| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2853109 | 08/07/2025 |
MMR |
MERCK & CO. INC. |
Y009430 |
Product contamination physical
Product contamination physical
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Describe Event, Problem, or Product Use Error: Foreign Object in MMR II (Lot # Y009430, Exp: 5/16/20...
Describe Event, Problem, or Product Use Error: Foreign Object in MMR II (Lot # Y009430, Exp: 5/16/2026) vaccine identified during vaccine preparation. Vaccine was not given or administered to patient. BD 3ml, 18G X1 1/2" blunt fill needle used. Staff only punctured the vial once and noticed the grey, rubber looking piece, as they were mixing the vaccine. It was an oblong shape.
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| 2853110 | 65 | M | MI | 08/07/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
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Arthralgia, Chills, Injected limb mobility decreased, Injection site pain, Injec...
Arthralgia, Chills, Injected limb mobility decreased, Injection site pain, Injection site swelling; Injection site warmth, Pyrexia
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Received the CapVaxive vaccine in the left arm on 7/17/25. On 7/18, woke up with a fever and had fev...
Received the CapVaxive vaccine in the left arm on 7/17/25. On 7/18, woke up with a fever and had fever/chills all day as well as swelling and soreness at the injection sight, and my joints ached. On 7/19, the fever broke around 4a.m. Arm not as sore, but injection sight still swollen, and could not raise arm above chest level. On 7/20, the injection sight felt very hot on both the front and backside of the upper arm, and was still sore, but not as sore as previous day. On 7/21, still swollen, but not hot anymore. On 7/25, a week since getting the injection, arm finally felt "normal" again.
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| 2853111 | 59 | F | 08/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Lymphadenopathy
Lymphadenopathy
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Received 1st dose Shingrix vaccine on 07/23/2025; developed swollen axillary lymph nodes on injectio...
Received 1st dose Shingrix vaccine on 07/23/2025; developed swollen axillary lymph nodes on injection side following day.
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| 2853112 | 08/07/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
9x7cd |
Product closure issue
Product closure issue
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Rubber stopper of Menveo vial fell inside the vial when punctured. Metal seal was loose on vial.
Rubber stopper of Menveo vial fell inside the vial when punctured. Metal seal was loose on vial.
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| 2853113 | 45 | F | DC | 08/07/2025 |
HPV9 |
MERCK & CO. INC. |
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Diarrhoea, Dizziness, Injection site mass, Nausea
Diarrhoea, Dizziness, Injection site mass, Nausea
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Gardisil 9. Second shot. Starting 24-48hr and lasting 1 week (so far). Adverse event. Bump at site l...
Gardisil 9. Second shot. Starting 24-48hr and lasting 1 week (so far). Adverse event. Bump at site lasting 1 week plus. Nausea at night, ongoing. Diarrhea @ 48-72hrs post shot. Dizziness 48hrs post shot and 1 other time.
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| 2853114 | 67 | F | CA | 08/07/2025 |
COVID19 COVID19 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Abdominal pain, Acute hepatic failure, Cardiac arrest, Death, Nausea; Unresponsi...
Abdominal pain, Acute hepatic failure, Cardiac arrest, Death, Nausea; Unresponsive to stimuli, Vomiting
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Date of Death: 6/29/25 Causality: unlikely related to ambrisentan and tadalafil. Per chart review, p...
Date of Death: 6/29/25 Causality: unlikely related to ambrisentan and tadalafil. Per chart review, pt went to ED via ambulance for consistent abdominal pain, nausea, and vomiting for the past 2 weeks after receiving COVID vaccine. Later found to have acute liver failure with unclear etiology. Pt became unresponsive during pending potential transfer to tertiary care facility. Pt had cardiac arrest despite aggressive interventions and passed away.
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| 2853115 | 56 | F | 08/07/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
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Fatigue, Incorrect route of product administration, Injection site induration, I...
Fatigue, Incorrect route of product administration, Injection site induration, Injection site mass, Injection site pain; Injection site warmth, Muscular weakness
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CAPVAXIVE was administered subcutaneously instead of intramuscularly. Soreness, redness with hot/war...
CAPVAXIVE was administered subcutaneously instead of intramuscularly. Soreness, redness with hot/warm to touch, lump/harden on the arm around the injection site, fatigue, and weakness in legs. Then readness hot/warm to touch has kept expanding further away from the injection site and the lump/harden area won't go away after a few days. This condition has been ongoing since late Wednesday, July 16, 2025 when this vaccine was administered.
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| 2853146 | MI | 08/07/2025 |
VARCEL |
MERCK & CO. INC. |
Y015559 |
Product storage error
Product storage error
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vaccine administered after temperature excursion; This spontaneous report was received from medical ...
vaccine administered after temperature excursion; This spontaneous report was received from medical assistant 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 14-JUL-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, lot #Y015559, expiration date was reported as 16-SEP-2026, 0.5 mL, diluted with sterile diluent (lot # and expiration date were not reported); administered by Subcutaneous route in Left Thigh for prophylaxis. The dose experienced a temperature excursion -8.4 Celsius degrees for time frame 48 minutes, no other previous temperature excursion was experienced.
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| 2853147 | GA | 08/07/2025 |
MMRV |
MERCK & CO. INC. |
Y013577 |
No adverse event, Product storage error
No adverse event, Product storage error
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Nurse Practitioner calling to report inadvertently administering a PROQUAD vaccine after experiencin...
Nurse Practitioner calling to report inadvertently administering a PROQUAD vaccine after experiencing a temperature excursion. Product was supported. See TE Case# 02848877. Permission to contact HCP was granted. Additional AE Case# 02848925 filed. No; No adverse event; This spontaneous report was received from a nurse practitioner 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 an unknown date, the patient was inadvertently vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vaccine, (lot #Y013577, expiration date: 03-Feb-2026) for prophylaxis, that on an unknown dates underwent temperature excursions of 17F for 1 Hour 30 Minutes, 17F for 1 Hour 45 Minutes, and 15F for 30 minutes. The vaccine was reconstituted with sterile diluent (lot #, expiration date: not reported). No adverse event was reported.; Reporter's Comments: Keywords :
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| 2853148 | 23 | F | CA | 08/07/2025 |
HPVX HPVX HPVX HPVX HPVX HPVX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Abnormal uterine bleeding, Blood pressure fluctuation, Burning sensation, C-reac...
Abnormal uterine bleeding, Blood pressure fluctuation, Burning sensation, C-reactive protein increased, Dysmenorrhoea; Gait disturbance, General physical health deterioration, Heart rate increased, Heavy menstrual bleeding, Hot flush; Impaired work ability, Laboratory test, Loss of personal independence in daily activities, Polymenorrhoea, Postural orthostatic tachycardia syndrome; Seizure like phenomena, Sensory disturbance, Serum ferritin increased, Small fibre neuropathy, Supraventricular tachycardia; Syncope, Systemic inflammatory response syndrome, Tilt table test positive, Urinary incontinence, Vomiting; Walking aid user
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systemic inflammation (elevated levels of C-reactive protein, ferritin high); small fiber neuropathy...
systemic inflammation (elevated levels of C-reactive protein, ferritin high); small fiber neuropathy/autonomic injuries/drooping sensation in body/loss of bladder control/abnormal gait; Postural Orthostatic Tachycardia Syndrome (POTS)/autonomic injuries/increased heart rate/hot flushes/fainted and lost bladder control/erratic blood pressure/vomit; Supraventricular Tachycardia/increased heart rate//faint; seizure-like episodes/On a separate occasion, pt awoke with burning sensation in her head, collapsed to the floor, and began experiencing seizure-like activity. She was transported to the ER; Autoimmune injuries; abnormal uterine bleeding, characterized by excessively heavy menstrual periods accompanied by debilitating cramping. For nearly a full year, she experienced menstrual cycles every two weeks; Information has been received from a lawyer, regarding a case in litigation and concerning an adult female patient (pt) of an unknown age. No information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, at the age of 23 years old, the pt received her first and only dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On an unknown date, shortly after receiving quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt began to experience a dropping sensation in her body, increased heart rate, and extreme hot flashes. On her drive home from her doctor's appointment, she was forced to pull over and call an ambulance. The paramedics administered Benadryl and took her to the Emergency Room. At the Emergency Room, the pt fainted and lost bladder control. She underwent testing at the hospital and was released without a diagnosis. In the weeks following her quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine, she experienced significant health complications, including erratic blood pressure, an abnormal gait, seizure-like episodes, and an inability to perform basic self-care, such as bathing. Due to the severity of her condition, she required assistance of a walker for mobility. Her overall health deteriorated to the point that she was compelled to move back in with her mother to receive full-time care. On an unknown date, following an episode of fainting accompanied by vomiting, the pt was hospitalized at the hospital. Laboratory testing revealed elevated levels of C-reactive protein, indicating systemic inflammation. On a separate occasion, on an unknown date, the pt awoke with an intense burning sensation in her head, collapsed to the floor and began experiencing seizure-like activity. She was transported to the emergency room via ambulance and underwent further testing; however, no definitive diagnosis was provided. She later began experiencing abnormal uterine bleeding, characterized by excessively heavy menstrual periods accompanied by debilitating cramping. For nearly a full year, she experienced menstrual cycles every two weeks. The pt was given testing, including a tilt table test, and was diagnosed with small fiber neuropathy. The physician who conducted the testing informed her that her levels of C-reactive protein and ferritin were the highest he had encountered in his professional career. She was ultimately diagnosed by a cardiologist with supraventricular tachycardia and postural orthostatic tachycardia syndrome (POTS). As a result of her quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) -induced injuries, the pt was forced to resign from her job to prioritize her health. To manage her condition, she has made significant lifestyle adjustments. Her long-term goals and aspirations have been significantly impacted, and her financial resources have been substantially depleted because of ongoing medical expenses and treatment costs. Based on her chronic and severe post- quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms and adverse events as outlined above and the tests performed by several medical providers, the pt has been diagnosed with small fiber neuropathy, supraventricular tachycardia, and postural orthostatic tachycardia syndrome (POTS). The pt sustained autoimmune, autonomic, and neurological injuries as a result of her quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) injection. As a direct and proximate result of her quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) -induced injuries, the pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. As a proximate result of the negligently prescribed and administered quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, she had suffered and continued to suffer severe and permanent physical injuries and associated symptomology, and had suffered severe and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL). The outcome of the events was not recovered. The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). All events were considered disabling.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-08-04 , MNSC number : , CLIC number : , ESTAR number : LEGCLAPOL , IRMS number : 68955 , Central date : 2025-08-01 , Classification : DMC, Attachment description : Legal , Safety case number :
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| 2853149 | TX | 08/07/2025 |
MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
X027447 Z005455 |
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
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No additional AE; HCP reports that the patient received a dose of VARIVAX on 07/21/2025 and then a d...
No additional AE; HCP reports that the patient received a dose of VARIVAX on 07/21/2025 and then a dose of MMR II on 07/28/2025. No symptomatic events were reported. No additional information provided. No additional AE/ no PQC. DILEUNT used to reconstitute the vacci; This spontaneous report was received from a Nurse and refers to a(n) 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 21-Jul-2025, the patient was vaccinated with a dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5ml/ series, lot #Z005455 (reported as z005455), expiration date: 04-Mar-2027, administered for prophylaxis (route and strength was not reported). The Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot #Y020249 (reported as y020249), expiration date: 19-Oct-2027). On 28-Jul-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, 0.5ml/ series, lot #X027447 (reported as x027447), expiration date: 27-Nov-2025, administered for prophylaxis (route and strength was not reported). The Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot #2050911, expiration date: 11-Feb-2027) (Inappropriate schedule of product administration). No symptomatic events were reported. No additional information provided. No additional adverse event (AE) (No adverse event).
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| 2853150 | MO | 08/07/2025 |
MMRV |
MERCK & CO. INC. |
Y003883 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No symptoms reported. No additional AE details reported.; inadvertently administered an expired dose...
No symptoms reported. No additional AE details reported.; inadvertently administered an expired dose of PROQUAD on 08/06/2025; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 06-Aug-2025, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (0.5 mL, lot #Y003883, expiration date: 05-Aug-2025; rout of administration and vaccination site were not reported) for prophylaxis (Expired product administered). The vaccine was reconstituted with sterile diluent (strength, dose, lot # and expiration date not reported). There was no temperature excursion. No symptoms were reported. No additional AE details were reported.
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| 2853151 | CA | 08/07/2025 |
MMR MMR VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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No additional AE; second dose of VARIVAX on 05AUG2025; a first dose of MMR-II on 30JUN2025; This spo...
No additional AE; second dose of VARIVAX on 05AUG2025; a first dose of MMR-II on 30JUN2025; This spontaneous report was received from a medical assistant and refers to a Child patient (currently 4-year-old, age at onset was not provided) of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-Jun-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Inappropriate age at vaccine administration) and sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported); with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) and sterile diluent (MERCK STERILE DILUENT). On 05-Aug-2025, the patient was vaccinated with the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and sterile diluent (MERCK STERILE DILUENT); with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (Inappropriate schedule of vaccine administered) and sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). All were for prophylaxis. No additional event was reported (no adverse event). Lot # is being requested and will be submitted if received.
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| 2853153 | M | 08/07/2025 |
COVID19 FLUX VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK |
Facial paralysis; Facial paralysis; Facial paralysis
Facial paralysis; Facial paralysis; Facial paralysis
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experienced a facial palsy; This serious case was reported by a consumer via call center representat...
experienced a facial palsy; This serious case was reported by a consumer via call center representative and described the occurrence of facial palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis and Influenza vaccine for prophylaxis. On 17-JUL-2025, the patient received Shingrix, COVID-19 vaccine and Influenza vaccine. On 17-JUL-2025, less than a day after receiving Shingrix, COVID-19 vaccine and Influenza vaccine, the patient experienced facial palsy (Verbatim: experienced a facial palsy) (serious criteria hospitalization and GSK medically significant). The outcome of the facial palsy was unknown. It was unknown if the reporter considered the facial palsy to be related to Shingrix, COVID-19 vaccine and Influenza vaccine. The company considered the facial palsy to be unrelated to Shingrix. It was unknown if the company considered the facial palsy to be related to COVID-19 vaccine and Influenza vaccine. Additional Information: GSK Receipt Date: 31-JUL-2025 This case was reported by the wife of the patient. The reporter reported that her husband (patient) experienced a facial palsy after receiving Shingrix. The patient also received the Covid and Influenza vaccine the same day. Patient had to go the ER (emergency room) on 17th July 2025.; Sender's Comments: A case of Facial paralysis, less than a day after receiving Shingrix, in a male patient. Causal relation is indeterminate considering multiple vaccines given concomitantly.
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| 2853154 | F | IL | 08/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Pruritus, Vaccination failure
Herpes zoster, Pruritus, Vaccination failure
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she was diagnosed with shingles/lack of effect/Itching; This non-serious case was reported by a cons...
she was diagnosed with shingles/lack of effect/Itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. In MAR-2025, the patient received the 1st dose of Shingrix. In JUN-2025, between 2 and 3 months after receiving Shingrix, the patient experienced shingles (Verbatim: she was diagnosed with shingles/lack of effect/Itching). The patient was treated with prednisone. The outcome of the shingles was resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 10-JUL-2025 The patient was the reporter. She stated that she had received her first dose of Shingrix in March 2025. In June 2025, she was diagnosed with shingles, indicating a lack of effect. She mentioned that she broke out on one side of her body (location not disclosed) and experienced itching but did not develop a rash, bumps, or lesions. She reported being prescribed an antiviral and Prednisone to take for 10 days (name, frequency, and dose not disclosed). She stated that she had recently finished her course of Prednisone, and her case of shingles appeared to be resolved. She also noted that she did not experience any pain or complications related to this case of shingles. No further information was provided or obtained.
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| 2853156 | M | TX | 08/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Abdominal pain upper, Chills, Fatigue, Myalgia
Abdominal pain upper, Chills, Fatigue, Myalgia
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Shivering; Fatigue; Muscle ache; Stomachache; This non-serious case was reported by a consumer via c...
Shivering; Fatigue; Muscle ache; Stomachache; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivering in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis and COVID-19 vaccine for prophylaxis. The patient's past medical history included heart disorder (Heart disorder unknown, has a pacemaker). Concomitant products included amiodarone hydrochloride (Amiodarone), hydrochlorothiazide, valsartan (Valsartan) and hydralazine hydrochloride (Hydralazine). In NOV-2023, the patient received the 1st dose of Shingrix, RSV vaccine and COVID-19 vaccine. On an unknown date, an unknown time after receiving Shingrix, RSV vaccine and COVID-19 vaccine, the patient experienced shivering (Verbatim: Shivering), fatigue (Verbatim: Fatigue), muscle pain (Verbatim: Muscle ache) and stomach pain (Verbatim: Stomachache). The outcome of the shivering, fatigue, muscle pain and stomach pain were resolved. It was unknown if the reporter considered the shivering, fatigue, muscle pain and stomach pain to be related to Shingrix, RSV vaccine and COVID-19 vaccine. It was unknown if the company considered the shivering, fatigue, muscle pain and stomach pain to be related to Shingrix, RSV vaccine and COVID-19 vaccine. Additional Information: GSK receipt date: 25-JUL-2025 In Nov 2023, the day after receiving the Shingrix vaccine (along with the Covid and RSV vaccine at the same time) the patient experienced shivering, fatigue, muscle aches and a stomachache which all resolved in a few days.
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| 2853157 | 08/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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missed 2nd dose of Shingrix; This non-serious case was reported by a pharmacist via call center repr...
missed 2nd dose of Shingrix; 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 (patient received 1st dose on unknown date). The patient did not receive the 2nd dose of Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed 2nd dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 28-JUL-2025 Other HCP inquired about the missed 2nd dose of Shingrix. A patient asked if she needed to restart the 1st dose because her 2nd dose fell off the window period of 2-6 months after the 1st dose. Also asked if she get the 2nd dose now even 12 months later or not. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2853158 | M | 08/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected Vaccination failure; developed shingles; This serious case was reported by a consumer via ...
Suspected Vaccination failure; developed shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles). The outcome of the vaccination failure and shingles were not reported. The reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. The company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 29-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter son developed shingles from the varicella vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided, regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2853159 | 08/07/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 31-JUL-2025 This case was reported by a patient via interactive digital media. Patient had received both shots, but he/she got Shingles now. There was no guarantee. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
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| 2853160 | 13 | F | TX | 08/07/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
DL4YY KR75K |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Extra dose administered/2nd dose administered of Boostrix and Menveo; This non-serious case was repo...
Extra dose administered/2nd dose administered of Boostrix and Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 13-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KR75K) for prophylaxis. Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number DL4YY) for prophylaxis. Previously administered products included Boostrix (received first dose of Boostrix on 19 Aug 2024) and Menveo (received first dose of Menveo on 19 Aug 2024). On 12-JUN-2025, the patient received the 2nd dose of Boostrix and the 2nd dose of Menveo. On 12-JUN-2025, an unknown time after receiving Boostrix and Menveo, the patient experienced extra dose administered (Verbatim: Extra dose administered/2nd dose administered of Boostrix and Menveo). The outcome of the extra dose administered 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: 11-JUL-2025 The patient did receive Boostrix and then Menveo when they were 12 years old, they came back at 13 years old, and they received it again which led to extra dose administered. During the call, the healthcare professional mentioned that the patient received for first time the Boostrix and Menveo on 19 Aug 2024. And the patient received again Boostrix and Menveo (1 vial) on 12 Jun 2025. The healthcare professional mentioned that for the 1st Menveo dose, they were not sure if this was the 1-vial or the 2-vials presentation and the 2nd Menveo dose was the 1-vial presentation.
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| 2853161 | 7 | F | TX | 08/07/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
A5573 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Infanrix administered after recommended age; This non-serious case was reported by a nurse via call ...
Infanrix administered after recommended age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa (Infanrix) (batch number A5573, expiry date 13-JUL-2025) for prophylaxis. Previously administered products included Pediarix and Kinrix. On 16-JAN-2025, the patient received Infanrix. On 16-JAN-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix administered after recommended 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: 22-JUL-2025 The nurse called on 22nd July 2025, to report that a 7-year-old patient had received Infanrix on 16th January 2025, which led to Inappropriate age at vaccine administration. The nurse explained that the incident had been discovered while reviewing a billing claim.
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| 2853162 | 70 | NY | 08/07/2025 |
HEP HEPAB HEPAB |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Interchange of vaccine products; Interchange of vaccine products; Interchange of...
Interchange of vaccine products; Interchange of vaccine products; Interchange of vaccine products
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Interchangeability with Heplisav; This non-serious case was reported by a pharmacist via call center...
Interchangeability with Heplisav; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 70-year-old patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis and HAB (Twinrix) for prophylaxis. On 13-JAN-2025, the patient received the 1st dose of Twinrix. On 13-FEB-2025, the patient received the 2nd dose of Heplisav b. On 24-JUL-2025, the patient received the 3rd dose of Twinrix. On 13-FEB-2025, 31 days after receiving Twinrix, Heplisav b and Twinrix and an unknown time after receiving Twinrix, Heplisav b and Twinrix, the patient experienced interchange of vaccine products (Verbatim: Interchangeability with Heplisav). The outcome of the interchange of vaccine products 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: 24-JUL-2025 Other HCP reported that they had a question about a schedule for the vaccine (Twinrix) that was done improperly. So, the initial vaccine for 2 people, a couple, they got their initial Twinrix vaccine in 13-Jan-2025. When they were supposed to received dose 2 of Twinrix, they were given Heplisav in error by a different pharmacist which led to interchange of vaccine products. And on the day of reporting, 6 months later, they were trying to get dose 3 of Twinrix. This case is linked with US2025095849 reported by same reporter.; Sender's Comments: US-GSK-US2025095849:same reporter, Different patient
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| 2853163 | 71 | NY | 08/07/2025 |
HEP HEPAB HEPAB |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Interchange of vaccine products, Wrong product administered; Interchange of vacc...
Interchange of vaccine products, Wrong product administered; Interchange of vaccine products, Wrong product administered; Interchange of vaccine products, Wrong product administered
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When they supposed to received dose 2 of Twinrix, they were given Heplisav in error by a different p...
When they supposed to received dose 2 of Twinrix, they were given Heplisav in error by a different pharmacist; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 71-year-old patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis and HAB (Twinrix) for prophylaxis. On 13-JAN-2025, the patient received the 1st dose of Twinrix. On 13-FEB-2025, the patient received the 2nd dose of Heplisav b. On 24-JUL-2025, the patient received the 3rd dose of Twinrix. On 13-FEB-2025, 31 days after receiving Twinrix, Heplisav b and Twinrix and an unknown time after receiving Twinrix, Heplisav b and Twinrix, the patient experienced interchange of vaccine products (Verbatim: When they supposed to received dose 2 of Twinrix, they were given Heplisav in error by a different pharmacist). The outcome of the interchange of vaccine products 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: 24-JUL-2025 Other HCP reported that they had a question about a schedule for the vaccine (Twinrix) that was done improperly. So, the initial vaccine for 2 people, a couple, they got their initial Twinrix vaccine in 13-Jan-2025. When they were supposed to received dose 2 of Twinrix, they were given Heplisav in error by a different pharmacist which led to interchange of vaccine products. And on the day of reporting, 6 months later, they were trying to get dose 3 of Twinrix. This case is linked with US2025095527 reported by same reporter.; Sender's Comments: US-GSK-US2025095527:same reporter, Different patient
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| 2853164 | 24 | M | FL | 08/07/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Product preparation issue
Product preparation issue
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Possible administration of only diluent; Possible administration of only diluent; patient being a 24...
Possible administration of only diluent; Possible administration of only diluent; patient being a 24-year-old male; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 24-year-old male patient who received MMR (Priorix) for prophylaxis. On 24-JUL-2025, the patient received the 1st dose of Priorix. On 24-JUL-2025, an unknown time after receiving Priorix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Possible administration of only diluent), inappropriate preparation of medication (Verbatim: Possible administration of only diluent) and inappropriate age at vaccine administration (Verbatim: patient being a 24-year-old male). The outcome of the inappropriate dose of vaccine administered, inappropriate preparation of medication and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 24-JUL-2025 A pharmacist called in to request data about the possible administration of Priorix after 2 patients where involved, where only one of them received only the diluent portion of the vaccine which led to inappropriate dose of vaccine administration and inappropriate preparation of medication, but they were unsure of whom. Only patient data was collected, with the first patient being a 24-year-old male which led to inappropriate age at vaccine administration.
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| 2853165 | F | IN | 08/07/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error
Product storage error
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administration of a Priorix dose no longer stable after a temperature excursion; This non-serious ca...
administration of a Priorix dose no longer stable after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: administration of a Priorix dose no longer stable after a temperature excursion). The outcome of the incorrect storage of drug 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: 24-JUL-2025 The office manager called to get stability information of Priorix exposed to minus18๏ฟฝF as the minimum for 30 days which led to, incorrect storage of drug. No prior excursions. After giving the stability info, she asked how to proceed if she administered one of the doses exposed to the excursion to a patient. The information was shared. The agent tried to collect the adverse event details, but she mentioned to have no access at the time, so the agent provided the case number for a call back from her to provide the details. The caller only confirmed the zip code of the facility where the vaccine was given, for the rest she mentioned to have no access at the time of the call, so would try to call us back to provide was needed (case number was given to her for so). The Vaccine Administration Facility was the same as Primary Reporter.
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| 2853166 | 5 | F | FL | 08/07/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
HR4RB |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Adult presentation given to pediatric patient; This non-serious case was reported by a other health...
Adult presentation given to pediatric patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 5-year-old female patient who received HAV (Havrix) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis. On 28-JUL-2025, the patient received Havrix. On 28-JUL-2025, an unknown time after receiving Havrix, the patient experienced adult product administered to child (Verbatim: Adult presentation given to pediatric patient). The outcome of the adult product administered to child 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: 28-JUL-2025 Other HCP reported that they administered an adult presentation of Havrix to a 5-year-old patient on July 28th, 2025, which led to adult product administered to child.
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| 2853167 | 65 | M | 08/07/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
T9TL9 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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received the fist dose of Havrix in October of 2024 and the second dose in January of 2025.; This no...
received the fist dose of Havrix in October of 2024 and the second dose in January of 2025.; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 65-year-old male patient who received HAV (Havrix) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis. Previously administered products included Havrix (received 1st dose in October 2024). In JAN-2025, the patient received the 2nd dose of Havrix. In JAN-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: received the fist dose of Havrix in October of 2024 and the second dose in January of 2025.). The outcome of the drug dose administration interval too short was not applicable. Additional Information: GSK Receipt Date: 29-JUL-2025 The nurse reports a patient received the first dose of Havrix vaccine in October of 2024 and the second dose in January of 2025. The patient received 2nd dose of Havrix vaccine earlier than recommended interval, which led to shortening of vaccination schedule.
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| 2853168 | NY | 08/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error
Product storage error
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Some patients might have received Arexvy after a temperature excursion (below the recommended storag...
Some patients might have received Arexvy after a temperature excursion (below the recommended storage range); This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Some patients might have received Arexvy after a temperature excursion (below the recommended storage range)). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 29-JUL-2025 A senior medical assistant called to ask about the stability of Arexvy, after a temperature excursion of 31.3 degree fahrenheit for 10 minutes. The healthcare professional mentioned that some patients might have received Arexvy after this temperature excursion but she was not sure, which led to incorrect storage of drug. She did not provide any patient information and she did not provide any lot number or expiration date. The reporter wanted to know if they have to revaccinate the patients who possibly received the vaccine after a temperature excursion.
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| 2853169 | 3 | M | TX | 08/07/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
TC3N5 |
Product preparation issue
Product preparation issue
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only diluent portion was administered; only diluent portion was administered; This non-serious case ...
only diluent portion was administered; only diluent portion was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 3-year-old male patient who received Hib (Hiberix) (batch number TC3N5, expiry date 17-MAR-2026) for prophylaxis. On 24-JUL-2025, the patient received Hiberix. On 24-JUL-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: only diluent portion was administered) and inappropriate dose of vaccine administered (Verbatim: only diluent portion was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 30-JUL-2025 Registered nurse explained that a colleague administered Hiberix to patient but only diluent portion was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
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| 2853170 | 62 | M | NV | 08/07/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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Contracted covid 19 infection; This spontaneous case was reported by a consumer and describes the oc...
Contracted covid 19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted covid 19 infection) in a 62-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In July 2022, the patient experienced COVID-19 (Contracted covid 19 infection) (seriousness criterion death). The patient died on 29-Jul-2022. The reported cause of death was contracted covid 19 infection. It is unknown if an autopsy was performed. Concomitant medication was not reported. It was reported that he contracted COVID-19 infection about one week before he died on 29-Jul-2022. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: contracted covid 19 infection
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| 2853171 | 08/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Autoimmune disorder, Tinnitus
Autoimmune disorder, Tinnitus
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autoimmune disease; developed tinnitus 2 weeks after 1st covid shot. It's worsened after 2nd an...
autoimmune disease; developed tinnitus 2 weeks after 1st covid shot. It's worsened after 2nd and 3rd shots.; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Tinnitus"; Bnt162b2 nos (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "autoimmune disease", "It's worsened after 2nd and 3rd shots", "Tinnitus". The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; TINNITUS (non-serious), outcome "unknown", described as "developed tinnitus 2 weeks after 1st covid shot. It's worsened after 2nd and 3rd shots". Clinical course: Patient developed tinnitus 2 weeks after 1st covid shot. It was worsened after 2nd and 3rd shots. Patient developed autoimmune disease after 3 covid vaccines. Patient developed autoantibodies but had no diagnosis after 3 covid shots. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500158063 same patient/reporter, different vaccine dose/AE;
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| 2853172 | 08/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Autoimmune disorder, Tinnitus
Autoimmune disorder, Tinnitus
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autoimmune disease; tinnitus/worsened after 2nd shot; This is a spontaneous report received from a C...
autoimmune disease; tinnitus/worsened after 2nd shot; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Tinnitus". The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus/worsened after 2nd shot". Additional information: The patient developed tinnitus 2 weeks after 1st covid shot. It's worsened after 2nd and 3rd shots. It was also reported that after the 2nd and 3rd vaccine, the patient developed an autoimmune disease. The patient asked if it is safe to get more and asked how to monitor heath after developing autoantibodies The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500158037 same patient/reporter, different vaccine dose/AE;US-PFIZER INC-202500157611 same patient/reporter, different vaccine dose/AE;
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| 2853173 | SD | 08/07/2025 |
RSV |
PFIZER\WYETH |
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Device breakage
Device breakage
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the tip injector of Abrysvo broke when they were mixing it; This is a spontaneous report received fr...
the tip injector of Abrysvo broke when they were mixing it; This is a spontaneous report received from a Pharmacist from product quality group. It was not reported if a patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MATERIAL ISSUE (non-serious), outcome "unknown", described as "the tip injector of Abrysvo broke when they were mixing it". Additional information: The reporter requested for a replacement because the tip injector of Abrysvo broke when they were mixing it. Causality for "the tip injector of abrysvo broke when they were mixing it" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
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| 2853174 | F | NV | 08/07/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective, SARS-Co...
COVID-19, Drug ineffective, SARS-CoV-2 test; COVID-19, Drug ineffective, SARS-CoV-2 test
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COVID After Pfizer Shots; COVID After Pfizer Shots; This is a spontaneous report received from a Con...
COVID After Pfizer Shots; COVID After Pfizer Shots; This is a spontaneous report received from a Consumer or other non HCP. A 91-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jul2025, outcome "unknown" and all described as "COVID After Pfizer Shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Aug2025) Positive. Clinical course: During an inbound call for Financial Assistance a Pfizer Representative, stated Patient's husband was calling on behalf of his wife. He did mention that patient was a 91-year-old, and she was given a prescription for Paxlovid. She became sick on Thursday. She had a high fever last night. He gave her a COVID test this morning, and it tested positive. They have had all of the Pfizer shots except this very latest one and they thought they were good. But she tested positive this morning. She called the Doctor, the Doctor called in this prescription, and the pharmacy did not have it in stock. They have ordered it, they were going to have it tomorrow. They don't know what is going to happen because she cannot afford this. He don't know whether he will have to take her to the hospital or what. When asked to speak with the patient, She was asleep in another room and she can not get up to get on the landline.
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| 2853175 | F | 08/07/2025 |
DTAP |
UNKNOWN MANUFACTURER |
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Rash
Rash
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rashes; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case...
rashes; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from patient. This case involves an unknown age female patient who had rashes after receiving vaccine diphtheria, tetanus and acellular pertussis vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (Unknown strength, formulation lot and expiry date) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date the patient developed rashes (rash) (unknown latency) following the administration of diphtheria and tetanus and acellular pertussis vaccine. Reportedly, Patient stated that 13 years ago, they received Tdap in the ER and they experienced rashes and it was reported. It was a Sanofi vaccine. It's been a while, so they should have another Tdap. In the meantime, they were diagnosed with celiac disease, so they wanted to know if there is any gluten-derived ingredient in the Sanofi vaccine. Action taken was not applicable. It was not reported if the patient received corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.
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| 2853176 | 43 | F | NH | 08/07/2025 |
TDAP |
SANOFI PASTEUR |
unknown |
Mobility decreased, Myalgia, X-ray
Mobility decreased, Myalgia, X-ray
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I fell on my forehead on 6/16. I was not up to date on tetanus so they gave me the vaccine. About ...
I fell on my forehead on 6/16. I was not up to date on tetanus so they gave me the vaccine. About 3 hours later my arm (shoulder area near muscle) was so sore I could not lift it. I went back the next day and they gave me an xray. I went back 10 days later when I still had limited range of motion and they did not really do anything. I am not in PT.
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| 2853177 | 33 | F | IL | 08/07/2025 |
RSV VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
0 0 |
Vomiting; Vomiting
Vomiting; Vomiting
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At 0430 vomiting started occurring. At 0515 emergency is declared and Zofran is dispensed at 0530 th...
At 0430 vomiting started occurring. At 0515 emergency is declared and Zofran is dispensed at 0530 the emergency is escalated to clinicians. At 0540 the situation is considered ?surveillance stable?
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| 2853178 | 16 | F | IN | 08/07/2025 |
MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
XL223 U8271AC |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Patient was administered two doses of MCV ACWY in place of one dose MCV4 and one dose Men B
Patient was administered two doses of MCV ACWY in place of one dose MCV4 and one dose Men B
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| 2853179 | 54 | F | NY | 08/07/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
014F21A 014F21A 014F21A |
Cardiac monitoring normal, Computerised tomogram normal, Echocardiogram normal, ...
Cardiac monitoring normal, Computerised tomogram normal, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal; Headache, Loss of consciousness, Magnetic resonance imaging head normal, Scan with contrast normal, Syncope; Ultrasound Doppler, Ultrasound scan normal
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On May 22, 2024 I experienced an episode of syncope with no prodrome and no apparent cause. I was se...
On May 22, 2024 I experienced an episode of syncope with no prodrome and no apparent cause. I was seated at my desk typing (after eating lunch and drinking fluids), and then I was on the floor with coworkers calling my name to revive me from passing out. They let me know that I was out for ~30-60 seconds. This has never happened to me before. I was taken to the ER to rule out heart- and brain-related causes. No cause was found. One year and two months later, on July 19, 2025, I was sitting at a table eating lunch with friends. I was in the middle of telling a story, and I suddenly passed out with no forewarning or physical signs (e.g., lightheadness, sweating). I was out for ~30 seconds. I regained consciousness in response to my husband calling my name and shaking me. The episode was followed with a persistent headache for about a week. The EKG and brain CT scan with contrast showed no irregularities. I am in the process of being evaluated a cardiologist and neurologist.
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| 2853180 | 17 | F | IN | 08/07/2025 |
MNQ |
SANOFI PASTEUR |
U8599AA |
Injection site erythema, Injection site mass, Injection site pruritus, Injection...
Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
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KNOT AT INJECTION SITE. REDNESS, ITCHING AND SWELLING. WARM TO TOUCH
KNOT AT INJECTION SITE. REDNESS, ITCHING AND SWELLING. WARM TO TOUCH
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| 2853181 | 13 | M | NY | 08/07/2025 |
RAB RAB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
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Ageusia, Arthralgia; Ageusia, Arthralgia
Ageusia, Arthralgia; Ageusia, Arthralgia
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Joint pain began after shot 3, worsened and isolated to lower back and knees after shot 4. After sho...
Joint pain began after shot 3, worsened and isolated to lower back and knees after shot 4. After shot 4, full sense of taste lost. Neither have been relieved.
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| 2853182 | 16 | F | PA | 08/07/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
CD44A U8169AB |
Syncope; Syncope
Syncope; Syncope
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Patient had a brief syncopal episode post injection, that may have also been due to having blood dra...
Patient had a brief syncopal episode post injection, that may have also been due to having blood drawn during the same office visit.
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| 2853184 | 17 | F | NY | 08/07/2025 |
UNK |
UNKNOWN MANUFACTURER |
7MN4C |
Chills, Discomfort, Erythema, Pyrexia, Swelling
Chills, Discomfort, Erythema, Pyrexia, Swelling
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Pt says 3 hrs after vaccine, she developed redness, swelling and discomfort. Also said she had fever...
Pt says 3 hrs after vaccine, she developed redness, swelling and discomfort. Also said she had fever/chills.
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| 2853185 | 46 | M | OH | 08/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
27LR2 |
Dyspnoea, Influenza like illness, Myalgia, Pyrexia
Dyspnoea, Influenza like illness, Myalgia, Pyrexia
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flu like sympotms, myalgias, fever, SOB. Symptoms began on his way home after getting the 2nd shing...
flu like sympotms, myalgias, fever, SOB. Symptoms began on his way home after getting the 2nd shingrix vaccine.
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| 2853186 | 1.17 | F | FL | 08/07/2025 |
IPV VARCEL |
SANOFI PASTEUR MERCK & CO. INC. |
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Rash, Rash erythematous, Rash papular, Rash pruritic; Rash, Rash erythematous, R...
Rash, Rash erythematous, Rash papular, Rash pruritic; Rash, Rash erythematous, Rash papular, Rash pruritic
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Red, itchy, raised rash on back/neck/abdomen
Red, itchy, raised rash on back/neck/abdomen
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| 2853187 | 10 | M | TN | 08/07/2025 |
HEP HEPA IPV TDAP VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
3N2ND J4K4X X1D141M PG3RP Y015558 |
Syncope; Syncope; Syncope; Syncope; Syncope
Syncope; Syncope; Syncope; Syncope; Syncope
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After receiving five vaccinations, the patient jumped off of the exam table then stood against the w...
After receiving five vaccinations, the patient jumped off of the exam table then stood against the wall to watch his sibling get their vaccination. Approximately, two minutes later the mother got my attention and I witnessed the mother holding the patient as he began to faint against the wall. The father and mother assisted me with putting the patient supine upon the examination table. The patient did not loose consciousness, I elevated both of his lower extremities while additional clinic staff arrived to assist with the patient's recovery. The patient's blood pressure was assessed to be within normal range, a bottle of water was provided, and sweet candy was given to the patient to eat. Advised the parents that a vasovagal syncope it is common for children getting vaccinations at this age. Patient laid supine for ten plus minutes then recovered. Prior to leaving the clinic the patient stated that he felt fine". Advised to continue with drinking water and can take Tylenol if discomfort is felt.
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| 2853188 | 88 | M | 08/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Confusional state, Hallucination
Confusional state, Hallucination
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Severe confusion, hallucinations, not making sense. Resolved in 24 hours.
Severe confusion, hallucinations, not making sense. Resolved in 24 hours.
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| 2853189 | 11 | F | AL | 08/07/2025 |
MMR |
MERCK & CO. INC. |
X026219 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received extra dose of MMR on 8/6/2025. Patient received MMR on 8/18/2015 and 11/18/2015....
Patient received extra dose of MMR on 8/6/2025. Patient received MMR on 8/18/2015 and 11/18/2015. No adverse event was reported at this time.
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| 2853190 | 18 | F | OR | 08/07/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
k7jy3 |
Syncope
Syncope
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After getting vaccination, patient fainted.
After getting vaccination, patient fainted.
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| 2853191 | 4 | M | FL | 08/07/2025 |
DTAPIPV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5C79N 4SB5S Y003892 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
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Left thigh with red, warm, raised area
Left thigh with red, warm, raised area
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