| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2827739 | F | AZ | 11/20/2024 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Exposure during pregnancy, Product use issue; Exposure during pregnancy, Product...
Exposure during pregnancy, Product use issue; Exposure during pregnancy, Product use issue
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administration to pregnant patients; administration to pregnant patients; This non-serious prospecti...
administration to pregnant patients; administration to pregnant patients; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of drug exposure during pregnancy in a female 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 drug exposure during pregnancy (Verbatim: administration to pregnant patients) and product use in unapproved population (Verbatim: administration to pregnant patients). The outcome of the drug exposure during pregnancy and product use in unapproved population were unknown. Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 30-OCT-2024 The reporter called inquiring if Arexvy was safe for pregnant woman. The office was giving it to pregnant patient. The reporter stated that there was pregnant patient who received Arexvy recently, which led to vaccine exposure during pregnancy and product use in unapproved population. The reporter had no additional information but would ask nurse practitioner to call with more details. No lot/expiration date were available. No patient details were available. No dates of administration were available. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments: US-GSK-US2024134993:patient 1 US-GSK-US2024AMR142776:Patient 2
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| 2859250 | 4 | M | CO | 09/16/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2504 |
Unevaluable event
Unevaluable event
|
n/a
n/a
|
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| 2859251 | 76 | M | FL | 09/16/2025 |
COVID19 |
MODERNA |
3031632 |
Polymyalgia rheumatica
Polymyalgia rheumatica
|
polymyalgia rheumatica
polymyalgia rheumatica
|
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| 2859252 | 45 | F | CO | 09/16/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
MY9547 MY9547 |
C-reactive protein increased, Chest X-ray normal, Electrocardiogram normal, Fibr...
C-reactive protein increased, Chest X-ray normal, Electrocardiogram normal, Fibrin D dimer normal, Pericarditis; Troponin normal
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pericarditis 3 days after vaccine. classic symptoms, elevated crp 50.
pericarditis 3 days after vaccine. classic symptoms, elevated crp 50.
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| 2859279 | 60 | M | PR | 09/16/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Extra dose administered
Extra dose administered
|
Patient came to the pharmacy asking for the shingles vaccine. The vaccine was billed with his insura...
Patient came to the pharmacy asking for the shingles vaccine. The vaccine was billed with his insurance and it was paid in full. The pharmacist administered the vaccine and told him that he had to come back for a second dose. The patient asked if this vaccine had to be administered like the flu shot,once a year and the pharmacist told him that it was a once in a lifetime vaccine. At that moment the patient told the pharmacist that he was not sure if he already had received a series of shingrix vaccine at another pharmacy. The pharmacist checked immune registry and,indeed,he had received two shingrix doses in 2023 at pharmacy.
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| 2859280 | 64 | M | FL | 09/16/2025 |
COVID19 |
PFIZER\BIONTECH |
No idea |
Gastrointestinal pain, Sleep disorder
Gastrointestinal pain, Sleep disorder
|
I have constant pain in my intestines, I haven?t slept through the night in 4.5 years.
I have constant pain in my intestines, I haven?t slept through the night in 4.5 years.
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| 2859281 | 63 | F | 09/16/2025 |
COVID19 |
MODERNA |
3052731 |
Syncope
Syncope
|
Patient fainted 10 minutes after vaccine was administered
Patient fainted 10 minutes after vaccine was administered
|
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| 2859282 | 67 | F | WA | 09/16/2025 |
COVID19 |
JANSSEN |
|
Computerised tomogram, Imaging procedure, Magnetic resonance imaging, Transverse...
Computerised tomogram, Imaging procedure, Magnetic resonance imaging, Transverse sinus thrombosis
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Nonocclusive, cerebral left transverse sinus thrombosis
Nonocclusive, cerebral left transverse sinus thrombosis
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| 2859283 | 69 | F | CA | 09/16/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
3052154 3052154 |
Pruritus, Urticaria; Urticaria; Pruritus, Urticaria; Urticaria
Pruritus, Urticaria; Urticaria; Pruritus, Urticaria; Urticaria
|
Generalized urticaria and itching
Generalized urticaria and itching
|
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| 2859284 | 2 | F | AZ | 09/16/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK342ZA |
Wrong product administered
Wrong product administered
|
Pt was supposed to be given Hep A, and The Siblings vaccines were on the same tray so the Medical as...
Pt was supposed to be given Hep A, and The Siblings vaccines were on the same tray so the Medical assistant accidently gave Pentacel
More
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| 2859285 | 58 | F | WA | 09/16/2025 |
COVID19 |
MODERNA |
3052671 |
Induration, Muscle twitching, Pain in extremity, Rash, Vertigo
Induration, Muscle twitching, Pain in extremity, Rash, Vertigo
|
had a reaction to spikevax, had a rash on strip on left leg, looks like broken blood vessels. forear...
had a reaction to spikevax, had a rash on strip on left leg, looks like broken blood vessels. forearm was experiencing a hardening and twitching sensation which was really painful. experienced vertigo
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| 2859286 | 46 | F | 09/16/2025 |
PNC21 |
MERCK & CO. INC. |
Z003579 |
Erythema, Fatigue, Pain in extremity, Skin warm
Erythema, Fatigue, Pain in extremity, Skin warm
|
local redness, warm to touch, feels fatigued, sore arm upon waking up
local redness, warm to touch, feels fatigued, sore arm upon waking up
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| 2859287 | 57 | M | CO | 09/16/2025 |
PNC21 |
MERCK & CO. INC. |
Y019157 |
Eye irritation, Ocular hyperaemia
Eye irritation, Ocular hyperaemia
|
Patient complained that one day after he received Capvaxive both of his eyes are red and have burnin...
Patient complained that one day after he received Capvaxive both of his eyes are red and have burning sensation
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| 2859288 | 61 | F | NM | 09/16/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
UT8826LA Z003579 |
Injection site bruising, Injection site swelling; Injection site bruising, Injec...
Injection site bruising, Injection site swelling; Injection site bruising, Injection site swelling
More
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Bruising/ swelling of the injection site and surrounding upper arm area.
Bruising/ swelling of the injection site and surrounding upper arm area.
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| 2859289 | 79 | F | GA | 09/16/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
HB2025 HB2025 |
Brain fog, Disturbance in attention, Injection site pain, Injection site reactio...
Brain fog, Disturbance in attention, Injection site pain, Injection site reaction, Injection site swelling; Pain in extremity, Urticaria
More
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Large red welt with puffiness and pain, from site of injection to below elbow; brain "fog"...
Large red welt with puffiness and pain, from site of injection to below elbow; brain "fog" sufficiently severe that I missed 2 days of some of my prescription medications (forgot to take them although these are routine); inability to concentrate; prostration (in bed for two days). I have had flu shots my entire long life and have never had a response like this to flu vaccine. Issues are very slowly resolving without medical intervention.
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| 2859290 | M | WA | 09/16/2025 |
SMALL SMALL |
EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS |
|
Cyanosis, Diarrhoea, Gastrooesophageal reflux disease, Odynophagia, Respiratory ...
Cyanosis, Diarrhoea, Gastrooesophageal reflux disease, Odynophagia, Respiratory arrest; Vomiting
More
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Within 30-45 minutes patient briefly stopped breathing, and body turned purple. Nurses were able to ...
Within 30-45 minutes patient briefly stopped breathing, and body turned purple. Nurses were able to get her breathing again quickly with chest massage. Since then she has also had multiple gastro troubles- unknown if related to vaccine or not but that would include vomiting, significant reflux, Diarrhea, pain while swallowing, etc.
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| 2859291 | 53 | F | IL | 09/16/2025 |
FLU3 VARZOS |
SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
406986 FT95N |
Rash; Rash
Rash; Rash
|
Patient broke out with local rase on upper body including chest
Patient broke out with local rase on upper body including chest
|
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| 2859292 | 86 | F | FL | 09/16/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781AA |
Asthenia, Chills, Feeling hot, Hyperhidrosis, Lethargy
Asthenia, Chills, Feeling hot, Hyperhidrosis, Lethargy
|
Approximately 1 hour after vaccine administration patient came down with chills, felt feverish ( di...
Approximately 1 hour after vaccine administration patient came down with chills, felt feverish ( did not know if fever developed) , lethargy , weakness, sweating
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| 2859293 | 55 | M | CA | 09/16/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
5ST5M |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Patient administered DTAP (Infantrix) at 04:09pm, but no adverse reaction was apparent after dose wa...
Patient administered DTAP (Infantrix) at 04:09pm, but no adverse reaction was apparent after dose was given.
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| 2859294 | 93 | F | WV | 09/16/2025 |
FLU3 |
SEQIRUS, INC. |
407245 |
Back pain, Dizziness, Hypotonia, Loss of consciousness, Pain in extremity
Back pain, Dizziness, Hypotonia, Loss of consciousness, Pain in extremity
|
PATIENT FELT DIZZY AND LIGHTHEADED APPROXIMATELY 5 MINUTES AFTER INJECTION. PATIENT WAS SEATED AND B...
PATIENT FELT DIZZY AND LIGHTHEADED APPROXIMATELY 5 MINUTES AFTER INJECTION. PATIENT WAS SEATED AND BEGAN TO SLUMP BACKWARDS AND LOSE CONSCIOUSNESS. PHARMACIST AND PATIENT CAREGIVER (DAUGHTER) SUPPORTED PATIENT WHILE SPEAKING HER NAME. PATIENT REGAINED CONSCIOUSNESS ABOUT 30 SECONDS LATER. PATIENT REPORTED EXTREME LIGHTHEADEDNESS, FAINTNESS, AND DIZZINESS. AFTER A FEW MINUTES SHE HAD PAIN IN HER BACK AND LEGS THAT LASTED FOR ABOUT 2-3 MINUTES. PATIENT SIPPED SOME WATER AND BEGAN TO FEEL BETTER ABOUT 10 MINUTES LATER. PATIENT AND DAUGHTER DECLINED MEDICAL AID AND LEFT ON THEIR OWN ABOUT 45 MINUTES AFTER IMMUNIZATION. PATIENT REPORTED FEELING WEAK BUT MUCH BETTER AT THAT TIME.
More
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| 2859295 | 62 | M | FL | 09/16/2025 |
PNC20 |
PFIZER\WYETH |
|
Extra dose administered
Extra dose administered
|
Patient recieved duplicate dose of prevnar 20. one dose on 9/23/2024 and the second dose on 9/15/25
Patient recieved duplicate dose of prevnar 20. one dose on 9/23/2024 and the second dose on 9/15/25
|
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| 2859296 | 69 | F | FL | 09/16/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
AZ2A3 |
Nausea, Retching
Nausea, Retching
|
NAUSEA, DRY HEAVING
NAUSEA, DRY HEAVING
|
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| 2859297 | 41 | F | WA | 09/16/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Abdominal pain upper, Body temperature increased, Brain fog, Cold sweat, Diaphra...
Abdominal pain upper, Body temperature increased, Brain fog, Cold sweat, Diaphragmalgia; Diaphragmatic spasm, Diarrhoea, Dysmenorrhoea, Dyspnoea, Ear pain; Fatigue, Feeling abnormal, Feeling of body temperature change, Headache, Heavy menstrual bleeding; Hyperhidrosis, Hypoacusis, Hypoaesthesia, Influenza like illness, Memory impairment; Nasal congestion, Nasopharyngitis, Oesophageal pain, Oesophageal spasm, Palpitations; Paraesthesia, Protein total decreased, Sleep disorder, Specific gravity urine increased, Tremor; Upper-airway cough syndrome, Urine analysis abnormal, Vomiting, pH urine increased
More
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Within 12 hours of receiving the 2nd vaccination, I started experiencing minor flu and cold-like sym...
Within 12 hours of receiving the 2nd vaccination, I started experiencing minor flu and cold-like symptoms that continuously come and go to the present.. I have struggled with fatigue, brain fog, short-term memory struggles, sleep issues, cramping and more heavy/painful periods, shaky hands at times, headaches, stomach aches, diaphragm/esophageal pain and spasms, vomiting, diarrhea, clammy with spike in temp./hot and cold sweats, heart racing, numbness and tingling on my back and legs, hand tremors, shortness of breath or not being able to take a deep breath at times, ear pain/hearing issues, nasal congestion with thin mucus and post-nasal drip. I am typically a very healthy and active woman, and I have not felt myself, mentally or physically since 2021.
More
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| 2859298 | 33 | F | OH | 09/16/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
|
Rash, Swelling; Rash, Swelling
Rash, Swelling; Rash, Swelling
|
Raised local rash/swelling, approx 2 inches wide, painful no itchiness
Raised local rash/swelling, approx 2 inches wide, painful no itchiness
|
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| 2859299 | 16 | F | CA | 09/16/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
Y015180 U8558BA |
Peripheral swelling, Pruritus, Rash, Rash pruritic, Urticaria; Peripheral swelli...
Peripheral swelling, Pruritus, Rash, Rash pruritic, Urticaria; Peripheral swelling, Pruritus, Rash, Rash pruritic, Urticaria
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about 6-7pm she began to have itchy rash on her face which progressed to neck and torso, also had it...
about 6-7pm she began to have itchy rash on her face which progressed to neck and torso, also had itchy and swelling of hands. no vomiting, no mouth swelling, no difficulty breathing. She presented to the ER at 9pm and was given 25mg benedryl and 12 mg decadron both po - after this rash resolved. ED physician states no signs of anaphylaxis, urticaria only noted. they did Rx epi pen for home. I saw patient 10 days later and no recurrence of any itching or rash.
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| 2859306 | 4 | F | CA | 09/16/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
5C79N Z008867 |
Erythema; Erythema
Erythema; Erythema
|
Parent reported redness of face + cheek/chin after shots (next day) no other symptoms. Child recover...
Parent reported redness of face + cheek/chin after shots (next day) no other symptoms. Child recovered after Benadryl x1
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| 2859307 | 1 | M | TX | 09/16/2025 |
FLUX HEPA HIBV MMRV PNC20 |
UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. PFIZER\WYETH |
33CM4 MB599 UK229AA Z007868 LP4946 |
Urticaria; Urticaria; Urticaria; Urticaria; Urticaria
Urticaria; Urticaria; Urticaria; Urticaria; Urticaria
|
Hives present approx 10 mins after administration. Zyrtec + prednisolone administered. Symptoms reso...
Hives present approx 10 mins after administration. Zyrtec + prednisolone administered. Symptoms resolved after 10 mins of medication administration.
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| 2858652 | F | KY | 09/15/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Electric shock sensation, Herpes zoster, Vaccination failure; Electric shock sen...
Electric shock sensation, Herpes zoster, Vaccination failure; Electric shock sensation, Herpes zoster, Vaccination failure
More
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She is experiencing another bout with shingles now; I had this electric shock going on; Suspected va...
She is experiencing another bout with shingles now; I had this electric shock going on; Suspected vaccination failure/ lack of drug effect; Her first bout of shingles occurred 13 May 2024; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JAN-2022, the patient received the 2nd dose of Shingrix. On 26-SEP-2021, the patient received the 1st dose of Shingrix. On 13-MAY-2024, more than 2 years after receiving Shingrix and 960 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: Her first bout of shingles occurred 13 May 2024). On an unknown date, the patient experienced shingles (Verbatim: She is experiencing another bout with shingles now) and electric shock (Verbatim: I had this electric shock going on). The patient was treated with antivirals. The outcome of the vaccination failure, shingles and electric shock were not resolved and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure, shingles, shingles and electric shock to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, shingles and electric shock to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 03-SEP-2025 The patient is the reporter who received two doses of Shingrix and have had shingles twice. The patient's first bout of shingles occurred 6 months ago. She was experiencing another bout (2nd) with shingles now (at the time of reporting). She took antiviral both times. She also had quiet a reaction when she got the Shingrix shot so it was not like it did not work, she thought she developed a mild case of shingles when she had it, she had this electric shock going on. The reporter wanted to contact GlaxoSmithKline and to know what GSK could do about it. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked to the case US2025113050, reported by the same reporter.; Sender's Comments: A case of Vaccination failure, More than 2 years after receiving 2nd dose of Shingrix, in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025113050:SAME REPORTER, DIFFERENT PATIENT
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| 2858653 | 09/15/2025 |
UNK |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
|
Sore; This non-serious case was reported by a consumer via interactive digital media and described t...
Sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received RSVPreF3 adjuvanted (AREXVY-GSK) for prophylaxis. On an unknown date, the patient received AREXVY-GSK. On an unknown date, an unknown time after receiving AREXVY-GSK, the patient experienced pain (Verbatim: Sore). The outcome of the pain was not resolved. It was unknown if the reporter considered the pain to be related to AREXVY-GSK. It was unknown if the company considered the pain to be related to AREXVY-GSK. Additional Information: GSK receipt date: 16-AUG-2025 This case was reported by a patient via interactive digital media.
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| 2858654 | 50 | F | KY | 09/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Abdominal discomfort, Muscle tightness, Nausea, Neck pain
Abdominal discomfort, Muscle tightness, Nausea, Neck pain
|
achiness in neck particularly the left side; muscle tightness; nausea; unsteady stomach; This non-se...
achiness in neck particularly the left side; muscle tightness; nausea; unsteady stomach; This non-serious case was reported by a consumer via call center representative and described the occurrence of neck pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (For tolerance to first dose refer case US2025AMR107941). On 13-AUG-2025, the patient received the 2nd dose of Shingrix. In AUG-2025, less than a week after receiving Shingrix, the patient experienced neck pain (Verbatim: achiness in neck particularly the left side), muscle tightness (Verbatim: muscle tightness), nausea (Verbatim: nausea) and upset stomach (Verbatim: unsteady stomach). The outcome of the neck pain and muscle tightness were not resolved and the outcome of the nausea and upset stomach were not reported. It was unknown if the reporter considered the neck pain, muscle tightness, nausea and upset stomach to be related to Shingrix. It was unknown if the company considered the neck pain, muscle tightness, nausea and upset stomach to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR107941 Additional Information: GSK receipt date: 18-AUG-2025 The patient reported side effects including a bit of nausea and unsteady stomach, along with muscle tightness and achiness in neck, particularly the left side. All of the recommended treatments were used (ice, heat, Ibuprofen and stretching). But the pain was not going away nor the tightness. For tolerance to first dose refer case US2025AMR107941.; Sender's Comments: US-GSK-US2025AMR107941:same patient first dose
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| 2858655 | 09/15/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
|
Hurt a little bit; This non-serious case was reported by a consumer via interactive digital media an...
Hurt a little bit; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 67-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurt a little bit). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 21-AUG-2025 This case was reported by a patient via interactive digital media. The patient never had chickenpox but has diabetes and other age-related health issues. The patient got the shingles vaccine anyway because it helps protect against both chickenpox and shingles. It requires two shots, and they hurt a bit more than usual, but it was worth it patient stated.
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| 2858656 | 09/15/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Epistaxis
Epistaxis
|
Nose bleed; This non-serious case was reported by a consumer via call center representative and desc...
Nose bleed; This non-serious case was reported by a consumer via call center representative and described the occurrence of epistaxis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 21-AUG-2025, the patient received the 1st dose of Shingles vaccine. On 21-AUG-2025, 4 hrs after receiving Shingles vaccine, the patient experienced epistaxis (Verbatim: Nose bleed). The outcome of the epistaxis was not reported. It was unknown if the reporter considered the epistaxis to be related to Shingles vaccine. It was unknown if the company considered the epistaxis to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 21-AUG-2025 The patient got the first dose of vaccine that day (the day of reporting), and got a nose bleed 4 hours later. The patient rarely ever got nose bleeds. The patient wanted to know if that could be from the vaccine.
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| 2858657 | F | NJ | 09/15/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Pain in extremity
Pain in extremity
|
Arm soreness; This non-serious case was reported by a physician via call center representative and d...
Arm soreness; This non-serious case was reported by a physician via call center representative and described the occurrence of pain in arm in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced pain in arm (Verbatim: Arm soreness). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Linked case(s) involving the same patient: US2025106260 Additional Information: GSK Receipt Date: 18-AUG-2025 The patient did fine with the first dose, but the arm was very sore way back. For tolerance of 2nd dose refer case US2025106260.; Sender's Comments: US-GSK-US2025106260:same reporter
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| 2858658 | 09/15/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Respiratory syncytial virus infection, Rhinorrhoea, Vaccination failure
Respiratory syncytial virus infection, Rhinorrhoea, Vaccination failure
|
suspected vaccination failure; RSV; Constantly having mucus issues; This serious case was reported b...
suspected vaccination failure; RSV; Constantly having mucus issues; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 82-year-old 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 vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and nasal mucus increased (Verbatim: Constantly having mucus issues). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection and nasal mucus increased were not resolved. It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and nasal mucus increased to be related to Arexvy. The company considered the vaccination failure to be unrelated to Arexvy. It was unknown if the company considered the respiratory syncytial virus infection and nasal mucus increased to be related to Arexvy. Additional Information: GSK Receipt Date: 02-SEP-2025 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient thought he/she was having RSV (respiratory syncytial virus infection) and constantly having mucus issues. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving Arexvy in a 82-year-old patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2858659 | 09/15/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Hypersensitivity
Hypersensitivity
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Had a severe allergic reaction; This non-serious case was reported by a consumer via interactive dig...
Had a severe allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: Had a severe allergic reaction). The outcome of the allergic reaction was not reported. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. It was unknown if the company considered the allergic reaction to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-SEP-2025 This case was reported by a patient via interactive digital media. Patient's doctor advised not to get vaccine anymore.
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| 2858660 | M | 09/15/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular, Vaccination failur...
Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular, Vaccination failure; Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular, Vaccination failure
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Suspected vaccination failure; I had one of the worst breakouts I had in a long time; Post herpetic ...
Suspected vaccination failure; I had one of the worst breakouts I had in a long time; Post herpetic neuralgia; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had one of the worst breakouts I had in a long time) and post herpetic neuralgia (Verbatim: Post herpetic neuralgia). The outcome of the vaccination failure, shingles and post herpetic neuralgia were not reported. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be possibly related to Shingrix and Shingrix. It was unknown if the company considered the post herpetic neuralgia to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 05-SEP-2025 This case was reported by a patient via interactive digital media. The patient developed shingles, a painful, blistering rash usually on one side of the face or body that can last for weeks. But the pain did not stop when the rash cleared. It lasted for three long months. Patient took the new one and after the booster patient had one of the worst breakout patient had in a long time. Patient experienced a painful condition known as postherpetic neuralgia as a complication of shingles. PHN occurred in about 10 to 18 percent people who had shingles. 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: A case of Vaccination failure, unknown time after receiving Shingrix (Dose 1 and Dose 2) in a adult male patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2858661 | 79 | F | NY | 09/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Somnolence
Somnolence
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Sleepiness; This non-serious case was reported by a consumer via call center representative and desc...
Sleepiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 29-MAY-2025, the patient received the 1st dose of Shingrix. On 29-MAY-2025, less than a day after receiving Shingrix, the patient experienced sleepiness (Verbatim: Sleepiness). On 30-MAY-2025, the outcome of the sleepiness was resolved (duration 24 hrs). It was unknown if the reporter considered the sleepiness to be related to Shingrix. It was unknown if the company considered the sleepiness to be related to Shingrix. Additional Information: GSK receipt date: 20-AUG-2025 Reporter and his wife both received their first dose and are scheduled for the second dose as PI recommends. Reporter stated that his wife was very sleepy the entire day. The case is linked with US2025107416 and US2025107983, same reporter.; Sender's Comments: US-GSK-US2025107983:same reporter US-GSK-US2025107416:same patient /another dose
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| 2858662 | 64 | F | NC | 09/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Late second dose; This non-serious case was reported by a pharmacist via call center representative ...
Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose back on twenty nineteen). On 05-SEP-2025, the patient received the 2nd dose of Shingrix. On 05-SEP-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 05-SEP-2025 The pharmacist called to ask about a patient vaccination schedule. The patient received a first dose of Shingrix back on twenty nineteen, and a second dose on 05th September 2025 which led to lengthening of vaccination schedule. The reporter asked was this patient ok with this timeframe, do they needed to revaccinate. No vaccine detail was obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.
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| 2858663 | 5 | F | GA | 09/15/2025 |
IPV |
SANOFI PASTEUR |
W1C831M |
No adverse event, Product storage error
No adverse event, Product storage error
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Temperature excursion: Max/low temperature reached: negative 2.4 CDuration: 13 hours and 30 minutes ...
Temperature excursion: Max/low temperature reached: negative 2.4 CDuration: 13 hours and 30 minutes with no reported adverse event; Initial information received on 09-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old female patient who was administered to IPV (Vero) [IPOL], which had Temperature excursion: Max/low temperature reached: negative 2.4 CDuration: 13 hours and 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5mL of suspect IPV (Vero), Suspension for injection (lot W1C831M, expiry date 21-Nov-2025, frequency once and strength standard) via intramuscular route in the left arm for Immunisation and Temperature excursion: Max/low temperature reached: negative 2.4 CDuration: 13 hours and 30 minutes with no reported adverse event (poor quality product administered) (latency same day). Reportedly, there was fridge malfunction. No, Previous excursion and no Human erro was involved. It was administered post-excursion. The extended stability data did not cover the excursion. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA270817:IPOL
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| 2858673 | 32 | M | MO | 09/15/2025 |
COVID19 COVID19 COVID19 COVID19 FLU3 FLU3 FLU3 FLU3 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
MY9547 MY9547 MY9547 MY9547 406981 406981 406981 406981 my9547 my9547 my9547 my9547 |
Blood test abnormal, Computerised tomogram, Confusional state, Electrocardiogram...
Blood test abnormal, Computerised tomogram, Confusional state, Electrocardiogram, Loss of consciousness; Seizure like phenomena, Syncope; Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope; Unresponsive to stimuli; Blood test abnormal, Computerised tomogram, Confusional state, Electrocardiogram, Loss of consciousness; Seizure like phenomena, Syncope; Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope; Unresponsive to stimuli; Blood test abnormal, Computerised tomogram, Confusional state, Electrocardiogram, Loss of consciousness; Seizure like phenomena, Syncope; Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope; Unresponsive to stimuli
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About a minute after the second vaccine, patient lost consciousness and had seizure like symptoms fo...
About a minute after the second vaccine, patient lost consciousness and had seizure like symptoms for about 40 seconds and then fainted. Upon waking up, he was extremely confused. We went to the emergency room and had a variety of tests (EKG, CT, blood sample) and we are now being sent to neurologist to test for seizure activity.
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| 2858678 | F | KY | 09/15/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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/lack of drug effect; Shingles; This serious case was reported by a con...
Suspected vaccination failure/lack of drug effect; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 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 vaccination failure (Verbatim: Suspected vaccination failure/lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 03-SEP-2025 The reporter mentioned in passing that her mother received both Shingrix doses and had shingles twice following her Shingrix vaccinations. No further information was known. 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. This case has been linked to the US2025113058 case reported by the same reporter.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingrix (dose 1) and Shingrix (dose 2), in a female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2025113058:SAME REPORTER, DIFFERENT PATIENT
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| 2858679 | F | TX | 09/15/2025 |
TDAP |
SANOFI PASTEUR |
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Exposure during pregnancy, No adverse event
Exposure during pregnancy, No adverse event
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Pregnant patient receive adacel with no reported adverse event; Initial information received on 08-S...
Pregnant patient receive adacel with no reported adverse event; Initial information received on 08-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age female patient who received Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On an unknown date, the pregnant patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation, with no reported adverse event (exposure during pregnancy) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Reportedly, Patient got a dose during pregnancy, and is requesting another because immigration is asking for a second dose. She has not been administered another dose.She had received a prior dose from an unknown provider. Action taken was not applicable. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
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| 2858680 | 10 | M | UT | 09/15/2025 |
MMR |
MERCK & CO. INC. |
Y019465 |
Pyrexia
Pyrexia
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Fever.
Fever.
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| 2858681 | 63 | M | WA | 09/15/2025 |
COVID19 COVID19 FLUX FLUX |
MODERNA MODERNA UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Asthenia, Blood test, Decreased appetite, Gait inability, Hyperhidrosis; Malaise...
Asthenia, Blood test, Decreased appetite, Gait inability, Hyperhidrosis; Malaise, Mobility decreased, Nausea, Pyrexia; Asthenia, Blood test, Decreased appetite, Gait inability, Hyperhidrosis; Malaise, Mobility decreased, Nausea, Pyrexia
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Weak. In bed. Lost Appetite. Nausea. Unable to Ambulate. Sweating. Fever 102 F. 14 Days Bed Ridden v...
Weak. In bed. Lost Appetite. Nausea. Unable to Ambulate. Sweating. Fever 102 F. 14 Days Bed Ridden very sick.
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| 2858737 | 18 | F | NY | 09/15/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
NDC: 58160-0842 |
Confusional state, Seizure
Confusional state, Seizure
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After receiving the TDaP vaccine in the morning (about 10am), I went biking in the evening (about 4p...
After receiving the TDaP vaccine in the morning (about 10am), I went biking in the evening (about 4pm), and while biking I had a seizure. I had another seizure. I spent two days in facility, and after they were unable to find a reason for seizures I was discharged. I did not tell them I received the vaccine earlier in the day as I was very confused at the time and did not attribute the event to the vaccine. It was my first ever seizures and I have not had a TDaP vaccine before.
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| 2858738 | 77 | F | IL | 09/15/2025 |
COVID19 |
PFIZER\BIONTECH |
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Malaise, Pyrexia, Rash
Malaise, Pyrexia, Rash
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Torso rash started 48 hrs after shot. Malaise started 24 hrs after shot. Low grade fever started 2...
Torso rash started 48 hrs after shot. Malaise started 24 hrs after shot. Low grade fever started 24 hrs after shot .
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| 2858739 | 81 | F | MI | 09/15/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Arthralgia, Chills, Frequent bowel movements, Headache, Muscle spasms; Pollakiur...
Arthralgia, Chills, Frequent bowel movements, Headache, Muscle spasms; Pollakiuria
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Chills, headache, joint pain ,back spasms, frequent urination and bowel movement
Chills, headache, joint pain ,back spasms, frequent urination and bowel movement
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| 2858740 | 34 | F | NJ | 09/15/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
80777011296 70461065503 |
Muscle twitching, Nausea, Sensation of foreign body; Muscle twitching, Nausea, S...
Muscle twitching, Nausea, Sensation of foreign body; Muscle twitching, Nausea, Sensation of foreign body
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Globus sensation beginning about 36 hours after vaccine administration. Tried eating, drinking, drin...
Globus sensation beginning about 36 hours after vaccine administration. Tried eating, drinking, drinking while lying down, antacids, lozenges. Nothing helped. Symptom mostly disappeared by the end of day 4, and was gone by day 5. Globus sensation was also occasionally accompanied by nausea paired with muscle fluttering in right ear (inside). No treatments were attempted. Symptoms were also relieved within the same time frame.
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| 2858741 | 11 | M | MD | 09/15/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Circumstance or information capable of leading to medication error, Wrong produc...
Circumstance or information capable of leading to medication error, Wrong product administered
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During the administration of the 11-year-old immunizations, the patient was extremely combative and ...
During the administration of the 11-year-old immunizations, the patient was extremely combative and uncooperative. Due to the level of resistance, an additional clinical assistant was called in to help safely restrain the patient for the vaccine administration. While attempting to manage the situation, the assisting clinical assistant removed a Shingrix vaccine from her pocket and inadvertently placed it in the same tray/area as the scheduled vaccines intended for the patient. Due to the chaotic circumstances and lack of clear labeling or communication, the Shingrix vaccine was mistakenly administered to the patient without my knowledge.
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| 2858742 | 35 | M | NJ | 09/15/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Angina pectoris, Arrhythmia, Cardiac stress test abnormal, Dyspnoea, Headache; H...
Angina pectoris, Arrhythmia, Cardiac stress test abnormal, Dyspnoea, Headache; Hyperhidrosis, Impaired work ability, Laboratory test, Passive smoking, Sleep disorder; Smoke sensitivity
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pt says that after four days he woke up in the middle of the night sitting up trying breath. It took...
pt says that after four days he woke up in the middle of the night sitting up trying breath. It took three minutes to catch his breath. Five days later he started having heart arrythmia at his work site. When walking he would have sharp pains in his heart. He was having myocarditis symptoms. He was seen at Hospital and another hospital. When he was seen at office visit he failed his stress test. He has lost his job because of he would have reactions to second hand smoke from his coworkers and family members. He never had any heart problems or allergic reactions from second hand smoke before his covid vaccine. He has to hide and/or stay away from people who smoke. It makes him sweat and gives him a headache. His heart will give him signals that smoke is nearby.
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