| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2824929 | 74 | F | VA | 02/06/2025 |
FLU3 |
SANOFI PASTEUR |
U8524CA |
Injection site pain, Loss of personal independence in daily activities, Pain, Sl...
Injection site pain, Loss of personal independence in daily activities, Pain, Sleep disorder, Swelling
More
|
Right upper arm pain that radiates circumferentially and down arm. Patient reports pain at the site ...
Right upper arm pain that radiates circumferentially and down arm. Patient reports pain at the site was severe. Developed swelling for about a week. Unable to lift weights with right arm, cannot sleep on right side due to pain.
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|
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| 2824930 | 69 | F | FL | 02/06/2025 |
COVID19-2 |
MODERNA |
052D22A |
Alopecia, Lichen planopilaris, Scar
Alopecia, Lichen planopilaris, Scar
|
Systemic: Hair Loss and scarring on scalp-Medium, Additional Details: Patient stated that she has be...
Systemic: Hair Loss and scarring on scalp-Medium, Additional Details: Patient stated that she has been diagnosed with Lichen planopilaris and the only thing she has in common with the other people that has this is that they received the COVID-19 shot
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| 2824931 | 60 | F | FL | 02/06/2025 |
COVID19 |
PFIZER\BIONTECH |
1234567 |
Abdominal discomfort, Axillary mass, Fatigue, Lethargy, Pyrexia
Abdominal discomfort, Axillary mass, Fatigue, Lethargy, Pyrexia
|
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: lump under arm/upset stoma...
Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: lump under arm/upset stomach-Severe
More
|
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| 2824932 | 53 | M | CA | 02/06/2025 |
COVID19 |
MODERNA |
1234567 |
Cerebrovascular accident
Cerebrovascular accident
|
Systemic: Stroke-Severe, Additional Details: Patient states he suffered a triple massive stroke
Systemic: Stroke-Severe, Additional Details: Patient states he suffered a triple massive stroke
|
โ | |||||
| 2824933 | 47 | F | WA | 02/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93kk4 |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
More
|
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injecti...
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: On 1/25/25, pt was seen at clinic for TB reading. During visit, pt reported pain, swelling, redness below injection site of shingrix vaccine (received 1/22/25). Bruising noted at injection site. Pt noticed symptoms one day after receiving injection. Pt advised to ice the area and schedule follow-up appointment with PCP or clinic for further management
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| 2824934 | 53 | F | TX | 02/06/2025 |
COVID19-2 |
PFIZER\BIONTECH |
hg4665 |
Autoimmune disorder, Skin discolouration, Stress, Vitiligo
Autoimmune disorder, Skin discolouration, Stress, Vitiligo
|
Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Additional Details: Patient discovered discol...
Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Additional Details: Patient discovered discolored patch of skin on right side of abdomen about 2 weeks after receiving vaccination. After a stressful event, discoloration spread all over body. She visited a dermatologist and was diagnosed with vitiligo. Dermatologist suspects it was triggered by vaccination.
More
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| 2824935 | 55 | M | NJ | 02/06/2025 |
COVID19-2 |
MODERNA |
3043335 |
Injection site pain, Injection site swelling
Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines: Vacci...
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: flulaval; Manufacturer: gsk; LotNumber: 72415; Route: im; BodySite: left; Dose: ; VaxDate: UNKNOWN
More
|
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| 2824936 | 90 | F | MD | 02/06/2025 |
COVID19-2 |
MODERNA |
3042560 |
Injection site pain, Pain
Injection site pain, Pain
|
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Other Vaccines: Vacci...
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Other Vaccines: VaccineTypeBrand: spikevax; Manufacturer: ; LotNumber: ; Route: ; BodySite: ; Dose: ; VaxDate: UNKNOWN
More
|
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| 2824937 | 74 | F | PA | 02/06/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
unkown unkown |
Dizziness, Fall, Fatigue, Influenza, Lethargy; Pain in extremity
Dizziness, Fall, Fatigue, Influenza, Lethargy; Pain in extremity
|
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: fatigue ...
Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: fatigue and arm soreness-Mild, Additional Details: similar feeling to the flu, had fallen getting out of her car. patient was able to recover normally that day.
More
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| 2824938 | 56 | M | FL | 02/06/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
Unknown Unknown |
Arthralgia, Asthenia, Fatigue, Lethargy, Mobility decreased; Nasopharyngitis
Arthralgia, Asthenia, Fatigue, Lethargy, Mobility decreased; Nasopharyngitis
|
Systemic: Exhaustion / Lethargy-Medium, Systemic: Cold Symptoms-Medium, Systemic: Joint Pain-Medium,...
Systemic: Exhaustion / Lethargy-Medium, Systemic: Cold Symptoms-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient reported experiencing cold symptoms after 3rd dose and being in bed for about a week after with no energy and hard to move.
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|
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| 2824939 | 70 | M | TX | 02/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
unknown |
Influenza like illness, Injection site pain, Injection site swelling
Influenza like illness, Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Patient stat...
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Patient stated he felt like he had the flu for 3 days-Severe, Additional Details: Patient reported swelling, soarness, and pain at the injection site. He says i lasted for 3 days and he felt like he had the flu. Patient stated he lives in a retirement center and Pharmacy came to administer the vaccine.
More
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| 2824940 | 67 | F | NV | 02/06/2025 |
MNQ |
SANOFI PASTEUR |
u8124ab |
Diarrhoea, Nausea, Oropharyngeal pain, Pyrexia
Diarrhoea, Nausea, Oropharyngeal pain, Pyrexia
|
Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Nausea-Medium, Additional Details: Also...
Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Nausea-Medium, Additional Details: Also Sore Throat reported.
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| 2824941 | 61 | F | FL | 02/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
m77cc |
Injection site erythema, Injection site pain, Pain
Injection site erythema, Injection site pain, Pain
|
Site: Redness at Injection Site-Mild, Systemic: Pain radiating up neck from sight of injection-Sever...
Site: Redness at Injection Site-Mild, Systemic: Pain radiating up neck from sight of injection-Severe
More
|
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| 2824942 | 61 | F | TX | 02/06/2025 |
FLUC4 |
SEQIRUS, INC. |
388520 |
Injection site cyst, Injection site erythema, Injection site pain, Injection sit...
Injection site cyst, Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
More
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: cyst formed at injection site because vaccine was given below deltoid-Medium
More
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| 2824943 | 23 | M | IA | 02/06/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945657 |
Hypoaesthesia, Injection site swelling
Hypoaesthesia, Injection site swelling
|
Site: Swelling at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
Site: Swelling at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
|
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| 2824944 | 70 | F | CO | 02/06/2025 |
FLU4 |
SANOFI PASTEUR |
ut8454ca |
Neck pain
Neck pain
|
Systemic: patient states no symptoms that correlate w/ vaccine-Mild, Additional Details: Patient rep...
Systemic: patient states no symptoms that correlate w/ vaccine-Mild, Additional Details: Patient reports pain in back of neck, other than that no symptoms reported
More
|
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| 2824945 | 54 | F | PA | 02/06/2025 |
COVID19 |
MODERNA |
UNKNOWN |
Flushing, Hyperhidrosis, Injection site erythema, Injection site pain, Pyrexia
Flushing, Hyperhidrosis, Injection site erythema, Injection site pain, Pyrexia
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Fever-Medium,...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
More
|
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| 2824946 | 49 | F | NY | 02/06/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Injection site bruising, Injection site erythema, Injection site pruritus, Pruri...
Injection site bruising, Injection site erythema, Injection site pruritus, Pruritus, Rash
More
|
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Inject...
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
More
|
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| 2824947 | 57 | F | CA | 02/06/2025 |
COVID19 COVID19 |
NOVAVAX NOVAVAX |
0000 0000 |
Chills, Fatigue, Injection site pain, Injection site swelling, Lethargy; Oedema ...
Chills, Fatigue, Injection site pain, Injection site swelling, Lethargy; Oedema peripheral, Pain
More
|
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches G...
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: underarm swelling for months afterward-Medium
More
|
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| 2824948 | 61 | F | KY | 02/06/2025 |
FLUC4 |
SEQIRUS, INC. |
104388521 |
Injection site pain
Injection site pain
|
Site: Pain at Injection Site-Mild, Additional Details: complained of mild pain at injection site, bu...
Site: Pain at Injection Site-Mild, Additional Details: complained of mild pain at injection site, but has returned for 2 other vaccines (covid and RSV) since the flucelvax. She did not mention the pain until returning for the 2nd vaccine. She said the pain is mild and not restricting any activity. No redness, bruising, swelling on the arm at all. She did not seem concerned at all, but we thought it should be reported as an adverse event.
More
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| 2824949 | 69 | M | NJ | 02/06/2025 |
COVID19-2 |
PFIZER\BIONTECH |
LM2210 |
Injection site pain, Musculoskeletal stiffness, Myalgia, Neck pain
Injection site pain, Musculoskeletal stiffness, Myalgia, Neck pain
|
Site: Pain at Injection Site-Mild, Additional Details: Patient is stating that he is experiencing a ...
Site: Pain at Injection Site-Mild, Additional Details: Patient is stating that he is experiencing a "coming and going" pain in his bicep. He also stated that about 5-6 weeks after the injection he starting experiencing nexk pain/stiffness in his neck.
More
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| 2824950 | 59 | M | PA | 02/06/2025 |
COVID19 |
NOVAVAX |
6024MF020 |
Pain, Pyrexia
Pain, Pyrexia
|
Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Additional Details: PATIENT SAYS HE EXP...
Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Additional Details: PATIENT SAYS HE EXPERIENCED MILD ACHES AND LOW GRADE FEVER W/ NOVOVAX. ALTHOUGH HER HAD SIDE EFFECTS, THEY WERE ABOUT 20% OF WHAT SIDE EFFECTS WERE W/ MODERNA. WHEN HE WAS VACCINATED WITH MODERNA HE HAD 101 DEGREE FEVER AND CHILLS.
More
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| 2824952 | 78 | F | VA | 02/06/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
pk9cs pk9cs |
Bacterial infection, Injection site bruising, Injection site erythema, Injection...
Bacterial infection, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling
More
|
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injec...
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: 1/29 patient came in to inform us of the situation. Her arm looks red and possible dead skin. complained of pain and red striking down arm the next day after vaccine. Went to patient first, states bacterial infections. Has gone several times for treatment. still hurts from today.
More
|
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| 2824953 | 20 | F | IN | 02/06/2025 |
FLU4 |
SANOFI PASTEUR |
U8531BA |
Loss of consciousness, Presyncope, Syncope, Unresponsive to stimuli
Loss of consciousness, Presyncope, Syncope, Unresponsive to stimuli
|
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt vasovagaled while in chair during flu...
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt vasovagaled while in chair during flu vaccine and TB administration. Brief LOC for 5-10 seconds. Pt woke up and vital signs were monitored for 15 minutes. No injury noted and pt did not fall out of chair. Pt reported history of vasovagal during procedures in past. Did not disclose this prior to shot. Pt Discharged home in stable condition. , Other Vaccines: VaccineTypeBrand: PPD test; Manufacturer: Sanofi Pasteur; LotNumber: 3CA4BC1; Route: ID; BodySite: Left lower forearm; Dose: 1; VaxDate: 01/08/2025
More
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| 2824954 | 63 | F | VA | 02/06/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LN4P2 LN4P2 |
Injection site pain, Muscle tightness, Myalgia, Neuralgia, Pain; Pyrexia
Injection site pain, Muscle tightness, Myalgia, Neuralgia, Pain; Pyrexia
|
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, ...
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Medium, Systemic: says her muscle "seized" when walking, muscle and nerve pain-Medium, Additional Details: patient said sore muscles, nerve pain and while walking felt like her muscles were seizing. she said slight fever she used tylenol and ibuprofen along with cold compresses. Also complained of back spasms.
More
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| 2824955 | 77 | F | FL | 02/06/2025 |
FLUA4 |
SEQIRUS, INC. |
312833 |
Dyspnoea
Dyspnoea
|
Systemic: Allergic: Difficulty Breathing-Severe
Systemic: Allergic: Difficulty Breathing-Severe
|
โ | |||||
| 2824956 | 81 | F | CA | 02/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
33fd3 |
Back pain, Chest discomfort, Chest pain, Headache, Neck pain
Back pain, Chest discomfort, Chest pain, Headache, Neck pain
|
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: back/neck pain-Severe, Systemic: Head...
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: back/neck pain-Severe, Systemic: Headache-Severe, Additional Details: pt experencied chest pain,neck and back pain along with headache with few minutes of vaccination. EMS was called and pt was taken to hospital
More
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| 2824957 | 22 | F | GA | 02/06/2025 |
FLUC4 FLUC4 |
SEQIRUS, INC. SEQIRUS, INC. |
946638 946638 |
Injection site bruising, Injection site erythema, Injection site pain, Injection...
Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Rash; Urticaria
More
|
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injecti...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Pt states having a rash and hives and that the injection site was raised as well. Resolved in 2 days
More
|
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| 2824958 | 81 | F | FL | 02/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2210 |
Cardiac disorder, Tachycardia
Cardiac disorder, Tachycardia
|
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Tachycardia-Severe
Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Tachycardia-Severe
|
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| 2824959 | 61 | M | CA | 02/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2212 |
Pruritus, Rash
Pruritus, Rash
|
Systemic: Allergic: Itch Generalized-Mild, Additional Details: Patient states the rash is cleared up...
Systemic: Allergic: Itch Generalized-Mild, Additional Details: Patient states the rash is cleared up mostly now. Did present with this before and went to the Emergency room, but did not go to emergency room this time. Patient is nit certain vaccine caused reaction, speculates it could also be due to cold weather, Other Vaccines: VaccineTypeBrand: FLUCELVAX TRIVAL 2024-2025; Manufacturer: ; LotNumber: 946619; Route: intramuscular; BodySite: left arm; Dose: 1; VaxDate: 01/08/2025
More
|
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| 2824960 | 66 | F | CA | 02/06/2025 |
RSV |
PFIZER\WYETH |
lg9829 |
Dizziness, Injection site bruising, Injection site erythema, Injection site pain...
Dizziness, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
More
|
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild
More
|
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| 2824961 | 19 | M | CA | 02/06/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
55n34 |
Injection site pain
Injection site pain
|
Site: Pain at Injection Site-Medium, Additional Details: Pain in injection site for 24 hours control...
Site: Pain at Injection Site-Medium, Additional Details: Pain in injection site for 24 hours controlled by an ice pack. Patient recovering almost to normal today on 1/31/25. Spoke with pt's Mom who checked in on her son and reported back to me., Other Vaccines: VaccineTypeBrand: bexsero; Manufacturer: glaxosmithkline; LotNumber: 55n34; Route: im; BodySite: r deltoid; Dose: ; VaxDate: UNKNOWN
More
|
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| 2824962 | 82 | F | MI | 02/06/2025 |
COVID19 |
MODERNA |
3043153 |
Injection site pain
Injection site pain
|
Site: Pain at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: Fluzone High-Dose; Manufactu...
Site: Pain at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: Fluzone High-Dose; Manufacturer: ; LotNumber: U8532BA; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
More
|
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| 2824963 | 34 | F | PA | 02/06/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
lp1780 lp1780 |
Confusional state, Dizziness, Flushing, Hyperhidrosis, Seizure; Syncope, Unrespo...
Confusional state, Dizziness, Flushing, Hyperhidrosis, Seizure; Syncope, Unresponsive to stimuli
More
|
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv...
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Additional Details: while not disclosed before vaccine administration, patient did say she has a neurological disorder, traumatic brain injury and has had absence seizures in the past. patient states she has not had an adverse reaction to vaccines previously but has had adverse reactions after blood draw . ambulance was called and patient taken to hospital for further evalation. patient was able to stand on own and speak when she left. patients mother was called by the patient to notify family
More
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| 2824964 | 67 | F | IN | 02/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93kk4 |
Injection site erythema, Injection site swelling, Pyrexia
Injection site erythema, Injection site swelling, Pyrexia
|
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Fever-Mild
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Fever-Mild
|
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| 2824965 | 35 | M | IN | 02/06/2025 |
TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
MC7HK MC7HK |
Confusional state, Dizziness, Flushing, Hyperhidrosis, Syncope; Tremor, Unrespon...
Confusional state, Dizziness, Flushing, Hyperhidrosis, Syncope; Tremor, Unresponsive to stimuli
More
|
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsiv...
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: Pattient checked in for Tdap, Flu, and Covid Vaccines. After the Flu and Tdap was administered, patient mentioned he may have had a fainting adverse reaction after receiving Tetanus vaccine in the past. The Covid vaccine was suspended to monitor for any reaction. Patient suddenly clenched his fists, shook and pushed his head backward against the wall of the immunization room. I called out for help and got the minute clinic nurse practitioner. Patient was confused, sweating and fainting., Other Vaccines: VaccineTypeBrand: FLUCELVAX; Manufacturer: SEQIRUS; LotNumber: 391416; Route: INTRAMUSCULAR; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN
More
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| 2824966 | 20 | F | PA | 02/06/2025 |
FLU4 FLU4 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
2724L 2724L |
Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope; Unresponsive...
Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope; Unresponsive to stimuli
More
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Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed ...
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient has a history of fainting from receiving flu shot in the past (2 years prior). She regain conciousness within 2 minutes of fainting and did not need to seek immediate medical attention
More
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| 2824968 | 1.17 | U | CA | 02/06/2025 |
PNC20 |
PFIZER\WYETH |
LC5483 |
Erythema, Swelling
Erythema, Swelling
|
Red, raised swollen Size 5inches x 3 Oval shape
Red, raised swollen Size 5inches x 3 Oval shape
|
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| 2824969 | 67 | F | WI | 02/06/2025 |
COVID19 |
PFIZER\BIONTECH |
206F232A |
Blood glucose increased
Blood glucose increased
|
Blood glucose went up 10-20 points fasting after the vaccine and haven't returned to pre vaccin...
Blood glucose went up 10-20 points fasting after the vaccine and haven't returned to pre vaccine range.
More
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| 2824970 | 9 | M | IL | 02/06/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3043823 3043823 |
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
More
|
gave patient covid vaccine on right arm, no reactions, covid -19 is for 12 years of age or older and...
gave patient covid vaccine on right arm, no reactions, covid -19 is for 12 years of age or older and patient is not of age for dosage.
More
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| 2824972 | 65 | M | MO | 02/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Arthralgia, Neck pain
Arthralgia, Neck pain
|
Patient reported shoulder and neck pain today while doing a medication review with him. He is still ...
Patient reported shoulder and neck pain today while doing a medication review with him. He is still experiencing some occasional pain
More
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| 2824977 | U | PA | 02/06/2025 |
HPV9 |
MERCK & CO. INC. |
W028573 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No other AE; Medical assistant calling to report the inadvertent administration of an expired dose o...
No other AE; Medical assistant calling to report the inadvertent administration of an expired dose of GARDASIL 9 to a patient on 02/04/2025.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-FEB-2025, the patient was vaccinated with expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W028573, expiration date: 06-JAN-2025, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) inadvertently by health professional (Expired product administered). No symptoms reported and no additional details provided. No other adverse event (no AE).
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| 2824978 | 9 | M | WV | 02/06/2025 |
HIBV |
MERCK & CO. INC. |
x017448 |
No adverse event, Product storage error
No adverse event, Product storage error
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The nurse is reporting that unknown number of patients received improperly stored vaccines. No addi...
The nurse is reporting that unknown number of patients received improperly stored vaccines. No additional AEs were reported, no further information provided. Names of vaccines involved (including lot/exp) PEDVAX x017448 11/7/2025 VAXELIS u7907aa; No additional AEs were reported; This spontaneous report was received from a nurse concerning unspecified number of patients of 9 years-old male patient. Patients' concurrent conditions, pertinent medical history and concomitant therapies were not provided. On 16-JAN-2025, the patient was vaccinated with an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #x017448 with expiration date: 07-NOV-2025, in his right deltoid and administered for prophylaxis (strength, dose, and anatomical location were nor reported). The vaccines were stored at a temperature of 33 degrees Fahrenheit for a time frame of 76 hours. There was no previous temperature excursions. No additional adverse events were reported. This case was previously considered as non valid, but upon follow up information received from the reporter on 03-FEB-2025, this case became valid. This is one of the 2 reports from the same reporter.
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| 2824979 | 1 | F | HI | 02/06/2025 |
VARCEL |
MERCK & CO. INC. |
Y011019 |
Incorrect route of product administration, No adverse event
Incorrect route of product administration, No adverse event
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no adverse event; a 12-month year old child was administered VARIVAX intradermally; This spontaneous...
no adverse event; a 12-month year old child was administered VARIVAX intradermally; This spontaneous report was received from a medical assistant, referring to a 12-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. On 04-FEB-2025, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y011019, expiration date: 18-JUN-2026, administered intradermally for prophylaxis (dose and strength not provided) (product use issue), diluted with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose description, lot #, expiry date, and indication were not provided). No adverse side effects were reported (no adverse event).
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| 2824980 | 17 | F | MD | 02/06/2025 |
HPV4 HPV4 HPV4 HPV4 HPV4 HPV4 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Abdominal distension, Anxiety, Asthenia, Blood pressure decreased, Body temperat...
Abdominal distension, Anxiety, Asthenia, Blood pressure decreased, Body temperature increased; Brain fog, Chest pain, Dizziness, Dyspnoea, Fatigue; Feeling hot, Headache, Hot flush, Hyperhidrosis, Loss of consciousness; Loss of personal independence in daily activities, Nausea, Pain, Palpitations, Paraesthesia; Peripheral coldness, Postural orthostatic tachycardia syndrome, Syncope, Tinnitus, Tremor; Visual impairment
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autonomic/neuro/POTS/SOB,lightheadedness,nausea,pounding headache,body temperature elevated,felt hot...
autonomic/neuro/POTS/SOB,lightheadedness,nausea,pounding headache,body temperature elevated,felt hot,blood pressure dropped,blacked out;was unconscious for 20min;dizziness, chronic fatigue,hotflashes,syncope,palpitations,chest pain,weakness,brain fog; anxiety; tinnitus; autoimmune injuries; Information has been received from a lawyer regarding a case in litigation and refers to an adult female patient (pt) (exact age was not provided). The patient's medical history, concurrent conditions and concomitant therapies were not provided. Prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, she was happy, extremely active, bright, and healthy. On 26-MAR-2021, at the age of 17 years, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided), as recommended by her health care provider. After receiving the second vaccination, while at the doctor's office, the patient experienced shortness of breath, lightheadedness, nausea, and a pounding headache. Her body temperature elevated, she felt hot, her blood pressure dropped, she blacked out and was unconscious for 20 minutes. It took an hour for the patient to gain strength to sit up. She had ringing in her ears, felt fatigued, shaky, and the pounding headache persisted with hot flashes. As the months progressed, so did the patient's injuries. She was seen by multiple physicians and specialists for her complaints which now include dizziness, chronic fatigue, hot flashes, syncope, palpitations, chest pain, shortness of breath, weakness, brain fog, increased nausea, bloating, tingling in the upper and lower extremities, sweating abnormality, visual disturbance, tinnitus, cold extremities, anxiety, bilateral leg tremors, and increased hand tremors. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient has been unable to engage in activities that a normal young person would enjoy. She enjoyed dancing, swimming, and running. She was actively engaged in cross country 5k races and swimming long distances at swim meets. These activities made her happy and were things she looked forward to every day. Unfortunately, she was not physically capable of maintaining her competitive sports lifestyle. The patient's ability to attend school has been affected due to physical exertion, fatigue, headaches, and chronic body pain, despite these challenges, she was able to graduate from High School. Now, as a college student, she required disability accommodations due to her ongoing symptoms. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient has been diagnosed with various medical conditions, including but not limited to, postural orthostatic tachycardia (POTS). The patient contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to postural orthostatic tachycardia (POTS) as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. The patient had suffered and continues to suffer severe and permanent physical injuries and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. She also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, she had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of the events was considered not recovered. The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The reporter considered all events to be disabling. Upon internal review, the event of autoimmune disorder was determined to be medically significant.
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| 2824981 | U | NC | 02/06/2025 |
HEPA |
MERCK & CO. INC. |
X006702 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No adverse effects were reported.; HCP called to report that an expired dose of VAQTA (expiry 10/1/2...
No adverse effects were reported.; HCP called to report that an expired dose of VAQTA (expiry 10/1/2024) was inadvertently administered to a patient today, 2/5/2025. Potency was not supported by the post expiry memo. No adverse effects were reported. Consent to contact is yes. No ad; This spontaneous report as received from a registered nurse refers to a 41-year-old patient. On 05-FEB-2025, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # X006702, expiration date: 01-OCT-2024, 0.5 mL for prophylaxis. No adverse event was reported.
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| 2824982 | F | PA | 02/06/2025 |
MMRV |
MERCK & CO. INC. |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No additional AE; Nurse called to report a Patient was given a dose of PROQUAD on 12/31/2024 and ano...
No additional AE; Nurse called to report a Patient was given a dose of PROQUAD on 12/31/2024 and another dose on 2/4/2025. Patient received her 1st dose at normal dosing schedule on unknown date, however received 3 doses in total accidentally; This spontaneous report was received from nurse and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 31-DEC-2024, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 04-FEB-2025, the patient was vaccinated with the third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection 0.5 milliliter, lot # Y017206 with expiration date of 13-APR-2026, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided) (extra dose administered). No additional adverse event (AE) was reported.
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| 2824983 | U | NM | 02/06/2025 |
MMR VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y000224 Y011019 |
Product storage error; Product storage error
Product storage error; Product storage error
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aMedical Assistant calling to report adverse event regarding MMR II and VARIVAX. Medical Assistant ...
aMedical Assistant calling to report adverse event regarding MMR II and VARIVAX. Medical Assistant stated that a patient was administered doses of MMR II and VARIVAX after the vaccines have been reconstituted and drawn into a syringe and left out at; any medical concerns or symptoms after the administration of the improperly stored vaccines/No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of a not reported age or gender. The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On an unknown date (reported as 27-JAN-2026 conflicting information), the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 ml / two dose series, lot# reported as Y000224 (which upon internal validation was found as valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)), expiration date reported as: 03-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml / two dose series, lot #Y011019, expiration date: 18-JUN-2026, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion for over 1 hour and 30 minutes while unprotected from light.. Medical Assistant confirmed the patient involved has not reported any medical concerns or symptoms after the administration of the improperly stored vaccines.
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| 2824984 | 20 | M | CA | 02/06/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
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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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Caller stated that PROQUAD was accidentally administered to a 20 year old male patient instead of MM...
Caller stated that PROQUAD was accidentally administered to a 20 year old male patient instead of MMR II.; It was administered concomitantly with VARIVAX; No additional AE/no PQC; This spontaneous report was received from a registered nurse referring to a 20 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported. On an unknown date, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, route, lot number, expiration date and anatomical location were not provided) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route, lot number, expiration date and anatomical location were not provided) for prophylaxis (wrong product administered). It was also reported that It was administered also concomitantly varicella virus vaccine live (oka/merck)(VARIVAX) (accidental overdose). No adverse events reported. Additional information is expected.
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| 2824985 | F | 02/06/2025 |
VARCEL |
MERCK & CO. INC. |
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Varicella virus test negative
Varicella virus test negative
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testing negative for chicken pox immunity; This spontaneous report was received from the patient...
testing negative for chicken pox immunity; This spontaneous report was received from the patient's mother, concerning her daughter, a female patient of unknown age. The patient's pertinent medical history, past drug reactions or allergies, concurrent conditions and concomitant therapies were not provided. On an unknown date in 2011, the patient was vaccinated with two doses of with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient was given a third dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1st dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) due to receiving testing and testing negative for chicken pox immunity. At the time of reporting, the outcome of the event testing negative for chicken pox immunity was not known. The causal relationship between testing negative for chicken pox immunity and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. Lot # is being requested and will be submitted if received.
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