| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2827277 | 69 | F | GA | 02/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
A2F3R |
Extra dose administered
Extra dose administered
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Patient into Health Dept. on 02/20/2025 stating that she had her vaccination record form her Primcar...
Patient into Health Dept. on 02/20/2025 stating that she had her vaccination record form her Primcary Care Physican's office and asked if we could enter those vaccines into the database system. The MD office does not use database they use a different system. Clerk entered them into the database system and it was found that when patient came in asking for first Shingles vaccine on 02/03/2025 it was acutally her 3rd dose. But unaware due to vaccines not being enter into database. She received her first Shingrix dose on 07/01/20219 and her second on 09/26/2019. Patient did not have any adverse reaction after any doses.
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| 2827278 | 54 | F | MI | 02/20/2025 |
PNC20 TDAP |
PFIZER\WYETH SANOFI PASTEUR |
LG5577 3CA30C1 |
Injection site reaction; Injection site reaction
Injection site reaction; Injection site reaction
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2cm x 2cm know at injection site post vaccine
2cm x 2cm know at injection site post vaccine
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| 2827279 | 40 | M | AZ | 02/20/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FC3180 FC3180 |
Hypoaesthesia, Magnetic resonance imaging, Musculoskeletal discomfort, Neck pain...
Hypoaesthesia, Magnetic resonance imaging, Musculoskeletal discomfort, Neck pain, Neuralgia; Pain
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Several months after taking the vaccine I woke up in the morning with excruciating pain in my neck a...
Several months after taking the vaccine I woke up in the morning with excruciating pain in my neck and along the right side of my body. I saw a pain doctor who provided pain meds and steroid shot. Since this incident I continue to have nerve pain on my right side and have discomfort in my right neck and shoulder which includes numbness in my right side fingertips Any subsequent doctors have not been able to provide any care that is helpful.
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| 2827280 | 12 | F | WA | 02/20/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LN0589 UT8468LA |
Condition aggravated, Electroencephalogram normal, Hypoaesthesia, Magnetic reson...
Condition aggravated, Electroencephalogram normal, Hypoaesthesia, Magnetic resonance imaging normal, Seizure; Condition aggravated, Electroencephalogram normal, Hypoaesthesia, Magnetic resonance imaging normal, Seizure
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Patient had 5 vaccines week before patient started having seizures. Patient has now had three seizur...
Patient had 5 vaccines week before patient started having seizures. Patient has now had three seizures and more episodes of leg numbness. Patient also received HPV Merck lot # x024650, Tdap glaxosmithkline lot #x449y, and MCV4 sanofi Pasteur lot # U837AA on 1/27.
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| 2827281 | 4 | F | FL | 02/20/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
42y93 y016872 |
Injection site cellulitis, Injection site erythema, Injection site swelling, Inj...
Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth; Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
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patient developed progressive redness, warmth, and swelling on her left upper thigh after the vaccin...
patient developed progressive redness, warmth, and swelling on her left upper thigh after the vaccine injection. She was evauated in office 3 days after the injection and diagnosed with cellulitis. She was prescribed cephalexin 7 day course to treat the infection.
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| 2827282 | 4 | M | AK | 02/20/2025 |
MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. |
Y000223 Y000223 |
Drooling, Dysphonia, Dyspnoea, Erythema, Flushing; Mouth breathing, Rash macular...
Drooling, Dysphonia, Dyspnoea, Erythema, Flushing; Mouth breathing, Rash macular, Urticaria, Wheezing
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1605 MMR vaccine administered 1615 MOC reports redness, hives and shortness of breath. Patient is al...
1605 MMR vaccine administered 1615 MOC reports redness, hives and shortness of breath. Patient is alert and oriented able to make needs known. Flushing to the face with hives, mouth breathing with drool. High pitched voice with speaking. Audible wheeze present 1617 Pediatric epi (0.15mg) administered IM right thigh. 1620 Spo2 93%, HR 134 - Dr, assessment = diminished breath sounds, requesting Albuterol and oxygen 1621 Inhaled albuterol 2 puffs with aerochamber no mask (supplied by MOC), applied O2 at 3L via face mask and given childrens zyrtec liquid 5mg. 1625 Spo2 94% - Dr. assessment = increasing air flow, request for benadryl. Dose clarification with Dr. 1627 EMT arrive on scene, report given with copy of medications and interventions 1629 Benadryl 21.25 mg administered IM left thigh, Spo2 98% 1630 Transferred to Hospital via ambulance Breath sounds and macular rash improving by exam at time of transfer and child maintaining sats on RA without difficulty.
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| 2827283 | 1.25 | M | NC | 02/20/2025 |
DTAP FLU3 HIBV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. PFIZER\WYETH |
Y97N7 JZ4J4 Y008355 LX2497 |
Injection site erythema, Pruritus; Injection site erythema, Pruritus; Injection ...
Injection site erythema, Pruritus; Injection site erythema, Pruritus; Injection site erythema, Pruritus; Injection site erythema, Pruritus
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4 vaccines administered on 2/17 by RN. Documentation noted DTAP/Hib/Prevnar 20 given via right thig...
4 vaccines administered on 2/17 by RN. Documentation noted DTAP/Hib/Prevnar 20 given via right thigh and only influenza given in left thigh however, upon checking patient, 2 vaccines given in each thigh (documentation incorrect). On 2/18, patient with large areas of redness of left leg. Parents gave ibuprofen for relief. No fever or other symptoms. Patient presented at clinic on 2/19 with continued redness on left thigh. Unclear which vaccine caused reaction. Provider instructed to give Benadryl or cetirizine for itching if it continues. Patient discharged home in stable condition.
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| 2827284 | 80 | M | TX | 02/20/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EN6207 EW1050 |
Biopsy skin, Eczema; Biopsy skin, Eczema
Biopsy skin, Eczema; Biopsy skin, Eczema
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June-July 2021 started to develop Eczema (whole body).
June-July 2021 started to develop Eczema (whole body).
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| 2827285 | 44 | M | MD | 02/20/2025 |
FLU3 |
SEQIRUS, INC. |
946615 |
Dizziness, Erythema, Pruritus
Dizziness, Erythema, Pruritus
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Patient received vaccine 9:40 AM, reported adverse reaction around 12:40 PM. States that he is exper...
Patient received vaccine 9:40 AM, reported adverse reaction around 12:40 PM. States that he is experiencing itching, red face, and is feeling light-headed. Advised patient to take Tylenol; if no improvement, should be seen at hospital. At this present time, adverse reaction is ongoing; no resolution as of yet.
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| 2827286 | 16 | F | NV | 02/20/2025 |
HPV9 |
MERCK & CO. INC. |
Y008640 |
Wrong product administered
Wrong product administered
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Doctor put in a n order for incorrect vaccine
Doctor put in a n order for incorrect vaccine
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| 2827287 | 30 | F | FL | 02/20/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Brain fog, C-reactive protein increased, Dizziness, Feeling drunk, Hemiparesis; ...
Brain fog, C-reactive protein increased, Dizziness, Feeling drunk, Hemiparesis; Hypoaesthesia, Impaired driving ability, Inflammatory marker increased, Loss of personal independence in daily activities, Paraesthesia; Photophobia
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Chronic dizziness, debilitating brain fog (feeling drunk when sober), light sensitivity, difficulty ...
Chronic dizziness, debilitating brain fog (feeling drunk when sober), light sensitivity, difficulty with every day tasks requiring focus (ex. Driving), numbness/weakness/tingling on one side
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| 2827288 | 27 | M | MI | 02/20/2025 |
FLU3 TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
745P4 L5229 |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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no adverse reaction. When list was printed there was two patient's with the same date of birt...
no adverse reaction. When list was printed there was two patient's with the same date of birth. This patient was not due for Flu vaccine
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| 2827289 | 79 | F | 02/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
99d52 |
Erythema, Peripheral swelling, Pruritus, Skin warm
Erythema, Peripheral swelling, Pruritus, Skin warm
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Reaction started 2 days after vaccine. Patient states redness slowing moving down her arm to her elb...
Reaction started 2 days after vaccine. Patient states redness slowing moving down her arm to her elbow. Redness, swelling, itching and warm to the touch. Patient took benadryl at night to help with reaction.
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| 2827290 | 66 | F | NM | 02/20/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Y013009 93KK4 |
Injection site rash; Injection site rash
Injection site rash; Injection site rash
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patient has rash about 3 days after shot right above the elbow
patient has rash about 3 days after shot right above the elbow
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| 2827291 | 0.67 | M | CA | 02/20/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient came in with mother for vaccine Update, Provider ordered injection, received order got injec...
Patient came in with mother for vaccine Update, Provider ordered injection, received order got injection ready confirmed with provider that injection was correct and was given to patient after confirmed. Patient's mother has not called into office regarding any symptoms or signs of side affects.
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| 2827292 | 1 | M | PA | 02/20/2025 |
MMR |
MERCK & CO. INC. |
X022410 |
Fall, Gait disturbance, Musculoskeletal disorder
Fall, Gait disturbance, Musculoskeletal disorder
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From the day the vaccine was administer our son would randomly fall, almost as though he tripped on ...
From the day the vaccine was administer our son would randomly fall, almost as though he tripped on something. He was walking at this point and had been for a couple months. It looked as though his leg would give out and he would hit the floor. I, first notices this and thought it was odd but he had no other symptoms. It was when our oldest daughter made the comment, patient has been falling ever since he got the vaccine that it made me concerned that it may have affected him neurologically. I was not the only one that noticed the distinct difference in his ability to walk without falling often. After about a week, the issue subsided. When we were at the pediatricians office on March 7, 2024, I mentioned the reaction to the CRNP just to have note of it in the medical record. She had advised us to keep track of that and possibility consider not giving him the next dose that is not due until 4-5 yo.
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| 2827293 | 1.08 | M | NE | 02/20/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Fatigue, Feeling hot, Irritability, Pyrexia
Fatigue, Feeling hot, Irritability, Pyrexia
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After receiving vaccine later that night they noticed patient developing a minor fever, felt warm to...
After receiving vaccine later that night they noticed patient developing a minor fever, felt warm to touch. Parents bathed child with warm water then applied warm cloths around the area of the site. No fever, but provided Ibuprofen to help prevent fever. They have noticed increase irritability and fussy. Some mild fatigue.
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| 2827294 | 31 | M | MI | 02/20/2025 |
VARCEL |
MERCK & CO. INC. |
X025846 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient was given MMR#2 at PCP office yesterday, 2/19/25 and sent to Clinic today 2/20/25 for VAR #2...
Patient was given MMR#2 at PCP office yesterday, 2/19/25 and sent to Clinic today 2/20/25 for VAR #2. RNs did not notice MMR given 2/19 and administered VAR. After VAR given, realized live-live rule was broken and vaccine will need to be repeated in 28-30 days. Patient noted.
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| 2827295 | 46 | F | OR | 02/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Pain
Pain
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they reported pain at "all of her body" after second series of Hep b vaccine.
they reported pain at "all of her body" after second series of Hep b vaccine.
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| 2827296 | 7 | M | NV | 02/20/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Extra dose of Hep A given. No reaction
Extra dose of Hep A given. No reaction
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| 2827297 | 11 | F | NY | 02/20/2025 |
UNK |
UNKNOWN MANUFACTURER |
unknown |
Enuresis, Hypersensitivity, Immediate post-injection reaction, Insomnia, Mood al...
Enuresis, Hypersensitivity, Immediate post-injection reaction, Insomnia, Mood altered
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My daughter immediately had strong allergic reaction on her hands and arms as well as troubles with ...
My daughter immediately had strong allergic reaction on her hands and arms as well as troubles with sleeping, drastic mood changes, bedwetting which all lasted for about 2-3 weeks
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| 2827298 | 31 | M | NY | 02/20/2025 |
COVID19 FLU3 TDAP |
PFIZER\BIONTECH SEQIRUS, INC. GLAXOSMITHKLINE BIOLOGICALS |
LN0591 946613 XN575 |
Dizziness, Immediate post-injection reaction, Tremor, Unresponsive to stimuli; D...
Dizziness, Immediate post-injection reaction, Tremor, Unresponsive to stimuli; Dizziness, Immediate post-injection reaction, Tremor, Unresponsive to stimuli; Dizziness, Immediate post-injection reaction, Tremor, Unresponsive to stimuli
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Patient came in for 3 vaccines (flu, covid, and tdap) since his is overdue and pt will be around a n...
Patient came in for 3 vaccines (flu, covid, and tdap) since his is overdue and pt will be around a newborn. Pt states that he gets anxious and lightheaded when receiving vaccines, but is usually fine after a few minutes. Pt received the vaccines, then immediately became unresponsive, staring in front of him. Pt recovered after a minute or so, to the shouting of the pharmacist and tapping of his shoulders. Pt was then very lightheaded and shaking uncontrollably. Pt was given water and rested for about 30 minutes, then recovered and went home. Pt was called twice afterwards (hour after returning home and the next day) and he said that he was feeling better.
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| 2827299 | 5 | F | KS | 02/20/2025 |
DTAP FLU3 HEP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
3CA03C3 5ZG92 95BJ9 |
Circumstance or information capable of leading to medication error, Wrong patien...
Circumstance or information capable of leading to medication error, Wrong patient; Circumstance or information capable of leading to medication error, Wrong patient; Circumstance or information capable of leading to medication error, Wrong patient
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Administration error - vaccines were given to wrong patient due to misidentification error
Administration error - vaccines were given to wrong patient due to misidentification error
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| 2827300 | 02/20/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Abdominal pain upper, Back pain, Burning sensation, Colitis microscopic, Colonos...
Abdominal pain upper, Back pain, Burning sensation, Colitis microscopic, Colonoscopy abnormal; Pain, Swelling
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Dose: 0.5 mL Route: Intramuscular Site: Left arm Manufacturer: Pfizer-BioNTech Lot#: EN6201 Location...
Dose: 0.5 mL Route: Intramuscular Site: Left arm Manufacturer: Pfizer-BioNTech Lot#: EN6201 Location: Referring Provider: ID: 76 y.o. female with past medical history of hypertension, hyperlipidemia, arthritis present for follow up visit for new complaint of right upper quadrant pain starting mid February. She just had labs with her primary care provider February 16 and the following week noted several episodes of intermittent upper right pain which also radiated to the back. Symptoms seem to occur more at bedtime and does not identify if these were specifically postprandial or any relation to food intake or type. The pain was of a burning quality and the area felt somewhat swollen. It was 5-6 out of 10 in severity she did not note any associated heartburn, nausea, vomiting or other digestive symptoms and her bowel pattern was unchanged. She has Bristol consistency 3-4 bowel movements occurring 3-4 times a day which has been since her COVID shot. She had prior treatment for collagenous colitis but not noting any diarrhea. Weight is stable good intake. No urinary symptoms. The pain actually has resolved in the last week or so and no symptoms at this time. She saw her primary care provider for low back pain October 23 and was treated with Macrobid for UTI. Last office visit Dr. 7/21/21: Patient is a 73 y.o. female presenting for follow-up of collagenous colitis. Patient has a history of uncontrollable diarrhea that initially started in February 2021 a few days following her COVID-19 vaccine. Her subsequent colonoscopy on 5/11/21 showed changes on random colon biopsies consistent with collagenous colitis. She was subsequently started on budesonide 3mg TID which she gradually tapered over a six-week period. She has not taken any budesonide over the last three-weeks. She is also no longer on miralax. She notes significant improvement in symptoms with resolved diarrhea. She feels well and denies bowel irregularity, anorexia, abd pain, nausea, vomiting, weight loss, or rectal bleeding. She maintains a relatively healthy diet. No colon polyps on last 2 colonoscopy 2018 and 2021 and was advised no further screening colonoscopies are needed. S/p CCY 2013 GI Problem list: collagenous colitis
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| 2827301 | 73 | M | 02/20/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient was administered the 3rd Bexsero dose too early. 3rd Bexsero dose was administered 1/23/25, ...
Patient was administered the 3rd Bexsero dose too early. 3rd Bexsero dose was administered 1/23/25, which should've been administered 4/10/2025
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| 2827302 | 02/20/2025 |
COVID19 |
MODERNA |
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Chest discomfort, Chest pain, Dyspnoea at rest, Dyspnoea exertional, Palpitation...
Chest discomfort, Chest pain, Dyspnoea at rest, Dyspnoea exertional, Palpitations
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HPI patient is a 55-year-old male with a known history of hypertension, hyperlipidemia, previous tob...
HPI patient is a 55-year-old male with a known history of hypertension, hyperlipidemia, previous tobacco use, family history of heart disease, who has recently developed intermittent episodes of chest discomfort, palpitations and shortness of breath. The patient describes the chest discomfort as a aching and painful sensation that can occur anytime during either rest or with exertion. The palpitations also occur at a time but more frequently in the evening. Is also noticed dyspnea on exertion and occasional mild shortness of breath at rest. The symptoms have occurred since his COVID-19 vaccination, Moderna vaccine. The patient denies near syncope or syncope. He does have a family history of heart disease. This is prompted him to have a more thorough evaluation. 55-year-old male presents to the emergency department for evaluation of chest pain. The patient describes several days to week of left-sided chest pressure, tightness and heaviness. He describes 2 days of exertional dyspnea and worsening of his pain with exertion. He states that his symptoms started shortly after receiving a COVID-19 vaccine. No fevers, chills, sweats, nauseousness although he had these symptoms at the onset. No vomiting or diarrhea. No rashes or skin changes. No prior history of coronary artery disease or stroke or acute coronary syndrome. Patient does have a history of hypertension, hyperlipidemia and chronic back pain status post 3 surgeries.
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| 2827303 | 16 | M | CA | 02/20/2025 |
MMRV |
MERCK & CO. INC. |
Y013583 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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MMR-V, Medication Pro-quad, was given in error, lot Y013583, expiration 2/3/2026. The clinic did not...
MMR-V, Medication Pro-quad, was given in error, lot Y013583, expiration 2/3/2026. The clinic did not receive any reports of reactions.
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| 2827304 | 78 | M | 02/20/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Back pain, Pain in extremity, Tremor
Back pain, Pain in extremity, Tremor
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Patient was administered the Bexsero booster dose on 2/17/25 and reported a possible reaction to the...
Patient was administered the Bexsero booster dose on 2/17/25 and reported a possible reaction to the vaccine. Patient reported having the "shakes and severe pain from his arm and back",
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| 2827305 | 14 | F | CA | 02/20/2025 |
MMRV |
MERCK & CO. INC. |
Y013583 |
Extra dose administered
Extra dose administered
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PROQUAD - MMR-V medication administered by error.
PROQUAD - MMR-V medication administered by error.
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| 2827306 | 61 | F | GA | 02/20/2025 |
COVID19 VARZOS |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
3043156 M7G39 |
Injection site pain, Pain in extremity, Rash; Injection site pain, Pain in extre...
Injection site pain, Pain in extremity, Rash; Injection site pain, Pain in extremity, Rash
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sore arm, rash, pain at injection site
sore arm, rash, pain at injection site
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| 2827307 | 59 | F | CA | 02/20/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
044A21A 044A21A |
Cardiac failure, Condition aggravated, Loss of consciousness, Peripheral swellin...
Cardiac failure, Condition aggravated, Loss of consciousness, Peripheral swelling, Scab; Seizure, Tooth injury
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pt says both legs swelled up after getting the first vaccine but after getting the second vaccine bo...
pt says both legs swelled up after getting the first vaccine but after getting the second vaccine both legs swelled up so bad they developed scabs. After a couple of days the swelling went down. However, her life continue to go down hill. Within a day or so of getting the vaccines she went into heart failure, would black out for a long periods of time. It caused her to have multiple seizures which caused her to knock several teeth. She would try to go to the hospital but was told to stay at home. She thinks it was because of the pandemic. She is not currently seeing a physician and is being asked to sign an behavioral agreement before she can have medical treatment. She was being seen by Dr.
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| 2827308 | 32 | M | NJ | 02/20/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Arthralgia, Asthenia, Bone pain, Brain fog, Fatigue; Gait inability, Headache, I...
Arthralgia, Asthenia, Bone pain, Brain fog, Fatigue; Gait inability, Headache, Immediate post-injection reaction, Impaired work ability, Inflammation; Inflammatory marker increased, Memory impairment, Pain
More
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After he received the vaccine, he immediately had total body aches and pain, brain fog, headaches an...
After he received the vaccine, he immediately had total body aches and pain, brain fog, headaches and he described the pain as having "body cancer." He has never complained of anything like this until the covid vaccine. He has seen multiple doctors from hematology, rheumatology, cardiology, pain management, his primary and a few trips to the emergency room. His bloodwork showed chronic inflammation which was causing him so much pain in his joints and bones that he wasn't able to walk. His brain fog is completely horrible as he forgets things most days and has been living on Tylenol or Advil or whatever is available at the time. He has been unable to work for the past few years due to his illness which means he has no income coming in and has borrowed thousands and thousands of dollars from his family. Chronic inflammation and chronic fatigue is devastating. He stays home most days and nights as he doesn't have any energy to get out of bed. I truly feel he is should be entitled to a compensation as the vaccine was a total sham and he only got it through a scare tactic. We need your help!
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✓ | |||||
| 2827309 | 35 | M | 02/20/2025 |
COVID19 |
MODERNA |
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Cheilitis, Rash, Rash erythematous, Rash pruritic, Urticaria
Cheilitis, Rash, Rash erythematous, Rash pruritic, Urticaria
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itchy red skin rashes and hives on forearms, neck, and lips
itchy red skin rashes and hives on forearms, neck, and lips
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| 2827310 | 1.33 | M | CA | 02/20/2025 |
DTAPHEPBIP DTAPHEPBIP DTAPHEPBIP HIBV HIBV HIBV PNC20 PNC20 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
5YB7L 5YB7L 5YB7L UK093AB UK093AB UK093AB LC5484 LC5484 LC5484 |
Injection site cellulitis, Injection site rash, Injection site reaction, Limb in...
Injection site cellulitis, Injection site rash, Injection site reaction, Limb injury, Nasal congestion; Productive cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea, Sinus congestion; Wound; Injection site cellulitis, Injection site rash, Injection site reaction, Limb injury, Nasal congestion; Productive cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea, Sinus congestion; Wound; Injection site cellulitis, Injection site rash, Injection site reaction, Limb injury, Nasal congestion; Productive cough, Pyrexia, Respiratory tract congestion, Rhinorrhoea, Sinus congestion; Wound
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Patient returned to clinic on 2/20/25, 13 days after vaccine administration. Presented with open wou...
Patient returned to clinic on 2/20/25, 13 days after vaccine administration. Presented with open wound & cellulitis to left thigh (15 cm by 25 cm), with yellow edges and pink/red wound. Parents report that patient had rash to both extremities but wound on left thigh developed following vaccine administration. Mother also reports intermittent fever for last week, as high as 102 F, cough, congestion, and runny nose. Mother reports that patient was seen at urgent care where he was prescribed antibiotic ointment for wound and cephalexin. Patient is positive for fever. Other symptoms include fevers up to 102 degrees, productive cough, sinus and nasal congestion, and runny nose. Patient received wound care during office visit today. Was prescribed vitamin C today and referred to Wound Clinic and Pediatric Dermatology.
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| 2827311 | 12 | M | TX | 02/20/2025 |
COVID19 |
MODERNA |
3043000 |
Underdose
Underdose
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Moderna for age 6 months to 11 year given to the patient
Moderna for age 6 months to 11 year given to the patient
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| 2827327 | 5 | M | FL | 02/20/2025 |
HEP |
MERCK & CO. INC. |
P7EE2 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE; HCP called to report inadvertent administration of expired RECOMBIVAX HB to a pati...
No additional AE; HCP called to report inadvertent administration of expired RECOMBIVAX HB to a patient. Vaccine expired on 09MAR2019 and was administered to a patient on 11MAR2019. No additional information was known by reporter. No additional AE/PQC.; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported. On 11-MAR-2019, the patient received inadvertent administration of expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, invalid lot P7EE2, expiration date: 09-MAR-2019, administered for prophylaxis (dosage, route of administration, and anatomical location were not provided) (Expired product administered). No additional adverse event was reported. This is non-valid because the patient is not identifiable. Follow-up information has been received from the nurse on 05-FEB-2025. It was confirmed that the patient was a 5-year-old male. This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2236723. The previous case ID: 2501USA003629. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report.
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| 2827328 | UT | 02/20/2025 |
MMR |
MERCK & CO. INC. |
K011317 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE reported.; a dose of MMR-II expired on 8/13/2016 and was administered on 11/3/2016....
No additional AE reported.; a dose of MMR-II expired on 8/13/2016 and was administered on 11/3/2016.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported. On 03-NOV-2016, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (lot#: K011317, expiration date: 13-AUG-2016; dose, strength, and route of administration were not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
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| 2827329 | M | NY | 02/20/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Incomplete course of vaccination, No adverse event; Incomplete course of vaccina...
Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event
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has not yet received their third dose; No additional AE; This spontaneous report was received from a...
has not yet received their third dose; No additional AE; This spontaneous report was received from a Pharmacist and refers to a 25-year-old male patient. The patient's medical, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported. On an unknown date in April 2023, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), (Dose 1) (strength, dose description, route of administration, lot # and expiration date were not reported). On an unknown date in June 2023, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) (GARDASIL�9), (dose 2) (strength, dose description, route of administration, lot # and expiration date were not reported) as prophylaxis, however, the patient has not yet received their third dose (Inappropriate schedule of product administration). No symptoms reported, No additional adverse event.
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| 2827330 | 2 | FL | 02/20/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y016876 Y013347 |
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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no adverse event; Nurse called and reported PROQUAD and VARIVAX were inadvertently concomitantly adm...
no adverse event; Nurse called and reported PROQUAD and VARIVAX were inadvertently concomitantly administered to a patient. Caller stated no patient symptoms have been reported. No additional AE/no PQC reported.; This spontaneous report was received from a Nurse and refers to a 2-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-FEB-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #Y013347, expiration date: 02-AUG-2026) (1 dose), for an unknown indication and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (lot #Y016876, expiration date: 07-APR-2026), dose number 1, (1 dose), for prophylaxis. The suspected vaccines were inadvertently concomitantly administered to a patient (accidental overdose). Reported stated no patient symptoms have been reported.
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| 2827331 | F | AZ | 02/20/2025 |
HEP HEP HEP |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Inappropriate schedule of product administration, Product administered to patien...
Inappropriate schedule of product administration, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, Product administered to patient of inappropriate age; Inappropriate schedule of product administration, Product administered to patient of inappropriate age
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inappropriate schedule of vaccine; Product administered to patient of inappropriate age; This sponta...
inappropriate schedule of vaccine; Product administered to patient of inappropriate age; This spontaneous report was received from a lawyer and refers to a 1-month-old female patient who was involved in a litigation process regarding quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (case). All details regarding the patient's medical history, concurrent conditions and concomitant therapies were captured in case. On 15-MAR-2005, at the age of 1 month, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (reported as Hepatitis B [Hep B]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (product administered to patient of inappropriate age). On 16-AUG-2005, the patient was vaccinated with the second dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (reported as Hepatitis B [Hep B]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis (inappropriate schedule of product administration). On 17-Nov-2005, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (reported as Hepatitis B [Hep B]) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) administered for prophylaxis. This was one of several reports regarding the same patient.
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| 2827332 | M | CO | 02/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
941579 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Received a Dose of HEPLISAV-B Today, Which Expired on 04-Jan-2025; Initial report received on 22-Jan...
Received a Dose of HEPLISAV-B Today, Which Expired on 04-Jan-2025; Initial report received on 22-Jan-2025. A nurse reported that a 39-year-old male received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired. No medical history or concomitant medications were reported. On 22-Jan-2025, the patient received a dose of a hepatitis B vaccine HEPLISAV-B (lot number 941579, expiration date 04-Jan-2025; NDC number not available) intramuscularly in the left deltoid. The dose of HEPLISAV-B administered had expired on 04-Jan-2025. No side effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious; Sender's Comments: The company assessed the event as non-serious
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| 2827333 | TX | 02/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Received 2nd Dose 2 1/2 Weeks Early; Initial report received on 31-Jan-2025. A pharmacist reported...
Received 2nd Dose 2 1/2 Weeks Early; Initial report received on 31-Jan-2025. A pharmacist reported that a patient (age, gender, race, ethnicity not reported) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization early. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, route, and site not available)]. On an unknown date, 17 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (lot #, expiration date, route, and site not available). The patient received the second dose two and a half weeks too early. No additional information was reported. Company Comment:The company assessed the event as non-serious; Sender's Comments: The company assessed the event as non-serious
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| 2827334 | M | 02/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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First Dose at pharmacy on Dec 20th 2023 and Took a Second Dose at pharmacy on Feb 1, 2025; Initial r...
First Dose at pharmacy on Dec 20th 2023 and Took a Second Dose at pharmacy on Feb 1, 2025; Initial report received on 03-Feb-2025. A consumer reported that he received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 20-Dec-2023 and received the second dose on 01-Feb-2025. No medical history or concomitant medications were reported. On 20-Dec-2023, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. On 01-Feb-2025, 409 days after receiving the first dose of HEPLISAV-B, the patient received dose 2 of HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported). The patient was inquiring if he was fully immunized. No adverse reactions were reported. The reporter declined to provide further information. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2827335 | F | GA | 02/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
944942 |
Interchange of vaccine products, No adverse event
Interchange of vaccine products, No adverse event
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Received First Dose of Heplisav-B, and Second Dose Recombivax; Initial report received on 03-Feb-202...
Received First Dose of Heplisav-B, and Second Dose Recombivax; Initial report received on 03-Feb-2025. A nurse reported that a female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, then one month later received a dose of RECOMBIVAX. No medical history or concomitant medications were reported. On an unknown date, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 944942, expiration date 31-Jan-2027, and NDC number 43528-003-05)] intramuscularly in the right deltoid. On an unknown date, one month after receiving HEPLISAV-B, the patient received a dose of a hepatitis B vaccine [RECOMBIVAX (lot number and expiration date not reported)]. No side effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2827336 | 48 | F | NY | 02/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Erythema, Rash
Erythema, Rash
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Second Dose of HEPLISAV-B Not Received; Rash; Red Skin; Initial report received on 05-Feb-2025. A...
Second Dose of HEPLISAV-B Not Received; Rash; Red Skin; Initial report received on 05-Feb-2025. A reporter reported that a 48-year-old female (ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed red skin and rash. No medical history or concomitant medications were reported. On 22-Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC # 43528-002-01, site not available)] intramuscularly. At the time of reporting, more than a year after receiving the first dose, the patient presented to receive the second dose, but the site would not administer it. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2827337 | F | WI | 02/20/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
945484 |
Interchange of vaccine products, No adverse event
Interchange of vaccine products, No adverse event
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Received First Dose Heplisav-B, and Second Dose Recombivax; Initial report received on 07-Feb-2025. ...
Received First Dose Heplisav-B, and Second Dose Recombivax; Initial report received on 07-Feb-2025. A pharmacist reported that a 24-year-old female (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization, then seven months later received a dose of RECOMBIVAX. No medical history or concomitant medications were reported. On 11-Jun-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 945484, expiration date 20-Apr-2026, NDC # 43528-0003-05, route, and site not available). In Jan-2025, approximately seven months after having been vaccinated with HEPLISAV-B, the patient received a dose of a hepatitis B vaccine [RECOMBIVAX (lot number and expiration date note reported)]. No side effects were reported. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2827338 | 0.17 | F | MI | 02/20/2025 |
DTAPIPV DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5G23D / D947X UNK |
Expired product administered, Extra dose administered, Product administered to p...
Expired product administered, Extra dose administered, Product administered to patient of inappropriate age; Expired product administered, Extra dose administered, Product administered to patient of inappropriate age
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Kinrix vaccine administered to infant; Wrong dose Vaccine was given twice; Expired vaccine used; Kin...
Kinrix vaccine administered to infant; Wrong dose Vaccine was given twice; Expired vaccine used; Kinrix vaccine administered to infant; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of inappropriate age at vaccine administration in a 12-week-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D / D947X, expiry date 25-JAN-2025) for prophylaxis. Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis. On 28-JAN-2025, the patient received Kinrix (intramuscular, right thigh). On 27-NOV-2024, the patient received Kinrix. On 27-NOV-2024, not applicable after receiving Kinrix and an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine administered to infant). On 28-JAN-2025, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine administered to infant), extra dose administered (Verbatim: Wrong dose Vaccine was given twice) and expired vaccine used (Verbatim: Expired vaccine used). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration, extra dose administered and expired vaccine used were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 12-FEB-2025 This case was reported by a medical assistant via patient support programs. The patient received wrong dose. The patient received expired dose of Kinrix, which led to expired vaccine used. No other products were reported.
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| 2827339 | 02/20/2025 |
TDAP VARZOS |
UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Feeling hot; Feeling hot
Feeling hot; Feeling hot
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Feel like warm garbage; This non-serious case was reported by a consumer and described the occurrenc...
Feel like warm garbage; This non-serious case was reported by a consumer and described the occurrence of feeling of warmth in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for prophylaxis. On 28-JAN-2025, the patient received Shingrix and Tdap. On 28-JAN-2025, less than a day after receiving Shingrix, the patient experienced feeling of warmth (Verbatim: Feel like warm garbage). The outcome of the feeling of warmth was resolved. It was unknown if the reporter considered the feeling of warmth to be related to Shingrix. It was unknown if the company considered the feeling of warmth to be related to Shingrix. Additional Information: GSK Receipt Date: 29-JAN-2025 The patient got Shingrix shot and TDAP on the same day (day of posting) and felt like warm garbage as because beats shingles or tetanus though.
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| 2827340 | 02/20/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Hypersensitivity
Hypersensitivity
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allergic reaction; This non-serious case was reported by a consumer via interactive digital media an...
allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: allergic reaction). The outcome of the allergic reaction was not reported. It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine. It was unknown if the company considered the allergic reaction to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-FEB-2025 The reporter reported that patient received Shingles vaccine and had an allergic reaction.
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| 2827341 | 02/20/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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It has been 9 months since my first Shingrix vaccination; This non-serious case was reported by a co...
It has been 9 months since my first Shingrix vaccination; 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 (1st dose received 9 months ago in 2024). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: It has been 9 months since my first Shingrix vaccination). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 13-FEB-2025 This case was reported by a patient via interactive digital media. The patient was concerned if it was still advisable to get the second dose now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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