🏥 VAERS Vaccine Data Browser

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This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

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Data Interpretation

The presence of a report does not mean the vaccine caused the adverse event.
Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
Serious adverse events must be reported by law, even if unrelated to the vaccine.
The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death

🏥 Hospitalized

🚑 Emergency Room

♿ Disability

⚠️ Life Threatening

How to Search

💡 Search Tips:

Select Year: Choose a specific year OR "All Years" to search across all data
All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
VAERS ID: Search for specific report by ID number
Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
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Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
Lot Number: Search specific vaccine lot (works great with "All Years")
Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

Reports are unverified: VAERS accepts all reports without medical verification
Not proof of causation: A report does not mean the vaccine caused the event
Anyone can report: Healthcare providers, patients, and family members can submit reports
Multiple vaccines: One report may list multiple vaccines given at the same time
Blank fields: Not all fields are required, so some data may be missing

Using the Table

Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
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Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

Year: VAERS ID: Age: Sex: State: Vaccine Type: Manufacturer: Lot Number: Site: Symptom: Death: Hospitalized:

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Showing 5,751 to 5,800 of 34,052 reports (Page 116 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀
2864074	33	M	UT	10/07/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	9JC49	Limb discomfort, Pain in jaw, Paraesthesia, Slow speech, Swollen tongue Limb discomfort, Pain in jaw, Paraesthesia, Slow speech, Swollen tongue	Pt reports tingling in his feet, heavy feeling in right arm, jaw pain, and tongue swelling. It was a... Pt reports tingling in his feet, heavy feeling in right arm, jaw pain, and tongue swelling. It was also noted that this Pt was speaking slow. More
2864075	69	F	TX	10/07/2025	COVID19	MODERNA		Breast cancer female Breast cancer female	breast cancer; This spontaneous case was reported by a pharmacist and describes the occurrence of BR... breast cancer; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST CANCER FEMALE (breast cancer) in a 69-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER FEMALE (breast cancer) (seriousness criterion medically significant). At the time of the report, BREAST CANCER FEMALE (breast cancer) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medications were not reported. It was reported that when patient called the pharmacy to confirm, they informed patient that they do not have the vaccine in stock and suggested to check back after the first of the month. Patient have had all the vaccines, and boosters since day one of the outbreak. All the vaccines were the Moderna product. Treatment information was not reported.; Reporter's Comments: The event of breast cancer was assessed as not related to to lack of biological plausibility additional it is unknown if patient developed breast cancer before or after vaccination. The benefit-risk relationship of product is not affected by this report. More
2864076	70	M	FL	10/07/2025	COVID19	MODERNA		Immunisation reaction, Pain in extremity Immunisation reaction, Pain in extremity	Sore arm; Minor side effects/other small things; This spontaneous case was reported by a consumer an... Sore arm; Minor side effects/other small things; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and IMMUNISATION REACTION (Minor side effects/other small things) in an 8-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and IMMUNISATION REACTION (Minor side effects/other small things). At the time of the report, PAIN IN EXTREMITY (Sore arm) and IMMUNISATION REACTION (Minor side effects/other small things) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not provided. Patient was at high risk and had never had a problem with health. It was reported that patient and his wife received constantly the Moderna vaccine since the beginning of the pandemic and they were very satisfied as they have had only some minor side effects, like sore arm and other small things that were tolerable. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789817, US-MODERNATX, INC.-MOD-2025-789818 (E2B Linked Report). This case was linked to MOD-2025-789815 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2025: Live follow-up received and updated narrative and references.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789817:Wife case, Monovalent product US-MODERNATX, INC.-MOD-2025-789818:Wife case, Spikevax NOS More
2864077	72	M		10/07/2025	COVID19	MODERNA		COVID-19 COVID-19	Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Co... Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid) in a 72-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) had resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as unknown. No concomitant medication was reported. The patient had taken 5 shots already, but last year he did not take it due to having Covid and his HCP told him to wait for 6 months to be vaccinated again. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. No reporter causality was provided. More
2864078	80	F		10/07/2025	COVID19	MODERNA		Rash Rash	skin rash in areas other than the injection site; This spontaneous case was reported by a consumer a... skin rash in areas other than the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (skin rash in areas other than the injection site) in an 80-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 04-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced RASH (skin rash in areas other than the injection site). At the time of the report, RASH (skin rash in areas other than the injection site) outcome was unknown. The action taken with mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) was unknown. Concomitant medications details were not reported by the reporter. Reporter wife received this injection on04-SEP-2025, and he received it on the same day. However, patient has developed a skin rash in areas other than the injection site and wanted to know if that was a normal side effect. Reporter had the same vaccine but did not experience any side effects. He doesn't want to share any other personal information and just wants to get the information regarding the side effects. Treatment details were not reported by the reporter.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report. More
2864079	84	M	NJ	10/07/2025	COVID19	MODERNA		Pemphigoid Pemphigoid	Patient developed pemphigoid resulting in horrific blistering over certain parts of body; This spont... Patient developed pemphigoid resulting in horrific blistering over certain parts of body; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (Patient developed pemphigoid resulting in horrific blistering over certain parts of body) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included Heart valve replacement (Artificial heart valve). In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PEMPHIGOID (Patient developed pemphigoid resulting in horrific blistering over certain parts of body) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (Patient developed pemphigoid resulting in horrific blistering over certain parts of body) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medication was reported. The patient did not have any additional medical history, concomitant disease or risk factor. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
2864080	73	F		10/07/2025	COVID19	MODERNA		COVID-19 COVID-19	Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ... Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spilevax in October 2023, Moderna COVID-19 (2nd dose, Batch Number :028A21A), Moderna COVID-19 (1st dose and Batch Number :002A21A). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19, Moderna COVID-19 and Spilevax. Concurrent medical conditions included Asthma. In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In August 2025, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. No concomitant medications provided by the reporter. It was reported that patient received Moderna COVID-19 vaccines since the start of the vaccination. The patient had no information for her 3rd and 4th doses except the date of the administration. The patient received a vaccination dose as Spikevax on Oct-2023, and the patient received a dose on Sep-2024 as Moderna Vaccine. No treatment medications provided by the reporter. More
2864081	38	M		10/07/2025	COVID19 COVID19	MODERNA MODERNA	003C21A 003C21A	Blood cholesterol, Hypoaesthesia, Magnetic resonance imaging, Pain in extremity,... Blood cholesterol, Hypoaesthesia, Magnetic resonance imaging, Pain in extremity, Paraesthesia; Peripheral swelling More	Feet go numb, and the left leg goes numb and tingles; Feet go numb, and the left leg goes numb and t... Feet go numb, and the left leg goes numb and tingles; Feet go numb, and the left leg goes numb and tingles; Sharp pain ran down his left leg; Couple weeks later, the bottoms of both feet "puffed out" and required a larger shoe (went from a size 10 to a size 10.5 and wears metatarsal pads on the bottom of feet); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sharp pain ran down his left leg), PERIPHERAL SWELLING (Couple weeks later, the bottoms of both feet "puffed out" and required a larger shoe (went from a size 10 to a size 10.5 and wears metatarsal pads on the bottom of feet)), HYPOAESTHESIA (Feet go numb, and the left leg goes numb and tingles) and PARAESTHESIA (Feet go numb, and the left leg goes numb and tingles) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 prophylaxis. The patient's past medical history included Hypercholesterolaemia (High cholesterol). On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (Sharp pain ran down his left leg). In 2021, the patient experienced PERIPHERAL SWELLING (Couple weeks later, the bottoms of both feet "puffed out" and required a larger shoe (went from a size 10 to a size 10.5 and wears metatarsal pads on the bottom of feet)). On an unknown date, the patient experienced HYPOAESTHESIA (Feet go numb, and the left leg goes numb and tingles) and PARAESTHESIA (Feet go numb, and the left leg goes numb and tingles). At the time of the report, PAIN IN EXTREMITY (Sharp pain ran down his left leg), PERIPHERAL SWELLING (Couple weeks later, the bottoms of both feet "puffed out" and required a larger shoe (went from a size 10 to a size 10.5 and wears metatarsal pads on the bottom of feet)), HYPOAESTHESIA (Feet go numb, and the left leg goes numb and tingles) and PARAESTHESIA (Feet go numb, and the left leg goes numb and tingles) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Magnetic resonance imaging: Pain in the left leg. On an unknown date, Blood cholesterol: High cholesterol. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. No concomitant medications were reported. The patient received the vaccine on 17-May-2021 and went to work that night, came home, and was watching a football game when a sharp pain ran down the left leg. The reporter first thought it was a charley horse; however, knew that it was not, as the patient experienced several charley horses before, having played sports in entire life. The next day, following the leg pain, patient called the doctor to schedule an appointment for the following day. The doctor prescribed muscle relaxers but did not help. To this day, the patient's feet go numb, and the left leg went numb and tingled. The pain in the left leg still remained to this day, and the left leg was still bigger than the right. Currently, the patient was not taking medication and was told by many doctors that there was "nothing they can do to help." Patient spoke with a doctor and knew what needed to be done but did not have the money to undergo the operation. In 2025, a doctor diagnosed the patient with having effects from the COVID vaccination shot. The patient could not work and had to quit the job. It was unknown if the patient experienced any additional symptoms/events. More
2864082	75	M		10/07/2025	COVID19	MODERNA		Vaccination site pain Vaccination site pain	arm's a little sore on the injection site; This spontaneous case was reported by a consumer and... arm's a little sore on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm's a little sore on the injection site) in a 75-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS (Had received every Moderna Covid vaccine and booster.). Past adverse reactions to the above products included No adverse effect with SPIKEVAX NOS. On 29-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 30-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced VACCINATION SITE PAIN (arm's a little sore on the injection site). At the time of the report, VACCINATION SITE PAIN (arm's a little sore on the injection site) was resolving. No concomitant medication was reported. The patient received a dose of Spikevax on 29-Sep-2025 and felt fine all day. On 30-Sep-2025, the patient's arm was a little sore at the injection site and that's it. That had not been completely resolved as of the time of reporting. The patient didn't feel it unless patient pushed on it. That's typically the way the patient reacted. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789835, US-MODERNATX, INC.-MOD-2025-789836, US-MODERNATX, INC.-MOD-2025-789837 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789835:Female patient US-MODERNATX, INC.-MOD-2025-789836:Female patient diffrent suspect US-MODERNATX, INC.-MOD-2025-789837:Case created for "People" More
2864083	69	F		10/07/2025	COVID19	MODERNA	040C21A	Vaccination site discolouration Vaccination site discolouration	"very dark discoloration" in her left arm, right in the vaccination area/It's got ver... "very dark discoloration" in her left arm, right in the vaccination area/It's got very, very dark. And it hasn't gone away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION ("very dark discoloration" in her left arm, right in the vaccination area/It's got very, very dark. And it hasn't gone away) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040D21A) for COVID-19 prophylaxis. On 04-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 02-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE DISCOLOURATION ("very dark discoloration" in her left arm, right in the vaccination area/It's got very, very dark. And it hasn't gone away). At the time of the report, VACCINATION SITE DISCOLOURATION ("very dark discoloration" in her left arm, right in the vaccination area/It's got very, very dark. And it hasn't gone away) had not resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as none. No concomitant medication was reported. The patient had developed a very dark discoloration in her left arm, right in the vaccination area after receiving her COVID-19 doses in 2021. When COVID just came about, the patient had 2 shots of the Moderna, and the arm was black to this day. It got very, very dark, and it hadn't gone away. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. The reporter causality was not reported. More
2864084	75	M	NY	10/07/2025	COVID19	MODERNA		Vaccination site erythema Vaccination site erythema	The last vaccine has been great, very little side effects afterwards except a little redness for a d... The last vaccine has been great, very little side effects afterwards except a little redness for a day or 2 and then it is nothing so it is a wonderful vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (The last vaccine has been great, very little side effects afterwards except a little redness for a day or 2 and then it is nothing so it is a wonderful vaccine) in a 75-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Hypothyroidism and Heart valve replacement (2 mechanical heart valves). On 06-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In June 2025, the patient experienced VACCINATION SITE ERYTHEMA (The last vaccine has been great, very little side effects afterwards except a little redness for a day or 2 and then it is nothing so it is a wonderful vaccine). In June 2025, VACCINATION SITE ERYTHEMA (The last vaccine has been great, very little side effects afterwards except a little redness for a day or 2 and then it is nothing so it is a wonderful vaccine) had resolved. Concomitant medication use information was not provided by reporter. The patient did not receive any vaccine 4 weeks prior to the Spikevax vaccine. The reporter clarified that it was right at the injection site, with no pain or anything else. It was basically the size of a dime. It was not like the whole arm got red or it was too much; it was just red about the size of a dime around the injection site. The redness resolved in a day. The patient got it on a Thursday, and it was gone by Saturday. It was confirmed that this occurred after receiving Spikevax in June. It was reported that it was not uncommon for him, he never had a problem with Moderna vaccine or Pfizer vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-789840 (Patient Link). More
2864085	82	F		10/07/2025	COVID19	MODERNA	AU3834B	COVID-19, Hypoacusis, Post-acute COVID-19 syndrome COVID-19, Hypoacusis, Post-acute COVID-19 syndrome	reduced hearing loss/ down to about 90% where it was around 50%/right ear; long-term COVID; got covi... reduced hearing loss/ down to about 90% where it was around 50%/right ear; long-term COVID; got covid; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (reduced hearing loss/ down to about 90% where it was around 50%/right ear), POST-ACUTE COVID-19 SYNDROME (long-term COVID) and COVID-19 (got covid) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3834B) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Niacin. Past adverse reactions to the above products included Drug allergy with Niacin. Concurrent medical conditions included Cancer, Heart disease, unspecified and Drug allergy (Reaction to Niacin). On 28-Dec-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. In 2024, the patient experienced POST-ACUTE COVID-19 SYNDROME (long-term COVID) and COVID-19 (got covid). On an unknown date, the patient experienced HYPOACUSIS (reduced hearing loss/ down to about 90% where it was around 50%/right ear). At the time of the report, HYPOACUSIS (reduced hearing loss/ down to about 90% where it was around 50%/right ear) had not resolved and POST-ACUTE COVID-19 SYNDROME (long-term COVID) and COVID-19 (got covid) outcome was unknown. Concomitant medications were not reported. It was reported that patient have had more vaccines but was reluctant ever since the symptoms happened. Patient's her current symptom was still reduced hearing loss. It was down to about 90% where it was around 50%. It was her right ear that went down, and the other ear didn't go down, her left ear. Patient went to have a flu shot and they had her fill out a form that said if had a reaction to "Niacin. Patient said she had a reaction to this, and they said they could not administer it so she got it done at her doctor's office. It was reported that her reaction was not pertaining to COVID or the flu, it was just. Patient confirmed that her doctor did end up administering the flu vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. More
2864086		F		10/07/2025	COVID19 COVID19	MODERNA PFIZER\BIONTECH		Asthenia, Chills, Pyrexia, Tremor; Asthenia, Chills, Pyrexia, Tremor Asthenia, Chills, Pyrexia, Tremor; Asthenia, Chills, Pyrexia, Tremor	shaking; incapacitated; chills; fever; This spontaneous case was reported by a consumer and describe... shaking; incapacitated; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), ASTHENIA (incapacitated), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking), ASTHENIA (incapacitated), CHILLS (chills) and PYREXIA (fever). At the time of the report, TREMOR (shaking), CHILLS (chills) and PYREXIA (fever) had resolved with sequelae and ASTHENIA (incapacitated) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient had previously taken Moderna and Pfizer COVID-19 vaccines and experienced side effects every time for about 9 hours after the injection. She experienced chills, fever, shaking, and was incapacitated for at least a day and a half, sometimes up to 2 to 3 days. Then it would resolve all by itself. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. More
2864087	72	M		10/07/2025	COVID19	MODERNA		COVID-19, SARS-CoV-2 test COVID-19, SARS-CoV-2 test	Covid infection; This spontaneous case was reported by a consumer and describes the occurrence of CO... Covid infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection) in a 72-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid infection). At the time of the report, COVID-19 (Covid infection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reportable as none. No concomitant medication was reported. A couple of years ago probably in 2023, patient got Covid infection. He used a home kit for the test, but the kit had expired, so he was not sure whether it was accurate. He had always taken Moderna vaccines. It was not confirmed what symptoms he had but only lasted for one day. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. More
2864088		F		10/07/2025	COVID19	MODERNA		Pain in extremity Pain in extremity	sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN E... sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The concomitant medication was not reported by the reporter. The relevant medical history (vaccines within the past 4 weeks, medical conditions) was reported as unknown. It was reported that the patient had two adult children, both with exercise-induced asthma. She asked if they were eligible to receive mNEXSPIKE or if it was only for over 65 years old. She mentioned that she received the vaccine without any issues, except for a sore arm. She was confused as her pharmacist told her that the vaccine was for those 65 years and older. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2864089		F		10/07/2025	COVID19	MODERNA		Fatigue, Fear, Headache, Pain in extremity Fatigue, Fear, Headache, Pain in extremity	so now I'm, I'm back to that initial fear again; sore arm; fatigue; a little headache; Thi... so now I'm, I'm back to that initial fear again; sore arm; fatigue; a little headache; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (so now I'm, I'm back to that initial fear again), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (a little headache) 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced FEAR (so now I'm, I'm back to that initial fear again), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (a little headache). At the time of the report, FEAR (so now I'm, I'm back to that initial fear again), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and HEADACHE (a little headache) outcome was unknown. No concomitant medication was reported. The patient did not have any side effects for the last 4 years but then noticed it was different. So, the patient was back to that initial fear again. The patient experienced the normal side effects and experienced a sore arm, fatigue and a slight headache. All the things indicated the vaccine was working. The patient's body was having a reaction to it. It was doing what it's supposed to be doing and alerting the body. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. Reporter did not allow further contact More
2864090	75	F	FL	10/07/2025	COVID19	PFIZER\BIONTECH		Abdominal pain upper, Diarrhoea, Peripheral coldness, Tremor Abdominal pain upper, Diarrhoea, Peripheral coldness, Tremor	Stomach cramping, and aching.; Diarrhea starting after bowels were emptied; Full body Violent shakin... Stomach cramping, and aching.; Diarrhea starting after bowels were emptied; Full body Violent shaking; Very cold esp hands and feet.; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 30Sep2025 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 7; MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: DIARRHOEA (non-serious) with onset 02Oct2025 at 08:30, outcome "recovering", described as "Diarrhea starting after bowels were emptied"; TREMOR (non-serious) with onset 02Oct2025 at 08:30, outcome "recovering", described as "Full body Violent shaking"; ABDOMINAL PAIN UPPER (non-serious) with onset 02Oct2025 at 08:30, outcome "recovering", described as "Stomach cramping, and aching."; PERIPHERAL COLDNESS (non-serious) with onset 02Oct2025 at 08:30, outcome "recovering", described as "Very cold esp hands and feet.". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, tremor, peripheral coldness. Additional information: Patient did not receive other vaccines on the same date as the vaccine(s) for which they are reporting. Patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. Patient taking any other medications within 2 weeks of the event starting: Yes. Patient has no known allergy. More
2864091		F	CA	10/07/2025	COVID19	PFIZER\BIONTECH		Asthenia, Condition aggravated, Neoplasm malignant, Smear cervix Asthenia, Condition aggravated, Neoplasm malignant, Smear cervix	after the 2nd Pfizer Covid vaccine she felt more weak; after the 2nd Pfizer Covid vaccine she felt m... after the 2nd Pfizer Covid vaccine she felt more weak; after the 2nd Pfizer Covid vaccine she felt more weak; Lost mom to stage 4 cancer; This is a spontaneous report received from a Nurse. A female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cervical cancer", start date: Feb2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (States her mom had the # Covid vaccine and started getting weak), administration date: 2021, for COVID-19 immunisation, reaction(s): "started getting weak". The following information was reported: NEOPLASM MALIGNANT (death) with onset 2021, outcome "fatal", described as "Lost mom to stage 4 cancer"; ASTHENIA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "after the 2nd Pfizer Covid vaccine she felt more weak". The patient underwent the following laboratory tests and procedures: Smear cervix: (Feb2021) Cervical cancer, notes: She had pap smear and told has cancer. Cervical cancer. The patient date of death was 2021. Reported cause of death: "Lost mom to stage 4 cancer". It was not reported if an autopsy was performed. Clinical course: During call while querying concomitant medication caller states in 2021 she lost her mom. Lost mom to stage 4 cancer. States her mom had the # Covid vaccine and started getting weak and after the 2nd # Covid vaccine she felt more weak. That is what took her out. It ended her. She died in 2021. They were talking about chemo. A couple of days after the 2nd Pfizer Covid vaccine she couldn't get out of bed. Cancer was diagnosed before she received the Covid vaccine. Caller went into her room to see her. It was after she got the vaccine she would at least get up. Her mom found out she had cancer in Feb2021. She had pap smear and told has cancer. Cervical cancer. Went to oncology to her extend life further. The moment she got the 2nd vaccine she couldn't get out of bed and her memory. Everything was exacerbated and literally everything went downhill. States for her mom, when she got diagnosed every once in a while, she would have to go to the hospital. She was admitted once with symptoms she was having. Caller went to her room and very unexpected she wasn't, she was alert, she doesn't know if oriented maybe to place, she doesn't know. Caller went in and got a call. She doesn't know if it was #. They asked if her mom got the vaccine and when she got it. It was kind of weird, they were asking when she got the vaccine and questions like trying to find out. Her mom was walking and was ok but it was like they were investigating. Caller walked into her room and they called. She doesn't know if it was the hospital or case manager. Not related to her visit. Caller does not have dates, NDC, lot or expiry to provide for # Covid vaccines. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Due to implausible temporal association, the event neoplasm malignant is assessed as unrelated to BNT162b2. The patient has taken second dose of BNT162B2 for covid immunization while Cancer was diagnosed before she received the Covid vaccine, and it is known that the process of carcinogenesis takes months to years to develop. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: Lost mom to stage 4 cancer More	✓
2864092	57	F	VA	10/07/2025	COVID19	PFIZER\BIONTECH	EP7534	Blood glucose, Glycosylated haemoglobin, Injection site injury Blood glucose, Glycosylated haemoglobin, Injection site injury	lump; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 57-year... lump; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 57-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EP7534) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; SIMVASTATIN taken for blood cholesterol increased; CETIRIZINE HCL taken for hypersensitivity; FUROSEMIDE taken for fluid retention; OMEPRAZOLE/SODIUM BICARBONATE taken for abdominal discomfort. The following information was reported: INJECTION SITE INJURY (non-serious), outcome "not recovered", described as "lump". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The very first shot was very painful thereafter, it really bothered her. There was hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot. Each time she would get Covid shots, lump would go back and forth between her two arms. Clarified, she experienced in lumps in both arms, had shots in both arms. More
2864093	44	F	CA	10/07/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	EW0191 EW0191	Blood test, Eye pain, Headache, Migraine, Muscle twitching; Pain in jaw Blood test, Eye pain, Headache, Migraine, Muscle twitching; Pain in jaw	her mandible which led to taking out her wisdom teeth; she got temporal pain; migraines; Orbits hurt... her mandible which led to taking out her wisdom teeth; she got temporal pain; migraines; Orbits hurting; eye twitching; This is a spontaneous report received from a Nurse. A 44-year-old female patient received BNT162b2 (BNT162B2), on 25Aug2021 (sometime in the afternoon) as dose 2, 0.3 ml single (Lot number: EW0191) at the age of 44 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "stress" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing), notes: got diabetes type 2 diabetes from the stress. Diabetes is stress induced. The patient took concomitant medications (Insulin). Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML, SINGLE; Lot Number: EW0183; Anatomical location: left deltoid), administration date: 04Aug2021, when the patient was 44-year-old, for Covid-19 Immunization. The following information was reported: PAIN IN JAW (medically significant), outcome "unknown", described as "her mandible which led to taking out her wisdom teeth"; HEADACHE (non-serious), outcome "unknown", described as "she got temporal pain"; MIGRAINE (non-serious), outcome "unknown", described as "migraines"; EYE PAIN (non-serious), outcome "unknown", described as "Orbits hurting"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "eye twitching". The events "her mandible which led to taking out her wisdom teeth", "she got temporal pain", "orbits hurting" and "eye twitching" required physician office visit. The event "migraines" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: perfect prior, notes: hasn't done damage to her at all. Therapeutic measures were taken as a result of pain in jaw. Clinical course: patient got diabetes because from the stress when she lost her mom to stage 4 cancer in 2021. Diabetes was stress induced. Reporter clarifies diabetes started just before her 1st Covid vaccine and she was taking insulin. Her bloodwork was perfect prior and hasn't done damage to her at all. She got the 1st Covid vaccine because she was in healthcare and was told she had to get the vaccine during covid. After the 2nd vaccine she got temporal pain, migraines and her mandible which led to taking out her wisdom teeth. Orbits hurting and eye twitching. Patient went to church and was feeling migraine. Left church and went to Urgent Care (ER). The doctor didn't think this was from the vaccine. It started getting worse.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pain in jaw and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500196591 Same patient, different vaccine dose and event; More
2864094	44	F	CA	10/07/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	330258D 330258D	Cataract, Computerised tomogram, Condition aggravated, Eye injury, Hypermetropia... Cataract, Computerised tomogram, Condition aggravated, Eye injury, Hypermetropia; Migraine, Muscle twitching, Presbyopia, Scar, Visual acuity tests More	Twitching in her eyes kept getting worse; Migraines; Twitching in her eyes kept getting worse; migra... Twitching in her eyes kept getting worse; Migraines; Twitching in her eyes kept getting worse; migraines; Farsighted; Scars on her eyes from surgery; Eyes were damaged; swimmer's eyes; Cataracts all over her eyes; Presbyopia; This is a spontaneous report received from a nurse. A 44-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2022 as dose 3 (booster), 0.3 ml single (Lot number: 330258D) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing), notes: Just before her first COVID vaccine and she was taking insulin; "Stress" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ML; Lot Number: EW0183; left deltoid), administration date: 04Aug2021, when the patient was 44-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, 0.3 ML; Lot Number: EW0191; left deltoid), administration date: 25Aug2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "Temporal pain", "Migraines", "Mandible which led to taking out her wisdom teeth", "Taking out her wisdom teeth", "Orbits hurting", "Eye twitching". The following information was reported: CATARACT (medically significant) with onset 2022, outcome "unknown", described as "Cataracts all over her eyes"; PRESBYOPIA (non-serious) with onset 2022, outcome "unknown"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "Twitching in her eyes kept getting worse"; MIGRAINE (non-serious), outcome "unknown", described as "Migraines"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Twitching in her eyes kept getting worse; migraines"; HYPERMETROPIA (non-serious), outcome "unknown", described as "Farsighted"; SCAR (non-serious), outcome "unknown", described as "Scars on her eyes from surgery"; EYE INJURY (non-serious), outcome "unknown", described as "Eyes were damaged; swimmer's eyes". The events "cataracts all over her eyes", "presbyopia", "twitching in her eyes kept getting worse", "migraines", "twitching in her eyes kept getting worse; migraines", "farsighted", "scars on her eyes from surgery" and "eyes were damaged; swimmer's eyes" required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Visual acuity tests: Better than 20/20; Everything was fine. Therapeutic measures were taken as a result of cataract, presbyopia, migraine, condition aggravated, hypermetropia, scar, eye injury. The patient was going in circles with ophthalmology. She got the first COVID vaccine (NDC Number: 59267-1000-1) because she is in healthcare and was told she had to get the vaccine during COVID. After the second vaccine (NDC Number: 59267-1000-1), she got temporal pain, migraines and her mandible which led to taking out her wisdom teeth. Orbits hurting and eye twitching. The doctor didn't think this was from the vaccine. It started getting worse. A few weeks after the third vaccine (NDC Number: 59267-1000-1; sometime in the afternoon), she picked up her phone and couldn't see the phone. She could see far but not up close. Diagnosed with presbyopia. Was told she should get better. Twitching in her eyes kept getting worse. The patient had never had migraines and started having migraines. The patient went to urgent care and did a CT scan that looked okay. Twitching kept on in November, right before holiday, she went out and all of a sudden her eyes were not seeing very well but that day it was almost like she lost her vision; she could barely see to drive home. She got glasses and then was going back every 2 weeks to optometry to increase the strength. She had better than 20/20 vision before COVID vaccine. She needed a screen to get glasses for protection for the computer, and they did the test and everything was fine. During that period, she got contacts and glasses, she couldn't get out of bed without them to see. The strength was up to almost a 4. Optometrist said it was definitely something she took. She now has cataracts all over her eyes. In her chart they put age-related. Per patient, age relatedness can't blind the eyes. Eyes were damaged so she put lenses in her eyes, and she is now far sighted, not near sighted. This has affected her life, changed her life. She is really struggling to try to see a computer and read. She is really struggling, and everyone is going on with their life. She must deal with this and it's not fair. The patient didn't do well from this. The patient reached out to ophthalmology because she doesn't want to keep changing glasses strength. Before she could see a speck of dirt on the floor. At the time of reporting, she is miserable because this has affected her physically, mentally, and physically. She has scars on her eyes from surgery. The patient was told it is going to be dangerous to open the capsule and put in another lens. She is stuck with this for the rest of her life. They said to wear sunglasses and dark sunglasses when she is out. She developed swimmer's eyes. They said it is dangerous to take it out. She has little scarring from the surgery; she can see little marks and is not too happy. For the past month she has tried to contact an attorney. She didn't know what to do. Someone told her to file a worker's compensation. Has seen optometry and ophthalmology. First, they put far sighted lenses, and she was grateful to see. But now, everything was well and now you are put at disadvantage you lose one sense it affects people. Just little tasks get so complicated because the eye controls, just one thing is off it confuses everything else. She has gone online to see what to do but didn't get much information. The third one basically took her out. She got diabetes because she lost her mother to stage 4 cancer. Diabetes started just before her first COVID vaccine, and she was taking insulin (unspecified). Her bloodwork was perfect prior and hasn't done damage to her at all. The patient got diabetes type 2 diabetes from the stress. Diabetes is stress-induced. The patient had retinal screening and had no retinal detachment. Went to optometry and had nothing to do with that, no retinal problems. If her sugar gets high, it's a problem because of eye problems she already has with the lenses that affects her vison. She had a clean bill of health just before diabetes which is caused by stress. She feels so bad today she was crying, upset and mad. Trying to figure out what she will do and how she will function for the rest of her life. Will it get worse as she ages. Her eyes were really sharp. Trying to pick up or look at something she can't see even with glasses. Can't see up close to focus she can't. It's a horrible way to live. Doctor said no she is too young for cataracts. Doctor did test and kept seeing it spreading and said it was definitely something she took. The patient did not receive any other vaccines within 4 weeks prior to the first administration or on the same date as the Pfizer vaccine. The patient went to church and was feeling migraine. Left church and went to urgent care (physician's office). As treatment, the patient did the lenses, that is all. She went for a second opinion to see about taking capsule out and was told it's dangerous. Feels down right now.; Sender's Comments: There is no reasonable possibility that the event cataract was related to BNT162b2. This is more likely associated with the medical history of Diabetes Type 2 or an intercurrent condition.,Linked Report(s) : US-PFIZER INC-202500196551 Same patient and product; different dose and event; More
2864096	69	F	KY	10/07/2025	COVID19	PFIZER\BIONTECH	FK9729	Condition aggravated, Tinnitus Condition aggravated, Tinnitus	Another increase in tinnitus; Another increase in tinnitus; This is a spontaneous report received fr... Another increase in tinnitus; Another increase in tinnitus; This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old female patient received BNT162b2 (BNT162B2), on 31Jan2022 as dose 4, single (Lot number: FK9729) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE Lot: EI3249), administration date: 19Jan2021, when the patient was 68-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE Lot: FM9810), administration date: 09Feb2021, when the patient was 68-year-old, for COVID-19 immunisation, reaction(s): "Had increase tinnitus from receiving the vaccine"; BNT162b2 (DOSE 3, SINGLE Lot: FC3181), administration date: 17Aug2021, when the patient was 69-year-old, for COVID-19 immunisation; Flu shot (flu shot in the proceeding September or October), for Immunization. The following information was reported: TINNITUS (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 31Jan2022, outcome "not recovered" and all described as "Another increase in tinnitus". Additional Information: On 02Apr2021 she reported an adverse effect to Pfizer and then had another one that never reported. She was calling to report it now. On 31Jan2022 the same thing occurred. Patient had the first Pfizer Vaccine in Jan2021 everything was fine. Mentioned she has had to movie the noise maker closer to her head so she can sleep, and she stated that when she took the vaccine on 09Feb2021 the tinnitus did not increase until 01Apr2021. She did not know if it was connected or not. Her tinnitus had not changed in years. After took the 4th vaccine on 31Jan2022 was driving away from pharmacy and it increased immediately. That was when sure it was the vaccine that did it. She went to the ear doctor two different times and both said they could not do anything. She did had vaccine at work facility. The patient did not had any other vaccines on the same date as the Pfizer vaccine. More
2864097	82	M	FL	10/07/2025	COVID19	PFIZER\BIONTECH	EL8982	Platelet count, Platelet count increased, Therapeutic response unexpected Platelet count, Platelet count increased, Therapeutic response unexpected	platelet count to rise 50% from the 50 K/uL to 75 K/uL each time he was vaccinated/this increased pl... platelet count to rise 50% from the 50 K/uL to 75 K/uL each time he was vaccinated/this increased platelet positive affect; platelet count to rise 50% from the 50 K/uL to 75 K/uL each time he was vaccinated/this increased platelet positive affect; This is a spontaneous report received from a Consumer or other non HCP. A male patient in his 80's received BNT162b2 (BNT162B2), on 01Feb2021 as dose 2, single (Lot number: EL8982) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EK9231), administration date: 11Jan2021, when the patient was 82-year-old, for COVID-19 immunization, reaction(s): "platelet count to rise 50% from the 50 K/uL to 75 K/uL each time he was vaccinated", "platelet count to rise 50% from the 50 K/uL to 75 K/uL each time he was vaccinated". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PLATELET COUNT INCREASED (non-serious), outcome "unknown" and all described as "platelet count to rise 50% from the 50 K/uL to 75 K/uL each time he was vaccinated/this increased platelet positive affect". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: For over 20 years, patient's platelet count has been in the 50 to 60 K/uL range. During the Pfizer vaccines injections (2021 to 2023), platelet count rose to 70/75 K/uL and then dropped back to 50/60 K/uL. Interestingly, during his January 2025 5-day-hospital for COVID, his platelet blood count also rose to 75 K/uL an all-time high. Patient was asking to review the COVID vaccines content to determine what products were included that might cause the platelet count to rise 50% from 50 K/uL to 75 K/uL each time he was vaccinated. This increased platelet positive effect might be a secondary or tertiary effect but would be beneficial for platelet treatment rather the normal drugs.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500116863 Same patient, different vaccine dose and event; More
2864098	83	M	FL	10/07/2025	COVID19	PFIZER\BIONTECH	FC3181	Platelet count, Platelet count increased, Therapeutic response unexpected Platelet count, Platelet count increased, Therapeutic response unexpected	this increased platelet positive affect; platelet count to rise 50% from the 50 K/ul to 75 K/ul each... this increased platelet positive affect; platelet count to rise 50% from the 50 K/ul to 75 K/ul each time I was; This is a spontaneous report received from a Consumer or other non HCP. An 83-year-old male patient received BNT162b2 (BNT162B2), on 21Aug2021 as dose 3 (booster), single (Lot number: FC3181) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single; Lot number: EK9231), administration date: 11Jan2021, when the patient was 82-year-old, for COVID-19 immunization, reaction(s): "this increased platelet positive affect/platelet count to rise 50% from the 50 K/ul to 75 K/ul each time", "this increased platelet positive affect/platelet count to rise 50% from the 50 K/ul to 75 K/ul each time"; BNT162b2 (Dose 2, single; Lot number: EL8982), administration date: 01Feb2021, when the patient was 82-year-old, for COVID-19 immunization, reaction(s): "this increased platelet positive affect/platelet count to rise 50% from the 50 K/ul to 75 K/ul each time", "this increased platelet positive affect/platelet count to rise 50% from the 50 K/ul to 75 K/ul each time". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "this increased platelet positive affect"; PLATELET COUNT INCREASED (non-serious), outcome "unknown", described as "platelet count to rise 50% from the 50 K/ul to 75 K/ul each time I was". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: for over 20 years, patient's platelet count has been in the 50 to 60 K/uL range. During the Pfizer vaccines injections (2021 to 2023), platelet count rose to 70/75 K/uL and then dropped back to 50/60 K/uL. Interestingly, during his January 2025 5-day-hospital for COVID, his platelet blood count also rose to 75 K/uL an all-time high. Patient was asking to review the COVID vaccines content to determine what products were included that might cause the platelet count to rise 50% from 50 K/uL to 75 K/uL each time he was vaccinated. This increased platelet positive effect might be a secondary or tertiary effect but would be beneficial for platelet treatment rather the normal drugs.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500116863 Same patient, different vaccine dose and event; More
2864099		F	MA	10/07/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	Reports she had previously taken all 5 Pfizer covid shots and has covid and is prescribed Paxlovid; ... Reports she had previously taken all 5 Pfizer covid shots and has covid and is prescribed Paxlovid; Reports she had previously taken all 5 Pfizer covid shots and has covid and is prescribed Paxlovid; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Reports she had previously taken all 5 Pfizer covid shots and has covid and is prescribed Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Reported she had previously taken all 5 Pfizer covid shots and had covid and was prescribed Paxlovid. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2864100	63	F		10/07/2025	COVID19	PFIZER\BIONTECH	NA0587	Dry mouth Dry mouth	Dry mouth x 2 days; This is a spontaneous report received from a Nurse. A 63-year-old female patien... Dry mouth x 2 days; This is a spontaneous report received from a Nurse. A 63-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 01Oct2025 at 09:30 as dose 1, single (Lot number: NA0587) at the age of 63 years, in left deltoid for covid-19 immunisation, Device Lot Number: NA0587. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRY MOUTH (non-serious) with onset 01Oct2025 at 16:00, outcome "recovered" (03Oct2025), described as "Dry mouth x 2 days". Therapeutic measures were not taken as a result of dry mouth. Additional information: patient did not receive ay other vaccine on the same date as COMIRNATY (2025-2026 FORMULA). More
2864101				10/07/2025	COVID19	PFIZER\BIONTECH		Vomiting Vomiting	Vomiting; This is a spontaneous report received from a Consumer or other non HCP. Other Case identif... Vomiting; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789725 (Moderna), MOD-2025-789730 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), in 2021 as dose number unknown, single and on 28Apr2022 as dose number unknown (booster), single for covid-19 immunisation; elasomeran, imelasomeran (SPIKEVAX BIVALENT ORIGINAL / OMICRON), on 15Jan2023 as dose number unknown, single for covid-19 immunisation; andusomeran (SPIKEVAX 2023-2024 FORMULA), on 19Oct2023 as dose number unknown, single for covid-19 immunisation; COVID-19 vaccine mrna omicron (kp.2) moderna (SPIKEVAX 2024-2025 FORMULA [COVID-19 VACCINE MRNA OMICRON (KP.2) MODERNA]), on 24Sep2024 as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "CPAD (dialysis)" (ongoing); "Type 1 diabetes" (ongoing). The patient's concomitant medications were not reported. The following information was reported: VOMITING (non-serious), 10 hrs after the suspect product(s) administration, outcome "recovered". Batch/lot number is not provided, and it cannot be obtained. Additional information: The patient received the Moderna COVID-19 vaccine in 2021. On 28Apr2022, patient received a 0.5 mL dose of the Moderna COVID-19 Vaccine Booster. On 15Jan2023, the patient was administered the Moderna COVID-19 Bivalent Vaccine. Subsequently, on 19Oct2023, patient received the Spikevax 2023-2024 PFS and on 24Sep2024 patient received the SPIKEVAX 2024-2025 PFS. It was reported that patient received all Covid vaccines since 2021 till now, which was 7-8 vaccines. It was reported that post COVID-19 vaccination each time almost 10 hours after the vaccine the patient used to start vomit for every 20 to 30 minutes and that vomit used to last for 6-8 hours for the patient. It was reported that patient used to receive Moderna vaccines except for once got Pfizer but experienced the same symptom. In addition, there were for other 4 other Moderna -Covid-19 vaccine patient had no information. No treatment medications provided by the reporter. More
2864102				10/07/2025	COVID19	PFIZER\BIONTECH		Tremor, Wrong product administered Tremor, Wrong product administered	body shook for about a half hour afterward; I think they gave it to me anyway in the guise of a flu ... body shook for about a half hour afterward; I think they gave it to me anyway in the guise of a flu shot; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient didn't receive influenza vaccine (INFLUENZA VACCINE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "body shook for about a half hour afterward"; WRONG PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "I think they gave it to me anyway in the guise of a flu shot". Additional information: the patient stated that the vaccine was given to him/her anyway in the guise of a flu shot. The patient's body shook for about half an hour afterward. It was further mentioned that patient always feel sick. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2864103	64	F	CA	10/07/2025	COVID19	PFIZER\BIONTECH		COVID-19, Vaccination failure COVID-19, Vaccination failure	she had a Pfizer vaccine 2 weeks ago, but she still got COVID/My wife is sick with COVID; she had a ... she had a Pfizer vaccine 2 weeks ago, but she still got COVID/My wife is sick with COVID; she had a Pfizer vaccine 2 weeks ago, but she still got COVID/My wife is sick with COVID; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "MS" (ongoing). Concomitant medication(s) included: OCREVUS taken for multiple sclerosis. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she had a Pfizer vaccine 2 weeks ago, but she still got COVID/My wife is sick with COVID". Clinical course: The patient husband, (withheld), advised, Reporter wife was sick with COVID, and her doctor prescribed Paxlovid. She was immunocompromised because she taking Ocrevus, which was a treatment for her MS, and she did have a Pfizer vaccine a couple of weeks ago for COVID, and she has got COVID. So, she was told she needs to be on that medicine. Later, after confirming that (withheld) was calling regarding financial assistance for the patient's medication, (withheld) advised, She was been on like disability from work because she was- She hurt herself first then she got diagnosed with MS and they put her on Ocrevus which suppressed her immune system, and so she was kind of sick, and she was worried about her. So, whatever you can do would be great, because she had to buy medicine regardless. Like she said, she had a Pfizer vaccine 2 weeks ago, but she still got COVID. Later, after explaining how the program works, (withheld) stated, she was not a government employee or anything like that. She just basically- Actually, her insurance terminated on 01Sep from (withheld) because she has been out of work for over 28 weeks. She was disabled and now she was sick. When asked if the patient was available to provide authorization for the husband to be able to enroll her over the phone, (withheld) stated, Yeah, she think she was, if she answers. Then sometimes she was sleeping. In addition, (withheld), She was sick, and she told me to go to the pharmacy to pick up the medicine and this was what she ran into when obtained consent to speak with (withheld) regarding financial assistance for the prescription, (withheld) stated, reporter was the one that went to the pharmacy for her because she cannot go out. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2864104				10/07/2025	COVID19	PFIZER\BIONTECH		Headache, Pain, Pain in extremity Headache, Pain, Pain in extremity	body aches; arm soreness; headache; This is a spontaneous report received from a Consumer or other n... body aches; arm soreness; headache; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Oct2025 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: PAIN IN EXTREMITY (non-serious) with onset 06Oct2025, outcome "recovered" (06Oct2025), described as "arm soreness"; PAIN (non-serious) with onset 06Oct2025, outcome "recovered" (06Oct2025), described as "body aches"; HEADACHE (non-serious) with onset 06Oct2025, outcome "recovered" (06Oct2025). Therapeutic measures were taken as a result of pain, pain in extremity, headache. Additional information: The patient received the new vaccine 05Oct2025 at a pharmacy and experienced body aches, arm soreness and headache by late morning on 06Oct2025. Symptoms resolved after taking Advil. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2864110	47	F	TX	10/07/2025	FLU3	SANOFI PASTEUR	UT8408MA	Expired product administered, No adverse event Expired product administered, No adverse event	they administered the fluzone tri (pf) to a staff member but noticed afterwards, that one was expire... they administered the fluzone tri (pf) to a staff member but noticed afterwards, that one was expired with no adverse event; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 47 years old female patient was administered the influenza USP trival A-B subvirion no preservative vaccine [Fluzone] but noticed afterwards, that one was expired with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitants: None On 01-Oct-2025, the patient received a dose of 0.5 ml once of suspect the influenza USP trival A-B subvirion no preservative vaccine (Suspension for injection) (lot: UT8408MA; expiry date: 30-Jun-2025; strength: standard) via intramuscular route in the left deltoid for Immunisation but noticed afterwards, that one was expired with no adverse event (expired product administered) (latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2864112	0.08	F	IN	10/07/2025	FLU3	SANOFI PASTEUR	U8827AA	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	6-week-old patient received the FLUZONE TRI in error with no reported adverse event; Initial informa... 6-week-old patient received the FLUZONE TRI in error with no reported adverse event; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 6 weeks old female patient who received the Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] in error with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis b vaccine (Hepatitis b), Pneumococcal vaccine (Pneumococcal vaccine), Diphtheria vaccine toxoid, HIB vaccine conj (tet tox), Pertussis vaccine acellular 5-component, Polio vaccine inact 3v (MRC 5), Tetanus vaccine toxoid (Pentacel) and Rotavirus vaccine (Rotavirus vaccine) for Immunisation. On 29-Sep-2025, the patient received 0.5mL of suspect Influenza Quadrival A-B Multidose Vaccine Preserved, Suspension for injection (lot U8827AA, expiry date 30-Jun-2026, strength standard and frequency once) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) and 6-week-old patient received the fluzone tri in error with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2864115	83	M	TN	10/07/2025	TD TDAP	SANOFI PASTEUR SANOFI PASTEUR		No adverse event, Wrong product administered; No adverse event, Wrong product ad... No adverse event, Wrong product administered; No adverse event, Wrong product administered More	administration of tenivac instead of adacel with no reported adverse event; Initial information rece... administration of tenivac instead of adacel with no reported adverse event; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 83 years old male patient who was administered diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza Vaccine [Flu] for Immunisation. On 02-Oct-2025, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (Suspension for injection) (strength: standard) (lot number; expiry date not reported) via intramuscular route in the deltoid NOS (Not Otherwise Specified) for Immunisation instead of diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number; expiry date not reported) (wrong product administered) (latency: same day). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2864132			WA	10/07/2025	HPV9	MERCK & CO. INC.		No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	Pharmacy intern called to inquire about the safety data of administrating the GARDASIL 9 vaccine to ... Pharmacy intern called to inquire about the safety data of administrating the GARDASIL 9 vaccine to an 18 month old; No additional AE; This spontaneous report was received from a medical student and refers to a) 18-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (dose, route, lot # and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age). When asked if there was a patient involved, caller reported "he thinks so". No additional adverse event was reported. More
2864144	64	F	NY	10/07/2025	VARZOS VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	UNK UNK UNK	Asthenia, Blister, Chills, Feeling hot, Headache; Hypersomnia, Lethargy, Nausea,... Asthenia, Blister, Chills, Feeling hot, Headache; Hypersomnia, Lethargy, Nausea, Photophobia, Pyrexia; Rash More	got a little outbreak that was itchy on her right wrist, like a cluster of bubbles, another blister ... got a little outbreak that was itchy on her right wrist, like a cluster of bubbles, another blister above her right wrist/chills, fever, headache, sleep excessive, lethargy, nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 22-AUG-2025 16:00, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 22-AUG-2025, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: got a little outbreak that was itchy on her right wrist, like a cluster of bubbles, another blister above her right wrist/chills, fever, headache, sleep excessive, lethargy, nausea). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 19-SEP-2025 The patient self-reported this case. The patient received her first dose of Shingrix on Friday from her pharmacist, and that by midnight that evening, she was experiencing chills which lasted until dinnertime on Sunday. The patient developed a fever at 2 AM on Saturday, that felt like a sunburn and her temperature was 101.4 Fahrenheit when she got up that morning, with the highest recorded temperature of 101.7 Fahrenheit. The patient reported that her fever was 99.9 Fahrenheit on Sunday and 99.3 Fahrenheit on Monday then dissipated on Monday and had a very bad headache, like a migraine, all day on Saturday and she could not look at her phone or TV but had to be in the dark. The patient lost days of work as a result of the headache and did not normally have headaches, and could function better on Sunday, and had to sleep all day or was in bed all day on Saturday, through half the day on Sunday. The patient was lethargic and had no real strength on Saturday, but this was better on Sunday, and she had nausea the whole day on Saturday that was gone on Sunday. The patient had only had fluids all day on Saturday and had about 10 days to 2 weeks (no specific date provided) after receiving the first dose of Shingrix, she got a little outbreak that was itchy on her right wrist, like a cluster of bubbles, another blister above her right wrist, and also on her left inner shoulder. The patient had these areas were very itchy and she still had the itchiness today (on the reporting day) The patient had these itchy areas which were not healing quickly and were leaving a mark. The patient did have these itchy areas checked out and whomever checked them out, did not know what they were. The patient reported that she did not normally had reactions to vaccines and had a solid immune system. More
2864145		M	CA	10/07/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Feeling abnormal, Influenza like illness Feeling abnormal, Influenza like illness	Flu like symptoms; Headache; felt terrible; This non-serious case was reported by a consumer via cal... Flu like symptoms; Headache; felt terrible; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms), headache (Verbatim: Headache) and feels awful (Verbatim: felt terrible). The outcome of the influenza-like symptoms, headache and feels awful were resolved. It was unknown if the reporter considered the influenza-like symptoms, headache and feels awful to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms, headache and feels awful to be related to Shingrix. Additional Information: GSK Receipt Date: 19-SEP-2025 The patient had a bad reaction to the Shingrix shot 2 which included flu-like symptoms and headache. Patient felt terrible for a day or two and then these events resolved. More
2864146		F	TX	10/07/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure	Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via call cente... Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female 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 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 unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 26-SEP-2025 The reporter heard from her doctor, while she herself was being seen for shingles in 2025 post-Shingrix vaccination. The batch number was not provided and request for this information was made. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingrix, in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought. More
2864147		F	CA	10/07/2025	RSV	PFIZER\WYETH		Exposure during pregnancy, Stillbirth Exposure during pregnancy, Stillbirth	had still born baby, same day as vaccination; The patient was 36 weeks and few days pregnant; The pa... had still born baby, same day as vaccination; The patient was 36 weeks and few days pregnant; The patient was 36 weeks and few days pregnant; This is a spontaneous report received from an Other HCP. A 21-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in 2024 as dose number unknown, single (Batch/Lot number: unknown) for maternal exposure timing unspecified. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 2024, outcome "unknown" and all described as "The patient was 36 weeks and few days pregnant"; STILLBIRTH (medically significant) with onset 2024, outcome "unknown", described as "had still born baby, same day as vaccination". The pregnancy resulted in still birth. Clinical course: The only patient information provided was that, patient was years old and this happened last year. The patient was 36 weeks and few days pregnant, when she got vaccinated and same day, had stillborn baby.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product to the development of the reported event STILLBIRTH cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate More
2864148			TX	10/07/2025	COVID19 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 PFIZER\BIONTECH	EN6205 EN6205 EN6205 EN6205 EN6205	Graves' disease, Hepatic function abnormal, Injury, Kidney enlargement, Lab... Graves' disease, Hepatic function abnormal, Injury, Kidney enlargement, Laboratory test; Liver disorder, Myocarditis, Pericarditis, Plasma cell myeloma, Renal impairment; Sinus node dysfunction, Small fibre neuropathy, Spleen disorder, Tachycardia; Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Fibrin D dimer increased, Heart rate, Illness; Lymphocyte count abnormal, Monocyte count abnormal, Neutrophil count abnormal; Graves' disease, Hepatic function abnormal, Injury, Kidney enlargement, Laboratory test; Liver disorder, Myocarditis, Pericarditis, Plasma cell myeloma, Renal impairment; Sinus node dysfunction, Small fibre neuropathy, Spleen disorder, Tachycardia; Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Fibrin D dimer increased, Heart rate, Illness; Lymphocyte count abnormal, Monocyte count abnormal, Neutrophil count abnormal More	Pericarditis; myocarditis; graves disease; multiple myeloma; SSS; kidney, spleen, liver swelling and... Pericarditis; myocarditis; graves disease; multiple myeloma; SSS; kidney, spleen, liver swelling and functions off; tachardia; Small fiber neuropathy -2; kidney, spleen, liver swelling and functions off; kidney, spleen, liver swelling and functions off; kidney, spleen, liver swelling and functions off; kidney, spleen, liver swelling and functions off; vaccine injury after the booster; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer unknown. 2 of my shots were E series), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown"; MYOCARDITIS (medically significant), outcome "unknown"; GRAVES' DISEASE (medically significant), outcome "unknown", described as "graves disease"; PLASMA CELL MYELOMA (medically significant), outcome "unknown", described as "multiple myeloma"; SINUS NODE DYSFUNCTION (medically significant), outcome "unknown", described as "SSS"; RENAL IMPAIRMENT (medically significant), KIDNEY ENLARGEMENT (non-serious), LIVER DISORDER (non-serious), HEPATIC FUNCTION ABNORMAL (non-serious), SPLEEN DISORDER (non-serious), outcome "unknown" and all described as "kidney, spleen, liver swelling and functions off"; TACHYCARDIA (non-serious), outcome "unknown", described as "tachardia"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "Small fiber neuropathy -2"; INJURY (non-serious), outcome "unknown", described as "vaccine injury after the booster". The events "pericarditis", "myocarditis" and "tachardia" required emergency room visit. The patient underwent the following laboratory tests and procedures: heart labs/tests: normal, notes: normal heart labs/tests. Therapeutic measures were taken as a result of plasma cell myeloma. Clinical course: Patient had vaccine injury after the booster. It was reported that 2 of my shots were E series. Diagnosed with Pericarditis, myocarditis, tachycardia, multiple ER Visits. Then graves disease, SSS, Small fiber neuropathy -2, kidney, spleen, liver swelling and functions off. Patient had normal heart labs/tests but massive pressure and pain from scaring. May have had multiple myeloma but self-treated with Ivermectin. Patient need help. Patient need it now. Patient had a 4-year-old child. Extremely healthy fit rugby. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. More
2864149				10/07/2025	COVID19	PFIZER\BIONTECH		Death Death	Dead; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(... Dead; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20250925000001 (Moderna). A patient (age and gender not provided) received BNT162b2 (COMIRNATY), in 2020 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "Dead". The patient date of death was 2020. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical information: The patient had the shot, a regular shot in back when COVID first started and a week later was dead. Further, it's when COVID first started, so it was back probably in 2020. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death More	✓
2864152	12	M	CA	10/07/2025	FLU3 HPV9 MNQ TDAP	SEQIRUS, INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR	406989 Y013407 U8573AA U8564AA 0	Contusion, Injection site erythema; Contusion, Injection site erythema; Contusio... Contusion, Injection site erythema; Contusion, Injection site erythema; Contusion, Injection site erythema; Contusion, Injection site erythema More	mother called 10/07/2025 morning stating pts arms wore bruised and red on injections site mother called 10/07/2025 morning stating pts arms wore bruised and red on injections site
2864154	49	F	CA	10/07/2025	FLU3	GLAXOSMITHKLINE BIOLOGICALS	B7C5B	Circumstance or information capable of leading to medication error, Hypoaesthesi... Circumstance or information capable of leading to medication error, Hypoaesthesia, Muscle spasms, Muscular weakness More	Patient is experiencing numbness and spasms post administration roughly a month later. She states t... Patient is experiencing numbness and spasms post administration roughly a month later. She states that her arm "moved" when needle was inserted during administration. She loses grip and numbness is intermittent. She describes what might be the superior tricep and axilla area as spasming too. She drops pencils/pens while holding them she reports due to weakness and spasms as well. More
2864155	82	M	WA	10/07/2025	COVID19 FLU3	MODERNA SEQIRUS, INC.	3052734 407257	Asthenia; Asthenia Asthenia; Asthenia	At around 2:45pm, staff came to me and asked what vaccine residents received, after looking at the V... At around 2:45pm, staff came to me and asked what vaccine residents received, after looking at the VAR I said flu and COVID vaccine then I handed her the VAR and I asked why she is asking, she stated that the resident was being seen by the EMT because the caregiver called them when the noticed that resident was walking using his walker and suddenly become weak. I went to the unit right away and when I get to the unit, I noticed the resident was seating in wheelchair and being assess by 4 EMT. I asked the caregivers if they were able to take vital signs before EMT arrived and they stated "yes" and it was BP 114/59, Pulse 72 and O2 sats 99% in room air. Resident was taken to the ER. More
2864156	74	F	FL	10/07/2025	COVID19 FLU3	PFIZER\BIONTECH SANOFI PASTEUR	MY9550 UT8781AA	Rash, Rash erythematous, Rash papular, Rash pruritic, Swelling of eyelid; Rash, ... Rash, Rash erythematous, Rash papular, Rash pruritic, Swelling of eyelid; Rash, Rash erythematous, Rash papular, Rash pruritic, Swelling of eyelid More	Patient Broke out in Rash all over Trunk(stomach and back), Groin area. Raised Red, and itchy. Ras... Patient Broke out in Rash all over Trunk(stomach and back), Groin area. Raised Red, and itchy. Rash lasted 3 to 4 days. Eyelids were swollen More
2864157	75	F	CO	10/07/2025	COVID19 COVID19	MODERNA MODERNA	80777-0400-60 80777-0400-60	Chest discomfort, Cough, Headache, Oropharyngeal pain, Pain; Tremor Chest discomfort, Cough, Headache, Oropharyngeal pain, Pain; Tremor	Around 8PM the day of the injection, I started getting a sore throat and a headache that occurs in t... Around 8PM the day of the injection, I started getting a sore throat and a headache that occurs in the middle of the head. My body started to ache. I had a heavy chest as though having an asthma attack. I had a dry hacky cough and i developed a temperature. My normal temperature runs around 97.4 but this was 99.4-100.1. I developed the shakes from the temperature and having had covid 4 times I knew these were all symptoms I ahe had when experiencing covid. I have NEVER had a reaction to vaccine like this. Usually get a sore arm and some lethargy. Not much else. I have had both Pfizer and Moderna vaccines starting with the original vaccinations after the original Covid 19. I have had verified Covid infection s four times. Original, two omicrons, and unknown strain from (withheld). More
2864158	78	F	NE	10/07/2025	COVID19 FLU3	PFIZER\BIONTECH SANOFI PASTEUR	na0738 u8837ca	Injection site pain, Pain, Product administered at inappropriate site; Injection... Injection site pain, Pain, Product administered at inappropriate site; Injection site pain, Pain, Product administered at inappropriate site More	Shot was administered too high into the deltoid tendon leading to increased pain with the immunizati... Shot was administered too high into the deltoid tendon leading to increased pain with the immunization and prolonged continuing pain after immunization. Patient followed up with primary care physician at annual appointment approximately 1 month after the immunization and they are having her start physical therapy to try to alleviate the pain. More
2864159	89	F	IA	10/07/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3052133 U8800AA	Back pain, Headache, Influenza, Myalgia; Back pain, Headache, Influenza, Myalgia Back pain, Headache, Influenza, Myalgia; Back pain, Headache, Influenza, Myalgia	Patient reports sever muscle and back pain, headache and other flu symptoms starting about 4 hours a... Patient reports sever muscle and back pain, headache and other flu symptoms starting about 4 hours after vaccination. She states that she laid down and took a nap for about 5 hours and is feeling much better More
2864160	73	F	NJ	10/07/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	94J5E	Influenza like illness, Injection site pain, Injection site warmth, Rash Influenza like illness, Injection site pain, Injection site warmth, Rash	Patient said that next day she felt flu like symptoms, then the area of the shot became hot and pain... Patient said that next day she felt flu like symptoms, then the area of the shot became hot and painful, today she developed a rash that she said looked like poison ivy. I advised that she go to her primary MD and they sent her in a script for doxycycline. More
2864177	57	M	GA	10/07/2025	FLU3	SANOFI PASTEUR	U8832DA	Vomiting Vomiting	Vomiting Vomiting
2864178	75	F	IL	10/07/2025	COVID19 FLU3	PFIZER\BIONTECH SEQIRUS, INC.	na0587 407252	Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More	No adverse event has been reported. Patient asked if they could get covid and flu vaccinations. We p... No adverse event has been reported. Patient asked if they could get covid and flu vaccinations. We proceeded to give patient covid and flu vaccinations. Upon printing records off of the state registry, it was determined that the patient had received covid and flu vaccinations on 9/8/25 at pharmacy. Due to the thought that there may be a language barrier given the situation, we informed the patient via translator that she should monitor for any side effects. If anything alarmingly abnormal occurs, she was encouraged to contact medical personnel. She was also told we would notify her doctor, and she was encouraged to do so as well. She stated that she forgot that she got covid and flu vaccinations at pharmacy on 9/8. Adverse events are unknown at this time. More

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