Could be an allergic reaction; Tired; Headache; Muscle pain; Joint pain / Pain in shoulder; she was having a problem with because that was the one starting aching; This is a spontaneous report received from a Consumer or other non HCP. A 55-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Jan2025 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 18Jan2025 as dose number unknown, single), in arm for immunisation. The patient’s relevant medical history included: “Diabetes” (ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Jan2025, outcome “unknown”, described as “Could be an allergic reaction”; HEADACHE (non-serious) with onset Jan2025, outcome “unknown”; ARTHRALGIA (non-serious) with onset Jan2025, outcome “unknown”, described as “Joint pain / Pain in shoulder”; MYALGIA (non-serious) with onset Jan2025, outcome “unknown”, described as “Muscle pain”; FATIGUE (non-serious) with onset Jan2025, outcome “unknown”, described as “Tired”; PAIN IN EXTREMITY (non-serious) with onset Jan2025, outcome “unknown”, described as “she was having a problem with because that was the one starting aching”. Therapeutic measures were not taken as a result of hypersensitivity, fatigue, headache, myalgia, arthralgia, pain in extremity. Additional information: Reporter stated as, she just wanted to report some side effected that she had with a vaccine that she had with a COVID vaccine. She had a COVID vaccine this past Saturday (18Jan2025) at here in (PRIVACY) and it was not anything major. She mean, the fact that She had to cancel, she had to cancel her house keeper because she was not feeling that good but (Incomplete sentence). She mean, she had some side effects, it was not anything, like she said major and then she had to skip (redacted) and cancel her house keeper because she was not feeling too good but it was she, now it could be an allergic reaction where she had pain and then she tired and she had a headache and muscle pain and ‘sores’ and maybe some joint pain and she think that, that was about it, you know, that was about it. She mean, she know where she live (PRIVACY). Anyways and she just and she just did not feeling very good but she was feeling little bit better today (20Jan2025) but do you think. She was asking a question, that she could take some aspirin or pain reliever to relieve the pain and in her shoulder. She said, she should take some aspirin or pain, do she think she should take some kind aspirin or some kind of pain reliever like Tylenol whatever to relive the pain that was in her shoulder. Reporter stated, Tylenol, she was think of taking Tylenol. Reporter stated, like she said, she forgot her card on Saturday (18Jan2025). She just went to (PRIVACY) and she thought, now was the good time for her to began her vaccination. She got one. She got flu vaccination on her right arm and a COVID vaccination on her left arm and so, she do not really start to feel bad until yesterday (19Jan2025) around 7 o’ clock in the morning when she was taking her shower and then she start, she was going to take a nap and she did not feel all that good. When clarified reporter also took the Flu vaccine on the same day (18Jan2025). Reporter stated, Yes. No, her right arm was just fine. It was just her left arm that she was having a problem with because that was the one starting aching and she needed that, not right then but she thought, maybe it had to do with that COVID vaccination because she knew that it was the COVID vaccination in her left arm because she knew the pharmacist, pharmacist given the flu vaccination in her right arm and given the COVID vaccination in her left arm. Reporter took the flu vaccination on the same day other than COVID vaccine. Reporter stated, she does not. She thinks it was flu vaccination but then she do not really know because she did not bring her card. Reporter also stated as, she took the Pfizer, she thinks she took the Pfizer COVID vaccination on Saturday (18Jan2025) in her right arm, yes. She took it in her right arm at. The patient does not really remember the exact time of vaccination. Reporter stated, well, she thinks it was just one shot. She was diabetic and because she was diabetic, she do take that medication. Reporter stated, no treatment received. No investigations reported.

patient got a shingles shot since two-thousand sixteen; 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 received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (Patient received first dose in 2016). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: patient got a shingles shot since two-thousand sixteen). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 06-JAN-2025 Pharmacist asked about a female patient that got a shingles shot since two-thousand sixteen. Asked if do they need to restart the series and also mentioned that the patient did not know if this first dose in two-thousand sixteen was a Shingrix or other brand vaccine shingles type. No specific vaccination date, vaccine detail or other patient demographics were provided from the pharmacist. No other information was provided from the pharmacist end. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.

administering an expired Engerix-B vaccine to a patient; 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 15-day-old female patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis. On 03-JAN-2025, the patient received Engerix B pediatric. On 03-JAN-2025, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: administering an expired Engerix-B vaccine to a patient). The outcome of the expired vaccine used was unknown. 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: 03-JAN-2025 Reporter requested information and reported adverse events after administering an expired Engerix-B vaccine to a patient on 03-JAN-2025 which led to expired vaccine used.

chills; falling asleep; tried to get up but had no function in left leg; strokes; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 65-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient’s relevant medical history included: “Congestive heart failure”, start date: 2019 (ongoing). The patient’s concomitant medications were not reported. The following information was reported: MONOPLEGIA (medically significant) with onset Jan2021, outcome “unknown”, described as “tried to get up but had no function in left leg”; CHILLS (non-serious) with onset 26Jan2021, outcome “unknown”; SOMNOLENCE (non-serious) with onset 26Jan2021, outcome “unknown”, described as “falling asleep”; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome “unknown”, described as “strokes”. The events “tried to get up but had no function in left leg”, “chills” and “falling asleep” required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Feb2021) Two strokes. Clinical course: The patient was one of the first to get the shot, when they said it was safe to take. The patient had two strokes from the Pfizer COVID shot. It all started on 26Jan2021, the day after taking the first Pfizer COVID shot. The patient was sitting and started having chills and drove home. He was falling asleep and had chills driving home. It was freezing, so he put a blanket around. The patient didn’t get up for three days, tried to get up but had no function in left leg. They missed the stokes when the patient went to emergency room, they were looking for Guillain-Barre, so they didn’t catch a stroke. Patient’s doctor sent him to neurologist,who did CT scan on the first week in Feb2021 and found two strokes. The lot number for BNT162b2, was not provided and will be requested during follow up.

Caller mentioned she has had Covid before and taken Paxlovid; Caller mentioned she has had Covid before and taken Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 61-year-old female patient received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: EW0161) and on 03May2021 as dose 2, single (Lot number: EW0176) for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications (regular vitamins and hormone replacement therapy). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome “unknown” and all described as “Caller mentioned she has had Covid before and taken Paxlovid”. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2025) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).

the glass tip broke so they were not able to draw it from the vial; The initial case was missing the following minimum criteria: no adverse event (Product complaint only – the vaccine was not administered to the patient). Upon receipt of follow-up information on 10Jan2025, this case now contains all required information to be considered valid (reportability assessment received). This is a spontaneous report received from a Pharmacist from product quality group, Program ID. An 83-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: KC7884, Expiration Date: Sep2025) for immunisation. The patient’s relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), described as “the glass tip broke so they were not able to draw it from the vial”. Additional information: A pharmacist reporter reported that he would like to get a replacement for an Abrysvo vaccine because when trying to administer it, the glass tip broke so they were not able to draw it from the vial and the patient was not able to get vaccinated because this was their only remaining dose. The presentation of this Abrysvo was the little sealed vacuum one with the vial and one cap and one syringe and it was not the pack of five. The reporter discarded the antigen vial, vial adaptor, diluent syringe and has no lots, expiry dates, NDC numbers or manufacturer names to provide from those components to provide; however, the reporter kept the box with the box lot number. The box was not damaged and was not squished. The complaint sample was not available to return. The reporter considered “the glass tip broke so they were not able to draw it from the vial” not related to rsv vaccine prot.subunit pref 2v. Causality for “the glass tip broke so they were not able to draw it from the vial” was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).

fever/ started fever within one hour and could not break it; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever/ started fever within one hour and could not break it) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever/ started fever within one hour and could not break it) (seriousness criterion medically significant). At the time of the report, PYREXIA (fever/ started fever within one hour and could not break it) had not resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient had no medical history, concomitant disease or risk factor. Reporter causality was not reported. The patient did not experience any additional symptoms or events. There were no lab data or results available. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 16-Jan-2025: Live significant follow-up information received contains reporter’s state, event verbatim and event seriousness criteria added as medically significant, and additional references were added.; Reporter’s Comments: The benefit-risk relationship of product is not affected by this report.

sensorineural hearing loss; Benign paroxysmal positional vertigo; Cerumen impaction; Temporomandibular joint DISORDER; Presbycusis; INJECTION SITE PAIN; FEVER; FATIGUE; MYALGIA; HEADACHE; This solicited report received from a physician by COV19VAC-NONCOMP: Jansen COVID 19 Non Company Solicited Study. This report was referenced in literature: and concerned a patient of unspecified age and sex (subject number and site number were not reported). The patients height and weight were not reported. Age at time of vaccination was unknown. Aim- Anecdotal reports of sudden sensorineural hearing loss (SSNHL) following COVID-19 vaccination have emerged in the otolaryngology community. Studies have demonstrated no association between COVID-19 vaccination and SSNHL. We aim to characterize the spectrum of otologic symptoms following COVID-19 vaccination. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patients received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported. Methods- Patients presenting to the otology clinic at a tertiary care, urban medical center between May and July 2021 were screened with a short questionnaire for development of otologic symptoms following COVID-19 vaccination. Patients were inquired about previous COVID-19 infection, method and date of diagnosis if previously infected, COVID- 19 vaccination status, and vaccine brand and dates if vaccinated. Screened symptoms included hearing loss, tinnitus, ear drainage, dizziness, vertigo, imbalance, facial nerve palsy, smell change, and taste change; patients were specifically asked if such symptoms appeared during active COVID-19 infection or within 4 weeks of any dose of COVID-19 vaccination. Additionally, demographic data, including age and gender, were obtained. All above uses of patient data were approved by the Regulatory Authority. For patients reporting any otologic symptoms, a retrospective chart review was performed to collect audiometric data and final diagnoses. Audiometric data from the initial presentation were gathered and notes written by the primary otologist were reviewed for relevant medical history, diagnoses, and treatments. Pearson’s chi-square test was used to evaluate for significant differences in vaccination proportions. On an unspecified date, the patients experienced sensorineural hearing loss, benign paroxysmal positional vertigo, cerumen impaction, temporomandibular joint disorder, presbycusis, injection site pain, fever, fatigue, myalgia, and headache. Dose series 1. Results- Between May and July 2021, 500 patients were screened. Median age was 56.6 years old, with 59.4 % female and 40.2 % male. 420 patients (84.0 %) were vaccinated, with 58.4 % receiving Pfizer, 29.1 % receiving Moderna, and 3.8 % receiving Johnson & Johnson. 61 patients (14.5 %) reported one or more otologic symptoms within 4 weeks of vaccination, including 21 (5.0 %) with hearing loss, 26 (6.2 %) with tinnitus, 33 (7.9 %) with dizziness, and 19 (4.5 %) with vertigo. Of the 16 patients (3.2 %) reporting tinnitus with no associated hearing loss, 8 were diagnosed with subjective tinnitus and 4 were diagnosed with temporomandibular joint syndrome. Of the 18 patients reporting hearing loss, 11 had exacerbations of underlying pathologies (e.g. Meniere’s disease, presbycusis) and 7 were newly diagnosed with SSNHL (1.4 %). The action taken with janssen covid-19 vaccine was not applicable. The outcome of sensorineural hearing loss, benign paroxysmal positional vertigo, cerumen impaction, temporomandibular joint disorder, presbycusis, injection site pain, fever, fatigue, myalgia and headache was not reported. The reporter considered the causality between janssen covid-19 vaccine and sensorineural hearing loss, benign paroxysmal positional vertigo, cerumen impaction, temporomandibular joint disorder, presbycusis, injection site pain, fever, fatigue, myalgia, and headache as not reported. Company causality between janssen covid-19 vaccine and Vertigo positional, Cerumen impaction, Temporomandibular pain and dysfunction syndrome, Presbyacusis, sensorineural hearing loss, injection site pain, fever, fatigue, myalgia, and headache was not related. Conclusion- Patients reporting otologic symptoms following COVID-19 vaccination received various diagnoses of uncertain etiology. The incidence of SSNHL in these patients is comparable to the general otology patient population. Additional studies are required to determine the incidence of specific diagnoses following vaccination. This report was serious (other medically important condition).; Sender’s Comments: V0-Deafness neurosensory, Vertigo positional, Cerumen impaction, Temporomandibular pain and dysfunction syndromePresbyacusis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.

autoimmune disease; autoimmune disease with interstitial lung disease; This serious case was reported by a pharmacist via call center representative and described the occurrence of autoimmune disorder in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced autoimmune disorder (Verbatim: autoimmune disease) (serious criteria GSK medically significant) and interstitial lung disease (Verbatim: autoimmune disease with interstitial lung disease) (serious criteria GSK medically significant). The patient was treated with rituximab (Rituxan). The outcome of the autoimmune disorder and interstitial lung disease were unknown. It was unknown if the reporter considered the autoimmune disorder and interstitial lung disease to be related to Shingrix and Shingrix. The company considered the autoimmune disorder and interstitial lung disease to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 08-JAN-2025 Pharmacist stated she had a patient that completed Shingrix series in 2020. The patient had an autoimmune disease with interstitial lung disease and was receiving Rituxin infusions. Pharmacist stated she really was not sure if the autoimmune disease was present before Shingrix series was administered, but she thought it was a newer development as the Rituxin was new for the patient. The pharmacist could no longer recall the name of the patient, so she was unable to look in the patient’s records to locate the exact date of Shingrix doses. The only patient specific information the pharmacist could provide was that this was a female patient in her 80s. The patient decided to not receive any further Shingrix dosing. The pharmacist was inquiring about recommendations on repeating the series in patients receiving Rituxin, as the patient’s physician had mentioned finding guidelines that advised repeating. Following an internal meeting on 15-January-2025, it was realized that clarification was needed to determine if the autoimmune condition with interstitial lung disease was pre-existing, or occurred after the Shingrix series, so an outbound call was placed back to the pharmacist on 15- January -2025. The vaccine administration facility was the same as primary reporter.; Sender’s Comments: Autoimmune disorder and Interstitial lung disease are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).

pin in left arm injection site; shivering; achiness; headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 14-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 15-JAN-2025, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pin in left arm injection site), shivering (Verbatim: shivering), pain (Verbatim: achiness) and headache (Verbatim: headache). The outcome of the injection site pain, shivering, pain and headache were not resolved. It was unknown if the reporter considered the injection site pain, shivering, pain and headache to be related to Shingrix. It was unknown if the company considered the injection site pain, shivering, pain and headache to be related to Shingrix. Linked case(s) involving the same patient: US2022174220 Additional Information: GSK Receipt Date: 15-JAN-2025 Patient received his second Shingrix vaccine on 14-JAN-2025 and experienced symptoms 24 hours later of shivering, achiness, headache and left arm painful. These symptoms were not resolved. For tolerance of first dose refer case US2022174220.; Sender’s Comments: US-GSK-US2022174220:Same patient