |
LJ5284 |
Injection site rash
Injection site rash
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LITTLE RASH AT THE INJECTION SITE WITH NO SWOLLEN
LITTLE RASH AT THE INJECTION SITE WITH NO SWOLLEN
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| 2828921 | 8 | F | CA | 02/28/2025 |
HEP HEP IPV IPV MMRV MMRV TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Cough, Immediate post-injection reaction, Immune thrombocytopenia, Immunoglobuli...
Cough, Immediate post-injection reaction, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased; Pyrexia, Respiratory tract congestion; Cough, Immediate post-injection reaction, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased; Pyrexia, Respiratory tract congestion; Cough, Immediate post-injection reaction, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased; Pyrexia, Respiratory tract congestion; Cough, Immediate post-injection reaction, Immune thrombocytopenia, Immunoglobulin therapy, Platelet count decreased; Pyrexia, Respiratory tract congestion
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Immune Thrombocytopenia requiring hospitalization and IVIG infusion
Immune Thrombocytopenia requiring hospitalization and IVIG infusion
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โ | |||||
| 2828922 | 65 | F | WA | 02/28/2025 |
MMRV |
MERCK & CO. INC. |
y012341 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No symptoms, patient was notified, provider was notified
No symptoms, patient was notified, provider was notified
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| 2828923 | 4 | M | 02/28/2025 |
MMRV |
MERCK & CO. INC. |
|
Pyrexia, Skin reaction
Pyrexia, Skin reaction
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local cutaneous reaction, fever.
local cutaneous reaction, fever.
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| 2829021 | 53 | F | CT | 02/28/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EJ1685 N/A N/A |
Alopecia, Chemotherapy, Colorectal cancer stage IV, Death, Hair growth abnormal;...
Alopecia, Chemotherapy, Colorectal cancer stage IV, Death, Hair growth abnormal; Alopecia, Chemotherapy, Colorectal cancer stage IV, Death, Hair growth abnormal; Alopecia, Chemotherapy, Colorectal cancer stage IV, Death, Hair growth abnormal
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Online report of premature death for a health care worker, a mid-50's female. Victim was diagno...
Online report of premature death for a health care worker, a mid-50's female. Victim was diagnosed with stage 4 colon cancer in late May 2022, exact date unknown. DOSE1 date 12/23/20 LOT# EJ1685, DOSE2 date UNK, LOT# UNK, DOSE3 date 10/03/2021. LOT# UNK. Online report states victim died at home surrounded by family. Online photos imply victim was injected at work, a facility. Victim went through cycles of hair loss and growth. By 09/22 she had undergone her 8th chemo administered by Dr. . Victim wore masks in occupational and non-occupational settings for 3+ years. Victim likely received medical care or had any hospital stay at Hospital
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โ | โ | ||||
| 2829022 | 79 | F | WI | 02/28/2025 |
PNC21 |
MERCK & CO. INC. |
|
Injection site erythema, Injection site pruritus, Injection site swelling
Injection site erythema, Injection site pruritus, Injection site swelling
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Started with red circle around inj. site, itchy, redness and slight swelling on upper arm. After 24 ...
Started with red circle around inj. site, itchy, redness and slight swelling on upper arm. After 24 hours, lasted 72 hours. Relieved with BENADRYL, resolved.
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| 2829023 | 1 | M | NY | 02/28/2025 |
MMR PNC20 VARCEL |
MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
Y005808 LG5578 Y014939 |
Injection site discolouration, Injection site induration; Injection site discolo...
Injection site discolouration, Injection site induration; Injection site discolouration, Injection site induration; Injection site discolouration, Injection site induration
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~ 1 1/2" x 3" pink area on deltoid, slight firmness right around injection site. No tender...
~ 1 1/2" x 3" pink area on deltoid, slight firmness right around injection site. No tenderness, no swelling or induration.
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| 2828495 | F | MN | 02/27/2025 |
HPV9 |
MERCK & CO. INC. |
Y007991 |
Exposure during pregnancy, Pregnancy test positive
Exposure during pregnancy, Pregnancy test positive
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no adverse event; vaccine exposure during pregnancy; This prospective spontaneous report has been re...
no adverse event; vaccine exposure during pregnancy; This prospective spontaneous report has been received from a health professional regarding a 31-year-old female patient. The patient's medical history included rash due to handling bleach. Information regarding concurrent conditions and concomitant therapies was not reported. On 08-JAN-2025, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis , lot number Y007991 which has been verified to be valid, expiration date reported and validated as 18-JUN-2026. (strength, dose, scheme, route of administration, and anatomical site not reported) On 12-NOV-2024, the patient's pregnancy test resulted negative. On an unknown date, the caller stated during ultrasound, patient was about 6 weeks and 3 days pregnant when she received vaccine (conflicting information, the reporter stated the patient was "unknowingly pregnant" when she received the vaccine) (vaccination exposure during pregnancy). On 28-JAN-2025, the patient's pregnancy test was positive. No additional information provided, no adverse event. The pregnancy and fetal outcome was unknown.
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| 2828496 | FL | 02/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Rash
Rash
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rash on face; This non-serious case was reported by a consumer via call center representative and de...
rash on face; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: rash on face). The outcome of the rash was not reported. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK receipt date: 13-FEB-2025 The reporter reported that the patient had recived Shingrix vaccine and experienced rash. The reporter had a question about Shingrix vaccine could it cause a rash on face and how long to go away.
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| 2828497 | 9 | M | NV | 02/27/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered, Incorrect dose administered
Extra dose administered, Incorrect dose administered
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9-year-old male patient was accidentally given two doses of Flulaval; should have received Flulaval ...
9-year-old male patient was accidentally given two doses of Flulaval; should have received Flulaval and Gardasil/9-year-old male patient was accidentally given two doses of Flulaval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 9-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis. Co-suspect products included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylaxis. Concomitant products included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL). On 30-JAN-2025 17:10, the patient received FluLaval 2024-2025 season (right deltoid). On an unknown date, the patient received GARDASIL. On 30-JAN-2025 17:10, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced accidental overdose (Verbatim: 9-year-old male patient was accidentally given two doses of Flulaval) and wrong vaccine administered (Verbatim: should have received Flulaval and Gardasil/9-year-old male patient was accidentally given two doses of Flulaval). The outcome of the accidental overdose and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date : 30-JAN-2025 The patient was accidentally given two doses of Flulaval, one in the Left Deltoid, and one in the Right Deltoid. The patient should have received Flulaval and Gardasil, and the patient's sibling was also going to get the flu shot, but she somehow put everything on one tray, and the 9-year-old got 2 doses of flu, which led to accidental overdose and wrong vaccine administered. No further details were provided. The reporter consented to follow up.
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| 2828515 | 25 | AZ | 02/27/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Chills, Pyrexia
Chills, Pyrexia
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High fever, shivers
High fever, shivers
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| 2828516 | 36 | F | CA | 02/27/2025 |
RSV |
PFIZER\WYETH |
KC7884 |
Exposure during pregnancy, Premature delivery, Premature labour
Exposure during pregnancy, Premature delivery, Premature labour
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Pre-term labor. Pregnancy was otherwise uncomplicated. Estimated date of delivery was 1/4/25. Birth ...
Pre-term labor. Pregnancy was otherwise uncomplicated. Estimated date of delivery was 1/4/25. Birth weight was 5 lbs 5 oz
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โ | |||||
| 2828517 | 29 | F | NC | 02/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Exposure during pregnancy, Foetal non-stress test normal, Uterine contractions d...
Exposure during pregnancy, Foetal non-stress test normal, Uterine contractions during pregnancy
More
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False labor contractions- due date 3/12/25
False labor contractions- due date 3/12/25
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| 2828520 | 02/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Dizziness, Syncope
Dizziness, Syncope
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Fainted; Dizzy; This serious case was reported by a consumer via interactive digital media and descr...
Fainted; Dizzy; This serious case was reported by a consumer via interactive digital media and described the occurrence of fainting in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 14-FEB-2025, the patient received the 1st dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant) and dizziness (Verbatim: Dizzy). The outcome of the fainting was resolved and the outcome of the dizziness was not resolved. It was unknown if the reporter considered the fainting and dizziness to be related to Shingles vaccine. The company considered the fainting and dizziness to be unrelated to Shingles vaccine. Additional Information: GSK receipt Date: 15-FEB-2025 This case was reported by a patient via interactive digital media. The patient received shingles vaccine a day before reporting . Now, the patient was extremely dizzy and fainted once.; Sender's Comments: Syncope and Dizziness are unlisted events which are considered unrelated to GSK Shingles vaccine.
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| 2828521 | F | 02/27/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
|
Suspected vaccination failure; shingles; This serious case was reported by a other health profession...
Suspected vaccination failure; shingles; This serious case was reported by a other health professional and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 12-FEB-2025 Patient received 2 doses of Shingrix and developed shingles. Patient was recovered. The symptoms were treated. 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 the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
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| 2828522 | M | 02/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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never received his second; This non-serious case was reported by a consumer via call center represen...
never received his second; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine in 2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received his second ). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 25-FEB-2025 The reporter reported that patient stated that he received his first dose of Shingrix in 2023 and never received his second because he moved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2828523 | 02/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Skin reaction
Skin reaction
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Skin reaction; This non-serious case was reported by a consumer via interactive digital media and de...
Skin reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin reaction (Verbatim: Skin reaction). The outcome of the skin reaction was not reported. It was unknown if the reporter considered the skin reaction to be related to Shingrix. It was unknown if the company considered the skin reaction to be related to Shingrix. Additional Information: GSK Receipt Date: 10-FEB-2025 The patient self reported this case for himself/herself This case was reported by a patient via (Shingrix GSK Chatbot) interactive digital media.
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| 2828524 | 58 | F | IL | 02/27/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Headache, Nausea, Pain, Pyrexia; Swelling, Tenderness
Chills, Headache, Nausea, Pain, Pyrexia; Swelling, Tenderness
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selling in her neck; tender to touch; States there are no visual signs of bruising it just feels lik...
selling in her neck; tender to touch; States there are no visual signs of bruising it just feels like bruising; she developed a headache; nausea; she had chills; fever; aches and pains; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 04-FEB-2025, 3 hrs after receiving Shingrix, the patient experienced chills (Verbatim: she had chills), fever (Verbatim: fever) and pain (Verbatim: aches and pains). On 05-FEB-2025, the patient experienced headache (Verbatim: she developed a headache) and nausea (Verbatim: nausea). On 06-FEB-2025, the patient experienced neck swelling (Verbatim: selling in her neck), tenderness (Verbatim: tender to touch) and contusion (Verbatim: States there are no visual signs of bruising it just feels like bruising). The outcome of the chills, fever, pain and headache were resolved and the outcome of the nausea and neck swelling were not resolved and the outcome of the tenderness and contusion were not reported. It was unknown if the reporter considered the chills, fever, pain, headache, nausea, neck swelling, tenderness and contusion to be related to Shingrix. It was unknown if the company considered the chills, fever, pain, headache, nausea, neck swelling, tenderness and contusion to be related to Shingrix. Additional Information: GSK receipt date: 06-FEB-2025 The reporter was the patient who received the first dose of Shingrix vaccine series in her left deltoid. The vaccine was administered at the pharmacy. The reporter stated she had experienced chills, fever, aches, and pains 3 hours after receiving vaccine and symptoms have resolved. Also, stated she developed a headache and nausea 1 day after receiving the vaccine. The headache had resolved but the nausea still remains. The reporter mentioned that 2 days after receiving the vaccine she noticed swelling in her left neck that was tender to touch and feels like bruising. The reporter stated there were no visual signs of bruising it just feels like bruising. The selling in her neck still remains. The patient did not have a lot number or number of vaccine on the papers she received from the pharmacy.
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| 2828525 | M | FL | 02/27/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
TX77L |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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16 day old receiving a infanrix vaccine; Administered Infanrix instead of hepatitis B vaccine; This ...
16 day old receiving a infanrix vaccine; Administered Infanrix instead of hepatitis B vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-day-old male patient who received DTPa (Infanrix) (batch number TX77L, expiry date 01-DEC-2025) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On 21-FEB-2025, the patient received Infanrix. On an unknown date, the patient received Engerix B. On 21-FEB-2025, an unknown time after receiving Infanrix and not applicable after receiving Engerix B, the patient experienced inappropriate age at vaccine administration (Verbatim: 16 day old receiving a infanrix vaccine) and wrong vaccine administered (Verbatim: Administered Infanrix instead of hepatitis B vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 21-FEB-2025 Other HCP started a 16 day old receiving a Infanrix vaccine. According to reporter, the dose was administered earlier that day. Reporter had a 16 days old baby that received Infanrix instead of the Hepatitis B, Engerix-B, which led to wrong vaccine administered. Reporter need to know what they need to do for this child. 16 day old receiving a Infanrix vaccine, which led to inappropriate age at vaccine administration.
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| 2828527 | 48 | F | FL | 02/27/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 027C21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A 039B21A |
Abdominal pain upper, Agitation, Aphasia, Arthritis, Blister; Blood pressure flu...
Abdominal pain upper, Agitation, Aphasia, Arthritis, Blister; Blood pressure fluctuation, Blood test, Brain fog, Chronic active Epstein-Barr virus infection, Chronic fatigue syndrome; Colonoscopy, Computerised tomogram head, Depression, Disturbance in attention, Dizziness; Dysgraphia, Echocardiogram, Electrocardiogram ambulatory, Endoscopy, Epstein-Barr virus test; Exercise tolerance decreased, Fatigue, Gastrointestinal disorder, Herpes zoster, Insomnia; Irritable bowel syndrome, Magnetic resonance imaging head, Malaise, Muscle atrophy, Myositis; Night sweats, Onychomadesis, Oral herpes, Pain in extremity, Photophobia; Pyrexia, Rash, Rash erythematous, Scan with contrast, Temperature regulation disorder; Trigeminal nerve disorder, Urinary incontinence, Visual impairment; Alpha 1 globulin, Alpha 2 globulin, Basophil count, Basophil percentage, Beta globulin; Bipolar disorder, Blood albumin, Blood pressure measurement, Blood test, Chronic fatigue syndrome; Constipation, Electrocardiogram ambulatory, Endoscopy, Eosinophil count, Eosinophil percentage; Epstein-Barr virus antibody, Epstein-Barr virus infection, Fibromyalgia, Haematocrit, Haemoglobin; Herpes zoster, Hypertension, Immature granulocyte count, Immunoglobulins, Infectious mononucleosis; Irritable bowel syndrome, Joint noise, Loss of libido, Lymphocyte count, Lymphocyte percentage; Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count; Monocyte percentage, Muscle atrophy, Neutrophil count, Neutrophil percentage, Nucleated red cells; Onychomadesis, Pain, Pain in extremity, Palpitations, Petechiae; Platelet count, Protein total, Red blood cell count, Red cell distribution width, Rheumatoid arthritis; Transient ischaemic attack, Trigeminal neuralgia, Weight, White blood cell count; Abdominal pain upper, Agitation, Aphasia, Arthritis, Blister; Blood pressure fluctuation, Blood test, Brain fog, Chronic active Epstein-Barr virus infection, Chronic fatigue syndrome; Colonoscopy, Computerised tomogram head, Depression, Disturbance in attention, Dizziness; Dysgraphia, Echocardiogram, Electrocardiogram ambulatory, Endoscopy, Epstein-Barr virus test; Exercise tolerance decreased, Fatigue, Gastrointestinal disorder, Herpes zoster, Insomnia; Irritable bowel syndrome, Magnetic resonance imaging head, Malaise, Muscle atrophy, Myositis; Night sweats, Onychomadesis, Oral herpes, Pain in extremity, Photophobia; Pyrexia, Rash, Rash erythematous, Scan with contrast, Temperature regulation disorder; Trigeminal nerve disorder, Urinary incontinence, Visual impairment; Alpha 1 globulin, Alpha 2 globulin, Basophil count, Basophil percentage, Beta globulin; Bipolar disorder, Blood albumin, Blood pressure measurement, Blood test, Chronic fatigue syndrome; Constipation, Electrocardiogram ambulatory, Endoscopy, Eosinophil count, Eosinophil percentage; Epstein-Barr virus antibody, Epstein-Barr virus infection, Fibromyalgia, Haematocrit, Haemoglobin; Herpes zoster, Hypertension, Immature granulocyte count, Immunoglobulins, Infectious mononucleosis; Irritable bowel syndrome, Joint noise, Loss of libido, Lymphocyte count, Lymphocyte percentage; Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count; Monocyte percentage, Muscle atrophy, Neutrophil count, Neutrophil percentage, Nucleated red cells; Onychomadesis, Pain, Pain in extremity, Palpitations, Petechiae; Platelet count, Protein total, Red blood cell count, Red cell distribution width, Rheumatoid arthritis; Transient ischaemic attack, Trigeminal neuralgia, Weight, White blood cell count; Abdominal pain upper, Agitation, Aphasia, Arthritis, Blister; Blood pressure fluctuation, Blood test, Brain fog, Chronic active Epstein-Barr virus infection, Chronic fatigue syndrome; Colonoscopy, Computerised tomogram head, Depression, Disturbance in attention, Dizziness; Dysgraphia, Echocardiogram, Electrocardiogram ambulatory, Endoscopy, Epstein-Barr virus test; Exercise tolerance decreased, Fatigue, Gastrointestinal disorder, Herpes zoster, Insomnia; Irritable bowel syndrome, Magnetic resonance imaging head, Malaise, Muscle atrophy, Myositis; Night sweats, Onychomadesis, Oral herpes, Pain in extremity, Photophobia; Pyrexia, Rash, Rash erythematous, Scan with contrast, Temperature regulation disorder; Trigeminal nerve disorder, Urinary incontinence, Visual impairment; Alpha 1 globulin, Alpha 2 globulin, Basophil count, Basophil percentage, Beta globulin; Bipolar disorder, Blood albumin, Blood pressure measurement, Blood test, Chronic fatigue syndrome; Constipation, Electrocardiogram ambulatory, Endoscopy, Eosinophil count, Eosinophil percentage; Epstein-Barr virus antibody, Epstein-Barr virus infection, Fibromyalgia, Haematocrit, Haemoglobin; Herpes zoster, Hypertension, Immature granulocyte count, Immunoglobulins, Infectious mononucleosis; Irritable bowel syndrome, Joint noise, Loss of libido, Lymphocyte count, Lymphocyte percentage; Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count; Monocyte percentage, Muscle atrophy, Neutrophil count, Neutrophil percentage, Nucleated red cells; Onychomadesis, Pain, Pain in extremity, Palpitations, Petechiae; Platelet count, Protein total, Red blood cell count, Red cell distribution width, Rheumatoid arthritis; Transient ischaemic attack, Trigeminal neuralgia, Weight, White blood cell count
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Since receiving the Moderna vaccine I have been diagnosed with chronic EBV, CFS/ME, uncontrollable B...
Since receiving the Moderna vaccine I have been diagnosed with chronic EBV, CFS/ME, uncontrollable BP, admitted in hospital under stroke alert. Depression.Unexplained fever. Often feel malaise. Severe inflammation in joints & muscles. Loss of muscle mass. Agitation, depression. Difficulty regulating body temperature.Trigeminal nerve flareup. Stomach & digestive issues, IBS. Worsening vision & sensitivity to light. Extreme fatigue, foggy brain & trouble concentrating. My handwriting has gotten worse. Please see additional symptoms below: At times, difficulty articulating sentences. Insomnia. Unregulated body temperature. Uncontrollable sweating at night. Admitted to the hospital under stroke watch. Stomach pain with digestive issues. Red rash on lower arms & legs. Rash on the right side of the face, more so on the right side. Excruciating thigh pain. Extreme exhaustion after low exercise or daily activities. EBV flareups will start in my face, work their way down my body, through my digestive tract, down my leg, and come out through my toe, where the toe will blister, and eventually, the nail will fall off. I have all the documentation & dates of "episodes." With EBV since Moderna, I am constantly in a cold sore breakout throughout my body. The scariest episode was when I showed one of my listings, and the seller was home by the grace of God. I got a head rush like I have never had in my life. It would not go away. My seller sat me down and gave me water & cold compress. Asked if she should call EMS. I said no, I don't need that bill.... I went to the ER the next morning, and my BP was at stroke levels, and that is when I was admitted. I can't imagine what my blood pressure was during the showing. I have seen my: A primary care provider on more than one occasion. She ran the EBV test and other bloodwork. That doctor left another doctor took her place and he said he won't run the EBV test again because once you have it, you always have it. I've paid out of pocket and have had myself tested, keeping an eye on my EBV load Gastroenterologist twice in the past few years who has performed endoscopy & colonoscopy to try and figure out if something was going on inside The podiatrist showing her blistered toes Rheumatoid Arthritis doctor who could not understand why my PCP referred me to her A Psychiatrist who tried to put me on antidepressant Cardiologist for heart ultrasound & to wear a halter for 5 days (waiting to see if they call me to let me know results because they never scheduled a follow-up appointment with me. Neurologist 1 to rule out MS Neurologist 2 to rule out MS again & to go over mini stroke Urologist 1 to go over incontinent issues with no resolve Urologist 2 to go over incontinent issues again with no resolve I have an appointment with an infectious disease doctor on March 3, 2025
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| 2828528 | 0.33 | F | CT | 02/27/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U7921AA LC5483 2081735 |
Infant irritability, Pyrexia; Infant irritability, Pyrexia; Infant irritability,...
Infant irritability, Pyrexia; Infant irritability, Pyrexia; Infant irritability, Pyrexia
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Fuzziness and low grade fever.
Fuzziness and low grade fever.
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| 2828564 | 75 | F | 02/27/2025 |
COVID19 |
MODERNA |
8081561 |
Expired product administered
Expired product administered
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Vaccine was given after the BUD - pt will be revaccinated
Vaccine was given after the BUD - pt will be revaccinated
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| 2828565 | 76 | F | 02/27/2025 |
COVID19 |
MODERNA |
8081561 |
Expired product administered
Expired product administered
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Vaccine was given after the BUD - pt will be revaccinated
Vaccine was given after the BUD - pt will be revaccinated
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| 2828566 | 73 | F | 02/27/2025 |
COVID19 |
MODERNA |
8081561 |
Expired product administered
Expired product administered
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Vaccine was given after the BUD - pt will be revaccinated
Vaccine was given after the BUD - pt will be revaccinated
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| 2828567 | 73 | M | 02/27/2025 |
COVID19 |
MODERNA |
8081561 |
Expired product administered
Expired product administered
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Vaccine was given after the BUD - pt will be revaccinated
Vaccine was given after the BUD - pt will be revaccinated
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| 2828568 | 78 | M | 02/27/2025 |
COVID19 |
MODERNA |
8081561 |
Expired product administered
Expired product administered
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Vaccine was given after the BUD - pt will be revaccinated
Vaccine was given after the BUD - pt will be revaccinated
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