| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2861646 | 8 | M | OH | 09/26/2025 |
HEPAB MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
P2443 Y017527 Z005456 |
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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Patient recived Twinrix on 09/15/2025 no reported signs or symptoms reported
Patient recived Twinrix on 09/15/2025 no reported signs or symptoms reported
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| 2861647 | 12 | F | MN | 09/26/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
P2443 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Mom states child is well, no concerns
Mom states child is well, no concerns
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| 2861648 | 69 | M | IN | 09/26/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
MY9547 MY9547 |
Erythema, Pain in extremity, Peripheral swelling, Skin warm; Chills, Pain, Vacci...
Erythema, Pain in extremity, Peripheral swelling, Skin warm; Chills, Pain, Vaccination site mass, Vaccination site pain; Erythema, Pain in extremity, Peripheral swelling, Skin warm; Chills, Pain, Vaccination site mass, Vaccination site pain
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Arm became swollen, red and hot to the touch. Patient states his arm hurt down to fingers
Arm became swollen, red and hot to the touch. Patient states his arm hurt down to fingers
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| 2861649 | 0.33 | M | ME | 09/26/2025 |
DTAPIPVHIB HIBV |
SANOFI PASTEUR MERCK & CO. INC. |
UK167AA X005171 |
Extra dose administered, No adverse event, Wrong product administered; Extra dos...
Extra dose administered, No adverse event, Wrong product administered; Extra dose administered, No adverse event, Wrong product administered
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Was accidentally given Hib (Pedvax HIB), when he should have gotten HepB. This is a duplicate vaccin...
Was accidentally given Hib (Pedvax HIB), when he should have gotten HepB. This is a duplicate vaccine given that this is a component of pentacel which was received at the same time. No adverse reaction.
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| 2861650 | 4 | F | MI | 09/26/2025 |
MMRV |
MERCK & CO. INC. |
Z011681 |
Injection site erythema, Injection site pain, Injection site vesicles, Injection...
Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
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Pt woke up in the morning with a half dollar sized patch of blisters on the outside of her left thig...
Pt woke up in the morning with a half dollar sized patch of blisters on the outside of her left thigh where vaccine was given. Blister area is red, hot, and painful. The reaction showed up between 40-48 hours after vaccine was given. PT was informed to keep that area clean. To use Vaseline or Aquafor on the blistered area, cover with a gauze pad, and use and non-adhesive like an ace band aid to cover the area. Use tylenol as needed for discomfort.
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| 2861651 | 30 | F | FL | 09/26/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Malaise
Malaise
|
Patient stated she had a flu shot in 1995 and was sick for 6 months afterwards and hasn't had a...
Patient stated she had a flu shot in 1995 and was sick for 6 months afterwards and hasn't had a flu shot since.
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| 2861652 | 59 | M | PA | 09/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
4ZS72 |
Eye swelling, Swelling face
Eye swelling, Swelling face
|
Facial and eye swelling started within hours of receiving vaccine. Swelling has since decreased and ...
Facial and eye swelling started within hours of receiving vaccine. Swelling has since decreased and patient states he is better other than some slight swelling in the right eye.
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| 2861653 | 77 | F | PA | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
U8764CB |
Headache, Injection site erythema, Injection site pain
Headache, Injection site erythema, Injection site pain
|
ARM REDNESS FROM INJECTION SITE TO SHOULDER FOR 3 DAYS, USUAL INJECTION PAIN, HEADACHE
ARM REDNESS FROM INJECTION SITE TO SHOULDER FOR 3 DAYS, USUAL INJECTION PAIN, HEADACHE
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| 2861654 | 67 | F | MO | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
U8800BA |
Urticaria
Urticaria
|
9/26/25 09:10 patient presented to pharmacy with dime size red whelps covering body. Started evening...
9/26/25 09:10 patient presented to pharmacy with dime size red whelps covering body. Started evening of shot and continued to today. No red whelps or redness near injection site, but suspected allergic reaction to flu shot. Patient treating topically with Hydrocortisone 1% cream.
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| 2861655 | 88 | M | ME | 09/26/2025 |
COVID19 |
MODERNA |
3052586 |
Pain in extremity
Pain in extremity
|
patient called and reported his arm is still sore, but not red or swollen after 9 days
patient called and reported his arm is still sore, but not red or swollen after 9 days
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| 2861656 | 74 | M | NC | 09/26/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0738 |
Hypoaesthesia, Injection site pain, Paraesthesia
Hypoaesthesia, Injection site pain, Paraesthesia
|
I received a Covid shot during my annual physical exam on September 16. I had the normal soreness at...
I received a Covid shot during my annual physical exam on September 16. I had the normal soreness at the injection site for the first couple of days, but then started experiencing numbness and tingling in my left arm. I hoped it would only be for a short time, but now it?s constant and possibly getting worse. It is very much like the feeling I experienced in my left hand before carpal tunnel surgery several years ago. I?m reporting this in case you track side effects of the new vaccines and also to seek your opinion whether this is a known side effect and if any treatment is recommended.
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| 2861657 | 77 | F | 09/26/2025 |
PNC21 |
MERCK & CO. INC. |
2004302 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Capvaxive was administered on 9/25/25 but patient has already received this vaccine on 6/11/25. Shou...
Capvaxive was administered on 9/25/25 but patient has already received this vaccine on 6/11/25. Should not have received dose on 9/25/25. Patient reports no adverse reaction to this vaccine per patient as of 9/26/25.
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| 2861658 | 57 | F | WV | 09/26/2025 |
TDAP |
SANOFI PASTEUR |
U8353BA |
Injection site erythema, Injection site oedema, Pyrexia, Rash
Injection site erythema, Injection site oedema, Pyrexia, Rash
|
Large bumpy rash on body, arms and under chin, fever of evening of vaccine, and erythema and edema t...
Large bumpy rash on body, arms and under chin, fever of evening of vaccine, and erythema and edema to site (remains day 4 post-injection)
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| 2861659 | 76 | F | ME | 09/26/2025 |
RSV |
PFIZER\WYETH |
kc7884 |
Extra dose administered, Wrong product administered
Extra dose administered, Wrong product administered
|
Technician was supposed to give patient vaccine for yearly high-dose flu shot and covid-19 vaccine, ...
Technician was supposed to give patient vaccine for yearly high-dose flu shot and covid-19 vaccine, but mixed up patients in waiting area and gave an additional RSV (first dose in 2023).
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| 2861660 | 42 | F | MD | 09/26/2025 |
COVID19 |
NOVAVAX |
|
Headache, Injection site pain, Myalgia, Pyrexia, Tremor
Headache, Injection site pain, Myalgia, Pyrexia, Tremor
|
Injection site soreness, fever of 101.3, muscle aches, headache, tremors
Injection site soreness, fever of 101.3, muscle aches, headache, tremors
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| 2861661 | 4 | M | PA | 09/26/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
Y49BZ Z010730 |
Injection site erythema, Injection site pain, Injection site rash, Injection sit...
Injection site erythema, Injection site pain, Injection site rash, Injection site swelling; Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
More
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L upper arm red, swollen, painful to touch. Parent stated the patient has rash around the site of o...
L upper arm red, swollen, painful to touch. Parent stated the patient has rash around the site of one of the injections and arm is red and swollen from elbow to shoulder. Parent said she was just about to place patient into bath for comfort. Patient less active today, "feels hot", parent does not have thermometer to check temp. Parent stated no other rash, redness, swelling. Parent denied patient having breathing/swallowing difficulties. Parent reported concern for LUE redness, swelling. (Triage note, Kinrix, and MMRV were administered to L arm).
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| 2861662 | 69 | M | NM | 09/26/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Herpes zoster, Neuralgia, Pain, Pruritus, Pustule; Pyrexia
Herpes zoster, Neuralgia, Pain, Pruritus, Pustule; Pyrexia
|
patient began to break out in shingles/ pustules approximately 5 hours post injection. pustules appe...
patient began to break out in shingles/ pustules approximately 5 hours post injection. pustules appeared bilaterally on the patients abdomen. symptoms included pain, itching, and low fever of 100.1F. patient indicated radiating nerve pain throughout arms and legs.
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| 2861663 | 46 | F | NY | 09/26/2025 |
COVID19 |
MODERNA |
3043259 |
Urticaria
Urticaria
|
started breaking out with hives at bedtime almost every night, mostly on the tops of my hands and fe...
started breaking out with hives at bedtime almost every night, mostly on the tops of my hands and feet, torso, and back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (started breaking out with hives at bedtime almost every night, mostly on the tops of my hands and feet, torso, and back) in a 46-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043259) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Dose 1, Lot: EW0150, Site: Left deltoid, Time: 10:10) on 06-Apr-2021, Pfizer COVID-19 Vaccine (Dose 2, Lot: EW0176, Site: Left deltoid, Time: 5.59 pm) on 30-Apr-2021, Pfizer booster (Dose 3, Lot: FJ8757) on 14-Dec-2021, MMR, Influenza vaccine, Hep B and DTP; for COVID-19 prophylaxis: Moderna bivalent (Dose 4, Lot: 021H22A) on 18-Nov-2022, Spikevax XBB.1.5 (Dose 5 and Lot: 3032707) on 24-Nov-2023. Past adverse reactions to the above products included No adverse effect with DTP, Hep B, Influenza vaccine, MMR, Moderna bivalent, Pfizer COVID-19 Vaccine, Pfizer COVID-19 Vaccine, Pfizer booster and Spikevax XBB.1.5. On 21-Sep-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2025, the patient experienced URTICARIA (started breaking out with hives at bedtime almost every night, mostly on the tops of my hands and feet, torso, and back). At the time of the report, URTICARIA (started breaking out with hives at bedtime almost every night, mostly on the tops of my hands and feet, torso, and back) outcome was unknown. Concomitant medication was not provided. The patient had no medical history, concomitant disease or risk factor. It was reported that over the previous summer (July/August 2025), the patient had started breaking out with hives at bedtime almost every night, mostly on the tops of her hands and feet, torso and back. The patient mentioned that icepacks had helped her to prevent or relieve them. There were no lab data or results available It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Reporter causality was not reported. This case was linked to MOD-2025-789549 (Patient Link).
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| 2861664 | 6 | F | MO | 09/26/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3052553 7345R |
No adverse event, Product preparation issue; No adverse event, Product preparati...
No adverse event, Product preparation issue; No adverse event, Product preparation issue
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A CMA in our office gave this patient the Moderna vaccine while it was still frozen. She got it out ...
A CMA in our office gave this patient the Moderna vaccine while it was still frozen. She got it out of the freezer. There were no adverse effects noted.
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| 2861665 | 8 | M | PA | 09/26/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
u8767aa u8767aa |
Cold sweat, Dizziness, Loss of consciousness, Pallor, Syncope; Vomiting
Cold sweat, Dizziness, Loss of consciousness, Pallor, Syncope; Vomiting
|
Syncope reaction - dizziness, lightheadedness, vomiting, loss of consciousness, loss of color, clamm...
Syncope reaction - dizziness, lightheadedness, vomiting, loss of consciousness, loss of color, clammy to the touch
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| 2861666 | 43 | F | IL | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2503 |
Injection site erythema, Injection site swelling, Lymphadenopathy
Injection site erythema, Injection site swelling, Lymphadenopathy
|
Patient reported swelling of injection site shortly after immunization, 2x2 red spot underneath the...
Patient reported swelling of injection site shortly after immunization, 2x2 red spot underneath the site within a day, and a swollen lymph node the next day.
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| 2861667 | 68 | M | FL | 09/26/2025 |
FLU3 PNC21 TDAP VARZOS |
SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
U8859BA Z006889 F9K3L 55KB9 |
Fatigue, Headache, Myalgia, Nausea; Fatigue, Headache, Myalgia, Nausea; Fatigue,...
Fatigue, Headache, Myalgia, Nausea; Fatigue, Headache, Myalgia, Nausea; Fatigue, Headache, Myalgia, Nausea; Fatigue, Headache, Myalgia, Nausea
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Nauseaous, headache, muscle aches, fatigue -no fever
Nauseaous, headache, muscle aches, fatigue -no fever
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| 2861668 | 46 | F | MN | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
TFAA2533 |
Syncope
Syncope
|
Fainted 10 minutes after receiving the shot.
Fainted 10 minutes after receiving the shot.
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| 2861669 | 5 | F | KS | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792MA |
Chest pain, Injection site bruising
Chest pain, Injection site bruising
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Pt was seen at drive through flu clinic. Staff report that pt was combative and did not want to rece...
Pt was seen at drive through flu clinic. Staff report that pt was combative and did not want to receive vaccine. Pt had to be restrained while being vaccinated and was very upset. Dose was administered at 5:00 pm. Pts mother reports that at 6:30 pm, pt reported that her chest hurt when she would take a breathe in. Pt was taken to the ER, where the mother states they administered a dose of Benedryl. Chest pain then subsided. Pts mother reports pt has had no other symptoms, besides slight bruising at injection site.
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| 2861670 | 80 | F | NC | 09/26/2025 |
COVID19 FLU3 PNC20 VARZOS |
MODERNA SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
3052669 UT8820CA MA2502 G2HA7 |
Fatigue, Headache, Mobility decreased; Fatigue, Headache, Mobility decreased; Fa...
Fatigue, Headache, Mobility decreased; Fatigue, Headache, Mobility decreased; Fatigue, Headache, Mobility decreased; Fatigue, Headache, Mobility decreased
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Patient received vaccinations on Wednesday afternoon. Patient returned Friday morning and said she i...
Patient received vaccinations on Wednesday afternoon. Patient returned Friday morning and said she is very tired and can't get out of bed and has a headache.
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| 2861671 | 34 | F | MT | 09/26/2025 |
RSV RSV RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
35P2C 35P2C 35P2C 35P2C |
Exposure during pregnancy, No adverse event, Product use issue; Exposure during ...
Exposure during pregnancy, No adverse event, Product use issue; Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue; Exposure during pregnancy, No adverse event, Product use issue; Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
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Arexvy Vaccine given to pregnant woman. No known adverse events at this time. Patient due date is 10...
Arexvy Vaccine given to pregnant woman. No known adverse events at this time. Patient due date is 10/4/2025, currently gestational age of 38 weeks, 6 days
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| 2861672 | 89 | F | AR | 09/26/2025 |
COVID19 |
MODERNA |
|
COVID-19
COVID-19
|
Covid infection with hospitalization after vaccination
Covid infection with hospitalization after vaccination
|
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| 2861673 | F | WI | 09/26/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
9cc9k |
Unevaluable event
Unevaluable event
|
None stated.
None stated.
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| 2861674 | 42 | F | PA | 09/26/2025 |
COVID19 |
PFIZER\BIONTECH |
MY9547 |
Extra dose administered
Extra dose administered
|
Patient had come in for scheduled appointment to get flu covid and hep b vaccine 9/12/25. patient fo...
Patient had come in for scheduled appointment to get flu covid and hep b vaccine 9/12/25. patient forgot she got covid already and had gotten company reminder calls to get her covid shot so came back in 9/26/25 to get covid vaccine. Vaccine processed through insurance and we didn't see patient had already gotten a couple weeks ago until after shot was give.
More
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| 2861675 | 0.17 | M | IA | 09/26/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
3RT93 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
Administered Kinrix to a 2 month old child. Father refused Hep B so nurse chose this immunization. N...
Administered Kinrix to a 2 month old child. Father refused Hep B so nurse chose this immunization. No known side effects or reactions noted thus far.
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| 2861676 | 71 | M | AR | 09/26/2025 |
COVID19 |
MODERNA |
939909 |
COVID-19
COVID-19
|
covid infection with hospitalization after vaccination
covid infection with hospitalization after vaccination
|
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| 2861677 | 54 | F | IN | 09/26/2025 |
PNC21 PNC21 VARZOS VARZOS |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
00006434702 00006434702 58160082311 58160082311 |
Fatigue, Headache, Injection site erythema, Injection site mass, Injection site ...
Fatigue, Headache, Injection site erythema, Injection site mass, Injection site swelling; Injection site warmth, Lip swelling, Pain, Pyrexia; Fatigue, Headache, Injection site erythema, Injection site mass, Injection site swelling; Injection site warmth, Lip swelling, Pain, Pyrexia
More
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Aches & pains, fever, headache, large lump in arm near injection site, injection site extremely ...
Aches & pains, fever, headache, large lump in arm near injection site, injection site extremely swollen with redness and hot to the touch, fatigue, swollen lip.
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| 2861678 | 9 | M | 09/26/2025 |
DTAPIPV |
SANOFI PASTEUR |
U7908AB |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Pt was behind on vaccine schedule. He received quadracel vaccine 9/11/2025. He is technically aged o...
Pt was behind on vaccine schedule. He received quadracel vaccine 9/11/2025. He is technically aged out of this vaccine. It is used in 4-6 years old age range.
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| 2861679 | 82 | M | FL | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
U8859BA |
Cold sweat, Diarrhoea
Cold sweat, Diarrhoea
|
diarrhea and cold sweat 3 days after vaccination
diarrhea and cold sweat 3 days after vaccination
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| 2861680 | 15 | F | MN | 09/26/2025 |
FLUN3 HEP HEPA HPV9 IPV MMR TDAP VARCEL |
MEDIMMUNE VACCINES, INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. SANOFI PASTEUR MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
YF3413B Y007989 L4EA4 Y007193 X1D141M X027902 PG3RP Z003882 |
Dyskinesia, Syncope; Dyskinesia, Syncope; Dyskinesia, Syncope; Dyskinesia, Synco...
Dyskinesia, Syncope; Dyskinesia, Syncope; Dyskinesia, Syncope; Dyskinesia, Syncope; Dyskinesia, Syncope; Dyskinesia, Syncope; Dyskinesia, Syncope; Dyskinesia, Syncope
More
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After giving the last vaccine which was HPV in a seated position, client fainted. Nurse was able to...
After giving the last vaccine which was HPV in a seated position, client fainted. Nurse was able to catch her and then client jerked for a couple seconds and then woke up. Dad came to hold her and comfort her while nurse got her some water. Client was able to leave the room. She said this had never had this happen before and did not report that she was nervous. She had all the vaccines before except the flumist which was given first. She has had a flu injection in the past.
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| 2861681 | 4 | M | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
UT8792LA |
Erythema, Swelling
Erythema, Swelling
|
redness, right leg swelling
redness, right leg swelling
|
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| 2861682 | 73 | F | WA | 09/26/2025 |
FLU3 |
SEQIRUS, INC. |
407247 |
Arthralgia
Arthralgia
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Patient's husband called to inform us patient had pain after the shot in left shoulder that pro...
Patient's husband called to inform us patient had pain after the shot in left shoulder that progressed over the next few days, and she ended up going to the hospital for treatment
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| 2861683 | 8 | M | NY | 09/26/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8383AB |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
On 09/24/2025, patient was being seen for his wellness check. He is a new patient and we couldn'...
On 09/24/2025, patient was being seen for his wellness check. He is a new patient and we couldn't get records on whether he had the 4/5 year old vaccines Dtap/IPV and MMRV. Patient came in to get those vaccines so he wouldn't be kicked out of school. Dr saw patient and ordered Quadracel (Dtap/IPV) and Proquad (MMRV). Writer did not catch that Quadracel can't be given past age 6 years old during visit or administration. Practice Manager was notified by billing to verify that the mistake happened. Discussed with on call provider on whether there is harm for patient. She advised no harm but to report in resource, VAERS on database and notify Dad of mistake. Spoke with Dad, explained what happened and how it won't effect the patient adversely but that we do have to report to VAERS and resource. Dad stated understanding of the mistake and was appreciative of the phone call notifying him.
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| 2861684 | 72 | F | AL | 09/26/2025 |
COVID19 |
MODERNA |
80777-0400-60 |
Back pain, Myalgia, Neck pain, Non-cardiac chest pain, Pain in extremity
Back pain, Myalgia, Neck pain, Non-cardiac chest pain, Pain in extremity
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Muscular pain increased from upper arm to right lumbar musculatone; Muscular pain increased from upp...
Muscular pain increased from upper arm to right lumbar musculatone; Muscular pain increased from upper arm to side of neck; Muscular pain increased from upper arm to right chest wall; Muscular pain increased from upper arm to right chest wall; Extreme muscle pain RT side; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Muscular pain increased from upper arm to right lumbar musculatone), NECK PAIN (Muscular pain increased from upper arm to side of neck), NON-CARDIAC CHEST PAIN (Muscular pain increased from upper arm to right chest wall), PAIN IN EXTREMITY (Muscular pain increased from upper arm to right chest wall) and MYALGIA (Extreme muscle pain RT side) in a 72-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 80777-0400-60) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: Amoxicillin, Erythromycin and Ampicillin. Past adverse reactions to the above products included Drug allergy with Amoxicillin, Ampicillin and Erythromycin. Concurrent medical conditions included Asthma since 2021, Sleep apnea since 2020, Selective IgG immunodeficiency since 2014, Allergy to metals (Gold allergy), Allergy to antibiotic (Amoxicillin allergy), Allergy to antibiotic (Ampicillin allergy), Allergy to antibiotic (Erythromycin allergy), Food allergy (Limbrell allergy), Iodine contrast media allergy (Iodinated contrast), Adhesive tape allergy (Glue on tape), Allergy to silk (Silk suture), Osteoporosis and Drug allergy (Tymlos). Concomitant products included Raloxifene hydrochloride (Raloxifene) from 2022 to an unknown date for Osteoporosis. On 18-Sep-2025 at 2:00 PM, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 20-Sep-2025 at 2:00 PM, the patient experienced BACK PAIN (Muscular pain increased from upper arm to right lumbar musculatone), NECK PAIN (Muscular pain increased from upper arm to side of neck), NON-CARDIAC CHEST PAIN (Muscular pain increased from upper arm to right chest wall), PAIN IN EXTREMITY (Muscular pain increased from upper arm to right chest wall) and MYALGIA (Extreme muscle pain RT side). The patient was treated with Paracetamol (Tylenol) for Muscle pain, at an unspecified dose and frequency and Methylprednisolone (oral use) for Muscle pain, at a dose of 4 milligram. On 23-Sep-2025, BACK PAIN (Muscular pain increased from upper arm to right lumbar musculatone), NECK PAIN (Muscular pain increased from upper arm to side of neck), NON-CARDIAC CHEST PAIN (Muscular pain increased from upper arm to right chest wall), PAIN IN EXTREMITY (Muscular pain increased from upper arm to right chest wall) and MYALGIA (Extreme muscle pain RT side) had resolved. Patient was also allergic to EKG leads. It was reported that patient was continuously taking Arnuity inhaler 100mg sip from 2021 for asthma. It was reported that patient had no soreness until 20-Sep-2025, 2:00 P.M. Then muscular pain increased from upper arm to right chest wall, right side of heart, right lumbar masculine, right side of neck and in the entire arm. Patient would scream loudly when tried to use muscle or joints involving muscles those were painful. She tried to control the pain with ice packs and Tylenol, but pain was too great and started wrenching. Patient ended up taking 4 mg methyl prednisolone orally and 6 hours later, she took 4 mg methyl prednisone. After that, pain became tolerable but it took the patient 4 days to recover. This case was linked to MOD-2025-789418 (Patient Link).
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| 2861685 | 65 | F | NC | 09/26/2025 |
FLU3 |
SANOFI PASTEUR |
u8859ba |
Injection site bruising, Injection site pruritus, Respiratory symptom
Injection site bruising, Injection site pruritus, Respiratory symptom
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pt experienced extreme itching at injection site which caused a bruise and flare of asthma symptoms
pt experienced extreme itching at injection site which caused a bruise and flare of asthma symptoms
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| 2861686 | 73 | F | IL | 09/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
FT95N |
Condition aggravated, Systemic lupus erythematosus
Condition aggravated, Systemic lupus erythematosus
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LUPUS FLARE
LUPUS FLARE
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| 2861687 | 49 | F | MA | 09/26/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
407000 407000 |
Ageusia, Chills, Fatigue, Hyperhidrosis, Oropharyngeal pain; Pain in extremity, ...
Ageusia, Chills, Fatigue, Hyperhidrosis, Oropharyngeal pain; Pain in extremity, Pyrexia, Streptococcus test negative
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I received the shot on Monday at 12:45p and began experiencing symptoms that night around 11p. I ha...
I received the shot on Monday at 12:45p and began experiencing symptoms that night around 11p. I had a fever, chills/sweats, sore throat, fatigue, pain in the arm and loss of taste. The sore throat felt severe like an allergic reaction but I could still breathe. I took Tylenol and some of the symptoms reduced (fever, chills and arm pain). Tuesday, I still had chills/fever and sore throat. Wednesday, the chills/fever and sore throat. On Thursday, I had only the sore throat. I called my doctor's office and they suggested I get tested for strept throat. On Friday, I got tested and it was negative. Friday the throat was a bit better with the use of Advil.
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| 2861688 | 76 | F | OH | 09/26/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5A4XG 5A4XG |
Erythema, Formication, Rash pruritic, Urticaria; Erythema, Formication, Rash pru...
Erythema, Formication, Rash pruritic, Urticaria; Erythema, Formication, Rash pruritic, Urticaria
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Patient, had first dose of Shingrix vaccine on Friday, 09/19/2025 at 1:45pm. She woke up the next da...
Patient, had first dose of Shingrix vaccine on Friday, 09/19/2025 at 1:45pm. She woke up the next day (Saturday, 09/20/2025) with hives on her chest and breasts. The rash was itching and she scratched it until bright red. She said that she started to itch and felt like something was crawling all over her body later on Saturday, 09/20/2025. She decided to go to Urgent Care on Wednesday, 09/24/25 because she still had rash/hives. The Urgent Care physician prescribed oral prednisone and hydroxyzine. Patient stated that she was better after first dose. She will finish prednisone as physician directed. The physician advised that she should not have the 2nd dose of Shingrix due to this reaction.
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| 2861689 | 11 | M | TX | 09/26/2025 |
MNQ TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
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Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
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1.5 inch red raised, round, warm area to bilat. area of injection to arms.
1.5 inch red raised, round, warm area to bilat. area of injection to arms.
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| 2861690 | 82 | M | NY | 09/26/2025 |
COVID19 UNK |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Arthralgia; Arthralgia
Arthralgia; Arthralgia
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Severe joint pain
Severe joint pain
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| 2861691 | 75 | F | TN | 09/26/2025 |
UNK UNK UNK FLU3 FLU3 FLU3 |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
UT8770KA UT8770KA UT8770KA |
Computerised tomogram, Dizziness postural, Electrocardiogram, Headache, Loss of ...
Computerised tomogram, Dizziness postural, Electrocardiogram, Headache, Loss of consciousness; Magnetic resonance imaging, Malaise, Nausea, Tenderness, Vertigo; Vertigo, Vomiting; Computerised tomogram, Dizziness postural, Electrocardiogram, Headache, Loss of consciousness; Magnetic resonance imaging, Malaise, Nausea, Tenderness, Vertigo; Vertigo, Vomiting
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Patient received a flu shot while having a routine visit to (withheld name)/ address above where she...
Patient received a flu shot while having a routine visit to (withheld name)/ address above where she is a paying member. Dr. (name withheld) is her Dr. The next morning she had a headache and starting having dizziness when standing. She went to bed early due to feeling generally unwell. The next morning headache was more severe, vertigo/dizziness severe and with any head movement, blacked out in bed when she sat up, blacked out again trying to stand up, severe nausea and wretching, pain being touched. Called (withheld name) who said go to ER. As symptoms worsened 911 was called; ambulance took her to ER at (withheld name) Hospital, (address withheld), where she was admitted on 9/24. The ER doctor called it "vertigo" but dismissed information that all symptoms had occurred since vaccine. She is currently in hospital and EKG, MRI, Cat Scan have been done; Dr and NP who have seen her dismissive when try to give info about vaccine
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| 2861692 | 19 | F | MT | 09/26/2025 |
MNQ |
SANOFI PASTEUR |
U8508AA |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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Pt was due for Men-B 2nd dose. Pt was given MenACWY (Menactra). No negative outcomes reported. Pt is...
Pt was due for Men-B 2nd dose. Pt was given MenACWY (Menactra). No negative outcomes reported. Pt is 19 years old.
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| 2861693 | 59 | F | PR | 09/26/2025 |
FLU3 HEP PNC21 |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
U8823BA EB9ZX Z006889 |
Erythema, Mobility decreased, Peripheral swelling, Rash; Erythema, Mobility decr...
Erythema, Mobility decreased, Peripheral swelling, Rash; Erythema, Mobility decreased, Peripheral swelling, Rash; Erythema, Mobility decreased, Peripheral swelling, Rash
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Patient presented light swelling, redness and rash in left arm that started day after administration...
Patient presented light swelling, redness and rash in left arm that started day after administration. Also reported difficulty in moving arm but has seen improvement in movement. Taking antihistamine and icing arm
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| 2861694 | 64 | M | TX | 09/26/2025 |
PNC20 |
PFIZER\WYETH |
LX4486 |
Injection site erythema, Injection site swelling, Injection site warmth, Rash
Injection site erythema, Injection site swelling, Injection site warmth, Rash
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REDNESS, SWELLING, WARM TO TOUCH AT SITE OF INJECTION. UNRAISED RASH COVERED ANTERIOR TORSO FROM CHE...
REDNESS, SWELLING, WARM TO TOUCH AT SITE OF INJECTION. UNRAISED RASH COVERED ANTERIOR TORSO FROM CHEST TO NAVEL.
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| 2861695 | 22 | F | OH | 09/26/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4n222 |
Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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Right posterior arm pruritic erythematous at vaccine site that has grown . Recommended oral antihist...
Right posterior arm pruritic erythematous at vaccine site that has grown . Recommended oral antihistamine for itching and redness and cool compresses for site to comfort. Education provided for any progression of redness, swelling, or systemic symptoms.
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