| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2856647 | 86 | F | FL | 09/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
FT95N |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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A female patient got the first dose back in 2022 and as of today (25 August 2025) she received the s...
A female patient got the first dose back in 2022 and as of today (25 August 2025) she received the 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 long in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number FT95N, expiry date 25-APR-2027) for prophylaxis. Previously administered products included Shingrix (First dose was received back in 2022.). On 25-AUG-2025, the patient received the 2nd dose of Shingrix. On 25-AUG-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: A female patient got the first dose back in 2022 and as of today (25 August 2025) she received the second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 25-AUG-2025 A pharmacist called to get guidance with the Shingrix vaccine series. A female patient got the first dose back in 2022 and as of today (25 August 2025) she received the second dose, which led to lengthening of vaccination schedule. The pharmacist called to know if the second dose could be counted or the patient has to restart the complete series again.
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| 2856648 | 73 | M | TN | 09/03/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
2553X |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Twinrix late second dose; This non-serious case was reported by a pharmacist via call center represe...
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 long in a 73-year-old male patient who received HAB (Twinrix) (batch number 2553X, expiry date 25-SEP-2026) for prophylaxis. Previously administered products included Twinrix (received 1st dose 07-MAR-2025). On 28-AUG-2025, the patient received the 2nd dose of Twinrix. On 28-AUG-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long 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: 28-AUG-2025 The pharmacist wanted to know when to administer the third dose of Twinrix after the patient received a late second dose according to the schedule. First dose was administered on 07th March 2025 and the second on 28th August 2025 (174 days apart) which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
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| 2856649 | 58 | M | IN | 09/03/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
37F34 |
Extra dose administered
Extra dose administered
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Boostrix - Extra dose administered one year apart; This non-serious case was reported by a nurse via...
Boostrix - Extra dose administered one year apart; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 58-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 37F34, expiry date 24-OCT-2027) for prophylaxis. Previously administered products included Boostrix (received 1st dose in 2024). On 29-AUG-2025, the patient received the 2nd dose of Boostrix. On 29-AUG-2025, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Boostrix - Extra dose administered one year apart). 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: 29-AUG-2025 The nurse practitioner mentioned that a patient received a Boostrix vaccine in 2024 and today another Boostrix dose was given, which led to extra dose administered.. The health care professional asked for recommendations on this situation.
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| 2856650 | F | 09/03/2025 |
COVID19 |
MODERNA |
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Blood test, Fatigue, Pain in extremity, Vaccination failure, Vaccine interaction
Blood test, Fatigue, Pain in extremity, Vaccination failure, Vaccine interaction
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sore arm; The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to ...
sore arm; The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine; The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective; got tired the next day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), VACCINATION FAILURE (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective) and FATIGUE (got tired the next day) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Obinutuzumab (Gazyva) infusion for CLL and Cilgavimab, Tixagevimab (Evusheld) for an unknown indication. Concurrent medical conditions included Chronic lymphocytic leukemia (diagnosed prior to receiving any Moderna COVID vaccine and was immunocompromised). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form, Obinutuzumab (Gazyva) (unknown route) at an unspecified dose and Cilgavimab, Tixagevimab (Evusheld) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), VACCINATION FAILURE (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective) and FATIGUE (got tired the next day). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), VACCINATION FAILURE (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective) and FATIGUE (got tired the next day) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: at the time of COVID her blood levels got to the point where she started needing treatment for her chronic lymphocytic leukemia diagnosis. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that, the patient had no side effects from the Moderna COVID vaccine, other than a sore arm and being a little bit tired the next day. She experienced the sore arm with every vaccine but got tired the next day with a couple of vaccine doses, she could not recall exact numbers. She was immunocompromised and had always gotten the Moderna COVID vaccine. She received at least one Moderna Covid-19 vaccine, had already been vaccinated, but she could not remember if once or twice. She required treatment with Gazyva for CLL. The Gazyva infusion neutralized the effect of the Covid vaccine(s), she was not responding to the vaccine. The Covid-19 vaccines were not effective for her. During that time, she was receiving Evusheld in lieu of Covid-19 vaccines. Evusheld was eventually discontinued due to not being as effective, but that had been discontinued. They stopped using it because they found that it was not as effective as they thought it was going to be for people. The treatment she was getting nullified the vaccine, so for two years, she did not respond to the vaccine at all. At the beginning of COVID, she was pretty much housebound for 2 years and did use an unintelligible but was then not considered viable. After about two years, they started testing her again after every vaccine, and she began responding to it, so now she received a Moderna COVID vaccine every 6 months. No other details were provided. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-788941 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2025: Live follow-up received included significant information included co-suspects added, new events (vaccine-drug interaction and vaccination failure) added, narrative updated, and reference numbers were added.; Reporter's Comments: Patients' Chronic lymphocytic leukemia under Obinutuzumab is strong confounder for the events. The benefit-risk relationship of product is not affected by this report.
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| 2856651 | F | 09/03/2025 |
COVID19 |
MODERNA |
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Blood test, Fatigue, Pain in extremity, Vaccination failure, Vaccine interaction
Blood test, Fatigue, Pain in extremity, Vaccination failure, Vaccine interaction
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The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccin...
The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective; The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine; sore arm; got tired the next day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), PAIN IN EXTREMITY (sore arm) and FATIGUE (got tired the next day) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect products included non-company products Obinutuzumab (Gazyva) for Chronic lymphocytic leukemia and Cilgavimab, Tixagevimab (Evusheld) for COVID-19 vaccination. Concurrent medical conditions included Chronic lymphocytic leukemia (was immunocompromised). In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Obinutuzumab (Gazyva) (unknown route) at an unspecified dose and dose of Cilgavimab, Tixagevimab (Evusheld) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), PAIN IN EXTREMITY (sore arm) and FATIGUE (got tired the next day). At the time of the report, VACCINATION FAILURE (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine/The Covid-19 vaccines were not effective), VACCINE INTERACTION (The Gazyva infusion neutralized the effect of the Covid vaccine(s)/ was not responding to the vaccine), PAIN IN EXTREMITY (sore arm) and FATIGUE (got tired the next day) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: at the time of COVID her blood levels got to the point where she started needing treatment for her chronic lymphocytic leukemia diagnosis. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medication was reported. The patient had no side effects from the Moderna COVID vaccine, other than a sore arm and being a little bit tired the next day. The patient experiences the sore arm with every vaccine, but she got tired the next day with a couple of vaccine doses, the patient could not recall exact numbers. The treatment she was getting nullified the vaccine, so for two years, she did not respond to the vaccine at all. At the beginning of COVID, she was pretty much housebound for 2 years. The patient required treatment with Gazyva for chronic lymphocytic leukemia (CLL). The COVID-19 vaccines were not effective for the patient. During that time, the patient was receiving Evusheld in lieu of COVID-19 vaccines. Evusheld was eventually discontinued due to not being as effective. They stopped using it because they found that it was not as effective as they thought it was going to be for people. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-788943 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2025: Significant live follow-up received: Co-suspects were added, additional events of vaccination failure and vaccine-drug interaction were added, and narrative was updated.; Reporter's Comments: Patients Chronic lymphocytic leukemia under Obinutuzumab is strong confounder for the events. The benefit-risk relationship of product is not affected by this report.
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| 2856652 | M | 09/03/2025 |
COVID19 |
MODERNA |
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Blood cholesterol, Blood cholesterol abnormal, Blood pressure measurement, Cardi...
Blood cholesterol, Blood cholesterol abnormal, Blood pressure measurement, Cardiac disorder, Hypothyroidism
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Hypothyroidism; General heart problems; Cholesterol problems; This spontaneous case was reported by ...
Hypothyroidism; General heart problems; Cholesterol problems; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHYROIDISM (Hypothyroidism) in an elderly male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. 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 HYPOTHYROIDISM (Hypothyroidism) (seriousness criterion medically significant), CARDIAC DISORDER (General heart problems) and BLOOD CHOLESTEROL ABNORMAL (Cholesterol problems). At the time of the report, HYPOTHYROIDISM (Hypothyroidism), CARDIAC DISORDER (General heart problems) and BLOOD CHOLESTEROL ABNORMAL (Cholesterol problems) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: Abnormal, Cholesterol problems. On an unknown date, Blood pressure measurement: Abnormal, Control BP (blood Pressure). The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not provided. It was reported that the patient had all the Moderna Covid vaccines available. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
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| 2856653 | 64 | F | FL | 09/03/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
5683MF008 |
Adverse event, Breakthrough COVID-19, Pain, SARS-CoV-2 test
Adverse event, Breakthrough COVID-19, Pain, SARS-CoV-2 test
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Minimal side effects no nearly as intense as with mRNA; Very mild body aches; Tested positive once f...
Minimal side effects no nearly as intense as with mRNA; Very mild body aches; Tested positive once for Covid 19, on 10Feb2024, after having the Novavax vaccine in 2023; This non serious initial spontaneous report was reported by a Nurse via Contact Center (MI No. NOV25-00655) and concerns a 64-year-old Female who experienced "VERY MILD BODY ACHES", "MINIMAL SIDE EFFECTS NO NEARLY AS INTENSE AS WITH MRNA" on unknown dates and "TESTED POSITIVE ONCE FOR COVID 19, ON 10FEB2024, AFTER HAVING THE NOVAVAX VACCINE IN 2023" on 10-Feb-2024 after receiving COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) on 30-Oct-2023. At the time of the report, the outcome of the Pain, Adverse event, Breakthrough COVID-19 was Unknown.; Sender's Comments: This 64-year-old Female experienced Pain, Adverse event and Breakthrough COVID-19 after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Pain, Adverse event, and Breakthrough COVID-19 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 Breakthrough COVID-19, Pain and Adverse event is considered Possible.
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| 2856654 | 65 | F | FL | 09/03/2025 |
COVID19 |
NOVAVAX |
6024MF020 |
Adverse event, Pain
Adverse event, Pain
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Minimal side effects no nearly as intense as with mRNA; Very mild body aches; This non serious initi...
Minimal side effects no nearly as intense as with mRNA; Very mild body aches; This non serious initial spontaneous report was reported by a Nurse via Contact Center (MI No. NOV25-00655) and concerns a 65-year-old Female who experienced "MINIMAL SIDE EFFECTS NO NEARLY AS INTENSE AS WITH MRNA" and "VERY MILD BODY ACHES" on unknown dates after receiving Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) on 19-Nov-2024. At the time of the report, the outcome of the Adverse event and Pain was Unknown. A discrepancy was identified in the source document. The patient's age group was reported as adult, but was captured as elderly according to the age of 65-years.; Sender's Comments: This 65-year-old Female experienced Adverse event and Pain after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Adverse event and Pain were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Adverse event and Pain is considered Possible.
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| 2856655 | 69 | M | TX | 09/03/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EN6198 EN6198 |
Bladder cancer stage III, Pancreatic cyst, Pancreatitis, Prostatectomy, Urethrec...
Bladder cancer stage III, Pancreatic cyst, Pancreatitis, Prostatectomy, Urethrectomy; Urinary cystectomy
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Stage 3 Bladder cancer and pancreatitis, pancreatic cyst
Stage 3 Bladder cancer and pancreatitis, pancreatic cyst
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| 2856656 | 80 | M | MO | 09/03/2025 |
FLU3 |
SANOFI PASTEUR |
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Rash, Rash pruritic
Rash, Rash pruritic
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Severe skin rash with itch at joints ... underarm and crouch
Severe skin rash with itch at joints ... underarm and crouch
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| 2856657 | 50 | M | TX | 09/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55KB9 |
Fatigue, Injection site erythema, Injection site swelling, Vertigo
Fatigue, Injection site erythema, Injection site swelling, Vertigo
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Redness and swelling below injection site, tiredness and vertigo
Redness and swelling below injection site, tiredness and vertigo
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| 2856658 | 81 | F | MA | 09/03/2025 |
PNC20 |
PFIZER\WYETH |
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Inflammation, Pain in extremity, Pruritus
Inflammation, Pain in extremity, Pruritus
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Shoulder to elbow became inflamed and itchy for at least days. Painful at effected area.
Shoulder to elbow became inflamed and itchy for at least days. Painful at effected area.
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| 2856659 | 33 | M | GA | 09/03/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Wrong product administered
Wrong product administered
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Requested 2025-2026 Comirnaty vaccination and was advised by pharmacy staff that the vaccine was ava...
Requested 2025-2026 Comirnaty vaccination and was advised by pharmacy staff that the vaccine was available and in stock. Prior to administration, the pharmacist verbally confirmed that I was receiving 2025-2026 Comirnaty. The vaccine was administered in my left deltoid without incident, but the wrong formula was administered. 2024-2025 Comirnaty (NDC# 00069243210) was actually administered, and the error was confirmed the next day by pharmacy staff.
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| 2856660 | 16 | F | IN | 09/03/2025 |
MENB |
PFIZER\WYETH |
MA2480 |
Vision blurred
Vision blurred
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Pt. received vaccine and shortly after had complaints of blurred vision while leaving exam room. Pt....
Pt. received vaccine and shortly after had complaints of blurred vision while leaving exam room. Pt. was then returned to exam room where she was prompted to lay down and was given juice and crackers while waiting 10 minutes before she was able to leave. Dr. notified and checked on pt. Pt. was then released to parent with no other complaints. or symptoms.
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| 2856661 | F | MS | 09/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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take our Pfizer shots/my best friend had it three times; take our Pfizer shots/my best friend had it...
take our Pfizer shots/my best friend had it three times; take our Pfizer shots/my best friend had it three times; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm and as dose 1,single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "take our Pfizer shots/my best friend had it three times". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the reporter's best friend had COVID-19 three times. They both got the Pfizer vaccine when it first came out. They got booster there too. Received Paxlovid. 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-202500173605 same patient, different dose/AE;
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| 2856662 | 60 | F | MI | 09/03/2025 |
FLU3 |
SANOFI PASTEUR |
U88308A |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Pt was given +65 flu dose. Pt is 60 year old female. She did not have any adverse reactions.
Pt was given +65 flu dose. Pt is 60 year old female. She did not have any adverse reactions.
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| 2856663 | 67 | M | FL | 09/03/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
F4AC3 |
Extra dose administered, Headache
Extra dose administered, Headache
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Patient had previously received the Arexvy vaccine on 10/12/23. He received a second vaccine on 09/0...
Patient had previously received the Arexvy vaccine on 10/12/23. He received a second vaccine on 09/02/25. Spoke with patient on 09/03/25 and informed him of the duplicate vaccine. He said the only side effect he had experienced so far was a mild headache in the morning of 09/03/25 that resolved on its own.
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| 2856664 | 32 | F | MS | 09/03/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9JT4S |
Pain in extremity
Pain in extremity
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Pt received Tdap L Deltoid on 8/25/25. On 9/3/25 reports L arm remains sore, unable to touch or lay ...
Pt received Tdap L Deltoid on 8/25/25. On 9/3/25 reports L arm remains sore, unable to touch or lay on L side.
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| 2856665 | 0.42 | M | ID | 09/03/2025 |
DTAP HIBV IPV |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR |
Y7JC3 UK304AA X1C891M |
No adverse event, Product preparation issue; No adverse event, Product preparati...
No adverse event, Product preparation issue; No adverse event, Product preparation issue; No adverse event, Product preparation issue
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Patient did not report any adverse events. Diluent was given and was not reconstituted with ActHib p...
Patient did not report any adverse events. Diluent was given and was not reconstituted with ActHib powder.
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| 2856666 | 35 | F | GA | 09/03/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
FH4YR FH4YR |
Blood folate, Full blood count, Glycosylated haemoglobin, Hypoaesthesia, Metabol...
Blood folate, Full blood count, Glycosylated haemoglobin, Hypoaesthesia, Metabolic function test; Paraesthesia, Vitamin B12, Vitamin B6
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New onset numbness and tingling in toes, ascending toward feet, related to Flu Vaccine. Supportive c...
New onset numbness and tingling in toes, ascending toward feet, related to Flu Vaccine. Supportive care is recommended at this time symptoms typically resolve within six to eight weeks.
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| 2856667 | 1 | F | MA | 09/03/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Z007853 Z008083 |
Extra dose administered, Product administered to patient of inappropriate age; E...
Extra dose administered, Product administered to patient of inappropriate age; Extra dose administered, Product administered to patient of inappropriate age
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Patient received MMRV outside of recommended age range and they received 2 doses of varicella
Patient received MMRV outside of recommended age range and they received 2 doses of varicella
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| 2856668 | 51 | F | OR | 09/03/2025 |
HEP VARZOS |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
946908 3E27G |
Pruritus, Rash; Pruritus, Rash
Pruritus, Rash; Pruritus, Rash
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PATIENT CAME TO THE CONSULTION WINDOW AROUND 11:00AM AFTER HER 2 VACCINATIONS (HEPATITIS B AND SHING...
PATIENT CAME TO THE CONSULTION WINDOW AROUND 11:00AM AFTER HER 2 VACCINATIONS (HEPATITIS B AND SHINGLES) AROUND 10:25AM AND STATED SHE HAD SOME ITCHINESS AND RASHES ON HER RIGHT SIDE OF THE FACE. SHE STATED BREATHING WAS FINE. ASKED PATIENT IF SHE WANTS PHARMACY TO CALL EMS. SHE SAID NO. RECOMMEND TO TAKE BENADRYL 25 MG WITH DIRECTIONS 1 TABLET BY MOUTH EVERY 4 TO 6 HOURS AS NEEDED. ALSO RECOMMENDED IF SHE HAS SHORTNESS OF BREATH, PLEASE CALL EMS.
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| 2856669 | 5 | F | MD | 09/03/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
px27D |
Gait inability, Muscular weakness, Pain in extremity, Peripheral swelling, Tic
Gait inability, Muscular weakness, Pain in extremity, Peripheral swelling, Tic
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Per the family recalled to the physician on 9/3/2025 and who requested that this form be completed. ...
Per the family recalled to the physician on 9/3/2025 and who requested that this form be completed. left arm swelling and pain. inability to walk well for a week due to leg pain and weakness. Since the vaccination with a facial motor tic that comes and goes.
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| 2856670 | 73 | F | FL | 09/03/2025 |
COVID19 |
MODERNA |
3052586 |
No adverse event
No adverse event
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Vaccine administered to patient with no approval guidelines. The state requires approval guidelines ...
Vaccine administered to patient with no approval guidelines. The state requires approval guidelines for the state for administration.
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| 2856671 | 65 | M | FL | 09/03/2025 |
COVID19 |
MODERNA |
3052586 |
No adverse event
No adverse event
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Vaccine administered to patient with no approval guideline. The state requires approval for admini...
Vaccine administered to patient with no approval guideline. The state requires approval for administration of this vaccine.
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| 2856672 | 20 | M | NJ | 09/03/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
GL0087 GL0087 GL0087 |
Blood thyroid stimulating hormone normal, C-reactive protein normal, Colonoscopy...
Blood thyroid stimulating hormone normal, C-reactive protein normal, Colonoscopy normal, Endoscopy gastrointestinal abnormal, Full blood count normal; Gastritis, Gastrointestinal motility disorder, Hydrogen breath test normal, Laboratory test normal, Metabolic function test normal; Pelvic discomfort, Pelvic pain, Red blood cell sedimentation rate normal, Stool analysis normal
More
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1-2 weeks after vaccination, began having incomplete bowel movements. Progressively getting worse. T...
1-2 weeks after vaccination, began having incomplete bowel movements. Progressively getting worse. Tried normal over the counter solutions and then sought out gastro, no change yet far. Approx a year later symptoms much worse, including constant chronic pelvic discomfort, pressure, and pain. Alongside other symptoms on worse days including worn out feelings in intestines and many (5+) uncomfortable movements of bits, and other negative gut feelings
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| 2856673 | 72 | M | TX | 09/03/2025 |
COVID19 |
MODERNA |
012A21A |
Autoimmune pancreatitis, Biopsy lymph gland, Immunoglobulin G4 related disease
Autoimmune pancreatitis, Biopsy lymph gland, Immunoglobulin G4 related disease
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Autoimmune Pancreatitis 2021 and IgG4 related diseases 2025
Autoimmune Pancreatitis 2021 and IgG4 related diseases 2025
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| 2856674 | 75 | F | FL | 09/03/2025 |
COVID19 |
MODERNA |
3052586 |
Unevaluable event
Unevaluable event
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Vaccine administered to patient with no guideline. The state requires approval for administration o...
Vaccine administered to patient with no guideline. The state requires approval for administration of this vaccine.
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| 2856675 | 81 | M | AR | 09/03/2025 |
COVID19 |
MODERNA |
3043030 |
COVID-19
COVID-19
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hospitalized with COVID
hospitalized with COVID
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| 2856676 | 09/03/2025 |
COVID19 |
PFIZER\BIONTECH |
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Deep vein thrombosis
Deep vein thrombosis
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unprovoked deep vein thrombosis blood clot; This is a spontaneous report received from a Consumer or...
unprovoked deep vein thrombosis blood clot; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) 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. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: DEEP VEIN THROMBOSIS (medically significant), outcome "unknown", described as "unprovoked deep vein thrombosis blood clot". 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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| 2856677 | 13 | M | FL | 09/03/2025 |
FLU3 |
SANOFI PASTEUR |
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Asthenia, Pyrexia
Asthenia, Pyrexia
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Patient had a high fever within 4 hours of getting does. Fever lasted for more than 24 hours and re...
Patient had a high fever within 4 hours of getting does. Fever lasted for more than 24 hours and reached a high temperature of 104 degrees. Patient was given ibuprofen for the fever. Fever would subside, but then return and would not drop below 101. Patient felt weak and did not eat much for about 36 hours. Fever eventually broke around 36 hours after receiving dose.
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| 2856678 | 1.58 | F | MA | 09/03/2025 |
MMR |
MERCK & CO. INC. |
Y013171 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Vax partially administered. Pt tolerated the vax well. No adverse reactions. Parent informed to resc...
Vax partially administered. Pt tolerated the vax well. No adverse reactions. Parent informed to reschedule and return for repeat MMR in 4 weeks. Mom agreed to plan w/no further questions or concerns.
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| 2856679 | 64 | F | NJ | 09/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
NY2AT |
Erythema, Headache, Peripheral swelling
Erythema, Headache, Peripheral swelling
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PT STATED SHE EXPERIENCED SKIN REDNESS AND SWELLING OF LEFT ARM AND SUBSEQUENTLY WENT TO HOSPITAL ON...
PT STATED SHE EXPERIENCED SKIN REDNESS AND SWELLING OF LEFT ARM AND SUBSEQUENTLY WENT TO HOSPITAL ON 8/11/25. PT STATED SHE RECEIVED IV ANTIBIOTICS IN HOSPITAL (EXACT MEDS UNKNOWN). PT ALSO EXPERIENCED HEADACHE WHICH WORSENED OVER TIME. HER HEADACHE BECAME SO SEVERE THAT SHE WENT TO THE HOSPITAL AGAIN ON 8/13/25. PT STATED THAT SHE RECEIVED IV FLUIDS & MEDS IN THE HOSPITAL (UNKNOWN WHICH MEDS SHE RECEIVED)
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| 2856680 | 1.25 | M | NY | 09/03/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8558BA U8352AA |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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At approximately 11:45am vaccines above administered in error to patient. No immediate adverse react...
At approximately 11:45am vaccines above administered in error to patient. No immediate adverse reaction or effects noted in patient after administration of the vaccines. No immediate or adverse reaction or effects noted up to 20 minutes after vaccine administration.
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| 2856681 | 36 | F | NJ | 09/03/2025 |
RSV TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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There have been no adverse events to report at this time.
There have been no adverse events to report at this time.
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| 2856682 | 1 | M | IA | 09/03/2025 |
MMRV PNC20 VARCEL |
MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC. |
Z008864 LN4932 Y003891 |
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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A dose of Varicella vaccine was given as well as a dose of MMR/Varicella(Proquad). At the same time...
A dose of Varicella vaccine was given as well as a dose of MMR/Varicella(Proquad). At the same time.
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| 2856683 | 38 | F | KY | 09/03/2025 |
MMRV |
MERCK & CO. INC. |
Z003309 |
Exposure during pregnancy, Product use issue
Exposure during pregnancy, Product use issue
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On 08/21/2025 patient came in to receive routine vaccines and establish care. MMR vaccine, hepatitis...
On 08/21/2025 patient came in to receive routine vaccines and establish care. MMR vaccine, hepatitis B vaccine, and Tdap vaccines were offered to patient. An MMR-Varicella combination vaccine was accidently given to patient and no pregnancy test was done prior to vaccination. On 8/22/2025, the patient returned to do H. Pylori testing and was informed that we failed to do a pregnancy test prior to yesterday's vaccinations. Patient agreed to do a pregnancy test today, 8/22/2025. The pregnancy test came back positive. This information was given to pt who agreed and understood the events. No further questions or concerns were discussed during out medical visit.
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| 2856684 | 68 | F | CA | 09/03/2025 |
PNC20 |
PFIZER\WYETH |
LX4486 |
Faeces discoloured, Pain in jaw
Faeces discoloured, Pain in jaw
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Resident noted on 8/27/2025 with jaw pain and black stool. Per resident, she stated that in the pas...
Resident noted on 8/27/2025 with jaw pain and black stool. Per resident, she stated that in the past, these symptoms were associated with blood clots and wanted to be sent to the hospital. Resident sent with daughter/RP to Hospital
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| 2856685 | 26 | F | AK | 09/03/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood test, Computerised tomogram, Decreased appetite, Diagnostic aspiration, Hy...
Blood test, Computerised tomogram, Decreased appetite, Diagnostic aspiration, Hypersomnia; Influenza, Lymphadenopathy, Ultrasound lymph nodes
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I received the first dose of COVID vaccine and had no reaction but the 2nd dose of the vaccine, I sl...
I received the first dose of COVID vaccine and had no reaction but the 2nd dose of the vaccine, I slept seriously all day, only waking for bathroom and barely ate that day. I felt like I had the flu and that lasted for two days. For 6 weeks after receiving the second, my left supraclavicular lymph node was swollen to the size of a golf ball. After the 6 weeks, the swollen lymph node went down but it comes and goes the last four years. As of February of 2025, the lymph node had been enlarged and has gotten bigger since February. Oncology provider believes my symptoms and issues I've been having since May of 2025 have been related to the COVID vaccines I received in 2020 and 2021
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| 2856686 | 25 | F | MS | 09/03/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Dizziness, Feeling abnormal
Dizziness, Feeling abnormal
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Lightheadedness, feeling hot and flush.
Lightheadedness, feeling hot and flush.
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| 2856687 | 4 | F | PA | 09/03/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U8209CB Y019174 |
Fatigue, Hypotonia, Lethargy, Pallor; Fatigue, Hypotonia, Lethargy, Pallor
Fatigue, Hypotonia, Lethargy, Pallor; Fatigue, Hypotonia, Lethargy, Pallor
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patient sat very still during the vaccines did not move, did not cry or anything. Once the second va...
patient sat very still during the vaccines did not move, did not cry or anything. Once the second vaccine was finished she went to get off the table and mom had helped her and she went "limp" mom put her back on table and patient was "lethargic", we did get provider who was trying to arouse patient, but she was still very fatigued and also very pale for approx 5 minutes. Provider placed cool compress on patient neck she was given apple juice and crackers and she sipped on the juice and took small bites of the crackers. she sat for sometime after drinking and taking small bites of the crackers.
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| 2856688 | 56 | F | GA | 09/03/2025 |
FLU3 |
SEQIRUS, INC. |
407244 |
No adverse event
No adverse event
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spoke with the patient, and she has not had any adverse reactions currently
spoke with the patient, and she has not had any adverse reactions currently
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| 2856689 | 19 | M | MD | 09/03/2025 |
HEP IPV MENB MNQ TD VARCEL |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR MERCK & CO. INC. |
7NX57 Y1A201M DD72H U8271AB U8491AA Y015559 |
Dizziness; Dizziness; Dizziness; Dizziness; Dizziness; Dizziness
Dizziness; Dizziness; Dizziness; Dizziness; Dizziness; Dizziness
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Client stated that he was becoming light headed and needed to stop vaccines and take a break. Clien...
Client stated that he was becoming light headed and needed to stop vaccines and take a break. Client was placed in a lying position with his legs elevated and an ice pack placed on his chest. Client recovered after about 7 minutes and was able to walk out of exam room with not problems.
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| 2856690 | 41 | F | 09/03/2025 |
FLU3 |
SANOFI PASTEUR |
UT8506JA |
Expired product administered
Expired product administered
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expired influenza vaccine administered
expired influenza vaccine administered
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| 2856691 | 65 | F | MA | 09/03/2025 |
FLU3 FLU3 VARZOS VARZOS |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Erythema, Injection site vesicles, Pruritus, Skin warm, Swelling; Tenderness; Er...
Erythema, Injection site vesicles, Pruritus, Skin warm, Swelling; Tenderness; Erythema, Injection site vesicles, Pruritus, Skin warm, Swelling; Tenderness
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Patient given shingles vaccine and flu vaccine at the pharmacy (unsure of lot number etc as it was n...
Patient given shingles vaccine and flu vaccine at the pharmacy (unsure of lot number etc as it was not given at this facility) on 8/31. 9/1 patient started to have redness and some mild itching. Throughout the day and into 9/2 with increased redness; area now tender, warm and swollen. A small blister also developed at the injection site. Treated with oral antibiotics, concerned for cellulitis at injection site. Zyrtec for itching.
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| 2856692 | 54 | F | GA | 09/03/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
202f21a 202f21a |
Dry eye, Dry mouth, Dry skin, Fatigue, Laboratory test; Sjogren's syndrome,...
Dry eye, Dry mouth, Dry skin, Fatigue, Laboratory test; Sjogren's syndrome, Systemic lupus erythematosus
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Extreme fatigue, dry skin, mouth, and eyes. Later diagnosed as Lupus and Sjogren's disease
Extreme fatigue, dry skin, mouth, and eyes. Later diagnosed as Lupus and Sjogren's disease
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| 2856693 | 62 | F | NY | 09/03/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
406982 |
Dizziness, Pain in extremity
Dizziness, Pain in extremity
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PAIN IN LEFT LEG , LIGHT HEADED, DIZZINESS
PAIN IN LEFT LEG , LIGHT HEADED, DIZZINESS
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| 2856694 | 1.33 | M | MO | 09/03/2025 |
UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
3CA25C1 MB599 Z005455 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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Wrong due date associated with encounter. Administered Hepatits A prior to due date. Aware of event ...
Wrong due date associated with encounter. Administered Hepatits A prior to due date. Aware of event prior to patient and dad leaving facility. Updated dad on what has happened. Encouraged to monitor patient and report back to clinic or ER with any abnormal symptoms. Patient was smiling at staff with no apparent discomfort when exiting the clinic.
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| 2856695 | 83 | M | WA | 09/03/2025 |
FLU3 PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
UT8779KA MA2505 |
Incorrect dose administered; Incorrect dose administered
Incorrect dose administered; Incorrect dose administered
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PATIENT INTENDED TO RECEIVE HIGH DOSE FLUZONE, IT WAS ENTERED INTO THE COMPUTER AS HIGH DOSE, BUT WA...
PATIENT INTENDED TO RECEIVE HIGH DOSE FLUZONE, IT WAS ENTERED INTO THE COMPUTER AS HIGH DOSE, BUT WAS CHOSEN INCORRECTLY AT IMMUNIZATION AS REGULAR FLUZONE DOSE
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| 2856696 | 73 | F | FL | 09/03/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Magnetic resonance imaging joint, Mobility decreased, Pain in extremity
Magnetic resonance imaging joint, Mobility decreased, Pain in extremity
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Patient called a couple of days after receiving vaccine stating that her arm was hurting more than u...
Patient called a couple of days after receiving vaccine stating that her arm was hurting more than usual after a vaccination. She called her doctor and reported event. Patient continues to have pain and now limited range of motion
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