🏥 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:

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Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
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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

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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
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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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⚠️ 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 4,901 to 4,950 of 34,052 reports (Page 99 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	🏥
2864975	40	M	AR	10/10/2025	FLU3 HPV9	SANOFI PASTEUR MERCK & CO. INC.	ut8861j1 y020531	Loss of consciousness, Muscle contusion, Respiratory arrest, Sleep disorder, Vom... Loss of consciousness, Muscle contusion, Respiratory arrest, Sleep disorder, Vomiting; Loss of consciousness, Muscle contusion, Respiratory arrest, Sleep disorder, Vomiting More	Patient was given a flu shot in his left arm followed immediately by his first gardasil shot in the ... Patient was given a flu shot in his left arm followed immediately by his first gardasil shot in the same arm (patient was to get two more vaccines in his other arm but did not get them due to the event). Two seconds after getting the gardasil, the patient said "Give me a minute" - He then appeared to be passing out followed by tense muscle contractions and also shouted a few words. He then raised his head back against the wall with his arms stretched out in front of him. His muscles contracted and it appeared he was not breathing for a few seconds. Management was called and after about a minute the patient returned to normal. Afterwards he threw up several times. We offered him water and monitored him for another 15 minutes. Patient insisted he has had episodes in the past (but not in the last 10 years) and that he was fine to go home. I called the patient 6 hours later. Patient said he was having trouble sleeping because he felt like he was still having a nervous system reaction causing him to stop breathing when he was sleeping. Patient still did not want to go to the Dr. More
2864976	64	F	PA	10/10/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Extra dose administered Extra dose administered	Patient denied ever having shingles vaccination and received vaccine, following this said she did ha... Patient denied ever having shingles vaccination and received vaccine, following this said she did have a series already More
2864977	73	F	MO	10/10/2025	FLU3 PNC21	SANOFI PASTEUR MERCK & CO. INC.	U8764DB Z006889	Mass, Rash erythematous; Mass, Rash erythematous Mass, Rash erythematous; Mass, Rash erythematous	Patient called and said she got a vaccine 2 days ago and starting yesterday noticed red rash like hi... Patient called and said she got a vaccine 2 days ago and starting yesterday noticed red rash like hives that itch intermittently and a knot on her collar bone. She denied any swelling of face or tongue. Advised pt to take dose of benadryl and call dr and if any swelling of face or tongue occured to go to ER. More
2864978	74	F	CA	10/10/2025	RSV	PFIZER\WYETH		Diarrhoea, Fatigue, Injection site inflammation, Injection site pruritus, Inject... Diarrhoea, Fatigue, Injection site inflammation, Injection site pruritus, Injection site rash More	LOCALIZED RASH ON INJECTION SITE WITH ITCHING AND INFLAMMATION. PT ALSO MENTIONED HAVING DIARRHEA AN... LOCALIZED RASH ON INJECTION SITE WITH ITCHING AND INFLAMMATION. PT ALSO MENTIONED HAVING DIARRHEA AND GENERALIZED FATIGUE. NO FEVER, NO TROUBLE BREATHING. More
2864979	27	M	TN	10/10/2025	COVID19 HEPAB TDAP	PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	na0587 az2a3 9py2y	Pain, Snoring, Syncope, Tremor, Unresponsive to stimuli; Pain, Snoring, Syncope,... Pain, Snoring, Syncope, Tremor, Unresponsive to stimuli; Pain, Snoring, Syncope, Tremor, Unresponsive to stimuli; Pain, Snoring, Syncope, Tremor, Unresponsive to stimuli More	While administering vaccinations to the patient, 2 shots were given in the left arm (covid and twinr... While administering vaccinations to the patient, 2 shots were given in the left arm (covid and twinrix) then Tdap was given in the right arm. Patient felt pain and had a vasovagal syncope, possible seizure. Patient leaned back in chair and snored and shook and nonresponsive. 911 was called. patient became aware of surroundings after about 20 seconds. The patient remembered the date, and their name. They stated this had happened before while giving blood. Patient declined medical services and ambulance was cancelled. Patient was given water and waited in the store approximately 30 minutes and felt okay to go home. They were counseled to reach out to us or their provider if they have any questions or issues with any symptoms. More
2864981	74	F	MA	10/10/2025	COVID19 FLU3	PFIZER\BIONTECH SEQIRUS, INC.	NA4452 407243	Abdominal discomfort, Paraesthesia; Abdominal discomfort, Paraesthesia Abdominal discomfort, Paraesthesia; Abdominal discomfort, Paraesthesia	The patient received both the influenza vaccine and the Pfizer COVID-19 vaccine on October 1, 2025, ... The patient received both the influenza vaccine and the Pfizer COVID-19 vaccine on October 1, 2025, at a community vaccine clinic held at the (withheld) Housing Authority, where she currently resides. At the patient?s request, both vaccines were administered in the same (right) arm. In the evening following vaccination, the patient reported tingling sensations in the head and down both arms, accompanied by an upset stomach. Due to these symptoms, she was transported to the emergency department for evaluation. The patient was hospitalized for three days for observation. During hospitalization, her care team explained that her symptoms may have been due to her body?s reaction to receiving both vaccines simultaneously. The patient was discharged in stable condition and has since returned home. More	✓
2864982	25	F	VA	10/10/2025	COVID19 FLU3	PFIZER\BIONTECH SEQIRUS, INC.	na4457 409608	Rash, Rash pruritic; Rash, Rash pruritic Rash, Rash pruritic; Rash, Rash pruritic	rash on leg and feet, rash is itching rash on leg and feet, rash is itching
2864983	65	F	CA	10/10/2025	FLU3	SANOFI PASTEUR	U8764DB	Inflammation, Nervous system disorder Inflammation, Nervous system disorder	INCREASE IN INFLAMMATION IN NERVE IRRIATION AT THE AREA OF NECK AND SCALP INCREASE IN INFLAMMATION IN NERVE IRRIATION AT THE AREA OF NECK AND SCALP
2864985	18	F	MA	10/10/2025	FLU3 FLU3 MENB MENB	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH	4D255 4D255 HP9988 HP9988	Arthralgia, Erythema, Scab, Skin lesion, Varicella virus test negative; Varicell... Arthralgia, Erythema, Scab, Skin lesion, Varicella virus test negative; Varicella virus test positive; Arthralgia, Erythema, Scab, Skin lesion, Varicella virus test negative; Varicella virus test positive More	Patient received Trumenba on left arm on 09/23/2025. On 09/26/2025 approx, she felt left shoulder pa... Patient received Trumenba on left arm on 09/23/2025. On 09/26/2025 approx, she felt left shoulder pain. on approx 09/27/2025, an erythematous lesion noted on left deltoid area, then a vesicle noted. Seen by NP (name withheld) in office (who had done her physical on 09/23/2025) on 10/03/2025 for multiple vesicles grouped together on an erythematous base on left deltoid area. another patch had shown on distal to left elbow area a few days later and another again a few days later again on wrist/left thenar area. all present at time of visit on 10/03/2025. Seen on 10/10/2025, after Varicella PCR came back positive, see below, and deltoid lesion is essentially resolved. mild irritation noted, adjacent to elbow lesion is crusted over vesicles. and left wrist/thenar lesions are mostly crusted over but some still vesiculated but to dry up soon. Shoulder pain is now 1-2 over 10 when it was 6 to 7 over 10 initiallly. No other symptoms reported I am aware of. Placed on Keflex on 10/03/2025 for concern for skin infection. and on Valcyclovir by Derm who saw her on 10/06/2025 for concern for HSV lesions (swab came back negative for HSV) More
2864986	73	F	IL	10/10/2025	FLU3	SANOFI PASTEUR	U8862BA	Injection site erythema, Injection site pruritus, Injection site rash, Injection... Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth More	The afternoon of the vaccine the patient's vaccine upper arm (L) became red, itchy, swollen, an... The afternoon of the vaccine the patient's vaccine upper arm (L) became red, itchy, swollen, and hot to the touch. 3"x6" in diameter on the front part of the arm. The patient showed us the vaccine injection site to be in the normal area of deltoid muscle but rash was to the front. Patient was taking benadryl and using hydrocortisone cream, we also recommended she start claritin once daily and pepcid once or twice daily along with tylenol as needed. No systemic symptoms of fever or malaise. More
2864987	33	F	VA	10/10/2025	FLU3	SEQIRUS, INC.	409608	Injection site rash, Rash pruritic Injection site rash, Rash pruritic	itchy rash develops after vaccination on left arm, no SOB nor wheezing itchy rash develops after vaccination on left arm, no SOB nor wheezing
2864989	31	F	MI	10/10/2025	HEPA	GLAXOSMITHKLINE BIOLOGICALS	DN273	Underdose Underdose	adult female patient got a pediatric dose of Havrix instead of the corresponding adult dose; adult f... adult female patient got a pediatric dose of Havrix instead of the corresponding adult dose; adult female patient got a pediatric dose of Havrix instead of the corresponding adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 31-year-old female patient who received HAV (Havrix pediatric) (batch number DN273, expiry date 28-AUG-2026) for prophylaxis. Previously administered products included Havrix (1st dose received on an unknown date). On 18-SEP-2025, the patient received the 2nd dose of Havrix pediatric. On 18-SEP-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: adult female patient got a pediatric dose of Havrix instead of the corresponding adult dose) and underdose (Verbatim: adult female patient got a pediatric dose of Havrix instead of the corresponding adult dose). The outcome of the adult use of a child product and underdose 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: 23-SEP-2025 On 23rd September 2025, a medical assistant called to inform that an adult female patient got a pediatric dose of Havrix instead of the corresponding adult dose which led to adult use of child product and underdose. She called to know how to proceed. She informed it was the second dose of the vaccine series. More
2864990	82	F	NC	10/10/2025	RSV	GLAXOSMITHKLINE BIOLOGICALS	52Z52	Extra dose administered Extra dose administered	Arexvy extra dose administration; This non-serious case was reported by a pharmacist via call center... Arexvy extra dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis. Previously administered products included Arexvy (received unknown dose on an unknown date). On 22-SEP-2025, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Arexvy extra dose administration). The outcome of the extra dose administered was not applicable. Additional Information: GSK receipt date 23-SEP-2025 The reporter asked for safety or efficacy data on the administration of an extra dose of Arexvy. The reporter consented to follow up. More
2864991		F	CA	10/10/2025	HEPAB	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	started the series (Twinrix) some time ago, the patient did not come back in time for the next one; ... started the series (Twinrix) some time ago, the patient did not come back in time for the next one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who did not receive HAB (Twinrix) for an unknown indication. Previously administered products included Twinrix (at least one year ago). On an unknown date, the patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: started the series (Twinrix) some time ago, the patient did not come back in time for the next one). 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: 23-SEP-2025 Registered pharmacist reported that the patient received the last dose at least one year ago. Health Care Professional was informed that the patient had only received 1 dose of Twinrix and did not specify the date of the last dose which led to incomplete course of vaccination. The batch number was not provided and a request for this information has been made. More
2864993		F	CA	10/10/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Herpes zoster, Incomplete course of vaccination Herpes zoster, Incomplete course of vaccination	Shingles after vaccination/ patient received only one dose of Shingrix in 2018 still having shingles... Shingles after vaccination/ patient received only one dose of Shingrix in 2018 still having shingles episodes.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after vaccination/ patient received only one dose of Shingrix in 2018 still having shingles episodes.). The outcome of the shingles was not resolved. 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: 24-SEP-2025 The pharmacist reported that a patient completed the Shingrix series few years ago but this patient still having shingles episodes. During the same call, the HCP checked the patient�s vaccine records and it seems that the patient received only one dose of Shingrix in 2018. The pharmacist asked how to proceed in case the patient had only one dose given in 2018. More
2864994			CO	10/10/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Product preparation issue Product preparation issue	Adjuvant only administration; a patient received only the diluent; This non-serious case was reporte... Adjuvant only administration; a patient received only the diluent; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant only administration) and inappropriate dose of vaccine administered (Verbatim: a patient received only the diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 24-SEP-2025 The reporter reported that one of the medical assistant, went to obtain the Shingrix to give to a patient, and there was only like one vial of powder left in the box. The reporter informed that as they find only the Shingrix powder portion alone, they may think that a patient received only the diluent. However, as they know which patient was, they did not provide any patient information. The batch number was not provided upon follow- up with the reporter. More
2864995	56	F	TX	10/10/2025	VARZOS VARZOS	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS		Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered	Extra dose administered; Late Dose; This non-serious case was reported by a other health professiona... Extra dose administered; Late Dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on08-NOV-2021). On 24-SEP-2025, the patient received the 3rd dose of Shingrix. On 13-DEC-2022, the patient received the 2nd dose of Shingrix. On 13-DEC-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late Dose). On 24-SEP-2025, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered and drug dose administration interval too long were not applicable. Additional Information: GSK Receipt Date: 24-SEP-2025 The reporter had a patient that got injected with a third dose of Shingrix and he/she was wondering if there was any information or recommendations. The reporter consented to follow up. More
2864996	75	M		10/10/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	342xp	Inappropriate schedule of product administration Inappropriate schedule of product administration	early 2nd dose; This non-serious case was reported by a pharmacist via call center representative an... early 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 342xp, expiry date 28-APR-2027) for prophylaxis. Concomitant products included Herpes zoster (Shingrix). On 29-SEP-2025, the patient received the 2nd dose of Shingrix. On 29-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: early 2nd dose). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 30-SEP-2025 The pharmacist reported that the patient received his first dose of Shingrix on 18-Sep-25 and second dose on 29-Sep-25. More
2864997	55	M		10/10/2025	TDAP TDAP TDAP	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS	2ZF9N 2ZF9N 2ZF9N	Arthralgia, Influenza like illness, Muscle tightness, Musculoskeletal stiffness,... Arthralgia, Influenza like illness, Muscle tightness, Musculoskeletal stiffness, Myalgia; Nausea, Neck pain, Neuralgia, Pain, Pneumonia; Radiculitis brachial, Rash More	pneumonia; Rash in the right side of the body (specially chest and right arm pit); Muscle pain; Nerv... pneumonia; Rash in the right side of the body (specially chest and right arm pit); Muscle pain; Nerve pain; Soreness of shoulders; Soreness of neck; Nausea; Flu-like symptoms; Intense body pain; Tightness of shoulder; Tightness of neck; Brachial Neuritis; Boostrix possible three doses one in 2023; This serious case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 55-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2ZF9N, expiry date 24-SEP-2023) for prophylaxis. Previously administered products included Boostrix with an associated reaction of essential tremor (received in MAR-2009 refer case US2025AMR126275) and Boostrix (received in 2015 with lot number-MO-a079B). On 02-FEB-2023, the patient received Boostrix. On 02-FEB-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Boostrix possible three doses one in 2023). On an unknown date, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant), rash (Verbatim: Rash in the right side of the body (specially chest and right arm pit)), muscle pain (Verbatim: Muscle pain), nerve pain (Verbatim: Nerve pain), shoulder soreness (Verbatim: Soreness of shoulders), neck pain (Verbatim: Soreness of neck), nausea (Verbatim: Nausea), influenza-like symptoms (Verbatim: Flu-like symptoms), general body pain (Verbatim: Intense body pain), shoulder muscle stiffness (Verbatim: Tightness of shoulder), neck tightness (Verbatim: Tightness of neck) and brachial neuritis (Verbatim: Brachial Neuritis). The outcome of the pneumonia, rash, muscle pain, nerve pain, shoulder soreness, neck pain, nausea, influenza-like symptoms, general body pain, shoulder muscle stiffness, neck tightness and brachial neuritis were unknown and the outcome of the extra dose administered was not applicable. It was unknown if the reporter considered the pneumonia, rash, muscle pain, nerve pain, shoulder soreness, neck pain, nausea, influenza-like symptoms, general body pain, shoulder muscle stiffness, neck tightness and brachial neuritis to be related to Boostrix and Boostrix Pre-Filled Syringe Device. The company considered the pneumonia to be unrelated to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the rash, muscle pain, nerve pain, shoulder soreness, neck pain, nausea, influenza-like symptoms, general body pain, shoulder muscle stiffness, neck tightness and brachial neuritis to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2025AMR126275 Additional Information: GSK Receipt Date: 30-SEP-2025 A Member of the Public called asking for the contraindications of Boostrix and mentioning several side effects due to, as he thinks, a multiple administration of this vaccine although he only had the lot number of one of these. The symptoms described since the shot in 2023 was rash in the right side on the body including the right chest and a round circular rash in the right arm pit (the side where he received the vaccine), flu-like symptoms, nausea, pneumonia, tightness and soreness of neck and shoulders, muscle and nerve pain and brachial neuritis. The reporter consented to follow up.; Sender's Comments: A case of Pneumonia, unknown time after receiving unknown dose of Boostrix and Boostrix PRE-FILLED SYRINGE DEVICE in a 55-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility. US-GSK-US2025AMR126275:Same patient/Different dose More
2864998	79	F		10/10/2025	COVID19 COVID19	MODERNA MODERNA	3052087 3052087	Dizziness, Eye irritation, Eye pain, Eye pruritus, Headache; Lip pruritus, Pruri... Dizziness, Eye irritation, Eye pain, Eye pruritus, Headache; Lip pruritus, Pruritus, Urticaria, Vision blurred More	Would get a little pain (alternating) in her eyes once or twice; Felt like a burning in her eyes rig... Would get a little pain (alternating) in her eyes once or twice; Felt like a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026; Like right now when blinking it itches/alternating itch to both eyes sometimes; little blurring and was a little dizzy; little blurring and was a little dizzy/blurriness of her vision; she did have a little headache; Started to get itchy eyes and itchy skin 2 hours after she had left/a facial itch and body itch too/itchy skin on her face and various parts of her body; had itchiness around her lips and might had one hive; Itchy skin on her face and various parts of her body; Also had itchiness around her lips and might had one hive and then had alternating itchy, burning eyes since then for 2 days; This spontaneous case was reported by a nurse and describes the occurrence of EYE PAIN (Would get a little pain (alternating) in her eyes once or twice), EYE IRRITATION (Felt like a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026), EYE PRURITUS (Like right now when blinking it itches/alternating itch to both eyes sometimes), DIZZINESS (little blurring and was a little dizzy) and PRURITUS (Started to get itchy eyes and itchy skin 2 hours after she had left/a facial itch and body itch too/itchy skin on her face and various parts of her body) in a 79-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052087) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dry eye, Seasonal allergy (Sometimes), GERD (GERD which sometimes irritates the lungs a little bit), Irritable bowel syndrome, Asthma (asthma types but unspecified) and Allergy (Some allergies). Concomitant products included Ciclosporin (Restasis) for Dry eyes. On 29-Sep-2025, the patient received first dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. In 2025, the patient experienced PRURITUS (Started to get itchy eyes and itchy skin 2 hours after she had left/a facial itch and body itch too/itchy skin on her face and various parts of her body), URTICARIA (had itchiness around her lips and might had one hive), PRURITUS (Itchy skin on her face and various parts of her body), LIP PRURITUS (Also had itchiness around her lips and might had one hive and then had alternating itchy, burning eyes since then for 2 days) and HEADACHE (she did have a little headache). On 29-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced EYE PAIN (Would get a little pain (alternating) in her eyes once or twice), EYE IRRITATION (Felt like a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026), EYE PRURITUS (Like right now when blinking it itches/alternating itch to both eyes sometimes), DIZZINESS (little blurring and was a little dizzy) and VISION BLURRED (little blurring and was a little dizzy/blurriness of her vision). On 29-Sep-2025, VISION BLURRED (little blurring and was a little dizzy/blurriness of her vision) had resolved. At the time of the report, EYE PAIN (Would get a little pain (alternating) in her eyes once or twice), EYE IRRITATION (Felt like a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026), EYE PRURITUS (Like right now when blinking it itches/alternating itch to both eyes sometimes), DIZZINESS (little blurring and was a little dizzy), PRURITUS (Started to get itchy eyes and itchy skin 2 hours after she had left/a facial itch and body itch too/itchy skin on her face and various parts of her body), URTICARIA (had itchiness around her lips and might had one hive), PRURITUS (Itchy skin on her face and various parts of her body) and HEADACHE (she did have a little headache) had not resolved and LIP PRURITUS (Also had itchiness around her lips and might had one hive and then had alternating itchy, burning eyes since then for 2 days) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. The patient was generally healthy. The patient always received Moderna vaccines. It was reported that patient never received two vaccines at once and said that she did not even get the flu vaccine because she always waited 2 weeks in between. The patient had not received any other vaccines within the past 4 weeks prior to receiving the mNEXSPIKE 2025-2026. The patient experienced a little pain (alternating) in her eyes once or twice. Patient felt a burning in her eyes right away after receiving the mNEXSPIKE 2025-2026, which described as a little blurring and dizzy. The pharmacist said that they had heard that this happens sometimes, but it would go away, within an hour. The blurriness of her vision went away probably after an hour and a half. The burning was an initial thing, but after she left the pharmacy, where she recalled waiting for an hour and a half, she started to experience itchy eyes and itchy skin 2 hours after she had left. She also had itchiness around her lips and might have had one hive, then experienced alternating itchy, burning eyes since then for 2 days. She did not know if the itchy eyes were a normal reaction to the vaccine. She had read somewhere that it could happen for a couple of days. She had received all the Moderna vaccines before and never had this problem. This was the first time she had ever experienced the eye issue, and it had already been 2 days with mainly alternating itchiness in both eyes sometimes. Patient had a little bit of pain in the eye, but during the call, it was described as very itchy. Patient never experienced the eye concerns until the mNEXSPIKE 2025-2026. Patient also had facial itch and body itch too. Patient received a total of eight doses. The reporter added that patient was expecting it to happen but not with the eye-related side effect. Patient had a little headache. Patient always sticked with Moderna. Patient complained that after a couple of days, still felt itchy, with pain and burning eyes, as well as itchy skin on her face and various parts of her body. Sometimes it alternates, sometimes it affects both eyes simultaneously. The patient did not experience any additional symptoms/events. No treatment medications were reported. This case was linked to MOD-2025-786055 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2025: Live follow up received that contains non-significant information includes reporter's phone number, allergy and reference numbers were added.; Reporter's Comments: Concurrent medical conditions Dry eye, Seasonal allergy, Asthma and Allergies are confounders for the events. The benefit -risk relationship of product is not affected by this report. More
2864999	77	F		10/10/2025	COVID19 COVID19	MODERNA MODERNA		Ear discomfort, Fatigue, Palpitations, Pyrexia, Upper-airway cough syndrome; Vac... Ear discomfort, Fatigue, Palpitations, Pyrexia, Upper-airway cough syndrome; Vaccination site pain More	A little pounding of the heart; Pressure in her ears; A little bit of post-nasal drip; Like a little... A little pounding of the heart; Pressure in her ears; A little bit of post-nasal drip; Like a little fever; Tiredness; Pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (A little pounding of the heart), EAR DISCOMFORT (Pressure in her ears), UPPER-AIRWAY COUGH SYNDROME (A little bit of post-nasal drip), PYREXIA (Like a little fever) and FATIGUE (Tiredness) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dry eye, Seasonal allergy (Sometimes), GERD (GERD which sometimes irritates the lungs a little bit), Irritable bowel syndrome, Asthma (asthma types but unspecified) and Allergy (Some allergies). Concomitant products included Ciclosporin (Restasis) for Dry eyes. In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (A little pounding of the heart), EAR DISCOMFORT (Pressure in her ears), UPPER-AIRWAY COUGH SYNDROME (A little bit of post-nasal drip), PYREXIA (Like a little fever), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, PALPITATIONS (A little pounding of the heart), EAR DISCOMFORT (Pressure in her ears), UPPER-AIRWAY COUGH SYNDROME (A little bit of post-nasal drip), PYREXIA (Like a little fever), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. The current age of the patient was reported as 79 years. The patient was pretty healthy. The patient always received Moderna vaccines. She clarified that she never received two vaccines at once and said that she did not even get the flu vaccine because she always waited 2 weeks in between. The only side effects patient had experienced were fever, tiredness, heart pounding, pressure in her ears and a little bit of post-nasal drip, and pain at the injection site. 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-2025-786055 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2025: Live follow up received that contains non-significant information includes reporter's phone number, allergy and reference numbers were added. More
2865000		M		10/10/2025	COVID19	MODERNA		Fatigue Fatigue	being tired the next day; This spontaneous case was reported by a consumer and describes the occurre... being tired the next day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (being tired the next day) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (being tired the next day). At the time of the report, FATIGUE (being tired the next day) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications were reported. The patient had reaction to his previous Moderna COVID-19 shots and was being tired the next day. Patient did not had rash. Patient had quite a few of the Moderna COVID-19 shots only once had the other one. No treatment information was provided. This case was linked to MOD-2025-789962 (E2B Linked Report).; Sender's Comments: MOD-2025-789962:wife case More
2865001		F		10/10/2025	COVID19 COVID19	MODERNA MODERNA		Asthenia, Body temperature, Illness, Pain, Pain in extremity; Pyrexia, Vaccinati... Asthenia, Body temperature, Illness, Pain, Pain in extremity; Pyrexia, Vaccination site swelling More	weakness; was achy; pain on the arm; usually get very ill/ get so sick from this; injection site swe... weakness; was achy; pain on the arm; usually get very ill/ get so sick from this; injection site swelling; the low grade temp; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PAIN (was achy), PAIN IN EXTREMITY (pain on the arm), ILLNESS (usually get very ill/ get so sick from this) and VACCINATION SITE SWELLING (injection site swelling) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concomitant products included Ibuprofen and Paracetamol (Tylenol) for an unknown indication. 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 ASTHENIA (weakness), PAIN (was achy), PAIN IN EXTREMITY (pain on the arm), ILLNESS (usually get very ill/ get so sick from this), VACCINATION SITE SWELLING (injection site swelling) and PYREXIA (the low grade temp). At the time of the report, ASTHENIA (weakness), PAIN (was achy), PAIN IN EXTREMITY (pain on the arm), ILLNESS (usually get very ill/ get so sick from this), VACCINATION SITE SWELLING (injection site swelling) and PYREXIA (the low grade temp) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low grade. The patient had all Moderna COVID -19 vaccines since Moderna started them. She always had some side effects post vaccination like weakness, unable to go to work for few days, injection site swelling and pain on the arm, etc. The patient gets very nervous while getting the COVID shots. The patient became nervous cause she gets so sick from this. On 03-Oct-2025, the patient got 8th Moderna vaccine. Prior to this, patient had received all 7 doses from Moderna. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789983 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live follow-up received contains non-significant information (reference numbers were added). On 06-Oct-2025: Live significant follow-up received: Patient's DOB was added, lab data was added, concomitant medication was added, additional events were added, and narrative was updated. On 06-Oct-2025: Live follow-up received contains non-significant information (reference numbers were added). On 07-Oct-2025: Live follow-up received contains non-significant information (reference numbers were added). More
2865002		M	FL	10/10/2025	COVID19	MODERNA		Malaise Malaise	felt sort of crummy the next day/ not congested, he just feels sort of "blah"/ just does n... felt sort of crummy the next day/ not congested, he just feels sort of "blah"/ just does not feel that well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sort of crummy the next day/ not congested, he just feels sort of "blah"/ just does not feel that well) in an elderly 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) (unknown route) 1 dosage form. In 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (felt sort of crummy the next day/ not congested, he just feels sort of "blah"/ just does not feel that well). In 2021, MALAISE (felt sort of crummy the next day/ not congested, he just feels sort of "blah"/ just does not feel that well) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. He had been taking Moderna COVID vaccines since they first came out. He was currently 71 years old. He never had any problems with his Moderna vaccines in the past; except he felt sort of crummy the next day. It was just for a day. He started taking Moderna shots when they first came out, in 2021. Every time he got a Moderna shot, he did not plan on doing much the next day, and then the next day after that he was fine again. By crummy - he meant not congested, he just feels sort of "blah", he just did feel that well. At the time of reporting, the patient had received 8 Moderna covid shots. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-789982 (Patient Link). More
2865003		M		10/10/2025	COVID19	MODERNA		Pyrexia Pyrexia	Patient had a fever; This spontaneous case was reported by a consumer and describes the occurrence o... Patient had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Patient had a fever) in a male 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 PYREXIA (Patient had a fever). At the time of the report, PYREXIA (Patient had a fever) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was reported that, at one point, the patient thought patient had a fever for two years. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2025: Upon internal review on 10-Oct-2025, significant correction was performed to update suspect product to Spikevax NOS, case updated as valid. More
2865004	36	F	MA	10/10/2025	COVID19 RSV	MODERNA PFIZER\WYETH	8146367 MF2162	Chills, Maternal exposure during pregnancy, Myalgia, Pregnancy test; Chills, Mat... Chills, Maternal exposure during pregnancy, Myalgia, Pregnancy test; Chills, Maternal exposure during pregnancy, Myalgia, Pregnancy test More	chills; muscle aches; drug exposure during pregnancy; This spontaneous prospective pregnancy case wa... chills; muscle aches; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle aches) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146367) for COVID-19 prophylaxis. Co-suspect product included non-company product RSV vaccine prot. subunit PreF 2v (Abrysvo) for an unknown indication. asthma, eczema Patient was diagnosed with Covid 19. The patient's past medical history included COVID-19 on 15-Aug-2024, Pregnancy (Breech delivery, C-section, Live full-term birth) on XX-Aug-2019, Pregnancy (Live full-term birth) on XX-Oct-2021, Alcohol use (2 drinks per week prior to pregnancy) on 20-Feb-2021 and C-section (Breech delivery, c section) on XX-Aug-2019. Concurrent medical conditions included Asthma since 1994 and Eczema. On 27-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of RSV vaccine prot. subunit PreF 2v (Abrysvo) (Intramuscular use) 1 dosage form. The patient's last menstrual period was on 21-Jan-2025 and the estimated date of delivery was 28-Oct-2025. On 27-Sep-2025, the patient experienced CHILLS (chills), MYALGIA (muscle aches) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). The patient received mRNA-1273.251 (Spikevax LP.8.1 PFS) beginning around the thirty-fifth week of the pregnancy and RSV vaccine prot. subunit PreF 2v (Abrysvo) beginning around the thirty-fifth week of the pregnancy. The patient was treated with Paracetamol (Tylenol) on 27-Sep-2025 at an unspecified dose and frequency. On 27-Sep-2025, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved. On 28-Sep-2025, CHILLS (chills) and MYALGIA (muscle aches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2025, Pregnancy test: Positive. No concomitant medications were provided. It was reported that there was no maternal history of infertility. The patient had no allergies to medications, food, and other products. The night of vaccination, patient had chills and muscle aches and took tylenol. This case was linked to US-MODERNATX, INC.-MOD-2022-607594 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-607594:same patient diffrent suspect More
2865005		F	IL	10/10/2025	COVID19 FLUX	MODERNA UNKNOWN MANUFACTURER	3052155	Rash; Rash Rash; Rash	rash around the neck and upper abdomen up to under the breasts, like a heat rash, not itchy; This sp... rash around the neck and upper abdomen up to under the breasts, like a heat rash, not itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash around the neck and upper abdomen up to under the breasts, like a heat rash, not itchy) in an elderly female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052155) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX NOS; for Drug use for unknown indication: penicillin and Sulpha. Past adverse reactions to the above products included Drug allergy with Sulpha and penicillin; and No adverse effect with SPIKEVAX NOS. Concurrent medical conditions included Sulfonamide allergy (sulpha drug) and Penicillin allergy. On 26-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 26-Sep-2025, the patient experienced RASH (rash around the neck and upper abdomen up to under the breasts, like a heat rash, not itchy). On 28-Sep-2025, RASH (rash around the neck and upper abdomen up to under the breasts, like a heat rash, not itchy) had resolved. The patient always received the Moderna COVID vaccines in the past. The concomitant medication was not reported by the reporter. On Friday, 26-Sep-2025, the patient received a dose of mNEXSPIKE and Flu shot. It was reported that within less than 12 hours of the vaccination, she developed a rash around the neck and upper abdomen, extending up to under the breasts. The rash looked like a heat rash and was not itchy. The symptoms were resolved by Sunday night, on 28-Sep-2025, after about two days. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.; Reporter's Comments: Flu vaccine was assessed as confounding factor for reported event of RASH. The benefit-risk relationship of product is not affected by this report. More
2865006	73	F	CO	10/10/2025	COVID19 COVID19	MODERNA MODERNA		Asthenia, Erythema, Fatigue, Headache, Musculoskeletal stiffness; Pain in extrem... Asthenia, Erythema, Fatigue, Headache, Musculoskeletal stiffness; Pain in extremity More	arm is still red and sore 5 days later; stiff neck; general feelings of weakness; arm is still red a... arm is still red and sore 5 days later; stiff neck; general feelings of weakness; arm is still red and sore 5 days later; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still red and sore 5 days later), MUSCULOSKELETAL STIFFNESS (stiff neck), ASTHENIA (general feelings of weakness), ERYTHEMA (arm is still red and sore 5 days later) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 27-Sep-2025, the patient experienced PAIN IN EXTREMITY (arm is still red and sore 5 days later), MUSCULOSKELETAL STIFFNESS (stiff neck), ASTHENIA (general feelings of weakness), ERYTHEMA (arm is still red and sore 5 days later), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (arm is still red and sore 5 days later), MUSCULOSKELETAL STIFFNESS (stiff neck), ASTHENIA (general feelings of weakness), ERYTHEMA (arm is still red and sore 5 days later), HEADACHE (headache) and FATIGUE (fatigue) was resolving. No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. More
2865007	75	M		10/10/2025	COVID19	MODERNA		Atrial fibrillation Atrial fibrillation	A-fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRI... A-fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A-fib) in a 75-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (received Moderna's vaccines). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced ATRIAL FIBRILLATION (A-fib) (seriousness criterion medically significant). The patient was treated with Apixaban (Eliquis) for Anticoagulant therapy, at an unspecified dose and frequency and Surgery (Afib surgery) for Atrial fibrillation. At the time of the report, ATRIAL FIBRILLATION (A-fib) outcome was unknown. No concomitant medication was reported. The patient had undergone Afib surgery in March 2024. He had received Moderna's vaccines and booster back in 2023 and the last one was in 28-Aug-2024 - 5 months after the Afib surgery. He was on a blood thinner- Eliquis. Patient had called his pharmacist, doctor, and cardiologist but they all told him the same thing, that it was up to him to take the vaccine or not. The patient was concerned about the safety of the mNEXSPIKE. He had read that the side effects include inflammation of heart tissue. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: Company comment: Patient's advanced age as risk factor for atrial fibrillation. The benefit-risk relationship of product is not affected by this report. More
2865008		F		10/10/2025	COVID19 COVID19	MODERNA MODERNA		Asthenia, Body temperature, Fatigue, Headache, Nausea; Pyrexia Asthenia, Body temperature, Fatigue, Headache, Nausea; Pyrexia	No energy; Debilitating fatigue/Exhausted/Extreme fatigue/Tiredness; Headache; Nauseous; Fever of 10... No energy; Debilitating fatigue/Exhausted/Extreme fatigue/Tiredness; Headache; Nauseous; Fever of 101.5/Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), PYREXIA (Fever of 101.5/Fever), FATIGUE (Debilitating fatigue/Exhausted/Extreme fatigue/Tiredness), HEADACHE (Headache) and NAUSEA (Nauseous) in a female patient of an unknown age who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 25-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 26-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced PYREXIA (Fever of 101.5/Fever). On 30-Sep-2025, the patient experienced ASTHENIA (No energy), FATIGUE (Debilitating fatigue/Exhausted/Extreme fatigue/Tiredness), HEADACHE (Headache) and NAUSEA (Nauseous). On 02-Oct-2025, PYREXIA (Fever of 101.5/Fever) had resolved. At the time of the report, ASTHENIA (No energy) and FATIGUE (Debilitating fatigue/Exhausted/Extreme fatigue/Tiredness) had not resolved and HEADACHE (Headache) and NAUSEA (Nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2025, Body temperature: fever of 101.5. On 27-Sep-2025, Body temperature: 100.5. On 28-Sep-2025, Body temperature: 100.5. On 29-Sep-2025, Body temperature: 100.5. On 30-Sep-2025, Body temperature: 100.5. On 01-Oct-2025, Body temperature: 99.8. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. Patient received over-65 Moderna COVID-19 vaccine on 25-Sep-2025. From 26-Sep-2025 patient had fever. Patient had no energy debilitating fatigue, exhausted headache, nauseous. On the reporting day (02-Oct-2025), fever was normal but still had extreme fatigue and tiredness. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. More
2865009	64	M	WA	10/10/2025	COVID19	MODERNA	80777-0112-96	Gait disturbance, Muscle tightness, Pain, Pyrexia Gait disturbance, Muscle tightness, Pain, Pyrexia	muscular tension; severe pains that move around the body; walking difficult; fever; This spontaneous... muscular tension; severe pains that move around the body; walking difficult; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCLE TIGHTNESS (muscular tension), PAIN (severe pains that move around the body), GAIT DISTURBANCE (walking difficult) and PYREXIA (fever) in a 64-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 80777-0112-96) for COVID-19 prophylaxis. No Medical History information was reported. On 24-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 28-Sep-2025, the patient experienced MUSCLE TIGHTNESS (muscular tension), PAIN (severe pains that move around the body), GAIT DISTURBANCE (walking difficult) and PYREXIA (fever). At the time of the report, MUSCLE TIGHTNESS (muscular tension), PAIN (severe pains that move around the body), GAIT DISTURBANCE (walking difficult) and PYREXIA (fever) had not resolved. The concomitant medication was not reported by the reporter. It was reported that the patient's side effects worsened four days after receiving the vaccine and did not go away. The patient had a fever, muscular tension, and severe pains that moved around the body and made walking difficult. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2865010		F	NY	10/10/2025	COVID19	MODERNA		Erythema, Hypersensitivity, Pruritus Erythema, Hypersensitivity, Pruritus	a pretty large area of erythema on her upper arm/her arm is red; had itching on other parts of her b... a pretty large area of erythema on her upper arm/her arm is red; had itching on other parts of her body/had body itching; allergic reaction to Spikevax 2025-2026; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (a pretty large area of erythema on her upper arm/her arm is red), PRURITUS (had itching on other parts of her body/had body itching) and HYPERSENSITIVITY (allergic reaction to Spikevax 2025-2026) in an elderly female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 08-May-2024; for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE and Spikevax NOS. On 26-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. In 2025, the patient experienced ERYTHEMA (a pretty large area of erythema on her upper arm/her arm is red), PRURITUS (had itching on other parts of her body/had body itching) and HYPERSENSITIVITY (allergic reaction to Spikevax 2025-2026). At the time of the report, ERYTHEMA (a pretty large area of erythema on her upper arm/her arm is red), PRURITUS (had itching on other parts of her body/had body itching) and HYPERSENSITIVITY (allergic reaction to Spikevax 2025-2026) had resolved with sequelae. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. It was reported that patient had an allergic reaction to Spikevax 2025-2026. Reporter did not see it at its peak, but she had a pretty large area of erythema on her upper arm and itching on other parts of her body as well. People with large erythema were seen and that was often a local reaction, but she had body itching. It was stated that her symptoms were resolved pretty much, when asked to her she said her arm was red still, but the itching was gone. They both had Moderna except for 1 injection that was Pfizer. Pfizer vaccine was on May 8, 2024. Spikevax 2025-2026 would have been the third injection since. All the other vaccines were Moderna covid-19 vaccines, they have been receiving them in roughly 6-month intervals except for the Pfizer vaccine. It was unknown how many vaccines there were, but when they started out it was 2 initials, and then about every 6 months roughly. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789956 (E2B Linked Report). This case was linked to MOD-2022-660560 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789956:Invalid case with multiple people More
2865011	69	F	AZ	10/10/2025	COVID19 COVID19	MODERNA MODERNA	3052736 3052736	Dizziness, Fatigue, Headache, Hypoaesthesia, Nausea; Vaccination site pain Dizziness, Fatigue, Headache, Hypoaesthesia, Nausea; Vaccination site pain	arm/injection site soreness; numbness on arm up to shoulder and into armpit; light headed; nausea/fe... arm/injection site soreness; numbness on arm up to shoulder and into armpit; light headed; nausea/feeling of wanting to vomit (not actually vomiting); headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm/injection site soreness), HYPOAESTHESIA (numbness on arm up to shoulder and into armpit), DIZZINESS (light headed), NAUSEA (nausea/feeling of wanting to vomit (not actually vomiting)) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052736) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: COVID-19 Vaccine (Since late 2020 except for annual arm-injection site soreness for a day or two.). Past adverse reactions to the above products included Vaccination site pain with COVID-19 Vaccine. On 02-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 02-Oct-2025, the patient experienced VACCINATION SITE PAIN (arm/injection site soreness), HYPOAESTHESIA (numbness on arm up to shoulder and into armpit), DIZZINESS (light headed), NAUSEA (nausea/feeling of wanting to vomit (not actually vomiting)), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with Paracetamol (Tylenol) from 2025 to 2025 for Headache, at a dose of 4x daily. In 2025, HEADACHE (headache) and FATIGUE (fatigue) had resolved. On 06-Oct-2025, VACCINATION SITE PAIN (arm/injection site soreness), HYPOAESTHESIA (numbness on arm up to shoulder and into armpit), DIZZINESS (light headed) and NAUSEA (nausea/feeling of wanting to vomit (not actually vomiting)) had resolved. The patient had no medical history, concomitant disease or risk factor. No concomitant medication was reported. Within 2 hours, the patient started having a headache and arm/injection site soreness. Within 4 hours, she had arm soreness increased substantially. Within 6 hours, the patient had numbness in the arm up to the shoulder and in the armpit. Within 10 hours, patient had nausea, light headache, fatigue, and a feeling of wanting to vomit (not actually vomiting). Next morning, all the symptoms were there, and the patient stayed in bed all day due to nausea and light-headed. After 48 hours, the nausea and feeling of wanting to vomit were gone, but arm soreness and numbness still remained. 72 hours later, the numbness in the arm pit was gone, and injection site soreness started to subside. After 84 hours, the headache started to subside and numbness near the shoulder/upper arm started to dissipate, and fatigue. 96 hours later, the headache was gone, and injection site soreness was almost entirely gone (very slight with certain movements). After 106 hours, all symptoms were gone. That was the first time the patient had extensive side effects. The patient never had any reactions to Covid vaccinations since late 2020 except for annual arm-injection site soreness for a day or two. The patient never had a FLU shot along with a Covid-19 vaccination because if reactions happened, it was unknown which vaccination caused the reactions; and this year the patient had this reaction. The patient would wait for the annual flu shot in a few weeks to make sure the arm soreness and other reactions were totally gone. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. Patient took Tylenol 500mg 4x daily to deal with headache for 3 days. Reporter causality was not provided. This case was linked to US-MODERNATX, INC.-MOD-2025-790000 (Patient Link). More
2865012		F		10/10/2025	COVID19	MODERNA		Transient acantholytic dermatosis Transient acantholytic dermatosis	Grover's disease; This spontaneous case was reported by a consumer and describes the occurrence... Grover's disease; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ACANTHOLYTIC DERMATOSIS (Grover's disease) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced TRANSIENT ACANTHOLYTIC DERMATOSIS (Grover's disease). At the time of the report, TRANSIENT ACANTHOLYTIC DERMATOSIS (Grover's disease) outcome was unknown. No concomitant medication was reported. The patient was being diagnosed with Grover's disease for 4 years. The patient had suffered so bad with these sores on her face and everywhere. The sores were on her body, the vaginal area and face. The patient did not have her vaccination records, thus, all information regarding her doses were unknown. No treatment medication was reported. It was unknown if the patient experienced any additional symptoms/events. The reporter causality was not reported. More
2865013	81	F	MD	10/10/2025	COVID19 COVID19	MODERNA MODERNA	3052733 3052733	Body temperature, COVID-19, Cough, Fatigue, Headache; Illness, Malaise, Pain in ... Body temperature, COVID-19, Cough, Fatigue, Headache; Illness, Malaise, Pain in extremity, Product label issue, SARS-CoV-2 test More	How confusing, right and when I looked at it online, it said syrup. Caller clarified that the code s... How confusing, right and when I looked at it online, it said syrup. Caller clarified that the code she used to search was "MN Spike 2025-26, 12 year up SYR; positive for COVID; headache; increasing deep cough/heavy cough/definitely bronchial cough; general malaise; real sore arm; sick; extreme fatigue; This spontaneous case was reported by a physician and describes the occurrence of COUGH (increasing deep cough/heavy cough/definitely bronchial cough), MALAISE (general malaise), PAIN IN EXTREMITY (real sore arm), ILLNESS (sick) and FATIGUE (extreme fatigue) in an 81-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052733) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. In 2025, the patient experienced COUGH (increasing deep cough/heavy cough/definitely bronchial cough), MALAISE (general malaise), PAIN IN EXTREMITY (real sore arm), ILLNESS (sick) and FATIGUE (extreme fatigue). On 05-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced HEADACHE (headache). On 06-Oct-2025, the patient experienced COVID-19 (positive for COVID). On an unknown date, the patient experienced PRODUCT LABEL ISSUE (How confusing, right and when I looked at it online, it said syrup. Caller clarified that the code she used to search was "MN Spike 2025-26, 12 year up SYR). The patient was treated with Ibuprofen on 05-Oct-2025 at a dose of every 4 to 6 hours and Paracetamol (Tylenol) on 05-Oct-2025 at a dose of every 4 to 6 hours. At the time of the report, COUGH (increasing deep cough/heavy cough/definitely bronchial cough), MALAISE (general malaise), PAIN IN EXTREMITY (real sore arm), ILLNESS (sick), FATIGUE (extreme fatigue), HEADACHE (headache) and COVID-19 (positive for COVID) had not resolved and PRODUCT LABEL ISSUE (How confusing, right and when I looked at it online, it said syrup. Caller clarified that the code she used to search was "MN Spike 2025-26, 12 year up SYR) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2025, Body temperature: 96.8 F. On 06-Oct-2025, SARS-CoV-2 test: Positive. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient got sick two days after getting the vaccine and was COVID-19 positive on an expired test with a really strong positive test and a blank control. The patient was really fatigued and had cough, general malaise, but an increasingly deep cough, it was a heavy cough, bronchial, definitely bronchial cough, headache and extreme fatigue. Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2025: Live non-significant information received included: Reference numbers were added. More
2865014	85	M		10/10/2025	COVID19	MODERNA		COVID-19 COVID-19	The caller wants to know if there are any free COVID tests available, as he has just been diagnosed ... The caller wants to know if there are any free COVID tests available, as he has just been diagnosed with COVID./He is scheduled to get the vaccine on 10-Oct-2025, but his healthcare provider advised him to postpone it for 3 months.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The caller wants to know if there are any free COVID tests available, as he has just been diagnosed with COVID./He is scheduled to get the vaccine on 10-Oct-2025, but his healthcare provider advised him to postpone it for 3 months.) in an 85-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2025, the patient experienced COVID-19 (The caller wants to know if there are any free COVID tests available, as he has just been diagnosed with COVID./He is scheduled to get the vaccine on 10-Oct-2025, but his healthcare provider advised him to postpone it for 3 months.). At the time of the report, COVID-19 (The caller wants to know if there are any free COVID tests available, as he has just been diagnosed with COVID./He is scheduled to get the vaccine on 10-Oct-2025, but his healthcare provider advised him to postpone it for 3 months.) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. The patient had just been diagnosed with COVID. He was unable to take medication because he was on other medications that interact with it. He was scheduled to get the vaccine on 10-Oct-2025, but his healthcare provider advised him to postpone it for 3 months. He had consistently received them whenever they were available. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. More
2865015	31	F		10/10/2025	COVID19	MODERNA	3052668	Injection site discharge Injection site discharge	after administering the vaccine to patient and upon removing the needle from the muscle the injected... after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE DISCHARGE (after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm) in a 31-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052668) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 08-Oct-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced INJECTION SITE DISCHARGE (after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm). At the time of the report, INJECTION SITE DISCHARGE (after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter considered INJECTION SITE DISCHARGE (after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started "spilling out" of the patient arm) to be related. Concomitant medication was not reported. HCP stated that after administering the vaccine to patient and upon removing the needle from the muscle the injected vaccine started spilling out of the patient arm. HCP confirmed that she was not exposed herself to the vaccine and that the vaccine leaked on the patient's arm. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. More
2865016	78	M		10/10/2025	COVID19	MODERNA		Nasopharyngitis Nasopharyngitis	have a little bit of a cold today; This spontaneous case was reported by a consumer and describes th... have a little bit of a cold today; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (have a little bit of a cold today) in a 78-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 08-Oct-2025, the patient experienced NASOPHARYNGITIS (have a little bit of a cold today). At the time of the report, NASOPHARYNGITIS (have a little bit of a cold today) outcome was unknown. The relevant medical history (vaccines within the past 4 weeks, medical conditions) was reported as unknown. The concomitant medication was not reported by the reporter. The patient had received all his COVID shots on time, and they had all been from Moderna. He mentioned that he had a bit of a cold that day. He did not know what it was, but it was something. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter. More
2865017	73	F		10/10/2025	COVID19	MODERNA		Pain in extremity Pain in extremity	my hand was hurting; This spontaneous case was reported by a consumer and describes the occurrence o... my hand was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my hand was hurting) in a 73-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (many COVID-19 vaccines). Past adverse reactions to the above products included No adverse effect with COVID-19 VACCINE. On 16-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. In September 2025, the patient experienced PAIN IN EXTREMITY (my hand was hurting). In 2025, PAIN IN EXTREMITY (my hand was hurting) had resolved. No other vaccines within the 4 weeks and no relevant medical history. No concomitant medication was reported. The patient was a right-handed person and when the patient went to open the jar, went to grab something or needed to crank something, her hand hurt. The patient couldn't even pick up the jar. It wasn't a heavy jar, and when she went to pick it up, her hand hurt. Patient though it was arthritis all of a sudden, she never had anything like that before. The patient didn't even think about that. The patient had the vaccine a few days before. She had it in her left arm, but it was the right hand that hurt. The only reason the patient didn't even think of an association was other than she was talking to somebody who she had just met, and she mentioned that her son had this weird side effect from the vaccine where his hand hurt him. It was just too much of a coincidence, and it's gone away. It's absolutely fine. The patient never had it before. The patient had many COVID vaccines. The patient planned on continuing them. It wasn't in the same hand or in the same arm. There was some connection. There was no definite correlation because it was days later. So, it didn't happen immediately after she had the vaccine. It was probably 3, even 4 days later and her hand was hurting. But at the time, she thought it should go away and wasn't even concerned when it happened. The patient was a little concerned, thinking, whether it could be arthritis. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. No causality provided This case was linked to US-MODERNATX, INC.-MOD-2025-790042 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790042:Son's case More
2865018		F	VA	10/10/2025	COVID19	PFIZER\BIONTECH		Blood glucose, COVID-19, Drug ineffective, Glycosylated haemoglobin, Weight Blood glucose, COVID-19, Drug ineffective, Glycosylated haemoglobin, Weight	Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year late... Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year later, was very similar to first time; Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year later, was very similar to first time; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "heart issues" (unspecified if ongoing); "Allergic to penicillin" (unspecified if ongoing), notes: with anaphylaxis; "Allergic to sulfa medications" (unspecified if ongoing), notes: with anaphylaxis; "arthritic" (unspecified if ongoing); "Covid" (unspecified if ongoing). 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; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity. The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: EP7534 (left arm)), administration date: 13Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, LOT: EW0151 (Right arm)), administration date: 03Apr2021, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT: Probably FH8020), administration date: 14Oct2021, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year later, was very similar to first time". The patient underwent the following laboratory tests and procedures: Blood glucose: (26Sep2025) 234, notes: was high; Unit: Not Provided; Glycosylated haemoglobin: (26Sep2025) 9.8, notes: a little high; Unit: Not Provided; Weight: (unspecified date) 230, notes: Approximately. Clinical course: Clarified omeprazole (20mg) with sodium bicarbonate (1100mg), it states the sodium bicarbonate allows for absorption. Clarifies this is all in one medication, all in one tablet. Caller states everything she has suffered, in her opinion, has been worse than what the vaccine the vaccine provided her, as in her ability to get Covid, to have it and not die from it like so many. Feels like much of what she suffered from, the vaccine and having Covid, has been relatively low, comparatively. Is still thankful. Was significantly affected, does not know if from the vaccination or from having had Covid. Got Covid after being vaccinated, she thinks, more than once. Thinks she had the vaccine a couple of times by then. Takes as precaution because she has autoimmune disease and her son suffers from autoimmune disease. Has had some lingering, guesses they might even call it long Covid. She has studied up on it, trying to decipher if its one thing or another. Thinks this would have been first shot. Knows she had Covid within first year or year and a half, think was in 2021, or may have been as late as 2022. Second time she had Covid, was not able to test since she saved the test for her son. Clarified, caller got Covid first time, after having a couple Covid vaccines. Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year later, was very similar to first time. Severity of it, was not as horrible but felt like it took forever to get over it. Finally, someone said it is maybe not matter of not being over it because she would probably not get anyone else sick. Is what they call long covid when having lingering effects. Clarified, she thinks she had significant effects first time having Covid that did sort of linger. Looking back on it, definitely had that the second time. Believes she only had covid twice, if that second time was in fact Covid, it was very similar. Had been well otherwise, all though she has diabetes, has heart issues. Is not a sickly person that is always sick with something. Because of her practices in handwashing and wearing masks out, which she still does, thinks was actually with all things she would normal get like she seasonal has terrible allergies, that would end up getting exacerbated and go into bronchitis and gets that once a year, almost faithfully, in the fall. Thankful to Pfizer because, between of her practices and having had the vaccines, has been more well overall as far as colds, flu, bronchitis. Has literally never had bronchitis since getting the first Covid shot. And she has learned to be more careful in public. Muscle aches and headaches: Clarified, she had the muscle aches and headaches both times having Covid. Muscle aches and headaches: Is something that has lingered, still experiencing now. In her mind she does not know what to zero in on for exact cause since she is 62 and is arthritic. Very specifically knows some of that muscle ache and pain was vaccine related because of how it came on, how it lingered. In general, it just took down her overall energy and stamina. Has not really gotten any better, thinks she just learned to just work through it. In general the muscle aches, are just so natural to her now and she can't really differentiate. She certainly has good days where she feels good. Also has to do with the weather which may make no sense but if there is terrible humidity, if there is a terrible humid day she can be in so much discomfort. And specifically where she got shots can be very tender. Rubbing arm right now, feels lumps still sore but not horrible. Is not anything that would keep her from doing what she needs to do, just makes it maybe a little less comfortable. Used to garden veraciously, does not do much anymore. If she even has half an afternoon of weeding the aftermath is pretty bad. Even if not immediate, the next day she literally has a down day, where she can't do very much but it is hard to tell exactly what that is from. Treatment: Really not able to take any NSAIDS so she would only rely on Tylenol and because she is diabetic, worries about kidneys so she does not take very much Tylenol. She would do more CBD, which is a derivative of hemp, she would rub that on there and it would sometimes be effective. Has tried another natural thing called Arnica. Results of those seem to be hit or miss. She is big on drinking water like when she is sick with anything in any kid of way she drinks as much good water as possible, that seems to help a bit. Being very purposeful about staying hydrated as best she can and just moving best as she can and stretching. Does not take any kind of prescribed medication for it, or anything like that. 4th Dose Pfizer covid vaccine: 09Apr2022 (LOT: FJ4991). 5th dose: Pfizer covid vaccine: 12Aug2022 (LOT: FP7138). Sixth Dose: Does not know what was written but states it says either RAW or DAW then provides GHA703 or maybe OHA703, but thinks they should have been more clear in the writing on her vaccine card and then states she thinks it is a G but she is not sure. She thinks it was also given at the (withheld). Something over to the left written really tiny and thinks it VOORW or maybe it says VOOM or V00M or V00N and then states maybe the R is a V but she does not know. It is horrible writing and then below that says BLBAWA or who knows what is written there. Unable to clarify further as caller states it is all on the same line and the handwriting is horrible and she does not know about this one. There is nothing else written by sixth dose. Seventh Dose: 04Aug2023. She thinks it says Pfizer and then thinks it says (withheld) LOT: AK0928, she thinks that is the lot number. Eighth Dose: Pfizer thinks it says 23-24. Administered on 16Dec2023. LOT: Can't tell since writing is messed up and states the first character is either a H or # and then J7324 or J7224. She cannot tell or confirm what it states for lot number due to handwriting. When clarifying that caller had total of 8 Covid vaccines, she states she is not sure if that is all of them. That is all she has documented, not sure if she had more. Caller confirms she does not have any further details to provide for any other covid vaccine or any other lot numbers. She only has what is on her three vaccine cards as provided above. Did the patient receive any other vaccines on the same date as the Pfizer vaccine? Would be almost impossible to remember but definitely does know it would not have been on the same day Did see recently that Pfizer is suggesting that which is what prompted her call in the first place that it is being suggested to get Covid shot when getting flu shot and she was unable to do that. Is there reason for that? Is that more beneficial to get covid and flu shot together? Caller advised to refer, advised that, they have product specific information to provide. When clarifying that she has not had any other vaccines on same day, or within 4 weeks prior to covid vaccines, caller states, she does not think so. Is her own personal habit that she would not have done vaccines at same time because if she were to have bad reaction, she would not know if it was from one thing or the other. 3. Did the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine? Unknown. Took Covid vaccine afterwards did get Covid, more than once. Believes she only had covid twice, if that second time was in fact Covid, it was very similar. When clarifying that, caller had total of 8 Covid vaccines, she states she is not sure if that is all of them. That is all she has documented, not sure if she had more. Caller confirms she does not have any further details to provide for any other covid vaccine or any further lot numbers. She only has what is on her three vaccine cards as provided above. Patient stated, "I am ma'am. I'm in a high risk category, "I have been now without my shots for almost a year I think It's been over a year actually you know in the very beginning you guys had us come like every 3 to 4 months and then I went out to 6 months and now it's been like I said over a yearI I am seen by a doctor in a local clinic here, and when I got my Flu and Pneumonia shot the other day, he informed me that they don't have any and they won't have any and they cannot provide it for me I'm like at the end of my rope and I feel this growing anxiety because you know the Flu and you know Pneumonia season is upon us everybody's coughing and getting sick and I mean even the tests I had for COVID when the last ones were sent by the (Withheld) service, they were the ones that had expired but they okayed them. You know for the extended time and so I wouldn't even know if I had it I just feel very anxious I just feel like I'm in a desperate situation I'm just as careful as possible but I've had COVID twice Or I think it was twice I know once I definitely had it and second time felt similar and I did not have a test and I just kind of sheltered in place and did all the things for myself I could I'm very anxious about it" After explaining to (Withheld) the enrollment requirements she stated, "I am unemployed I am as I know of in the state of (Withheld) under the poverty level" When asked if had any questions, (Withheld) stated, "I guess not Before when I was vaxed I still wear my mask out because I'm just that careful, because not all, and I wasn't even thinking all that much for me. When asked to confirm that she had COVID before, (Withheld) stated "I got COVID yes, in, I think it was the first or second year of the pandemic and I had had my shots by then. I only think that I had it a second time because it was so similar to the first but it was, it wasn't horribly severe, but it seemed to last for a long time, and I'll be honest I haven't felt like the same since then I feel like a lot of things in my natural life" When asked to confirm that this was all after the vaccine, (Withheld) stated, "Yes but like I said I imagine that when you think about it, what I had was so much less than what it could've been um, so, but even at that you know you feel crappy anyway, but It was like a, maybe like a hard Flu, um, but the worst thing of it was the, was the terrible muscle aches and you know the soreness, the shot spot you know which I can still feel, I still feel a knot under my skin in several spots of my arms spots, but I'm still grateful because you know that's a small price to pay." More
2865019	57	F	VA	10/10/2025	COVID19	PFIZER\BIONTECH	EW0151	Limb mass, Vaccination site mass Limb mass, Vaccination site mass	hard lump that stayed there quite a long time and then the lump traveled a little bit from where fir... hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms; hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID. A 57-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2021 as dose 2, single (Lot number: EW0151) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "she has autoimmune disease" (unspecified if ongoing); "has heart issues" (unspecified if ongoing); "she seasonal has terrible allergies" (unspecified if ongoing), notes: would end up getting exacerbated and go into bronchitis; "bronchitis" (unspecified if ongoing), notes: gets that once a year, almost faithfully, in the fall; "arthritic" (unspecified if ongoing); "Allergic to penicillin" (unspecified if ongoing), notes: Allergic to penicillin and sulfa medications both with anaphylaxis.; "Allergic to sulfa medications" (unspecified if ongoing), notes: Allergic to penicillin and sulfa medications both with anaphylaxis. 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. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; LOT: EP7534; Clarified first shot in left arm), administration date: 13Mar2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "lump", "lump in both arms", "Vaccination site pain". The following information was reported: VACCINATION SITE MASS (non-serious), LIMB MASS (non-serious) all with onset 2021, outcome "not recovered" and all described as "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms". The events "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get covid shots, lump would go back and forth between her two arms" required physician office visit. Therapeutic measures were taken as a result of vaccination site mass, limb mass. 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. Clarified first one in left arm. Happened in right arm as well, was just terrible. Started in arm where she initially had shot was in left arm. Then over time lump seems to have traveled a little bit in the same arm and then again later when she had a shot in her right arm. Now, has multiple lumps, in both arms. Specific date this started, unknown. Was when she got first shot, within a few days after that the lump was still there. Had called pharmacy, wondering if that was normal. Was told by pharmacist that it is a significant lump that the pharmacist would call the lump an injection injury. When she mentioned to her doctor, doctor said did not know what she was talking about. Clarified, she now has multiple lumps. Almost every time she has gotten a shot, she would get a lump and has multiple lumps in both arms. There is not really treatment because, when she asked if she should use hot or cold compress was told no. Said it would work itself out over time and told her to just take Tylenol, or Aspirin. Was afraid to massage too much and did not really rub it but would check to see if still there and if still as big and if it was moving. It did move some, she thinks, from where it was initially. More
2865020	58	F	VA	10/10/2025	COVID19	PFIZER\BIONTECH	FH8020	Limb mass, Vaccination site mass Limb mass, Vaccination site mass	hard lump that stayed there quite a long time and then the lump traveled a little bit from where fir... hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms; hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID. A 58-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "heart issues" (unspecified if ongoing); "she seasonal has terrible allergies" (unspecified if ongoing), notes: would end up getting exacerbated and go into bronchitis; "bronchitis" (unspecified if ongoing), notes: gets that once a year, almost faithfully, in the fall; "arthritic" (unspecified if ongoing); "Allergic to penicillin" (unspecified if ongoing), notes: Allergic to penicillin and sulfa medications both with anaphylaxis.; "sulfa" (unspecified if ongoing), notes: Allergic to penicillin and sulfa medications both with anaphylaxis. 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. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; LOT: EP7534; Clarified first shot in left arm), administration date: 13Mar2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "lump", "lump in both arms", "Vaccination site pain"; BNT162b2 (Dose 2, Single; LOT: EW0151; right arm), administration date: 03Apr2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms", "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms". The following information was reported: VACCINATION SITE MASS (non-serious), LIMB MASS (non-serious) all with onset 2021, outcome "not recovered" and all described as "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms". The events "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get covid shots, lump would go back and forth between her two arms" required physician office visit. Therapeutic measures were taken as a result of vaccination site mass, limb mass. 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. Clarified first one in left arm. Happened in right arm as well, was just terrible. Started in arm where she initially had shot was in left arm. Then over time lump seems to have traveled a little bit in the same arm and then again later when she had a shot in her right arm. Now, has multiple lumps, in both arms. Specific date this started, unknown. Was when she got first shot, within a few days after that the lump was still there. Had called pharmacy, wondering if that was normal. Was told by pharmacist that it is a significant lump that the pharmacist would call the lump an injection injury. When she mentioned to her doctor, doctor said did not know what she was talking about. Clarified, she now has multiple lumps. Almost every time she has gotten a shot, she would get a lump and has multiple lumps in both arms. There is not really treatment because, when she asked if she should use hot or cold compress was told no. Said it would work itself out over time and told her to just take Tylenol, or Aspirin. Was afraid to massage too much and did not really rub it but would check to see if still there and if still as big and if it was moving. It did move some, she thinks, from where it was initially.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500199016 same patient/events, different dose; More
2865021	58	F	VA	10/10/2025	COVID19	PFIZER\BIONTECH	FJ4991	Blood glucose, Glycosylated haemoglobin, Limb mass, Vaccination site mass Blood glucose, Glycosylated haemoglobin, Limb mass, Vaccination site mass	Each time she would get Covid shots, lump would go back and forth/every time she got a shot she woul... Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms; Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID. A 58-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic/she has diabetes" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing), notes: Takes as precaution because she has autoimmune disease; "heart issues" (unspecified if ongoing); "she seasonal has terrible allergies/allergies" (unspecified if ongoing); "bronchitis" (unspecified if ongoing), notes: would end up getting exacerbated and go into bronchitis and gets that once a year, almost faithfully, in the fall; "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "Allergic to penicillin" (unspecified if ongoing), notes: with anaphylaxis; "Allergies: sulfa medications" (unspecified if ongoing), notes: with anaphylaxis; "afterwards did get Covid, more than once" (unspecified if ongoing), notes: first or second year of the pandemic in 2021 or 2022; "arthritic/arthritis" (unspecified if ongoing). 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 gastrointestinal disorder. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; LOT: EP7534, in left arm), administration date: 13Mar2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "lump traveled a little bit from where the first shot", "very first shot was very painful", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms"; BNT162b2 (DOSE 2, SINGLE; LOT: EW0151, in right arm), administration date: 03Apr2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "lump an injection injury", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; LOT: FH8020), administration date: 14Oct2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "lump an injection injury", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms". The following information was reported: VACCINATION SITE MASS (non-serious), LIMB MASS (non-serious) all with onset 2022, outcome "not recovered" and all described as "Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms". 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 the first shot was. Within a few days after that the lump was still there. Had called pharmacy, wondering if that was normal. Was told by pharmacist that it is a significant lump that the pharmacist would call the lump an injection injury. Each time she would get Covid shots, lump would go back and forth between her two arms. Then over time lump seems to have traveled a little bit in the same arm and then again later when she had a shot in her right arm. Almost every time she got a shot she would get a lump and has multiple lumps in both arms. There is no real treatment because, when she asked if she should use hot or cold compress was told no. Said it would work itself out over time and told her to just take Tylenol, or Aspirin. Was afraid to massage too much and did not really rub it but would check to see if still there and if still as big and if it was moving. It did move some, she thinks, from where it was initially. More
2865022	59	F	VA	10/10/2025	COVID19 COVID19	PFIZER\BIONTECH PFIZER\BIONTECH	FP7138 FP7138	Asthenia, Blood glucose, Discomfort, Glycosylated haemoglobin, Headache; Malaise... Asthenia, Blood glucose, Discomfort, Glycosylated haemoglobin, Headache; Malaise, Myalgia, Vaccination site mass, Vaccination site pain More	Muscle aches; headaches; it just took down her overall energy and stamina; if there is a terrible hu... Muscle aches; headaches; it just took down her overall energy and stamina; if there is a terrible humid day she can be in so much discomfort; it just took down her overall energy and stamina; where she got shots can be very tender; Almost every time she got a shot she would get a lump; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID. A 59-year-old female patient received BNT162b2 (BNT162B2), on 12Aug2022 as dose 5 (booster), single (Lot number: FP7138) at the age of 59 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "muscle aches" (ongoing), notes: she had the muscle aches and headaches both times having Covid; "headaches" (ongoing), notes: she had the muscle aches and headaches both times having Covid; "did get Covid" (unspecified if ongoing), notes: first or second year of the pandemic in 2021 or 2022; "autoimmune disease" (unspecified if ongoing); "heart issues" (unspecified if ongoing); "seasonal has terrible allergies" (unspecified if ongoing); "bronchitis" (unspecified if ongoing), notes: end up getting exacerbated and go into bronchitis; "arthritic" (unspecified if ongoing); "Has high blood pressure" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "Allergic to penicillin" (unspecified if ongoing), notes: with anaphylaxis; "sulfa" (unspecified if ongoing), notes: with anaphylaxis; "High cholesterol" (unspecified if ongoing). 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 gastrointestinal disorder; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity. Vaccination history included: BNT162b2 (Dose 1, single; LOT: EP7534, in left arm), administration date: 13Mar2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "lump an injection injury", "very first shot was very painful", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms"; BNT162b2 (Dose 2, single; LOT: EW0151, in right arm), administration date: 03Apr2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "lump an injection injury", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms"; BNT162b2 (DOSE 3 (BOOSTER); lot: FH8020), administration date: 14Oct2021, when the patient was 58-year-old, for COVID-19 Immunization, reaction(s): "lump an injection injury", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms"; BNT162b2 (DOSE 4; lot: FJ4991), administration date: 09Apr2022, when the patient was 58-year-old, for COVID-19 Immunizatio, reaction(s): "lump an injection injury", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms". The following information was reported: VACCINATION SITE MASS (non-serious) with onset 2022, outcome "not recovered", described as "Almost every time she got a shot she would get a lump"; MYALGIA (non-serious), outcome "not recovered", described as "Muscle aches"; HEADACHE (non-serious), outcome "not recovered", described as "headaches"; ASTHENIA (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "it just took down her overall energy and stamina"; DISCOMFORT (non-serious), outcome "unknown", described as "if there is a terrible humid day she can be in so much discomfort"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "where she got shots can be very tender". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, headache, vaccination site pain. 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 the first shot was. Within a few days after that the lump was still there. Had called pharmacy, wondering if that was normal. Was told by pharmacist that it is a significant lump that the pharmacist would call the lump an injection injury. Each time she would get Covid shots, lump would go back and forth between her two arms. Then over time lump seems to have traveled a little bit in the same arm and then again later when she had a shot in her right arm. Almost every time she got a shot she would get a lump and has multiple lumps in both arms. There is no real treatment because, when she asked if she should use hot or cold compress was told no. Said it would work itself out over time and told her to just take Tylenol, or Aspirin. Was afraid to massage too much and did not really rub it but would check to see if still there and if still as big and if it was moving. It did move some, she thinks, from where it was initially. With regards to muscle aches and headaches, the patient very specifically knows some of that muscle ache and pain was vaccine related because of how it came on, how it lingered. In general, it just took down her overall energy and stamina. Has not really gotten any better, thinks she just learned to just work through it. In general the muscle aches, are just so natural to her now and she can't really differentiate. She certainly has good days when she feels good. Also has to do with the weather, which may make no sense but if there is terrible humidity, if there is a terrible humid day she can be in so much discomfort. And specifically, where she got shots can be very tender. Rubbing arm right now, feels lumps still sore but not horrible. Is not anything that would keep her from doing what she needs to do, just makes it maybe a little less comfortable. Used to garden veraciously, does not do much anymore. If she even has half an afternoon of weeding the aftermath is pretty bad. Even if not immediate, the next day she literally has a down day, where she can't do very much but it is hard to tell exactly what that is from. Treatment: Really not able to take any NSAIDS so she would only rely on Tylenol and because she is diabetic, worries about kidneys so she does not take very much Tylenol. She would do more CBD, which is a derivative of hemp, she would rub that on there and it would sometimes be effective. Has tried another natural thing called Arnica. Results of those seem to be hit or miss. She is big on drinking water like when she is sick with anything in any kind of way she drinks as much good water as possible, that seems to help a bit. Being very purposeful about staying hydrated as best she can and just moving best as she can and stretching. Does not take any kind of prescribed medication for it, or anything like that. More
2865023	60	F	VA	10/10/2025	COVID19	PFIZER\BIONTECH	AK0928	Limb mass, Vaccination site mass, Weight Limb mass, Vaccination site mass, Weight	gotten a shot she would get a lump and has multiple lumps in both arms/over time lump seems to have ... gotten a shot she would get a lump and has multiple lumps in both arms/over time lump seems to have traveled; same arm and then again later; a shot in her right arm; has multiple lumps, in both arms; gotten a shot she would get a lump and has multiple lumps in both arms/over time lump seems to have traveled; same arm and then again later; a shot in her right arm; has multiple lumps, in both arms; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID. A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Aug2023 as dose 7 (booster), single (Lot number: AK0928) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: 1st time in 2021 or 2022 after a couple Covid vaccines, Covid again, probably about a year later; "headaches" (ongoing), notes: both times having Covid; "muscle aches" (ongoing), notes: both times having Covid; "allergic to penicillin" (unspecified if ongoing), notes: anaphylaxis; "allergic to sulfa medications" (unspecified if ongoing), notes: anaphylaxis; "heart disease" (unspecified if ongoing); "arthritis" (unspecified if ongoing), notes: heart issues; "terrible seasonal allergies" (unspecified if ongoing), notes: would end up getting exacerbated and go into bronchitis; "bronchitis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High blood cholesterol" (unspecified if ongoing); "water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing), notes: son suffers from autoimmune disease; "long covid" (unspecified if ongoing), notes: felt like it took forever to get over it. Covid that did sort of linger. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; SIMVASTATIN taken for hypercholesterolaemia; CETIRIZINE HCL taken for hypersensitivity; FUROSEMIDE taken for fluid retention; OMEPRAZOLE/SODIUM BICARBONATE taken for abdominal discomfort. Vaccination history included: BNT162b2 (dose 1, batch/lot number EP7534, left arm which was done at a school), administration date: 13Mar2021, when the patient was 57-year-old, for Covid-19 Immunization, reaction(s): "lump"; BNT162b2 (dose 2, batch/lot number EW0151, shot in right arm), administration date: 03Apr2021, when the patient was 57-year-old, for Covid-19 Immunization, reaction(s): "lump"; BNT162b2 (dose 3, batch/lot number FH8020, administered in arm), administration date: 14Oct2021, when the patient was 58-year-old, for Covid-19 Immunization, reaction(s): "lump"; BNT162b2 (dose 4, batch/lot number FJ4991, administered in arm), administration date: 09Apr2022, when the patient was 58-year-old, for Covid-19 Immunization, reaction(s): "lump"; BNT162b2 (dose 5, batch/lot number FP7138, administered in arm), administration date: 12Aug2022, when the patient was 59-year-old, for Covid-19 Immunization, reaction(s): "lump"; Bnt162b2 (dose 6, batch/lot number GHA703 or maybe OHA703 (not sure), administered in arm), for Covid-19 Immunization, reaction(s): "lump". The following information was reported: VACCINATION SITE MASS (non-serious), LIMB MASS (non-serious), outcome "not recovered" and all described as "gotten a shot she would get a lump and has multiple lumps in both arms/over time lump seems to have traveled; same arm and then again later; a shot in her right arm; has multiple lumps, in both arms". The events "gotten a shot she would get a lump and has multiple lumps in both arms/over time lump seems to have traveled; same arm and then again later; a shot in her right arm; has multiple lumps, in both arms" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site mass, limb mass. Additional information: The patient had total of 8 Covid vaccines, she was not sure if that was all of them. That was all she has documented, not sure if she had more. The patient informed that the facility where vaccine was administered was in pharmacies. The patient did receive any other vaccines but definitely it would not have been on the same day. She has not had any other vaccines on same day, or within 4 weeks prior to covid vaccines, her own personal habit that she would not have done vaccines at same time because if she were to have bad reaction, she would not know if it was from one thing or the other. The patient informed that 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. The patient clarified that she experienced in lumps in both arms, had shots in both arms. The first one in left arm and happened in right arm as well, was just terrible. She certainly has good days where she felt good. Also has to do with the weather which may make no sense but if there was terrible humidity day she can be in so much discomfort and specifically where she got shots can be very tender. The patient was rubbing arm right now, felt lumps still sore but not horrible. It was not anything that would keep her from doing what she needed to do, just made it maybe a little less comfortable. The patient informed that the lump started in arm where she initially had shot was in left arm. Then over time lump seems to have traveled a little bit in the same arm and then again later when she had a shot in her right arm. Now, has multiple lumps, in both arms. She had called pharmacy, wondering if that was normal. She was told by pharmacist that it was a significant lump that the pharmacist would call the lump an injection injury. When she mentioned to her doctor, doctor said did not know what she was talking about. She clarified, she now has multiple lumps. Almost every time she has gotten a shot she would get a lump and has multiple lumps in both arms. The adverse event did not require a visit to the Emergency Room. The patient informed that there was not really treatment because, when she asked if she should use hot or cold compress was told no. Said it would work itself out over time and told her to just take Tylenol, or Aspirin. She was afraid to massage too much and did not really rub it but would check to see if still there and if still as big and if it was moving. It did move some, she thinks, from where it was initially. She informed that treatment was really not able to take any NSAIDS so she would only rely on Tylenol and because she was diabetic, worried about kidneys so she did not take very much Tylenol. She would do more CBD, which was a derivative of hemp, she would rub that on there and it would sometimes be effective. She has tried another natural thing called Arnica. The results of those seem to be hit or miss. She was big on drinking water like when she was sick with anything in any kind of way she drinks as much good water as possible, that seems to help a bit. Being very purposeful about staying hydrated as best she can and just moving best as she can and stretching. She did not take any kind of prescribed medication for it, or anything like that.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500198984 same patient/events, different dose;US-PFIZER INC-202500196438 same patient/events, different dose;US-PFIZER INC-202500196502 same patient/product, different dose/events;US-PFIZER INC-202500197706 same patient/product, different dose/events;US-PFIZER INC-202500199013 same patient/events, different dose;US-PFIZER INC-202500199014 same patient/events, different dose;US-PFIZER INC-202500199015 same patient/events, different dose;US-PFIZER INC-202500199012 same patient/events, different dose; More
2865024	56	F	NC	10/10/2025	PNC20 PNC20	PFIZER\WYETH PFIZER\WYETH		Arthralgia, Breast swelling, Erythema, Joint swelling, Palpitations; Peripheral ... Arthralgia, Breast swelling, Erythema, Joint swelling, Palpitations; Peripheral swelling, Pyrexia, Skin discolouration More	Severe swelling in the arm; swelling from the shoulder down through the right side into the right br... Severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip; Severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip; Severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip; Arm started turning red; discoloration in the arm; White spots; Fever; Heart palpitations; Increased amount of joint pain; This is a spontaneous report received from a consumer. A 56-year-old female patient received Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), in Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "Arm started turning red; discoloration in the arm"; PYREXIA (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "Fever"; PALPITATIONS (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "Heart palpitations"; ARTHRALGIA (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "Increased amount of joint pain"; EXTENSIVE SWELLING OF VACCINATED LIMB (medically significant), JOINT SWELLING (medically significant), BREAST SWELLING (medically significant) all with onset Jun2025, outcome "recovered" (2025) and all described as "Severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip"; SKIN DEPIGMENTATION (non-serious) with onset Jun2025, outcome "recovered" (2025), described as "White spots". The events "severe swelling in the arm; swelling from the shoulder down through the right side into the right breast down to the right hip", "arm started turning red; discoloration in the arm", "white spots", "fever", "heart palpitations" and "increased amount of joint pain" required physician office visit. Therapeutic measures were taken as a result of extensive swelling of vaccinated limb, joint swelling, breast swelling, erythema, skin depigmentation, pyrexia, palpitations, arthralgia. The patient had an adverse reaction to Prevnar 20. The patient was vaccinated in Jun2025 in the right shoulder and that night (of the same day) began to experience severe swelling, discoloration in the arm. The arm started turning red, these white spots, fever and also experienced heart palpitations and the swelling went from the shoulder down through the right side into the right breast down to the right hip, and increased amount of joint pain. All of this, the patient was not hospitalized, the patient was treated at home outpatient service, but these symptoms persisted for approximately roughly three months. The patient was not hospitalized. The patient had multiple doctor visits with her doctor, now she did not know what kind of treatment the doctor gave or prescribed to the patient. The information on the batch/lot number for Pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) will be requested and submitted if and when received. More
2865025		F	NV	10/10/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	I took all of your vaccinations and 2 boosters; Patient has received Pfizer Vaccines and now she is ... I took all of your vaccinations and 2 boosters; Patient has received Pfizer Vaccines and now she is prescribed Paxlovid to treat Covid 19; I took all of your vaccinations and 2 boosters; Patient has received Pfizer Vaccines and now she is prescribed Paxlovid to treat Covid 19; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "I took all of your vaccinations and 2 boosters; Patient has received Pfizer Vaccines and now she is prescribed Paxlovid to treat Covid 19". Clinical course: Patient took all of your vaccinations and 2 boosters. Doctor prescribed Paxlovid. The reporter asked whether the drug can still be effective after 6 or 7 days since symptoms onset. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2865026	49	F	PA	10/10/2025	COVID19	PFIZER\BIONTECH		COVID-19, Drug ineffective COVID-19, Drug ineffective	AECOPD 2/2 COVID infection; AECOPD 2/2 COVID infection; This is a spontaneous report received from a... AECOPD 2/2 COVID infection; AECOPD 2/2 COVID infection; This is a spontaneous report received from a Lawyer and a Physician from legal division. A 49-year-old female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown), on 13Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma-COPD overlap", start date: 12Nov2018 (unspecified if ongoing); "Back pain", start date: 30Jul2014 (unspecified if ongoing); "Hilar lymphadenopathy", start date: 30Jul2014 (unspecified if ongoing); "Lymphadenopathy", start date: 30Jul2014 (unspecified if ongoing); "Major depression", start date: 10Sep2016 (unspecified if ongoing); "Mixed anxiety depressive disorder", start date: 10Sep2016 (unspecified if ongoing); "Pelvic inflammatory disease", start date: 27Aug2011 (unspecified if ongoing); "post-traumatic stress disorder", start date: 08Jan2021 (unspecified if ongoing); "Seasonal allergic rhinitis", start date: 21Sep2019 (unspecified if ongoing); "Sinus Problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "AECOPD 2/2 COVID infection". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More	✓
2865027		F	ME	10/10/2025	COVID19	PFIZER\BIONTECH		Malaise Malaise	With previous doses would feel crummy for a day or two, as people do after any immunization; This is... With previous doses would feel crummy for a day or two, as people do after any immunization; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 2, 0.3 ml single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; in left arm), for COVID-19 Immunization, reaction(s): "previous doses would feel crummy". The following information was reported: MALAISE (non-serious), outcome "recovered", described as "With previous doses would feel crummy for a day or two, as people do after any immunization". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2865028		F	IA	10/10/2025	COVID19	PFIZER\BIONTECH		Vaccination site swelling, Vaccination site warmth Vaccination site swelling, Vaccination site warmth	Within 24 hours of receiving the vaccine, I have a 2-3" diameter red warm welt; bump on my arm ... Within 24 hours of receiving the vaccine, I have a 2-3" diameter red warm welt; bump on my arm at the site of injection; This is a spontaneous report received from a Consumer or other non HCP. A 62-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Oct2025 at 10:00 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Nov2004; ROSUVASTATIN, start date: Feb2022; FLUARIX taken for immunisation, start date: 29Sep2025, stop date: 29Sep2025. Past drug history included: Penicillin, reaction(s): "Penicillin allergy"; Levaquin, reaction(s): "Allergy". The following information was reported: VACCINATION SITE WARMTH (non-serious) with onset 08Oct2025, outcome "not recovered", described as "Within 24 hours of receiving the vaccine, I have a 2-3" diameter red warm welt"; VACCINATION SITE SWELLING (non-serious) with onset 08Oct2025, outcome "not recovered", described as "bump on my arm at the site of injection". Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site swelling. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Additional information: Within 24 hours of receiving the vaccine, I have a 2-3" diameter red warm welt/bump on my arm at the site of injection. More

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