| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843279 | 05/30/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Injection site erythema, Injection site pain, Injection site warmth
Injection site erythema, Injection site pain, Injection site warmth
|
area of injection is sore; injection site is has a 4 by 4 red area; is warm to the touch; This non-s...
area of injection is sore; injection site is has a 4 by 4 red area; is warm to the touch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 21-MAY-2025, the patient received Shingles vaccine. In MAY-2025, less than a week after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: area of injection is sore), injection site erythema (Verbatim: injection site is has a 4 by 4 red area) and injection site warmth (Verbatim: is warm to the touch). The outcome of the injection site pain was resolving and the outcome of the injection site erythema and injection site warmth were not reported. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to Shingles vaccine. It was unknown if the company considered the injection site pain, injection site erythema and injection site warmth to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient reported that he/she got a shingles vaccine shot on May 21st and area of injection was sore but getting better. However have a large red area about 4 by 4 and is warm to the touch. The injection site is has a 4 by 4 red area. The reporter enquired if that was normal.
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| 2843280 | 05/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
first shot of Shingrix in 2022 but did not go back for my second shot; This non-serious case was rep...
first shot of Shingrix in 2022 but did not go back for my second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose in 2022). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: first shot of Shingrix in 2022 but did not go back for my second shot). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 26-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient reported he/she received first shot of Shingrix in 2022 but did not go back for his/her second shot which led to incomplete course of vaccination. The patient enquired if they need to start over with the vaccine or just get my second shot.
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| 2843281 | F | OH | 05/30/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
Late 2nd dose/did not receive the 2nd dose; This non-serious case was reported by a pharmacist via c...
Late 2nd dose/did not receive the 2nd 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 adult female patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (1st dose received on 25-MAR-2025, batch number-Y5X9T and expiry date-30-SEP-2026). 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: Late 2nd dose/did not receive the 2nd 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: 27-MAY-2025 The patient did not come back to get the 2nd dose on the 2nd month. Till the time of reporting the patient had not received the second dose of Engerix-B, which led to incomplete course of vaccination. The reporter consented to follow up.
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| 2843282 | 74 | F | CA | 05/30/2025 |
COVID19 |
MODERNA |
3043837 |
Discomfort, Insomnia, Pain
Discomfort, Insomnia, Pain
|
unable to sleep without waking up from pain or discomfort every 15-20 minutes; unable to sleep witho...
unable to sleep without waking up from pain or discomfort every 15-20 minutes; unable to sleep without waking up from pain or discomfort every 15-20 minutes; unable to sleep without waking up from pain or discomfort every 15-20 minutes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (unable to sleep without waking up from pain or discomfort every 15-20 minutes), DISCOMFORT (unable to sleep without waking up from pain or discomfort every 15-20 minutes) and INSOMNIA (unable to sleep without waking up from pain or discomfort every 15-20 minutes) in a 74-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043837) for COVID-19 prophylaxis. No Medical History information was reported. On 24-May-2025, the patient received tenth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 25-May-2025, the patient experienced PAIN (unable to sleep without waking up from pain or discomfort every 15-20 minutes) and INSOMNIA (unable to sleep without waking up from pain or discomfort every 15-20 minutes). 25-May-2025, the patient experienced DISCOMFORT (unable to sleep without waking up from pain or discomfort every 15-20 minutes). At the time of the report, PAIN (unable to sleep without waking up from pain or discomfort every 15-20 minutes), DISCOMFORT (unable to sleep without waking up from pain or discomfort every 15-20 minutes) and INSOMNIA (unable to sleep without waking up from pain or discomfort every 15-20 minutes) outcome was unknown. No concomitant medication was reported. Patient and her husband had no issues or problems until they received the 10th COVID-19 vaccines on 24-May-2025. On 25-May-2025, both of them were unable to sleep without waking up from pain or discomfort every 15-20 minutes. The pharmacist started injecting the shots into the shoulders. Patient's husband asked him to inject the vaccine in the bicep at the widest point of the arms (into the softest padded area of the upper arm), but he said he had to inject them in the shoulder. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
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| 2843284 | 4 | M | MA | 05/30/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
YN2X2 |
Injection site pruritus, Injection site reaction
Injection site pruritus, Injection site reaction
|
Patient received DTaP-IPV in left thigh and MMRV in right thigh on 5/27/25 Mother reports pt c/o itc...
Patient received DTaP-IPV in left thigh and MMRV in right thigh on 5/27/25 Mother reports pt c/o itching of left thigh at bedtime on 5/27/25 - minimal redness noted The following day pt c/o itching of right thigh - no decrease in activity or pain no fever At bedtime 5/28/25 noted to have and pain of right thigh. No fever Seen for sick visit on morning of 5/29/25 Right thigh with 18cm x 20cm area of redness - not painful Left thigh - with 3cm x 2cm area of redness - not painful No fever No restriction of activity Parents report areas of redness decreased on morning of 5/29/25 as compared to bedtime of 5/28/25
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| 2843286 | 83 | F | MT | 05/30/2025 |
PNC20 |
PFIZER\WYETH |
LN4927 |
Cellulitis, Erythema, Pain, Swelling
Cellulitis, Erythema, Pain, Swelling
|
redness, swelling, pain. Cellulitis. Started on cephalexin 500mg q6hrs for 5 days.
redness, swelling, pain. Cellulitis. Started on cephalexin 500mg q6hrs for 5 days.
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| 2843287 | 1.33 | M | MA | 05/30/2025 |
DTAP HIBV |
SANOFI PASTEUR SANOFI PASTEUR |
3CA03C3 UK210AA |
Product preparation error; Product preparation error
Product preparation error; Product preparation error
|
HIB vaccine given with non-preferred diluent. Unknown sx and/or reactions from this error.
HIB vaccine given with non-preferred diluent. Unknown sx and/or reactions from this error.
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| 2843288 | 1.75 | M | IL | 05/30/2025 |
DTAPIPVHIB PNC20 |
SANOFI PASTEUR PFIZER\WYETH |
UK196AA MF0415 |
Differential white blood cell count, Full blood count, Injection site erythema, ...
Differential white blood cell count, Full blood count, Injection site erythema, Injection site nodule, Injection site swelling; Differential white blood cell count, Full blood count, Injection site erythema, Injection site nodule, Injection site swelling
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Redness and swelling. Two small knots at injection site.
Redness and swelling. Two small knots at injection site.
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| 2843318 | 8 | F | PA | 05/30/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8209CB |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Administered combo vaccine to an 8-year-old patient that is only indicated for ages 4-6, so she shou...
Administered combo vaccine to an 8-year-old patient that is only indicated for ages 4-6, so she should have received DTaP and IPV as separate injections. No adverse events or side effects reported by patient or her parents.
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| 2843319 | 5 | F | AR | 05/30/2025 |
DTPPVHBHPB HEPA MMRV |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U7801BA X025482 X027624 |
No adverse event, Product administered to patient of inappropriate age; No adver...
No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age
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Vaxelis given to a 5 year old. It is only licensed to give the ages 6 weeks - 4 years of age. Consu...
Vaxelis given to a 5 year old. It is only licensed to give the ages 6 weeks - 4 years of age. Consulted with the Immunization program and no doses need to be repeated. No adverse events.
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| 2843320 | 11 | M | NC | 05/30/2025 |
MNP |
GLAXOSMITHKLINE BIOLOGICALS |
Z92L4 |
Diarrhoea, Pyrexia, Swelling, Vomiting
Diarrhoea, Pyrexia, Swelling, Vomiting
|
Vomiting, diarrhea, swelling, fever
Vomiting, diarrhea, swelling, fever
|
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| 2843321 | 65 | M | FL | 05/30/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
f4ac3 |
Extra dose administered
Extra dose administered
|
pt received 2nd dose of rsv
pt received 2nd dose of rsv
|
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| 2843322 | 62 | F | TN | 05/30/2025 |
COVID19 HEP PNC20 VARZOS |
PFIZER\BIONTECH DYNAVAX TECHNOLOGIES CORPORATION PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
md3414 946062 lj5281 pj353 |
Feeling abnormal, Pain, Peripheral swelling, Pyrexia; Feeling abnormal, Pain, Pe...
Feeling abnormal, Pain, Peripheral swelling, Pyrexia; Feeling abnormal, Pain, Peripheral swelling, Pyrexia; Feeling abnormal, Pain, Peripheral swelling, Pyrexia; Feeling abnormal, Pain, Peripheral swelling, Pyrexia
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swelling of the arms--patient got 4 vaccines that day: Shingrix and Comirnaty in the left arm and P...
swelling of the arms--patient got 4 vaccines that day: Shingrix and Comirnaty in the left arm and Prevnar and Heplisav in the right arm. She started having fever and body aches that same day after administration. She was still feeling bad the next day and called her PCP, who advised her to go to the ER. She went to the ER and got a muscle relaxant, Promethazine and fluids (according to the pt). She is feeling much better now, but still have swelling in the Arms.
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| 2843323 | 15 | F | IN | 05/30/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
XL223 |
Dyspnoea, Hypotonia, Immediate post-injection reaction, Loss of consciousness, P...
Dyspnoea, Hypotonia, Immediate post-injection reaction, Loss of consciousness, Pallor
More
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Patient became pale and limp immediately following the vaccine administration. Patient moved to the...
Patient became pale and limp immediately following the vaccine administration. Patient moved to the floor and given ice packs. Patient in and out of consciousness. Patient complained of trouble breathing. 911 called. Patient responded to EMS and began to improve. Patient's mother did not want patient to go to the hospital. Patient given fluids and released to her mother's care at 2:31pm.
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| 2843324 | 2 | M | MN | 05/30/2025 |
MMRV MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
Y008282 Y008282 |
Erythema, Induration, Injection site rash, Rash, Rash pruritic; Skin discharge, ...
Erythema, Induration, Injection site rash, Rash, Rash pruritic; Skin discharge, Skin lesion, Varicella virus test positive, Varicella zoster virus infection
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On February 25, 2025, patient received vaccinations in his left leg. Subsequently, he developed a ra...
On February 25, 2025, patient received vaccinations in his left leg. Subsequently, he developed a rash on the left leg, which began on March 11, 2025. The rash has progressively enlarged and is associated with itching. patient has been scratching the area, leading to scratch marks. The rash became noticeable with red cheeks and ears on March 17, 2025, followed by a full-body rash on March 18, 2025, which lasted until March 21, 2025, before diminishing. There is some drainage from a particular spot on the rash, and the area underneath the skin has become hard. Patient has not experienced any fevers and continues his regular activities. He is aware of the rash and finds it bothersome. There is no history of eczema or similar rashy conditions. Patient is two years post-bone marrow transplant and is not on any active oncology treatments.
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| 2843325 | 11 | F | KS | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
11 year old inadvertently given 12+ COVID dose
11 year old inadvertently given 12+ COVID dose
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| 2843326 | 1 | F | OK | 05/30/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
y014096 y014096 |
Crying, Malaise, Muscle rigidity, Postictal state, Pyrexia; Seizure
Crying, Malaise, Muscle rigidity, Postictal state, Pyrexia; Seizure
|
On thursday my daughter started to get sick and had a 102๏ฟฝF fever rectally. I medicated her with T...
On thursday my daughter started to get sick and had a 102๏ฟฝF fever rectally. I medicated her with Tylenol and she woke up on Friday 04/25 with no fever. That afternoon she had a fever of 100.5๏ฟฝF rectally, I did not medicate, and she fell asleep on me. I transferred her to her crib and got in the shower. She had cried out in her sleep and my husband checked on the monitor and she was repositioning in her crib. Not even a minute later I got out of the shower and checked the monitor and she was seizing. I grabbed her out of the crib and she continued to seize in my arms. We called 911 and they were at our house within 5 minutes and my daughter was still seizing. They administered a dose of versed and she started to cry and enter a post ictal phase. She seized for probably 7-8 minutes and she had equal movements bilaterally during the seizure. Her eyes rolled up during the seizure and she was breathing. She did not vomit. Her post ictal phase lasted less than 5 minutes and she was rigid and crying. Her legs were straight out with her toes pointed inward and her arms were up towards her chest with her hands curled inward. They took her temperature in the ambulance and it was 102.7๏ฟฝF axillary. The seizure only occurred once. She was day 10 post MMR vaccine and CDC website states highest risk of febrile seizure occurs days 8-15 post MMR vaccine. And my child just happened to viruses during that window of time frame. My child has had viruses before with a 103๏ฟฝF over a couple of days and been fine.
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| 2843327 | 49 | F | PA | 05/30/2025 |
HEPAB TDAP |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR |
d4774 u8115aa |
Aphasia, Condition aggravated, Seizure, Tinnitus; Aphasia, Condition aggravated,...
Aphasia, Condition aggravated, Seizure, Tinnitus; Aphasia, Condition aggravated, Seizure, Tinnitus
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Patient stopped speaking and went into a seizure. After coming too, she claimed she had ringing in ...
Patient stopped speaking and went into a seizure. After coming too, she claimed she had ringing in her ear before it happened. She use to get that same feeling when she used cocaine and her blood pressure spiked. EMT was called. They monitored the patient, but she refused to go to the hospital
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| 2843329 | 34 | F | NY | 05/30/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
PG3RP |
Arthralgia, Mobility decreased, Ultrasound joint
Arthralgia, Mobility decreased, Ultrasound joint
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On 5/28 patient received Tdap vaccine. Patient seen in clinic on 5/29/25 for worsening pain in her l...
On 5/28 patient received Tdap vaccine. Patient seen in clinic on 5/29/25 for worsening pain in her left shoulder. Felt ok initially, but had progressive discomfort through the day. Limited range of motion, pain 9/10. Patient very tender over area of injection, guarding. Pain with resisted RTC testing and weak with sharper pain on abduction and external rotation. Does not tolerated impingement testing. Diagnostic ultrasound performed by provider: Long and Short axis view of the biceps shows no tear of the tendon without fluid in the sheath and negative subluxation. AC joint appears normal in long axis. Pectoralis major tendon in long axis is intact. Short and long axis view of the subscapularis shows no tear of the tendon and no subcoracoid bursitis or impingement. Short and long axis views of the supraspinatus shows tendinopathy of the tendon. With dynamic resistance testing there is no retraction of the tendon. There is no significant subacromial bursitis. Short and long axis views of the infraspinatus shows no tear of the tendon. With dynamic resistance testing there is no retraction of the tendon. There is no joint effusion and GH joint appears normal. Evaluation of the posterior labrum shows no tear. Impression : Diagnostic ultrasound of the left shoulder with findings supporting accidental vaccine administration into the supraspinatus tendon as a contribution to the patients pain and dysfunction. ASSESSMENT & PLAN 1. Shoulder injury related to vaccine administration (SIRVA) meloxicam (MOBIC) 15 mg tablet She has significant pain and dysfunction in her shoulder following vaccine administration yesterday. Based on location of bandage and hypoechogenic focus in the supraspinatus tendon in concert with her symptoms and physical exam, it appears that there was inadvertent administration of the Tdap booster into the subacromial space instead of IM into the deltoid muscle belly. Follow up in 2 weeks with me at Ortho. We will plan for xrays at that time if needed. May consider repeat US of shoulder. May consider referral to PT.
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| 2843330 | 34 | M | FL | 05/30/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Heart rate increased; P...
Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Heart rate increased; Pulmonary function test
More
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Rapid heart rate while at rest at times, shortness of breath all day, everyday, chest pain, abnormal...
Rapid heart rate while at rest at times, shortness of breath all day, everyday, chest pain, abnormal heart rate after running
More
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| 2843331 | 12 | F | OR | 05/30/2025 |
HPV9 PNC20 |
MERCK & CO. INC. PFIZER\WYETH |
Y007197 MF0416 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
|
wrong vaccine given
wrong vaccine given
|
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| 2843332 | 60 | M | TX | 05/30/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
T5D73 |
Erythema, Rash, Urticaria
Erythema, Rash, Urticaria
|
VERBALIZED UTICARIA ON BACK, ASSESSED RED, AND PALPATED 5-7 MM SIZE BUMPS
VERBALIZED UTICARIA ON BACK, ASSESSED RED, AND PALPATED 5-7 MM SIZE BUMPS
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| 2843333 | 36 | M | DC | 05/30/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
KY27J |
Extra dose administered
Extra dose administered
|
Received TDAP on 5/23/2025 & on 5/30/2025 in error
Received TDAP on 5/23/2025 & on 5/30/2025 in error
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| 2843334 | 0.25 | M | CA | 05/30/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
9at95 |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
No s/s noted or reported. The diluent only was given.
No s/s noted or reported. The diluent only was given.
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| 2843335 | 22 | F | CO | 05/30/2025 |
MENB |
PFIZER\WYETH |
FN5547 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Trumenba was administered today in office. It was discovered after the patient left she had had a B...
Trumenba was administered today in office. It was discovered after the patient left she had had a Bexsero dose previously on 8-19-19. No adverse reaction or symptoms have been noticed by patient.
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| 2843337 | 61 | M | CA | 05/30/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
MD9SL |
Dizziness, Hyperhidrosis
Dizziness, Hyperhidrosis
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Patient presented to clinic today and received a hepatitis B vaccine. He reports that after the vac...
Patient presented to clinic today and received a hepatitis B vaccine. He reports that after the vaccine he felt dizzy and lightheaded and started sweating. - He reports that he is now feeling better. He did have some apple juice and was able to sit for a while and now feels well. No longer having any symptoms when seen by physician. States that he has always had this happen with vaccines and blood draws. This has been happening ever since he was a kid. He wonders why this is the case.
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| 2843338 | 52 | F | FL | 05/30/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019158 Y019158 |
Burning sensation, Erythema, Injection site erythema, Injection site pain, Pyrex...
Burning sensation, Erythema, Injection site erythema, Injection site pain, Pyrexia; Renal pain
More
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REDNESS AND SORENESS AT INJECTION SITE, FEVER, PAIN IN AREA OF KIDNEY. FELT LIKE ON FLAME AND REDNES...
REDNESS AND SORENESS AT INJECTION SITE, FEVER, PAIN IN AREA OF KIDNEY. FELT LIKE ON FLAME AND REDNESS ON INNER THIGH.
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| 2843339 | 8 | M | ID | 05/30/2025 |
TYP YF |
SANOFI PASTEUR SANOFI PASTEUR |
Y2A021M UK117AA |
Pallor, Thirst; Pallor, Thirst
Pallor, Thirst; Pallor, Thirst
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After about 10 minutes from receiving the vaccines, patient stated he was feeling very thirsty. Mom ...
After about 10 minutes from receiving the vaccines, patient stated he was feeling very thirsty. Mom noticed patient looked a little pale in the face. I walked over to the patient to check vaccine injection sites for any reaction, no reaction seen. I noticed as well that he was pale. Mom and I had patient lay down on exam table. I had the provider come back into the room and we raised his feet into the air and check his vitals. Had the epi-pen available if needed. We had patient drink a little bit of water and some apple juice. Patient started feeling better and his color was coming back. We had patient wait in the exam room for an additional 15-20 Minutes before provider felt he was ok to leave.
More
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| 2843340 | 64 | F | TX | 05/30/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Extra dose administered, Lower urinary tract symptoms, Pain, Pruritus; P...
Chills, Extra dose administered, Lower urinary tract symptoms, Pain, Pruritus; Pyrexia, Urine analysis, Vomiting
More
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Patient was administered a 3rd dose by mistake thinking she only had one dose on 4/24. had fever chi...
Patient was administered a 3rd dose by mistake thinking she only had one dose on 4/24. had fever chills body aches and vomiting from vaccine administration to 2 days after. after 10 days has chills, scalp itching (also has possible UTI today)
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| 2843341 | 40 | M | CA | 05/30/2025 |
HEP TDAP |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
946062 793PT |
Tinnitus; Tinnitus
Tinnitus; Tinnitus
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Ringing of the LEFT ear.
Ringing of the LEFT ear.
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| 2843342 | 77 | F | FL | 05/30/2025 |
HEPAB VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
SKB 2553X SKB Y7XG3 |
Erythema, Injection site erythema, Injection site pain, Paraesthesia, Pruritus; ...
Erythema, Injection site erythema, Injection site pain, Paraesthesia, Pruritus; Erythema, Injection site erythema, Injection site pain, Paraesthesia, Pruritus
More
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Redness at injections site., Soar, Redness on face and itching/tingle
Redness at injections site., Soar, Redness on face and itching/tingle
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| 2843343 | 49 | M | TX | 05/30/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
ER8733 EW0169 |
Parosmia, Tinnitus; Parosmia, Tinnitus
Parosmia, Tinnitus; Parosmia, Tinnitus
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Following first shot, constant ringing in my right ear developed and experienced the smell of onions...
Following first shot, constant ringing in my right ear developed and experienced the smell of onions. The phantom smell dissipated after a day or two but the ringing in the right ear has been constant since 1 Apr 2021.
More
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| 2843344 | 25 | F | CO | 05/30/2025 |
HEP VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION MERCK & CO. INC. |
946060 Y017062 |
Injection site haemorrhage, Paraesthesia, Peripheral swelling; Injection site ha...
Injection site haemorrhage, Paraesthesia, Peripheral swelling; Injection site haemorrhage, Paraesthesia, Peripheral swelling
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Heplisav-B dose 2 of 2 and Varicella 2 of 2 given in clinic. 10 minutes post vaccination patient st...
Heplisav-B dose 2 of 2 and Varicella 2 of 2 given in clinic. 10 minutes post vaccination patient stated she began feeling a tingling sensation in her left arm where the varicella vaccine was given. She reports that it radiated from her shoulder down into her fingers. She reported to nurse that she felt her left hand was beginning to swell. Nurse observed petechiae around injection site 10 minutes post vaccination. Petechiae did not spread further then around injection site. Clinic provider ordered 25mg PO Benadryl STAT to be given, and ice pack applied to site. Patient rested in chair and was observed in clinic for 3 hours. Symptoms began improving 20 minutes after Benadryl was given. At the end of 3-hour observation period petechiae around injection site was minimal, patient reported itching sensation went from severe to mild, and patient reported the swelling sensation in her left hand decreased. No symptoms occurred in arm that Heplisav-B was given.
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| 2843345 | 1.08 | F | MI | 05/30/2025 |
VARCEL |
MERCK & CO. INC. |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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3/15 Patient arrived with parent and received Varicella vaccine by RN Patient was given MMR 10 days...
3/15 Patient arrived with parent and received Varicella vaccine by RN Patient was given MMR 10 days prior. Dose not valid 5/29 Parent notified by physician, patient doing well and will receive Varicella dose at 2 year visit
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| 2843346 | 15 | M | CA | 05/30/2025 |
HPV9 |
MERCK & CO. INC. |
Z005055 |
Rash
Rash
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1 day later developed rash on buttocks, pubic area, bilateral legs and antecubital fossae. Rash reso...
1 day later developed rash on buttocks, pubic area, bilateral legs and antecubital fossae. Rash resolved with Hibilcens wash, oral clindamycin, and topical mupirocin.
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| 2843347 | 83 | F | IA | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
MD3414 |
Herpes zoster
Herpes zoster
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Shingles to underside of right breast with pain to the area noted on 4/25-25 2246. COVID19 vaccine ...
Shingles to underside of right breast with pain to the area noted on 4/25-25 2246. COVID19 vaccine given on 4/21 between 1100-1300. Treated with Valtrex 500 mg TID until 5/3/25
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| 2843348 | 46 | F | CA | 05/30/2025 |
FLU3 |
SANOFI PASTEUR |
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Arthralgia, Bursitis, Pain, Periarthritis, X-ray limb
Arthralgia, Bursitis, Pain, Periarthritis, X-ray limb
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Frozen shoulder -adhesive bursitis, shoulder pain, physical therapy, stable but still painful on c...
Frozen shoulder -adhesive bursitis, shoulder pain, physical therapy, stable but still painful on certain movements
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| 2843349 | 11 | M | MI | 05/30/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
9YB4G |
Extra dose administered
Extra dose administered
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Patient was seen at his doctors on 5/28/25 and received a Tdap vaccine. Patient came to school vacci...
Patient was seen at his doctors on 5/28/25 and received a Tdap vaccine. Patient came to school vaccine clinic and grandfather consented to patient getting Tdap - did not state that patient had received it on 5/28/25. Tdap was administered, again, on 5/30/25.
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| 2843350 | 43 | F | TN | 05/30/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL1284 EL1284 EL1284 EL3302 EL3302 EL3302 |
Computerised tomogram head, Dizziness, Headache, Hypoaesthesia, Laboratory test;...
Computerised tomogram head, Dizziness, Headache, Hypoaesthesia, Laboratory test; Magnetic resonance imaging head, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Muscular weakness, Palpitations; Postural orthostatic tachycardia syndrome, Tachycardia; Computerised tomogram head, Dizziness, Headache, Hypoaesthesia, Laboratory test; Magnetic resonance imaging head, Magnetic resonance imaging neck, Magnetic resonance imaging spinal, Muscular weakness, Palpitations; Postural orthostatic tachycardia syndrome, Tachycardia
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Dizziness/lightheadedness, Numbness to the face/head, Severe muscle weakness, POTS, Tachycardia/Palp...
Dizziness/lightheadedness, Numbness to the face/head, Severe muscle weakness, POTS, Tachycardia/Palpitations, Headaches.
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| 2843351 | 42 | F | OH | 05/30/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FC3182 FC3182 FC3182 |
Arthropathy, Bedridden, Cardiac disorder, Headache, Hypoaesthesia; Inflammation,...
Arthropathy, Bedridden, Cardiac disorder, Headache, Hypoaesthesia; Inflammation, Injection site pain, Injection site swelling, Laboratory test, Muscle atrophy; Pain, Paraesthesia, Rash, Scar
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Site injection started to swell up and then got sore per usual for a vaccine. Immediately was sick ...
Site injection started to swell up and then got sore per usual for a vaccine. Immediately was sick that evening with headache, horrific BODY ACHES , numbness and tingling in my extremities. Rash all over but suffered through it. I knew that whatever that vaccine contained was NOT SUPPOSED to go into a human body!! Refused any other vaccines and quit my job. Became unemployed after that day of taking that poison. I?ve now suffered with heart issues inflammation all over my body. They don?t know what?s wrong with me, but they know somethings wrong. I?ve been to every specialist under the sun multiple times. And all my joints are wasting away. I also have a bad heart now. I was healthy and working. I am bed fast now and disabled. I am in severe pain on a daily basis. I have to have both of my knees replaced and I?m 46 years old. I?ve had rashes uncontrollably all over my face, leaving scars on my arms and legs with white stringy things that come out of them. I would love to know what it is, but I do know that it?s some form of their site.
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| 2843352 | 74 | F | NC | 05/30/2025 |
COVID19 |
MODERNA |
3043838 |
Musculoskeletal stiffness
Musculoskeletal stiffness
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lingering stiffness in right arm/deltoid
lingering stiffness in right arm/deltoid
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| 2843353 | 81 | M | NM | 05/30/2025 |
COVID19 |
MODERNA |
8080748 |
Cough, Dry throat, Fatigue
Cough, Dry throat, Fatigue
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Experienced fatigue for the first 3-4 days, dry throat, and chronic cough - still coughing (over 1 w...
Experienced fatigue for the first 3-4 days, dry throat, and chronic cough - still coughing (over 1 week).
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| 2843354 | 74 | F | NM | 05/30/2025 |
COVID19 |
MODERNA |
8080748 |
Cough, Dry throat, Fatigue
Cough, Dry throat, Fatigue
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Experienced fatigue for the first 3-4 days, dry throat, and chronic cough - still coughing (over 1 w...
Experienced fatigue for the first 3-4 days, dry throat, and chronic cough - still coughing (over 1 week).
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| 2843355 | 1 | M | FL | 05/30/2025 |
MMRV |
MERCK & CO. INC. |
YO17514 |
Unevaluable event
Unevaluable event
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no tx needed
no tx needed
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| 2843356 | 37 | F | GA | 05/30/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
xx9n4 |
Product preparation issue
Product preparation issue
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Priorix antigen was not reconstituted with diluent, so only diluent was administered to patient.
Priorix antigen was not reconstituted with diluent, so only diluent was administered to patient.
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| 2843366 | CA | 05/30/2025 |
HPV9 |
MERCK & CO. INC. |
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No adverse event, Syringe issue
No adverse event, Syringe issue
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No adverse event; reported on behalf of HCP that a GARDASIL 9 syringe broke while a nurse in the pra...
No adverse event; reported on behalf of HCP that a GARDASIL 9 syringe broke while a nurse in the practice was administering to a patient. Unkown at time of report if patient actually received the dose. Filing this precautionary AE. No additional information pro; Poor quality device used; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 22-APR-2025, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9) administered by intramuscular route as prophylaxis (dose, anatomical location, lot # and expiration date were not reported). On that same day, the reporter informed that the syringe broke while a nurse in the practice was administering to a patient (however it was unknown if patient actually received the dose). On that same day, another nurse was injured in the practice while administering product (captured in case #2282098) No additional adverse events reported. Lot # is being requested and will be submitted if received. This is non-valid report due to lack of patients' identifiers. This is one of several reports received from the same reporter.
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| 2843367 | 52 | M | KS | 05/30/2025 |
VARCEL |
MERCK & CO. INC. |
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Wrong product administered
Wrong product administered
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HCP confirmed that patient did not have any symptomatic events; HCP reported that a patient who init...
HCP confirmed that patient did not have any symptomatic events; HCP reported that a patient who initially was looking to receive SHINGRIX was accidently administered VARIVAX; This spontaneous report was received from a Register Nurse and refers to a 52-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 02-MAY-2025, the patient was accidentally vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection (lot #, dose, strength, route of administration and anatomical location of vaccine and expiration date were not reported) diluted with sterile diluent (MERCK STERILE DILUENT); instead of a dose of Varicella zoster vaccine rgE (CHO) (SHINGRIX) (Wrong vaccine administered) for prophylaxis. It was confirmed that the patient did not have any symptomatic events. Lot # is being requested and will be submitted if reported.
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| 2843368 | KS | 05/30/2025 |
MMR |
MERCK & CO. INC. |
X028353 |
No adverse event, Underdose
No adverse event, Underdose
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no adverse event; some of the vaccine spilled out resulting in a lower than recommended dose; some ...
no adverse event; some of the vaccine spilled out resulting in a lower than recommended dose; some of the vaccine spilled out; that this was a user error; This spontaneous report was received from a medical assistant and refers to a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-May-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #X028353 was verified to be a valid number, expiration date: 11-Dec-2025) (dose, scheme, injection site, formulation and route of administration was not reported), reconstituted with sterile diluent (BAXTER Sterile Diluent) (dose, formulation, expiration date and lot # were not reported) for prophylaxis; while administering some of the vaccine spilled out (product leakage) resulting in a lower than recommended dose (underdose). The Medical Assistant reports that this was a user error (wrong technique in product usage process) and not related to any product quality issue with the vaccine or syringe. No additional adverse event was reported.
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| 2843369 | ID | 05/30/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
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Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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confirmed that patient had no symptomatic events; patient had accidently received PROQUAD and VARIVA...
confirmed that patient had no symptomatic events; patient had accidently received PROQUAD and VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-MAY-2025, the patient was accidently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Injection (lot # and expiration date were not reported) with sterile diluent (MERCK STERILE DILUENT), Solution for injection (lot # and expiration date were not reported) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot # and expiration date were not reported) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (Accidental overdose). The patient had no symptomatic events (No adverse event). Lot # is being requested and will be submitted if received.
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| 2843370 | NE | 05/30/2025 |
PNC15 |
MERCK & CO. INC. |
Y019380 |
No adverse event, Syringe issue
No adverse event, Syringe issue
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no injury to patient, No additional AE; a broken finger flange for VAXNEUVANCE during administration...
no injury to patient, No additional AE; a broken finger flange for VAXNEUVANCE during administration on 05/20/2025, "near the barrel at the end of the plunger" for the broken finger flange; a broken finger flange for VAXNEUVANCE during administration on 05/20/2025, "near the barrel at the end of the plunger" for the broken finger flange; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-May-2025, the patient was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) (lot #Y019380, expiration date reported as and upon internal validation confirmed to be 28-May-2027) (dose, route of administration and vaccination site were not reported) administered for prophylaxis. The nurse reported a broken finger flange for with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) during administration (poor quality device used). The location was described as "near the barrel at the end of the plunger" for the broken finger flange (syringe issue). Defective unit has been set aside for return and photos were provided. No injury to patient was confirmed (no adverse event). No other information was available. No additional adverse event (AE) and no additional product quality complaint (PQC) was noted.; Sender's Comments: Priority : 5 , Is case serious : No , number : , number : , number : , number : 500UW00000bQFPWYA4|28052025230010|6658 , Central date : 2025-05-29 , Classification :, Attachment description : Call , Safety case number : , case number : , interaction number : , Integration log UniqueID : 500UW00000bQFPWYA4|28052025230010|6658 , Service cloud CaseID : 500UW00000bQFPWYA4
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