| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2819907 | U | AR | 01/08/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
|
Incorrect route of product administration
Incorrect route of product administration
|
think it was subcutaneous vaccine but it was given intramuscularly; This non-serious case was report...
think it was subcutaneous vaccine but it was given intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: think it was subcutaneous vaccine but it was given intramuscularly). The outcome of the subcutaneous injection formulation administered by other route was 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: 10-DEC-2024 Pharmacist reported the Priorix was subcutaneous vaccine but given intramuscularly, which led subcutaneous injection formulation administered by other route. The reporter consented to follow up.
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| 2819908 | 29 | F | AL | 01/08/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
9594A |
Expired product administered
Expired product administered
|
patient received Priorix after the expiration date; This non-serious case was reported by a nurse vi...
patient received Priorix after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received MMR (Priorix) (batch number 9594A, expiry date 01-DEC-2024) for prophylaxis. On 10-DEC-2024, the patient received Priorix. On 10-DEC-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient received Priorix after the expiration date). The outcome of the expired vaccine used was 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: 10-DEC-2024 The nurse reported that the patient received Priorix after the expiration which led to, expired vaccine used. The vaccine administration facility was the same as primary reporter.
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| 2819909 | M | 01/08/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
patient did not receive 2nd dose yet; This non-serious case was reported by a pharmacist via call ce...
patient did not receive 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 45-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on 30th September 2024 with batch number: H7RF2 and expiry date: 17 January 2026). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not receive 2nd dose yet). The outcome of the incomplete course of vaccination was 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-DEC-2024 The reporter reported that the patient received 1st dose of Twinrix on 30th September 2024. The reporter reported that it was supposed to be a 3 doses series, at zero-month, 1 month and 6 months the reporter had question if the 2nd dose was not given in 1 month, what was the protocol. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter.
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| 2819910 | 0.33 | F | OK | 01/08/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
D947X |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Kinrix was administered to a 4-month patient instead of a 4-year old patient; patient was intended t...
Kinrix was administered to a 4-month patient instead of a 4-year old patient; patient was intended to receive Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. On 06-DEC-2024, the patient received Kinrix. On an unknown date, the patient received Pediarix. On 06-DEC-2024, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 4-month patient instead of a 4-year old patient) and wrong vaccine administered (Verbatim: patient was intended to receive Pediarix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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-DEC-2024 The reporter reported that a dose of Kinrix was administered to a 4-month patient instead of a 4-year-old patient which led to, inappropriate age at vaccine administration. The reporter reported that the patient was intended to receive Pediarix which led to, wrong vaccine administered. The vaccine administration facility was the same as primary reporter.
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| 2819911 | 82 | M | MN | 01/08/2025 |
COVID19 VARZOS |
UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
|
Burning sensation, Injection site pain, Paraesthesia; Burning sensation, Injecti...
Burning sensation, Injection site pain, Paraesthesia; Burning sensation, Injection site pain, Paraesthesia
More
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burning sensation; left side of his body had a tingling sensation; injection site pain; This non-ser...
burning sensation; left side of his body had a tingling sensation; injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. Previously administered products included Shingrix (Patient received first dose on an unknown date). On 08-OCT-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) and COVID-19 vaccine (left arm). On 12-OCT-2024, 4 days after receiving Shingrix, the patient experienced burning sensation (Verbatim: burning sensation) and tingling sensation (Verbatim: left side of his body had a tingling sensation). In OCT-2024, the patient experienced injection site pain (Verbatim: injection site pain). The outcome of the injection site pain was unknown and the outcome of the burning sensation and tingling sensation were not resolved. It was unknown if the reporter considered the injection site pain, burning sensation and tingling sensation to be related to Shingrix. It was unknown if the company considered the injection site pain, burning sensation and tingling sensation to be related to Shingrix. Additional Information: GSK Receipt Date:12-DEC-2024 Patient reported a reaction after receiving his second Shingrix vaccine and Covid-19 vaccine at the same time in the same arm. He reported that 2 days later he had injection site pain. Also reported that 2 days later the left side of his body had a tingling sensation the tingling was on the left side of the face, neck arm and thigh. Patient reported the tingling on the left arm was the most bothersome and there was a burning sensation on the left thigh. The doctor was just watching it to see if it goes away, no medications were prescribed. The doctor informed the patient that it was a reaction to the Shingrix vaccine, not the Covid-19 vaccine.
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| 2819912 | 11 | F | NJ | 01/08/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
3S54K |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
11 year old female received Havrix adult vaccine; 11 year old female received Havrix adult vaccine; ...
11 year old female received Havrix adult vaccine; 11 year old female received Havrix adult vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 11-year-old female patient who received HAV (Havrix 1440 adult) (batch number 3S54K, expiry date 18-DEC-2025) for prophylaxis. On 12-DEC-2024, the patient received the 1st dose of Havrix 1440 adult (left deltoid). On 12-DEC-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced adult product administered to child (Verbatim: 11 year old female received Havrix adult vaccine) and overdose (Verbatim: 11 year old female received Havrix adult vaccine). The outcome of the adult product administered to child and overdose 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-DEC-2024 The health care professional reported that an 11 year old female received Havrix-adult vaccine today on 12th December 2024 which led to adult product administration to child and overdose. She stated it was given in left deltoid.
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| 2819913 | U | IL | 01/08/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
received first dose of Engerix-B 20mcg on 16-AUG-2023 and were asking how to proceed with schedule; ...
received first dose of Engerix-B 20mcg on 16-AUG-2023 and were asking how to proceed with schedule; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B adult) for prophylaxis. Previously administered products included Engerix b adulto (received first dose on 16-AUG-2023). On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: received first dose of Engerix-B 20mcg on 16-AUG-2023 and were asking how to proceed with schedule). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 16-DEC-2024 The pharmacist reported that the patient received their first dose of Engerix-B adult and were asking how to proceed with schedule. Till the time of reporting, the patient did not receive 2nd dose of Engerix B adult, which led to incomplete course of vaccination.
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| 2819914 | U | KY | 01/08/2025 |
COVID19-2 |
MODERNA |
043H22A |
Balance disorder, Fall, Headache, Limb injury, Multi-organ disorder
Balance disorder, Fall, Headache, Limb injury, Multi-organ disorder
|
My balance and equilibrium etc was affected by COVID-19 Virus; My balance and equilibrium etc was af...
My balance and equilibrium etc was affected by COVID-19 Virus; My balance and equilibrium etc was affected by COVID-19 Virus, as well as All of my vital organs, Etc; Headaches that are a 10+; fell in my bed room; injured my right leg; This spontaneous case was reported by a patient and describes the occurrence of FALL (fell in my bed room), LIMB INJURY (injured my right leg), BALANCE DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus), MULTI-ORGAN DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus, as well as All of my vital organs, Etc) and HEADACHE (Headaches that are a 10+) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. In December 2024, the patient experienced FALL (fell in my bed room) and LIMB INJURY (injured my right leg). On an unknown date, the patient experienced BALANCE DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus), MULTI-ORGAN DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus, as well as All of my vital organs, Etc) and HEADACHE (Headaches that are a 10+). At the time of the report, FALL (fell in my bed room), LIMB INJURY (injured my right leg), BALANCE DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus) and MULTI-ORGAN DISORDER (My balance and equilibrium etc was affected by COVID-19 Virus, as well as All of my vital organs, Etc) outcome was unknown and HEADACHE (Headaches that are a 10+) had resolved. On 14-Jan-2021, the patient received first dose of Moderna COVID-19 Vaccine. On 12-Feb-2021, received second dose of Moderna COVID-19 Vaccine (Lot: 006M20A). Concomitant medication was not reported. It was reported that patient was over 92 years old now, fell in bedroom 11 days ago and injured right leg severely. Patient balance equilibrium etc. was affected by the covid-19 virus, as well as all of vital organs etc. Headache that was a 10+ and last for several days and nights and required two ice packs 24/7 until finally dissipate. It was mentioned that patient has more than a dozen symptoms from covid-19 infection that deal with daily. Treatment medication was not reported. This case was linked to MOD-2024-776499 (Patient Link).
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| 2819915 | 60 | F | ME | 01/08/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
8080803 8080803 DA7P5 DA7P5 |
CSF glucose decreased, CSF protein increased, CSF red blood cell count positive,...
CSF glucose decreased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Headache; Magnetic resonance imaging spinal abnormal, Meningitis, Nausea, Spinal cord haemorrhage, Vomiting; CSF glucose decreased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Headache; Magnetic resonance imaging spinal abnormal, Meningitis, Nausea, Spinal cord haemorrhage, Vomiting
More
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PRESENTED TO ER WITH HEADACHE, NAUSEA, VOMITING. FOUND TO HAVE MENINGITIS AND SPINAL HEMORRAHGE
PRESENTED TO ER WITH HEADACHE, NAUSEA, VOMITING. FOUND TO HAVE MENINGITIS AND SPINAL HEMORRAHGE
|
โ | |||||
| 2819916 | 30 | F | NC | 01/08/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
lm2216 388518 |
Injected limb mobility decreased, Muscular weakness, Pain in extremity; Injected...
Injected limb mobility decreased, Muscular weakness, Pain in extremity; Injected limb mobility decreased, Muscular weakness, Pain in extremity
More
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Patient is feeling consistent pain, weakness, and restricted movement in the left arm since the vacc...
Patient is feeling consistent pain, weakness, and restricted movement in the left arm since the vaccination. Patient went to her dr who is referring her to an orthopedic specialist
More
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| 2819917 | 0.17 | F | TX | 01/08/2025 |
HEPA PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
A3X2K HR3650 Y003996 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
More
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Havrix was ordered and administered in lieu of Vaxelis.
Havrix was ordered and administered in lieu of Vaxelis.
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| 2819918 | 33 | F | 01/08/2025 |
MMR |
MERCK & CO. INC. |
Y011637 |
Exposure during pregnancy
Exposure during pregnancy
|
32 WEEKS GESTATION received MMR vaccine
32 WEEKS GESTATION received MMR vaccine
|
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| 2819919 | 85 | F | 01/08/2025 |
FLU3 |
SANOFI PASTEUR |
|
Neck pain, Pain in extremity
Neck pain, Pain in extremity
|
sore arm and neck still on 1/6/25 from this
sore arm and neck still on 1/6/25 from this
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| 2819920 | 65 | F | NC | 01/08/2025 |
COVID19 COVID19 RSV RSV |
PFIZER\BIONTECH PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
LN0588 LN0588 J9493 J9493 |
Brain fog, Dizziness, Fall, Head injury, Headache; Loss of consciousness; Brain ...
Brain fog, Dizziness, Fall, Head injury, Headache; Loss of consciousness; Brain fog, Dizziness, Fall, Head injury, Headache; Loss of consciousness
More
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On January 7; while walking dog, I started getting dizzy reached out and grabbed nearby fence and b...
On January 7; while walking dog, I started getting dizzy reached out and grabbed nearby fence and blacked out -- fell to ground hit and back of head. Husband was with me and he woke me up and we came home. Put ice on head to reduce swelling on bump. I was foggy and had a slight headache. January 8, I still have a headache and foggy and waiting for doctor to recommend course of action
More
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| 2819921 | 71 | M | 01/08/2025 |
PNC20 |
PFIZER\WYETH |
|
Extra dose administered
Extra dose administered
|
Patient received Prevnar 20 twice. Secon vaccine was not needed
Patient received Prevnar 20 twice. Secon vaccine was not needed
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| 2819922 | 17 | F | WI | 01/08/2025 |
HEP MMR MNQ TDAP VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
944941 JE9TP U8194AA 3RE73 Y008361 |
No adverse event; No adverse event; No adverse event; No adverse event; No adver...
No adverse event; No adverse event; No adverse event; No adverse event; No adverse event
More
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No Known Adverse Events
No Known Adverse Events
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| 2819923 | 83 | F | FL | 01/08/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
52z52 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
pt received an inappropriate 2nd Arexvy vaccine 14 months after receiving the 1st - pt had no advers...
pt received an inappropriate 2nd Arexvy vaccine 14 months after receiving the 1st - pt had no adverse reactions or other issues
More
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| 2819924 | 13 | F | MD | 01/08/2025 |
PNC20 |
PFIZER\WYETH |
HH4722 |
No adverse event
No adverse event
|
Patient received PCV 20 instead of the second dose of HPV she was scheduled to receive. There was no...
Patient received PCV 20 instead of the second dose of HPV she was scheduled to receive. There was no known adverse reaction but an vaccine administration error. This has been reported to the parent of the child and discussed in length with the Nurse and MA responsible for the error. The person reporting is the program Supervisor whom was not in the room when the error took place. Discussed with parent that the child will still require her second HPV to complete the series if they would like it.
More
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| 2819925 | 56 | F | LA | 01/08/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Fatigue, Pyrexia, Vaccination site erythema, Vaccination site swelling
Fatigue, Pyrexia, Vaccination site erythema, Vaccination site swelling
|
Pain and 5cm area of redness and swelling to vaccination site on left upper arm, lasting about 5 da...
Pain and 5cm area of redness and swelling to vaccination site on left upper arm, lasting about 5 days. Low grade fever of 99.5 and feeling very tired on 2nd and 3rd day.
More
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| 2819926 | 88 | F | NC | 01/08/2025 |
FLU3 |
SEQIRUS, INC. |
388490 |
Dizziness
Dizziness
|
Patient became dizzy after receiving Fluad vaccine.
Patient became dizzy after receiving Fluad vaccine.
|
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| 2819927 | 38 | F | OH | 01/08/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
Y3ME2 |
No adverse event, Underdose
No adverse event, Underdose
|
Vaccination error occurred when pediatric Hep A dose was given instead of the adult Hep B dose that ...
Vaccination error occurred when pediatric Hep A dose was given instead of the adult Hep B dose that was requested. Once identified, discussed with patient signs and symptoms to report. Offered to come back to clinic to give Hep B and patient declined at this time. She reported she will get vaccine next month if she is still at Works. Discussed error with administrator. No Adverse reaction occurred.
More
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| 2819928 | 67 | F | SC | 01/08/2025 |
COVID19 |
PFIZER\BIONTECH |
lp1776 |
Pain in extremity, Product administered at inappropriate site
Pain in extremity, Product administered at inappropriate site
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Patient called on 01/03/25 to inform us that she received this vaccination in the wrong area of her ...
Patient called on 01/03/25 to inform us that she received this vaccination in the wrong area of her deltoid. Patient expressed her arm hurt even after it being 2 weeks and was seen by a provider for the issue.
More
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| 2819929 | 90 | M | IA | 01/08/2025 |
COVID19 |
MODERNA |
3043159 |
COVID-19, Death, SARS-CoV-2 test positive
COVID-19, Death, SARS-CoV-2 test positive
|
Death
Death
|
โ | |||||
| 2819930 | 77 | F | TN | 01/08/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
NM5G5 |
Injection site bruising, Injection site swelling
Injection site bruising, Injection site swelling
|
The patient reported swelling and bruising at the injection site. She used over the counter pain me...
The patient reported swelling and bruising at the injection site. She used over the counter pain medications and ice therapy. She did not come back in for me to examine the site but states it was very swollen and black and blue
More
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| 2819931 | 1.33 | M | MI | 01/08/2025 |
DTAP FLU3 HEPA MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
TX77L 4795R HR4RB X018904 X000999 |
Incorrect dose administered; Incorrect dose administered; Incorrect dose adminis...
Incorrect dose administered; Incorrect dose administered; Incorrect dose administered; Incorrect dose administered; Incorrect dose administered
More
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The Hepatitis A vaccination given to 16 month old child was the adult dose. Called and informed heal...
The Hepatitis A vaccination given to 16 month old child was the adult dose. Called and informed health department and patients mother. 01/08/2025 at 10:45am
More
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| 2819932 | 65 | F | VA | 01/08/2025 |
COVID19 |
MODERNA |
NDC 80777-0110- |
Injection site mass, Rash erythematous, Rash pruritic, Skin warm
Injection site mass, Rash erythematous, Rash pruritic, Skin warm
|
A couple of days after I received the vaccine, I noticed a large bump (like a muscular knot) on my l...
A couple of days after I received the vaccine, I noticed a large bump (like a muscular knot) on my left arm, but it was three or four inches below the injection site. Also, below and to the right of this bump/knot (i.e., even FURTHER away from the injections site), there was a red, rashy/itchy place on my arm that was the size of a baseball and almost perfectly round. It was warm to the touch. Concerned and not knowing what else to do, I did what I have often read that one should do with areas around the injection site of a normal flu shot -- I massaged the bump/knot and the red, rashy/itchy area that was the size of a baseball. In a day or two, it was gone. NOTE: This was my EIGHTH COVID vaccine, and all I have been Moderna. Although I have had some sort of fatigue with all of the COVID vaccines, this was the first time I experienced an outward manifestation of this type.
More
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| 2819933 | 0.5 | M | CT | 01/08/2025 |
DTPPVHBHPB FLU3 PNC20 RV5 |
MSP VACCINE COMPANY SEQIRUS, INC. PFIZER\WYETH MERCK & CO. INC. |
U7767BA 391439 HN2630 2003166 |
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; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
More
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Pt was given dose number 2 of flucelevax too soon to first dose. No symptoms.
Pt was given dose number 2 of flucelevax too soon to first dose. No symptoms.
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| 2819934 | 64 | F | MA | 01/08/2025 |
PNC20 |
PFIZER\WYETH |
LG5578 |
Headache
Headache
|
headache which lasted for about 18 hours. no treatment needed.
headache which lasted for about 18 hours. no treatment needed.
|
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| 2819935 | 0.33 | F | GA | 01/08/2025 |
DTAPHEPBIP HIBV PNC20 RV5 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH MERCK & CO. INC. |
|
Immediate post-injection reaction, Skin lesion, Urticaria; Immediate post-inject...
Immediate post-injection reaction, Skin lesion, Urticaria; Immediate post-injection reaction, Skin lesion, Urticaria; Immediate post-injection reaction, Skin lesion, Urticaria; Immediate post-injection reaction, Skin lesion, Urticaria
More
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Immediately broke out in urticaria after all injections administered. Urticaria developed on legs bi...
Immediately broke out in urticaria after all injections administered. Urticaria developed on legs bilaterally first, and then developed two lesions on lower lip. Benadryl administered in office. No respiratory complaints noted. No vomiting noted.
More
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| 2819936 | 83 | M | MN | 01/08/2025 |
COVID19 |
MODERNA |
036A21A |
COVID-19, SARS-CoV-2 test positive
COVID-19, SARS-CoV-2 test positive
|
Hospitalization related to COVID 19 following completion of primary vaccine series
Hospitalization related to COVID 19 following completion of primary vaccine series
|
โ | |||||
| 2819937 | 11 | M | NY | 01/08/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
FX3ED |
Erythema, Fall
Erythema, Fall
|
Received a phone call from school nurse stating child's left arm looked slightly red on 01/07/2...
Received a phone call from school nurse stating child's left arm looked slightly red on 01/07/2025. Nurse circled area and kept an eye on it until child came to school on 01/08/2025 with redness now outside of border drawn by nurse on the day before. Nurse called Pediatrician's office and had child come in to be evaluated by Pediatrician. Father states child was playing after receiving vaccines and fell on left arm. Child had no pain or complaints. Given Benadryl 25mg in office. Pediatrician advised father to give Benadryl for 3 days and to follow up in one week.
More
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| 2819938 | 29 | F | CO | 01/08/2025 |
RSV TDAP |
PFIZER\WYETH SANOFI PASTEUR |
|
Pyrexia, Tachycardia; Pyrexia, Tachycardia
Pyrexia, Tachycardia; Pyrexia, Tachycardia
|
Tachycardia x 36 hours; Fever 101.3
Tachycardia x 36 hours; Fever 101.3
|
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| 2819939 | 74 | F | IA | 01/08/2025 |
FLU3 |
SANOFI PASTEUR |
u8429aa |
Pain in extremity
Pain in extremity
|
Patient states that her arm has been hurt since the vaccine. Patient did show me location where shot...
Patient states that her arm has been hurt since the vaccine. Patient did show me location where shot was administered and it was in the appropriate location on the deltoid muscle on the left arm .
More
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| 2819940 | 8 | M | AZ | 01/08/2025 |
COVID19 |
MODERNA |
|
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 8 years old and was accidentally given the Moderna COVID vaccine meant for patients 12 an...
Patient is 8 years old and was accidentally given the Moderna COVID vaccine meant for patients 12 and older. He experienced no adverse side effects.
More
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| 2819942 | 84 | F | MN | 01/08/2025 |
COVID19 |
PFIZER\BIONTECH |
EN6199 |
COVID-19, SARS-CoV-2 test positive
COVID-19, SARS-CoV-2 test positive
|
Hospitalization related to COVID 19 following completion of primary vaccine series
Hospitalization related to COVID 19 following completion of primary vaccine series
|
โ | |||||
| 2819943 | 21 | F | TX | 01/08/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
lm2221 tfaa2448 |
Dizziness, Gait disturbance; Dizziness, Gait disturbance
Dizziness, Gait disturbance; Dizziness, Gait disturbance
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Patient felt dizzy 5min after injection and was staggering a little. She felt better after 20 minute...
Patient felt dizzy 5min after injection and was staggering a little. She felt better after 20 minutes.
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| 2819944 | 69 | M | MN | 01/08/2025 |
COVID19 |
PFIZER\BIONTECH |
EN6199 |
COVID-19, SARS-CoV-2 test positive
COVID-19, SARS-CoV-2 test positive
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Hospitalization related to COVID 19 following completion of primary vaccine series
Hospitalization related to COVID 19 following completion of primary vaccine series
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| 2819945 | 76 | F | MD | 01/08/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
LN0588 U8429CA |
Confusional state, Crying, Screaming; Confusional state, Crying, Screaming
Confusional state, Crying, Screaming; Confusional state, Crying, Screaming
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Patient was getting both Comirnaty as well as Fluzone HD. She was pleasant and alert throughout the ...
Patient was getting both Comirnaty as well as Fluzone HD. She was pleasant and alert throughout the vaccination process. After receiving the vaccination, while she was putting her coat, she started to cry and say, "It is so hard", "My mother came in with me", and then started screaming for her mother, stating "Mom, mom, where are you?" We were able to calm her down a little by telling her to sit and we would find her mother. She then stated that, "My mom is in heaven but sometimes she is here with me." She sat for about a minute but then insisted on going home. The pharmacist made sure she was comfortable with going on her own, asked if there was anyone we could call. She stated no and that she would be fine to go. She seemed to be back to her normal state of mind. She insisted on going home and the pharmacy clerk walked her to her car. At 2:00PM, the pharmacist called her to make sure she made it home safely. She was at home and stated that she is resting. She did indicate that she has been feeling sudden onset confusion lately.
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| 2819946 | 68 | F | FL | 01/08/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site erythema, Nausea, Vomiting
Injection site erythema, Nausea, Vomiting
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Nausea, vomiting and large red area where I got injection
Nausea, vomiting and large red area where I got injection
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| 2819948 | 59 | F | 01/08/2025 |
PNC21 |
MERCK & CO. INC. |
y013009 |
Pruritus, Urticaria
Pruritus, Urticaria
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Within 12-24 hour after inection, patient experienced widespred hives and intense itching. Denies a...
Within 12-24 hour after inection, patient experienced widespred hives and intense itching. Denies any fever/chills/swelling/difficulty breathing. Took zyrtec, pepcid, and benadryl without any improvement in symptoms. On 1/8, was seen by provider for course of prednisone.
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| 2819949 | 79 | F | MN | 01/08/2025 |
COVID19 |
MODERNA |
002B21A |
COVID-19, SARS-CoV-2 test positive
COVID-19, SARS-CoV-2 test positive
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Hospitalization related to COVID 19 following completion of primary vaccine series
Hospitalization related to COVID 19 following completion of primary vaccine series
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| 2819950 | 6 | M | OK | 01/08/2025 |
MMRV |
MERCK & CO. INC. |
Y002099 |
No adverse event, Product storage error
No adverse event, Product storage error
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patient was given immunization that was not storred appropriately, no adverse reaction reported by p...
patient was given immunization that was not storred appropriately, no adverse reaction reported by patient
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| 2819951 | 72 | M | NC | 01/08/2025 |
COVID19 |
MODERNA |
3044202 |
Dizziness, Vomiting
Dizziness, Vomiting
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Dizziness and had vomited once ,the symptoms started 4 days after getting the vaccination
Dizziness and had vomited once ,the symptoms started 4 days after getting the vaccination
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| 2819952 | 40 | F | MS | 01/08/2025 |
VARCEL |
MERCK & CO. INC. |
y006523 |
Dizziness, Hyperhidrosis
Dizziness, Hyperhidrosis
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After receiving Varivax, the patient complained of increased sweating and complaints of being dizzy....
After receiving Varivax, the patient complained of increased sweating and complaints of being dizzy. Vital signs were obtained and were WNL. Nurse encouraged the patient to go to the ER if s/s worsened. A follow up was made to contact number listed and nurse. Unable to reach the patient. On 1/7/2025 the patient called the clinic and stated that the reason she was unable to be reached on 12/17/1014 evening is due to fact that she went to the ER related to worsening symptoms. Was triaged at ER. Vital signs WNL. Patient left the ER without seeing a doctor/provider.
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| 2819953 | 83 | M | MN | 01/08/2025 |
COVID19 |
MODERNA |
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COVID-19, SARS-CoV-2 test positive
COVID-19, SARS-CoV-2 test positive
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Hospitalization related to COVID 19 following completion of primary vaccine series
Hospitalization related to COVID 19 following completion of primary vaccine series
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| 2819954 | 66 | F | FL | 01/08/2025 |
FLU3 FLU3 FLU3 PNC20 PNC20 PNC20 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
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Dysgeusia, Headache, Hypoaesthesia, Nasopharyngitis, Pain; Paraesthesia, Periphe...
Dysgeusia, Headache, Hypoaesthesia, Nasopharyngitis, Pain; Paraesthesia, Peripheral swelling, Pruritus, Sinus congestion, Sneezing; Vision blurred; Dysgeusia, Headache, Hypoaesthesia, Nasopharyngitis, Pain; Paraesthesia, Peripheral swelling, Pruritus, Sinus congestion, Sneezing; Vision blurred
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pt says after getting the shots she started tasting the the medicine in the back of her throat and t...
pt says after getting the shots she started tasting the the medicine in the back of her throat and then her left index finger started itching. Her left heel started itching. These symptoms only lasted seconds. By the evening time her left arm was very swollen. Her left arm and fingers were numb and tingling. This lasted a couple of days and it would come and go. A few days after that she had some swelling in the left forearm, hand and fingers that caused some tingling and itching. On Dec. 30th she had some head congestion, head aches, blurred vision, sneezing, and body aches with no fever. The cold symptoms are better today but she is having more numbness and tingling in the left arm, palm of her hand and fingers. She has taken some photos of the swelling. She contacted her her PCP but is still waiting on a call back. She will also give her allergist a call to let him know if case she needs medical treatment.
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| 2819955 | 65 | F | MN | 01/08/2025 |
COVID19 |
PFIZER\BIONTECH |
EN6203 |
COVID-19, SARS-CoV-2 test positive
COVID-19, SARS-CoV-2 test positive
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Hospitalization related to COVID 19 following completion of primary vaccine series
Hospitalization related to COVID 19 following completion of primary vaccine series
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| 2819956 | 1.33 | M | NC | 01/08/2025 |
MMR MMR MMR MMR |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Aphasia, Blood test normal, Crying, Decreased interest, Discomfort; Flat affect,...
Aphasia, Blood test normal, Crying, Decreased interest, Discomfort; Flat affect, Irritability, Lethargy, Mobility decreased, Musculoskeletal stiffness; Opisthotonus, Pain, Pyrexia, Restlessness, Somnolence; Ultrasound scan normal, Vomiting, X-ray normal
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On December 20th patient developed a 102 temperature and was fussy. On December 4th he started vomit...
On December 20th patient developed a 102 temperature and was fussy. On December 4th he started vomiting (7 times within 24 hours), then developed a 102 temperature next day. He was lethargic and had random outbursts of pain and discomfort. After 3 days of him being lethargic, not mobile, won't walk, won't talk, has no interest in anything, and hasn't smiled, something was wrong. We took him to Urgent Care then they wanted me to take him to the ER By the time we took him there, his neck was stiff and he was curling his back and wouldn't rest. I was worried about Meningitis but the stiff neck was really the only symptom. He was and still is irritable, won't move, and is in pain. X-ray came back normal, no ammonia. Sonogram came back normal Blood work came back ok. What's interesting is that Monday night at bedtime when I was holding him upright, he suddenly thrusted his neck back and arched his back. I remember his eyes looking at me but he wasn't crying. He is a strong kid and sometimes will forcefully move when he wants out of my arms but this was different. I laid him back as I continued to feel force. I think at that time something internally was happening and the thrust gave him Torticollis. What I mentioned to the Urgent Care & Emergency Room visits is that he was given the MMR shot less than 3 weeks of all this happening. I'd like it noted and recorded in his records. that he had this adverse reaction to the vaccine.? This was the first vaccine where he developed a high fever the next day and ever since that vaccine he has been fussier than he typically is.? If he really had Neurovirus or a stomach flu - both highly contagious, no one else in the house got it.? We think the vomiting, fever, neck thrusting, stiff neck, and arched back area an adverse reaction from the metals in the MMR vaccine. This was an is still very scary. We're just praying patient comes back to life and normal sometime soon. He isn't showing interest in toys, lies/sleeps (lethargic) all day, randomly cries, isn't talking, isn't singing, no dancing or walking, and even baths are miserable.
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| 2819957 | 83 | F | NC | 01/08/2025 |
COVID19 |
PFIZER\BIONTECH |
EL1283 |
Dementia with Lewy bodies, Loss of personal independence in daily activities, Ne...
Dementia with Lewy bodies, Loss of personal independence in daily activities, Neurological symptom
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Within weeks, patient began having Guillain Barre Syndrome symptoms and then neurological symptoms. ...
Within weeks, patient began having Guillain Barre Syndrome symptoms and then neurological symptoms. She was no longer able to do any physical work due to GBS symptoms and was diagnosed not long after with Lewy Body Dementia.
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| 2819958 | 3 | F | TN | 01/08/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered
Extra dose administered
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Pediarix was given as dose 4 of polio vaccination. Pediarix is not authorized for dose 4 of polio va...
Pediarix was given as dose 4 of polio vaccination. Pediarix is not authorized for dose 4 of polio vaccination.
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