| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2847272 | 72 | F | CA | 06/25/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
|
Illness
Illness
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sick; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female ...
sick; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), on 11Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: The consumer stated that she is sick. She thinks they gave her a vaccination of COVID . When paraphrased the above concern, consumer stated, "I never had COVID, but they gave me a vaccination on June 11th after I got those vaccination, I started getting sick, every day I got sicker. I am not getting any better. I feel like I am dying." The patient stated that she was on blood pressure medication The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2847273 | 06/25/2025 |
COVID19 |
PFIZER\BIONTECH |
EW0161 |
Discomfort
Discomfort
|
The first five doses had minimal side effects, causing only minor discomfort for a couple of days; T...
The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP. An elderly patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Lot number: EW0161) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Lot number: ER8734), administration date: 01Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
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| 2847274 | 06/25/2025 |
COVID19 |
PFIZER\BIONTECH |
FJ1620 |
Discomfort
Discomfort
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The first five doses had minimal side effects, causing only minor discomfort for a couple of days; T...
The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP. An elderly patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FJ1620) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot number: ER8734), administration date: 01Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 2, lot number: EW0161), administration date: 22Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
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| 2847275 | 06/25/2025 |
COVID19 |
PFIZER\BIONTECH |
GJ5342 |
Discomfort
Discomfort
|
The first five doses had minimal side effects, causing only minor discomfort for a couple of days; T...
The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP. An elderly patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GJ5342) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot number: ER8734), administration date: 01Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 2, lot number: EW0161), administration date: 22Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 3 (BOOSTER), lot number: FJ1620), administration date: 07Dec2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
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| 2847276 | 06/25/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Discomfort
Discomfort
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The first five doses had minimal side effects, causing only minor discomfort for a couple of days; T...
The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP. An elderly patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot number: ER8734), administration date: 01Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 2, lot number: EW0161), administration date: 22Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 3 (BOOSTER), lot number: FJ1620), administration date: 07Dec2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), lot number: GJ5342), administration date: 04Nov2022, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
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| 2847277 | 06/25/2025 |
COVID19 |
PFIZER\BIONTECH |
ER8734 |
Discomfort
Discomfort
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The first five doses had minimal side effects, causing only minor discomfort for a couple of days; T...
The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP. An elderly patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
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| 2847278 | 5 | M | WV | 06/25/2025 |
IPV |
SANOFI PASTEUR |
W1B511M |
Product storage error
Product storage error
|
administration of Ipol after Temperature excursion not viable for use which reached 47.03F for 41 mi...
administration of Ipol after Temperature excursion not viable for use which reached 47.03F for 41 mins due to a failure of battery backup with no adverse event; Initial information received on 19-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old male patient (36 cm and 18.64 kg) for whom administration of IPV (VERO) [IPOL] after temperature excursion not viable for use which reached 47.03f for 41 mins due to a failure of battery backup with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a Dose 1 (0.5ml) of suspect IPV (VERO); Suspension for injection with unknown strength (lot W1B511M with expiry date 08-SEP-2025) via intramuscular route in unknown administration site for Immunization; after temperature excursion not viable for use which reached 47.03f for 41 mins due to a failure of battery backup with no adverse event (poor quality product administered) (latency: same day) Reportedly: patient was advising and scheduled to repeat. No previous excursion reported. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: 2025SA164290:IT-00537292
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| 2847290 | TN | 06/25/2025 |
HEP |
MERCK & CO. INC. |
W036624 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
No additional AE reported.; A HCP called and reported that an expired dose of RECOMBIVAX HB was admi...
No additional AE reported.; A HCP called and reported that an expired dose of RECOMBIVAX HB was administered to a patient on 6/23/2025 with expiry date of 5/23/2025. The caller confirmed the dose has never been stored outside of the recommended range. No symptoms reported. Call; Primary Product Identification: Primary Product Name: RECOMBIVAX HB INJ 10/1.0 mcrg/ml ------------------------- Product Details #1 (Primary Product) : Product Name: RECOMBIVAX HB INJ 10/1.0 mcrg/ml Lot Number: w036624 Expiration Date: 5/23/2025 Operator of Device: Health Professional Obtain: False Hazardous Product?: False ------------------------- Adverse Event Details: Description: A HCP called and reported that an expired dose of RECOMBIVAX HB was administered to a patient on 6/23/2025 with expiry date of 5/23/2025. The caller confirmed the dose has never been stored outside of the recommended range. No symptoms reported. Caller declined to report the AE at this time. Consent was obtained to follow up with the HCP. No additional AE reported. No PQC. AE Onset Date/Date PQC First Identified: 6/23/2025 ------------------------- PQC Details: PQC Present?: false QIR Requested?: False -------------------------
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| 2847291 | 06/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; Had it twice even though got the shots; This serious case was reporte...
Suspected vaccination failure; Had it twice even though got the shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had it twice even though got the shots). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 20-JUN-2025 This case was reported by a patient via interactive digital media. The patient mentioned that they had shingles twice even though had got the shots of Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
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| 2847292 | M | TX | 06/25/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
Missing second and third dose; This non-serious case was reported by a pharmacist via call center re...
Missing second and third dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old male patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix b (received first dose of Engerix b somewhere last June 2024). On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Missing second and third dose). The outcome of the incomplete course of vaccination was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-JUN-2025 The pharmacist reported that a patient that received only a first dose of Engerix b somewhere last June twenty-twenty four. The pharmacist wanted some advice about the patient๏ฟฝs schedule for the second and third dose. No specific vaccination date, no vaccine detail and patient demographics were obtained in this call (no initials provided from the Pharmacist๏ฟฝs end in this call). No further information was obtained. Till the time of reporting the patient did not receive the second dose of Engerix b which led to incomplete course of vaccination.
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| 2847293 | CO | 06/25/2025 |
RSV |
PFIZER\WYETH |
|
Product container issue
Product container issue
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Had a defect; It broke; The person was not able to use the vaccine; The vial broke; The initial case...
Had a defect; It broke; The person was not able to use the vaccine; The vial broke; The initial case was missing the following minimum criteria: not reportable product complaint. Upon receipt of follow-up information on 23Jun2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Physician from product quality group. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), described as "Had a defect; It broke; The person was not able to use the vaccine; The vial broke". Additional information: a sales representative reported that a customer that had the rsv vaccine prot.subunit pref 2v and when they were about to administer it, however, they had a defect with the vaccine. When they were reconstituting one of their rsv vaccine prot.subunit pref 2v vaccines, it did not reconstitute, and it messed up the bottle. The customer was unable to administer, as they thought it broke. The reporter stated that was the defect that happened, and the person was not able to use the vaccine. It was further reported, "while they were administering it, there occurred an issue, where the vial broke. She was with the customer that time." It was clarified that the defective product was not given to any patient. The reporter considered "had a defect; it broke; the person was not able to use the vaccine; the vial broke" not related to rsv vaccine prot.subunit pref 2v. Causality for "had a defect; it broke; the person was not able to use the vaccine; the vial broke" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). Product Quality Group provided investigational results on 03Mar2025 for rsv vaccine prot.subunit pref 2v (device constituent): Investigation Summary and Conclusion: (withheld) 03Mar2025. No further investigation was required as no valid lot number or returned sample was available. This complaint will continue to be trended. If additional information becomes available, this complaint will be reopened.
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| 2847294 | 32 | F | GA | 06/25/2025 |
COVID19 |
PFIZER\BIONTECH |
en6204 |
Chest discomfort, Dizziness postural, Dyspnoea, Dyspnoea exertional, Fatigue
Chest discomfort, Dizziness postural, Dyspnoea, Dyspnoea exertional, Fatigue
|
Shortness of breath without exertion, chest tightness, constantly exhausted, dizziness when I would ...
Shortness of breath without exertion, chest tightness, constantly exhausted, dizziness when I would stand up. These symptoms lasted for a little over two weeks but were still noticed very mildly for a few weeks following. I would get exhausted and completely out of breath when climbing my home stairs to my bedroom. This is only one flight of stairs and I never have these symptoms when climbing them. I am an active person. I also had to sit down after extremely short walks to my car and back. My doctor instructed me to take Benadryl 1 hour before receiving the COVID vaccine on my second round, which was on 04/12/2021, but I had the same reaction, just milder.
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| 2847296 | 66 | F | FL | 06/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
G97Y2 |
Injected limb mobility decreased, Injection site pain, Pain
Injected limb mobility decreased, Injection site pain, Pain
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Felt extreme pain in arm when injection was given. Injection site continued to be painful for weeks...
Felt extreme pain in arm when injection was given. Injection site continued to be painful for weeks and then the pain started spreading down the arm and then up the arm. Now having muscular pain from shoulder to elbow with limited mobility.
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| 2847297 | 20 | F | GA | 06/25/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
AZ4TN |
No adverse event, Underdose
No adverse event, Underdose
|
Incorrect dosage given. Patient received the pediatric/adolescent dosage of 0.5ml instead of 1ml ful...
Incorrect dosage given. Patient received the pediatric/adolescent dosage of 0.5ml instead of 1ml full adult dose. No signs and symptoms of adverse reaction at this time.
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| 2847298 | 35 | M | 06/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
354M3 |
Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
|
TWELVE HOURS AFTER INJECTION, PATIENT EXPERIENCED HIGH FEVER, ARTHRALGIA, HEADACHE, MYALGIAS AND FAT...
TWELVE HOURS AFTER INJECTION, PATIENT EXPERIENCED HIGH FEVER, ARTHRALGIA, HEADACHE, MYALGIAS AND FATIGUE.
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| 2847299 | 23 | F | OH | 06/25/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
943888 |
Anaphylactic reaction, Dyspnoea, Rash, Swelling of eyelid
Anaphylactic reaction, Dyspnoea, Rash, Swelling of eyelid
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Patient had anaphylaxis, swelling eyelids, difficulty breathing, rash on upper torso and arms that s...
Patient had anaphylaxis, swelling eyelids, difficulty breathing, rash on upper torso and arms that started about 15 minutes after vaccine. She was given 10ml oral benadryl and one dose of epipen 0.3 and squad was called to transport her to ER.
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| 2847300 | 58 | F | OR | 06/25/2025 |
HEPAB HEPAB HEPAB PNC20 PNC20 PNC20 VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
P2443 P2443 P2443 LN4928 LN4928 LN4928 35A77 35A77 35A77 |
Arthralgia, Chills, Fatigue, Feeling abnormal, Impaired work ability; Injection ...
Arthralgia, Chills, Fatigue, Feeling abnormal, Impaired work ability; Injection site erythema, Injection site pain, Injection site warmth, Mental impairment, Pain; Pyrexia; Arthralgia, Chills, Fatigue, Feeling abnormal, Impaired work ability; Injection site erythema, Injection site pain, Injection site warmth, Mental impairment, Pain; Pyrexia; Arthralgia, Chills, Fatigue, Feeling abnormal, Impaired work ability; Injection site erythema, Injection site pain, Injection site warmth, Mental impairment, Pain; Pyrexia
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First night I had fever, chills, joint pain, and ached all over. Took ibuprofen in the middle of th...
First night I had fever, chills, joint pain, and ached all over. Took ibuprofen in the middle of the night but still felt awful. Fatigued all day and too tired to think, unable to work. Two days later, left arm injection site is red and warm to touch. Feels like I've been punched in the deltoid.
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| 2847301 | 56 | F | CA | 06/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
594G2 |
Injection site erythema, Injection site swelling, Injection site warmth
Injection site erythema, Injection site swelling, Injection site warmth
|
Noticed redness to site, warm to the touch the next day, some swelling observed as well. Came in on ...
Noticed redness to site, warm to the touch the next day, some swelling observed as well. Came in on 06/25/25 to show medical staff. Site observed and did notice redness, warm to touch and some swelling. She was instructed to do cool compress and to take Claritin to help with reaction. Was also instructed to go to ER should the site start getting very painful and not feeling well.
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| 2847303 | 11 | M | TX | 06/25/2025 |
HPV9 |
MERCK & CO. INC. |
Y013407 |
Abdominal distension, Erythema, Pain, Skin plaque
Abdominal distension, Erythema, Pain, Skin plaque
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Erythematous plaque circular in nature, minimal swelling and pain
Erythematous plaque circular in nature, minimal swelling and pain
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| 2847309 | 0.33 | F | AK | 06/25/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
34mf9 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Med error child too young for Kinrix should have had individual vaccines no adverse reaction or eve...
Med error child too young for Kinrix should have had individual vaccines no adverse reaction or event
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| 2847310 | 1.25 | M | MN | 06/25/2025 |
DTAP DTAP HIBV HIBV PNC20 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH |
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Injection site discomfort, Injection site erythema, Injection site induration, I...
Injection site discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling; Injection site warmth; Injection site discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling; Injection site warmth; Injection site discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling; Injection site warmth
More
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I noticed a lot of redness and swelling on the thigh where two shots were given. The skin was hard ...
I noticed a lot of redness and swelling on the thigh where two shots were given. The skin was hard and warm to the touch. It started about 24 hours after the injections were given and was approximately 4? in diameter. That quickly changed to covering my child?s entire thigh, up to the buttocks and into the diaper area/inner thigh. He was itching and wincing in discomfort, but had no other symptoms. I was told by phone triage that this was not anything to be too concerned about and that it should clear up by day 3. It has continued to spread and doesn?t appear to be resolving.
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| 2847311 | 66 | F | WA | 06/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
f95ys |
Erythema, Pain in extremity, Sleep disorder, Tenderness
Erythema, Pain in extremity, Sleep disorder, Tenderness
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pt states their arm was red and painful following injection but the pain has continued a couple of w...
pt states their arm was red and painful following injection but the pain has continued a couple of weeks after administration. pt states their arm still hurts when they lay on it to sleep or touch it. Did advise tylenol, ibuprofen, cold compress, and to follow up with their pcp.
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| 2847314 | 4 | M | FL | 06/25/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4L454 2006279 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
More
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Site redness and swelling 3in x 3in. Treated with Augmentin x 10 days. Has f/u on 6/25/25.
Site redness and swelling 3in x 3in. Treated with Augmentin x 10 days. Has f/u on 6/25/25.
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| 2846999 | F | TX | 06/24/2025 |
HPV9 |
MERCK & CO. INC. |
Y015179 |
Exposure during pregnancy, Product use issue, Wrong product administered
Exposure during pregnancy, Product use issue, Wrong product administered
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Caller reported AE on behalf of a patient who is currently pregnant (third trimester) and was inadve...
Caller reported AE on behalf of a patient who is currently pregnant (third trimester) and was inadvertently administered GARDASIL 9 instead of TDAP vaccine on 05/29/2025. Caller reported that patient was not administered TDAP. No symptoms reported. N; No symptoms reported.; Caller reported AE on behalf of a patient who is currently pregnant (third trimester) and was inadvertently administered GARDASIL 9 instead of TDAP vaccine on 05/29/2025. Caller reported that patient was not administered TDAP. No symptoms reported. N; This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, obstetric history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On an unspecified date, the patient became pregnant. On 29-May-2025, the patient was inadvertently vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection (lot #Y015179, expiration date: 28-Jan-2027), 0.5mL/dose, as prophylaxis (route of administration were not provided), instead of instead of Diphtheria vaccine toxoid; Pertussis vaccine acellular; Tetanus vaccine toxoid (TDAP) vaccine when she was in her third trimester (Vaccine exposure during pregnancy) (Wrong vaccine administered). However, no symptoms, additional adverse events (AE), nor details were reported.
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| 2847000 | 2 | M | IL | 06/24/2025 |
UNK |
UNKNOWN MANUFACTURER |
X022986 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE.; nurse calling to report administration of expired MMR-II to a patient on 16-JUN-2...
No additional AE.; nurse calling to report administration of expired MMR-II to a patient on 16-JUN-2025.; This spontaneous report has been received from a nurse referring to a 2-year-old male patient. The patient's concurrent conditions, pertinent medical history, previous drug reactions/allergies, and concomitant therapies were not provided. On 16-JUN-2025, the patient was vaccinated with Measles and Mumps Virus Vaccine, Live (M-M-R II) with valid lot # X022986 and expiration date 11-JUN-2025 (+) sterile diluent (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) as prophylaxis (Expired product administered). There was confirmed no temperature excursion (TE), nor additional adverse event (AE).
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| 2847013 | M | 06/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Neoplasm malignant
Neoplasm malignant
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solid tumor cancer; This serious case was reported by a consumer via interactive digital media and d...
solid tumor cancer; This serious case was reported by a consumer via interactive digital media and described the occurrence of malignant solid tumor in a 80-year-old male 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 malignant solid tumor (Verbatim: solid tumor cancer) (serious criteria GSK medically significant). The outcome of the malignant solid tumor was not reported. It was unknown if the reporter considered the malignant solid tumor to be related to Shingrix. The company considered the malignant solid tumor to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a consumer via interactive digital media. The reporter reported the information on booster Shingrix series after 7 years for 80 years old male with solid tumor cancers and taking immunosuppressive drugs.; Sender's Comments: Neoplasm malignant is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2847014 | 06/24/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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TWO MONTHS LATER I got SHINGLES; Suspected vaccination failure; This serious case was reported by a ...
TWO MONTHS LATER I got SHINGLES; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: TWO MONTHS LATER I got SHINGLES) (serious criteria hospitalization). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 14-JUN-2025 This case was reported by a patient via interactive digital media. Reporter reported that did not fall for it. He/she did, regrettably, at the urging of his/her brother. Two months later he/she got shingles. Horribly, horrible, indescribable pain. Hospitalized for 5 days. Of course physician said just imagine how much worse it would have been if you had not taken the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
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| 2847015 | 4 | F | WV | 06/24/2025 |
IPV |
SANOFI PASTEUR |
W1B511M |
Product storage error
Product storage error
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administration of Ipol after Temperature excursion that reached 47.03F for 41 mins due to a failure ...
administration of Ipol after Temperature excursion that reached 47.03F for 41 mins due to a failure of battery backup; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 4 years old female patient (113 cm and 27.73 kg) who who received IPV (Vero) [IPol] which were exposed to temperature excursion at 47.03 Fahrenheit for 41 mins due to a failure of battery backup. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jun-2025, the patient received 0.5 ml dose of suspect IPV (VERO),Suspension for injection, lot W1B511M ,expiry date:08-Sep-2025, strength:0.5 ml, frequency: one dose, via intramuscular route in unknown administration site.for prophylactic vaccination which was exposed to temperature excursion that 47.03 Fahrenheit for 41 mins due to a failure of battery backup (poor quality product administered) (Latency:same day). Reportedly,This excursion did not occur due to a human error, There was also a previous excursion on 18-Jun-2024 that reached 52 Fahrenheit for 1 hour for IPol(opened) from a different vial and was told it was still suitable for use per the stability calculator. Patient's mother notified and advised that the dose would need to be repeated. Vaccine temperature excursion due to battery backup failure on 06-Jun-2025 in the evening hours. Temperature data thermometer notified myself at home. Came into clinic to evaluate situation and restored power to fridge and freezer units. The morning of 09-Jun-2025, called Sanofi to report excursion and to determine viability. During the call, Sanofi representative asked about previous excursions. IPOL did have a previous excursion. Representative asked if any doses had been given from the vial since the excursion and I had. The representative explained that due to IPOL being in a multidose vial and being opened, the IPOL is not viable for use and should have been disposed after previous excursion.Thoroughly investigated documentation from previous excursions and determined that the staff member that was supposed to call manufacturer only used the Sanofi Temperature Stability calculator to determine stability. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information was received on 19-Jun-2025 from Other Health Care Professional in which the case classification has upgraded to Valid ICSR with no AE in which patient details has been updated, batch no W1B511M ,expiry date:08-Sep-2025, strength:0.5 ml, route has been added, however narrative amended accordingly.
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| 2847018 | 38 | F | WA | 06/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
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Agitation, Alopecia, Anaemia, Antiphospholipid syndrome, Brain fog; Confusional ...
Agitation, Alopecia, Anaemia, Antiphospholipid syndrome, Brain fog; Confusional state, Cytokine release syndrome, Depression, Dizziness, Ehlers-Danlos syndrome; Gastrointestinal microorganism overgrowth, Generalised oedema, Headache, Hypothalamo-pituitary disorder, Inflammation; Laboratory test, Malaise, Manipulation, Mast cell activation syndrome, Memory impairment; Nausea, Palpitations, Plasmapheresis, Postural orthostatic tachycardia syndrome, Spinal manipulation; Vision blurred, Vomiting
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- whole body swelling, edema and inflammation (to huge proportions) - major hair loss in clumps - na...
- whole body swelling, edema and inflammation (to huge proportions) - major hair loss in clumps - nausea & vomiting - dizziness - pounding headache - blurry eyes - confusing (brain fog) & memory issues - depression - racing heart and agitation - SMy medical odyssey: Medications, Therapies and Supplements I have tried: - Ivermectin - Hydroxychloroquine - Ketotifen (for Mast Cell Activation Syndrome - MCAS) - Many supplements (more than 30) - Many anti-histamines - Xifaxan (for Small Intestinal Bacterial Overgrowth (SIBO) - Triple Anti-Coagulation Therapy - Physicians Elemental Diet Powder - Maraviroc anti-viral - Cyclosporine - Ultraviolet blood irradiation and ozone therapy - Muscle and spinal manipulations - Glutathione - Red Light Therapy - Plasmapheresis - Pyridostigmine - Valacyclovir - Phosphatidylserine - Eliquis - Terzepatide - Vitamin B12 shots My current diagnoses: -Antiphospholipid syndrome (an autoimmune disease) -High risk for blood clots and thrombotic events -SIBO -MCAS -Ehlers-Danlos syndrome -Postural Orthostatic Tachycardia syndrome (POTS) -Hypothalamic dysfunction -Anemia -Headaches -Cytokine Release syndrome I am still very sick and disabled, nearly 4 years later!
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| 2847064 | 58 | M | MI | 06/24/2025 |
MMR TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
y020517 l5229 |
Amnesia, Feeling cold, Hyperhidrosis, Malaise, Memory impairment; Amnesia, Feeli...
Amnesia, Feeling cold, Hyperhidrosis, Malaise, Memory impairment; Amnesia, Feeling cold, Hyperhidrosis, Malaise, Memory impairment
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Beginning about 24 hours later, had short-term memory issues for about 3 days. It was like I was ha...
Beginning about 24 hours later, had short-term memory issues for about 3 days. It was like I was half asleep. I forgot immediate things that I was focused on and discovered them a short time later. Was traveling for work and left a bag in a rental car that I later had to retrieve. Then upon going through airport security on the way home, I put my wallet through the xray and left security without getting the wallet. I had to go back to security to get it too. On the night of the 21st, I woke up in a cold, full body sweat. The forgetfulness and malaise went away after about a week.
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| 2847065 | 16 | F | IN | 06/24/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
7MN4C XL223 |
Syncope; Syncope
Syncope; Syncope
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Patient fainted within an hour of vaccines. Patient reported she had not eaten/drank since breakfas...
Patient fainted within an hour of vaccines. Patient reported she had not eaten/drank since breakfast and it was after 2pm.
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| 2847066 | 2 | F | GA | 06/24/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Vomiting
Vomiting
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Vomitting multiple times, coming from childs mouth and nose. sOUNDED LIKE A BURST WATER PIPE IN CHIL...
Vomitting multiple times, coming from childs mouth and nose. sOUNDED LIKE A BURST WATER PIPE IN CHILD BEFORE THE CHILD REGURGITATED.
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| 2847067 | 61 | M | SC | 06/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
35A77 |
Hyperhidrosis, Pollakiuria
Hyperhidrosis, Pollakiuria
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Increased sweating and increased urination frequency that did not start until day 3 and continued th...
Increased sweating and increased urination frequency that did not start until day 3 and continued through today (Day 7.) He denies fever of loss of blood sugar control and not high at the moment but most recent A1C, 3 months ago, was 9.2 mg/dl. Advised to call primary care provider as symptoms could also be due to UTI, especially with SGLT2 inhibitor and average blood sugar 217 based on most recent A1c. Increased urination and sweating from high blood sugar, which he denies, can also cause increased urination and sweating. He was advised that we would fill out VAERS to document symptoms, but that they were likely due to another cause. Patient also said no redness, warmth or irritation around injection site that might be signs of cellulitis. He called PCP after we spoke and reported symptoms message to her staff.
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| 2847068 | 51 | M | SC | 06/24/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Z002626 332L4 |
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
Erythema, Peripheral swelling, Pruritus; Erythema, Peripheral swelling, Pruritus
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Patient had Redness, swelling, and itching encircling upper right arm. Notified pharmacy on evening...
Patient had Redness, swelling, and itching encircling upper right arm. Notified pharmacy on evening of 6/23/25. Swelling had gone down some, but the site still itched. Advised patient to take oral benadryl 25mg every 6 hours as needed and to notify physician or urgent care if swelling increased of patient experienced shortness of breath.
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| 2847069 | 22 | M | ID | 06/24/2025 |
IPV |
SANOFI PASTEUR |
y1a201m |
Loss of consciousness
Loss of consciousness
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Following immunization, patient passed out. Patient came to shortly after and felt fine.
Following immunization, patient passed out. Patient came to shortly after and felt fine.
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| 2847070 | 18 | F | NY | 06/24/2025 |
MNQ |
SANOFI PASTEUR |
u8438aa |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Client was supposed to receive Meningococcal B vaccine- not Meningococcal conjugate vaccine. The cli...
Client was supposed to receive Meningococcal B vaccine- not Meningococcal conjugate vaccine. The client did not report any adverse reactions.
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| 2847071 | 59 | F | KY | 06/24/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
35A77 35A77 |
Arthralgia, Injection site pain, Injection site rash, Malaise, Myalgia; Neck pai...
Arthralgia, Injection site pain, Injection site rash, Malaise, Myalgia; Neck pain, Rash vesicular
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Patient described a "speckled" rash that looked like chicken pox around the area of the in...
Patient described a "speckled" rash that looked like chicken pox around the area of the injection site. Rather severe pain extending up through shoulder and neck. General malaise, muscle pain, feeling of being unwell. No fever noted. All symptoms occurring within 24 hours of vaccination.
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| 2847072 | 0.33 | F | OR | 06/24/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
34MF9 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient was given kinrix, which was outside the approved age range for the patient. No adverse event...
Patient was given kinrix, which was outside the approved age range for the patient. No adverse event happened to the patient.
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| 2847073 | 31 | M | OR | 06/24/2025 |
UNK |
UNKNOWN MANUFACTURER |
4DS4N |
Chills, Feeling abnormal, Hyperhidrosis, Paraesthesia
Chills, Feeling abnormal, Hyperhidrosis, Paraesthesia
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sweating a lot, weird feeling, cold chill down to get, tingly feeling.
sweating a lot, weird feeling, cold chill down to get, tingly feeling.
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| 2847074 | 4 | M | TN | 06/24/2025 |
DTAP DTAP MMRV MMRV PNC20 PNC20 DTAP DTAP MMRV MMRV PNC20 PNC20 |
SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH |
3CA25C1 3CA25C1 y013578 y013578 LC5483 LC5483 3CA25C1 3CA25C1 Y013578 Y013578 LC5483 LC5483 |
Extra dose administered, Inappropriate schedule of product administration, No ad...
Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered; Extra dose administered, Inappropriate schedule of product administration, No adverse event; Extra dose administered
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Vaccines were given according to record. The child had vaccines at pediatrician's office on 04...
Vaccines were given according to record. The child had vaccines at pediatrician's office on 04-08-25 but were not reported until 5-14-25. Dtap was given too early, MMRV was given as too many doses. Father of the child brought child to clinic on 5-8-25. Mother was called to let her know what had happened-she reported that child was fine and had no problems after the vaccines he received on 5-8-25.
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| 2847075 | 18 | F | PR | 06/24/2025 |
HPV9 MNQ |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
YO12776 X7R4Z |
Rash; Rash
Rash; Rash
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On June 20, 2025, the young woman was given the first dose of HPV and the second dose of MCV (MENVEO...
On June 20, 2025, the young woman was given the first dose of HPV and the second dose of MCV (MENVEO) in her right arm. On Saturday, she had a rash around her eyes and different areas of the face, behind her right ear and on her right arm. She had no fever or difficulty breathing. Her mother gave her oral Benadryl and called us on Monday and told us what happened. I told her to bring her to the clinic. She brought her to me today, June 24, and a mild rash was still observed in those areas.
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| 2847076 | 0.17 | F | CA | 06/24/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
3Z34X |
Periorbital swelling, Underdose, Vomiting
Periorbital swelling, Underdose, Vomiting
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Pt was administered Rotavirus. Pt started to vomit after a portion of the dose was administered. Per...
Pt was administered Rotavirus. Pt started to vomit after a portion of the dose was administered. Per medical assistant half of the dose was administered. Pt started to vomit x1 and puffy eyes were noted. Upon arrival vitals were monitored. Pulse: 155, O2: 100%. No cyanosis, wheezing per provider. Per provider EMS was called. Pt was taken to Hospital to continue monitoring. Pt was discharged from Hospital the same day.
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| 2847077 | 75 | F | GA | 06/24/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
793PT |
Dizziness
Dizziness
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Patient had dizziness for about 20 minutes. She stated she usually she has dizziness right after rec...
Patient had dizziness for about 20 minutes. She stated she usually she has dizziness right after receiving a vaccine. called the patient 2 hours later and she stated she was feeling better
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| 2847078 | 65 | F | VA | 06/24/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2224 |
Joint noise, Mobility decreased
Joint noise, Mobility decreased
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Patient stated she "could not hardly move her right arm for 5 days after receiving the vaccine....
Patient stated she "could not hardly move her right arm for 5 days after receiving the vaccine." Also stated it "it still pops and cracks"
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| 2847079 | 4 | M | MD | 06/24/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
YN2X2 Z003311 |
Injection site erythema, Injection site swelling, Pruritus, Urticaria; Injection...
Injection site erythema, Injection site swelling, Pruritus, Urticaria; Injection site erythema, Injection site swelling, Pruritus, Urticaria
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Patient received his vaccination shots on Monday, June 16, 2025.His left arm, NOTED THE NIGHT OF 6/1...
Patient received his vaccination shots on Monday, June 16, 2025.His left arm, NOTED THE NIGHT OF 6/18/2025, where KINRIXt was administered, appeared very red and is suspected to be a reaction .The guardian first noticed the redness while giving him a bath. Later that day, after returning home, Patient was observed itching his neck and his back was covered in hives. A photograph of the reaction was taken before administration of Benadryl. Patient had a prior similar hive episode under his eyes a couple of weeks ago. Benadryl was given by the guardian with noted improvement of the hive appearance. Left arm at vaccine site with erythema raised, hive reaction about 1 1/2 inch in diameter, slightly warm to touch back with large erythematous area of hives central, no raised areas or warmth noted no other hives noted on exam. Continue Benadryl every six hours to manage the hives.Apply cool compresses and use oatmeal baths to relieve itching.Monitor for any worsening symptoms including increased swelling, joint swelling, or systemic involvement.Reassure that this reaction is not severe and does not contraindicate future tetanus vaccination when indicated.Instruct the guardian to report any new or worsening symptoms promptly
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| 2847080 | 60 | M | 06/24/2025 |
JEV1 |
INTERCELL AG |
JEV24B20E |
Pruritus, Rash, Urticaria
Pruritus, Rash, Urticaria
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Diffuse upper extremity itching x ~4 days with 12 hours of rash or hives on abdomen . Resumed cetir...
Diffuse upper extremity itching x ~4 days with 12 hours of rash or hives on abdomen . Resumed cetirizine for seasonal allergies and improved.
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| 2847081 | 54 | F | FL | 06/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Lymph node pain, Lymphadenopathy
Lymph node pain, Lymphadenopathy
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Swollen, slightly painful lymph nodes around the collar bone on the same side as the injection sit...
Swollen, slightly painful lymph nodes around the collar bone on the same side as the injection site(left).
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| 2847082 | 74 | F | MA | 06/24/2025 |
PNC20 |
PFIZER\WYETH |
lx4482 |
Erythema, Peripheral swelling, Tenderness
Erythema, Peripheral swelling, Tenderness
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Patient received vaccine on 6/18/25. Was achy and weak in arm for 3-4 days. Then on 6/23/25, patient...
Patient received vaccine on 6/18/25. Was achy and weak in arm for 3-4 days. Then on 6/23/25, patient reports redness and tenderness in most of her right arm. Was very concerned and made an appointment to follow up with physician. Was given antibiotics per patient on 6/23/25 and on 6/24/25 reported swelling reduced and improvement in arm.
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| 2847083 | 0.5 | F | TX | 06/24/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
U8335AA MF0416 2096657 |
Injection site erythema, Injection site induration; Injection site erythema, Inj...
Injection site erythema, Injection site induration; Injection site erythema, Injection site induration; Injection site erythema, Injection site induration
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L ANTERIOR MID THIGHT AT INJECTION SITE IS RED TENDER AND INDURATED. A PATCH OF 2 INCHES BY 1.5 INCH...
L ANTERIOR MID THIGHT AT INJECTION SITE IS RED TENDER AND INDURATED. A PATCH OF 2 INCHES BY 1.5 INCHES WITH ERYTHEMA. R THIGH ONLY INDURATED AT INJECTION SITE.
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| 2847084 | 1.17 | M | MT | 06/24/2025 |
HIBV HIBV PNC20 PNC20 VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
Y016315 Y016315 LX4484 LX4484 Y010045 Y010045 |
Injection site erythema, Injection site haemorrhage, Injection site mass, Inject...
Injection site erythema, Injection site haemorrhage, Injection site mass, Injection site pain, Injection site swelling; Injection site warmth, Pyrexia; Injection site erythema, Injection site haemorrhage, Injection site mass, Injection site pain, Injection site swelling; Injection site warmth, Pyrexia; Injection site erythema, Injection site haemorrhage, Injection site mass, Injection site pain, Injection site swelling; Injection site warmth, Pyrexia
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Right thigh (PCV-20) had a hard sensitive lump at the injection site, was slightly raised/swollen, a...
Right thigh (PCV-20) had a hard sensitive lump at the injection site, was slightly raised/swollen, and hot to the touch. Parent stated it bled a bit more than usual upon injection. Upon follow up on 06.24.2025, it is still red and has a small lump, along with it still being mildly sensitive. Left thigh (HIB) was sensitive to the touch and mildly raised. Upon follow up on 06.24.2025. It is still a little red and warm to the touch, but is no longer sensitive. Child had a slight fever for roughly 24 hours, and was given motrin on 06.20.2025 and 06.21.2025. They went to their primary care physician determining it an adverse reaction.
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