| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2804098 | 74 | F | OR | 10/30/2024 |
FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8499BA U8499BA U8499BA U8499BA U8499BA |
Diarrhoea, Dizziness, Feeling cold, Headache, Hot flush; Mobility decreased, Pyr...
Diarrhoea, Dizziness, Feeling cold, Headache, Hot flush; Mobility decreased, Pyrexia, Tremor, Vomiting; Anal incontinence, Chills, Dizziness, Feeling of body temperature change, Insomnia; Tinnitus, Vomiting; Diarrhoea, Dizziness, Feeling cold, Headache, Hot flush; Mobility decreased, Pyrexia, Tremor, Vomiting; Anal incontinence, Chills, Dizziness, Feeling of body temperature change, Insomnia; Tinnitus, Vomiting; Breast cancer female, Breast mass, Diarrhoea, Dizziness, Vomiting
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Patient called in to report that she became very dizzy several hours after receiving her Influenza v...
Patient called in to report that she became very dizzy several hours after receiving her Influenza vaccine. She reported she had dizziness, felt faint, and had to lay on the floor. She stated this had happened before. She reported she had vomiting and diarrhea while on the floor. She said she couldn't move. Later she felt better and said she was shaking with hot and cold flashes. She reported a headache that evening and took a tylenol which didn't help. Then at 5 am she took a motrin and her headache went away. She said during the evening she had a 100.5 degree fever.
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| 2802386 | 72 | F | NE | 10/25/2024 |
COVID19 FLU3 COVID19 COVID19 FLUX FLUX |
PFIZER\BIONTECH SANOFI PASTEUR PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
NDC:00069-2432- NDC:49281-0124- |
Audiogram normal, Dizziness, Electronystagmogram; Audiogram normal, Dizziness, E...
Audiogram normal, Dizziness, Electronystagmogram; Audiogram normal, Dizziness, Electronystagmogram; Brain fog, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory; Magnetic resonance imaging, Ultrasound scan; Brain fog, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory; Magnetic resonance imaging, Ultrasound scan
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Dizziness since 09/15/2024. Has not gone away and is continuous
Dizziness since 09/15/2024. Has not gone away and is continuous
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| 2794415 | 0.17 | M | TX | 09/27/2024 |
DTPPVHBHPB PNC15 RV5 DTPPVHBHPB PNC15 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
47907AA Y002963 X028575 47907AA Y002963 X028575 |
Livedo reticularis; Livedo reticularis; Livedo reticularis; Livedo reticularis; ...
Livedo reticularis; Livedo reticularis; Livedo reticularis; Livedo reticularis; Livedo reticularis; Livedo reticularis
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PATIENT BOTH LEG GOT MOTTLED AFTER RECEIVING THE VACCINES FOR ABOUT 20 MINUTES. *ARE WE ABLE TO GI...
PATIENT BOTH LEG GOT MOTTLED AFTER RECEIVING THE VACCINES FOR ABOUT 20 MINUTES. *ARE WE ABLE TO GIVE HIS 4 MONTHS VACCINE?
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| 2792808 | 20 | F | MN | 09/23/2024 |
DTPPVHBHPB DTPPVHBHPB |
MSP VACCINE COMPANY MSP VACCINE COMPANY |
U7296AA U7296AA |
No adverse event, Product administered to patient of inappropriate age; Product ...
No adverse event, Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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No reaction
No reaction
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| 2780719 | 0.42 | M | GA | 07/23/2024 |
DTPPVHBHPB PNC15 DTPPVHBHPB PNC15 |
MSP VACCINE COMPANY MERCK & CO. INC. MSP VACCINE COMPANY MERCK & CO. INC. |
U7623AA X019324 U7623AA X019324 |
Crying, Injection site nodule, Insomnia, Pyrexia; Crying, Injection site nodule,...
Crying, Injection site nodule, Insomnia, Pyrexia; Crying, Injection site nodule, Insomnia, Pyrexia; Crying, Injection site erythema, Injection site mass, Pyrexia, Sleep disorder; Crying, Injection site erythema, Injection site mass, Pyrexia, Sleep disorder
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mom called on 07/22/2024 1318 to report her son cried for 3 days straight and never slept. Has a non...
mom called on 07/22/2024 1318 to report her son cried for 3 days straight and never slept. Has a non-red knot on the RAT and ran a fever off/on and she alternated tyl/Ibuprofen and used cool compresses on the leg but is still concerned because the knot is still there. Mom reports not taking the child to the ER nor the pediatrician.
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| 2779988 | M | CA | 07/17/2024 |
DTPPVHBHPB PNC15 DTPPVHBHPB PNC15 |
MSP VACCINE COMPANY MERCK & CO. INC. MSP VACCINE COMPANY MERCK & CO. INC. |
X019624 U7829AA X019624 U7829AA |
Swelling, Wheezing; Swelling, Wheezing; Swelling, Wheezing; Swelling, Wheezing
Swelling, Wheezing; Swelling, Wheezing; Swelling, Wheezing; Swelling, Wheezing
|
Patient came in 07-16-2024. For swelling and wheezing.
Patient came in 07-16-2024. For swelling and wheezing.
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| 2777135 | 0.17 | M | SC | 07/03/2024 |
DTPPVHBHPB PNC15 RV5 DTPPVHBHPB PNC15 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U7623AA X022028 1979980 U7623AA X022028 1979980 |
Crying, Injection site induration, Injection site swelling, Irritability, Pyrexi...
Crying, Injection site induration, Injection site swelling, Irritability, Pyrexia; Crying, Injection site induration, Injection site swelling, Irritability, Pyrexia; Crying, Injection site induration, Injection site swelling, Irritability, Pyrexia; Crying, Injection site induration, Injection site swelling, Irritability, Pyrexia; Crying, Injection site induration, Injection site swelling, Irritability, Pyrexia; Crying, Injection site induration, Injection site swelling, Irritability, Pyrexia
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RIGHT LEG AT INJECTION SITE SWOLLEN AND HARD, HIGH FEVER GREATER THAN 3 DAYS, IRRITABILITY AND CONST...
RIGHT LEG AT INJECTION SITE SWOLLEN AND HARD, HIGH FEVER GREATER THAN 3 DAYS, IRRITABILITY AND CONSTANT CRYING.
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| 2819430 | 0.17 | F | 01/06/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
X9HS4 |
Expired product administered
Expired product administered
|
gave an expired vaccine; This non-serious case was reported by a nurse via call center representativ...
gave an expired vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25-MAR-2024) for prophylaxis. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: gave an expired vaccine). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 11-DEC-2024 The licensed practical nurse reported that one of their nurses in their office gave an expired dose of Pediarix vaccine , which led to expired vaccine used.
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| 2819431 | F | MO | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Varicella
Varicella
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developed chicken pox on her feet; This non-serious case was reported by a consumer via call center ...
developed chicken pox on her feet; This non-serious case was reported by a consumer via call center representative and described the occurrence of chickenpox in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chickenpox (Verbatim: developed chicken pox on her feet). The outcome of the chickenpox was unknown. It was unknown if the reporter considered the chickenpox to be related to Shingrix. It was unknown if the company considered the chickenpox to be related to Shingrix. Additional Information: GSK Receipt Date: 13-DEC-2024 The patient self-reported this case. The patient received the first dose of Shingrix she developed chicken pox on her feet.
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| 2819432 | F | TX | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
E7335 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
1st dose was in "January 2022, 2nd dose was October 2024 of this year; This non-serious case wa...
1st dose was in "January 2022, 2nd dose was October 2024 of this year; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) (batch number E7335, expiry date 15-JUN-2026) for prophylaxis. Previously administered products included Shingrix (received 1st dose in January 2022). In OCT-2024, the patient received the 2nd dose of Shingrix. In OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose was in "January 2022, 2nd dose was October 2024 of this year). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 16-DEC-2024 The pharmacist reported that the patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2819433 | F | SD | 01/06/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
YJ4KC |
Expired product administered
Expired product administered
|
Expired dose administered; This non-serious case was reported by a nurse via call center representat...
Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received Hib (Hiberix) (batch number YJ4KC, expiry date 14-DEC-2024) for prophylaxis. On 16-DEC-2024, the patient received the 4th dose of Hiberix. On 16-DEC-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt date: 16-DEC-2024 Nurse stated they administered an expired dose of Hiberix, which led to expired vaccine used. The reporter explained that the patient already received 3 prior doses of Haemophilus influenzae type b vaccine, but they did not have dates of administration of those 3 doses. The reporter consented to follow up.
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| 2819434 | 18 | F | WA | 01/06/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
ZP72S |
Expired product administered
Expired product administered
|
received an expired Engerix-B Vaccine; This non-serious case was reported by a other health professi...
received an expired Engerix-B Vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HBV (Engerix B) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis. On 16-DEC-2024, the patient received Engerix B (intramuscular). On 16-DEC-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: received an expired Engerix-B Vaccine). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-DEC-2024 The reporter calling to report one of their patients received an expired Engerix-B Vaccine at the time of reporting, which led to expired vaccine used. The reporter consented to follow up.
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| 2819435 | 3 | F | TN | 01/06/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
LG722 |
Expired product administered
Expired product administered
|
expired dose of Priorix was accidentally given to a patient; This non-serious case was reported by a...
expired dose of Priorix was accidentally given to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received MMR (Priorix) (batch number LG722, expiry date 01-DEC-2024) for prophylaxis. On 16-DEC-2024, the patient received the 1st dose of Priorix. On 16-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: expired dose of Priorix was accidentally given to a patient). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:16-DEC-2024 A nurse practitioner contacted GSK to report that an expired dose of Priorix was accidentally given to a patient , which led to expired vaccine used. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2819436 | U | LA | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
administer to a patient less than 50 years of age; This non-serious case was reported by a other hea...
administer to a patient less than 50 years of age; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient 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 inappropriate age at vaccine administration (Verbatim: administer to a patient less than 50 years of age). The outcome of the inappropriate age at vaccine administration was unknown. Additional Information: GSK Receipt Date: 18-DEC-2024 The medical office manager reported that Shingrix was administered to a patient less than 50 years of age. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration.
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| 2819437 | 82 | F | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
HN24H |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
administration of a second dose of Shingrix 2 years after the initial dose.; This non-serious case w...
administration of a second dose of Shingrix 2 years after the initial dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number HN24H) for prophylaxis. Previously administered products included Shingrix (received 1st dose 2 years ago). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: administration of a second dose of Shingrix 2 years after the initial dose.). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 18-DEC-2024 The healthcare professional reported about the administration of a second dose of Shingrix 2 years after the initial dose. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
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| 2819438 | 40 | M | MI | 01/06/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
95DB2 |
Expired product administered
Expired product administered
|
a patient accidentally received their first Havrix dose, but it was expired; This non-serious case w...
a patient accidentally received their first Havrix dose, but it was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 40-year-old male patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis. On 23-DEC-2024, the patient received the 1st dose of Havrix. On 23-DEC-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: a patient accidentally received their first Havrix dose, but it was expired). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-DEC-2024 The reporter called to report that a patient accidentally received their first Havrix dose, but it was expired, which led to expired vaccine used. The data about the vaccine, patient and event given. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
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| 2819439 | F | 01/06/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Diarrhoea, Influenza
Diarrhoea, Influenza
|
Diarrhea; Initial information received on 01-Jan-2025 regarding an unsolicited valid social media no...
Diarrhea; Initial information received on 01-Jan-2025 regarding an unsolicited valid social media non-serious case received from a Patient. This case involves Adult female patient who experienced diarrhea after receiving Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Aug-2024, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization.Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date the patient developed diarrhea (diarrhoea) (unknown latency) following the administration of Influenza Vaccine. Reportedly,Had it in August, the big one "flu/covid"..diarrhea for 10 days. Today was diagnosed with the "flu". Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (Diarrhea). At time of reporting, the outcome was Unknown for the event diarrhea.
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| 2819449 | M | NJ | 01/06/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
745P4 |
Nasopharyngitis, Underdose
Nasopharyngitis, Underdose
|
development of cold like symptom; they are not sure the patient received a full dose/underdose; This...
development of cold like symptom; they are not sure the patient received a full dose/underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of cold symptoms in a 3-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 745P4, expiry date 30-JUN-2025) for prophylaxis. On 07-DEC-2024, the patient received Fluarix 2024-2025 season. On 07-DEC-2024, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced underdose (Verbatim: they are not sure the patient received a full dose/underdose). On an unknown date, the patient experienced cold symptoms (Verbatim: development of cold like symptom). The outcome of the cold symptoms and underdose were unknown. It was unknown if the reporter considered the cold symptoms to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the cold symptoms to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-DEC-2024 Pharmacist reported that in the weekend his colleague administered a Fluarix vaccine to a three-year-old male patient. They were not sure the patient received a full dose, they wanted advise for this situation. Pharmacist also reported development of cold like symptom (not specified in the call) by this patient as well. Vaccine detail, vaccination date and patient demographics were retrieved during this call. No further information was obtained during this call. The patient did not receive the full dose which led to underdose.
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| 2819453 | 45 | F | IA | 01/06/2025 |
TDAP TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8015AA U8015AA U8015AA |
Arthralgia, Asthenia, Chills, Fatigue, Hyperhidrosis; Injection site erythema, I...
Arthralgia, Asthenia, Chills, Fatigue, Hyperhidrosis; Injection site erythema, Injection site swelling, Myalgia, Nausea, Palpitations; Pyrexia, Rash, Rash erythematous
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Patient woke up at 2:00 am on 1/3/25 with low grade fever, chills, sweats, major muscle and joint pa...
Patient woke up at 2:00 am on 1/3/25 with low grade fever, chills, sweats, major muscle and joint pain, fatigue, racing heart, nausea and weakness. Lasted 24 hours and had injection site redness, swelling. Broke out with red bumps on left flank and abdomen.
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| 2819495 | M | NY | 01/06/2025 |
DTOX DTOX HIBV HIBV MMRV MMRV TTOX TTOX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Anti-vimentin antibody positive, Antibody test, Blast cell count decreased, Bloo...
Anti-vimentin antibody positive, Antibody test, Blast cell count decreased, Blood immunoglobulin G decreased, Bone lesion; Cytokine abnormal, Measles antibody negative, Rubella antibody negative; Anti-vimentin antibody positive, Antibody test, Blast cell count decreased, Blood immunoglobulin G decreased, Bone lesion; Cytokine abnormal, Measles antibody negative, Rubella antibody negative; Anti-vimentin antibody positive, Antibody test, Blast cell count decreased, Blood immunoglobulin G decreased, Bone lesion; Cytokine abnormal, Measles antibody negative, Rubella antibody negative; Anti-vimentin antibody positive, Antibody test, Blast cell count decreased, Blood immunoglobulin G decreased, Bone lesion; Cytokine abnormal, Measles antibody negative, Rubella antibody negative
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absent specific antibody response to all vaccines tested; This literature marketed report has been r...
absent specific antibody response to all vaccines tested; This literature marketed report has been received from the authors of a published literature article, titled as stated below, referring to a male child. The patient's concurrent conditions included cherubism, developmental delay, autism, dysmorphic face, downturned and lowset ears, down-slanted eye, tethered tongue base, generalized joint hypermoblilty, cutis laxa, asthma, allergic rhinitis, gastric outlet obstruction from pyloric stenosis, a palate fistula with velopharyngeal insufficiency since age 9, and an aortic aneurysm involving the ascending aorta and intra-abdominal descending aorta at age 10. His medical history included recurrent episodes of otitis media, mastoiditis, sinusitis, several bilateral myringotomy and tubes surgeries since age 3, several functional several functional endoscopic sinus surgeries with sinus debridement since age 4, right tympanomastoidectomy at age 5, several instances of left mastoid debridement from ages 5 to 6, episodes of nodular, vesicular, pustular, or pannicular rash, recurrent episodes granuloma annulare, recurrent episodes of onychomycosis, paronychia, and cellulitis complicated by right third toe amputation at age 9 for an inflammatory mass associated with Staphylococcus pseudintermedius. On unknown dates, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown), measles, mumps, rubella and varicella (oka-merck) virus vaccine live (manufacturer unknown), tetanus vaccine (unspecified), diphtheria vaccine (unspecified), Streptococcus pneumoniae vaccine (unspecified) and rubeola vaccine (unspecified) (dose, route of administration, anatomical location, lot# and expiry date were not reported); all the suspect vaccines were administered for prophylaxis. On an unknown date, in radiologic evaluation, the patient was found to have bilateral expansile lucent bone lesions within the maxilla and mandibular rami soap-bubble appearance. Incisional biopsy showed bland cellular fibroproliferative ovoid to spindle-shaped stromal cells with associated scattered multinucleated giant cells, irregular spicules of lamellar and woven bone, and small-caliber intralesional blood vessels surrounded by cuff-like deposits of eosinophilic material. Spindled lesional cells analysis was positive for vimentin, which confirmed the lesion's mesenchymal origin, and negative for S100, smooth muscle actin, and CD1a, which ruled out smooth muscle or myofibroblast proliferations, Langerhans cell histiocytosis, and nerve sheath or melanocytic tumors. Giant cells analysis was positive for CD68. The Ki-67 proliferation index was low (less than 3%). Clinical laboratory results demonstrated that total B cell count was decreased, and CD27+ memory B cells were decreased, precluding the assessment of switched versus unswitched memory T cells. The patient's immunoglobin G (IgG) was less than 61 mg/dL (decreased), and the specific antibody response was absent to all vaccines tested; tetanus IgG was less than 0.1 IU/mL, diphtheria IgG was less than 0.1 IU/mL, Haemophilus influenzae B IgG was less than 0.15 ug/mL, measles IgG was less than 25 AU/mL, rubella IgG was less than 1 (index), varicella zoster vaccine response was less than 135.000 (index), rubeola vaccine response was absent, and Streptococcus pneumoniae vaccine response was absent. Natural killer (NK) function was absent. A limited serum inflammatory cytokine panel showed only that soluble interleukin-2 (IL-2) receptor level was 1318 pg/mL (mildly elevated). Exome sequencing showed a heterozygous phospholipase C gamma 2 (PLCG2) variant. The outcome of the event of vaccine induced antibody absent was not reported. The authors considered the event of vaccine induced antibody absent as related to suspect vaccines. A copy of the published article is attached as further documentation of the patient's experience. This is one of two reports referring to the same literature article. Literature Report: Lot # is being requested and will be submitted if received.; Sender's Comments: US-009507513-2412USA009745:
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| 2819496 | U | CT | 01/06/2025 |
MMR |
MERCK & CO. INC. |
X022410 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No additional AE; Expired MMR II was administered on 18-DEC-2024 with an expiration date of 06-NOV-2...
No additional AE; Expired MMR II was administered on 18-DEC-2024 with an expiration date of 06-NOV-2024 (Lot # X022410); This spontaneous report was received from the nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-DEC-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, recombinant human albumin (rHa), valid lot # X022410, expiration date: 06-NOV-2024, administered for prophylaxis (dose, strength and route of administration were not provided) (expired product administered). There were no reported signs/symptoms of adverse effects from administered dose. No additional adverse event (AE) was reported.
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| 2819497 | 74 | F | NY | 01/06/2025 |
COVID19 |
MODERNA |
|
Rash, Rash erythematous, Rash papular
Rash, Rash erythematous, Rash papular
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Starting at 6:00 am 10/17/2024 red, burning, raised rash on face (like having a very bad sunburn but...
Starting at 6:00 am 10/17/2024 red, burning, raised rash on face (like having a very bad sunburn but in this instance I was not in the sun that day for previous days).
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| 2819498 | 53 | M | CT | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Rash vesicular
Rash vesicular
|
Blistery rash
Blistery rash
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| 2819499 | 24 | M | TN | 01/06/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
AW1605C |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
Patient had already received an annual influenza vaccine prior to 12/5/24. This nurse did not realiz...
Patient had already received an annual influenza vaccine prior to 12/5/24. This nurse did not realize that. This nurse gave a second dose on 12/5/24.
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| 2819501 | 71 | F | FL | 01/06/2025 |
COVID19 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 PFIZER\BIONTECH |
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Bone pain, Breast pain, Chest X-ray normal, Injection site pain, Laboratory test...
Bone pain, Breast pain, Chest X-ray normal, Injection site pain, Laboratory test; Limb discomfort, Oxygen saturation decreased, Pain; Asthenia, Bone pain, Breast pain, Bronchitis, Chest pain; Fatigue, Joint range of motion decreased, Muscle strain, Oxygen saturation, Pain in extremity; Panic disorder, Sleep disorder due to general medical condition, insomnia type, Vaccination site pain, X-ray; Bone pain, Breast pain, Chest X-ray normal, Injection site pain, Laboratory test; Limb discomfort, Oxygen saturation decreased, Pain; Asthenia, Bone pain, Breast pain, Bronchitis, Chest pain; Fatigue, Joint range of motion decreased, Muscle strain, Oxygen saturation, Pain in extremity; Panic disorder, Sleep disorder due to general medical condition, insomnia type, Vaccination site pain, X-ray
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after the vaccine the pain came into the arm around the injection site into the bone and it went aro...
after the vaccine the pain came into the arm around the injection site into the bone and it went around the breast. Used heating pads to try to help with the pain. On 12/19/24 went to hospital, Was given chest xray which was negative. Her O2 level was low so was kept until 12/21/24. She was given IV with antibiotics. They told her they could not find anything wrong with her arm and told her they felt like she must have slept wrong but she feels like it was from the injection since it started at the injection site and the pain moved into the bone in the arm and then down around the breast. Now when lifting the arm there is a feeling of pressure and if there is anymore extension then that is when she starts having the pain in the arm and breast. She was discharged with a precription of zithromax. She is going to follow with PCP on 1/22/25 and her pulmonologist Dr., MD. on 1/16/25.
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| 2819502 | 60 | M | MN | 01/06/2025 |
COVID19 COVID19 |
JANSSEN MODERNA |
203A21A 059H21A |
SARS-CoV-2 test, Unevaluable event; SARS-CoV-2 test, Unevaluable event
SARS-CoV-2 test, Unevaluable event; SARS-CoV-2 test, Unevaluable event
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Unknown
Unknown
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| 2819503 | 66 | F | NY | 01/06/2025 |
FLU4 FLU4 |
SANOFI PASTEUR SANOFI PASTEUR |
U8429DA U8429DA |
Autoimmune disorder, Dermatitis allergic, Herpes zoster, Injection site erythema...
Autoimmune disorder, Dermatitis allergic, Herpes zoster, Injection site erythema, Injection site pain; Injection site pruritus, Injection site swelling, Injection site vesicles
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Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: 2 Oblong blisters at injection site-Severe, Additional Details: Recent (>30 days) Shingles infection
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| 2819504 | 62 | F | OH | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
GJ6796 |
Asthenia, Mobility decreased
Asthenia, Mobility decreased
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Systemic: "Weak in bed"-Medium, Systemic: Weakness-Medium
Systemic: "Weak in bed"-Medium, Systemic: Weakness-Medium
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| 2819505 | 29 | F | CA | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
lm2224 |
Dizziness, Hypotension, Vomiting
Dizziness, Hypotension, Vomiting
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Medium
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Vomiting-Medium
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| 2819506 | 24 | F | MD | 01/06/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3043822 3043822 |
Chills, Fatigue, Headache, Injection site erythema, Insomnia; Lethargy, Pain
Chills, Fatigue, Headache, Injection site erythema, Insomnia; Lethargy, Pain
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Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild...
Site: Redness at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Unable to Sleep-Severe
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| 2819507 | 16 | F | MI | 01/06/2025 |
FLUC4 |
SEQIRUS, INC. |
388522 |
Syncope, Unresponsive to stimuli
Syncope, Unresponsive to stimuli
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Systemic: Fainting / Unresponsive-Severe, Additional Details: PATIENT FAINTED FOR 2 MINUTES AFTER VA...
Systemic: Fainting / Unresponsive-Severe, Additional Details: PATIENT FAINTED FOR 2 MINUTES AFTER VACCINATION, BUT WOKE UP AFTERWARDS, Other Vaccines: VaccineTypeBrand: BOOSTRIX TDAP; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2819508 | 63 | F | NY | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
e7335 |
Injection site pruritus, Pruritus
Injection site pruritus, Pruritus
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Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)...
Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: no exeternal rash seen but pt has extreme itching-Severe
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| 2819509 | 17 | F | FL | 01/06/2025 |
FLUC4 FLUC4 FLUC4 |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
391416 391416 391416 |
Blood glucose normal, Dizziness, Dysarthria, Fatigue, Flushing; Hyperhidrosis, L...
Blood glucose normal, Dizziness, Dysarthria, Fatigue, Flushing; Hyperhidrosis, Lethargy, Lymphadenopathy, Presyncope, Syncope; Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainti...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: After getting vaccinated with the Meningitis and Flu vaccines, patient had her 1st vagal episode at approximately 1:09pm on 12/28/24. She was revived within minutes by her putting her legs up and alcohol swabs. 2nd vagal episode was at approximately 1:25pm in the waiting room. Patient was drenched with sweat, having slurred speech. 911 called, arrived at 1:40pm. Paramedics put her on a stretcher to her Mom's car, after confirming: vitals, blood sugar all normal. , Other Vaccines: VaccineTypeBrand: Sanofi MenQuadfi; Manufacturer: Sanofi; LotNumber: 391416 ; Route: ; BodySite: left deltoid; Dose: 1; VaxDate: 12/28/2024
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| 2819510 | 61 | F | FL | 01/06/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Injection site bruising, Injection site pain, Injection site reaction, Joint swe...
Injection site bruising, Injection site pain, Injection site reaction, Joint swelling, Rash
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Told to take claritin and to keep watch on her left arm and if it gets bigger or starts to feel hot to go to the dr's office., Other Vaccines: VaccineTypeBrand: Flucelvax Trival 2024-20245 Syr; Manufacturer: Seqirus; LotNumber: 391416; Route: IM; BodySite: Left Arm; Dose: 1; VaxDate: 12/23/2024
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| 2819511 | 79 | F | RI | 01/06/2025 |
COVID19 |
MODERNA |
3042560 |
Arthralgia, Asthenia, Gait inability, Injection site erythema, Pyrexia
Arthralgia, Asthenia, Gait inability, Injection site erythema, Pyrexia
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Site: Redness at Injection Site-Mild, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Systemic:...
Site: Redness at Injection Site-Mild, Systemic: Fever-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: Right hip pain with inability to walk for 2 days post injection,
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| 2819512 | 68 | U | WI | 01/06/2025 |
HEPA |
MERCK & CO. INC. |
X025485 |
No adverse event, Underdose
No adverse event, Underdose
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No additional AE; an adult patient was given a pediatric dose of VAQTA; This spontaneous report was ...
No additional AE; an adult patient was given a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 68-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-DEC-2024, the patient was vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (Incorrect dose administered), administered for prophylaxis (lot #X025485, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 13-MAY-2025; strength, dose and route of administration were not provided). No adverse side effects were reported. There was no additional adverse event (AE) or product quality complaint (PQC) provided.
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| 2819513 | 27 | M | MA | 01/06/2025 |
FLUC4 |
SEQIRUS, INC. |
946639 |
Hypoaesthesia
Hypoaesthesia
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Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Pt got covid and ...
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Pt got covid and flu vaccine at 11am 12/29/24 then called the pharmacy at 6pm. Pt stated he was watching tv when he noticed numbness in his feet he waited an hour before calling the pharmacy to ask what he should do. I (the rph that day) told the pt if it continues or gets worse to call his doctor tomorrow., Other Vaccines: VaccineTypeBrand: covid; Manufacturer: moderna; LotNumber: 3043836; Route: im; BodySite: left arm; Dose: 1; VaxDate: 12/29/2024
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| 2819514 | 24 | F | NY | 01/06/2025 |
HPV9 |
MERCK & CO. INC. |
y007322 |
Asthenia, Dizziness
Asthenia, Dizziness
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Systemic: Dizziness / Lightheadness-Mild, Systemic: Weakness-Mild
Systemic: Dizziness / Lightheadness-Mild, Systemic: Weakness-Mild
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| 2819515 | 15 | F | TX | 01/06/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
3043335 3043335 3043335 |
Condition aggravated, Confusional state, Fatigue, Flushing, Hyperhidrosis; Immed...
Condition aggravated, Confusional state, Fatigue, Flushing, Hyperhidrosis; Immediate post-injection reaction, Injection site pain, Lethargy, Loss of consciousness, Tremor; Vomiting
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Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Exhaustion / Lethargy-Mild, S...
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Vomiting-Mild, Additional Details: Patient passed out immediately when covid vaccine was administered, assisted to lay down in bed, then immediately became awake and alert, patient a bit confused, unsure of what happened. Patient then had large amount of emesis, she was afebrile. Patient was stabilized after incident, awake, oriented, vital signs stable at 107/76, pulse oximetry 99% on room air. Mom present at time of incident., Other Vaccines: VaccineTypeBrand: Flucelvax; Manufacturer: Seqirus; LotNumber: 388534; Route: im; BodySite: ld; Dose: unknown; VaxDate: 12/30/2024
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| 2819516 | 75 | F | CA | 01/06/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4F45Z 4F45Z |
Abdominal pain upper, Asthenia, Fatigue, Headache, Injection site pain; Injectio...
Abdominal pain upper, Asthenia, Fatigue, Headache, Injection site pain; Injection site swelling, Lethargy, Peripheral swelling
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Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion /...
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT SAID HAVING HEADACHE, STOMACH ACHE, SORED, SWOLLEN ARM, WEAKNESS AND FELT TIRED
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| 2819517 | 76 | F | CT | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LE1811 |
Hypoaesthesia, Injection site pain, Pain in extremity
Hypoaesthesia, Injection site pain, Pain in extremity
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Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Addi...
Site: Pain at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient reports left arm pain and left hand numbness after previous covid vaccine.
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| 2819518 | 70 | M | TX | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
HM7010 |
Pyrexia
Pyrexia
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Systemic: Fever-Medium, Additional Details: Patient's wife reports after COVAX she and her husb...
Systemic: Fever-Medium, Additional Details: Patient's wife reports after COVAX she and her husband became very sick, & experienced high fevers.
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| 2819519 | 67 | F | PA | 01/06/2025 |
COVID19 |
MODERNA |
8080803 |
Infection, Injection site pruritus, Injection site swelling, Pruritus
Infection, Injection site pruritus, Injection site swelling, Pruritus
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Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: infection...
Site: Itching at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: infection and itiching on whole arm after vaccine-Medium, Additional Details: patient was given azithromycin 250mg, prednisone 20mg, ibuprofen 600mg and cetirizine 10mg on 12/31/24 by PCP, Other Vaccines: VaccineTypeBrand: shingrix; Manufacturer: gsk; LotNumber: 445tk; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
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| 2819520 | 65 | M | TX | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
2737j |
Vomiting
Vomiting
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Systemic: Vomiting-Medium, Additional Details: Patient threw up the evening after the receiving the ...
Systemic: Vomiting-Medium, Additional Details: Patient threw up the evening after the receiving the vaccine and the next day.
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| 2819521 | 54 | F | NC | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9r397 |
Immediate post-injection reaction, Injection site pain
Immediate post-injection reaction, Injection site pain
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Site: Pain at Injection Site-Severe, Additional Details: immediately after adminstering vaccine into...
Site: Pain at Injection Site-Severe, Additional Details: immediately after adminstering vaccine into patient's left arm, she felt intense pain and burning. She stated that she could feel the vaccine go into her arm and that i pushed to hard
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| 2819522 | 70 | F | FL | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4BN95 |
Contusion, Dizziness, Fall, Seizure, Tongue biting
Contusion, Dizziness, Fall, Seizure, Tongue biting
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Systemic: Seizure-Medium, Additional Details: PATIENT REPORTS SEIZURE DURING SHOWER ON 12/25/24 (A C...
Systemic: Seizure-Medium, Additional Details: PATIENT REPORTS SEIZURE DURING SHOWER ON 12/25/24 (A COUPLE OF DAYS AFTER VACCINES) CAUSING HER TO FALL OUT OF THE SHOWER. BRUISED HEAD, ARM, AND LEGS, BIT TONGUE. WAS BROUGHT TO THE ER WHERE SEIZURE DIAGNOSED. STILL FEELING "WOOZY" AS OF TODAY, 01/01/25 , Other Vaccines: VaccineTypeBrand: INACTIVATED FLU (FLUZONE HIGH-DOSE TRIVALENT 2024-25); Manufacturer: SANOFI-PASTEUR; LotNumber: U8515DA; Route: IM; BodySite: LEFT DELTOID (ARM); Dose: ; VaxDate: UNKNOWN
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| 2819523 | 61 | F | PA | 01/06/2025 |
FLU4 |
SANOFI PASTEUR |
ut8408la |
Arthralgia, Asthenia, Injection site pain, Speech disorder
Arthralgia, Asthenia, Injection site pain, Speech disorder
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Site: Pain at Injection Site-Mild, Systemic: Difficlty with speach-Medium, Systemic: Joint Pain-Medi...
Site: Pain at Injection Site-Mild, Systemic: Difficlty with speach-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: previously reported but pt not contacted, Other Vaccines: VaccineTypeBrand: fluzone trivalent pf syringe; Manufacturer: sanofi pasteur; LotNumber: ut8408la; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
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| 2819524 | 67 | M | PA | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
m4dy4 |
Tinnitus
Tinnitus
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Systemic: Tinnitus-Severe, Additional Details: Previously reported, but pt was never contacted. pati...
Systemic: Tinnitus-Severe, Additional Details: Previously reported, but pt was never contacted. patient would like to be contacted. patient reported long term tinnitus. please contact pt, Other Vaccines: VaccineTypeBrand: shingrix; Manufacturer: GlaxoSmithKline; LotNumber: M4DY4; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
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| 2819525 | 64 | F | AL | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
g97y2 |
Injection site cellulitis, Injection site erythema, Injection site pain, Injecti...
Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
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Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient experienced intense redness and swelling at the injection site that she and her doctor think in cellulitis and will require an antibiotic
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| 2819526 | 59 | M | IN | 01/06/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
342rc |
Injection site pain
Injection site pain
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Site: Pain at Injection Site-Mild
Site: Pain at Injection Site-Mild
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