| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2822377 | 53 | F | WA | 01/22/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Chills, Feeling abnormal, Night sweats, Pain in extremity, Pyrexia; Sleep disord...
Chills, Feeling abnormal, Night sweats, Pain in extremity, Pyrexia; Sleep disorder, Tremor
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(Please note that I also received a flu vaccine in the left arm on the same day at the same pharmacy...
(Please note that I also received a flu vaccine in the left arm on the same day at the same pharmacy.) I developed first chills (8pm to midnight), then a low fever (1.5 degrees F), and spent a pretty miserable night waking up sweating and miserable. I got up at 9 the next morning and took 400 mg ibuprofen. Within a couple of hours my fever was gone. My left arm was sore but nothing out of the norm for having received a vaccine. I gradually started feeling better over the next two days (Jan. 19 and 20). However: I also developed an intermittent hand tremor that lasted for the same two days. It was almost gone on Jan. 21 and is now gone completely. I just thought it was worth reporting. I had Covid in September of 2024 and at that time developed a sensation of internal tremors. Which was very weird. It lasted about 1 week after I stopped testing positive and has not returned.
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| 2822378 | 5 | F | FL | 01/22/2025 |
DTAPIPV DTAPIPV |
SANOFI PASTEUR SANOFI PASTEUR |
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Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection ...
Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus; Injection site swelling, Injection site warmth
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Redness, swelling, warm to the touch, tender to the touch, itchy around the injection site, streaky ...
Redness, swelling, warm to the touch, tender to the touch, itchy around the injection site, streaky erythema. Antibiotics given told it was cellulitis and an allergic reaction. Could not tolerate antibiotics given 4 shots of clindamycin over a few days period. Then given an antibiotic ointment. Redness has lasted for 15 days. 1/07/2025-1/22/2025
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| 2822379 | 76 | F | CA | 01/22/2025 |
PNC21 |
MERCK & CO. INC. |
y013009 |
Back pain
Back pain
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Patient started to have strong lower back pain 4 hours after receiving the vaccine and it stays. She...
Patient started to have strong lower back pain 4 hours after receiving the vaccine and it stays. She has gone to a chiropractor and got treatment for 5 times.
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| 2822380 | 50 | F | CA | 01/22/2025 |
UNK |
UNKNOWN MANUFACTURER |
KP2YT |
Injection site erythema, Injection site pain, Injection site warmth
Injection site erythema, Injection site pain, Injection site warmth
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Pt reported red patch and pain, hot to touch, at injection area
Pt reported red patch and pain, hot to touch, at injection area
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| 2822381 | 25 | F | CA | 01/22/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
HY1812 HY1812 |
Exposure during pregnancy, Immunoglobulin therapy, Increased tendency to bruise,...
Exposure during pregnancy, Immunoglobulin therapy, Increased tendency to bruise, Petechiae, Platelet count decreased; Thrombocytopenia
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Patient is a 25-year-old G4P2103 with EDD 2/17/25, who was admitted to the hospital on 1/20/25 at 36...
Patient is a 25-year-old G4P2103 with EDD 2/17/25, who was admitted to the hospital on 1/20/25 at 36w0d due to 1-week of petechiae and easy bleeding/bruising. She was found to have new profound thrombocytopenia on admission, with platelet count of 5k. The presumed diagnosis is ITP, either as a primary autoimmune condition or as a vaccine adverse event. She remains admitted today (1/22/25) and work-up for alternative causes of thrombocytopenia, but no other cause has been identified thus far. She is receiving steroids and IVIg with the goal to improve her platelet count prior to delivery.
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| 2822382 | 59 | F | AK | 01/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
LM7786 LM7786 |
Erythema, Injection site erythema, Injection site induration, Injection site pai...
Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site rash; Injection site warmth
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7 days after the injection husband noticed a red patch on pts arm. The next day seen at the clinic ...
7 days after the injection husband noticed a red patch on pts arm. The next day seen at the clinic with a rash below the injection site, red, warm, indurated, 6 x 4 cm, and tender to touch.
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| 2822383 | 3 | M | PA | 01/22/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
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Cellulitis, Peripheral swelling, Pruritus, Skin irritation
Cellulitis, Peripheral swelling, Pruritus, Skin irritation
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I was told he would have no reaction as this is his 3rd time getting the vaccine have waited two yea...
I was told he would have no reaction as this is his 3rd time getting the vaccine have waited two years to get this vaccine since the last one he had he got a staff infection as well. His shot was January 17th he had itched at it for 3 days the night on January 20th it started to appear extremely swollen and by the morning of January 21st his arm was 5x the size I called office to be seen the refused to see him so that?s when I rushed to the emergency room where they gave him his first round a Benadryl and perscribed him cephalexin he has currently had 3 doses of if and the swelling and irritation has not reduced at all
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| 2821918 | 0.17 | U | MN | 01/21/2025 |
PPV |
MERCK & CO. INC. |
X027348 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Patient is asymptomatic / No additional AE; HCP reported a dose of PNEUMOVAX23 was inadvertently adm...
Patient is asymptomatic / No additional AE; HCP reported a dose of PNEUMOVAX23 was inadvertently administered to a 2 month old patient on 11/12/2024; This spontaneous report was received from a medical assistant, concerning a 2-month-old patient of unknown age. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported. On 12-NOV-2024, the patient was inadvertently vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter (mL) (lot number X027348 was verified to be valid, expiration date was reported and confirmed as 24-JAN-2026), administered as prophylaxis by a Health Professional (route of administration and anatomical location were not provided) (Product administered to patient of inappropriate age). The patient was asymptomatic. No additional details nor adverse event (AE) were reported.
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| 2821919 | U | GA | 01/21/2025 |
RV5 |
MERCK & CO. INC. |
2073367 |
No adverse event, Product storage error
No adverse event, Product storage error
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No additional AE reported; Medical Assistant stated ROTATEQ was administered on 1/16/2025 during a t...
No additional AE reported; Medical Assistant stated ROTATEQ was administered on 1/16/2025 during a temperature excursion; This spontaneous report was received from a medical assistant, concerning to a female patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) suffered a temperature excursion (TE) at 1.0 Celsius degrees for 5 hours. On 16-JAN-2025, the patient stwas vaccinated with the vaccine involved in the TE: rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (strength, dose, and route of administration were not provided; lot #2073367 has been verified to be valid for this vaccine, expiration date reported and confirmed as 26-NOV-2025). (Product storage error). No additional adverse event reported (No adverse event).
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| 2821920 | 71 | M | WA | 01/21/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Bell's palsy; Bell's palsy; Bell's palsy; Bell's palsy
Bell's palsy; Bell's palsy; Bell's palsy; Bell's palsy
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Bells Palsy; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old ...
Bells Palsy; This is a spontaneous report received from a Consumer or other non HCP. A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in arm for covid-19 immunisation. The patient did not receive any other vaccine on the same date and within four weeks of vaccination. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. Other medical history reported as "several". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (hospitalization, disability, medically significant), outcome "recovered with sequelae" (01Jan2025), described as "Bells Palsy". The patient was hospitalized for bell's palsy (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of bell's palsy (steroids). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2821933 | 1 | U | MO | 01/21/2025 |
MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y012343 Y013349 |
Incorrect dose administered, No adverse event; Incorrect dose administered, No a...
Incorrect dose administered, No adverse event; Incorrect dose administered, No adverse event
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No additional AEs; VARIVAX and PROQUAD administered at the same visit; This spontaneous report was r...
No additional AEs; VARIVAX and PROQUAD administered at the same visit; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) subcutaneous injection (0.5 ml, lot #Y012343, expiration date: 11-JAN-2026) subcutaneously for prophylaxis (strength was not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 ml, lot #Y013349, expiration date: 02-AUG-2026) subcutaneously for prophylaxis (strength, and route of administration were not provided), both diluted with sterile diluent (BAXTER STERILE DILUENT), at the same visit (overdose). No additional adverse event (no adverse event) was reported.
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| 2821934 | U | 01/21/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK UNK |
Blister, Herpes zoster, Post herpetic neuralgia, Rash, Scab; Vaccination failure...
Blister, Herpes zoster, Post herpetic neuralgia, Rash, Scab; Vaccination failure; Blister, Herpes zoster, Post herpetic neuralgia, Rash, Scab; Vaccination failure
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Post herpetic neuralgia; Suspected vaccination failure; Diagnosed with shingles/the blister and scab...
Post herpetic neuralgia; Suspected vaccination failure; Diagnosed with shingles/the blister and scabbing finally cleared up /the rash and blistering clears up and goes away; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 24-AUG-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Diagnosed with shingles/the blister and scabbing finally cleared up /the rash and blistering clears up and goes away). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Post herpetic neuralgia). The patient was treated with gabapentin, ibuprofen (Advil Liqui Gels) and paracetamol (Tylenol). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the post herpetic neuralgia was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure, shingles and post herpetic neuralgia to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 06-JAN-2025 and 09-JAN-2025 This case was reported by a patient via interactive digital media. The patient got the second dose Shingrix vaccine in 2019 and was diagnosed with shingles on 24 August 2024. The blisters and scabbing finally cleared up in about 2 and a half to 3 weeks and had the post herpetic neuralgia. The patient went to primary care physician and he prescribed gabapentin for the nerve pain. It helps some but not for very long at a time. The patient was currently living on Advil liquigels and Tylenol rapid release. Hopefully yours and the patient's would finally went away. The patient had been told that the nerve pain could last for months even years after the rash/blistering clears up and goes away. The commercials the patient had seen said that the vaccine was only effective in about 90 percent of people who get the vaccine, so he/she guess that he/she was in that 10 percent out of 100 percent who it did not help, since he/she got the 2 doses of Shingrix vaccine. This case was considered as suspected vaccination failure as details regarding time laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster and Post herpetic neuralgia are unlisted events which are considered unrelated to GSK vaccine Shingrix.
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| 2821935 | 81 | F | 01/21/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
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Urticaria; Urticaria
Urticaria; Urticaria
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Started breaking out in hives; Initial information received on 13-Jan-2025 regarding an unsolicited ...
Started breaking out in hives; Initial information received on 13-Jan-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-healthcare professional. This case was received from Pfizer Inc. This case involves a 81 years old female patient (173 cm and 72.57 kg) who started breaking out in hives after receiving Influenza USP trival a-b high dose subvirion vaccine [Fluzone HD] and Comirnaty (Tozinameran). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via intramuscular route in the left arm (strength and expiration date: not provided) for immunization and received a dose of suspect Comirnaty not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for immunization. Information regarding batch number and expiration date corresponding to the one at a time of event occurrence cannot be requested. On an unknown date the patient started breaking out in hives (urticaria) (unknown latency). Action taken- not applicable. The patient was treated with Fexofenadine hydrochloride (Allegra). At time of reporting, the outcome was Recovering / Resolving for the event.
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| 2821936 | U | NY | 01/21/2025 |
TDAP |
SANOFI PASTEUR |
2CA94C1 |
No adverse event, Product storage error
No adverse event, Product storage error
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This situation is pre-assessed as a medication error/an inappropriate use due to administration of A...
This situation is pre-assessed as a medication error/an inappropriate use due to administration of ADACEL after a shipping excursion with no reported adverse event; This situation is pre-assessed as a medication error/an inappropriate use due to administration of ADACEL after a shipping excursion with no reported adverse event; Initial information received on 13-Jan-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves, this situation is pre-assessed as a medication error/an inappropriate use due to administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] to the unspecified number of patients after a shipping excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, this situation is pre-assessed as a medication error/an inappropriate use due to administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot 2CA94C1, expiry date:31-Aug-2025) (unknown strength, dosage, and route) via unknown administration site for prophylactic vaccination on 13-Jan-2025 to the unspecified number of patients after a shipping excursion with no reported adverse event (product storage error) (unknown latency). Reportedly, They said that they realized it after administering the vaccine to some patients. They were unsure of whether the vaccine is still suitable for use and wanted to know what to do. Nurse said that they administered Adacel post-excursion to three patients. They also said that the administered vaccines were from the same package. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2821944 | 38 | M | OH | 01/21/2025 |
TDAP |
SANOFI PASTEUR |
U8339BA |
Erythema, Pain, Skin warm, Swelling
Erythema, Pain, Skin warm, Swelling
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red, raised, warm area 8x8 cm, soreness
red, raised, warm area 8x8 cm, soreness
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| 2821945 | 77 | F | IL | 01/21/2025 |
COVID19 |
MODERNA |
3043823 |
Product storage error
Product storage error
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Patient was given a Spikevax Covid vaccine after it was refrozen and thawed
Patient was given a Spikevax Covid vaccine after it was refrozen and thawed
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| 2821946 | 77 | F | IL | 01/21/2025 |
COVID19 |
MODERNA |
3043823 |
Product storage error
Product storage error
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Patient was given Spikevax covid vaccine that was refrozen and thawed
Patient was given Spikevax covid vaccine that was refrozen and thawed
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| 2821947 | 78 | F | IL | 01/21/2025 |
COVID19 |
MODERNA |
3043823 |
Product storage error
Product storage error
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Patient was given a spikeax covid vaccine that was refrozen and thawed
Patient was given a spikeax covid vaccine that was refrozen and thawed
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| 2821948 | 66 | M | IL | 01/21/2025 |
COVID19 |
MODERNA |
3043823 |
Product storage error
Product storage error
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Patient was given Spikevax Covid vaccine that was refrozen and thawed
Patient was given Spikevax Covid vaccine that was refrozen and thawed
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| 2821949 | 66 | F | IL | 01/21/2025 |
COVID19 |
MODERNA |
3043823 |
Product storage error
Product storage error
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Patient was given a Spikevax Covid vaccine that was refrozen and thawed
Patient was given a Spikevax Covid vaccine that was refrozen and thawed
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| 2821950 | 63 | F | IL | 01/21/2025 |
COVID19 |
MODERNA |
3043823 |
Product storage error
Product storage error
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Patient was given a Spikevax Covid vaccine that was refrozen and thawed
Patient was given a Spikevax Covid vaccine that was refrozen and thawed
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| 2821951 | 83 | F | IL | 01/21/2025 |
COVID19 |
MODERNA |
3043823 |
Product storage error
Product storage error
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Patient was given a Spikevax Covid vaccine that had been refrozen and thawed
Patient was given a Spikevax Covid vaccine that had been refrozen and thawed
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| 2821952 | 0.2 | F | MN | 01/21/2025 |
DTPPVHBHPB PNC20 RV5 |
MSP VACCINE COMPANY PFIZER\WYETH MERCK & CO. INC. |
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Underdose; Underdose; Underdose
Underdose; Underdose; Underdose
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0 adverse reaction lower dose was administered (50)
0 adverse reaction lower dose was administered (50)
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| 2822001 | 25 | M | WI | 01/21/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
300213A |
Urticaria
Urticaria
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Delayed (4 days) localized urticarial reaction left forearm (arm received vaccine)
Delayed (4 days) localized urticarial reaction left forearm (arm received vaccine)
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| 2822002 | 72 | M | CA | 01/21/2025 |
PNC13 RSV |
PFIZER\WYETH MODERNA |
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Arthralgia; Arthralgia
Arthralgia; Arthralgia
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Very severe pain in right shoulder where the injection of vaccine was administered. 3 days after an...
Very severe pain in right shoulder where the injection of vaccine was administered. 3 days after and the pain is still present
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| 2822003 | 79 | F | OH | 01/21/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
713ST |
Illness, Pain in extremity, Surgery
Illness, Pain in extremity, Surgery
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Severe sore arm for 2-3 days, Progressed to illness and hospitalization. Patient stated had surgery ...
Severe sore arm for 2-3 days, Progressed to illness and hospitalization. Patient stated had surgery and discharged on iv antibiotics
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| 2822004 | 45 | F | OH | 01/21/2025 |
HEP MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
MD9SL Y004116 Y013347 |
Injected limb mobility decreased, Injection site nodule, Injection site pruritus...
Injected limb mobility decreased, Injection site nodule, Injection site pruritus, Musculoskeletal discomfort; Injected limb mobility decreased, Injection site nodule, Injection site pruritus, Musculoskeletal discomfort; Injected limb mobility decreased, Injection site nodule, Injection site pruritus, Musculoskeletal discomfort
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Varivax - client states approximately 20 minutes after receiving vaccine, below R arm site was itchy...
Varivax - client states approximately 20 minutes after receiving vaccine, below R arm site was itchy and a knot developed. Client left voicemail for us on Monday but we were closed. I spoke with client Tuesday approx 8:15 am and that issue was resolved. Engerix B and MMR - Client states that had difficulty raising L arm and neck was uncomfortable. RN forgot to ask when this started. Client said that today (1/21/25) range of motion was much better of left arm and neck discomfort very little at this point. Instructed client to call her pcp if her symptoms do not improve or she is not satisfied with how she feels. Client had already called PCP yesterday and was instructed by that office to call us.
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| 2822005 | F | 01/21/2025 |
RSV |
PFIZER\WYETH |
LN5490 |
Foetal exposure during pregnancy, Respiratory syncytial virus infection, Respira...
Foetal exposure during pregnancy, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
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Mother had the Abrysvo vaccine when she was pregnant. Date of vaccine: 10/16/2024. Infant was born. ...
Mother had the Abrysvo vaccine when she was pregnant. Date of vaccine: 10/16/2024. Infant was born. Infant was diagnosed with RSV on 1/16/25.
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| 2822006 | 80 | M | MI | 01/21/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Back pain, Balance disorder, Chills, Diplopia, Fatigue; Hyperhidrosis, Hypoaesth...
Back pain, Balance disorder, Chills, Diplopia, Fatigue; Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep; COVID-19, Drug ineffective; Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia; Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis; Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test; Weight, Weight decreased; COVID-19, Drug ineffective; Guillain-Barre syndrome; Back pain, Balance disorder, Chills, Diplopia, Fatigue; Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep; COVID-19, Drug ineffective; Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia; Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis; Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test; Weight, Weight decreased; COVID-19, Drug ineffective; Guillain-Barre syndrome; Back pain, Balance disorder, Chills, Diplopia, Fatigue; Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep; COVID-19, Drug ineffective; Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia; Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis; Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test; Weight, Weight decreased; COVID-19, Drug ineffective; Guillain-Barre syndrome; Back pain, Balance disorder, Chills, Diplopia, Fatigue; Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep; COVID-19, Drug ineffective; Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia; Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis; Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test; Weight, Weight decreased; COVID-19, Drug ineffective; Guillain-Barre syndrome; Back pain, Balance disorder, Chills, Diplopia, Fatigue; Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep; COVID-19, Drug ineffective; Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia; Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis; Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test; Weight, Weight decreased; COVID-19, Drug ineffective; Guillain-Barre syndrome; Back pain, Balance disorder, Chills, Diplopia, Fatigue; Hyperhidrosis, Hypoaesthesia, Neurological symptom, Pain in extremity, Poor quality sleep; COVID-19, Drug ineffective; Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia; Guillain-Barre syndrome, Illness, Myalgia, Myocardial infarction, Myocarditis; Pneumonia, Post-acute COVID-19 syndrome, Productive cough, Respiratory disorder, SARS-CoV-2 test; Weight, Weight decreased; COVID-19, Drug ineffective; Guillain-Barre syndrome
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pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness ...
pt says his arm was a little sore after the vaccine but he also experienced double vision, numbness in both arms, had severe low back pain with pain that went down both legs. He had profound tiredness and the feeling of being unsteady. These symtoms were very similar to GBS and lasted about 10 days. Within the past couple of days has had an episode of shivering that lasted a couple of hours and another espisode of sweating that lasted about a couple of hours. Today is still not sleeping well but is feeling some better. He will contact his PCP to discuss future covid vaccines.
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| 2822007 | 9 | M | WI | 01/21/2025 |
COVID19 |
MODERNA |
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Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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9 year old was administered an adult dose (Moderna 12y & older). No adverse reactions/symptoms ...
9 year old was administered an adult dose (Moderna 12y & older). No adverse reactions/symptoms noted.
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| 2822008 | 20 | M | PA | 01/21/2025 |
CHIK YF |
VALNEVA USA, INC. SANOFI PASTEUR |
24B011 UK124AB |
Hyperhidrosis, Syncope, Vision blurred; Hyperhidrosis, Syncope, Vision blurred
Hyperhidrosis, Syncope, Vision blurred; Hyperhidrosis, Syncope, Vision blurred
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AFTER 5 MINUTES PATIENT BECAME DIAPHORETIC, BLURRY VISION THEN FAINTED. PATIENT RESPONDED WHEN I SHO...
AFTER 5 MINUTES PATIENT BECAME DIAPHORETIC, BLURRY VISION THEN FAINTED. PATIENT RESPONDED WHEN I SHOOK HIM AND CALLED HIS NAME. I ELEVATED HIS FEET AND HE DRANK WATER. HE FELT BETTER IN ABOUT 10 MINUTES, I MADE STAY SEATED FOR ABOUT 50 MINUTES. HE STATED , HE FELT FINE AND LEFT.
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| 2822009 | 4 | M | ID | 01/21/2025 |
MMRV |
MERCK & CO. INC. |
Y012594 |
Injection site rash
Injection site rash
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A very local reaction appearing as a rash on the left thigh to the Proquad (MMR V) vaccine, does not...
A very local reaction appearing as a rash on the left thigh to the Proquad (MMR V) vaccine, does not appear to be infected, does not appear to be warm to the touch
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| 2822010 | 0.67 | M | CT | 01/21/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7921AA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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ADVERSE EVENT- Extra dose of Vaxelis given to patient when not needed. No reactions/ side effects fr...
ADVERSE EVENT- Extra dose of Vaxelis given to patient when not needed. No reactions/ side effects from extra dose given.
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| 2822011 | 9 | M | VA | 01/21/2025 |
DTAP |
SANOFI PASTEUR |
2CA54C3 |
Extra dose administered, Product administered to patient of inappropriate age
Extra dose administered, Product administered to patient of inappropriate age
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9 year old child given Dtap after age 7. Child had 5 previous doses documented in medical record.
9 year old child given Dtap after age 7. Child had 5 previous doses documented in medical record.
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| 2822012 | 15 | M | WI | 01/21/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
3043836 3043836 3043836 3043836 3043836 3043836 3043836 |
Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumi...
Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase increased, Blood bicarbonate normal; Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal; Blood potassium normal, Blood pressure increased, Blood sodium normal, Blood urea normal, C-reactive protein normal; Chest X-ray normal, Chest discomfort, Dyspnoea, Echocardiogram normal, Ejection fraction normal; Electrocardiogram ambulatory normal, Immediate post-injection reaction, Magnetic resonance imaging heart abnormal, Myalgia, Myocarditis; Pericardial effusion, Protein total normal, Pyrexia, Rash, Tachycardia; Troponin T increased
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Immediately after vaccination and overnight he felt well. However the following morning he noted th...
Immediately after vaccination and overnight he felt well. However the following morning he noted that he had muscle aches and an anterior precordial discomfort which did not resolve. He describes the chest discomfort as being a palm sized area near the left lower sternal border. His description of the actual discomfort is quite vague. He states that he did feel somewhat more comfortable propped up on a few pillows. But he does not describe much shortness of breath. The pain did not worsen with deep inspiration. He was seen in the emergency room For these complaints on the 29th. Parents report a history of fever, although I do not have a specific maximum temperature. By the time he was seen in the emergency room his temperature had normalized. He was noted to have a fine, lacy appearing rash diffusely over all of his chest and neck. This was not itchy or raised. During the emergency room visit he was slightly tachycardic with a heart rate of about 110 and showed a mildly elevated blood pressure. There was no description of any irregular rhythm. Concern was raised regarding possible post COVID vaccine myocarditis in the number of laboratory studies were performed. Troponin T at baseline was mildly elevated at 20 and after 2 hours increased to 36 prompting a formal diagnosis of early myocarditis. Chest x-ray was normal as was a limited bedside echocardiogram. He was given a one week course of colchicine after the initial ED visit. Within about 24-48 hours of the emergency room visit pt states that he felt normal again. He was seen by me about 10 days after presentation and he was asymptomatic. Echocardiogram, cardiac MRI and Holter monitor were all normal. There was no evidence of ongoing inflammation or myocardial scarring by cMR. He was instructed to avoid strenuous exercise for 3 months and will have ongoing evaluation in our cardiology clinic
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| 2822013 | 82 | M | MO | 01/21/2025 |
UNK UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
G97Y2 G97Y2 G97Y2 G97Y2 |
Blood creatinine increased, Blood glucose normal, Blood urea increased, Chest X-...
Blood creatinine increased, Blood glucose normal, Blood urea increased, Chest X-ray normal, Full blood count; Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Injected limb mobility decreased, Lymphocyte percentage decreased; Malaise, Neutrophil percentage increased, Pain in extremity, SARS-CoV-2 test negative, Tremor; Urine analysis normal, White blood cell count increased
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Patient reported shortly after receiving the shingles vaccination he began experiencing severe arm p...
Patient reported shortly after receiving the shingles vaccination he began experiencing severe arm pain, inablitity to raise his arm, tremors and feeling unwell. Planned discharge hom 1/21/2025.
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| 2822014 | 67 | F | MA | 01/21/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
3043335 3043335 |
Blood test, Brain fog, Cerebrovascular accident, Confusional state, Diplopia; Ec...
Blood test, Brain fog, Cerebrovascular accident, Confusional state, Diplopia; Echocardiogram, Feeling abnormal, Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck
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double vision, brain fog, not "feeling right" confusion; MRI of brain on December 9, 2024 ...
double vision, brain fog, not "feeling right" confusion; MRI of brain on December 9, 2024 confirmed 2 (recent) strokes. NOTE: No previous history of any strokes or symptoms of same
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| 2822015 | 0.5 | M | TX | 01/21/2025 |
DTAPHEPBIP FLU3 |
GLAXOSMITHKLINE BIOLOGICALS SEQIRUS, INC. |
D252F AW1613A |
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
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PATIENT RECEIVED FLU FOR AGE 3 AND UP BUT PATIENT IS ONLY 6 MONTHS OLD. PATIENT HAD NO ADVERSE REAC...
PATIENT RECEIVED FLU FOR AGE 3 AND UP BUT PATIENT IS ONLY 6 MONTHS OLD. PATIENT HAD NO ADVERSE REACTIONS.
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| 2822016 | 74 | F | CA | 01/21/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
3041770 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No adverse event, treatment or outcome. Patient received dose of Arexvy on 1/7/2025 despite already ...
No adverse event, treatment or outcome. Patient received dose of Arexvy on 1/7/2025 despite already receiving it on 12/21/2023, reporting only.
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| 2822017 | 16 | F | GA | 01/21/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Bell's palsy, Facial paralysis
Bell's palsy, Facial paralysis
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right sided facial droop; bells palsy
right sided facial droop; bells palsy
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| 2822018 | 69 | M | WA | 01/21/2025 |
FLU3 |
SANOFI PASTEUR |
UT8419DA |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Staff member received high dose flu vaccine 9/11/24. Staff member requested and received high dose f...
Staff member received high dose flu vaccine 9/11/24. Staff member requested and received high dose flu vaccine again today, 1/21/25. No adverse reaction.
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| 2822019 | 62 | F | CA | 01/21/2025 |
RSV |
MODERNA |
3041770 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No adverse event, treatment or outcome, reporting only. Patient received mResvia on 1/8/2025 despite...
No adverse event, treatment or outcome, reporting only. Patient received mResvia on 1/8/2025 despite receiving Arexvy on 12/7/2023.
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| 2822020 | 43 | F | MI | 01/21/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
012H21B 012H21B |
Arthralgia, Borrelia test negative, C-reactive protein normal, Musculoskeletal s...
Arthralgia, Borrelia test negative, C-reactive protein normal, Musculoskeletal stiffness, Peripheral swelling; Red blood cell sedimentation rate normal
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2 days later patient had joint pain in hands and feet , stiffness and swelling in hands and feet
2 days later patient had joint pain in hands and feet , stiffness and swelling in hands and feet
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| 2822021 | 28 | F | IA | 01/21/2025 |
COVID19 |
MODERNA |
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Axillary mass, Breast pain
Axillary mass, Breast pain
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Right side breast hurt, lumps under arm pit, doctor said to come back in 2 weeks if not gone. Gone a...
Right side breast hurt, lumps under arm pit, doctor said to come back in 2 weeks if not gone. Gone after a week.
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| 2822022 | 36 | F | NH | 01/21/2025 |
TDAP TDAP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Allergy to vaccine, Breast pain, Chest pain, Dark circles under eyes, Eye pain; ...
Allergy to vaccine, Breast pain, Chest pain, Dark circles under eyes, Eye pain; Headache, Injection site pain, Muscle tightness, Neck pain, Skin discolouration; Throat tightness
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Pt was given the TdaP vaccine in her left deltoid by MA in usual protocol. Approx 30 seconds after v...
Pt was given the TdaP vaccine in her left deltoid by MA in usual protocol. Approx 30 seconds after vaccine was administered she developed pain at the injection site that progressed to the left breast. Dr came back to the exam room to evaluate patient. She was rocking back and forth holding her left arm with ice pack in place. Dr laid patient back on the exam table with the HOB elevated and asked for EpiPen to be available in the exam room. Patient reported pain progressed up the left side of her chest, neck and head. She then developed HA with pain behind the left eye and jaw tightness. Dr asked for EMS to be called, patient aware. Dr noticed a darkening of the skin of both eyelids and under the eyes. Discoloration then started in the perioral area. Patient then developed some throat tightness. A single dose of EpiPen was administered into the lateral R thigh at 11:51a. Patient reported breathing better approx 2-3 min after Epi was delivered. She denied abdominal pain, nausea, vomiting. Patient was taken to hospital by ambulance. TdaP added to allergy list.
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| 2822023 | 36 | F | 01/21/2025 |
COVID19 |
PFIZER\BIONTECH |
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Injection site erythema, Injection site pruritus
Injection site erythema, Injection site pruritus
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Red itchy skin reaction around the injection area (circle size about 10cm diameter).
Red itchy skin reaction around the injection area (circle size about 10cm diameter).
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| 2822024 | 8 | F | MI | 01/21/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FK5127 FK5127 |
Cerebral cyst, Computerised tomogram head, Electroencephalogram, Gene mutation i...
Cerebral cyst, Computerised tomogram head, Electroencephalogram, Gene mutation identification test positive, Generalised tonic-clonic seizure; Intracranial calcification, Labrune syndrome, Leukodystrophy, Magnetic resonance imaging head abnormal
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4 months to the day after she received this vaccine she had her first grand Maul Seizure. She had an...
4 months to the day after she received this vaccine she had her first grand Maul Seizure. She had an MRI and it shows Global white matter change calcifications and cyst throughout her brain. She has had genetic testing and was diagnosed with Labrune syndrome however the geneticist stated that she only had 1 of the missing components and that it generally takes 2 to have active disease which she does. but if the MRNA changed her DNA than that could account for this change and now my child has a terminal diagnosis
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| 2822025 | 69 | M | PA | 01/21/2025 |
PNC20 |
PFIZER\WYETH |
LP8151 |
Injection site reaction, Muscle twitching, Paraesthesia
Injection site reaction, Muscle twitching, Paraesthesia
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Systemic: Muscle twitching in area of administration-Medium, Systemic: Tingling (specify: facial are...
Systemic: Muscle twitching in area of administration-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: In addition to tinigling in the lower left arm, the patient is experiencing muscle twitching in the area of administation.
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| 2822026 | 60 | M | FL | 01/21/2025 |
COVID19 |
PFIZER\BIONTECH |
N/A |
Cerebrovascular accident, Myocardial infarction
Cerebrovascular accident, Myocardial infarction
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Systemic: Heart Attack-Severe, Systemic: Stroke-Severe, Additional Details: PATIENT SAYS LAST COVID ...
Systemic: Heart Attack-Severe, Systemic: Stroke-Severe, Additional Details: PATIENT SAYS LAST COVID 19 VACCINE HE RECEIVED RESULTED IN HOSPITALIZATION, HE HAD A HEART ATTACK/STROKE ACCORDING TO HIS CARDIOLOGIST.
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| 2822027 | 79 | F | CA | 01/21/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5j959 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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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, Additional Details: patient will go to urgent care, had the same reaxction with pneuminia vaccine, was given antibiotic , Other Vaccines: VaccineTypeBrand: Fluzone High dose; Manufacturer: Sanofi; LotNumber: U8527CA; Route: IM; BodySite: Right arm; Dose: ; VaxDate: UNKNOWN
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