| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2781442 | 80 | F | KY | 07/26/2024 |
RSV RVX VARZOS |
PFIZER\WYETH UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
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Pain; Arthralgia, Back pain, Headache, Pain in extremity; Arthralgia, Back pain,...
Pain; Arthralgia, Back pain, Headache, Pain in extremity; Arthralgia, Back pain, Headache, Pain in extremity
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extreme body pain
extreme body pain
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| 2824825 | 34 | F | AK | 02/05/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
CX4HL |
Product storage error
Product storage error
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Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vacc...
Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use.
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| 2824826 | 87 | F | GA | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52Z52 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was vaccinated twice (12/2023 and 2/2025) when there is only one dose in series at this time...
Patient was vaccinated twice (12/2023 and 2/2025) when there is only one dose in series at this time. No adverse reactions to record at time of submission of this report.
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| 2824827 | 84 | M | FL | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received RSV on 10/10/2023; Software and ins did not catch duplication; Patient did not re...
Patient received RSV on 10/10/2023; Software and ins did not catch duplication; Patient did not recall he had in October of 2023 as well and requested vaccine. I called patient on 2/5/2025 to follow up with his well being and he reported no SE or reaction from 2nd shot.
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| 2824829 | 82 | F | FL | 02/05/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received RSV in October 2023. Software and agency did not recall she had RSV in October of ...
Patient received RSV in October 2023. Software and agency did not recall she had RSV in October of 2023 and requested vaccine. I called patient on 2/5/2025 to follow up with her well being and she reported no SE or reaction from 2nd shot.
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| 2824838 | 67 | F | NC | 02/05/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
F42B2 F42B2 |
Cyanosis, Erythema, Inflammation, Limb injury, Nodule; Peripheral swelling, Scab
Cyanosis, Erythema, Inflammation, Limb injury, Nodule; Peripheral swelling, Scab
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Patient arm turned red + blue + inflamed and knotted initially did not get any better with time so s...
Patient arm turned red + blue + inflamed and knotted initially did not get any better with time so sought help from her primary care MD who prescribed her an oral + topical antibiotic her imz was 1/8/25 - she presented to us today 2-4-25 - she says treated w smaller that is smaller than it was initially - it scabbed over and is red around it and swollen in a little. She did hit the area with her refrigerator handle - she has a follow up appt with her MD on Tues 2-11-25
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| 2824360 | 63 | M | FL | 02/04/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
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Anxiety, Confusional state, Fatigue, Headache, Injection site pain; Loss of pers...
Anxiety, Confusional state, Fatigue, Headache, Injection site pain; Loss of personal independence in daily activities, Malaise
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he didn't feel good; he was unable to ride his bike; he felt unusually tired/ exhausted/ exhaus...
he didn't feel good; he was unable to ride his bike; he felt unusually tired/ exhausted/ exhausted just doing his regular daily activities; headache; little bit of confusion; he's worried; injection site is a little sore; This spontaneous report was received from a consumer and referrint to himself as a 63-year-old male patient. He was very active and bikes frequently, he has never experienced a vaccine reaction, he has had two COVID vaccines, shingles, and flu. On 27-JAN-2025 18:00:00, the patient was vaccined with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection, administered for prophylaxis (dose, injection site, vaccination scheme, strength, lot #, expiration date, and route of administration were not provided). On 28-JAN-2025, at night, he felt unusually tired after his regular bikeride. On Wednesday, 29-JAN-2025, he again felt exhausted after his regular bikeride, which was not normal for him (fatigue). He reported that, on Thursday 30-JAN-2025, he felt better in the morning but felt exhausted just doing his regular daily activities; he further described this exhaustion as "not horrible" but it made him wonder what was going on and if it could be from the vaccine. On the same date, he was so exhausted that he canceled plans because he didn't feel good (malaise), he was unable to ride his bike (exercise tolerance decreased), and he took a four-hour nap, none of which are normal for him. He also reported that on an unspecified date in January 2025, he had a little bit of confusion, a headache, and the injection site is a little sore (vaccination site pain) but was nothing bad. When asked about the soreness he reported that there was not redeness or anything visible at the injection site and that the soreness is the same soreness he has experienced in the past after a vaccine. He reported that, for him not to go biking on 30-JAN-2025 was really bad and he was worried (anxiety) that the exhaustion won't go away. He reported no fever but that he had a very good appetite. At the time of reporting, he had not recovered from fatigue, the outcome of the rest of the events was not reported. The causal relationship between the events and the suspect vaccine was not reported. Lot # is being requested and will be submitted if received.
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| 2824374 | U | FL | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Rash
Rash
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Rash; This non-serious case was reported by a physician via sales rep and described the occurrence o...
Rash; This non-serious case was reported by a physician via sales rep and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash). The outcome of the rash was unknown. The reporter considered the rash to be related to Shingrix. The company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that patients said they had gotten a rash after the Shingrix vaccine and worry if it was shingles. The reporter wanted to know could this be the case.
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| 2824375 | M | 02/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Feeling abnormal, Herpes zoster, Vaccination failure
Feeling abnormal, Herpes zoster, Vaccination failure
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My brother in law got the shingles shot and got shingles six weeks later/ suspected vaccination fail...
My brother in law got the shingles shot and got shingles six weeks later/ suspected vaccination failure; Shingles; Feeling miserable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My brother in law got the shingles shot and got shingles six weeks later/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and feeling miserable (Verbatim: Feeling miserable). The outcome of the vaccination failure, shingles and feeling miserable were not reported. It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable 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 and feeling miserable to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-JAN-2025 This case was reported via interactive digital media. Reporter reported that the brother in law got the shingles shot and got shingles six weeks later. He was miserable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2824376 | F | 02/04/2025 |
PPV PPV VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Dizziness, Dyspnoea, Myalgia, Pain in extremity, Peripheral swelling; Vomiting; ...
Dizziness, Dyspnoea, Myalgia, Pain in extremity, Peripheral swelling; Vomiting; Dizziness, Dyspnoea, Myalgia, Pain in extremity, Peripheral swelling; Vomiting
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soreness on the left arm; swelling on the left arm; muscle pain on her left arm; felt like she was g...
soreness on the left arm; swelling on the left arm; muscle pain on her left arm; felt like she was going to faint; vomit; could not breathe; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. On 21-JAN-2025, the patient received the 1st dose of Shingrix (left arm) and Pneumococcal vaccine (right arm). In JAN-2025, 3 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: muscle pain on her left arm), felt faint (Verbatim: felt like she was going to faint), vomiting (Verbatim: vomit) and difficulty breathing (Verbatim: could not breathe). On 21-JAN-2025, the patient experienced pain in arm (Verbatim: soreness on the left arm) and swelling arm (Verbatim: swelling on the left arm). The outcome of the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing were unknown. It was unknown if the reporter considered the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing to be related to Shingrix. It was unknown if the company considered the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing to be related to Shingrix. Additional Information: GSK Receipt Date: 24-JAN-2025 Patient was the reporter. Patient received her first dose of Shingrix on 21st January 2025. She received the dose on her left arm and she received a pneumonia vaccine on her right arm. She experienced soreness and swelling on the left arm the same day. 3 days later, she felt muscle pain on her left arm and felt like she was going to faint, vomit, and could not breathe. It was unknown if the reporter considered the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing to be related to Pneumococcal vaccine.
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| 2824377 | 44 | U | IL | 02/04/2025 |
HIBV |
SANOFI PASTEUR |
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No adverse event, Off label use, Product administered to patient of inappropriat...
No adverse event, Off label use, Product administered to patient of inappropriate age
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44-year-old patient prescribed ACTHIB by another provider with no reported adverse event; Initial in...
44-year-old patient prescribed ACTHIB by another provider with no reported adverse event; Initial information received on 29-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 44 years old and unknown gender patient who was prescribed with haemophilus type B (HIB) vaccine [ACT-HIB] by another provider with no reported adverse event. The patient's past medical history included Sinusitis bacterial. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Multiple sclerosis. On an unknown date, the patient was prescribed with HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization) (off label use). Reportedly, the nurse reported that they do not know the exact reason the patient was prescribed ACTHIB for. The patient did not know their vaccination status. Information on the batch number was requested corresponding to the one at time of event occurrence.
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| 2824379 | M | CO | 02/04/2025 |
COVID19 |
MODERNA |
3042648 |
Chills, Dyspnoea, Hypoxia, Platelet count decreased, Renal impairment
Chills, Dyspnoea, Hypoxia, Platelet count decreased, Renal impairment
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Reported Symptoms: 10013963:DYSPNEA; Narrative: Pt admitted to the hospital with chills, difficulty ...
Reported Symptoms: 10013963:DYSPNEA; Narrative: Pt admitted to the hospital with chills, difficulty breathing after receiving Covid and Influenza vaccines earlier in the day. he was diagnosed with hypoxia, elevated kidney function, low plts and worsening of his AS -moderate AS other Relevant HX: Pt admitted to the hospital with chills, difficulty breathing after receiving Covid and Influenza vaccine earlier in the day. he was diagnosed with hypoxia, elevated kidney function, low plts and worsening of his AS -moderate AS Other: DYSPNEA
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| 2824380 | 37 | M | NV | 02/04/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
NG5FM |
Pruritus, Rash, Respiratory tract congestion
Pruritus, Rash, Respiratory tract congestion
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Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10052251:RESPIRATORY TRACT CONGESTION; Narrativ...
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10052251:RESPIRATORY TRACT CONGESTION; Narrative: Other Relevant HX: Other: THROAT CONGESTION
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| 2824381 | 41 | M | CO | 02/04/2025 |
COVID19 |
MODERNA |
8080799 |
Rash
Rash
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Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX:
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX:
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| 2824382 | 75 | M | CA | 02/04/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
027L20A 031M20A |
Sensory disturbance, Skin burning sensation; Sensory disturbance, Skin burning s...
Sensory disturbance, Skin burning sensation; Sensory disturbance, Skin burning sensation
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Reported Symptoms: 10047904:WEIRD FEELING; 10079791:BURNING SENSATION SCALP; Narrative: Other Releva...
Reported Symptoms: 10047904:WEIRD FEELING; 10079791:BURNING SENSATION SCALP; Narrative: Other Relevant HX: Other: spider web feeling in skin, scalp burning
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| 2824383 | 69 | M | NV | 02/04/2025 |
COVID19 |
MODERNA |
009C21A |
Lip swelling, Rash
Lip swelling, Rash
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Reported Symptoms: 10024570:LIP SWELLING; 10037844:RASH; Narrative: Other Relevant HX: Other: LIP SW...
Reported Symptoms: 10024570:LIP SWELLING; 10037844:RASH; Narrative: Other Relevant HX: Other: LIP SWELLING
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| 2824384 | 74 | M | MI | 02/04/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7554T |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Reported Symptoms: Narrative: Patient received his influenza vaccine on 9/16/2024 at the clinic. He ...
Reported Symptoms: Narrative: Patient received his influenza vaccine on 9/16/2024 at the clinic. He came in on 10/3/24 and received a second influenza vaccine, also at the clinic. Patient was notified the next day that he received a second vaccine for the 2024-2025 season. Patient did not report any adverse events. Other Relevant HX: Patient received his influenza vaccine on 9/16/2024 at the clinic. He came in on 10/3/14 and received a second influenza vaccine, also at the clinic. Patient was notified the next day that he received a second vaccine for the 2024-2025 season. Patient did not report any adverse events. Other: N/A
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| 2824385 | 72 | F | MI | 02/04/2025 |
FLU3 |
SANOFI PASTEUR |
UT8437DA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Reported Symptoms: Narrative: Patient received a trivalent influenza vaccine on 9/12/24. She came i...
Reported Symptoms: Narrative: Patient received a trivalent influenza vaccine on 9/12/24. She came in again on 10/9/24 and received a trivalent high dose influenza vaccine. Patient was called on 10/16/24 to tell her that she received a second dose and she stated that she had forgotten about receiving the first dose. Patient reported no adverse events. Patient should have initially received the high dose based on her age. Other Relevant HX: Patient received a trivalent influenza vaccine on 9/12/24. She came in again on 10/9/24 and received a trivalent high dose influenza vaccine. Patient was called on 10/16/24 to tell her that she received a second dose and she stated that she had forgotten about receiving the first dose. Patient reported no adverse events. Patient should have initially received the high dose based on her age. Other: N/A
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| 2824386 | 82 | M | MI | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
LM47J7 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Reported Symptoms: Narrative: Patient received his RSV vaccine on 12/21/2023. Patient came in to the...
Reported Symptoms: Narrative: Patient received his RSV vaccine on 12/21/2023. Patient came in to the facility on 10/29/24 and received a second RSV vaccine. RSV is only indicated as a single lifetime dose vaccine. Patient did not report any adverse events. Other Relevant HX: Patient received his RSV vaccine on 12/21/2023. Patient came in to the facility on 10/29/24 and received a second RSV vaccine. RSV is only indicated as a single lifetime dose vaccine. Patient did not report any adverse events. Other; N/A
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| 2824387 | 69 | M | MI | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
2432Z |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Reported Symptoms: Narrative: Patient received his RSV vaccine on 10/31/2023 at the clinic. He came ...
Reported Symptoms: Narrative: Patient received his RSV vaccine on 10/31/2023 at the clinic. He came in on 10/28/24 and received a second dose of the RSV vaccine. RSV is only indicated as a single lifetime dose vaccine. Patient has not reported any adverse events. Other Relevant HX: Patient received his RSV vaccine on 10/31/2023 at the clinic. He came in on 10/28/24 and received a second dose of the RSV vaccine. RSV is only indicated as a single lifetime dose vaccine. Patient has not reported any adverse events. Other: N/A
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| 2824388 | 54 | M | FL | 02/04/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LA6406 LA6406 |
Erythema multiforme, Headache, Injection site erythema, Injection site pain, Inj...
Erythema multiforme, Headache, Injection site erythema, Injection site pain, Injection site swelling; Injection site warmth, Nausea, Pruritus, Vomiting
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Reported Symptoms: 10015218:ERYTHEMA MULTIFORME 10019211:HEADACHE; 10037087:PRURITUS; 10047700:VOMIT...
Reported Symptoms: 10015218:ERYTHEMA MULTIFORME 10019211:HEADACHE; 10037087:PRURITUS; 10047700:VOMITING; Narrative: On 10/8/24 the patient received Prevnar 20 in the left deltoid. On 10/11/24 the patient returned to the primary care clinic with a red spot on the bicep area where he received the injection. The 10/11/24 PCP notes that "pt c/o Lt bicep circular redness, swollen, warm and tender to touch x 3 days. Pt just received a Pneumococcal Vaccine in that area 10/8/24. Pt also report feeling nauseated, h/a, soreness in the area. Redness is spreading down his arm. No fever/chills, no SOB, no sore throat or wheezes. Pt has been icing and taking Tylenol and Ibuprofen with no relief." The PCP then gave Benadryl and solumedrol IM and also wrote a prescription for cephalexin, Benadryl and prednisone. Other Relevant HX: Other:
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| 2824389 | 75 | M | 02/04/2025 |
TDAP |
UNKNOWN MANUFACTURER |
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Wrong product administered
Wrong product administered
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Reported Symptoms: 10048055:WRONG DRUG ADMINISTERED; Narrative: Other Relevant HX: Other Incorrect m...
Reported Symptoms: 10048055:WRONG DRUG ADMINISTERED; Narrative: Other Relevant HX: Other Incorrect medication given
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| 2824390 | 82 | F | FL | 02/04/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
KJ3N3 KJ3N3 |
Cough, Dizziness, Dyspnoea, Paraesthesia, Syncope; Vomiting, Wheezing
Cough, Dizziness, Dyspnoea, Paraesthesia, Syncope; Vomiting, Wheezing
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Reported Symptoms: 10011232:COUGHING; 10013573:DIZZINESS; 10040604:SHORTNESS OF BREATH; 10042772:SYN...
Reported Symptoms: 10011232:COUGHING; 10013573:DIZZINESS; 10040604:SHORTNESS OF BREATH; 10042772:SYNCOPE; 10043876:TINGLING; 10047700:VOMITING; Narrative: Patient presented to primary care clinic on 10/1/24 stating that she had been wheezing since receiving the Shingles vaccine the day prior. Staff observed the patient gasping for air and having difficulty speaking. Pt also reported hand tingling, dizziness, and nausea. A code assist was called and patient was treated for allergic reaction with benadryl, famotidine, and solumedrol. Other Relevant HX: Other: hand tingling, shortness of breath
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| 2824391 | 74 | M | MI | 02/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Reported Symptoms: Narrative: Patient received his RSV vaccine outside of the clinic on 10/25/23. Pa...
Reported Symptoms: Narrative: Patient received his RSV vaccine outside of the clinic on 10/25/23. Patient was then again given an RSV vaccine on 11/20/2024. Patient was asked if he had received this vaccine before and he stated no. The chart was not reviewed prior to administering which shows that he did receive the vaccine in 2023. It is possible that the patient believed it was an annual vaccine, this has been a common misconception by patients. Patient is additionally 74 years of age and does not appear to meet any of the requirements to receive the vaccine before 75 years of age. Patient is not reporting any adverse effects. Other Relevant HX: Other: N/A
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| 2824392 | 75 | M | MI | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93ET2 |
Extra dose administered, No adverse event, Wrong product administered
Extra dose administered, No adverse event, Wrong product administered
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Reported Symptoms: Narrative: Patient received his zoster vaccine on 1/8/24 and 7/8/24. Shingrix is ...
Reported Symptoms: Narrative: Patient received his zoster vaccine on 1/8/24 and 7/8/24. Shingrix is only intended to be given as a 2 dose series. Patient was intended to receive the Arexvy vaccine today however due to similarities in packaging the patient was accidentally given the Shingrix vaccine instead of Arexvy. Patient reports no adverse events. Other Relevant HX: Patient received his zoster vaccine on 1/8/24 and 7/8/24. Shingrix is only intended to be given as a 2 dose series. Patient was intended to receive the Arexvy vaccine today however due to similarities in packaging the patient was accidentally given the Shingrix vaccine instead of Arexvy. Patient reports no adverse events. Other: N/A
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| 2824393 | 58 | M | MI | 02/04/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
H7RF2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Reported Symptoms: Narrative: Patient received his first dose of Twinrix on 2/9/24, his second dose ...
Reported Symptoms: Narrative: Patient received his first dose of Twinrix on 2/9/24, his second dose on 3/13/24, and his third dose on 6/5/24. The typical dosing schedule for Twinrix is dose #2 1 month after dose #1, and dose #2 6 months after dose #1. Patient should have received his 3rd dose in August 2024. Patient experienced no adverse events. Other Relevant HX:: Patient received his first dose of Twinrix on 2/9/24, his second dose on 3/13/24, and his third dose on 6/5/24. The typical dosing schedule for Twinrix is dose #2 1 month after dose #1, and dose #2 6 months after #1. Patient should have received his 3rd dose in August 2024. Patient experienced no adverse events. Other: N/A
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| 2824394 | 69 | M | NV | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
X3M27/539A2 |
Asthenia, Hyperhidrosis, Malaise
Asthenia, Hyperhidrosis, Malaise
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Reported Symptoms: 10012703:DIAPHORESIS; 10025482:MALAISE; 10047862:WEAKNESS; Narrative: Other Relev...
Reported Symptoms: 10012703:DIAPHORESIS; 10025482:MALAISE; 10047862:WEAKNESS; Narrative: Other Relevant HX: Other: Malaise, diaphoresis, weakness
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| 2824395 | 73 | M | NV | 02/04/2025 |
PPV VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
N019838 L7F7E |
Myalgia; Myalgia
Myalgia; Myalgia
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Reported Symptoms: 10028411:MYALGIA; Narrative; Muscle pain has lasted for 4 months. Other Relevant ...
Reported Symptoms: 10028411:MYALGIA; Narrative; Muscle pain has lasted for 4 months. Other Relevant HX: Other:
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| 2824396 | 64 | F | NV | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
37kL2 |
Pruritus, Rash
Pruritus, Rash
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Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Rash and itching on arm of injection...
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Rash and itching on arm of injection site that lasted approx one week after first dose. Patient did not come in at that time for evaluation. Resolved on own, took more than 6 days. Other Relevant HX: Other:
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| 2824397 | 61 | F | NV | 02/04/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Myalgia
Myalgia
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Reported Symptoms: 10028411:MYALGIA; Narrative: Patient appears to have been given this vaccine at a...
Reported Symptoms: 10028411:MYALGIA; Narrative: Patient appears to have been given this vaccine at an outside facility. allergy was documented for continuity of care. Other Relevant HX: Other:
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| 2824398 | 62 | M | NV | 02/04/2025 |
PPV |
MERCK & CO. INC. |
T017385 |
Erythema multiforme, Myalgia
Erythema multiforme, Myalgia
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Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10028411;MYALGIA; Narrative: Other Relevant HX: Oth...
Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10028411;MYALGIA; Narrative: Other Relevant HX: Other:
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| 2824399 | 60 | M | NV | 02/04/2025 |
COVID19 COVID19 COVID19 |
JANSSEN JANSSEN JANSSEN |
042A21A 042A21A 042A21A |
Acute respiratory failure, Anaphylactic reaction, COVID-19 pneumonia, Cough, Dea...
Acute respiratory failure, Anaphylactic reaction, COVID-19 pneumonia, Cough, Death; Dehydration, Dyspnoea, General physical health deterioration, Hypophagia, Pyrexia; Respiratory tract congestion, Syncope
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Reported Symptoms: 10011906:DEATH; 10021143:HYPOXIA; 10084380:COVID-19 PNEUMONIA; Narrative: Pati...
Reported Symptoms: 10011906:DEATH; 10021143:HYPOXIA; 10084380:COVID-19 PNEUMONIA; Narrative: Patient received J+J vaccine in May 2021. Was seen in ED for syncope likely to dehydration; was also short of breath. Marked as anaphylaxis in chart. Later presented to ED 08/16/2021 with fever, increasing cough, congestion, shortness of breath, decreased oral intake, admitted to COVID-19 Unit. PMH significant for CLL, colon cancer, dementia. Patient DNR/DNI code status, wishes were to transition to comfort care in the setting of rapid deterioration or suffering. Acute worsening of respiratory status despite non-invasive ventilatory support occured on 08/25/2021 AM, based on his wishes he was transitioned to comfort care and passed away at 10:02 AM on 08/25/021. Other Relevant HX: Other: Death - AHRF from COVID-19 Pneumonia
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| 2824400 | 70 | M | NV | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ML532/A4X57 |
Arthralgia, Myalgia
Arthralgia, Myalgia
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Reported Symptoms: 10003239:ARTHRALGIA; 10028411:MYALGIA; Narrative: Patient experiences muscle and ...
Reported Symptoms: 10003239:ARTHRALGIA; 10028411:MYALGIA; Narrative: Patient experiences muscle and joint pain throughout body the next day after administration of Shingrix vaccine. Pain continues about 1 month after Shingrix administration and is not relieved by APAP. Patient states it is painful for him to move. Other Relevant HX: Other:
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| 2824401 | 78 | M | NV | 02/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
37KL2 |
Erythema multiforme, Injection site swelling, Rash
Erythema multiforme, Injection site swelling, Rash
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Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10037844:RASH; 10053425:INJECTION SITE SWELLING; Na...
Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10037844:RASH; 10053425:INJECTION SITE SWELLING; Narrative: Patient presented to ED for evaluation of local reaction in 2018. Per ED, could also have other cause such as bug bite. Patient was later given the 2nd Shingrix dose in 2019 appears to have tolerated. Other Relevant HX: Other: Swelling at injection site
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| 2824402 | 66 | M | NV | 02/04/2025 |
PPV |
MERCK & CO. INC. |
r002354 |
Injection site erythema, Injection site swelling, Injection site warmth, Rash
Injection site erythema, Injection site swelling, Injection site warmth, Rash
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Reported Symptoms: 10037844:RASH; Narrative: Patient presented to the ER at a non-facility care hosp...
Reported Symptoms: 10037844:RASH; Narrative: Patient presented to the ER at a non-facility care hospital on 09/08/2018 for redness, swelling and warmth around the area where he was given the Pneumococcal polysaccharide vaccine PPSV23 the day prior. He was given dexamethasone and famotidine with improvement in symptoms. He was discharged on famotidine and loratadine. Doses of the medications given at this outside facility was not provided. Other Relevant HX: Other: L arm redness and swelling
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| 2824451 | 12 | F | TN | 02/04/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
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Unevaluable event
Unevaluable event
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none
none
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| 2824453 | 80 | M | AR | 02/04/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
011F21A 042B21A 023M20A |
COVID-19, Death, SARS-CoV-2 test positive; COVID-19, Death, SARS-CoV-2 test posi...
COVID-19, Death, SARS-CoV-2 test positive; COVID-19, Death, SARS-CoV-2 test positive; COVID-19, Death, SARS-CoV-2 test positive
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Pt was hospitalized for covid and died.
Pt was hospitalized for covid and died.
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| 2824454 | 68 | M | WI | 02/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chest X-ray, Computerised tomogram thorax, Hilar lymphadenopathy, Sarcoidosis, S...
Chest X-ray, Computerised tomogram thorax, Hilar lymphadenopathy, Sarcoidosis, Scan with contrast
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Sarcoidosis, bilateral hilar lymphadenopathy.
Sarcoidosis, bilateral hilar lymphadenopathy.
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| 2824455 | 0.25 | M | FL | 02/04/2025 |
PNC15 PNC15 |
MERCK & CO. INC. MERCK & CO. INC. |
Y002963 Y002963 |
Brief resolved unexplained event, Cyanosis, Depressed level of consciousness, Ga...
Brief resolved unexplained event, Cyanosis, Depressed level of consciousness, Gaze palsy, Hypotonia; Seizure, Unresponsive to stimuli
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36 hours after PCV 15, had episode at home where became limp, unresponsive, eyes rolling back in hea...
36 hours after PCV 15, had episode at home where became limp, unresponsive, eyes rolling back in head. Went to ED and difficult to arouse but did, then when in ED, again turned blue, limp, unresponsive. They believe seizure and gave anti-epileptic. Transferred to pediatric center and they said BRUE. Per mom, neurologist thinks was a seizure and will do follow up appt.
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| 2824456 | 14 | F | MD | 02/04/2025 |
HPV9 |
MERCK & CO. INC. |
Y008986 |
Limb mass
Limb mass
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Bump on right arm after vaccine administration, informed mother to put cold compress and if still bo...
Bump on right arm after vaccine administration, informed mother to put cold compress and if still bothering her, to make a follow up in the office to get it checked. -
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| 2824457 | 16 | F | PR | 02/04/2025 |
MENB MNQ |
PFIZER\WYETH NOVARTIS VACCINES AND DIAGNOSTICS |
GP8622 NR394 |
Interchange of vaccine products, No adverse event; Interchange of vaccine produc...
Interchange of vaccine products, No adverse event; Interchange of vaccine products, No adverse event
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Minor attends vaccination clinic on 01/08/2024 for the administration of his 16-year-old vaccines, m...
Minor attends vaccination clinic on 01/08/2024 for the administration of his 16-year-old vaccines, menveo (MCV) and trumemba (MCV B) are administered with a booster dose in 6 months. Minor arrives today 04/02/2025 for administration of the 2nd dose of trumemenba (MCV B) when validating the vaccine in the system indicates an invalidation in the area of the trumemba vaccine (MCV B) administered on 01/08/2024 since the minor received the bexsero vaccine (MCV B) in 2019. It is validated with the health department, vaccination division area and notification was received via email from doctor with the indication that Bexsero (MCV B) be administered since she was started with it. Her primary doctor and mother are notified of the event, she expresses her understanding, and the minor is vaccinated. At the time of the interview with the mother, the same verbal statement was made: "The minor has not presented any changes or symptoms."
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| 2824458 | 15 | M | IL | 02/04/2025 |
PNC15 |
MERCK & CO. INC. |
X026480 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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RN administered Pneumococcal vaccine to patient. Patient is out of the age range to receive it.
RN administered Pneumococcal vaccine to patient. Patient is out of the age range to receive it.
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| 2824459 | 0.58 | M | NY | 02/04/2025 |
RSV |
PFIZER\WYETH |
HP1193 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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The patient received the incorrect RSV vaccine on 1/29/25. At the time, our office was unaware that ...
The patient received the incorrect RSV vaccine on 1/29/25. At the time, our office was unaware that the vaccine being carried was intended for pregnant mom's only, not for infants. On 2/3/25, this writer was made aware by staff the vaccine was showing Invalid in system, this writer then proceeded to contact our rep through the County Health Dept and was made aware that the vaccine is incorrect. This writer then took the appropriate steps to ensure no vaccines are given to infants going forward, placed an order for the correct vaccines, then on the follow day 2/4/25 reached out to the parents to make them aware and got them scheduled for appointments to come in for the correct vaccine. Parent reports no side effect or adverse reaction to the vaccine at this time.
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| 2824460 | 5 | M | KY | 02/04/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
327E3 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Child received twinrix who was 5 years old. The age of 18+ for this vaccine was not discovered unti...
Child received twinrix who was 5 years old. The age of 18+ for this vaccine was not discovered until after vaccine had been administered.
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| 2824461 | 0.08 | F | NY | 02/04/2025 |
RSV |
PFIZER\WYETH |
HP1193 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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The patient received the incorrect RSV vaccine on 1/10/25. At the time, our office was unaware that ...
The patient received the incorrect RSV vaccine on 1/10/25. At the time, our office was unaware that the vaccine being carried was intended for pregnant mom's only, not for infants. On 2/3/25, this writer was made aware by staff the vaccine was showing Invalid in database, this writer then proceeded to contact our rep through the Health Dept and was made aware that the vaccine is incorrect. This writer then took the appropriate steps to ensure no vaccines are given to infants going forward, placed an order for the correct vaccines, then on the follow day 2/4/25 reached out to the parents to make them aware and got them scheduled for appointments to come in for the correct vaccine. Parent reports no side effect or adverse reaction to the vaccine at this time.
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| 2824462 | 61 | M | GA | 02/04/2025 |
PNC20 |
PFIZER\WYETH |
LJ5280 |
Extra dose administered
Extra dose administered
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Patient has already received one dose of Prevnar 20 in 04/10/2023. Patient stated he has never gotte...
Patient has already received one dose of Prevnar 20 in 04/10/2023. Patient stated he has never gotten a Pneumonia vaccine in the past. The pharmacist failed to check the system and verify the clinical appropriateness of the vaccine.
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| 2824463 | 11 | M | MD | 02/04/2025 |
MNQ TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
7GF79 3RE731 |
Injection site mass, Injection site pain; Injection site mass, Injection site pa...
Injection site mass, Injection site pain; Injection site mass, Injection site pain
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Red lump in right arm 2 x 2 inches that appeared after vaccines were given on area of shots on 01-...
Red lump in right arm 2 x 2 inches that appeared after vaccines were given on area of shots on 01-27-25, area is painful only if and when pressed, no bleeding, no discharge, no warmth. he is able to move his arm well, no fever. no chills. Start Triamcinolone Acetonide Cream, 0.1 %, 1 application sparingly to affected area, Externally, Once a day, 7 days, 30 grams, Refills 0Start Mupirocin Ointment, 2 %, 1 application to affected area small amount, Externally, Three times a day, 7 days, 22 grams, Refills 0. If rash does not improve or resolve in a few days, or if rash changes in appearance, gets worse, symptoms seem uncontrollable, or other symptoms develop, to seek medical attention immediately.. Keep area clean and practice hygiene, using running water and soap.
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| 2824464 | F | NY | 02/04/2025 |
RSV |
PFIZER\WYETH |
HP1193 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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The patient received the incorrect RSV vaccine on 1/24/25. At the time, our office was unaware that ...
The patient received the incorrect RSV vaccine on 1/24/25. At the time, our office was unaware that the vaccine being carried was intended for pregnant mom's only, not for infants. On 2/3/25, this writer was made aware by staff the vaccine was showing Invalid in database, this writer then proceeded to contact our rep through the Health Dept and was made aware that the vaccine is incorrect. This writer then took the appropriate steps to ensure no vaccines are given to infants going forward, placed an order for the correct vaccines, then on the follow day 2/4/25 reached out to the parents to make them aware and got them scheduled for appointments to come in for the correct vaccine. Parent reports no side effect or adverse reaction to the vaccine at this time.
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| 2824465 | 90 | F | NC | 02/04/2025 |
PNC20 |
PFIZER\WYETH |
LJ5281 |
Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
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arm became red and swollen around injection site, 2-3in in diameter, warm to touch
arm became red and swollen around injection site, 2-3in in diameter, warm to touch
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| 2824466 | 70 | F | GA | 02/04/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LJ5280 LJ5280 |
Axillary pain, Injection site erythema, Injection site pain, Injection site prur...
Axillary pain, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Injection site warmth
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Patient came in 6 days after her vaccine with swollen, red patch on arm right under injection site. ...
Patient came in 6 days after her vaccine with swollen, red patch on arm right under injection site. Stated it feels hot and itches. Also reported some pain there and in armpit on same arm. She stated she hadn't taken any medicine to alleviate any symptoms. Pharmacist advised her to take some Benadryl for itching/swelling, Advil or Tylenol for pain and to apply a cold compress to swollen area. Advised her to keep monitoring and if there is any worsening to seek medical attention at ER/hospital.
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