🏥 VAERS Vaccine Data Browser

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

Data Source & Accuracy

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

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Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death

🏥 Hospitalized

🚑 Emergency Room

♿ Disability

⚠️ Life Threatening

How to Search

💡 Search Tips:

Select Year: Choose a specific year OR "All Years" to search across all data
All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
VAERS ID: Search for specific report by ID number
Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
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Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
Lot Number: Search specific vaccine lot (works great with "All Years")
Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

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

Using the Table

Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
Expand text: Click "More" to see full narrative or symptom text
Navigate pages: Use pagination controls at top and bottom of table
Export results: Click "📥 Export CSV" to download filtered data (max 10,000 records)

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

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

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

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Showing 10,201 to 10,250 of 34,052 reports (Page 205 of 682)

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ID	Age	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative	💀	🏥	♿
2857369	64	F	NJ	09/08/2025	FLU3 FLU3 FLU3 FLU3 FLU3 FLU3	SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR	U8897CA U8897CA U8897CA	Pruritus, Throat tightness, Urticaria; Chills, Dysphonia, Nausea, Pyrexia, Urtic... Pruritus, Throat tightness, Urticaria; Chills, Dysphonia, Nausea, Pyrexia, Urticaria; Wheezing; Pruritus, Throat tightness, Urticaria; Chills, Dysphonia, Nausea, Pyrexia, Urticaria; Wheezing More	4:30 pm-hives and throat closing. Took Benadryl and Pepcid, used rescue inhaler twice. Itching laste... 4:30 pm-hives and throat closing. Took Benadryl and Pepcid, used rescue inhaler twice. Itching lasted for 1 1/2 hours. Throat better after second use of inhaler. Hives remain. More
2857370	56	F	CA	09/08/2025	PNC21	MERCK & CO. INC.	Y019157	Injection site reaction, Urticaria Injection site reaction, Urticaria	Left upper arm red urticarial patches at site of injection 1 day after injection of PCV21 Left upper arm red urticarial patches at site of injection 1 day after injection of PCV21
2857371	1	M	CA	09/08/2025	FLU3 HEPA MMRV VARCEL	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC.	7f299 3255P z008867 z004246	Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More	None to report at this time None to report at this time
2857385			FL	09/08/2025	VARCEL	MERCK & CO. INC.	Z005232	No adverse event, Product storage error No adverse event, Product storage error	no AE; temperature excursion. VARIVAX was given to one patient on 08/13/2025; This spontaneous repor... no AE; temperature excursion. VARIVAX was given to one patient on 08/13/2025; This spontaneous report was received from a Pharmacist and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 13-Aug-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Solution for injection (lot #Z005232, expiration date: 27-Feb-2027) 0.5 mL, for an unknown indication. It was reconstituted with sterile diluent (BAXTER STERILE DILUENT), Solution for injection (indication, expiration date, and lot # were not reported). The vaccine underwent a temperature excursion of 8.6 F for 6 hours. There was no previous temperature excursion. No symptoms were reported. More
2857386	4	M	CA	09/08/2025	MMRV	MERCK & CO. INC.	Z008866	No adverse event, Product storage error No adverse event, Product storage error	a dose of PROQUAD was administered to a patient after it was not stored immediately and sat in the s... a dose of PROQUAD was administered to a patient after it was not stored immediately and sat in the sealed shipping container; No adverse effects were noted.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Z008866, expiration date reported as 10-Nov-2026) 0.5 mL (route of administration and anatomical location of vaccine were not reported), the vaccine was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (lot #, expiration date and dose were not reported) administered for prophylaxis. This dose of was administered to the patient after it was not stored immediately and sat in the sealed shipping container (Product storage error). The nurse used the room temperature as the maximum temperature for a worst case scenario temperature excursion evaluation; the registered temperature was 75 Fahrenheit for 6 hours. No adverse effects were noted. No additional information was provided to further clarify the details. Follow-up information was received from the nurse on 03-Sep-2025. This report referred to a 4-year-old male patient. More
2857387	17	M	MD	09/08/2025	HPV9 HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC.		Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More	No side effects or symptoms reported; Physician called to report a set of twins got the GARDASIL 9 v... No side effects or symptoms reported; Physician called to report a set of twins got the GARDASIL 9 vaccine and didn't follow the recommended schedule, Male patient had initial dose 6/27/2024, second dose 1/8/2025 (7 months later) and third dose 3/12/2025 (2 months later).; This spontaneous report was received from a physician and referred to a male patient of unknown age. The patient's medical history, concurrent condition, and concomitant therapy were not reported. On 27-Jun-2024 (when the patient was 17 years old), the patient vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, does, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 08-Jan-2025, the patient vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, does, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 12-Mar-2025, the patient vaccinated with the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, does, frequency, route, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No side effects or symptoms reported. Lot# is being requested and will be submitted if received. This is one of two cases from the same reporter. More
2857388	17	F	MD	09/08/2025	HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC.		Inappropriate schedule of product administration, No adverse event; Inappropriat... Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event More	Physician called to report a set of twins got the GARDASIL 9 vaccine and didn't follow the reco... Physician called to report a set of twins got the GARDASIL 9 vaccine and didn't follow the recommended schedule, Female patient had first dose 6/27/2024, 1/8/2025, but never received the third dose.; No side effects or symptoms reported; This spontaneous report was received from a physician and referred to a female patient of unknown age. The patient's medical history, concurrent condition, and concomitant therapy were not reported. On 27-Jun-2024 (when the patient was 17 years old), the patient vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, does, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 08-Jan-2025, the patient vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, does, frequency, route, lot # and expiration date were not reported) for prophylaxis. The patient never received the third dose (Inappropriate schedule of vaccine administered). No side effects or symptoms reported. Lot# is being requested and will be submitted if received. This is one of two cases from the same reporter. More
2857389	9	F	CO	09/08/2025	HPV9	MERCK & CO. INC.		Human papilloma virus test positive Human papilloma virus test positive	tested positive for HPV; This spontaneous report was received from a non-health professional and ref... tested positive for HPV; This spontaneous report was received from a non-health professional and refers to a 42-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 03-Aug-1991 (date before suspect's registration; conflicting information), the patient received a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), Injection (lot # and expiration date were not reported) as HPV Vaccination. In approximately 2025 (reported as currently), the patient tested positive for HPV. No other symptomatic adverse events were reported. At the reporting time, the outcome of tested positive for HPV was unknown. The causal relationship between the event of tested positive for HPV and Human Papillomavirus 9-valent Vaccine, Recombinant was unknown/not reported/not provided. More
2857390	25		NY	09/08/2025	VARCEL	MERCK & CO. INC.	Z008196	No adverse event, Product storage error No adverse event, Product storage error	No additional AE; HCP called to report a TE for VARIVAX; This spontaneous report was received from a... No additional AE; HCP called to report a TE for VARIVAX; This spontaneous report was received from a Nurse and refers to a 25-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-AUG-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, 0.5 mL, administered as prophylaxis (lot number Z008196 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date 30-APR-2027; route of administration, dose number and anatomical site of injection were not reported), which was reconstituted with sterile diluent (Hollister-Stier STERILE DILUENT) (expiration date and lot number were not reported). The vaccine was administered after a temperature excursion (TE) at -11.8 degree C for 45 minutes, with no previous TE (Product storage error). No additional adverse event was reported for the patient. This is one of several reports from the same reporter. More
2857391	26		NY	09/08/2025	VARCEL	MERCK & CO. INC.	Z008196	No adverse event, Product storage error No adverse event, Product storage error	No additional AE; HCP called to report a TE for VARIVAX; This spontaneous report has been received f... No additional AE; HCP called to report a TE for VARIVAX; This spontaneous report has been received from a nurse, regarding to a 26-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 21-AUG-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at a dose of 0.5 milliliter (ml), lot number Z008196 which had been verified to be a valid number; expiration date reported and upon internal validation established as 30-APR-2027 with sterile diluent (anatomical site of injection was not provided). Administered doses were stored at a temperature of -11.8 degrees Celsius (C) during a time frame of 45 minutes. There was no previous temperature excursion. No additional adverse events were reported in the patient. More
2857392				09/08/2025	HPV9	MERCK & CO. INC.	Y011043	Cellulitis Cellulitis	after receiving two doses of Gardasil 9 (Merck/MSD). On both occasions, I developed cellulitis of th... after receiving two doses of Gardasil 9 (Merck/MSD). On both occasions, I developed cellulitis of the finger following the injection; This spontaneous report has been received from a consumer, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) as prophylaxis, lot number Y011043 which had been verified to be a valid number; expiration date reported and upon internal validation established as 05-FEB-2027 (dose, vaccination scheme, route of administration, and anatomical site of injection were not reported). On an unknown date, the patient developed Cellulitis of the finger. At the time of the report the outcome of the event was not provided. The causal relationship between the event and the suspect vaccine was not provided. More
2857393		F	DC	09/08/2025	HPV4	MERCK & CO. INC.		Miller Fisher syndrome Miller Fisher syndrome	Miller Fisher variants of Guillain-Barre Syndrome (GBS); Information was received from a lawyer, via... Miller Fisher variants of Guillain-Barre Syndrome (GBS); Information was received from a lawyer, via social media regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-FEB-2007, the patient received the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) suspension for injection as Prophylaxis (dose, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On an unknown day in April 2007, the patient experienced Miller Fisher variants of Guillain-Barre Syndrome (GBS). Moreover, the patient was entitled to compensation. At the reporting time, the outcome of Guillain-Barre Syndrome was not reported. The reporter considered Guillain-Barre Syndrome as a result of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (related). Upon internal review, Guillain-Barre Syndrome was determined to be medically significant. More
2857394			TX	09/08/2025	RV5	MERCK & CO. INC.	Y018378	No adverse event, Product storage error No adverse event, Product storage error	HCP called to report a TE for ROTATEQ; No additional AE; This spontaneous report was received from a... HCP called to report a TE for ROTATEQ; No additional AE; This spontaneous report was received from a other health care professional referring to a patient, age and gender not reported. Information regarding the patient's pertinent medical history, drug allergies/reactions, or concomitant medications was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral pentavalent (ROTATEQ), for prophylaxis (dose, vaccination scheme frequency, anatomical location was not reported, lot number Y018378, which was verified to be valid, expiration date on 10-MAY-2026). It was not reported if the information was recorded by a data logger or not. There was no adverse effect reported. More
2857395		F	CA	09/08/2025	HEP	DYNAVAX TECHNOLOGIES CORPORATION		Injection site pain Injection site pain	Given HEPLISAV-B In Their Vein; Pain At The Injection Site; Soreness At The Injection Site; Initial ... Given HEPLISAV-B In Their Vein; Pain At The Injection Site; Soreness At The Injection Site; Initial report received on 25-Aug-2025. A pharmacist reported that a 21-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in her vein and experienced soreness and pain at the injection site. No medical history or concomitant medications were reported. On 18-Jul-2025, the patient received dose 1 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, and NDC number not available) intravenously in the left deltoid. The patient reported that she received HEPLISAV-B in her vein instead of her deltoid at her pharmacy. Documentation of the immunization showed that the patient received HEPLISAV-B in the left deltoid. The administering technician confirmed the patient received the product in her left deltoid and not a vein. On an unknown date, the patient received dose 2 of a hepatitis B vaccine HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available. On an unknown date, after receiving HEPLISAV-B, the patient experienced soreness and pain at the injection site. No additional information was reported Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious. More
2857396		M		09/08/2025	RVX	UNKNOWN MANUFACTURER	UNK	Death Death	that poison killed my father-in-law; This serious case was reported by a consumer via interactive d... that poison killed my father-in-law; This serious case was reported by a consumer via interactive digital media and described the occurrence of death in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced death (Verbatim: that poison killed my father-in-law) (serious criteria death and GSK medically significant). The reported cause of death was death. The reporter considered the death to be related to RSV vaccine. The company considered the death to be unrelated to RSV vaccine. Additional Information: GSK receipt date: 04-SEP-2025 This case was reported by a patient's relative via interactive digital media. The reporter indicated that, this poison killed reporter's father-in-law, and the brother-in-law so reporter stated that do not tell them that it was safe and effective because it was not, also indicated that it was designed to take lives not save lives. This case is linked with US2025AMR114235 reported by same reporter.; Sender's Comments: A case of Death, unknown time after receiving unknown dose of RSV vaccine in a male subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR114235:Case for Brother-in-law/Same reporter; Reported Cause(s) of Death: Death More	✓
2857397		F		09/08/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Fatigue, Malaise, Pain in extremity Fatigue, Malaise, Pain in extremity	arm soreness; general fatigue; not feeling well; This non-serious case was reported by a consumer vi... arm soreness; general fatigue; not feeling well; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a 50-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 pain in arm (Verbatim: arm soreness), fatigability generalized (Verbatim: general fatigue) and feeling unwell (Verbatim: not feeling well). The outcome of the pain in arm, fatigability generalized and feeling unwell were not reported. It was unknown if the reporter considered the pain in arm, fatigability generalized and feeling unwell to be related to Shingrix. It was unknown if the company considered the pain in arm, fatigability generalized and feeling unwell to be related to Shingrix. Additional Information: GSK receipt date: 11-AUG-2025 A female patient has had dose 1 of Shingrix. She reported not feeling well for the evening after the shot. She had arm soreness and general fatigue.; Sender's Comments: US-GSK-US2025AMR105842:Same reporter/ Case for reporter husband More
2857398		F		09/08/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Swelling face Swelling face	swelling on face; This non-serious case was reported by a consumer via call center representative an... swelling on face; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 66-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 facial swelling (Verbatim: swelling on face). The outcome of the facial swelling was resolved. It was unknown if the reporter considered the facial swelling to be related to Shingrix. It was unknown if the company considered the facial swelling to be related to Shingrix. Linked case(s) involving the same patient: US2025104007; Sender's Comments: US-GSK-US2025104007:same patient More
2857399				09/08/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Product administered at inappropriate site Product administered at inappropriate site	received the first dose of the vaccine shingrix in my gluteus; This non-serious case was reported by... received the first dose of the vaccine shingrix in my gluteus; This non-serious case was reported by a consumer via call center representative and described the occurrence of vaccine administered at inappropriate site in a 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 vaccine administered at inappropriate site (Verbatim: received the first dose of the vaccine shingrix in my gluteus). The outcome of the vaccine administered at inappropriate site was not applicable. Additional Information: GSK Receipt Date: 27-AUG-2025 The patient received the first dose of the vaccine Shingrix in gluteus which led to vaccine administered at inappropriate site. More
2857400				09/08/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Malaise Malaise	The first shot made me so sick; This non-serious case was reported by a consumer via interactive dig... The first shot made me so sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 sickness (Verbatim: The first shot made me so sick). The outcome of the sickness was unknown. The reporter considered the sickness to be related to Shingrix. The company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 29-AUG-2025 This case was reported by a patient via interactive digital media. Reporter stated that the first shot made him/her sick. More
2857401				09/08/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Fatigue Fatigue	slight reaction (fatigue) to Shingrix vaccine; This non-serious case was reported by a consumer and ... slight reaction (fatigue) to Shingrix vaccine; This non-serious case was reported by a consumer and described the occurrence of fatigue in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Covid-19 vaccine. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: slight reaction (fatigue) to Shingrix vaccine). The outcome of the fatigue was resolved (duration 2 days). It was unknown if the reporter considered the fatigue to be related to Shingrix. It was unknown if the company considered the fatigue to be related to Shingrix. Additional Information: GSK Receipt Date: 25-AUG-2025 The reporter reported that he/she had lots of allergies and had reactions to the covid shots and a slight reaction (fatigue) to Shingrix vaccine. But in very case they only lasted 2 days at most. And with all of them the patient would do it over again without any hesitation. The actual diseases were far, far worse and their effects last much longer. More
2857402	24	F	KY	09/08/2025	DTAP	GLAXOSMITHKLINE BIOLOGICALS	47Y5M	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	Wrong age; This non-serious case was reported by a other health professional via call center represe... Wrong age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 24-year-old female patient who received DTPa (Infanrix) (batch number 47Y5M, expiry date 26-JUN-2026) for prophylaxis. On 19-AUG-2025, the patient received Infanrix. On 19-AUG-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-AUG-2025 Practice manager explained that a 22 year old patient received Infanrix instead of Tetanus, Diphtheria Toxoid and Acellular Pertussis vaccine on 19 Aug 2025 which led to Inappropriate age at vaccine administration. Agent asked caller if patient received any prior Diphtheria, Tetanus or Acellular Pertussis vaccines in the past. More
2857403	4	F	CO	09/08/2025	DTAPHEPBIP	GLAXOSMITHKLINE BIOLOGICALS	A32BB	Expired product administered Expired product administered	Pediarix expired dose administration; This non-serious case was reported by a other health professio... Pediarix expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number A32BB, expiry date 10-AUG-2025) for prophylaxis. On 20-AUG-2025, the patient received Pediarix. On 20-AUG-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix expired dose administration). The outcome of the expired vaccine used 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: 20-AUG-2025 A health care provider wanted to know how to proceed after administering an expired (dose less than 30 days) of Pediarix to a patient. More
2857404			OH	09/08/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Incomplete course of vaccination Incomplete course of vaccination	Do they need to revaccinate/restart the vaccination schedule; This non-serious case was reported by ... Do they need to revaccinate/restart the vaccination schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose August twenty twenty-three and August twenty twenty-four). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Do they need to revaccinate/restart the vaccination schedule). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 25-AUG-2025 The pharmacist reported that the patient were administered with a first dose of Shingrix vaccine between August twenty twenty-three and August twenty twenty-four. Did they need to revaccinate/restart the vaccination schedule, was there any percentage drop on effectiveness. No specific vaccination date and patient demographics were obtained in this call. No vaccine detail was obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. This was 1 of the 5 cases, reported by the different reporter.; Sender's Comments: US-GSK-US2025109352:same reporter, different patient US-GSK-US2025109358:same reporter, different patient US-GSK-US2025109359:same reporter, different patient US-GSK-US2025109361:same reporter, different patient More
2857405		M	PA	09/08/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS	UNK	Inappropriate schedule of product administration Inappropriate schedule of product administration	inappropriate schedule of vaccine/never received a second dose; This non-serious case was reported b... inappropriate schedule of vaccine/never received a second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose of Shingrix in Dec 2019). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: inappropriate schedule of vaccine/never received a second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 27-AUG-2025 Nurse reported a patient received the first dose of Shingrix in Dec 2019 and never received a second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2857406		F	NC	09/08/2025	VARZOS	GLAXOSMITHKLINE BIOLOGICALS		Herpes zoster Herpes zoster	Shingles case after 1st dose; This non-serious case was reported by a other health professional via ... Shingles case after 1st dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 18-AUG-2025, the patient received the 1st dose of Shingrix. In AUG-2025, less than 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles case after 1st dose). The outcome of the shingles was unknown. 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: 29-AUG-2025 The reporter reported that the patient was vaccinated on 18th August 2025 and was here today (on the reporting day) with shingles. The reporter asked can a patient get shingles from vaccine. More
2857407	1	F	IL	09/08/2025	MMR	GLAXOSMITHKLINE BIOLOGICALS	je9tp	Expired product administered Expired product administered	Expire dose; This non-serious case was reported by a other health professional via call center repre... Expire dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-month-old female patient who received MMR (Priorix) (batch number je9tp, expiry date 01-SEP-2025) for prophylaxis. On 03-SEP-2025, the patient received Priorix. On 03-SEP-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expire dose). The outcome of the expired vaccine used 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: 04-SEP-2025 The reporter reported that the reporter gave a patient an expire vaccine which led to expired vaccine used. More
2857408	67	M	FL	09/08/2025	COVID19	MODERNA	0261-20A	Body temperature, Chills, Pyrexia Body temperature, Chills, Pyrexia	fever with 100.4; Chills; This spontaneous case was reported by a physician and describes the occurr... fever with 100.4; Chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever with 100.4) and CHILLS (Chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 0261-20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PYREXIA (fever with 100.4). 31-Aug-2021, the patient experienced CHILLS (Chills). At the time of the report, PYREXIA (fever with 100.4) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Body temperature: 100.4 F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was reported. No treatment medication details was reported. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Upon internal review the case was reassessed and determined to be valid, hence significant correction was performed on 28-Aug-2025. More
2857409		M		09/08/2025	COVID19	MODERNA		Nausea Nausea	Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nau... Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) 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 NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown. Concomitant medication not reported. It was stated that, the patient got it too and they were okay within 24 hours they were really chill compared to Moderna. Treatment medication not reported. This case was linked to US-MODERNATX, INC.-MOD-2024-766622 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 01-May-2024: Non-significant follow-up received reference ID added. On 01-May-2024: Upon internal review the case was reassessed and determined to be valid, hence significant correction was performed on 28-Aug-2025.; Sender's Comments: US-MODERNATX, INC.-MOD-2024-766622:Reporter (Female case) More
2857410	62	F		09/08/2025	COVID19	MODERNA		Back pain, Chills, Nausea, Weight Back pain, Chills, Nausea, Weight	strong backache; chills; nausea; This spontaneous case was reported by a consumer and describes the ... strong backache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (strong backache), CHILLS (chills) and NAUSEA (nausea) in a 62-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (Bad case) in January 2023. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, upper arm, EW0164) on 16-Apr-2021, Pfizer (Dose 2, upper arm, EW0165) on 07-May-2021, Pfizer (Dose 3, upper arm and FH8030) on 26-Nov-2021. Past adverse reactions to the above products included Vaccination adverse reaction with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Menopause (Strong menopause symptoms). Concomitant products included Estradiol and Progesterone for Menopause. In 2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (strong backache), CHILLS (chills) and NAUSEA (nausea). At the time of the report, BACK PAIN (strong backache), CHILLS (chills) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 160. The patient had bad adverse reactions to the Moderna vaccine received in 2023. The patient had strong negative reactions- causing backache/ nausea/ chills to the COVID vaccine received since getting actual COVID- bad case but not hospitalized in early 2023. On an unknown date, patient received Comirnaty (2024-2025 Formula) intramuscularly in arm. The patient did not receive any other vaccines on the same date as the Pfizer vaccine nor received any other vaccines within 4 weeks prior to the first administration of the vaccine. Following Comirnaty, the patient had severe back aches and pain, chills and stomach nausea. The symptoms were like those when the patient had COVID, back aches were very painful. The patient also had a cough. The adverse event did not require an emergency room visit nor visit to the physician's office. The patient recovered from these symptoms. It was unknown if the patient was allergic to any previous vaccination, medications, food or other products. No treatment medication was reported. More
2857411	58	F		09/08/2025	COVID19 COVID19 COVID19	MODERNA MODERNA MODERNA		Abdominal pain upper, Autoimmune disorder, BRCA1 gene mutation assay, Body tempe... Abdominal pain upper, Autoimmune disorder, BRCA1 gene mutation assay, Body temperature, Chest pain; Dizziness, Dyspnoea, Head discomfort, Insomnia, Panic attack; Pyrexia, Rheumatoid arthritis, Scar pain More	autoimmune disease, rheumatoid arthritis/ joint pain/swelling in her legs and feet and could hardly ... autoimmune disease, rheumatoid arthritis/ joint pain/swelling in her legs and feet and could hardly lift her arms; autoimmune disease; her head felt like concrete (second dose); felt dizzy (second dose); bad stomach pains; old surgical scars (from surgical removal of her ovaries and fallopian tubes 5 years earlier) hurt more than after her original surgery.; shortness of breath; panic attack; Could not sleep; chest pains; After the first dose (date unknown) the reporter states that she experienced high fevers of 104' for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (autoimmune disease, rheumatoid arthritis/ joint pain/swelling in her legs and feet and could hardly lift her arms) and AUTOIMMUNE DISORDER (autoimmune disease) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Salpingo-oophorectomy NOS (surgical removal of her ovaries and fallopian tubes 5 years earlier.) in 2020. Concurrent medical conditions included BRCA1 gene mutation (tested positive for BRCA gene.). On 14-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced ABDOMINAL PAIN UPPER (bad stomach pains) and SCAR PAIN (old surgical scars (from surgical removal of her ovaries and fallopian tubes 5 years earlier) hurt more than after her original surgery.). In 2022, the patient experienced DYSPNOEA (shortness of breath), PANIC ATTACK (panic attack), INSOMNIA (Could not sleep) and CHEST PAIN (chest pains). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (autoimmune disease, rheumatoid arthritis/ joint pain/swelling in her legs and feet and could hardly lift her arms) (seriousness criterion medically significant), AUTOIMMUNE DISORDER (autoimmune disease) (seriousness criterion medically significant), HEAD DISCOMFORT (her head felt like concrete (second dose)), DIZZINESS (felt dizzy (second dose)) and PYREXIA (After the first dose (date unknown) the reporter states that she experienced high fevers of 104' for 2 days). At the time of the report, RHEUMATOID ARTHRITIS (autoimmune disease, rheumatoid arthritis/ joint pain/swelling in her legs and feet and could hardly lift her arms), ABDOMINAL PAIN UPPER (bad stomach pains), SCAR PAIN (old surgical scars (from surgical removal of her ovaries and fallopian tubes 5 years earlier) hurt more than after her original surgery.), DYSPNOEA (shortness of breath), PANIC ATTACK (panic attack) and INSOMNIA (Could not sleep) had not resolved, AUTOIMMUNE DISORDER (autoimmune disease), HEAD DISCOMFORT (her head felt like concrete (second dose)) and DIZZINESS (felt dizzy (second dose)) outcome was unknown and CHEST PAIN (chest pains) and PYREXIA (After the first dose (date unknown) the reporter states that she experienced high fevers of 104' for 2 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, BRCA1 gene mutation assay: Positive. On an unknown date, Body temperature: 104. No concomitant medications were reported. Patient had an autoimmune disease and rheumatoid arthritis, and it all started the day she had the Moderna vaccine. Patient had 3 doses of the Moderna vaccine. After the first dose (date unknown), she experienced high fever of 104degree for 2 days. After the second dose (date unknown), she missed a week of work due to pain all over her body, her head felt like concrete, and she felt dizzy. She did not want to get the third dose, but her workplace required it, so she did not lose her job. After the third dose, she experienced pain all over her body, bad stomach pains, and old surgical scars (from surgical removal of her ovaries and fallopian tubes 5 years earlier) hurt more than after her original surgery. She also experienced chest pains, shortness of breath and joint pain. She went to the emergency room (ER), since her HCP would not treat her. She missed work for a week and was unable to sleep. She also experienced chest pain for 2 months and swelling in her legs and feet and could hardly lift her arms. Patient was diagnosed with rheumatoid arthritis this time last year. Prior to the vaccine, she was 100percent healthy, running 5 miles, 3 times a week but now she still had SOB when talking. It was unknown if the patient experienced any additional symptoms/events. She was treated in the ER as if she was having a panic attack and sent home. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788977, US-MODERNATX, INC.-MOD-2025-788978, US-MODERNATX, INC.-MOD-2025-788980 (E2B Linked Report).; Reporter's Comments: Past surgical history is a contributor for scar pain. The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788977:Patient 1 of 3 US-MODERNATX, INC.-MOD-2025-788980:Patient 3 of 3 US-MODERNATX, INC.-MOD-2025-788978:Patient 2 of 3 More
2857412		M	CA	09/08/2025	COVID19	PFIZER\BIONTECH		Auditory disorder, Schizophrenia Auditory disorder, Schizophrenia	This is giving me full schizophrenia.; hearing beeping and hissing in ears; The initial case was mis... This is giving me full schizophrenia.; hearing beeping and hissing in ears; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 02Sep2025, this case now contains all required information to be considered valid. This is a spontaneous report and received from Consumer or other non HCPs from License Party and medical information team. Other Case identifier(s): AE-017568 (BioNTech), AE-017736 (BioNTech), AE-017802 (BioNTech), AE-018585 (BioNTech), AE-018715 (BioNTech), AE-018861 (BioNTech), AE-020584 (BioNTech), AE-018698 (BioNTech), AE-019685 (BioNTech), AE-019869 (BioNTech), AE-020496 (BioNTech). A 40-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SCHIZOPHRENIA (medically significant), outcome "unknown", described as "This is giving me full schizophrenia."; AUDITORY DISORDER (non-serious), outcome "unknown", described as "hearing beeping and hissing in ears". Clinical course: Interaction with mind and body is occurring, and the patient wants to have an investigation done. Every soundbite, even the hiss and beeping that the patient is hearing in ears, constitutes Assault, Battery, and violation of Article 3 of the International Declaration of Human Rights. Right now, the patient is hearing beeping and hissing in ears. This is giving him full schizophrenia. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400180272 Same patient and product; different dose and event; More
2857413	74	F	OR	09/08/2025	COVID19	PFIZER\BIONTECH	HG4680	Cardiac monitoring, Investigation, Pulmonary function test, Transient ischaemic ... Cardiac monitoring, Investigation, Pulmonary function test, Transient ischaemic attack More	Ministroke; Series of mini strokes; This is a spontaneous report received from a Consumer or other n... Ministroke; Series of mini strokes; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 74-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 as dose 1 (toppac); single (Lot number: HG4680) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis", start date: 2010 (unspecified if ongoing), notes: Myasthenia gravis. The patient used to take another medication years ago, but she it stopped at around 2016. There is no family history of that at all. Concomitant medication(s) included: PYRIDOSTIGMINE oral taken for myasthenia gravis, start date: 2010 (ongoing). The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (DOSE 1), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), Manufacturer Unknown), for Covid-19 Immunization. After her sixth vaccination, on Oct2023, she had a few mini strokes and that she was in the hospital and she had her vaccine three weeks prior to having her stroke and the Doctor said that, that is the only thing that they could think of that she had a out of the normal 'wood scout' vaccine. She was not in the hospital right now. The patient was actually always so pretty careful when she get her vaccinations to pay attention to what her symptoms are because sometime she have. Patient was no longer experiencing the event. It went away. Therapeutic measures were not taken as a result of transient ischaemic attack. They did a great many test on her. She had her heart and lungs checked. In fact, patient was wearing a cardiac monitor which is never showed any indication or problems and she have never had that happen since, but her neurologist who treats her for the myasthenia gravis told her not to take the Covid vaccines anymore. So, she haven't gotten them since then. More		✓
2857414	60	F	CA	09/08/2025	HEP HEP HEP PNC20 PNC20 PNC20	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH		Abdominal pain upper, Back pain, Chills, Decreased appetite, Erythema; Fatigue, ... Abdominal pain upper, Back pain, Chills, Decreased appetite, Erythema; Fatigue, Injection site erythema, Injection site pain, Lethargy, Mass; Nausea, Pain in extremity, Peripheral swelling, Pyrexia; Abdominal pain upper, Back pain, Chills, Decreased appetite, Erythema; Fatigue, Injection site erythema, Injection site pain, Lethargy, Mass; Nausea, Pain in extremity, Peripheral swelling, Pyrexia More	stomach ache; redness spreading down arm; Swollen arm; nausea; pain in arm at site and down arm; pai... stomach ache; redness spreading down arm; Swollen arm; nausea; pain in arm at site and down arm; pain in arm at site and down arm; lump; redness at injection site; loss of appetite; low grade fever; chills; tired; lethargic; back ache; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Aug2025 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in arm for immunisation; hepatitis B vaccine rhbsag (yeast) (ENGERIX B), on 12Aug2025 as dose 2, single, in right arm for immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: recovery; "Drug allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Engerix b (DOSE 1, SINGLE), for Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 13Aug2025, outcome "not recovered", described as "Swollen arm"; BACK PAIN (non-serious) with onset 13Aug2025, outcome "not recovered", described as "back ache"; CHILLS (non-serious) with onset 13Aug2025, outcome "not recovered"; LETHARGY (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lethargic"; DECREASED APPETITE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "loss of appetite"; PYREXIA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "low grade fever"; VACCINATION SITE MASS (non-serious) with onset 13Aug2025, outcome "not recovered", described as "lump"; NAUSEA (non-serious) with onset 13Aug2025, outcome "not recovered"; VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 13Aug2025, outcome "not recovered" and all described as "pain in arm at site and down arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Aug2025, outcome "not recovered", described as "redness at injection site"; FATIGUE (non-serious) with onset 13Aug2025, outcome "not recovered", described as "tired"; ERYTHEMA (non-serious) with onset 16Aug2025, outcome "not recovered", described as "redness spreading down arm"; ABDOMINAL PAIN UPPER (non-serious) with onset 16Aug2025, outcome "not recovered", described as "stomach ache". Therapeutic measures were taken as a result of peripheral swelling, nausea, vaccination site pain, pain in extremity, vaccination site mass, vaccination site erythema, decreased appetite, pyrexia, chills, fatigue, lethargy, back pain, abdominal pain upper, erythema. Causality for "swollen arm", "nausea", "pain in arm at site and down arm", "lump", "redness at injection site", "loss of appetite", "low grade fever", "chills", "tired", "lethargic", "back ache", "stomach ache" and "redness spreading down arm" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: PREVNAR 20 was vaccinated on the upper arm. Swollen arm, nausea, pain in arm at site and down arm, lump, redness at injection site, loss of appetite, low grade fever, chills, tired, lethargic, back ache. Day 4 stomach ache, redness spreading down arm, back ache, chills. Antibiotic treatment received for the adverse events. It was reported that patient did not received any other vaccines within 4 weeks PRIOR to the vaccines for which reporting. The patient wasn't receiving any other medications within 2 weeks of the event starting. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. Amendment: This follow-up report is being submitted to amend previously reported information: case seriousness should be update to serious. Amendment: This follow-up report is being submitted to amend previously reported information: case seriousness should be downgraded to non-serious. More
2857415		F		09/08/2025	COVID19	PFIZER\BIONTECH		Musculoskeletal stiffness Musculoskeletal stiffness	reported being bedridden and having her limbs stiffen making it difficult to move; This is a spontan... reported being bedridden and having her limbs stiffen making it difficult to move; This is a spontaneous report received from a Consumer or other non HCP. A female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (disability), outcome "recovered" (04Sep2025), described as "reported being bedridden and having her limbs stiffen making it difficult to move". It was unknown if therapeutic measures were taken as a result of musculoskeletal stiffness. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More			✓
2857416	51	M		09/08/2025	COVID19	PFIZER\BIONTECH	5F628A	Hypersensitivity, Nervous system disorder, Rash Hypersensitivity, Nervous system disorder, Rash	had affected nervous system; breakout; normally gets allergies at end of the year; This is a spontan... had affected nervous system; breakout; normally gets allergies at end of the year; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-020617 (BIONTECH). A 53-year-old male patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown, single (Lot number: 5F628A, Expiration Date: 30Jun2027) at the age of 51 years for covid-19 immunisation; dupilumab (DUPIXENT), at 300 mg (300 mg,qow (every other week)), subcutaneous for chronic rhinosinusitis with nasal polyps. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREDNISONE; BUDESONIDE. The patient also took other concomitant therapy.The following information was reported: NERVOUS SYSTEM DISORDER (disability, medically significant), outcome "not recovered", described as "had affected nervous system"; RASH (non-serious), outcome "not recovered", described as "breakout"; HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "normally gets allergies at end of the year". The event "normally gets allergies at end of the year" required emergency room visit. The action taken for dupilumab was unknown. Therapeutic measures were taken as a result of nervous system disorder, rash, hypersensitivity. Clinical course: Initial information received on 06Aug2025 regarding an unsolicited valid serious case received from a patient. This patient had affected nervous system and was wheelchair bound after vaccine, normally gets allergies at end of the year, and breakouts while being treated with Dupilumab [Dupixent] delivered via dupixent Single dose pre-filled pen and COVID-19 VACCINE. The patient reported he normally got allergies (hypersensitivity) at the end of the year for 1 to 2 days and went to urgent care, where he was prescribed breathing treatments, and everything went back to normal. He stated he Injected himself with allergy shots weekly and had also been prescribed an EPiPen for breakout (rash). The patient stated the COVID vaccine (3 years ago) had affected his nervous system (nervous system disorder) and he was wheelchair-bound after the vaccine (Unknown onset date, latency for all events). He stated he worked his way up to a walker and was then on crutches. Corrective treatment: Epipen for rash, breathing treatment for hypersensitivity, walker, wheelchair and crutches for nervous system disorder. Company Comment: Sanofi company comment dated 13Aug2025: This case involves Adult male patient had affected nervous system and was wheelchair bound after vaccine, while being treated with Dupilumab [Dupixent] delivered via dupixent single dose pre-filled pen and COVID-19 VACCINE. The causal role of the drug and co suspect cannot be denied for the event. However, lack of information regarding event details, medicinal treatment received, lab data, medical history precludes the comprehensive assessment of the case. The case would be re-evaluated post the receipt of follow-up information. No follow-up attempts are possible. BNT162B2 is under agreement with BIONTECH SE. More			✓
2857417	34	F	PA	09/08/2025	FLU3	SANOFI PASTEUR		Exposure during pregnancy, No adverse event Exposure during pregnancy, No adverse event	taking fluzone during pregnancy with no reported adverse event; Initial information received on 27-A... taking fluzone during pregnancy with no reported adverse event; Initial information received on 27-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 34 years old female patient who was exposed to influenza quadrival a-b multidose vaccine preserved [Fluzone] in context of taking fluzone during pregnancy with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported vaccine fluzone during pregnancy with no reported adverse event occurred at 8 weeks of pregnancy and the patient was exposed to influenza quadrival a-b multidose vaccine preserved at 8 weeks of pregnancy, during first pregnancy trimester for influenza quadrival a-b multidose vaccine preserved. The date of last menstrual period was reported as 30-Jun-2025. The estimated due date is 06-Apr-2026. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 27-Aug-2025, the patient received a dose 1 of suspect influenza quadrival a-b multidose vaccine preserved, suspension for injection (lot number, strength and expiry date not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) during pregnancy with no reported adverse event (exposure during pregnancy) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. There was no information related to relevant prenatal testing after exposure. Reportedly, Patient was no AE after administration. Action taken was not applicable. Additionally, at time of reporting, the pregnancy is still ongoing. More
2857418	1	M	CA	09/08/2025	IPV	SANOFI PASTEUR	Y1A212M	Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	inappropriate use due to dose administered too early with no reported adverse event; Initial informa... inappropriate use due to dose administered too early with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 months old male patient who was inappropriately administered to IPV (Vero) [IPOL] dose too early with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Aug-2025, the patient received 0.5mL (dose 4) of suspect IPV (Vero), Suspension for injection (lot Y1A212M, expiry date 31-JAN-2027, strength not reported) via intramuscular route in the right thigh for Immunization and dose administered too early with no reported adverse event (inappropriate schedule of product administration) (latency same day). Reportedly, caller stated that the nurse checked with the physician if the dose for IPOL should be given and was told yes. Patient received the immunization at 12 months old, but they were indicated to receive it at 4 years old. No other Immunizations. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2857419	0.25	F	NJ	09/08/2025	DTAP TDAP	SANOFI PASTEUR SANOFI PASTEUR	4CA28C1	No adverse event, Product administered to patient of inappropriate age, Wrong pr... No adverse event, Product administered to patient of inappropriate age, Wrong product administered; No adverse event, Product administered to patient of inappropriate age, Wrong product administered More	adacel was given to the 3 months and 6 days old infant instead of daptacel with no reported adverse ... adacel was given to the 3 months and 6 days old infant instead of daptacel with no reported adverse event; adacel was given to the 3 months and 6 days old infant instead of daptacel with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves a 3 months and 6 days old infant female patient who was administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Sep-2025, 3 months and 6 days old patient received a dose 0.5 ml (dose 1) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection (lot 4CA28C1) (frequency: once and strength: standard) (expiry date 31-Mar-2027) via intramuscular route in the left thigh instead of diphtheria-15/tetanus/5 ac pertussis vaccine, Suspension for injection (unknown strength, lot and expiry date not reported) with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (Latency: same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2857420	0.67	F	NY	09/08/2025	DTAPIPVHIB	SANOFI PASTEUR	UK036AB	Expired product administered, No adverse event Expired product administered, No adverse event	administration of expired pentacel with no reported adverse event; Initial information received on 0... administration of expired pentacel with no reported adverse event; Initial information received on 04-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 months old female patient who received expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Sep-2025, the patient received dose 1 of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of standard strength, frequency once with lot UK036AB and expiry date 30-Jun-2025 via intramuscular route in leg for Immunization (expired product administered) (Latency same day) Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2857445				09/08/2025	COVID19	MODERNA		Headache, Vision blurred, Visual impairment Headache, Vision blurred, Visual impairment	Vision problems; Blurred vision - it occurs temporarily lasts for a few seconds and then goes back ... Vision problems; Blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision problems), VISION BLURRED (Blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (Vision problems), VISION BLURRED (Blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal) and HEADACHE (Headache). At the time of the report, VISUAL IMPAIRMENT (Vision problems) and VISION BLURRED (Blurred vision - it occurs temporarily lasts for a few seconds and then goes back to normal) was resolving and HEADACHE (Headache) outcome was unknown. No concomitant medications were reported. Patient went to the ophthalmologist and neurologist who confirmed of patient having no vision and neurogenic problem. Patient is using butox for treatment of headache. This case was linked to MDEM21-03211, MDEDM21-03230 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Upon internal review the case was reassessed and determined to be valid, hence significant correction was performed on 29-Aug-2025. On 23-Sep-2021: follow up received and contain NNI More
2857446	67	F	NC	09/08/2025	COVID19 COVID19	MODERNA PFIZER\BIONTECH	Unknown FC3184	Interchange of vaccine products, Vaccination site pain; Interchange of vaccine p... Interchange of vaccine products, Vaccination site pain; Interchange of vaccine products, Vaccination site pain More	Injection site pain; immunocompromised patient who received the 1st and 2nd dose of the Moderna COVI... Injection site pain; immunocompromised patient who received the 1st and 2nd dose of the Moderna COVID 19 vaccine was given Pfizer as the 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Injection site pain) and INTERCHANGE OF VACCINE PRODUCTS (immunocompromised patient who received the 1st and 2nd dose of the Moderna COVID 19 vaccine was given Pfizer as the 3rd dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Concurrent medical conditions included Immunocompromised. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient received third dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 22-Sep-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain) and INTERCHANGE OF VACCINE PRODUCTS (immunocompromised patient who received the 1st and 2nd dose of the Moderna COVID 19 vaccine was given Pfizer as the 3rd dose). At the time of the report, VACCINATION SITE PAIN (Injection site pain) and INTERCHANGE OF VACCINE PRODUCTS (immunocompromised patient who received the 1st and 2nd dose of the Moderna COVID 19 vaccine was given Pfizer as the 3rd dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Upon internal review the case was reassessed and determined to be valid, hence significant correction was performed on 29-Aug-2025. More
2857447				09/08/2025	COVID19	MODERNA		COVID-19 COVID-19	Had the 2 Moderna shots and then contracted Covid; This spontaneous case was reported by an other he... Had the 2 Moderna shots and then contracted Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Had the 2 Moderna shots and then contracted Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had the 2 Moderna shots and then contracted Covid). At the time of the report, COVID-19 (Had the 2 Moderna shots and then contracted Covid) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medication were provided. Other HCP asked, If someone had the 2 Moderna shots and then contracted Covid, how soon can this person get the booster after you've recovered? Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Upon internal review significant corrections were performed on 28-Aug-2025 to update the Case Classification. More
2857448		F		09/08/2025	COVID19	PFIZER\BIONTECH		Pancreatitis relapsing Pancreatitis relapsing	Acute recurrent pancreatitis/Acute mild pancreatitis; This is a literature report for the following ... Acute recurrent pancreatitis/Acute mild pancreatitis; This is a literature report for the following literature source(s). A 12-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Idiopathic pancreatitis" (unspecified if ongoing), notes: 17mo prior; "viral infection" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PANCREATITIS RELAPSING (medically significant), 11 days after the suspect product(s) administration, outcome "unknown", described as "Acute recurrent pancreatitis/Acute mild pancreatitis". Therapeutic measures were taken as a result of pancreatitis relapsing which included IV fluids, Famotidine, and Maalox.; Sender's Comments: As there is limited information in the case provided, the causal association between the event pancreatitis relapsing and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. More
2857449	45	F	SC	09/08/2025	FLU3	SANOFI PASTEUR	u8863ca	Injection site inflammation, Injection site pain Injection site inflammation, Injection site pain	Patient had pain/inflamation at injection site Patient had pain/inflamation at injection site
2857450	1	F	ND	09/08/2025	HEPA HIBV MMR PNC20 VARCEL	GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH MERCK & CO. INC.	H3N97 X020943 Y015995 LN4931 Y017915	Rash, Rash macular; Rash, Rash macular; Rash, Rash macular; Rash, Rash macular; ... Rash, Rash macular; Rash, Rash macular; Rash, Rash macular; Rash, Rash macular; Rash, Rash macular More	RED BLOTCHY PATCHES APPEARED TO FOREHEAD 10 MINUTES POST VACCINATION. DR ASSESSED PATIENT. NO S/S OF... RED BLOTCHY PATCHES APPEARED TO FOREHEAD 10 MINUTES POST VACCINATION. DR ASSESSED PATIENT. NO S/S OF RESPIRATORY DISTRESS OR ANAPHYLAXIS, ORDERED 5ML OF BENADRYL PO FOR PATIENT. PATIENT CONSUMED WITHOUT DIFFICULTY. PATIENT RE-ASSESSED, EXIT FACILITY IN STABLE CONDITION. More
2857451	73	F	VA	09/08/2025	HEPAB HEPAB PNC21 PNC21	GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC.	58160-0815-52 58160-0815-52 00006-4347-02 00006-4347-02	Arthralgia, Condition aggravated, Drug hypersensitivity, Injection site erythema... Arthralgia, Condition aggravated, Drug hypersensitivity, Injection site erythema, Injection site pain; Injection site rash, Injection site swelling, Injection site warmth, Lymph node pain, Trigger points; Arthralgia, Condition aggravated, Drug hypersensitivity, Injection site erythema, Injection site pain; Injection site rash, Injection site swelling, Injection site warmth, Lymph node pain, Trigger points More	Vaccines given with almost no stick sense and in proper location, however, hep a and b medicine stun... Vaccines given with almost no stick sense and in proper location, however, hep a and b medicine stung, but severed sting from capvaxive medicine. No initial reaction. Later swelling, red, hot, raised pain area, rash in arm around location approximately 1 inch by 2 inch, Much larger by the next morning across much lager area of arm. Messaged my gp and then as continued saw Dr who photographed on 08/29 early morning. Took benadryl and tylenol as directed, and got epi-pen prescribed. By Sunday, the area began to move to the right and include the under arm area and lymph nodes. On Monday September 1, I had a rolfing deep tissue appointment. Area of arm was addressed. New area of pain in shoulder from the shot which continues at present. This was not an area noted in prior vaccine reaction. Recurring at that time and at present is an area that exercise and physical therapy had addressed successfully at the end of the shoulder. Recurring and more severe at present is the trigger point area of pain in my middle left arm. About the same as prior is the lower trigger point that is near the elbow. Dr has used myofacial on these areas and indicated they form a band from one area to the other. Clearly these areas were impacted again by one or both new vaccines. I have had covid 19 and RSV vaccines in my right arm since the flu vaccine. These are the first vaccines attempted in my left arm since 2020. No prior issues with vaccines until 2020. More
2857462	42	F	KS	09/08/2025	COVID19	MODERNA	Unknown	Burning sensation, Erythema, Injection site pain, Injection site pruritus, Skin ... Burning sensation, Erythema, Injection site pain, Injection site pruritus, Skin warm More	My right arm is red and hot to the touch. The injection site itches and at times, hurts. There is a ... My right arm is red and hot to the touch. The injection site itches and at times, hurts. There is a burning sensation where the redness is. I have taken prilosec, benadryl, and Xyzal as a regular course of daily meds. More
2857463	67	M	FL	09/08/2025	FLU3 PNC20	SANOFI PASTEUR PFIZER\WYETH	UT8781AA LP4948	Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered	Patient Got Prevnar 20 Vaccine on 09/05/2025, but he was not due for it since he got the same vaccin... Patient Got Prevnar 20 Vaccine on 09/05/2025, but he was not due for it since he got the same vaccine on 04/04/2025 and the CDC guidlines for that vaccine is once per life More
2857464	65	M	OH	09/08/2025	PNC21	MERCK & CO. INC.	y019157	Injected limb mobility decreased, Pain, Pain in extremity Injected limb mobility decreased, Pain, Pain in extremity	Patient wanted to let us know he is still having some pain in his RIGHT arm. He is having painful l... Patient wanted to let us know he is still having some pain in his RIGHT arm. He is having painful limitation of motion when he raises his arm. He has not seen a doctor yet in hopes that it would go away, but vaccine was 3 months ago. Vaccine logged as given in the LEFT arm for administration site, but patient says he got it in the right arm. More
2857465	44	F	FL	09/08/2025	HPV9 HPV9	MERCK & CO. INC. MERCK & CO. INC.	Y007193 Y007193	Discomfort, Immediate post-injection reaction, Mobility decreased, Pain, Pain in... Discomfort, Immediate post-injection reaction, Mobility decreased, Pain, Pain in extremity; Sleep disorder More	immediate pain and discomfort following vaccination Patient unable to raise arm above her shoulder ... immediate pain and discomfort following vaccination Patient unable to raise arm above her shoulder for the 14 days following administration. 4 weeks post administration she perceived the pain might be subsiding until her husband had grabbed her shoulder lightly and it causes a "shockwave like sensation of pain" to radiate down her arm to her fingers. She reports her pain as moderate to this day and is using ibuprofen every 6 hours to suppress the pain and allow for sleep. More

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