| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2852881 | 85 | M | ID | 08/05/2025 |
PNC20 |
PFIZER\WYETH |
P-LN4931 |
Extra dose administered
Extra dose administered
|
Patient received a 2nd dose of prevnar 20. He was vaccinated 8/5/2024 with prevnar 20.
Patient received a 2nd dose of prevnar 20. He was vaccinated 8/5/2024 with prevnar 20.
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| 2852882 | 54 | M | AR | 08/05/2025 |
PNC21 |
MERCK & CO. INC. |
Z004301 |
Injection site nodule
Injection site nodule
|
Patient perceives small nodule in left arm near area where vaccine was provided. He reports no pain...
Patient perceives small nodule in left arm near area where vaccine was provided. He reports no pain, and no swelling or redness observed. He first noticed about a day after vaccine and still slightly perceives it.
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| 2852883 | 21 | F | IN | 08/05/2025 |
YF |
SANOFI PASTEUR |
UK137AA |
Product preparation error
Product preparation error
|
There were 2 boxes of diluent next to each other. Unfortunately, the pharmacist giving vaccine for t...
There were 2 boxes of diluent next to each other. Unfortunately, the pharmacist giving vaccine for the first time saw the bigger box of sterile water and the not the small YF diluent box. Pharmacist used STERILE WATER to reconstitute. The error was detected when there was more YF diluent than vaccine. The manufacturer and the patient was contacted. Based on the manufacturer recommendations, the patient decided to get revaccinated upon returning from her trip.
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| 2852884 | 76 | M | IL | 08/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
X72D2 |
Discomfort, Hypoaesthesia, Peripheral swelling
Discomfort, Hypoaesthesia, Peripheral swelling
|
Swelling of left arm, numbness that has persisted for 3+ months, discomfort level 4+
Swelling of left arm, numbness that has persisted for 3+ months, discomfort level 4+
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| 2852893 | 60 | M | 08/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
E754F |
Asthenia, Hypoaesthesia, Musculoskeletal pain, Pain
Asthenia, Hypoaesthesia, Musculoskeletal pain, Pain
|
Lt arm numbness, weakness, pain, stabbing pain to LT shoulder blade area.
Lt arm numbness, weakness, pain, stabbing pain to LT shoulder blade area.
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| 2852894 | 17 | F | CA | 08/05/2025 |
PNC20 |
PFIZER\WYETH |
LN4931 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
The adverse event involved the administration of the incorrect vaccine (PCV20) to a patient who was ...
The adverse event involved the administration of the incorrect vaccine (PCV20) to a patient who was due for the HPV vaccine. The error was identified during the verification process by the supervising provider; however, the vaccine was administered despite the warning. At the time of this report, the patient has not exhibited any immediate adverse symptoms or signs (e.g., fever, injection site reaction, allergic response). The patient was notified of the incident and is being monitored for any delayed reactions. The correct vaccine (HPV) has been rescheduled per provider recommendation. As a precaution, no specific treatment was required following the administration error. The incident was documented, and follow-up care instructions were provided to the patient/guardian.
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| 2852895 | 79 | F | NV | 08/05/2025 |
FLU3 |
SANOFI PASTEUR |
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Injection site bruising, Injection site erythema, Injection site pain
Injection site bruising, Injection site erythema, Injection site pain
|
Patient reported to pharmacy #5619 where she received her vaccination 2 days ago, and showed that he...
Patient reported to pharmacy #5619 where she received her vaccination 2 days ago, and showed that her upper left arm around the vaccination site was visibly red and bruised. Reported that there was pain and a burning sensation that's been progressing since she received her vaccine. Patient was advised to treat any symptoms and discomfort with ibuprofen and/or acetaminophen and to ice around the site, and that the pharmacist will check with her tomorrow and see how she is feeling. Will also reach out to her physician if anything progresses.
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| 2852896 | 73 | F | PA | 08/05/2025 |
FLU3 |
SANOFI PASTEUR |
U8764BB |
Pruritus, Skin irritation
Pruritus, Skin irritation
|
Pharmacy was contacted by physician stating patient's left arm was irritated and itchy
Pharmacy was contacted by physician stating patient's left arm was irritated and itchy
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| 2852897 | 80 | F | 08/05/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Feeling cold, Retching, Tremor
Feeling cold, Retching, Tremor
|
In the middle of the night after receiving the vaccine, patient started getting shakes, dray heaves,...
In the middle of the night after receiving the vaccine, patient started getting shakes, dray heaves, and felt freezing cold. Symptoms lasted for about 2 days
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| 2852898 | 52 | F | CA | 08/05/2025 |
UNK |
UNKNOWN MANUFACTURER |
LP4948 |
Injection site pain, Injection site reaction, Rash erythematous
Injection site pain, Injection site reaction, Rash erythematous
|
red rash and tenderness below injection site 6 inches in width and 1 inch high.
red rash and tenderness below injection site 6 inches in width and 1 inch high.
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| 2852899 | 67 | F | TX | 08/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
2a3hy |
Dizziness, Headache, Nausea
Dizziness, Headache, Nausea
|
patient experienced headache, nausea, light headedness for 8 days plus after vaccination
patient experienced headache, nausea, light headedness for 8 days plus after vaccination
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| 2852900 | 67 | F | 08/05/2025 |
PNC20 |
PFIZER\WYETH |
lx4482 |
Extra dose administered
Extra dose administered
|
additional dose received
additional dose received
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| 2852901 | 42 | M | OH | 08/05/2025 |
COVID19 |
MODERNA |
|
Herpes zoster
Herpes zoster
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I got shingles a week after the Covid 19 vaccine. It was early onset (I was in my young 40s) and I b...
I got shingles a week after the Covid 19 vaccine. It was early onset (I was in my young 40s) and I believed it to be directly related to the vaccine. I?ve heard from others that shingles activation is not uncommon.
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| 2852452 | 16 | F | GA | 08/04/2025 |
MMRV |
MERCK & CO. INC. |
|
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
|
No symptomatic events were reported; PROQUAD dose given to a 16 year old female; This spontaneous re...
No symptomatic events were reported; PROQUAD dose given to a 16 year old female; This spontaneous report was received from a Physician Assistant (reported as medical assistant) and refers to a 16-years-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 17-JUL-2025, the 16-years-old patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection, administered for prophylaxis (dose, route of administration, anatomical site of injection, lot number and expiration date were not reported), which was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) (Product administered to patient of inappropriate age). No symptomatic events or additional adverse events were reported for the patient (No adverse event). No additional information was provided.
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| 2852453 | 1.08 | VA | 08/04/2025 |
VARCEL |
MERCK & CO. INC. |
Y019318 |
No adverse event, Product storage error
No adverse event, Product storage error
|
No additional AE; HCP reporting that a patient received a dose of improperly stored VARIVAX; This sp...
No additional AE; HCP reporting that a patient received a dose of improperly stored VARIVAX; This spontaneous report was received from a Nurse and refers to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 09-Jun-2025, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka-merck) (VARIVAX), 0.5 mL, administered as prophylaxis (Lot No. Y019318 has been verified to be a valid lot number for [varicella virus vaccine live (oka-merck)], expiration date reported and upon internal validation established as 21-Nov-2026) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided); that was reconstituted with sterile diluent (Lot No., expiration date, route and indication was not provided (product storage error), after a temperature excursion of 52.2 degree Fahrenheit (F) with an unknown time frame. No previous temperature excursion was reported. No additional information or adverse events were provided (no adverse event).
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| 2852454 | F | 08/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Exposure during pregnancy, Product use issue
Exposure during pregnancy, Product use issue
|
Arexvy given to pregnant women; Arexvy given to pregnant women; This non-serious prospective pregnan...
Arexvy given to pregnant women; Arexvy given to pregnant women; This non-serious prospective pregnancy case was reported by a pharmacist via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy given to pregnant women) and product use in unapproved population (Verbatim: Arexvy given to pregnant women). The outcome of the vaccine exposure during pregnancy and product use in unapproved population were not applicable. Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 22-JUL-2025 The pharmacist reported that while attending the meeting, the presenter mentioned that several pregnant women had been given Arexvy which led to drug used in unapproved population and vaccine exposure during pregnancy. It was asked to remember that the one with the x should not be used in pregnancy.
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| 2852455 | F | MT | 08/04/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
late for her 2nd dose of the accelerated schedule for Twinrix; This non-serious case was reported by...
late for her 2nd dose of the accelerated schedule for Twinrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: late for her 2nd dose of the accelerated schedule for Twinrix). The outcome of the drug dose administration interval too long was not applicable. 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: 25-JUL-2025 The patient self-reported this case. The patient was late for her 2nd dose of the accelerated schedule for Twinrix. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
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| 2852456 | 08/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; had my vaccine and still got them right now; This serious case was r...
Suspected vaccination failure; had my vaccine and still got them right now; 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 (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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had my vaccine and still got them right now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 25-JUL-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she had vaccine and still got them right now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and 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 the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2852457 | 7 | F | OH | 08/04/2025 |
HIBV |
SANOFI PASTEUR |
UK113AB |
No adverse event, Product preparation error
No adverse event, Product preparation error
|
acthib vaccination was prepared with a merck sterile diluent, not the diluent provided in the packag...
acthib vaccination was prepared with a merck sterile diluent, not the diluent provided in the packaging, with no reported adverse event; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 7 years old female patient (124.46 cm and 21.82 kg) who was vaccinated with HIB (PRP/T) Vaccine [ACT-HIB] which was prepared with a merck sterile diluent, not the diluent provided in the packaging, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Jun-2025, the patient received 0.5mL of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK113AB, expiry date and strength not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) and vaccination was prepared with a merck sterile diluent, not the diluent provided in the packaging, with no reported adverse event (product preparation error) (latency same day). Reportedly, acthib vaccination was prepared with a merck sterile diluent, not the diluent provided in the packaging. Error was detected during monthly inventory of vaccines when 5 diluents were noted and only 4 vials of the powder. Action taken was not applicable. 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. Additional information was received on 30-Jul-2025 via Physician: Patient details has been added, lot number and dose of the suspect have been added. Narrative amended accordingly.
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| 2852458 | 16 | M | CA | 08/04/2025 |
MEN |
UNKNOWN MANUFACTURER |
U8493AA |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
|
reconstituted MENQUADFI with sterile diluent for vaccines, with no reported adverse event; Initial i...
reconstituted MENQUADFI with sterile diluent for vaccines, with no reported adverse event; Initial information received on 30-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA222935 (cluster case). This case involves a 16-year-old male patient who was administered with Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] which was reconstituted with sterile diluent for vaccines, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV Vaccine for Immunisation. On 29-Jul-2025, the patient received an unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection standard strength (lot U8493AA and expiry date- 31-Aug-2025) (frequency-once) via intramuscular route in the left deltoid for Immunization, which was reconstituted with sterile diluent for vaccines with no reported adverse event (product preparation error) (latency-same day). Action taken was not applicable. 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.; Sender's Comments: US-SA-2025SA222935:
More
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| 2852459 | 2 | M | WV | 08/04/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK038AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
expired PENTACEL was administered to a patient with no reported adverse event; Initial information r...
expired PENTACEL was administered to a patient with no reported adverse event; Initial information received on 30-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient who received expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hepatitis A vaccine INACT (havrix) and measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella VACCINE LIVE (wistar RA 27/3), varicella zoster vaccine live (OKA/MERCK) (proquad), both for Immunisation. On 30-Jul-2025, the patient received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of standard strength with lot UK038AA and expiry date 30-Jun-2025, frequency: once via intramuscular route in the right deltoid for Immunization with no reported adverse event (expired product administered) (Latency same day) Action taken was not applicable. 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.
More
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| 2852460 | 2 | F | IL | 08/04/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
E4A39 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Administration to a 2-year-old patient; This non-serious case was reported by a other health profess...
Administration to a 2-year-old patient; 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 2-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number E4A39) for prophylaxis. On 16-MAY-2025, the patient received Menveo. On 16-MAY-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to a 2-year-old patient). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK receipt date: 17-JUL-2025 Other HCP needed to verify if the Menveo that they had was the 1 vial or 2 vials. They just wanted to see what was given to the patient. Patient's age at vaccination was 2 years, which led to inappropriate age at vaccine administration.
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| 2852461 | 76 | M | FL | 08/04/2025 |
COVID19 |
PFIZER\BIONTECH |
ME6072 |
Pain in extremity
Pain in extremity
|
Pt came in 8/1/25 stated arm is still sore and painful. Dr advised him to take Advil.
Pt came in 8/1/25 stated arm is still sore and painful. Dr advised him to take Advil.
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| 2852462 | 63 | M | 08/04/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
7554T |
Myalgia
Myalgia
|
Reported Symptoms: 10028411:MYALGIA; Narrative: Other Relevant: HX:
Reported Symptoms: 10028411:MYALGIA; Narrative: Other Relevant: HX:
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| 2852463 | M | AL | 08/04/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
TK3YE TK3YE |
Bradycardia, Chest X-ray, Electrocardiogram, Feeling abnormal, Hypotension; Pres...
Bradycardia, Chest X-ray, Electrocardiogram, Feeling abnormal, Hypotension; Presyncope
More
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Reported Symptoms: 10047166:VASOVAGAL REACTION; Narrative: Patient administered COVID vaccine and in...
Reported Symptoms: 10047166:VASOVAGAL REACTION; Narrative: Patient administered COVID vaccine and influenza vaccine during same clinic visit and reported feeling like about to pass out. Patient was hypotension and bradycardia. Patient was taken to ER for evaluation. Received IVF and work up to include EKG and chest x-ray. Patient was discharged home same day with plan to follow up with primary care doctor. Other Relevant HX: Other: VASOVAGAL REACTION
More
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| 2852464 | 43 | M | MT | 08/04/2025 |
PNC20 |
PFIZER\WYETH |
LG5575 |
Headache, Lymphadenopathy, Oropharyngeal discomfort, Streptococcus test negative...
Headache, Lymphadenopathy, Oropharyngeal discomfort, Streptococcus test negative, Tenderness
More
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Reported Symptoms: 10025197:LYMPHADENOPATHY; Narrative: Patient stops into clinic, he reports receiv...
Reported Symptoms: 10025197:LYMPHADENOPATHY; Narrative: Patient stops into clinic, he reports receiving a Prevnar 20 on the 8th in his left deltoid, on the evening of the 10th he started to feel his lymph nodes swelling in his left neck. He also reports tenderness in his left armpit. He reports a HA with exercise and feeling of fullness when he swallows. Patient tested for strep throat that was negative but did test positive for covid. Patient was told to increase fluid, rest and use Tylenol as needed for pain. Other Relevant HX: Other: LYMPHADENOPATHY
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| 2852465 | 58 | M | TX | 08/04/2025 |
FLUX |
UNKNOWN MANUFACTURER |
|
Pruritus, Rash
Pruritus, Rash
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Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other: RASH; PRUR...
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other: RASH; PRURITUS
More
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| 2852466 | 63 | M | TX | 08/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dyspnoea, Rales
Dyspnoea, Rales
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Reported Symptoms: 10013963: DYSPNEA; 10054910:CRACKLE LUNG; Narrative: Other Relevant HX: Other: RE...
Reported Symptoms: 10013963: DYSPNEA; 10054910:CRACKLE LUNG; Narrative: Other Relevant HX: Other: RESPIRATORY CRACKLES; DYSPNEA
More
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| 2852467 | 70 | M | MN | 08/04/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Hypothermia
Hypothermia
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Reported Symptoms: 10021113:HYPOTHERMIA; Narrative: Other Relevant HX: Other: HYPOTHERMIA
Reported Symptoms: 10021113:HYPOTHERMIA; Narrative: Other Relevant HX: Other: HYPOTHERMIA
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| 2852468 | M | TX | 08/04/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Rash
Rash
|
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant: HX: Other: Rash
Reported Symptoms: 10037844:RASH; Narrative: Other Relevant: HX: Other: Rash
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| 2852469 | 62 | F | VA | 08/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
42KG3 |
Myalgia
Myalgia
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Reported Symptoms: 10028411:MYALGIA; Narrative: Other Relevant HX: Other
Reported Symptoms: 10028411:MYALGIA; Narrative: Other Relevant HX: Other
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| 2852470 | 61 | M | NY | 08/04/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
da7p5 |
Peripheral swelling, Pruritus, Throat tightness, Wheezing
Peripheral swelling, Pruritus, Throat tightness, Wheezing
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Reported Symptoms: 10023094: ITCHY SKIN; 10043517: THROAD CONSTRICTION; Narrative: Other Relevant HX...
Reported Symptoms: 10023094: ITCHY SKIN; 10043517: THROAD CONSTRICTION; Narrative: Other Relevant HX: 62 y/o male PMH HTN, HLD, DM2, PTSD, CKD, osteoarthritis, obesity. Patient had previously been vaccinated for this flu season on 10/7/2024 at outside facility, documented via immunization note by LPN on 11/22/24. Of note, patient had appointment on 10/7/24 where he refused influenza vaccine. At most recent visit on 1/8/2025, patient reported received second influenza vaccine approximately one week prior through Employee Health, as they had not noticed previous immunization in October. On the day of the immunization, he reported experiencing throat constriction, difficulty breathing, left arm swelling and itching. Patient considered going to the ED but symptoms mostly subsided. Wheezing lasted for a few days. The patient attributed this to use of influenza vaccine. There is no record of the second influenza vaccination in system. Unable to view occupation health documentation. Other: itchy arm, throat constriction
More
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| 2852471 | 73 | M | AZ | 08/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
425CR |
Dry skin, Formication, Pain of skin, Peripheral swelling, Rash
Dry skin, Formication, Pain of skin, Peripheral swelling, Rash
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Reported Symptoms: 10037844:RASH; Narrative: Patient received first dose of Shingrix series. He had ...
Reported Symptoms: 10037844:RASH; Narrative: Patient received first dose of Shingrix series. He had an apparent allergic reaction/rash of the left forearm within 2 days that precipitated an ER visit for workup. Patient stated that he treated with Benadryl oral which eventually resolved the rash but only after 2 weeks. Other Relevant HX: Left arm and lateral abdomen rash location. Noted Patient has prior history of shingles and requested vaccination. Presented to ER on 11/4/24 due to swelling in arm after vaccination. 11/18/24The patient states that he was treated with Benadryl oral which eventually resolved the rash but only after 2 weeks. Currently he is without rash but does have residually "rough skin"where the rash was. The patient states that he has left upper quadrant abdominal sensation of "something crawling around with a stinging sensation under my skin." The symptoms are alleviated by application of ice or cold water and is improving steadily over the last 2 weeks. Other:
More
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| 2852472 | 33 | F | SC | 08/04/2025 |
COVID19 COVID19 COVID19 |
MODERNA PFIZER\BIONTECH PFIZER\BIONTECH |
FF8839 FE3590 |
Asthma, Rash; Asthma, Rash; Asthma, Rash
Asthma, Rash; Asthma, Rash; Asthma, Rash
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Reported Symptoms: 10003553:ASTHMA; 10037844:RASH; Narrative: Other Relevant HX: Other: asthma
Reported Symptoms: 10003553:ASTHMA; 10037844:RASH; Narrative: Other Relevant HX: Other: asthma
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| 2852473 | 1.5 | F | IA | 08/04/2025 |
COVID19 HEPA |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN8272 42DM9 |
Epistaxis; Epistaxis
Epistaxis; Epistaxis
|
profuse bloody nose (epistaxis) 10 minutes long treated with vaseline in L nostril and pressure to ...
profuse bloody nose (epistaxis) 10 minutes long treated with vaseline in L nostril and pressure to bridge of nose occured within 10 minutes of receiving vaccines
More
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| 2852474 | 75 | M | TX | 08/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3K3E7 |
Arthralgia, Erythema, Rash, Swollen tongue, Urticaria
Arthralgia, Erythema, Rash, Swollen tongue, Urticaria
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Reported Symptoms: 10014257:EDEMA TONGUE; 10020197:HIVES; 10037087:PRURITUS; 10037844:RASH; Narrativ...
Reported Symptoms: 10014257:EDEMA TONGUE; 10020197:HIVES; 10037087:PRURITUS; 10037844:RASH; Narrative: Patient was administered first dose of zoster vaccine at primary care visit on 8/29/2024. On 9/3/2024 the pt messaged the provider stating he had tongue swelling (not life threatening) which has gone away and most of body covered in hives. Provider recommended pt to go to ER. Pt did not agree to go to the ER that day. Pt presented to emergency department on 9/5/2024 after going to an urgent care which recommended he seek emergency care. At the emergency department the patient had a rash and joint pain which he stated occurred after administration of the zoster vaccine. The emergency department note, reports that he had a rash and redness that was diffuse in nature. He was experiencing urticarial but seemed to have resolved. He did not have a fever or trouble breathing. The pt was stable and discharged the same day with prednisone. Other Relevant HS: Other: Tongue swelling/Rash/Hives
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| 2852475 | 95 | M | ME | 08/04/2025 |
COVID19 |
MODERNA |
203J23A |
Abnormal dreams, Insomnia
Abnormal dreams, Insomnia
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Reported Symptoms: 10022437:INSOMNIA; 10047666:VIVID DREAMS; Narrative: 95 year old male reports to ...
Reported Symptoms: 10022437:INSOMNIA; 10047666:VIVID DREAMS; Narrative: 95 year old male reports to that he had reaction to moderna vaccine. The vaccine was administered on 7/3/24 and the adverse reaction was reported on 7/8/24 to primary care team. He experienced insomnia and vivd dreams after having the vaccination. No further report of issue after 7/8. Other Relevant HX: Other: INSOMNIA, VIVID DREAMS
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| 2852476 | M | OH | 08/04/2025 |
FLUX |
UNKNOWN MANUFACTURER |
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Guillain-Barre syndrome
Guillain-Barre syndrome
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Reported Symptoms: 10018767: GUILLAIN-BARRE SYNDROME; Narrative: Other Relevant HX: Other: GUILLAIN ...
Reported Symptoms: 10018767: GUILLAIN-BARRE SYNDROME; Narrative: Other Relevant HX: Other: GUILLAIN BARRE
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| 2852477 | 72 | M | MN | 08/04/2025 |
RSV |
PFIZER\WYETH |
KC7884 |
Product quality issue
Product quality issue
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Reported Symptoms: 10069327:PRODUCT QUALITY ISSUE; Narrative: Other Relevant HS: Other: this is forc...
Reported Symptoms: 10069327:PRODUCT QUALITY ISSUE; Narrative: Other Relevant HS: Other: this is forcing me to enter a symptom even though this is a product problem that never reached the patient
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| 2852478 | M | OH | 08/04/2025 |
COVID19 |
JANSSEN |
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Hypotension
Hypotension
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Reported Symptoms: 10021097:HYPOTENSION; Narrative: Other Relevant HX: Other: HYPOTENSION
Reported Symptoms: 10021097:HYPOTENSION; Narrative: Other Relevant HX: Other: HYPOTENSION
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| 2852479 | 55 | F | OR | 08/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
53LK5 |
Oedema, Pruritus
Oedema, Pruritus
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Reported Symptoms: 10014210:EDEMA; 10037087:PRURITUS; Narrative: Other Relevant HX: Other: EDEMA
Reported Symptoms: 10014210:EDEMA; 10037087:PRURITUS; Narrative: Other Relevant HX: Other: EDEMA
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| 2852480 | M | WI | 08/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Myasthenia gravis
Myasthenia gravis
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Reported Symptoms: 10028418;MYASTHENIA GRAVIS AGGRAVATED; Narrative: myasthenia gravis Other Relevan...
Reported Symptoms: 10028418;MYASTHENIA GRAVIS AGGRAVATED; Narrative: myasthenia gravis Other Relevant HX: Other: myasthenia gravis
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| 2852481 | 76 | M | AR | 08/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
MS245 |
Diarrhoea, Injection site erythema, Injection site swelling, Rash, Vomiting
Diarrhoea, Injection site erythema, Injection site swelling, Rash, Vomiting
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Reported Symptoms: 10012727:DIARRHEA; 100022098:INJECTION SITE REDNESS; 10037844:RASH; 10047700:VOMI...
Reported Symptoms: 10012727:DIARRHEA; 100022098:INJECTION SITE REDNESS; 10037844:RASH; 10047700:VOMITING; 10053425:INJECTION SITE SWELLING; Narrative: Other Relevant HX: Other: Redness, swelling at injection site
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| 2852482 | M | WI | 08/04/2025 |
COVID19 |
MODERNA |
3031283 |
Angioedema, Oedema mouth, Swelling face
Angioedema, Oedema mouth, Swelling face
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Reported Symptoms: 1002424:ANGIOEDEMA; 10042691:SWELLING OF FACE; 10054496:EDEMA MOUTH; Narrative: P...
Reported Symptoms: 1002424:ANGIOEDEMA; 10042691:SWELLING OF FACE; 10054496:EDEMA MOUTH; Narrative: Pt is a 81 y/o who received his 6th COVID-19 injection into left deltoid. Following injection administration, left jaw swelling/warm to touch noted. Patient seen in the ED for orofacial angioedema with a localized reaction without anaphylaxis and provided with acetaminophen and methylprednisolone IV doses x 1. ACEI also discontinued. Decreased swelling noted following methylprednisolone dose. Other Relevant HX: Per ED notes: "#Acute orofacial angioedema/localized reaction without anaphylxis following COVID-19 booster (Moderna), improved: - Improved, but not fully resolved following Methylprednisolone 40mg IV x1 - Acetaminophen 650mg x 1 administered in fast track Pt was seen for orofacial swelling following his COVID-19 vaccination. As he is also on lisinopril, opted to discontinue and start amplodipine for hypertension. Given a potential drug-drug interaction between simvastatin and amlodipine, stopped simvastatin and started atorvastatin. He was given 7 day course of cetirizine 10mg BID to start the evening of 10/26 and a 5 day course or prednisone 20mg to start 10/27. He may not need to take the prednisone, but opted to provide as a true allergic reaction cannot be fully excluded at this time." Other: FACIAL SWELLING; ORAL SWELLING
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| 2852483 | 68 | M | WI | 08/04/2025 |
COVID19 |
MODERNA |
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Confusional state, Pyrexia
Confusional state, Pyrexia
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Reported Symptoms: 10010300:CONFUSION; 10016558:FEVER; Narrative: Other Relevant HX: Other:
Reported Symptoms: 10010300:CONFUSION; 10016558:FEVER; Narrative: Other Relevant HX: Other:
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| 2852484 | 87 | M | OR | 08/04/2025 |
COVID19 |
PFIZER\BIONTECH |
HG5967 |
Asthenia, Pyrexia, Vomiting
Asthenia, Pyrexia, Vomiting
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Reported Symptoms: 10016558:FEVER; 10047700:VOMITING; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZ...
Reported Symptoms: 10016558:FEVER; 10047700:VOMITING; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: Other: weakness
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| 2852485 | M | OH | 08/04/2025 |
COVID19 |
MODERNA |
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Cough, Erythema, Muscle spasms
Cough, Erythema, Muscle spasms
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Reported Symptoms: 10011232:COUGHING; 10011290:CRAMP LEGS; 10015150:ERYTHEMA; Narrative: Unable to f...
Reported Symptoms: 10011232:COUGHING; 10011290:CRAMP LEGS; 10015150:ERYTHEMA; Narrative: Unable to find documentation on when/where vaccine was given. Other Relevant HX: Other: COUGH, ERYTHEMA; LEG CRAMP
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| 2852486 | 74 | M | OH | 08/04/2025 |
FLUX FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Guillain-Barre syndrome, Hyporeflexia, Muscular weakness, Papular-purpuric glove...
Guillain-Barre syndrome, Hyporeflexia, Muscular weakness, Papular-purpuric gloves-and-socks syndrome; Guillain-Barre syndrome, Hyporeflexia, Muscular weakness, Papular-purpuric gloves-and-socks syndrome
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Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDOME; Narrative: ER (recently released from outside ho...
Reported Symptoms: 10018767:GUILLAIN-BARRE SYNDOME; Narrative: ER (recently released from outside hospital), bilat LE weakness 4/5 in some muscle groups, diffuse hyporeflexia, glove and stocking syndrome Other Relevant HX: Other: guillain barre
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| 2852487 | 76 | M | PA | 08/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
JP573 |
Pruritus, Rash
Pruritus, Rash
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Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other:
Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Other Relevant HX: Other:
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| 2852488 | M | OH | 08/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Lymphadenopathy
Lymphadenopathy
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Reported Symptoms: 10025186:LYMPH NODES ENLARGED; Narrative: Other Relevant HX: Other: swollen lymph...
Reported Symptoms: 10025186:LYMPH NODES ENLARGED; Narrative: Other Relevant HX: Other: swollen lymph nodes under arms
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