🏥 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
Expand text: Click "More" to see full narrative or symptom text
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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 8,401 to 8,450 of 34,052 reports (Page 169 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥	♿
2860048	37	M	HI	09/19/2025	UNK	UNKNOWN MANUFACTURER		Pruritus, Sleep disorder Pruritus, Sleep disorder	Extreme itch under my skin. Disrupts my sleep for hours. Worst itch ever! Happens 2-3 times a year. ... Extreme itch under my skin. Disrupts my sleep for hours. Worst itch ever! Happens 2-3 times a year. For over 2 decades. More
2860049	32	M	KY	09/19/2025	FLU3	SANOFI PASTEUR	308521	Deafness, Ear pain, Meniere's disease, Vertigo Deafness, Ear pain, Meniere's disease, Vertigo	Within two days of receiving this vaccine, I began experience symptoms of Meniere's Disease inc... Within two days of receiving this vaccine, I began experience symptoms of Meniere's Disease including vertigo, severe ear pain, and hearing loss. I was later diagnosed with Meniere's Disease and am still being treated for it. More		✓
2860050	73	F	PR	09/19/2025	FLU3 FLU3 PNC21 PNC21	SEQIRUS, INC. SEQIRUS, INC. MERCK & CO. INC. MERCK & CO. INC.	407258 407258 z006076 z006076	Abdominal discomfort, Blood pressure decreased, Chest pain, Erythema, Fatigue; H... Abdominal discomfort, Blood pressure decreased, Chest pain, Erythema, Fatigue; Headache, Pruritus, Syncope; Abdominal discomfort, Blood pressure decreased, Chest pain, Erythema, Fatigue; Headache, Pruritus, Syncope More	Patient detailed that se experienced redness in hands and itching. She applied ice and it improved. ... Patient detailed that se experienced redness in hands and itching. She applied ice and it improved. Subsequently, she experienced fatigue, headache, chest pain and stomach discomfort all throughout the day. During the evening and while attending church service she fainted. A local doctor was attending service as well and took her blood pressure indicating it was low. She was placed on the floor, on her back and elevating her legs to assist bringing BP up. She recovered and the local MD called the pharmacy on 09/19 to report the incident. During a follow up call with the patient, she shared she was feeling better and explained the symptoms described above. More
2860051	62	M	TX	09/19/2025	PNC20	PFIZER\WYETH	LP4948	Erythema, Limb discomfort, Pain in extremity, Skin warm Erythema, Limb discomfort, Pain in extremity, Skin warm	Patient reported redness, warmth and pain to the touch on the left arm late evening on 9/12/25. The ... Patient reported redness, warmth and pain to the touch on the left arm late evening on 9/12/25. The redness and discomfort continued for the next few days and on 9/17/25 the patient visited the urgent care where he was prescribed Cephalexin and Triamcinolone. On 9/19/25, the patient notified the pharmacy of the happenings and stated he had an appointment with his PCP. The PCP office was notified of the symptoms being experienced and after the appointment, the patient stated he was advised to give the symptoms time to subside by his provider. More
2860052	17	F	TN	09/19/2025	MNQ	SANOFI PASTEUR		Extra dose administered Extra dose administered	Administered extra dose of MenQuadfi by mistake. Administered extra dose of MenQuadfi by mistake.
2860053	14	M	OR	09/19/2025	MMRV	MERCK & CO. INC.		No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	Vaccine administration erro.r. Patient age was beyond the FDA approved age to receive this vaccine. ... Vaccine administration erro.r. Patient age was beyond the FDA approved age to receive this vaccine. Otherwise, no physical effects noted. More
2860054	31	F	NJ	09/19/2025	MENB	PFIZER\WYETH	lx2636	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	Patient who is 31 years of age was given the Trumenba which was for 10 to 25 years of age. Patient who is 31 years of age was given the Trumenba which was for 10 to 25 years of age.
2860055	5	M	MD	09/19/2025	FLU3 HEP	SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS	UT8792NA 7NX57	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 sign and symptom during or after vaccination. Hep B given due to negative Hep B titer on ... No adverse sign and symptom during or after vaccination. Hep B given due to negative Hep B titer on 9/4/25. More
2860056	81	F	CA	09/19/2025	FLU3	SANOFI PASTEUR	u8837ca	Injected limb mobility decreased, Mobility decreased, Pain, Peripheral swelling Injected limb mobility decreased, Mobility decreased, Pain, Peripheral swelling	Patient is reporting a swollen arm and pain. She is also reporting that the swelling now has moved t... Patient is reporting a swollen arm and pain. She is also reporting that the swelling now has moved to her other arms and that she cannot left her arms. More
2860057	1.33	F	AL	09/19/2025	DTAP HIBV IPV	GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR	JP227 UK304AA Y1DO3P1	Injection site reaction, Rash macular; Injection site reaction, Rash macular; In... Injection site reaction, Rash macular; Injection site reaction, Rash macular; Injection site reaction, Rash macular More	Rash Appeared the night pt. received vaccines. Pts. mother reported a splotchy rash to the upper (L)... Rash Appeared the night pt. received vaccines. Pts. mother reported a splotchy rash to the upper (L) Thigh. Mother applied hydrocortisone cream to the area after noticing the rash. More
2860058	76	F		09/19/2025	HIBV MEN MENB PNC	SANOFI PASTEUR UNKNOWN MANUFACTURER NOVARTIS VACCINES AND DIAGNOSTICS PFIZER\WYETH	UNK UNK UNK UNK	Allergy to vaccine, Hypoaesthesia oral; Allergy to vaccine, Hypoaesthesia oral; ... Allergy to vaccine, Hypoaesthesia oral; Allergy to vaccine, Hypoaesthesia oral; Allergy to vaccine, Hypoaesthesia oral; Allergy to vaccine, Hypoaesthesia oral More	Allergy to vaccine/ allergic reaction; minor numbness around mouth and spreading to tongue; This se... Allergy to vaccine/ allergic reaction; minor numbness around mouth and spreading to tongue; This serious case was reported by a other health professional via other manufacturer and described the occurrence of allergic reaction in a 76-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis, HIB vaccine conj (tet tox) (Act hib) for prophylaxis and Pneumococcal vaccine conj 7v (CRM197) (Prevenar) for prophylaxis. Concurrent medical conditions included asthma, open angle glaucoma, hypersensitivity, osteoporosis, thyroid disorder, tremor, glaucoma, dry age-related macular degeneration, neovascular age-related macular degeneration, seizure and hypothyroidism. Additional patient notes included The patient's past medical history, medical treatments, and family history were not provided.. Concomitant products included fluticasone, alendronate sodium (Alendronate), levothyroxine, primidone, folic acid, timolol maleate, astaxanthin, ascorbic acid;cupric oxide;dl-alpha tocopheryl acetate;xantofyl;zeaxanthin;zinc oxide (Preservision Areds 2), biotin, faricimab svoa (Vabysmo) and gabapentin. On 20-DEC-2023, the patient received the 1st dose of Bexsero, Menquadfi, Act hib and Prevenar. On 20-DEC-2023, less than a day after receiving Bexsero, Menquadfi, Act hib and Prevenar, the patient experienced allergic reaction (Verbatim: Allergy to vaccine/ allergic reaction) (serious criteria other: Serious as per reporter) and hypoesthesia oral (Verbatim: minor numbness around mouth and spreading to tongue). The patient was treated with diphenhydramine hydrochloride (Benadryl). On 20-DEC-2023, the outcome of the allergic reaction and hypoesthesia oral were resolved (duration 1 day). The reporter considered the allergic reaction to be possibly related to Bexsero, Menquadfi, Act hib and Prevenar. It was unknown if the reporter considered the hypoesthesia oral to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Menquadfi, Act hib and Prevenar. It was unknown if the reporter considered the allergic reaction to be related to Bexsero Pre-Filled Syringe Device. The company considered the allergic reaction to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the hypoesthesia oral to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Menquadfi, Act hib and Prevenar. The company considered the allergic reaction to be possibly related to Menquadfi, Act hib and Prevenar. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 05-SEP-2025 The nurse administered the vaccines Menquadfi, Bexsero, Prevnar, and Act HIB of an unknown dose. Reportedly, after the nurse administered the vaccines, the patient reported minor numbness around her mouth that spread to her tongue. The nurse administered Benadryl as treatment medication. The nurse monitored the patient, and the patient reported that the symptoms were going away. The nurse did not leave the patient's home until the patient was free from symptoms. Both events, vaccine allergy and Hypoaesthesia oral were resolved on the same day. The diagnosed events, allergy to vaccine (medically significant) was considered serious by the investigator. The causality of the allergic reaction to the vaccine, with suspects Menquadfi, Bexsero, Prevnar, and Hib, was suspected.; Sender's Comments: A case of Hypersensitivity, less than a day after receiving Bexsero and Bexsero PRE-FILLED SYRINGE DEVICE in a 76-year-old female patient. Causal relation is indeterminate considering multiple vaccines given concomitantly (Menquadfi, Act hib and Prevenar). More
2860059				09/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Discomfort, Herpes zoster, Vaccination failure Discomfort, Herpes zoster, Vaccination failure	suspected vaccination failure; had shingles twice since; This serious case was reported by a consum... suspected vaccination failure; had shingles twice since; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles twice since). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 08-SEP-2025 This case was reported by a patient via interactive digital media. The reporter reported that put it off when doctor suggested it then it hit, and it was hell. Since had the shot patient had shingles twice since but fortunately minimal discomfort. The reporter said do not put it off. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860061				09/19/2025	VARZOS	UNKNOWN MANUFACTURER	UNK	Herpes zoster, Stress, Vaccination failure Herpes zoster, Stress, Vaccination failure	suspected vaccination failure; I just went through a very bad break out; stress; This serious case w... suspected vaccination failure; I just went through a very bad break out; stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I just went through a very bad break out) and stress (Verbatim: stress). The outcome of the vaccination failure, shingles and stress were not reported. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles and stress to be related to Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 10-SEP-2025 This case was reported by a patient via interactive digital media. The patient just went through a very bad break out (shingles). The stress was so severe. The patient has been instructed to just eat well try to rest and not stress out about everything, had no control over. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Herpes Zoster vaccine, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2860062		F		09/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Herpes zoster, Pain, Vaccination failure Herpes zoster, Pain, Vaccination failure	Suspected vaccination failure; Shingles and they were so painful; This serious case was reported by ... Suspected vaccination failure; Shingles and they were so painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult 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 and they were so painful). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 This case was reported by a patient via interactive digital media. The patient got her Shingrix vaccination but still got shingles and they were so painful 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, an unknown time after receiving Shingrix, in a adult female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2860063	77	F	NC	09/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Abdominal pain, Musculoskeletal chest pain, Pruritus, Rash vesicular, Urticaria Abdominal pain, Musculoskeletal chest pain, Pruritus, Rash vesicular, Urticaria	right abdomen and left rib area she is having itching; right abdomen she is having stinging; left ri... right abdomen and left rib area she is having itching; right abdomen she is having stinging; left rib area she is having stinging; look like insect bites/ they are not insect bites and appear like chickenpox; swell up into big whelps at night; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose of vaccine on 14th april 2025, for tolerance to dose 1 refer case US2025107976). Concurrent medical conditions included hypothyroidism and glaucoma. On 06-AUG-2025, the patient received the 2nd dose of Shingrix (left arm). In AUG-2025, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: right abdomen and left rib area she is having itching), abdominal pain (Verbatim: right abdomen she is having stinging), rib pain (Verbatim: left rib area she is having stinging), varicella-like rash (Verbatim: look like insect bites/ they are not insect bites and appear like chickenpox) and welts (Verbatim: swell up into big whelps at night). Rechallenge with Shingrix was positive. The outcome of the pruritus, abdominal pain, rib pain, varicella-like rash and welts were not resolved. It was unknown if the reporter considered the pruritus, abdominal pain, rib pain, varicella-like rash and welts to be related to Shingrix. It was unknown if the company considered the pruritus, abdominal pain, rib pain, varicella-like rash and welts to be related to Shingrix. Linked case(s) involving the same patient: US2025107976 Additional Information: GSK Receipt Date: 21-AUG-2025 The consumer was the reporter. She stated that she had received her second dose of Shingrix on 6th August 2025 in her left arm. She reported experiencing itching and stinging on her right abdomen and left rib area. She mentioned that after both vaccinations, she developed a rash that looked like insect bites, although she believed they were not insect bites and resembled chickenpox. She noted that the rash would disappear during the day and swell into big whelps at night. She stated that the right side had resolved, but the left side remained affected. She also mentioned that she was very healthy and an active runner For tolerance to 1st dose, refer case US2025107976 More
2860064		F	NJ	09/19/2025	DTAPIPV	GLAXOSMITHKLINE BIOLOGICALS	4L454	Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered	Unapproved age; Incorrect vaccine; This non-serious case was reported by a other health professional... Unapproved age; Incorrect vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-week-old female patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Kinrix and did not receive Hepatitis B vaccine. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age) and wrong vaccine administered (Verbatim: Incorrect vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-AUG-2025 The primary care office staff reported that one of their employees instead of giving Hepatitis B, he gave kinrix to a 2-week-old baby. More
2860065			MA	09/19/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS		Inappropriate schedule of product administration Inappropriate schedule of product administration	Twinrix Late Third Dose; This non-serious case was reported by a pharmacist via call center represen... Twinrix Late Third Dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received first dose on unknown date) and Twinrix (received second dose on unknown date). On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Twinrix Late Third Dose). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 25-AUG-2025 The reporter reported that call was received from Medical Information mentioning that a patient who got two doses of Twinrix some time ago and they wondered if they need to restart the series or how should they proceed. Till the time of reporting, the patients did not receive the third dose of Twinrix, which led to incomplete course of vaccination. More
2860066			AR	09/19/2025	COVID19	MODERNA	041J21A	Nausea, Palpitations Nausea, Palpitations	Racing heart; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrenc... Racing heart; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (Racing heart) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PALPITATIONS (Racing heart) and NAUSEA (Nausea). At the time of the report, PALPITATIONS (Racing heart) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case contains information for the 3 of 3 patients described by the reporter. No concomitant medication was reported. The reporter stated that, on 30-Dec-2021, they administered vaccines dose to patient and on 31-Dec-2021, patient called back and reported after vaccine experienced racing heart and nausea. Reporter stated that it was 3 patients in a row from 1 vial of moderna vaccine, it was their 1st dose for this patient. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-436397 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-436397:Master case (Patient 3 out of 3) More
2860067			SC	09/19/2025	COVID19	MODERNA		COVID-19 COVID-19	got COVID after getting vaccinated; This spontaneous case was reported by an other health care profe... got COVID after getting vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (got COVID after getting vaccinated) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID after getting vaccinated). At the time of the report, COVID-19 (got COVID after getting vaccinated) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. This case contains information for the 2 of 2 patients described by the reporter. No concomitant medication was reported. Reporter stated that the patient got COVID after getting vaccinated and said it was not as bad as the flu. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2022-629975 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2022-629975:Master Case (Patient 2 of 2) More
2860068			NC	09/19/2025	COVID19 COVID19 COVID19 COVID19 COVID19	MODERNA MODERNA MODERNA MODERNA MODERNA		Antinuclear antibody, Antiphospholipid antibodies, Arthritis, Autoantibody test,... Antinuclear antibody, Antiphospholipid antibodies, Arthritis, Autoantibody test, Cognitive disorder; Dysphagia, Dysphemia, Fatigue, Hypersomnia, Idiopathic intracranial hypertension; Magnetic resonance imaging, Malaise, Muscular weakness, Nausea, Neuralgia; Pain, Pyrexia, Retinal tear, Retinal vasculitis, Urinary incontinence; Uveitis, Visual impairment More	Pars planitis; retinal tears; Partial empty sella suggesting idiopathic intracranial hypertension; v... Pars planitis; retinal tears; Partial empty sella suggesting idiopathic intracranial hypertension; venous sheathing; Progressive vision changes with episodes of gray cast; Electric shocks/zaps in the feet; limb weakness and limp; stuttering and speech/swallowing difficulties; stuttering and speech/swallowing difficulties; cognitive difficulties; episodes of extreme fatigue and excessive sleepiness; Widespread body pain; arthritis-like joint pain; Intermittent loss of bladder control; generalized malaise; episodes of extreme fatigue and excessive sleepiness; Nausea; fevers; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Pars planitis), RETINAL TEAR (retinal tears), IDIOPATHIC INTRACRANIAL HYPERTENSION (Partial empty sella suggesting idiopathic intracranial hypertension) and RETINAL VASCULITIS (venous sheathing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced UVEITIS (Pars planitis) (seriousness criterion medically significant), RETINAL TEAR (retinal tears) (seriousness criterion medically significant), IDIOPATHIC INTRACRANIAL HYPERTENSION (Partial empty sella suggesting idiopathic intracranial hypertension) (seriousness criterion medically significant), RETINAL VASCULITIS (venous sheathing) (seriousness criterion medically significant), VISUAL IMPAIRMENT (Progressive vision changes with episodes of gray cast), NEURALGIA (Electric shocks/zaps in the feet), MUSCULAR WEAKNESS (limb weakness and limp), DYSPHEMIA (stuttering and speech/swallowing difficulties), DYSPHAGIA (stuttering and speech/swallowing difficulties), COGNITIVE DISORDER (cognitive difficulties), HYPERSOMNIA (episodes of extreme fatigue and excessive sleepiness), PAIN (Widespread body pain), ARTHRITIS (arthritis-like joint pain), URINARY INCONTINENCE (Intermittent loss of bladder control), MALAISE (generalized malaise), FATIGUE (episodes of extreme fatigue and excessive sleepiness), NAUSEA (Nausea) and PYREXIA (fevers). At the time of the report, UVEITIS (Pars planitis), RETINAL TEAR (retinal tears), IDIOPATHIC INTRACRANIAL HYPERTENSION (Partial empty sella suggesting idiopathic intracranial hypertension), RETINAL VASCULITIS (venous sheathing), VISUAL IMPAIRMENT (Progressive vision changes with episodes of gray cast), NEURALGIA (Electric shocks/zaps in the feet), MUSCULAR WEAKNESS (limb weakness and limp), DYSPHEMIA (stuttering and speech/swallowing difficulties), DYSPHAGIA (stuttering and speech/swallowing difficulties), COGNITIVE DISORDER (cognitive difficulties), HYPERSOMNIA (episodes of extreme fatigue and excessive sleepiness), PAIN (Widespread body pain), ARTHRITIS (arthritis-like joint pain), URINARY INCONTINENCE (Intermittent loss of bladder control), MALAISE (generalized malaise), FATIGUE (episodes of extreme fatigue and excessive sleepiness), NAUSEA (Nausea) and PYREXIA (fevers) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: Fluctuating. On an unknown date, Antiphospholipid antibodies: antiphospholipid and Lyme antibody reactivity (band 41 which is non specific to Lyme) despite no known exposure. On an unknown date, Autoantibody test: presence of both cytoplasmic and nuclear autoantibodies. On an unknown date, Magnetic resonance imaging: Showed nonspecific punctate white matter foci, possible spinal cord lesions, tapered stenosis of distal transverse sinuses bilaterally, and a partial empty sella suggesting idiopathic intracranial hypertension. No concomitant medications were reported. The patient planned lumbar puncture to rule out MS and/or the possible intracranial hypertension (which has been deemed idiopathic). It was possible that the vaccine triggered adverse reactions and provoked an uproar within my immune system, genuinely believe that it activated something, unmasking or accelerating an underlying vulnerability that may had already existed. The patient fully understood the difference between causation and correlation and took into account. However, considering the broader picture and the fact that the patient had no prior autoimmune markers or symptoms before this vaccination. It was difficult not to associate the patient current health issues with it. No treatment medications were reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2860069		F	OK	09/19/2025	COVID19	MODERNA		Supraventricular tachycardia Supraventricular tachycardia	diagnosed with SVT with her heart in February 2022; This spontaneous case was reported by a consumer... diagnosed with SVT with her heart in February 2022; This spontaneous case was reported by a consumer and describes the occurrence of SUPRAVENTRICULAR TACHYCARDIA (diagnosed with SVT with her heart in February 2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Janssen COVID-19 vaccine (Dose 1) on 10-Mar-2021. Past adverse reactions to the above products included No adverse effect with Janssen COVID-19 vaccine. Concurrent medical conditions included Crohn's, Colitis and Disability NOS. On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (diagnosed with SVT with her heart in February 2022). At the time of the report, SUPRAVENTRICULAR TACHYCARDIA (diagnosed with SVT with her heart in February 2022) outcome was unknown. No concomitant medication was reported. It was reported that when Johnson and Johnson COVID vaccine was no longer available, patient started getting the Moderna COVID vaccine. The patient received Moderna vaccines on 31-Mar-2022 and on 20-Sep-2022. Two other doses were not documented on shot record but on a vaccine sheet patient had received. The patient was considered high risk as she had an underlying condition and was disabled. The patient had Crohn's and other health issues which were pre-existing before any COVID vaccine, however she was diagnosed with SVT with her heart in February 2022. It was reported that this condition might have pre-existed as patient went to the hospital and they diagnosed it, patient had the same symptoms her entire life and they always diagnosed it as she was having an anxiety attack. The reporter stated that the symptoms would not stop, and patient had been since diagnosed with SVT. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789363 (E2B Linked Report).; Reporter's Comments: In view of the long non-suggestive onset latency the causality of the event was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789363:Reporter's daughter case More
2860070	77	F		09/19/2025	COVID19 FLUX	MODERNA UNKNOWN MANUFACTURER		Anxiety, COVID-19, Influenza, Seizure, Wound; Anxiety, COVID-19, Influenza, Seiz... Anxiety, COVID-19, Influenza, Seizure, Wound; Anxiety, COVID-19, Influenza, Seizure, Wound More	wounded up having a seizure; anxiety; wounded up having a seizure; COVID; Flu; This spontaneous case... wounded up having a seizure; anxiety; wounded up having a seizure; COVID; Flu; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (wounded up having a seizure) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Influenza vaccine (Flu) for an unknown indication, Buspirone hydrochloride (Buspar) for Anxiety and Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. In August 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In August 2025, the patient started Buspirone hydrochloride (Buspar) (unknown route) at an unspecified dose and Nirmatrelvir, Ritonavir (Paxlovid) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. In January 2025, the patient experienced COVID-19 (COVID). In 2025, the patient experienced INFLUENZA (Flu). In August 2025, the patient experienced SEIZURE (wounded up having a seizure) (seriousness criterion medically significant), ANXIETY (anxiety) and WOUND (wounded up having a seizure). At the time of the report, SEIZURE (wounded up having a seizure), ANXIETY (anxiety), COVID-19 (COVID), INFLUENZA (Flu) and WOUND (wounded up having a seizure) outcome was unknown. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient had received all her vaccinations. The patient was afraid of getting COVID again. The patient had COVID in Jan-2025 and around 10-Aug-2025 got COVID again. The patient took Paxlovid for 5 days, and then on that Sunday, she took a dose of Buspar for anxiety and wounded up having a seizure. Treatment medication was not reported.; Reporter's Comments: Co-suspect products Influenza vaccine, Buspar and Paxlovid are confounders for the events. In view of the long non-suggestive onset latency the causality of the events flu, seizure and anxiety were assessed as not related to the vaccine. Wound was also assessed as not related due it was a consequence of seizure. The benefit -risk relationship of product is not affected by this report. More
2860071	65	F	CA	09/19/2025	UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER		Arthralgia, Bone pain, Chills, Headache, Lethargy; Myalgia, Pyrexia Arthralgia, Bone pain, Chills, Headache, Lethargy; Myalgia, Pyrexia	lethargic; her muscle, joint, and bones hurt; aches; her muscle, joint, and bones hurt; her muscle, ... lethargic; her muscle, joint, and bones hurt; aches; her muscle, joint, and bones hurt; her muscle, joint, and bones hurt; she had chills; bad headache; bad fever, 102 (measured with a forehead thermometer); This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), BONE PAIN (her muscle, joint, and bones hurt), PAIN (aches), MYALGIA (her muscle, joint, and bones hurt) and ARTHRALGIA (her muscle, joint, and bones hurt) in a 65-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 11-Sep-2025, the patient experienced BONE PAIN (her muscle, joint, and bones hurt), PAIN (aches), MYALGIA (her muscle, joint, and bones hurt), ARTHRALGIA (her muscle, joint, and bones hurt), CHILLS (she had chills), HEADACHE (bad headache) and PYREXIA (bad fever, 102 (measured with a forehead thermometer)). On 12-Sep-2025, the patient experienced LETHARGY (lethargic). On 12-Sep-2025, HEADACHE (bad headache) and PYREXIA (bad fever, 102 (measured with a forehead thermometer)) had resolved. At the time of the report, LETHARGY (lethargic) had not resolved and BONE PAIN (her muscle, joint, and bones hurt), PAIN (aches), MYALGIA (her muscle, joint, and bones hurt), ARTHRALGIA (her muscle, joint, and bones hurt) and CHILLS (she had chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2025, Body temperature: 102 (measured with a forehead thermometer). The action taken with mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) was unknown. No concomitant medications were reported. The patient received vaccine on 10-Sep-2025 around 5 o'clock in the evening. It made her sick for a day. She had no side effects that night but the next day she experienced her muscle, joint, and bones hurt and had a bad headache but then took pain relievers in the afternoon. 24 hours later after taking the shot, she had chills, aches, and a bad fever, 102 (measured with a forehead thermometer) and skipped class. For now, she was lethargic, but the headache and temperature were gone. This case was linked to US-MODERNATX, INC.-MOD-2025-789413 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789413:Husband case More
2860072	78	M		09/19/2025	COVID19	MODERNA		COVID-19 COVID-19	Patient had mild case of COVID last summer after a cruise; This spontaneous case was reported by a c... Patient had mild case of COVID last summer after a cruise; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had mild case of COVID last summer after a cruise) in a 78-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Immunocompromised. 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 (Patient had mild case of COVID last summer after a cruise). At the time of the report, COVID-19 (Patient had mild case of COVID last summer after a cruise) 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 always got Moderna COVID-19 vaccines since they were first released. He had mild case of COVID last summer after a cruise. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789427 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2025: Live follow-up received: Reference numbers added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789427:Husband case, Same Report More
2860073	67	F		09/19/2025	UNK	UNKNOWN MANUFACTURER	3052154	Lymphadenopathy, Myalgia, Neck pain Lymphadenopathy, Myalgia, Neck pain	her neck is really just kind of achy; swollen lymph nodes; some muscle aches; This spontaneous case ... her neck is really just kind of achy; swollen lymph nodes; some muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (her neck is really just kind of achy), LYMPHADENOPATHY (swollen lymph nodes) and MYALGIA (some muscle aches) in a 67-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052154) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced NECK PAIN (her neck is really just kind of achy), LYMPHADENOPATHY (swollen lymph nodes) and MYALGIA (some muscle aches). At the time of the report, NECK PAIN (her neck is really just kind of achy) outcome was unknown and LYMPHADENOPATHY (swollen lymph nodes) and MYALGIA (some muscle aches) had not resolved. No concomitant medication was reported. She received a booster or the new vaccine on 8-Sep-2025, and her reaction this time was completely different from any previous reactions. After receiving the mNEXSPIKE 2025-2026 vaccine, she felt fine, which she was happy and surprised. But a week later, she seemed to be kind of swollen lymph nodes and some muscle aches. She did not have the usual flu-like symptoms. She recounted that she was fine that evening, woke up in the morning felt fine, and went about her life. She was able to do pretty much anything, but her neck was just kind of achy. She never had covid. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported. This case was linked to MOD-2025-789449 (Patient Link). More
2860074	73	M	FL	09/19/2025	UNK	UNKNOWN MANUFACTURER		Diarrhoea Diarrhoea	diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA... diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 73-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 16-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 16-Sep-2025, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) was resolving. No concomitant medication was reported. The patient had diarrhea which started 4 hours after administering vaccine. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not provided. No treatment medication was reported. More
2860075	59	F		09/19/2025	PNC UNK	PFIZER\WYETH UNKNOWN MANUFACTURER		Asthenia, Pain in extremity, Peripheral swelling; Asthenia, Pain in extremity, P... Asthenia, Pain in extremity, Peripheral swelling; Asthenia, Pain in extremity, Peripheral swelling More	her arm is swollen and excruciatingly painful; her arm is swollen and excruciatingly painful.; didn&... her arm is swollen and excruciatingly painful; her arm is swollen and excruciatingly painful.; didn't have the energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm is swollen and excruciatingly painful), PERIPHERAL SWELLING (her arm is swollen and excruciatingly painful.) and ASTHENIA (didn't have the energy) in a 59-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for an unknown indication. Concurrent medical conditions included Sjogren's. On 13-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter and dose of Pneumococcal vaccine conj 7v (CRM197) (Prevnar) (unknown route) .5 milliliter. In September 2025, the patient experienced PAIN IN EXTREMITY (her arm is swollen and excruciatingly painful), PERIPHERAL SWELLING (her arm is swollen and excruciatingly painful.) and ASTHENIA (didn't have the energy). The patient was treated with Naproxen for Inflammation, at an unspecified dose and frequency and Paracetamol (Tylenol) for Inflammation, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her arm is swollen and excruciatingly painful), PERIPHERAL SWELLING (her arm is swollen and excruciatingly painful.) and ASTHENIA (didn't have the energy) had not resolved. The concomitant medication was not reported by the reporter. On 13-Sep-2025, the patient received mNEXSPIKE 2025-2026 around 9:35 AM and reported that her arm was swollen and excruciatingly painful. She said that she went to a dental appointment, where it was pointed out that her arm was swollen and that she should go to the emergency room. She mentioned that she had worked all day and did not have the energy. She took naproxen for inflammation but had stopped it due to the pharmacist recommended Tylenol. It was unknown if the patient experienced any additional symptoms or events. More
2860076		F	NJ	09/19/2025	COVID19	MODERNA		Body temperature, Pyrexia Body temperature, Pyrexia	she developed had low grade fever (never going above 100 degrees); This spontaneous case was reporte... she developed had low grade fever (never going above 100 degrees); This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (she developed had low grade fever (never going above 100 degrees)) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Crohn's disease. 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 PYREXIA (she developed had low grade fever (never going above 100 degrees)). At the time of the report, PYREXIA (she developed had low grade fever (never going above 100 degrees)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low grade fever. 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. The concomitant medication was not reported by the reporter. About one or two years ago, the patient received a COVID-19 vaccine (believed to be a Moderna product). She developed a low-grade fever (that never went above 100 degrees). The fever lasted intermittently for about two weeks. She had no other symptoms, did not feel ill, and after two weeks, the fever disappeared. She experienced no further problems. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2860077	41	F	WA	09/19/2025	UNK	UNKNOWN MANUFACTURER		Immediate post-injection reaction, Injection site haemorrhage Immediate post-injection reaction, Injection site haemorrhage	Bleeding at injection site; This spontaneous case was reported by a pharmacist and describes the occ... Bleeding at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) in a 41-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for Pain. Concurrent medical conditions included Hypertension. On 16-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 16-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at injection site). On 16-Sep-2025, VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) had resolved. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The concomitant medication was not reported by the reporter. The patient had bleeding at the injection site, which resolved within seconds after the injection. The patient did not experience pain. The patient did not have any additional medical history, concomitant disease or risk factor. There was no lab data or results available. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2860078	81	M		09/19/2025	UNK UNK	UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER	6328773 6328773	Balance disorder, Condition aggravated, Discomfort, Dizziness, Impaired driving ... Balance disorder, Condition aggravated, Discomfort, Dizziness, Impaired driving ability; Insomnia, Nervousness More	he cannot drive and he is afraid he is going to fall.; very off balance; he is feeling dizzy/I am so... he cannot drive and he is afraid he is going to fall.; very off balance; he is feeling dizzy/I am so dizzy, it's terrible/Light headedness; I'm very very uncomfortable and really nervous; insomnia/his lack of sleep/as I say/I am not sleeping anyway; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia/his lack of sleep/as I say/I am not sleeping anyway), PHOBIA OF DRIVING (he cannot drive and he is afraid he is going to fall.), NERVOUSNESS (I'm very very uncomfortable and really nervous), DIZZINESS (he is feeling dizzy/I am so dizzy, it's terrible/Light headedness) and BALANCE DISORDER (very off balance) in an 81-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 6328773) for COVID-19 prophylaxis. Concurrent medical conditions included Insomnia in April 2025. Concomitant products included Eszopiclone (Lunesta) from 2025 to an unknown date for Insomnia. On 11-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 13-Sep-2025, the patient experienced PHOBIA OF DRIVING (he cannot drive and he is afraid he is going to fall.), DIZZINESS (he is feeling dizzy/I am so dizzy, it's terrible/Light headedness) and BALANCE DISORDER (very off balance). In September 2025, the patient experienced INSOMNIA (insomnia/his lack of sleep/as I say/I am not sleeping anyway) and NERVOUSNESS (I'm very very uncomfortable and really nervous). At the time of the report, INSOMNIA (insomnia/his lack of sleep/as I say/I am not sleeping anyway), PHOBIA OF DRIVING (he cannot drive and he is afraid he is going to fall.), NERVOUSNESS (I'm very very uncomfortable and really nervous), DIZZINESS (he is feeling dizzy/I am so dizzy, it's terrible/Light headedness) and BALANCE DISORDER (very off balance) had not resolved. No vaccines were given 4 weeks prior to the mNEXSPIKE. The patient had a nuclear stress test (cardiac stress test). He was injected with nuclear medicine on 8-Sep-2025 (Monday). The patient received the vaccine on 11-Sep-2025 and had no reaction on 12-Sep-2025, but from 13-Sep-2025 up till the day of reporting, he had a powerful reaction. He was feeling dizzy, light-headed and very off balance. The patient could not drive, and he was afraid he was going to fall. He did not experience it in the middle of the night because he got up plenty of times as he was not sleeping anyway. He was fine in the morning until he ate something. He walked 4 streets, for a little exercise, and when he came in and had breakfast, he couldn't navigate his way across the living room. The patient was having insomnia for several months, since April 2025 and was taking Lunesta (sleeping pill). The patient was homebound and was very uncomfortable and really nervous about this. It was not reducing. He was not feeling any better. Because of his lack of sleep, he didn't know what the situation was on Friday, but Saturday was terrible, and Sunday was also very bad. Patient did not know if it was decreasing, it might be somewhat. The patient was so dizzy, it was terrible. It is unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. More
2860079		F		09/19/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	FJ5683 FJ5683	Bundle branch block, Cardiac disorder, Joint effusion, Myocardial infarction, Sc... Bundle branch block, Cardiac disorder, Joint effusion, Myocardial infarction, Scan myocardial perfusion; Silent myocardial infarction More	silent heart attack; Infarction in my heart; draining of my elbow; she had clear fluid built up in h... silent heart attack; Infarction in my heart; draining of my elbow; she had clear fluid built up in her elbows "it had to be drained it's like big ball of whatever"; heart issues; electrical issues where you have your heart; left branch block in my heart; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Lot number: FJ5683) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, EW0171), administration date: 22Apr2021, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, EW0173), administration date: 13May2021, for Covid-19 immunization. The following information was reported: BUNDLE BRANCH BLOCK (non-serious) with onset 2022, outcome "unknown", described as "left branch block in my heart"; SILENT MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "silent heart attack"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Infarction in my heart"; JOINT EFFUSION (non-serious), outcome "unknown", described as "draining of my elbow; she had clear fluid built up in her elbows "it had to be drained it's like big ball of whatever""; CARDIAC DISORDER (non-serious), outcome "not recovered", described as "heart issues; electrical issues where you have your heart". The patient underwent the following laboratory tests and procedures: Scan myocardial perfusion: (2022) left branch blockage. Therapeutic measures were taken as a result of silent myocardial infarction, myocardial infarction, cardiac disorder. Clinical course: Caller stated she took Pfizer vaccines and the booster. She received her first shot on 20Apr2021 it was EW0171 - She saw online that "E" in front of the vaccine means "early death", asking is it true or not. On 13May2021 she received her second dose, EW0173 on 12Jan2022 she received her booster FJ5883. Caller stated "Somebody had posted things about the vaccines, and there's been a lot of side effects which she think got from the vaccine. she got weird side effects so thought oh well that maybe that is it's it's a way to call the world population. "being patient and definitely record symptoms as you know, just even the draining of elbow. That was weird. That was really weird. "Caller stated "Somebody had posted things about the vaccines, and there's been a lot of side effects which she think she got from the vaccine. "She stated that she had clear fluid built up in her elbows "it had to be drained it's like big ball of whatever" "it's in her health record at (withheld) that they drained elbow after getting the vaccine. And then the big thing is, since the vaccine, had a lot of heart issues. One includes a silent heart attack. Then had electrical issues where we have heart. It goes down and goes. slower to go up. And had left branch block whatever it's called, it left branch block in heart so could not took a normal stress test. she had to do another nuclear test. she already done this after the vaccine. she thought had it done in 2022, And right now wearing a heart monitor and didn't have these issues before the vaccine. " She knew about Myocarditis. "She had a very healthy regiment. She didn't drink, didn't smoke and exercise 7 days a week on a vegetarian.". "she never got COVID and been around people with COVID" she had RH negative blood "maybe I'm a rare case". "well it's very alarming to her, she felt it and everything else and heart's just not doesn't feel right but as far as my age that that doesn't affect me like had a job and everything else. her age she didn't think it was just oh cause, eat a lot of donuts and an alcoholic and none of that and never got a COVID". "The only thing that was treated was the elbow. They drained her elbow". "She had a nuclear test done. she had a stress test. she almost passed down on that one. And they found out with a nuclear test that she had a left branch blockage. So she could not take the treadmill. She had to go in for another nuclear test which was radioactive." "she never gonna get a vaccine of any kind ever again. No shingles, vaccine, no fluid, no pneumonia. And if she die from that, you know, tried to let my body just figure it out on its own, so I'll end on that note" "thought oh is this is this hereditary; No, dad lived to be 97 and mom died at age 90 of an accident. She would have probably lived in other so parents live a long life knock on wood. So didn't think it's hereditary, but you never know about this stuff." Failed to find relevant information about adverse reactions on her age group (65 and older) aside from the Participants 12 years of age and older pain at the injection site (up to 90.5%), Injection site reactions: pain/tenderness, swelling, redness, arm pain. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Because doctor/healthcare provider was most familiar with your medical condition, clinical history, how treatment has been conducted and any relevant information to specific case. Per "CONS - the risks of the vaccine; Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following administration of mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. In most of these people, symptoms began within a week following vaccination. Based on available data, estimated rates of myocarditis and/or pericarditis from 1 through 7 days after getting a dose of the 2023-2024 Formula of mRNA COVID-19 vaccines were approximately 8 cases per million doses in people 6 months through 64 years of age and approximately 27 cases per million doses in males 12 years through 24 years of age. Consumer stated, wanted to know if you know what the, she got Pfizer vaccine and a booster. When was it in 22Apr2021 and wanted to know what the code for the vaccines mean EW0171 and then the other one got was EW0173. problems after taking vaccine, consumer stated, "did have a problem and currently having heart issues that occurred right after, soon after that she got the vaccine. had a silent heart attack so, had infarction in heart, left block, left branch block issues. she took another nuclear test, which had to do about 3 years ago and had electrical problem in heart, which she never had that before so, wanted to know that and after she got the vaccine elbow filled up with fluid so if she had a popeye character, my elbow almost like that." Further probing: Consumer stated, "No, that is okay. kind of need to get going but wanted to make sure you all were on her call list today because she had side effects, she thought from the vaccine. More
2860080				09/19/2025	COVID19	PFIZER\BIONTECH		Bacterial infection, Cardiac disorder, Pneumonia, Pyrexia Bacterial infection, Cardiac disorder, Pneumonia, Pyrexia	pneumonia, twice; bacterial infection; fever; heart trouble; This is a spontaneous report received f... pneumonia, twice; bacterial infection; fever; heart trouble; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20250829000003 (Moderna). 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) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Coronary heart disease" (unspecified if ongoing); "Breathing difficult" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hepatitis A" (unspecified if ongoing); "Sick with flu" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "covid-19". The following information was reported: PNEUMONIA (hospitalization, medically significant), outcome "recovered with sequelae", described as "pneumonia, twice"; BACTERIAL INFECTION (hospitalization, medically significant), outcome "recovered with sequelae"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart trouble". The event "fever" required emergency room visit. Therapeutic measures were taken as a result of pneumonia, cardiac disorder. Clinical course: The last time the patient got it (vaccine), it was months later, it was horrifying. The patient got the fever and they didn't have no room in the hospital. So the patient had to wait till the next morning to go to the hospital when they had a bed, enough room in emergency. And there was twice the patient had pneumonia. Patient had COVID-19 four times and pneumonia. Patient was given steroids as well as other medications when had those COVID-19 disease events but doesn't know the brand names just remembered the steroids as kind of orangey or had orange in them and were pulled up in the syringe and put them through IV. As for other medications, the patient was given shots in stomach/belly. Also stated was given blood thinners but don't remember what else was given with. The last time when they went to (Withheld), the patient got sick with a bacterial infection which doctor has said. Batch/lot number is not provided, and it cannot be obtained. More	✓
2860081				09/19/2025	COVID19	PFIZER\BIONTECH		COVID-19, COVID-19 pneumonia, Disease recurrence, Drug ineffective COVID-19, COVID-19 pneumonia, Disease recurrence, Drug ineffective	the first one was so fast and I got theshots and I still got COVID 4 times; the first one was so fas... the first one was so fast and I got theshots and I still got COVID 4 times; the first one was so fast and I got theshots and I still got COVID 4 times; the first one was so fast and I got theshots and I still got COVID 4 times; pneumonia, twice/COVID-19 disease for four times and that had pneumonia twice but then stated 3 times later; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOC20250829000003 (Moderna). A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Coronary heart disease" (unspecified if ongoing); "Breathing difficult" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hepatitis A" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), DISEASE RECURRENCE (hospitalization, medically significant), outcome "recovered with sequelae" and all described as "the first one was so fast and I got theshots and I still got COVID 4 times"; COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "recovered with sequelae", described as "pneumonia, twice/COVID-19 disease for four times and that had pneumonia twice but then stated 3 times later". Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence, covid-19 pneumonia. Clinical course: MOP asked whether Moderna's Spikevax 2025-2026 if that has been tested for its safety. MOP stated that the first one was so fast and got the shots and patient still got COVID 4 times. MOP confirmed had the Pfizer COVID-19 vaccines with previous doses and hasn't had any Moderna COVID-19 vaccines. MOP said that I don't know anything about Moderna. MOP reiterated still got COVID four times. MOP added got heart trouble, coronary heart disease, also can't breathe too good from the COVID. MOP asked repeatedly the MIS agent if the Spikevax cannot give COVID-19 for confirmation and MIS agent confirmed it cannot per the patient information. MOP confirmed does not remember the lot numbers of the said Pfizer COVID-19 vaccines had in the past but confirmed. MOP then confirmed that when had COVID four times, these events were so close together. MOP also got pneumonia with two of those events. The 3rd time they sent patient on home cause there was nothing else they could do cause patient done had the, when patient went in the hospital the first time with pneumonia, they gave the plasma of people, of somebody who had COVID and they gave steroids to the vein and treated with different medications and then sent to home and patient was sick for a while. The second time they gave the piggyback. The third time, they said they were going home, it won't be so bad and there's nothing else they could do. Then the last time, patient got it, it was months later, it was horrifying. Patient got the fever and they didn't have no room in the hospital. So, patient had to wait till the next morning to go to the hospital when they had a bed. I mean, enough room in emergency. There was twice patient had pneumonia. The other times, patient didn't, but 3 times patient did. MIS agent asked for clarification since the MOP said had COVID-19 disease for four times and that had pneumonia twice but then stated 3 times later, MOP clarified had COVID-19 four times and pneumonia, twice. MOP stated was given steroids as well as other medications when those COVID-19 disease events had but doesn't know the brand names just remembered the steroids as kind of orangey or had orange in them and were pulled up in the syringe and put them through IV. As for other medications, just remember they gave shots in stomach/belly. Also stated was given blood thinners but don't remember what else was given with. Also do not know the brand name/s of the said blood thinners. Regarding the other medications administered to in belly, added, "They do that every time patient go to the hospital, that's kind of hard to remember because patient was very sick". MOP mentioned had already been sick with a flu before. expressed wanted to get both COVID shot and flu shot so will be protected. MOP added is being exposed by people who go to different places and go to (Withheld) all the time. The last time when they went to (Withheld), the MOP got sick with a bacterial infection which doctor has said. MOP added, "I'm old and I got, I got so much underlying conditions that patient catch everything that comes through. Patient don't hardly go anywhere. The first time they went to (Withheld) after that, they come back sick, all of them and then got it. Patient guess patient could get the flu shot too, but patient don't, if it's a new flu shot or. Patient just scared of vaccines. So I need to get these vaccines. MIS agent clarified if is scared of the vaccines since wanting to get while being scared with it ironic. MOP clarified, since the COVID vaccine, last time, few years ago. Because it was made so fast and it made a lot of people sick and they came down with lifelong things. MOP reiterated that after the COVID vaccines were released, people got sick with lifelong problems which the MOP then added has breathing problem from it. Then stated, patient thought it made scared of all vaccines like the flu vaccine. Patient need it and the COVID vaccine. MOP also had COPD, breathing problem from catching COVID many times, osteoporosis, GERD and hepatitis A. MOP didn't have any vaccines within the past 4 weeks prior to receiving the Pfizer COVID-19 doses. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More	✓
2860082				09/19/2025	COVID19 FLU3	MODERNA SANOFI PASTEUR	3046714	Oropharyngeal pain; Oropharyngeal pain Oropharyngeal pain; Oropharyngeal pain	sometimes feel had a sore throat/oropharyngeal pain (sore throat); Initial information received on 1... sometimes feel had a sore throat/oropharyngeal pain (sore throat); Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-health care professional. This case involves an unknown age and unknown gender patient who sometimes feel had a sore throat/oropharyngeal pain (sore throat) after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] and Spikevax 2024-2025 Formula [Covid-19 Vaccine Mrna Omicron (Jn.1) Moderna]. The patient's past medical treatment(s), and family history were not provided. Patient(s) Medical History information was not reported. Concomitant medications were not reported. On 22-Aug-2025, the patient received 1 DF (dosage form) of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot number and expiry date not reported via unknown route for prophylactic vaccination and received 0.5 ml dose of suspect Spikevax 2024-2025 Formula [Covid-19 Vaccine Mrna Omicron (Jn.1) Moderna] not produced by Sanofi Pasteur, unknown formulation, lot 3046714, expiry date:-06-Sep-2025, via intramuscular route for Covid-19 prophylaxis and product used for unknown indication (both withstrength not reported) in unknown administration site. Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date In 2025 the patient sometimes feel had a sore throat/oropharyngeal pain (sore throat) (oropharyngeal pain) (latency: few days approximately). Reportedly, It was reported that patient's all previous vaccines shots were Moderna. Patient did not had effect like this. It was the first time. Patient had a negative effect to where patient was in bed all day the following day, and don't know if it was the flu shot, or the extra COVID shot. Regarding whether patient was still experiencing symptoms it was reported that it was probably a phantom thing. Patient was so upset about it. Patient sometimes feel had a sore throat, when it's probably just normal. It was unknown if the patient experienced any additional symptoms/events Action was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Not Recovered / Not Resolved for the event. More
2860083	17	M	HI	09/19/2025	MEN	UNKNOWN MANUFACTURER	U8558BA	No adverse event, Underdose No adverse event, Underdose	patient did not get 0.5 mL, which was the full recommended dose of MENQUADFI, with no reported adver... patient did not get 0.5 mL, which was the full recommended dose of MENQUADFI, with no reported adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old male patient who did not get 0.5 ml, which was the full recommended dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] 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 Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero) for Immunisation. On 16-Sep-2025, the patient received Dose 1 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine 1x(once) Solution for injection (strength standard) expiry date-30-Sep-2028 lot U8558BA via intramuscular route in the left deltoid for Immunization did not get 0.5 ml, which was the full recommended dose of menquadfi, with no reported adverse event (incorrect dose administered) (latency same day). Action taken- 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
2860089	72	F	NC	09/19/2025	COVID19 FLU3	MODERNA SEQIRUS, INC.		Peripheral swelling; Peripheral swelling Peripheral swelling; Peripheral swelling	PATIENT STATED WAKING UP MORNING AFTER VACCINE WITH SWOLLEN FINGERS ON THE ARM IN WHICH SHE GOT THE ... PATIENT STATED WAKING UP MORNING AFTER VACCINE WITH SWOLLEN FINGERS ON THE ARM IN WHICH SHE GOT THE COVID VACCINE More
2860090	7	F	MD	09/19/2025	FLU3 HEP	SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS	UT8792NA 7NX57	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	None during or after the vaccination. None during or after the vaccination.
2860091	37	F	CO	09/19/2025	RSV RSV RSV	PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH	LL8396 LL8396 LL8396	Bell's palsy, Blood pressure increased, Caesarean section, Exposure during ... Bell's palsy, Blood pressure increased, Caesarean section, Exposure during pregnancy, Facial paralysis; Headache, Hypoaesthesia, Liver function test normal, Magnetic resonance imaging normal, Platelet count normal; Pre-eclampsia, Proteinuria, Visual impairment More	Patient received Abrysvo vaccination 9/18/25 at 0917. Patient then brought to hospital by ambulance ... Patient received Abrysvo vaccination 9/18/25 at 0917. Patient then brought to hospital by ambulance for concerns of left sided facial droop and left hand numbness. Patient admitted to hospital at 36w4d by 7 week US with preeclampsia with severe features, bells palsy. Patient had cesarean section for preeclampsia with severe features. Neurology consulted, plan for treatment of Bells palsy with prednisone burst. More	✓
2860092	11	F	CA	09/19/2025	HPV9 MNQ TDAP	MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR	Y018416 U859AA U8274AA	Asthenia, Dizziness, Pallor, Syncope, Tremor; Asthenia, Dizziness, Pallor, Synco... Asthenia, Dizziness, Pallor, Syncope, Tremor; Asthenia, Dizziness, Pallor, Syncope, Tremor; Asthenia, Dizziness, Pallor, Syncope, Tremor More	MINUTES AFTER RECEIVING VACCINES PT PER MOM GOT WEAK AND DIZZY THEN WENT BACK. ONCE MA WENT INTO ROO... MINUTES AFTER RECEIVING VACCINES PT PER MOM GOT WEAK AND DIZZY THEN WENT BACK. ONCE MA WENT INTO ROOM PT WAS LAYED OUT ELEVATED NOTICED PT IN SYNOPAL EPISODE THEN FEW SECONDS LATER PT STOPPED SHAKING TURNED PALE. More
2860093	100	M	PA	09/19/2025	FLU3	SEQIRUS, INC.	407579	Wrong product administered Wrong product administered	Patient was brought to pharmacy by his son. He initially intended to receive the Covid Vaccine. Howe... Patient was brought to pharmacy by his son. He initially intended to receive the Covid Vaccine. However, the patient's son believes he misspoke and asked for, and was administered the Flu vaccine. Patient was due for flu vaccine. Will return to pharmacy to receive Covid vaccine another day. More
2860094	68	M	MT	09/19/2025	TDAP TDAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	H4K3S H4K3S	Arthralgia, Back pain, Burning sensation, Fatigue, Insomnia; Paraesthesia, Sitti... Arthralgia, Back pain, Burning sensation, Fatigue, Insomnia; Paraesthesia, Sitting disability More	9 days after vaccinations pt reports low back pain, 14 days after vaccinations reports legs feeling ... 9 days after vaccinations pt reports low back pain, 14 days after vaccinations reports legs feeling like they are on fire, tingling, pain in hips and low back, fatigue, unable to sleep or sit due to pain More
2860095	78	F	MT	09/19/2025	COVID19 COVID19	MODERNA MODERNA	030B21A 030B21A	Computerised tomogram, Differential white blood cell count, Discomfort, Dysphemi... Computerised tomogram, Differential white blood cell count, Discomfort, Dysphemia, Full blood count; Gait inability, Hemiparesis, Limb discomfort, Neurological symptom, Sensory loss More	HEAVINESS (LIKE AN ANCHOR) IN RIGHT FOOT AND COULDN'T WALK- ABOUT 2 MONTHS AFTER, 9/3/21- ADMIT... HEAVINESS (LIKE AN ANCHOR) IN RIGHT FOOT AND COULDN'T WALK- ABOUT 2 MONTHS AFTER, 9/3/21- ADMITTED TO ED WITH RIGHT SIDE OF BODY SHOWING STROKE LIKE SYMPTOMS (RIGHT SIDE WEAKNESS AND HEAVINESS, LOSS OF SENSATION, AND STUTTERING OF SPEECH More	✓	✓
2860096	18	F	TX	09/19/2025	MENB	PFIZER\WYETH		Dizziness, Visual impairment Dizziness, Visual impairment	dizziness and vision changes without syncope after standing up after getting the vaccine dizziness and vision changes without syncope after standing up after getting the vaccine
2860097	51	F	MD	09/19/2025	COVID19 COVID19 COVID19 FLU3 FLU3 FLU3	MODERNA MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Abdominal pain, Chest pain, Chills, Dizziness, Fatigue; Headache, Hot flush, Nau... Abdominal pain, Chest pain, Chills, Dizziness, Fatigue; Headache, Hot flush, Nausea, Pain in extremity, Photophobia; Taste disorder; Abdominal pain, Chest pain, Chills, Dizziness, Fatigue; Headache, Hot flush, Nausea, Pain in extremity, Photophobia; Taste disorder More	Nausea, extreme fatigue, mild dizziness, taste changes, mild headaches, arm aches, chills, hot flash... Nausea, extreme fatigue, mild dizziness, taste changes, mild headaches, arm aches, chills, hot flashes, abdominal pain, light sensitivity, chest pain. More
2860100	85	M	VA	09/19/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	MY9550 MY9550	Back pain, Dysstasia, Fall, Muscular weakness, Musculoskeletal disorder; Spinal ... Back pain, Dysstasia, Fall, Muscular weakness, Musculoskeletal disorder; Spinal operation More	Patient came into the pharmacy, informing us that they had some adverse effects after getting the CO... Patient came into the pharmacy, informing us that they had some adverse effects after getting the COVID shot. Patient said their legs were weak where they couldn't stand properly and sometimes would have moments of not able to respond. Pt also fell due to not able to stand properly when going to the bathroom one night. Patient had a few back surgeries and felt the back pain. More
2860101	70	M	WY	09/19/2025	FLU3	SANOFI PASTEUR	UT8763GA	Fatigue, Oropharyngeal pain, Rhinorrhoea Fatigue, Oropharyngeal pain, Rhinorrhoea	PATIENT COMPLAINT WAS STARTING 2 HOURS AFTER VACCINE HE HAD A SOAR THROAT AND RUNNY NOSE, SYMPTOMS ... PATIENT COMPLAINT WAS STARTING 2 HOURS AFTER VACCINE HE HAD A SOAR THROAT AND RUNNY NOSE, SYMPTOMS WORSENED OVER THE NEXT FEW DAYS TO INCLUDE GENERAL FATIGUE. WE TRIED TO EXPLAIN THAT THE VACCINE DID NOT CAUSE INFLUENZA AND THAT HE WAS PROBABLY EITHER HAVING A RESPONSE OR HAD ALREADY BEEN CARRYING THE VIRUS. HE WAS ADAMANT THAT HE WANTED THE EVENT DOCUMENTED IN CASE THERE WAS SOMETHING WRONG WITH THE LOT. More
2860102	18	F	WA	09/19/2025	MENB PNC20	NOVARTIS VACCINES AND DIAGNOSTICS PFIZER\WYETH	LT7C9 LX2496	Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered	Patient was to get HPV and Men B immunizations. Received PCV20 and Men B instead. Patient was to get HPV and Men B immunizations. Received PCV20 and Men B instead.
2860103	54	F		09/19/2025	COVID19 FLU3 PNC21	MODERNA GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC.		Injection site erythema, Injection site pruritus, Injection site swelling, Injec... Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia; Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia; Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia More	High fever (above 101�F) for two days. Left shoulder: erythema, itching, heat, swelling, covering ... High fever (above 101�F) for two days. Left shoulder: erythema, itching, heat, swelling, covering approximately two palm widths of my shoulder and upper bicep. Still there 6 days later, but appears to be decreasing in severity now. More
2860104	50	F	OR	09/19/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More	Pt presented with round, red, raised, slightly warm (not hot) reaction at injection sight, and immed... Pt presented with round, red, raised, slightly warm (not hot) reaction at injection sight, and immediately below (x2 bumps). Pt stated they were previously painful, but no longer. Advised that this sounds like common reaction, but to please circle with marker and watch to ensure not spreading (ie- no infection). Also advised pt to use cold compress, Ibuprofen or Tylenol as needed if pain persists. Pt returned a few hours later and no significant spread showing outside markings drawn. More
2860105	9	F	AZ	09/19/2025	COVID19	MODERNA	3052586	No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age	No adverse side effects noted but this was a 12+ age shot given to a 9 year old No adverse side effects noted but this was a 12+ age shot given to a 9 year old

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