| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843906 | 11 | M | SD | 06/04/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
0006-4121-01 49281-590-58 49281-400-89 |
Dizziness, Vomiting; Dizziness, Vomiting; Dizziness, Vomiting
Dizziness, Vomiting; Dizziness, Vomiting; Dizziness, Vomiting
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Patient felt lightheaded and threw up shortly after receiving 3 vaccinations (HPV, tetanus, meningit...
Patient felt lightheaded and threw up shortly after receiving 3 vaccinations (HPV, tetanus, meningitis). Patient returned to normal state of health afterwards.
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| 2843907 | 55 | F | CA | 06/04/2025 |
MENB MENB MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
NA NA NA NA |
Arthralgia, Back pain, Bone pain, Cyanosis, Decreased appetite; Gait disturbance...
Arthralgia, Back pain, Bone pain, Cyanosis, Decreased appetite; Gait disturbance, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling; Joint swelling, Mobility decreased, Muscle spasms, Musculoskeletal stiffness, Neck pain; Pain, Pain in extremity, Peripheral coldness
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Vaccine area is red very tender after 39 minutes of receiving vaccine. The filling day same redness...
Vaccine area is red very tender after 39 minutes of receiving vaccine. The filling day same redness and tender and swollen Very soar can?t lift my arm. Back of my neck is very tights very soar and very painful if I move my head in any direction. Both shoulder blast are very painful upper back spasms having a hard time moving and walking due to stiff neck and upper back pain All my joints are swollen and very painful to move them the worse pain is my upper back and neck and injection area, no appetite and I have swollen ankles /cankles my hand and fingertips are cold they are blue purple and swollen my hip bones hurt when I walk my entire body is in pain and all my joints. I came home from work and laying down with my feet elevated to see if my ankles return to normal size. The back pain still persist lying in bed.
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| 2843908 | 06/04/2025 |
FLUN4 FLUN4 FLUN4 FLUN4 |
MEDIMMUNE VACCINES, INC. MEDIMMUNE VACCINES, INC. MEDIMMUNE VACCINES, INC. MEDIMMUNE VACCINES, INC. |
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Arthritis, Condition aggravated, Dry skin, Dyspnoea exertional, FEV1/FVC ratio d...
Arthritis, Condition aggravated, Dry skin, Dyspnoea exertional, FEV1/FVC ratio decreased; Limb injury, Mobility decreased, Nasal congestion, Obesity, Obstructive airways disorder; Productive cough, Prostate cancer, Respiratory tract congestion, Rhinitis, Sputum discoloured; Total lung capacity abnormal, Weight decreased, Wheezing
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prostate cancer; loss weight, has dropped 4 pounds; shortness of breath; chest tightness; cough, int...
prostate cancer; loss weight, has dropped 4 pounds; shortness of breath; chest tightness; cough, intermittent coughing, increasing coughing; wheezing, wheezing throughout, intermitent wheeze; mobility is severely limited; Dyspnea on exertion, lingering dyspnea on exertion; Morbid obesity, obesity; occasional congestion, some nasal congestion; persisting leg wound; air trapping; decreased diffusing capacity; arthritis; chronic rhinitis; coughing now productive of green phlegm, cough with phlegm; decreased FEV1 and FVC with marginal bronchodilator response; skin is dry; worse after he lies down/if misses dose of Symbicort significantly worse; never heard back from pharmacy on obtaining Tezspire so he has not gotten any further injections, still not on regular Tezspire; A solicited report has been received from a physician in Patient Support Program concerning a male patient. No medical history was reported. Concomitant medication included Folvite (since 02-DEC-2012), Toprol Xl (since 30-MAY-2017), Kevzara (since 05-AUG-2018), Trelegy Ellipta (since 08-JAN-2024), Albuterol for chest tightness, shortness of breath and wheezing (since 29-JAN-2024), Prednisone (from MAR-2024 to JUL-2024), Loniten (since 10-MAY-2024), Benicar (since 09-JUL-2024), Flonase (since 24-AUG-2024), Cipro (since 09-SEP-2024), Albuterol Hfa (since 29-OCT-2024), Singulair (since 31-OCT-2024), Sarilumab, Doxycycline, Percocet, Mobic for rheumatoid arthritis, Azulfidine and Xopenex. During 2019, the patient started treatment with Symbicort (budesonide, formoterol) 160 milligram bid. During OCT-2021, the patient started treatment with Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv (flumist, influenza virus vaccine polyvalent, q/laiv) UNK. On 25-JUN-2024, the patient started treatment with Airsupra (budesonide, albuterol) unknown dose, q4h, Inhalation use. During JUL-2024, the patient started treatment with Tezepelumab (tezepelumab) 210 milligram q4w, Subcutaneous use, for asthma. It is unknown who administered Airsupra, Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv, Symbicort, Tezepelumab to the patient. During 15-JUN-19, the patient experienced prostate cancer (preferred term: Prostate cancer). During 15-JAN-24, the patient experienced dyspnea on exertion, lingering dyspnea on exertion (preferred term: Dyspnoea exertional), wheezing, wheezing throughout, intermitent wheeze (preferred term: Wheezing), cough, intermittent coughing, increasing coughing (preferred term: Cough) and occasional congestion, some nasal congestion (preferred term: Nasal congestion). During 15-MAR-24, the patient experienced coughing now productive of green phlegm, cough with phlegm (preferred term: Productive cough). On an unknown date, the patient experienced loss weight, has dropped 4 pounds (preferred term: Weight decreased), decreased diffusing capacity (preferred term: Total lung capacity abnormal), air trapping (preferred term: Obstructive airways disorder), persisting leg wound (preferred term: Limb injury), shortness of breath (preferred term: Dyspnoea), chest tightness (preferred term: Chest discomfort), chronic rhinitis (preferred term: Rhinitis), skin is dry (preferred term: Dry skin), decreased fev1 and fvc with marginal bronchodilator response (preferred term: FEV1/FVC ratio decreased), morbid obesity, obesity (preferred term: Obesity), arthritis (preferred term: Arthritis), severe mobility is severely limited (preferred term: Mobility decreased) and worse after he lies down/if misses dose of symbicort significantly worse (preferred term: Condition aggravated). The report described a medication error for Tezepelumab. The reported term was never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire (preferred term: Product dose omission issue). The dose of Airsupra (budesonide, albuterol) and Tezepelumab (tezepelumab) was not changed. Treatment with Symbicort (budesonide, formoterol) was discontinued during MAR-2024. At the time of reporting, the event decreased diffusing capacity was improving. The outcome of the event(s) of air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, prostate cancer, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse was unknown. The following event(s) were considered serious due to medically significant:prostate cancer. The following events were considered non-serious:air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The reporter did not assess causality for air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, prostate cancer, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, prostate cancer, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Airsupra and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Evocap Metered Dose Inhaler and the following event(s): air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, prostate cancer, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Evocapxs Metered Dose Inhaler and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, prostate cancer, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Symbicort and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Tezepelumab and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Ypsomate Automatic Injector and the following event(s): air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, prostate cancer, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Airsupra and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound, prostate cancer and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Evocapxs Metered Dose Inhaler and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound, prostate cancer and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Symbicort and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound, prostate cancer and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Tezepelumab and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound, prostate cancer and skin is dry. Laboratory values are available. Device Information: Combination Product Report: Yes Product As Reported: Symbicort Brand Name: SYMBICORT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Product As Reported: Symbicort Brand Name: SYMBICORT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Product As Reported: Symbicort Brand Name: SYMBICORT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Product As Reported: Symbicort Brand Name: SYMBICORT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No All required follow-up attempts have been completed to obtain the Lot / Batch number for Symbicort, Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv, Airsupra and Tezepelumab, however the Lot / Batch number was not received. Summary of follow-up information received by AstraZeneca/MedImmune from physician via solicited source on 02-Dec-2024: new suspects (Symbicort, Airsupra, Influenza vaccine) and concomitant drugs added, new serious event of prostate cancer added, non-serious events of loss weight, has dropped 4 pounds, mobility is severely limited, dyspnea on exertion, lingering dyspnea on exertion, morbid obesity, occasional congestion, some nasal congestion, arthritis, chronic rhinitis, coughing now productive of green phlegm, cough with plegm, worse after he lies down, decreased FEV1 and FVC with marginal bronchodilator response, skin is dry, if misses dose of Symbicort significantly worse, never heard back from pharmacy on obtaining Tezspire so he has not gotten any further injections, still not on regular Tezspire added, outcome for the event of new serious event of Total lung capacity abnormal was updated to recovering, start date for the events of cough, wheezing added, patient's gender, relevant histories and lab test added, start date of Tezspire was updated to Jul-2024 from Sep-2024, frequency added as q4w, patient's allergies added, narrative was updated. Minor correction on 09-Dec-2024: ethnic group was updated to no information from unknown, batch information on Tezspire corrected. Summary of follow-up information received by AstraZeneca on 02-Jan-2025 from marketing company: Summary of unsuccessful Lot/Batch number attempts added. Event never heard back from pharmacy on obtaining Tezspire so he has not gotten any further injections, still not on regular Tezspire recoded. Event verbatim updated to worse after he lies down/if misses dose of Symbicort significantly worse. Updated lot number as ASKU. Narrative updated. Corrected report on 29-Apr-2025: Recoding of suspect flumist, influenza virus vaccine polyvalent, q/laiv and device was added for the same. Narrative amended. Summary of follow-up information received by AstraZeneca on 22-May-2025 from Marketing company: Summary of unsuccessful Lot/Batch number attempts added. Narrative updated.; Sender's Comments: Prostate cancer is not listed in the core data sheet of Tezepelumab, Budesonide, formoterol, Flumist, Influenza virus vaccine polyvalent, Q/LAIV and Budesonide, albuterol. Due to limited information on underlying comorbidities, past medical history and concomitant medications, complete etiologic and diagnostic workup the evaluation did not find evidence to exclude a reasonable possibility of a causal relationship between Event and suspect drugs.
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| 2843909 | 06/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster, Visua...
Herpes zoster, Incomplete course of vaccination, Ophthalmic herpes zoster, Visual impairment
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Mine started behind my eye, my vision was affected; Mine started behind my eye, my vision was affect...
Mine started behind my eye, my vision was affected; Mine started behind my eye, my vision was affected,; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: Mine started behind my eye, my vision was affected) (serious criteria hospitalization and GSK medically significant) and facial herpes zoster (Verbatim: Mine started behind my eye, my vision was affected,) (serious criteria hospitalization). The patient was treated with gabapentin. The outcome of the ophthalmic herpes zoster and facial herpes zoster were not resolved. It was unknown if the reporter considered the ophthalmic herpes zoster and facial herpes zoster to be related to Shingles vaccine. The company considered the ophthalmic herpes zoster and facial herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date : 27-MAY-2025 This case was reported by a patient via interactive digital media. The patient was on year four with shingles. The patient started behind his/her eye, his/her vision was affected, side of his/her nose up to his/her scalp back to his/her forehead. The patient was in the hospital for two days for fear of sepsis. The patient was taken Gabepentin and a cream for forehead. The patient got the shingles shot but did not go back for the second shot. The physician said after this long it probably would not go away.; Sender's Comments: Ophthalmic herpes zoster and Herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine.
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| 2843911 | M | 06/04/2025 |
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; Some time later developed Shingles; This serious case was reported by...
Suspected vaccination failure; Some time later developed Shingles; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 72-year-old 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. In JAN-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Some time later developed Shingles). The outcome of the vaccination failure and shingles were not reported. 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 :29-MAY-2025 Nurse reported that patient was fully vaccinated with shingrix vaccines, 2 doses as indicated. She did not have dates of 1st or 2nd doses given. Some time later developed shingles. No additional information was provided regarding events at time of receiving 1st or 2nd dose. Shingles was believed to had developed in January 2025 exact dates not provided when did this happened. This case was considered as suspected vaccination failure as details regarding 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
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| 2843912 | 51 | F | NC | 06/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Hypoaesthesia, Paraesthesia oral
Hypoaesthesia, Paraesthesia oral
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Tingling tongue; numbness in arm; This non-serious case was reported by a other health professional ...
Tingling tongue; numbness in arm; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of tingling tongue in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 28-MAR-2025, the patient received Shingrix. On 28-MAR-2025, less than a day after receiving Shingrix, the patient experienced tingling tongue (Verbatim: Tingling tongue) and numbness of upper extremities (Verbatim: numbness in arm). The outcome of the tingling tongue and numbness of upper extremities were resolving. The reporter considered the tingling tongue and numbness of upper extremities to be related to Shingrix. The company considered the tingling tongue and numbness of upper extremities to be related to Shingrix. Additional Information: GSK Receipt Date: 29-MAY-2025 The weight of the patient was reported as 80.29 kgs. Healthcare professional reported that patient had an allergic reaction to Shingrix vaccine. Patient experienced a tingling tongue and numbness in her arm. No other information was provided.
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| 2843913 | 70 | F | NC | 06/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Burning sensation
Burning sensation
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burning sensation underneath her left shoulder blade in her back; This non-serious case was reported...
burning sensation underneath her left shoulder blade in her back; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included tick bite, diabetes, blood pressure high, blood cholesterol increased, indigestion and heartburn. Concomitant products included doxycycline, semaglutide (Ozempic) and potassium. On 28-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 29-MAY-2025, 1 days after receiving Shingrix, the patient experienced burning sensation (Verbatim: burning sensation underneath her left shoulder blade in her back). The outcome of the burning sensation was not resolved. It was unknown if the reporter considered the burning sensation to be related to Shingrix. It was unknown if the company considered the burning sensation to be related to Shingrix. Additional Information: GSK Receipt Date: 02-JUN-2025 The patient received first dose of Shingrix in her right arm on 28-MAY-2025, and reported that the next night 29-MAY-2025, she started having a deep, burning sensation underneath her left shoulder blade in her back. The patient reported that this sensation was still there today on 2-JUN-2025, but was not as bad as it was. The patient also reported that she was taking Doxycycline 100MG (Unknown Product Information) by mouth twice a day for a tick bite that was diagnosed on 13-APR-2025, and she started this antibiotic the evening of 29-MAY-2025, after receiving the first dose of Shingrix.
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| 2843914 | M | KS | 06/04/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
UNK |
Immediate post-injection reaction, Injection site erythema, Injection site pain,...
Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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injection site was hot; injection site was red; injection site was swollen; injection site was painf...
injection site was hot; injection site was red; injection site was swollen; injection site was painful; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel). On 13-MAR-2025, the patient received Menveo (intramuscular, left arm). On 13-MAR-2025, immediately after receiving Menveo, the patient experienced injection site warmth (Verbatim: injection site was hot), injection site erythema (Verbatim: injection site was red), injection site swelling (Verbatim: injection site was swollen) and injection site pain (Verbatim: injection site was painful). On 16-MAR-2025, the outcome of the injection site warmth, injection site erythema, injection site swelling and injection site pain were resolved. It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site swelling and injection site pain to be related to Menveo. It was unknown if the company considered the injection site warmth, injection site erythema, injection site swelling and injection site pain to be related to Menveo. Additional Information: GSK Receipt Date: 02-JUN-2025 The patient mother was the reporter. The patient mother stated that her son, 11 years old, received Menveo vaccine on 13 MAR 2025. The reporter stated almost immediately a space measuring about 3 by 4 below the injection site was hot, red, swollen and painful which resolved approximately in 3 days. The reporter also stated when her son received another vaccine containing diphtheria (Daptacel) he had the same type of reaction. The reporter mentioned this reaction occurred after receiving dose 4 and 5 in the dose vaccination series of Daptacel. The reporter did have her son examined by his Primary care physician (PCP) and the Primary care physician stated this reaction could be a histamine type reaction. The reporter also stated that her son is scheduled for an examination with an allergy doctor.
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| 2843915 | F | 06/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; getting shingles a second time; This serious case was reported by a c...
Suspected vaccination failure; getting shingles a second time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: getting shingles a second time). The outcome of the vaccination failure and shingles were not reported. It was unknown if 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. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-MAY-2025 This case was reported by a reporter via interactive digital media. Reporter reported that the vaccine did not prevent his/her mother (patient) from getting it (shingles) a second time. 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 about the clinical description time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
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| 2843916 | 06/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Got the shots but still got shingles; This serious case was reported ...
Suspected vaccination failure; Got the shots but still got 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. 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: Got the shots but still got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if 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. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 27-MAY-2025 This case was reported by a patient via interactive digital media. Patient got the shots but still got shingles. 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 about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2843917 | 06/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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I did not go back for the second shingles; This non-serious case was reported by a consumer via inte...
I did not go back for the second shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included sickness. Previously administered products included Shingles vaccine (received first dose on an unknown date). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I did not go back for the second shingles). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 30-MAY-2025 This case was reported by a patient via interactive digital media. The patient did not go back for the second shingles vaccine which led to incomplete course of vaccination. The patient stated that he/she have enough health problems without getting sick again.
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| 2843918 | 06/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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slightly sore arm; This non-serious case was reported by a consumer via interactive digital media an...
slightly sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: slightly sore arm). 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 Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-JUN-2025 This case was reported by a patient via interactive digital media. The patient had zero reaction other than slightly sore arm after receiving Shingles vaccine
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| 2843919 | MN | 06/04/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
MZ474 |
Underdose
Underdose
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accidentally administered a pediatric dose of Havrix to an adult patient; accidentally administered ...
accidentally administered a pediatric dose of Havrix to an adult patient; accidentally administered a pediatric dose of Havrix to an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix pediatric) (batch number MZ474, expiry date 24-APR-2026) for prophylaxis. In MAY-2025, the patient received Havrix pediatric. In MAY-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: accidentally administered a pediatric dose of Havrix to an adult patient) and accidental underdose (Verbatim: accidentally administered a pediatric dose of Havrix to an adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable. Additional Information: GSK Receipt Date: 02-JUN-2025 The pharmacist reported that they accidentally administered a pediatric dose of Havrix to an adult patient, which led to adult use of a child product and accidental underdose
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| 2843920 | CA | 06/04/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Late 2nd dose/ the 2nd dose was given at 6 months; This non-serious case was reported by a other hea...
Late 2nd dose/ the 2nd dose was given at 6 months; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received first dose on an unknown date). On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose/ the 2nd dose was given at 6 months). The outcome of the drug dose administration interval too long 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: 02-JUN-2025 On 02 June 2025, a GSK Sales Representative contacted Medical Information on behalf of a provider (Internal Medicine) with a query regarding the Twinrix vaccine. They had a question about the dosing and schedule of Twinrix, the normal schedule is 0, 1, 6 months. The patient got the 1st dose but then the 2nd dose was given at 6 months which led to , which led to lengthening of vaccination schedule. The reporter enquired if the patient needs one more dose and if so, when it should be administered. The Sales representative and HCP did not have any patient or product details.
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| 2843921 | 76 | M | PA | 06/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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never got the second dose; This non-serious case was reported by a other health professional via cal...
never got the second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 06-NOV-2020). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 02-JUN-2025 The pharmacy intern contacted via chat and reported that the reporter had a patient get the first dose 06th November 2020 and never got the second dose. The reporter asked what do you recommend. The Vaccine Administration Facility was the same as Primary Reporter. The healthcare professional did not had the vaccine lot number nor the expiration date of the 1st Shingrix dose Also, healthcare professional did not provide consent for Safety team follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
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| 2843922 | 47 | F | NC | 06/04/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
79S54 |
Expired product administered
Expired product administered
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expired dose of Engerix B was administration; This non-serious case was reported by a nurse via call...
expired dose of Engerix B was administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HBV (Engerix B) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis. Previously administered products included Engerix B (received 1st dose on an unknown date) and Engerix B (received 2nd dose on an unknown date). On 30-MAY-2025, the patient received the 3rd dose of Engerix B. On 30-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix B was administration). The outcome of the expired vaccine used was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 02-JUN-2025 The nurse called to report that the expired dose of Engerix B was administered to a patient which led to, expired vaccine used. The vaccine administration facility was the same as primary reporter.
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| 2843923 | 06/04/2025 |
COVID19 |
MODERNA |
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Biopsy, COVID-19, Rash
Biopsy, COVID-19, Rash
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I took a Moderna 2024 booster, got COVID; Skin rash spreading; This spontaneous case was reported by...
I took a Moderna 2024 booster, got COVID; Skin rash spreading; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I took a Moderna 2024 booster, got COVID) and RASH (Skin rash spreading) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Pfizer BioNTech COVID-19 vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer BioNTech COVID-19 vaccine. On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I took a Moderna 2024 booster, got COVID) and RASH (Skin rash spreading). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) at an unspecified dose and frequency. At the time of the report, COVID-19 (I took a Moderna 2024 booster, got COVID) and RASH (Skin rash spreading) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: Show nothing. Concomitant medication was not provided. It was reported that since Covid in 2020 the patient took Pfizer booster prior to Moderna 2024 booster vaccine at Pharmacy and suspects that it may cause rashes. The patient had done biopsy for rashes, and nothing shown and 4 dermatologists puzzled going on for 5 months.
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| 2843924 | 70 | F | FL | 06/04/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Blood creatinine, Blood potassium, CSF glucose, CSF protein, CSF red blood cell ...
Blood creatinine, Blood potassium, CSF glucose, CSF protein, CSF red blood cell count; CSF test, CSF white blood cell count, Computerised tomogram head, Guillain-Barre syndrome, Hyponatraemia; Mononuclear cell percentage, Myelodysplastic syndrome, Neurological examination, Physical examination, Renal failure
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Guillain-Barr๏ฟฝ Syndrome (GBS); hyponatremia; new-onset renal failure; myelodysplastic syndrome; Th...
Guillain-Barr๏ฟฝ Syndrome (GBS); hyponatremia; new-onset renal failure; myelodysplastic syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barr๏ฟฝ Syndrome (GBS)), RENAL FAILURE (new-onset renal failure), MYELODYSPLASTIC SYNDROME (myelodysplastic syndrome) and HYPONATRAEMIA (hyponatremia) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. LITERATURE REFERENCE: Concurrent medical conditions included Hypertension, Atrial fibrillation (atrial fibrillation status post Watchman procedure), Chronic back pain, Macrocytic anemia and Dyslipidemia. Concomitant products included Hydrochlorothiazide for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barr๏ฟฝ Syndrome (GBS)) (seriousness criteria hospitalization and medically significant), RENAL FAILURE (new-onset renal failure) (seriousness criterion medically significant), MYELODYSPLASTIC SYNDROME (myelodysplastic syndrome) (seriousness criterion medically significant) and HYPONATRAEMIA (hyponatremia) (seriousness criterion hospitalization). The patient was hospitalized on sometime in 2021 due to GUILLAIN-BARRE SYNDROME and HYPONATRAEMIA. The patient was treated with Immunoglobulins nos (Immunoglobulin i.v) (intravenous use) in 2021 at a dose of 35 gram once a day. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barr๏ฟฝ Syndrome (GBS)) was resolving and RENAL FAILURE (new-onset renal failure), MYELODYSPLASTIC SYNDROME (myelodysplastic syndrome) and HYPONATRAEMIA (hyponatremia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood creatinine: 1.7 mg/dl elevated. In 2021, Blood potassium: 3.1 millimole per litre Hypokalaemia. In 2021, CSF glucose: 52 mg/dl. In 2021, CSF protein: 80 mg/dl CSF total protein was high. In 2021, CSF red blood cell count: 5000000 cells per cubic millimetre. In 2021, CSF test: CSF appearance was clear, and CSF color was Xanthrochromic. In 2021, CSF white blood cell count: 60 % CSF polynuclear WBCs and 5000 cells per cubic millimetre. In 2021, Computerised tomogram head: negative for acute abnormalities. In 2021, Mononuclear cell percentage: 40 % CSF mononuclear cells. In 2021, Neurological examination: history and examination findings were consistent with GBS.. In 2021, Physical examination: Physical examination was remarkable for decreased strength in all extremities and absent deep tendon reflexes of Achilles and patellar tendons. The patient's muscular weakness was worse in her proximal muscles.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPONATRAEMIA (hyponatremia) to be not related. No further causality assessments were provided for GUILLAIN-BARRE SYNDROME (Guillain-Barr๏ฟฝ Syndrome (GBS)), RENAL FAILURE (new-onset renal failure) and MYELODYSPLASTIC SYNDROME (myelodysplastic syndrome). Patient presented to the emergency department in early 2021 with progressive bilateral ascending weakness and numbness. The numbness started in her lower extremities and progressed to her upper extremities. She denied COVID-19 pneumonia associated symptoms, such as fever, shortness of breath, cough, nausea, vomiting, abdominal pain, and myalgia. She also confirmed no recent travel history. Neurology recommended lumbar puncture for cerebrospinal fluid (CSF) analysis, followed by initiation of IVIG. A lumbar puncture was performed. CSF findings were consistent with albuminocytologic dissociation, and a diagnosis of GBS was established. The patient underwent frequent monitoring of forced vital capacity and negative inspiratory force to assess pulmonary function. After completing treatment with IVIG, she was discharged to the inpatient rehabilitation facility after 1 week. While in the rehabilitation program, the patient was fully participatory with physical therapy and occupational therapy. Her lower extremity weakness improved, but she did not fully recover before discharge as she still had weakness and needed to use mobility devices. Nevertheless, the patient met all discharge goals within 3 weeks. Patient had other developments complicating her hospital course. She had new-onset neutropenic leukopenia and thrombocytopenia and worsening of her macrocytic anemia. Hematology was consulted and determined the neutropenia and thrombocytopenia were attributed to IVIG; however, it was recommended that reporter evaluated her macrocytic anemia for myelodysplastic syndrome in the outpatient setting. She also had mild to moderate hyponatremia and new-onset renal failure requiring a nephrology consult. It was determined that the hyponatremia was multifactorial as a result of GBS, poor oral solute intake, excessive water intake, and secondary to medication use (hydrochlorothiazide).; Reporter's Comments: The event hyponatremia was assessed as not related due to alternative explanation. The benefit-risk relationship of the product is not affected by this report.
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| 2843925 | 76 | M | CA | 06/04/2025 |
COVID19 |
MODERNA |
3043837 |
Discomfort, Insomnia, Pain
Discomfort, Insomnia, Pain
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were unable to sleep due to pain or discomfort; were unable to sleep due to pain or discomfort; were...
were unable to sleep due to pain or discomfort; were unable to sleep due to pain or discomfort; were unable to sleep due to pain or discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (were unable to sleep due to pain or discomfort), DISCOMFORT (were unable to sleep due to pain or discomfort) and INSOMNIA (were unable to sleep due to pain or discomfort) in a 76-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043837) for COVID-19 prophylaxis. No Medical History information was reported. On 25-May-2025, the patient received tenth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 25-May-2025, the patient experienced PAIN (were unable to sleep due to pain or discomfort), DISCOMFORT (were unable to sleep due to pain or discomfort) and INSOMNIA (were unable to sleep due to pain or discomfort). At the time of the report, PAIN (were unable to sleep due to pain or discomfort), DISCOMFORT (were unable to sleep due to pain or discomfort) and INSOMNIA (were unable to sleep due to pain or discomfort) outcome was unknown. No concomitant medication was reported. Patient and her husband had no issues or problems until they received the 10th COVID-19 vaccines on 24-May-2025. On 25-May-2025, both were unable to sleep without waking up from pain or discomfort every 15-20 minutes. The pharmacist started injecting the shots into the shoulders. Patient's husband asked him to inject the vaccine in the bicep at the widest point of the arms (into the softest padded area of the upper arm), but he said he had to inject them in the shoulder. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
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| 2843926 | F | 06/04/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
032M20A 032M20A |
Antinuclear antibody, Chronic fatigue syndrome, Nasopharyngitis, Sjogren's ...
Antinuclear antibody, Chronic fatigue syndrome, Nasopharyngitis, Sjogren's syndrome, Thyroid disorder; Tinnitus, Tooth loss, Vaginal haemorrhage
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Sjogren's/ Temperature cannot be regulate (Dysautonomia)/ Sweating/bouts of sweating/freezing a...
Sjogren's/ Temperature cannot be regulate (Dysautonomia)/ Sweating/bouts of sweating/freezing at the same time/ Sensory polyneuropathy/Left leg has gone completely numb/ Gets pain eye (both and thinks its vascular)/ Joint pain/ Bone pain; Bleeding in private area; Ringing in the ear; Chronic fatigue syndrome/ I can't hold my head up I am in so much pain/ Head pressure and ringing in the ear (right)/pain/excruciating pain 24/7/ Can't think (head feels like there's lot in it)/ Forgets; Cold; Teeth cracked (lost 8 teeth); Thyroid not been regulated (It's all a mess since I got the shot),; This spontaneous case was reported by a consumer and describes the occurrence of SJOGREN'S SYNDROME (Sjogren's/ Temperature cannot be regulate (Dysautonomia)/ Sweating/bouts of sweating/freezing at the same time/ Sensory polyneuropathy/Left leg has gone completely numb/ Gets pain eye (both and thinks its vascular)/ Joint pain/ Bone pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 046B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hysterectomy. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SJOGREN'S SYNDROME (Sjogren's/ Temperature cannot be regulate (Dysautonomia)/ Sweating/bouts of sweating/freezing at the same time/ Sensory polyneuropathy/Left leg has gone completely numb/ Gets pain eye (both and thinks its vascular)/ Joint pain/ Bone pain) (seriousness criterion medically significant), VAGINAL HAEMORRHAGE (Bleeding in private area), TINNITUS (Ringing in the ear), CHRONIC FATIGUE SYNDROME (Chronic fatigue syndrome/ I can't hold my head up I am in so much pain/ Head pressure and ringing in the ear (right)/pain/excruciating pain 24/7/ Can't think (head feels like there's lot in it)/ Forgets), NASOPHARYNGITIS (Cold), TOOTH LOSS (Teeth cracked (lost 8 teeth)) and THYROID DISORDER (Thyroid not been regulated (It's all a mess since I got the shot),). At the time of the report, SJOGREN'S SYNDROME (Sjogren's/ Temperature cannot be regulate (Dysautonomia)/ Sweating/bouts of sweating/freezing at the same time/ Sensory polyneuropathy/Left leg has gone completely numb/ Gets pain eye (both and thinks its vascular)/ Joint pain/ Bone pain), VAGINAL HAEMORRHAGE (Bleeding in private area), TINNITUS (Ringing in the ear), CHRONIC FATIGUE SYNDROME (Chronic fatigue syndrome/ I can't hold my head up I am in so much pain/ Head pressure and ringing in the ear (right)/pain/excruciating pain 24/7/ Can't think (head feels like there's lot in it)/ Forgets), NASOPHARYNGITIS (Cold), TOOTH LOSS (Teeth cracked (lost 8 teeth)) and THYROID DISORDER (Thyroid not been regulated (It's all a mess since I got the shot),) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: (Positive) High ANA. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. It was reported that the shots were made too fast and that an SV40, which could potentially cause cancer, had been included. The reporter mentioned that various substances had been added to the shots, and people were unaware of what they had received. Some had reportedly received placebos, while others had received components that led to multiple side effects. The reporter mentioned as one of the affected individuals. The reporter noted that the first lot number had not caused harm but reported uncertainty about its effects. However, the second lot number had been described as dangerous. The reporter stated that after receiving the second lot, they had experienced unexpected bleeding despite having undergone a hysterectomy. Two days later, they reportedly developed head pressure and ringing in the right ear. The reporter also had developed joint pain and bone pain, which had not been present before the vaccination. They described experiencing excruciating pain throughout their body and stated that their life had been severely affected. The caller had additional symptoms but was too tired to continue detailing them. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787036, US-MODERNATX, INC.-MOD-2025-787038 (E2B Linked Report). Reporter did not allow further contact; Reporter's Comments: Company comment: Event Nasopharyngitis was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787036:For people US-MODERNATX, INC.-MOD-2025-787038:For somebody Known
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| 2843927 | M | CA | 06/04/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Alopecia, Laboratory test; Therapeutic response unexpected; Body height, COVID-1...
Alopecia, Laboratory test; Therapeutic response unexpected; Body height, COVID-19, Drug ineffective; Alopecia, Laboratory test; Therapeutic response unexpected; Body height, COVID-19, Drug ineffective; Alopecia, Laboratory test; Therapeutic response unexpected; Body height, COVID-19, Drug ineffective
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the patches of hair lost/when hair loss started, was losing hair all over body; This is a spontaneou...
the patches of hair lost/when hair loss started, was losing hair all over body; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 79-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization. The following information was reported: ALOPECIA (medically significant) with onset May2025, outcome "unknown", described as "the patches of hair lost/when hair loss started, was losing hair all over body". The patient underwent the following laboratory tests and procedures: tests: Unknown results, notes: They did all sorts tests. Therapeutic measures were not taken as a result of alopecia. Clinical course: The patches of hair lost, started a couple weeks ago. Maybe, are just falling out some places, is nothing major. Clarified, when hair loss started, was losing hair all over body. Eyelashes coming back a little bit, everything else, no. Treatment: No, absolutely not, not had he ever intended to. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The event did not require a visit to the Emergency Room or Physician's office. The patient does not smoke, never smoked in life, does not drink, maybe a little wine with dinner. Used to drink twice a week, now, not much at all. Patient had no allergies to any previous vaccination, medications, food or other products. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500113368 same patient and drug, different dose and event;
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| 2843929 | F | 06/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Tinnitus
Tinnitus
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describes having developed mild to moderate tinnitus after the first dose; This is a literature repo...
describes having developed mild to moderate tinnitus after the first dose; This is a literature report for the following literature source(s). A 42-year-old nulliparous White female with no past medical history of illness or disease presented to the clinic six months after receiving her two doses of Pfizer COVID-19 vaccine. The patient denies having had COVID-19 previously and describes having developed mild to moderate tinnitus after the first dose. Although she felt it somewhat improving, she was still expected to receive the second shot or compromise her diplomatic status abroad despite her voiced concerns. Discussion: As people continue to ensure appropriate access to COVID-19 mRNA vaccinations, it is as important to know which groups or individuals may not be such candidates. Neurological issues from vaccination may be the direct toxic effect of S-spike proteins as it damages the blood-brain barrier and can lead to immune dysregulation processes. The authors also know tinnitus is not an exclusively auditory problem but may result from neurological changes within the auditory system and has been known to have neurological etiology from peripheral and central cytokine-mediated responses. Tinnitus is not new in the literature after COVID-19 and mRNA vaccines. In fact, recently, a case series of three patients reported tinnitus following Pfizer mRNA vaccination where two of the three people were also younger reaffirming this as a concerning risk factor. The case represents a unique scenario since the patient developed tinnitus after the first shot yet became more pronounced and persistent after the second. According to the literature search, this implies causation with a dose-dependent impact not seen before. Since S-spike protein has already been identified as causing blood-brain barrier permeability as well as promoting intestinal permeability, this may explain such an inflammatory phenomenon.; Sender's Comments: The event of tinnitus is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500113629 same patient/product/events, different dose;US-PFIZER INC-PV202500066251 Same article/drug; different patient/event;
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| 2843930 | 42 | F | 06/04/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Audiogram, Cardiovascular examination, Neurological examination, Physical examin...
Audiogram, Cardiovascular examination, Neurological examination, Physical examination, Tinnitus; Vestibular function test
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Tinnitus worsened after the second dose; This is a literature report for the following literature so...
Tinnitus worsened after the second dose; This is a literature report for the following literature source(s). A 42-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Nulliparous" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Tinnitus". Here the authors illustrate three individuals with an average age of 36 who presented with distinct neurological side effects, all within hours after the Pfizer mRNA vaccine. The fact that each presented within eight weeks of one another by Jan2022 to a small volume practice, while none of these individuals had prior vaccination adverse reactions as children, raises serious safety concerns among younger populations. All three patients are still struggling with these symptoms. A 42-year-old nulliparous female with no past medical history of illness or disease presented to the clinic six months after receiving her two doses of Pfizer COVID-19 vaccine. The patient denies having had COVID-19 previously and describes having developed mild to moderate tinnitus after the first dose. Although she felt it somewhat improving, she was still expected to receive the second shot or compromise her diplomatic status abroad despite her voiced concerns. Her tinnitus worsened after the second dose and has since been persistent. Her physical exam was unremarkable for any auricular or middle ear findings, Dix-Hallpike maneuver, as well as a complete neurological and cardiac exam. The patient was referred by the primary care physician to an otolaryngologist who performed audiometric testing, which was negative, with no subsequent blood work. She was later told that nothing else could be done, and no labs were further ordered. As people continue to ensure appropriate access to COVID-19 mRNA vaccinations, it is as important to know which groups or individuals may not be such candidates. Neurological issues from vaccination may be the direct toxic effect of S-spike proteins as it damages the blood-brain barrier and can lead to immune dysregulation processes. The authors also know tinnitus is not an exclusively auditory problem but may result from neurological changes within the auditory system and has been known to have neurological etiology from peripheral and central cytokine-mediated responses. Tinnitus is not new in the literature after COVID-19 and mRNA vaccines. In fact, recently, a case series of three patients reported tinnitus following Pfizer mRNA vaccination where two of the three people were also younger reaffirming this as a concerning risk factor. The case represents a unique scenario since the patient developed tinnitus after the first shot yet became more pronounced and persistent after the second. According to the literature search, this implies causation with a dose-dependent impact not seen before. Since S-spike protein has already been identified as causing blood-brain barrier permeability as well as promoting intestinal permeability, this may explain such an inflammatory phenomenon.These three cases in young individuals with serious neurologic sequelae may, in fact, indicate only the beginning of adverse reactions lurking in younger populations as time and proper reporting are the only way to tell in the future. This raises concern of risk vs. benefit as there is no long-term safety with rising concerns in the short run.; Sender's Comments: The event worsening of tinnitus is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient, previous vaccinations and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500113628 Same patient and product; different dose and events;
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| 2843931 | F | 06/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Feeling hot
Feeling hot
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she feels like she have an internal heat of 140F/had been experiencing the internal heat for 4 and a...
she feels like she have an internal heat of 140F/had been experiencing the internal heat for 4 and a half years; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 79-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset 2021, outcome "not recovered", described as "she feels like she have an internal heat of 140F/had been experiencing the internal heat for 4 and a half years". The events "she feels like she have an internal heat of 140f/had been experiencing the internal heat for 4 and a half years" required physician office visit. Therapeutic measures were taken as a result of feeling hot. Additional information: The reporter is a patient, stated that for the last 4 and a half/5 years, she feels like she have an internal heat of 140F since her Pfizer Covid-19 vaccine shots. She's asking more information if anyone has complained or happened about it as she also has autoimmune disease and "bolus". All COVID-19 vaccines were from Pfizer. When asked if she already went to see her HCP, she stated already went to a clinic and that there was nothing that they could do about it. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2843932 | 06/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Neoplasm malignant
Neoplasm malignant
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aggressive cancer; This is a spontaneous report received from a Consumer or other non HCP from Licen...
aggressive cancer; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019505 (BioNTech). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (death), outcome "fatal", described as "aggressive cancer". The patient date of death was unknown. Reported cause of death: "aggressive cancer". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. COMIRNATY is under agreement with BIONTECH SE.; Reported Cause(s) of Death: aggressive cancer
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| 2843933 | F | CO | 06/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Vaccination site pain, Vaccination site reaction
Vaccination site pain, Vaccination site reaction
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have a mark where injection was given and it was very painful; have a mark where injection was given...
have a mark where injection was given and it was very painful; have a mark where injection was given and it was very painful; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Every booster pfizer (Primary Immunization series complete; Dose number unknown), for Covid-19 immunisation. The following information was reported: VACCINATION SITE REACTION (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "have a mark where injection was given and it was very painful". Additional information: The patient just got a covid Comirnaty vaccine. Her last one was 04Sep2024. The patient would like to know why the needle was so big this time. Usually she barely feel the injection. She had had every booster pfizer has put out. This time she had a mark where injection was given and it was very painful. She watched the person gave on to her husband and the needle was so long she was shocked. The patient loved the small ones. She just got a Dtap and it was small and hardly felt it." The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2843934 | 38 | M | 06/04/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Blood calcium, Blood chloride, Blood creatinine, Blood glucose, Blood potassium;...
Blood calcium, Blood chloride, Blood creatinine, Blood glucose, Blood potassium; Blood sodium, Blood thyroid stimulating hormone, Blood urea, Carbon dioxide, Cardiac function test; Electrocardiogram, Laboratory test, Magnetic resonance imaging head, Neurological examination, Syncope; Urinary incontinence, Vital signs measurement, Vitamin D
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syncopal episode along with loss of bladder control; syncopal episode along with loss of bladder con...
syncopal episode along with loss of bladder control; syncopal episode along with loss of bladder control; This is a literature report for the following literature source(s). A 38-year-old male patient received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: SYNCOPE (medically significant), 2 hrs after the suspect product(s) administration, outcome "recovered", URINARY INCONTINENCE (non-serious), 2 hrs after the suspect product(s) administration, outcome "unknown" and all described as "syncopal episode along with loss of bladder control". The event "syncopal episode along with loss of bladder control" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood calcium (8.7-10.2): 22 mg/dl; Blood chloride (96-106): 103 mmol/L; Blood creatinine (0.76-1.27): 0.98 mg/dl; Blood glucose (65-99): 96 mg/dl; Blood potassium (3.5-5.2): 4.5 mmol/L; Blood sodium (134-144): 140 mmol/L; Blood thyroid stimulating hormone (0.450-4.500): 1.2 uiU/mL; Blood urea (6-20): 12 mg/dl; Carbon dioxide (20-29): 22 mmol/L; Cardiac function test: normal and unremarkable for any deficits, notes: including cognitive or mood impairment; Electrocardiogram: unremarkable; labs: unremarkable; Magnetic resonance imaging head: unremarkable, notes: other than a vascular loop anomaly at the level of the left middle cerebral artery bifurcation, which was believed to be unrelated according to his neurology team; unremarkable, notes: other than a vascular loop anomaly at the level of the left middle cerebral artery bifurcation, which was believed to be unrelated according to his neurology team; Neurological examination: normal and unremarkable for any deficits, notes: including cognitive or mood impairment; Vital signs measurement: unremarkable; Vitamin D (30.0-100.0): 20.9 ng/ml. Clinical course: A 38-year-old male with no pertinent past medical history, former high school football player and wrestler with no family history, presented to the clinic after having a syncopal episode along with loss of bladder control. The syncopal event lasted around 30 seconds, about two hours after his third Pfizer booster injection. The patient had a recollection of events prior to the event, and his wife, who witnessed this, denied any seizure-like activity or him describing chest pain or arrhythmia. His wife immediately called emergency medical services; EKG and vitals were performed on the scene, which were unremarkable, and the patient was not taken to the hospital. The patient denies palpitations prior to or after the event. The patient was seen by a neurologist where an MRI of the head was ordered with and without contrast which was unremarkable other than a vascular loop anomaly at the level of the left middle cerebral artery bifurcation, which was believed to be unrelated according to his neurology team. Neurological and cardiac exams were normal and unremarkable for any deficits, including cognitive or mood impairment. His labs were also unremarkable. Discussion: Syncope has diverse etiologies ranging from cardiogenic to neurally mediated. While most of the syncopal episodes in the literature following mRNA vaccination are attributed to anxiety-related events, this was not the case in this patient. The World Health Organization mentions this to be a serious neurologic adverse event warranting reporting to VAERS despite not having been done by the patient's physicians previously. A cardiogenic inflammatory response might have caused transient neurologic symptoms if myocarditis ensued, which propagated a transient arrhythmia in this 38-year-old patient, given the presence of his syncopal episode. Given that the relative risk of myocarditis in young males has shown to be higher after COVID-19 mRNA second vaccination vs. from infection, this is very troublesome given how many people are infected on top of being vaccinated and a true concern for many eligible children and adolescents. This case contributes to prior concerns of adverse events showing up only after already passing through authorization phase trials, which are defined as serious. While the pathology and location of S-spike protein deposition was also not an endpoint in any of the initial trials, the authors do know now that this has been shown to induce central nervous system (CNS) inflammation.; Sender's Comments: The event syncope is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient, concomitant medications, and/or immunization-anxiety related. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202500065305 Same article/drug; different patient/event;US-PFIZER INC-202500113628 Same article/drug; different patient/event;
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| 2843935 | M | 06/04/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Prostate cancer stage IV, Suicidal ideation
Prostate cancer stage IV, Suicidal ideation
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planning to commit assisted suicide this summer; late stage prostate cancer; This is a spontaneous r...
planning to commit assisted suicide this summer; late stage prostate cancer; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-019505 (BioNTech). A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUICIDAL IDEATION (medically significant), outcome "unknown", described as "planning to commit assisted suicide this summer"; PROSTATE CANCER STAGE IV (medically significant), outcome "unknown", described as "late stage prostate cancer". The reporter stated that the consequences of Covid and the vaccines used for it were piling up at an increased rate. The patient had late-stage prostate cancer and blamed the vaccines for it. He was planning to commit assisted suicide this summer. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. COMIRNATY is under agreement with BIONTECH SE.
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| 2843936 | 06/04/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Illness; Illness
Illness; Illness
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sick; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and ge...
sick; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2843937 | 06/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cardiac disorder
Cardiac disorder
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affects the heart; This is a spontaneous report received from a Consumer or other non HCP, Program I...
affects the heart; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "affects the heart". Additional information: the patient stated that it had a variety of side effects for the COVID vaccine one of which affects the heart. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2843938 | 83 | M | WY | 06/04/2025 |
TD |
SANOFI PASTEUR |
U7183AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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administration of an expired product with no reported adverse event; Initial information received on...
administration of an expired product with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 83 years old male patient who received an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] with no reported adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-May-2025, the patient received an expired, 0.5ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Strength Standard, (Once) Suspension for injection, (Unknown strength) lot U7183AA and expiry date 23-Sep-2024 via intramuscular route in the right deltoid for immunization with no reported adverse event (expired product administered) (Latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2843939 | M | 06/04/2025 |
TD |
SANOFI PASTEUR |
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Product storage error
Product storage error
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was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for le...
was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA155611. This case involves an unknown age male patient who was administered with diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] to 0.5 ml that had been exposed to minus 0.8 degree celsius for less than 10 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 in 2024, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult that has been exposed to minus 0.8 degree celsius for less than 10 minutes with no reported adverse event (poor quality product administered) (product storage error) (Latency: same day) (route, lot number, strength and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. 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-2025SA155611:Patient 2
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| 2843940 | F | 06/04/2025 |
TD |
SANOFI PASTEUR |
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Product storage error
Product storage error
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was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for le...
was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; was administered with the vaccine to 0.5 ml that had been exposed to minus 0.8 degree Celsius for less than 10 minutes with no reported adverse event; Initial information received on 29-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who was administered with Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult [Tenivac] to 0.5 ml that had been exposed to minus 0.8 degree celsius for less than 10 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 in 2024, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids no Preservative Adult suspension for injection that had been exposed to minus 0.8 degree celsius for less than 10 minutes (poor quality product administered) (product storage error) (latency: same day) (strength, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. No adverse event was reported. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. Action taken: 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: 2025SA155495:
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| 2843941 | 1.25 | M | CO | 06/04/2025 |
IPV |
SANOFI PASTEUR |
Y1A201M |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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patient has already received three doses of IPOL prior, and a fourth dose was administered today, wh...
patient has already received three doses of IPOL prior, and a fourth dose was administered today, which was too soon, with no reported adverse event; Initial information received on 30-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient who was administered with fourth dose of IPV (VERO) [IPOL] today which was too soon, patient has already received three doses prior 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 an unknown dose 4 of suspect IPV (VERO) Suspension for injection (lot Y1A201M and expiry date- 31-Jan-2027) (strength-unknown) via unknown route in unknown administration site for Immunization today which was too soon, patient has already received three doses prior with no reported adverse event (inappropriate schedule of product administration) (latency-same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2843943 | 39 | M | UT | 06/04/2025 |
COVID19 |
JANSSEN |
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Abdominal distension, Abdominal pain upper, Diarrhoea, Muscle spasms, Tinnitus
Abdominal distension, Abdominal pain upper, Diarrhoea, Muscle spasms, Tinnitus
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Tinnitus, cramps, bloating, stomach pain, diarrhea.
Tinnitus, cramps, bloating, stomach pain, diarrhea.
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| 2843944 | 67 | M | AZ | 06/04/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
PJ353 PJ353 PJ353 UNK UNK UNK |
Headache, Lip swelling, Pruritus, Swelling; Arthralgia, Lip swelling, Oropharyng...
Headache, Lip swelling, Pruritus, Swelling; Arthralgia, Lip swelling, Oropharyngeal pain, Pharyngeal swelling, Pruritus; Swelling; Headache, Lip swelling, Pruritus, Swelling; Arthralgia, Lip swelling, Oropharyngeal pain, Pharyngeal swelling, Pruritus; Swelling
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Patient came into the pharmacy on 6/3/25 and said about 5-6 days after receiving Shingrix he had a s...
Patient came into the pharmacy on 6/3/25 and said about 5-6 days after receiving Shingrix he had a swollen neck, headache, itchy palms, and swollen lips. He said the symptoms were resolved by 6/3 except for mild itchiness on his palms.
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| 2843945 | 1.58 | M | OR | 06/04/2025 |
PNC20 |
PFIZER\WYETH |
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Febrile convulsion
Febrile convulsion
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Simple febrile seizure the evening after the vaccination was given. Temp was 103 at that time. Las...
Simple febrile seizure the evening after the vaccination was given. Temp was 103 at that time. Lasted 5 minutes.
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| 2843946 | 1.33 | F | CA | 06/04/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN7302 9P74A |
Mass; Mass
Mass; Mass
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With report of facial bumps on RIGHT cheek - occurred 2 weeks after getting vaccines. Parent concern...
With report of facial bumps on RIGHT cheek - occurred 2 weeks after getting vaccines. Parent concerned due to pfizer vaccine as a vaccine error occurred and patient was given a higher dose of pfizer.
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| 2843947 | 2 | F | MA | 06/04/2025 |
HEPA |
MERCK & CO. INC. |
Y018582 |
Unevaluable event
Unevaluable event
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None stated.
None stated.
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| 2843948 | 21 | F | UT | 06/04/2025 |
VARCEL |
MERCK & CO. INC. |
Y014181 |
Injection site erythema, Injection site warmth
Injection site erythema, Injection site warmth
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red spot noted at sight in am 6/4 by afternoon approx 24 hours after site had grown to about 2-3 inc...
red spot noted at sight in am 6/4 by afternoon approx 24 hours after site had grown to about 2-3 inches and was red and warm to touch.
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| 2843949 | 81 | F | WA | 06/04/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Dysphagia, Headache, Mobility decreased, Myalgia
Dysphagia, Headache, Mobility decreased, Myalgia
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Patient describes onset of headache about 30 minutes after injection. During the night she developed...
Patient describes onset of headache about 30 minutes after injection. During the night she developed muscle pains. By the next morning (5/28/25) she couldn't move her neck. By 5/29/25 she had difficulty swallowing. After a doctor visit, she was prescribed Tizanidine and Tylenol on 5/30/25, which was filled at a different pharmacy. Patient came in on 6/4/25 to the pharmacy to report - still has residual headaches.
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| 2843950 | 57 | F | CO | 06/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9L944 |
Heart rate increased, Hypertension
Heart rate increased, Hypertension
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36 hours after receiving the vaccine pt said she was having a fast heart rate and high blood pressur...
36 hours after receiving the vaccine pt said she was having a fast heart rate and high blood pressure...was checked out by paramedics and HR was 120, BP was 190/120... refused to go to ER and spoke to her PCP... pt was on a beta blocker and was told to take a double dose. That worked to control her blood pressure back to normal and hasn't had any other symptoms since.
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| 2843951 | 18 | F | IN | 06/04/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION |
945665 945665 |
Abdominal pain, Feeling abnormal, Hyperhidrosis, Malaise, Muscle contractions in...
Abdominal pain, Feeling abnormal, Hyperhidrosis, Malaise, Muscle contractions involuntary; Mydriasis, Pallor, Tremor, Unresponsive to stimuli
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0955 Heplisav B #4 given Left Deltoid 1000 Conversing with candidate to schedule Hep titer and putti...
0955 Heplisav B #4 given Left Deltoid 1000 Conversing with candidate to schedule Hep titer and putting in her phone 1005 Candidate states "she doesn't feel good" becomes pale & sweating, water offered & cold rag to face. No breathing issues. 1010 Candidates mother called to pick up candidate. Still feeling weird. 1015 Candidate unresponsive for 1 minute opens eyes suddenly with eyes dilated (pupils) fists to chest shaking states she was dreaming 1020 juice given 83P 80/52 BP O2 sats Room Air 98% 1025 Candidate stated she was cramping & needed to have BM, walked with RN to bathroom. Had BM then sweating profusely. Candidate immediately after layed on floor with feet up on comode stating she was cramping and felt terrible. 1030 Candidate helped to recliner layed back, fanning patient. V/S 59P 99% on RA, 90/60 B/P parents to be seen by medical provider. 1040 Candidate wheelchaired to front entrance with parents. Candidate going to see PCP. 1400 Candidate called to state she saw her PCP / Nurse Practioner with no further issues.
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| 2843968 | 0.25 | M | TX | 06/04/2025 |
DTAPIPVHIB PNC13 |
SANOFI PASTEUR PFIZER\WYETH |
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Crying, Diarrhoea, Discomfort, Pyrexia, Rash; Crying, Diarrhoea, Discomfort, Pyr...
Crying, Diarrhoea, Discomfort, Pyrexia, Rash; Crying, Diarrhoea, Discomfort, Pyrexia, Rash
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? Persistent, inconsolable crying for 3?4 days ? Low-grade fever 3-4 days ? Mild full-body rash 3-4 ...
? Persistent, inconsolable crying for 3?4 days ? Low-grade fever 3-4 days ? Mild full-body rash 3-4 days ? Diarrhea 3-4 days ? Discomfort when laid flat or touched 3-4 days
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| 2843969 | 17 | M | TX | 06/04/2025 |
MENB |
PFIZER\WYETH |
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Nausea, Vomiting
Nausea, Vomiting
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Nausea/vomiting within 2 hours of administration of meningococcal serogroup B vaccination
Nausea/vomiting within 2 hours of administration of meningococcal serogroup B vaccination
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| 2843981 | 16 | F | TX | 06/04/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8204CB |
Unevaluable event
Unevaluable event
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None stated.
None stated.
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| 2843983 | 78 | F | WA | 06/04/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LN0591 774KG |
Injected limb mobility decreased, Pain in extremity, Shoulder injury related to ...
Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration; Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
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R & L Shoulder were both sore after injections. R side got better but L did not. Arm was sore an...
R & L Shoulder were both sore after injections. R side got better but L did not. Arm was sore and could not lift arm up all the way without pain. No redness, swelling or warmth. Shoulder is sore and has pain even with slight internal rotation. Dx with SIRVA. Referred pt to Physical Therapy
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| 2843623 | M | MA | 06/03/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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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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pharmacist who said a patient received a dose of GARDASIL 9 "last August" and came back to...
pharmacist who said a patient received a dose of GARDASIL 9 "last August" and came back to get his second shot of the series last week.; no adverse event; This spontaneous report was received from a pharmacist and refers to a 29-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. In August 2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Injection; In May 2025, also reported as last week, the patient came back to get his second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) ( for both doses, lot #, dose, route of administration, anatomical location of vaccine and expiration date were not reported) for Prophylaxis (inappropriate schedule of vaccine administered). No additional adverse event was reported.
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| 2843624 | PA | 06/03/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
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Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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VARIVAX and PROQUAD. AE was filed as both vaccines contained varicella component; intended to provi...
VARIVAX and PROQUAD. AE was filed as both vaccines contained varicella component; intended to provide patient with VARIVAX and MMR II.; No symptomatic events reported; This spontaneous report was received from a nurse practitioner referring to a patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported. On an unknown date, the patient was intended to receive varicella virus vaccine live (oka/merck)(VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis, but on 20-May-2025, was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strengths, specific dosages, dose numbers, routes of administration, anatomical sites of application, lot numbers and expiration dates were not provided). AE was filed as both vaccines contained varicella component. No symptomatic events. Lot # is being requested and will be submitted if received.
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| 2843625 | CA | 06/03/2025 |
VARCEL |
MERCK & CO. INC. |
Z003767 |
No adverse event, Product storage error
No adverse event, Product storage error
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Nurse confirmed the patient has not reported any medical concerns or symptoms after being administer...
Nurse confirmed the patient has not reported any medical concerns or symptoms after being administered the improperly stored dose of VARIVAX.; Nurse calling with a report of an adverse event regarding an improperly stored and administered dose of VARIVAX. Nurse stated that the VARIVAX was involved in a temperature excursion beginning on 5/8/2025 and was administered to a patient on 5/16/20; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Beginning on 08-MAY-2025, the Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was involved in a temperature excursion, then, on 16-May-2025, the patient was vaccinated with this vaccine, which was the second dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003767, expiration date: 30-Jan-2027), 0.5 mL administered by Unknown route as prophylaxis. The vaccine was reconstituted with a Sterile diluent (lot# and expiration date not reported. Nurse confirmed the patient has not reported any medical concerns or symptoms after being administered the improperly stored dose of VARIVAX. No additional information provided. No additional AE/PQC.
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