| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2831484 | 16 | F | TX | 03/14/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
52N4S 3E99M |
Dizziness, Hypotonia, Loss of consciousness, Pallor; Dizziness, Hypotonia, Loss ...
Dizziness, Hypotonia, Loss of consciousness, Pallor; Dizziness, Hypotonia, Loss of consciousness, Pallor
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Several minutes after receiving vaccines patient started walking out of room and became lightheaded....
Several minutes after receiving vaccines patient started walking out of room and became lightheaded. Per doctor face and lips became pale. Doctor caught her as she started to slump forward, she passed out 2-3 seconds while she was sat down on chair, she gasped and suddenly sat up and started speaking. Facemask with 2L O2 applied. Some coloring returned and walked back to room with assistance. Placed on exam table with legs up on wall in supine position. Over the next 5 minutes coloring returned to lips and cheeks. Remained slightly lightheaded but answering questions appropriately. Vital sign taken but nurse. Mom remained in room with patient throughout event. 30 min later on follow up exam patient sitting up normally, normal exam. Discharged in stable condition.
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| 2831485 | 0.17 | M | CA | 03/14/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
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Intussusception, Urinary retention, Vomiting
Intussusception, Urinary retention, Vomiting
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Started vomiting 2 days later, did not have any wet diapers 2 days later
Started vomiting 2 days later, did not have any wet diapers 2 days later
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✓ | |||||
| 2831486 | 0.33 | F | MI | 03/14/2025 |
MNQ |
SANOFI PASTEUR |
U8369BA |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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N/A
N/A
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| 2831487 | 69 | F | MA | 03/14/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
LM2221 LM2221 LP1776 LP1776 |
Dyspnoea; Chronic fatigue syndrome, Dyspnoea; Dyspnoea; Chronic fatigue syndrome...
Dyspnoea; Chronic fatigue syndrome, Dyspnoea; Dyspnoea; Chronic fatigue syndrome, Dyspnoea
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This writer administered the Covid Pfizer Vaccine at 2:10pm. At 2:20pm the patient reported SOB. Pat...
This writer administered the Covid Pfizer Vaccine at 2:10pm. At 2:20pm the patient reported SOB. Patient has hx of allergies to lobster, sumac, mold , osteoporosis medication, denied allergy to vaccine or vaccine component. Pt denied hives, itching, flushing, swollen lips/face/throat/eyes, denied nasal congestion, change in voice, sensation of throat closing, stridor, wheeze, cough, denied nausea, vomiting, cramping, abdominal pain, denied feeling dizzy, faint, heart racing. Pt reported SOB, that improved after taking 2 puffs of inhaler and took 2 doses of their benadryl which they had on hand. This writer stayed with the patient and observed for 60 minutes, I observed the patient ambulating throughout the house with 2 N95 masks on; no worsening of symptoms were observed. Pt remained alert and oriented for 60 minutes, did not show signs of lethargy or struggling to breathe. Patient is known to me as this writer administered a homebound vaccine on 09/24. I reviewed the Vaccine Information Sheet, specifically Step 5. When to Seek Medical Attention, signs/symptoms of anaphylaxis, when to call 9-1-1 and when to call PCP. Pt verbalized understanding. Pt reported symptoms of SOB had improved, patient alert, oriented. Pt had on hand their own 0.3mg EpiPen AutoInjector. This writer reviewed the above information with the patient's spouse who was going to remain with the patient, who also verbalized understanding of when to seek medical care.
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| 2831488 | 7 | F | MD | 03/14/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Expired vaccine was given. But there was no adverse reaction to the vaccination.
Expired vaccine was given. But there was no adverse reaction to the vaccination.
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| 2831489 | 50 | F | WI | 03/14/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5J959 |
Wrong product administered
Wrong product administered
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Patient here for her second Shingles vaccine. Given the RSV vaccine. VIS Shingles given. Covering...
Patient here for her second Shingles vaccine. Given the RSV vaccine. VIS Shingles given. Covering provider updated right away as well as RN supervisor updated. Patient informed with 20 minutes of event.
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| 2831491 | 21 | F | MI | 03/14/2025 |
COVID19 FLU3 MENB MNQ TDAP |
MODERNA SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
3044060 U8523DA DD72H 9M2R7 DY3K7 |
Contraindication to vaccination, No adverse event; Contraindication to vaccinati...
Contraindication to vaccination, No adverse event; Contraindication to vaccination, No adverse event; Contraindication to vaccination, No adverse event; Contraindication to vaccination, No adverse event; Contraindication to vaccination, No adverse event
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Client showed no adverse effects.
Client showed no adverse effects.
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| 2831492 | 79 | F | NY | 03/14/2025 |
COVID19 |
MODERNA |
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Back pain, Dyspnoea, Implantable cardiac monitor insertion, Pain in extremity, P...
Back pain, Dyspnoea, Implantable cardiac monitor insertion, Pain in extremity, Palpitations
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shortness of breath, heart palpitations, pain in lower back and along outside of thighs and legs
shortness of breath, heart palpitations, pain in lower back and along outside of thighs and legs
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| 2831493 | 67 | F | TN | 03/14/2025 |
PNC20 |
PFIZER\WYETH |
LG5575 |
Erythema, Injection site erythema, Injection site pain, Injection site vesicles
Erythema, Injection site erythema, Injection site pain, Injection site vesicles
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The night of the vaccine the patient reports pain in the injection site, and then developed a red sp...
The night of the vaccine the patient reports pain in the injection site, and then developed a red spot around the injection site. She drew a marker around it and then the redness expanded all the way down her arm and the injection site bubbled up with some fluid retention.
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| 2831494 | 1 | M | 03/14/2025 |
MMRV PPV |
MERCK & CO. INC. MERCK & CO. INC. |
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Rash; Rash
Rash; Rash
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Rash on thighs, back, face
Rash on thighs, back, face
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| 2831495 | 50 | F | WA | 03/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3X97J |
Pain, Product administered at inappropriate site
Pain, Product administered at inappropriate site
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S- 50 year old, female calls clinic from work and states they received the shingles vaccination at t...
S- 50 year old, female calls clinic from work and states they received the shingles vaccination at their last drs appointment. Now pt is experiencing body aches & pain on right buttocks where she received the injection; along with a huge bump on it. B- Pt had an office visit on 3/11/25 with Dr. for headache follow up. Pt received Zoster vaccine 0.5ml, IM, right gluete during appointment. A- Pt states that she received shingles vaccine in her right butt check because her arms were too small. At vaccine injection site pt has a "goose egg" size hard lump. It's red but not hot to touch. Pt has been using heat & cold on lump. Heat works better. By utilizing heat and massage the lump goes down a little bit but comes right back an hour later. Pt states the lump hurts but it hurts like a bruise; can't lay down on right side. Pt feels like they have body aches all over their body and aches in their joints. Pt states that symptoms have been occurring since she received shingles vaccination. Pt has been taking 600mg Ibuprofen and 1,000 mg of Tylenol; medications have not really been helping pt. Pt denies hives, swelling of face or throat, difficulty breathing, heart palpitations, dizziness, or severe muscle weakness. R- Based on pt symptoms ER or urgent care not indicated at this time. Will talk to provider about pt symptoms. Pt gave verbal ok for detailed message to be left on her phone. RN Spoke with Dr. regarding pt's symptoms. Dr. states that this is an injection site reaction. This is your [pts] body's immune response to the vaccine. The lump is more noticeable because it is on the butt; It will go away. Keep taking pain medications as needed, stay hydrated (at least 8 cups of water per day) and rest. Lump should be gone by next Tuesday; by latest two weeks. Pt gave verbal ok for a detailed message to be left on her phone. This RN left voicemail on pt's phone communicating Dr.'s recommendations. RN
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| 2831496 | 26 | M | AR | 03/14/2025 |
FLU3 IPV TYP YF |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
TFAA2406 X1C891M Y2A021M UK118AA |
Immediate post-injection reaction, Vomiting; Immediate post-injection reaction, ...
Immediate post-injection reaction, Vomiting; Immediate post-injection reaction, Vomiting; Immediate post-injection reaction, Vomiting; Immediate post-injection reaction, Vomiting
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Pt presented for travel consultation and vaccines for a trip. He requested vaccination on typhoid, y...
Pt presented for travel consultation and vaccines for a trip. He requested vaccination on typhoid, yellow fever, polio and flu. Offered pt administration of vaccines split between both arms or he could get all in 1 arm if he preferred. He requested all 4 in his left arm. Upon administration of 4 vaccines, pt briefly vomited into the trash can. This happened immediately after his last shot. Pt believes it may have been from his lunch and/or shot anxiety. He received 4 vaccines total: YF Vax Left back arm subQ, FluBlok2024-2025 Left delt top, Typhim left delt bottom left, and IPOL left delt bottom right all 1 inch apart. Post emesis, he drank about 8oz of water and said he felt fine. Pt was monitored for appox 30 min after vaccination before he left and said he felt great.
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| 2831515 | NY | 03/14/2025 |
HPV9 |
MERCK & CO. INC. |
Y007322 |
Needle issue, No adverse event
Needle issue, No adverse event
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No additional AE/PQC reported.; AE AND PRECAUTIONARY PQC FILED: HCP calling to report patient receiv...
No additional AE/PQC reported.; AE AND PRECAUTIONARY PQC FILED: HCP calling to report patient received less than recommended dose of GARDASIL 9 due to needle leakage while administering vaccine. Caller stated patient was receiving dose of GARDASIL 9 when leakage occurred, caller st; GARDASIL 9 due to needle leakage while administering vaccine.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 18-FEB-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant Injection (GARDASIL 9) lot # Y007322 and expiration date 18-AUG-2026 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The patient received less than recommended dose of GARDASIL 9 due to needle leakage while administering vaccine (needle leakage and accidental underdose). Caller stated patient was receiving dose of GARDASIL 9 when leakage occurred, caller stated it was unknown if leakage was from a product defective or improperly attaching needle. Product was administered. No additional AE/PQC reported (no adverse event).
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| 2831516 | 0.5 | TX | 03/14/2025 |
HPV9 |
MERCK & CO. INC. |
Y000206 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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no AE; GARDASIL 9 was administered to a 6-month-old patient; This spontaneous report was received fr...
no AE; GARDASIL 9 was administered to a 6-month-old patient; This spontaneous report was received from a Physician and refers to a 6-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-Feb-2025, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y000206, expiration date: 23-Sep-2026) 0.5 mL for prophylaxis. On 19-Feb-2025, the patient was vaccinated GARDASIL 9 (inappropriate age at vaccination). No adverse events reported.
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| 2831517 | 1 | M | PR | 03/14/2025 |
HEPA HIBV MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER MERCK & CO. INC. |
t5727 437EK Y008290 Y015108 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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no adverse event; Caller reported VARIVAX administered after temperature excursion. No other inform...
no adverse event; Caller reported VARIVAX administered after temperature excursion. No other information provided. ? Names of vaccines involved (including lot/exp) VARIVAX Y015108 9/6/2026 ? Temperature (-2.1C) ? Time frame 6; This spontaneous report was received from a Other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-Feb-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015108, expiration date: 06-Sep-2026) for prophylaxis. On 06-Feb-2025, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), for prophylaxis (lot # and expiration date were not reported). This vaccine underwent temperature excursion in -2.1 degree Celsius for 6 hours 45 minutes (Product storage error). Follow up information has been received on 06-FEB-2025. The patient experienced no adverse event. The route of administration for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) was subcutaneously in the right arm. On the same date, the subject was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live lyophilisate (MMR-II) injection, subcutaneously in the left arm, lot number Y008290 which has been verified to be valid, expiration date reported and validated as 24-APR-2026 (doe, scheme, strength not provided). The patient was vaccinated with HIB vaccine conj (tet tox) (HIBERIX), intramuscular , left thigh, lot number 437EK, expiration date reported as 13-JUL-2026. Consequently, the patient was vaccinated with Hepatitis A vaccine (HARVIX) intramuscularly in the right thigh, lot number T5727, expiration date 05-MAY-2026 (doses, formulations, strengths not provided).
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| 2831518 | 4 | M | ND | 03/14/2025 |
UNK |
UNKNOWN MANUFACTURER |
Y013583 |
No adverse event, Product storage error
No adverse event, Product storage error
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no additional AE; received improperly stored PROQUAD since it "was stored in the refrigerator f...
no additional AE; received improperly stored PROQUAD since it "was stored in the refrigerator for months" instead of the freezer; This spontaneous report was received from a Nurse and refers to a(n) 4-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus (VAXELIS) Havrix (Hepatitis a vaccine inact), Fluarix quadrivalent (Influenza vaccine inact split 4v). On 02-Dec-2024, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), Injection (lot #Y013583, expiration date: 03-Feb-2026), dose number 2, administered by subcutaneous route in Left Thigh together with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported) as prophylaxis. The suspect vaccine "was stored in the refrigerator for months" instead of the freezer (incorrect product storage). There was no additional AE (no adverse event). Temperature excursion was reported as "Total time in the range 15�F to 46�F (-9�C to 8�C): 1488" (time units not reported).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : @merck.com , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 10/xx/2020 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2831521 | 4 | F | TX | 03/14/2025 |
MMR |
MERCK & CO. INC. |
Y011709 |
Device connection issue, Granuloma skin, Needle issue
Device connection issue, Granuloma skin, Needle issue
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The HCP stated the needle stayed in the patient; No other adverse issues or side effects were report...
The HCP stated the needle stayed in the patient; No other adverse issues or side effects were reported related to the incident.; It was unknown if the patient got the full dose and the physician plans to check titers going forward; This spontaneous report was received from a Nurse and refers to a 4-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 20-Feb-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y011709, expiration date: 02-Jul-2026) 0.5 mL (0.5mL / once), with sterile diluent (lot #2050911, expiration date: 11-Feb-2027) 0.5 mL (0.5mL / once), injection administered by Unknown route. This was a routine vaccination for 4-year check up. The nurse reported that the hub/luer lock on the sterile diluent syringe became loose causing the needle to fall off. She stated when trying to screw the needle on tight, it caused the hub to become loose and detach (captured in Case# 2260119). The nurse stated the needle stayed in the patient after she administered the injection (Needle issue) and a "few drops" splattered in her (nurse's) face, in which she had to flush her face and eyes (Nurse's report captured in Case# 2260119). It was unknown if the patient got the full dose and it was reported that the physician planned to check titers going forward (Underdose). It was also unknown what amount splattered onto the HCP (nurse's) face/eyes. The nurse and patient were not injured during the incident, the needle was removed easily and quickly without concern of sanitation issues, and no other medical attention was required. No other adverse issues or side effects were reported related to the incident (No adverse event).;
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| 2831522 | F | PA | 03/14/2025 |
HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Abdominal pain upper, Arthralgia, Asthenia, Blood test, Depression; Dizziness, F...
Abdominal pain upper, Arthralgia, Asthenia, Blood test, Depression; Dizziness, Fatigue, General physical health deterioration, Headache, Heart rate decreased; Incomplete course of vaccination, Laboratory test normal, Malaise, Mobility decreased, Nausea; Petechiae, Postural orthostatic tachycardia syndrome, Syncope, Ultrasound scan, Vascular rupture; Vein disorder, Vomiting; Abdominal pain upper, Arthralgia, Asthenia, Blood test, Depression; Dizziness, Fatigue, General physical health deterioration, Headache, Heart rate decreased; Incomplete course of vaccination, Laboratory test normal, Malaise, Mobility decreased, Nausea; Petechiae, Postural orthostatic tachycardia syndrome, Syncope, Ultrasound scan, Vascular rupture; Vein disorder, Vomiting
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fainting; debilitate; vein disorders with many broken blood vessels; vein disorders; depressed; POTS...
fainting; debilitate; vein disorders with many broken blood vessels; vein disorders; depressed; POTS syndrome/dizziness/nausea/vomiting/headache/dizzy/nauseous; chronic fatigue; Petechiae; joint pain; stomach ache; low heart rate; decline in health; er daughter received first dose of GARDAIL 9 on 2019 and second dose on 2021.; This spontaneous report was received from a consumer or other non health professional (patient's mother) via email and refers to a(n) 20-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. In 2019, the patient received first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), administered for vaccination (strength, dose, route of administration, lot # and expiration date were not reported). In 2021, the patient received second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9), administered for vaccination (strength, dose, route of administration, lot # and expiration date were not reported) (Inappropriate schedule of product administration). She did not receive the third dose. Patient's mother only remembered consenting to one vaccine but apparently the patient received two doses. The patient was sick from receiving Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) from the pediatrician. Patient's mother was outraged about this. It was reported that the vaccine has debilitated the patient. Patient's mother had records for years on these symptoms since getting the vaccine. It was disgusting to have to go through this as a parent and watch the patient decline in health and doctors told the patient that all labs all tests were normal yet there were clear symptoms: she had been chronically fatigued, dizzy/dizziness, nauseous/nausea, vomiting, fainted/fainting, petechiae and vein disorders with many broken blood vessels, joint pain, stomach ache, headaches and low heart rate. The patient was still having those symptoms but not as severe. Patient's mother answered Yes to "Intervention to Prevent Serious Criteria" question because when her daughter fainted, they had to give her oxygen and answered Yes to "Significant Disability or Incapacity" because her daughter could not move normally because of severe chronic fatigue. Before the vaccination, the patient was very energetic but now she was so fatigue that she applied for disability benefit. The patient was depressed and see a psychologist and she could be depressed from her physical symptoms that have taken over. The patient was being a top athlete and just going down hill because she had Postural orthostatic tachycardia syndrome (POTS) syndrome but the reporter wondered where did that come from and requested company to explain this which many people have reported the same symptoms. Patient's mother mentioned attorney because she decided to join the class action lawsuit against Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9). Blood tests and ultrasound were performed but no results provided. No additional adverse events (AEs) were reported, no further information provided. At the time of reporting, the outcome of all events was reported as not recovered. The causality relationship between all events and suspect vaccine was considered as related. The reporter considered the event of fainting to be medically significant. The reporter considered the event of chronic fatigue to be disabling/incapacitating. Lot is being requested and will be submitted if received.
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| 2831523 | 14 | F | NY | 03/14/2025 |
MMRV |
MERCK & CO. INC. |
Y010292 |
No adverse event, Product storage error
No adverse event, Product storage error
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No adverse event; A HCP called to report a TE for PROQUAD that occurred on 02/23/2025 and was also i...
No adverse event; A HCP called to report a TE for PROQUAD that occurred on 02/23/2025 and was also inadvertently administered on 02/25/2025. The HCP stated the patient did not experience any adverse issues or side effects related to the administered dose. Please also; This spontaneous report has been received from a registered nurse (R.N), regarding a 12-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported. On 23-FEB-2025, it was stated that a temperature excursion occurred for measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (PROQUAD), after a temperature excursion of 54 degree Fahrenheit (F) during a time frame of 13 hours with 10 minutes; thus on 25-FEB-2025 the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection (rHA [recombinant Human albumin]) (PROQUAD) 0.5 mL, administered as prophylaxis (Lot No. Y010292 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live lyophilisate and solvent for solution for injection], expiration date reported and upon internal validation established as 01-DEC-2025) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided) that was reconstituted with sterile diluent solution for injection (BAXTER STERILE DILUENT) (Lot No., expiration date and route of administration were not provided) (product storage error). Previous temperature excursions were not provided. No additional adverse event was reported (no adverse event).
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| 2831524 | UT | 03/14/2025 |
HEP |
MERCK & CO. INC. |
Y009436 |
Needle issue
Needle issue
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no additional AE; was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administrat...
no additional AE; was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe.; Medical assistant called stating another medical assistant at their facility was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe. Caller an; Event Medical assistant called stating another medical assistant at their facility was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe.; Medical assistant called stating another medical assistant at their facility was preparing 1 RECOMBIVAX HB (NDC 0006-4094-02) prefilled syringe for administration when the luer lock detached while trying to attach the needle to the syringe.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 12-MAR-2025, the patient was vaccinated with one dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX) (valid lot number Y009436, expiration date: 12-FEB-2027) for prophylaxis (dose, dose number, anatomical location, route of administration was not provided). Medical assistant called stating another medical assistant at their facility was preparing one of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX) prefilled syringe for administration (product preparation issue) when the luer lock detached while trying to attach the needle to the syringe (syringe issue, device issue). Caller stated the medical assistant attached a new needle to the syringe without the luer lock and administered the product to the patient without further issue (poor quality device used). Caller stated no patient symptoms have been reported. Caller stated the product was discarded after use so was not available for return however pictures were taken which they would send in. Caller declined needing a replacement for this product. No additional adverse event (AE) reported.
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| 2831525 | F | 03/14/2025 |
HPV4 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Immediate post-injection reaction, Syncope; Immediate post-injection reaction, S...
Immediate post-injection reaction, Syncope; Immediate post-injection reaction, Syncope
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an adolescent female patient that was vaccinated with first dose of GARDASIL or GARDASIL 9 on unknow...
an adolescent female patient that was vaccinated with first dose of GARDASIL or GARDASIL 9 on unknown date, had tried to get up right after receiving it and fainted and went down; an adolescent female patient that was vaccinated with first dose of GARDASIL or GARDASIL 9 on unknown date, had tried to get up right after receiving it and fainted and went down; This spontaneous report was received from a Consumer or other non health professional and refers to an Adolescent female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) or Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL�9) (unconfirmed which one) (dose, units, route of administration, lot#, and expiration date were not reported) for prophylaxis. The patient had tried to get up right after receiving it and fainted and went down. The outcome of the events was not reported. The causality between the events and suspect vaccine was not provided. Upon internal review, the event of syncope was considered to be medically significant. Lot# is being requested and will be submitted if received.
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| 2831526 | UT | 03/14/2025 |
HIBV |
MERCK & CO. INC. |
y003144�� |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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No symptomatic adverse events were reported; HCP called to state that the patient received a third d...
No symptomatic adverse events were reported; HCP called to state that the patient received a third dose of PEDVAXHIB at 6 months of age.; This spontaneous report was received from a Nurse regarding a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 16-JAN-2025, at 6 months of age, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) 0.5ml/series, administered as prophylaxis (lot number y003144 has been verified to be a valid number for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) [LIQUID PEDVAX HIB], expiration date 11-SEP-2026; anatomical site of injection, formulation and route of administration were not reported) (Inappropriate schedule of product administration). No symptomatic adverse events were reported (no adverse event). This is one of several reports from the same reporter.
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| 2831528 | F | WI | 03/14/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
943187 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Received First Dose of HEPLISAV-B on 09/10/2024 and Second Dose of the Series Engerix-B on 10/10/202...
Received First Dose of HEPLISAV-B on 09/10/2024 and Second Dose of the Series Engerix-B on 10/10/2024; Initial report received on 10-Mar-2025. A pharmacist reported that a female patient received HEPLISAV-B (hepatitis B vaccine) for the first dose of hepatitis B immunization and received ENGERIX-B for the second dose of the series. Medical history included an allergy to amoxicillin (unknown reaction). No concomitant medications were reported. On 10-Sep-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 943187, expiration date 30-Nov-2025, and NDC 43528-003-05)] intramuscularly in the left deltoid. On 10-Oct-2024, 31 days after receiving HEPLISAV-B, the patient received dose 2 of a hepatitis B vaccine [ENGERIX-B (lot number, expiration date, route, and site not available)]. The patient had no side effects. No other information was available. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2831529 | 57 | M | GA | 03/14/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Cerebral thrombosis, Cerebrovascular accident, Hemiparesis, Thrombectomy
Cerebral thrombosis, Cerebrovascular accident, Hemiparesis, Thrombectomy
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stroke; Cerebral thrombosis; Weakness of the left side; This serious case was reported by a consumer...
stroke; Cerebral thrombosis; Weakness of the left side; This serious case was reported by a consumer via patient support programs and described the occurrence of stroke in a 62-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included dolutegravir sodium, lamivudine (Dovato) film-coated tablet (batch number) for hiv positive. The patient's past medical history included heart attack (Patient experienced heart attack on 2017), left ventricular assist device insertion and stroke. Concurrent medical conditions included chronic kidney disease stage 3 (Chronic kidney disease stage 3 Not currently taking any medication for this.). Concomitant products included warfarin and acetylsalicylic acid (Aspirin). On 23-MAR-2024, the patient received Shingles vaccine (right arm). On 23-MAR-2019, the patient started Dovato daily. On 29-MAR-2024, 6 days after receiving Shingles vaccine and 1833 days after starting Dovato, the patient experienced stroke (Verbatim: stroke) (serious criteria hospitalization and GSK medically significant) and weakness left or right side (Verbatim: Weakness of the left side) (serious criteria GSK medically significant). On an unknown date, the patient experienced cerebral thrombosis (Verbatim: Cerebral thrombosis) (serious criteria GSK medically significant). Dovato was continued with no change. On 29-MAR-2024, the outcome of the stroke was unknown. In APR-2024, the outcome of the cerebral thrombosis was resolved. The outcome of the weakness left or right side was not resolved. The reporter considered the stroke to be possibly related to Shingles vaccine. It was unknown if the reporter considered the weakness left or right side and cerebral thrombosis to be related to Shingles vaccine and Dovato. It was unknown if the reporter considered the stroke to be related to Dovato. The company considered the stroke, weakness left or right side and cerebral thrombosis to be unrelated to Shingles vaccine and Dovato. Additional Information: GSK Receipt Date: 07-MAR-2025 Consumer reported that he had a heart attack in 2017, and his sister took to her house and last year had a stroke in 2024 and patient was in hospital for Stroke from 29 Mar 2024 to 3 May 2024. Patient said on speaker and the left side was weaker because of the stroke. His stroke and heart attack were before starting the Dovato. Patient thought stroke came from taking the shingles vaccine. Patient got Left Ventricular Assist Device (LVAD) in 2018. 7 days after he had the vaccine and had the stroke. She changed to Dovato and gave him a shingles shot on Mar. 23, 2024. He was admitted in the regular hospital from March 29th and discharged to the on April 3rd. When patient went into that was when they diagnosed with the blood clot. Patient was wheeled into and went right into surgery; they went into side and cleared the blood clot.; Sender's Comments: Cerebrovascular accident, Hemiparesis and Cerebral thrombosis are unlisted events which are considered unrelated to GSK Shingles vaccine and Dovato.
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| 2831530 | M | FL | 03/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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consumer had his first dose of SHINGRIX approximately two yaers ago; This non-serious case was repor...
consumer had his first dose of SHINGRIX approximately two yaers ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (consumer had his first dose of SHINGRIX approximately two years ago). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: consumer had his first dose of SHINGRIX approximately two yaers ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date : 11-MAR-2025 Reporter reported that he had his first dose of SHINGRIX approximately two years ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2831531 | F | 03/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. The reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 07-MAR-2025 This case was reported by a patient via interactive digital media. Consumer reported that got the vaccine and got shingles anyway and her friends at church and discovered most who had shingles also had the vaccine. 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. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix.
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| 2831532 | 03/14/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Lethargy, Pain in extremity
Lethargy, Pain in extremity
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sore arm; lethargy; This non-serious case was reported by a consumer via interactive digital media a...
sore arm; lethargy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm) and lethargy (Verbatim: lethargy). The outcome of the pain in arm and lethargy were not reported. It was unknown if the reporter considered the pain in arm and lethargy to be related to Shingles vaccine. It was unknown if the company considered the pain in arm and lethargy to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-MAR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient had the second half of the vaccine and stated that it did pack a wallop. Patient experienced sore arm, lethargic, but said it was manageable and was much less painful than getting shingles.
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| 2831533 | 03/14/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Hypersensitivity
Hypersensitivity
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severe allergy in the upper part of my body; This non-serious case was reported by a consumer via in...
severe allergy in the upper part of my body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 04-MAR-2025, the patient received Shingles vaccine. On 05-MAR-2025, 1 days after receiving Shingles vaccine, the patient experienced allergy (Verbatim: severe allergy in the upper part of my body). The outcome of the allergy was not reported. It was unknown if the reporter considered the allergy to be related to Shingles vaccine. It was unknown if the company considered the allergy to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-MAR-2025 This case was reported by a patient via interactive digital media. The patient got Shingles vaccine since then have had a severe allergy in the upper part of body.
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| 2831534 | 75 | F | NY | 03/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3334y |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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late second dose; This non-serious case was reported by a pharmacist via call center representative ...
late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334y, expiry date 25-MAR-2027) for prophylaxis. Previously administered products included Shingrix (Patient received first dose in DEC-2020). On 04-MAR-2025, the patient received the 2nd dose of Shingrix. On 04-MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 04-MAR-2025 Pharmacist reported that patient received 1st dose of Shingrix in DEC-2020 and received 2nd dose on 4-MAR-2025. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
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| 2831535 | 8 | M | UT | 03/14/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
2YS34 |
Expired product administered
Expired product administered
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administered an expired dose of Havrix; This non-serious case was reported by a other health profess...
administered an expired dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-year-old male patient who received HAV (Havrix) (batch number 2YS34, expiry date 02-MAR-2025) for prophylaxis. Previously administered products included Havrix (Received 1st dose of vaccine on 27-AUG-2024 (Lot number 423NL and expiration date 16 November 2025 )). On 04-MAR-2025, the patient received the 2nd dose of Havrix. On 04-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Havrix). The outcome of the expired vaccine used 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: 04-MAR-2025 Medical assistant reported that they accidentally administered an expired dose of Havrix on 04 March 2025 which led to expired vaccine administered. The dose was expired on 02 March 2025. The patient got a first dose of Havrix on 27 August 2024. Consented to follow up.
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| 2831536 | 47 | F | MS | 03/14/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
95D74 |
Underdose
Underdose
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a pediatric dose of Engerix-B was given to an adult patient; a pediatric dose of Engerix-B was given...
a pediatric dose of Engerix-B was given to an adult patient; a pediatric dose of Engerix-B was given to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 95D74, expiry date 28-MAR-2025) for prophylaxis. On 24-FEB-2025, the patient received Engerix B pediatric. On 24-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: a pediatric dose of Engerix-B was given to an adult patient) and adult use of a child product (Verbatim: a pediatric dose of Engerix-B was given to an adult patient). The outcome of the underdose and adult use of a child product were not applicable. Additional Information: GSK Receipt Date : 05-MAR-2025 Nurse called on March 5, 2025 to report on February 24, 2025 a pediatric dose of Engerix-B was given to an adult patient which led to adult use of a child product and underdose.
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| 2831537 | KY | 03/14/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
JE9GP |
Product storage error
Product storage error
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had accidentally been exposed to 13.9 degree Fahrenheit/ accidentally administered to six pediatric ...
had accidentally been exposed to 13.9 degree Fahrenheit/ accidentally administered to six pediatric patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in specified number of pediatric patients who received MMR (Priorix) (batch number JE9GP, expiry date 01-SEP-2025) for prophylaxis. On an unknown date, the specified number of pediatric patients received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: had accidentally been exposed to 13.9 degree Fahrenheit/ accidentally administered to six pediatric patients). The outcome of the incorrect storage of drug 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: 06-MAR-2025 A nurse practitioner contacted the GSK to report that Priorix vaccine had accidentally been exposed to 13.9 degree Fahrenheit for what would seem a period of one month but the health care professional was uncertain if this was true and accidentally administered to six pediatric patients which led to incorrect storage of drug. The health care professional did not their age gender or initials. Follow up was consented to for this case and they requested thermostability data and clinical recommendations, receiving the standard response letter and the contact information for the CDC immunization hotline.
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| 2831538 | 57 | F | WI | 03/14/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Pneumonia, Product administered to patient of inappropriate age
Pneumonia, Product administered to patient of inappropriate age
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Pneumonia; Take Arevxy at 57 years; This serious case was reported by a nurse via call center repres...
Pneumonia; Take Arevxy at 57 years; This serious case was reported by a nurse via call center representative and described the occurrence of pneumonia in a 57-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On 30-NOV-2023, the patient received Arexvy. On 30-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Take Arevxy at 57 years). On an unknown date, the patient experienced pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant). The outcome of the pneumonia was resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the pneumonia to be related to Arexvy. The company considered the pneumonia to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 07-MAR-2025 A registered nurse reported a patient that probably received Arexvy on 30 November 2023, at 57 years which led to Inappropriate age at vaccine administration, but there was no certainty of it due to an incomplete paperwork fulfillment. Then, the patient came back to their facility with a previous case of pneumonia (already treated) and the registered nurse wondered if she could administer Arexvy to her. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments: Pneumonia is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
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| 2831539 | 54 | F | MD | 03/14/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Fatigue, Headache, Injection site erythema, Injection site induration; I...
Chills, Fatigue, Headache, Injection site erythema, Injection site induration; Injection site pain, Injection site rash
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Shingrix allergic reaction to first dose; Headache; Fatigue; Chills; Soreness at the injection site;...
Shingrix allergic reaction to first dose; Headache; Fatigue; Chills; Soreness at the injection site; Hardness at the injection site.; Bumpy rash five inches away of the injection site; Erythema five inches away of the injection site/Rubor five inches away of the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (when she was 40 years prior to receipt of Shingrix). On 21-FEB-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Shingrix allergic reaction to first dose), headache (Verbatim: Headache), fatigue (Verbatim: Fatigue), chills (Verbatim: Chills), injection site pain (Verbatim: Soreness at the injection site), injection site induration (Verbatim: Hardness at the injection site.), papular rash (Verbatim: Bumpy rash five inches away of the injection site) and erythema (Verbatim: Erythema five inches away of the injection site/Rubor five inches away of the injection site). The outcome of the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema were unknown. It was unknown if the reporter considered the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema to be related to Shingrix. It was unknown if the company considered the allergic reaction, headache, fatigue, chills, injection site pain, injection site induration, papular rash and erythema to be related to Shingrix. Additional Information: GSK receipt date: 07-MAR-2025, 10-MAR-2025 Pharmacist asked if she could get the second dose of Shingrix after presenting an allergic reaction to the first dose of this vaccine. The health care provider did not know the vaccine lot number and expiration date. Per follow up with Pharmacist, she states she had a prior history of shingles when she was 40 years prior to receipt of Shingrix. She states she was usually not sensitive to any vaccines in the past.
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| 2831540 | 74 | F | TX | 03/14/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
M4B34 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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came back for the 2nd dose in 11/Mar/2025; This non-serious case was reported by a pharmacist via ca...
came back for the 2nd dose in 11/Mar/2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received HAB (Twinrix) (batch number M4B34, expiry date 28-SEP-2026) for prophylaxis. Previously administered products included Twinrix (the 1st dose of Twinrix was administered to the patient back in September 2024). On 11-MAR-2025, the patient received the 2nd dose of Twinrix. On 11-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: came back for the 2nd dose in 11/Mar/2025). 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 : 11-MAR-2025 A pharmacist called to inform that a patient delayed their 2nd dose of Twinrix. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
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| 2831541 | F | TN | 03/14/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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did not receive the 2nd dose on time; This non-serious case was reported by a pharmacist via call ce...
did not receive the 2nd dose on time; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received first dose in 2019). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive the 2nd dose on time). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-MAR-2025 Pharmacist called to inform that a patient got a vaccine, Shingrix in 2019 and did not receive the 2nd dose on time, the doctor told she should start the series over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
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| 2831542 | 03/14/2025 |
COVID19 |
JANSSEN |
Unknown |
Herpes zoster, Myocardial infarction, Neck mass
Herpes zoster, Myocardial infarction, Neck mass
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Myocardial infarction; Lump in neck; Shingles; This spontaneous report received from a patient conce...
Myocardial infarction; Lump in neck; Shingles; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. The report was received via social media (JNJ managed site - JNJNews at x.com). No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: Dose series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported. On an unspecified date, the patient experienced myocardial infarction, lump in neck, and shingles. (Dose series: 1). The patient reported patient grew a lump in my neck 10 days after and then had the shingles six times over the next couple years and a full blown MI. The action taken with janssen covid-19 vaccine was not applicable. The outcome of myocardial infarction, lump in neck and shingles was not reported. This report was serious (other medically important condition).; Sender's Comments: V0: Myocardial infarction. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
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| 2831543 | 03/14/2025 |
COVID19 |
JANSSEN |
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Adverse drug reaction
Adverse drug reaction
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mild symptoms; This spontaneous report received from a patient by a business partner (Pfizer Inc.) o...
mild symptoms; This spontaneous report received from a patient by a business partner (Pfizer Inc.) on 25-Feb-2025 was received by Johnson and Johnson Innovative Medicine on 25-Feb-2025 and concerned multiple unspecified age and sex patients. The patients height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patients received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose Series: 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patients experienced mild symptoms. Dose Series: 1 The action taken with janssen covid-19 vaccine was not applicable. The outcome of mild symptoms was not reported. This report was non-serious.
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| 2831544 | 73 | F | 03/14/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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COVID-19, Electrocardiogram, Heart rate, Heart rate increased, Herpes virus infe...
COVID-19, Electrocardiogram, Heart rate, Heart rate increased, Herpes virus infection; Illness, Immune system disorder, Infection, Migraine
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She states she had an outbreak after the first COVID vaccine/it started up again; She states she had...
She states she had an outbreak after the first COVID vaccine/it started up again; She states she had an outbreak after the first COVID vaccine/it started up again; Also reports getting COVID after I had the first booster/Says she started sneezing "like a kitten/it started going right for my lungs; The only thing I got was a pounding headache, which I had gotten from the first 3 shots� I mean a massive migraine.; High heart rate; Messed up her immune system; Getting "very ill", "horribly ill" with both shots/made her sick "same as the other ones"; This spontaneous case was reported by a patient and describes the occurrence of HERPES VIRUS INFECTION (She states she had an outbreak after the first COVID vaccine/it started up again), INFECTION (She states she had an outbreak after the first COVID vaccine/it started up again), COVID-19 (Also reports getting COVID after I had the first booster/Says she started sneezing "like a kitten/it started going right for my lungs), MIGRAINE (The only thing I got was a pounding headache, which I had gotten from the first 3 shots� I mean a massive migraine.) and HEART RATE INCREASED (High heart rate) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Herpes infection: L Lysine (Herpes at bay by taking L Lysine) and Vitamin D (Herpes at bay by taking Vitamin D). Past adverse reactions to the above products included No adverse effect with L Lysine and Vitamin D. Concurrent medical conditions included Herpes infection (Exposed to herpes in the past but had not been breaking out at all except maybe a few times when she was younger). On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (She states she had an outbreak after the first COVID vaccine/it started up again), INFECTION (She states she had an outbreak after the first COVID vaccine/it started up again), COVID-19 (Also reports getting COVID after I had the first booster/Says she started sneezing "like a kitten/it started going right for my lungs), MIGRAINE (The only thing I got was a pounding headache, which I had gotten from the first 3 shots� I mean a massive migraine.), HEART RATE INCREASED (High heart rate), IMMUNE SYSTEM DISORDER (Messed up her immune system) and ILLNESS (Getting "very ill", "horribly ill" with both shots/made her sick "same as the other ones"). The patient was treated with Aciclovir (Acyclovir) at an unspecified dose and frequency and Serrapeptase at an unspecified dose and frequency. At the time of the report, HERPES VIRUS INFECTION (She states she had an outbreak after the first COVID vaccine/it started up again), INFECTION (She states she had an outbreak after the first COVID vaccine/it started up again), MIGRAINE (The only thing I got was a pounding headache, which I had gotten from the first 3 shots� I mean a massive migraine.), HEART RATE INCREASED (High heart rate), IMMUNE SYSTEM DISORDER (Messed up her immune system) and ILLNESS (Getting "very ill", "horribly ill" with both shots/made her sick "same as the other ones") had not resolved and COVID-19 (Also reports getting COVID after I had the first booster/Says she started sneezing "like a kitten/it started going right for my lungs) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: Did not seem to yield any abnormal results except a high heart rate. On an unknown date, Heart rate: High, 116. Concomitant medication was not provided. It was reported that patient got the first COVID vaccination when it first came out. Like many other people she also had been exposed to herpes in the past but had not been breaking out at all except maybe a few times when she was younger until she had the first shot. She had an outbreak after the first COVID vaccine and after a while it quit. She thought it was just some kind of reaction but then she got a second shot, and it started up again. She got very horribly ill with both shots. She was in bed for 3 days and it was like she had COVID. Then it finally went away after a while, a couple of months to 3 months. She got the booster which made her sick same as the other ones and she had never been able to get rid of the herpes ever since, as it kept recurring. She got COVID after the first booster and she felt is as strange as she never had those kinds of symptoms before. She started sneezing like a kitten and it started going right to lungs. She kept acyclovir on hand because she had so many reactions to the herpes. She had been seen by her physician. She also mentioned that she did not take an antiviral prophylactically but rather as needed. Since she could not get a hold of her doctor and could not get into a clinic, she took one acyclovir because it had headed to her lungs and then took another one 8 hours later and did that for 3 days and reported that all her symptoms were gone. The only thing she got was a pounding headache, which had gotten from the first 3 shots. But reported that the antivirals helped and then she felt very tired and slept for another few days. While looking for solutions online, she found information regarding about serrapeptase which people took for COVID, and she took it for 3 weeks to knock out herpes. It gave her weird diarrhea. After taking it, she did not have herpes outbreak for 3 months, but then it started again. Generally, she had reactions to everything and even her doctor agreed that she was chemically sensitive. She went to see her cardiologist for a checkup of some symptoms but did not remember what they were originally. They kept her on a heart monitor, did an EKG and gave her a stress test but it did not seem to yield any abnormal results except a high heart rate. She took an antiviral and noticed her heart rate go down. She stated that it somehow messed up her immune system and it was not back to normal yet. This case was linked to US-MODERNATX, INC.-MOD-2025-783045, US-MODERNATX, INC.-MOD-2025-783046 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-783045:Friend case US-MODERNATX, INC.-MOD-2025-783046:Invalid case for some people
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| 2831546 | M | CO | 03/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I just got COVID again; I just got COVID again; This is a spontaneous report received from a Consume...
I just got COVID again; I just got COVID again; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Pfizer COVID vaccinations every year since they were released.), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I just got COVID again". 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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| 2831547 | M | FL | 03/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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had 4 vaccinations for COVID and had covid after these vaccinations; had 4 vaccinations for COVID an...
had 4 vaccinations for COVID and had covid after these vaccinations; had 4 vaccinations for COVID and had covid after these vaccinations; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "unknown" and all described as "had 4 vaccinations for COVID and had covid after these vaccinations". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient's husband mentioned that he had COVID six months ago and Paxlovid was covered at that time. He recalled that they were covered for COVID previously and both had received four vaccinations. He stated that he has never had COVID. When asked if the vaccinations were Pfizer, the patient's wife responded that she did not remember which ones they had received. Both the patient and his wife had four COVID vaccinations and contracted COVID after these vaccinations. Additionally, the patient's wife was unsure of the Manufacturer and name of the vaccines they both received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500029896 same reporter, drug and event, different patient;
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| 2831548 | F | 03/14/2025 |
PNC20 |
PFIZER\WYETH |
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Headache, Injection site erythema, Injection site pain, Injection site swelling,...
Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
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Redness, pain swelling at injection site; Redness, pain swelling at injection site; Redness, pain sw...
Redness, pain swelling at injection site; Redness, pain swelling at injection site; Redness, pain swelling at injection site; headache; fever; This is a spontaneous report received from a Consumer or other non HCP from a sales representative. An adult female patient (unknown if pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 03Mar2025 as dose 1, single (Batch/Lot number: unknown), in deltoid for immunisation. The patient's relevant medical history included: "Drug Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines on the same date as Prevnar20. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 03Mar2025, outcome "recovering" and all described as "Redness, pain swelling at injection site"; PYREXIA (non-serious) with onset 03Mar2025, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 03Mar2025, outcome "recovering". Therapeutic measures (Tylenol) were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pain, headache, pyrexia. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2831549 | 55 | F | 03/14/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site pain, Injection site reaction, Musculoskeletal stiffness
Injection site pain, Injection site reaction, Musculoskeletal stiffness
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Muscle soreness/stiffness at injection site; Muscle soreness/stiffness at injection site; This is a ...
Muscle soreness/stiffness at injection site; Muscle soreness/stiffness at injection site; This is a spontaneous report received from a Consumer or other non HCP. A 55-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Mar2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; AMLODIPINE. The following information was reported: VACCINATION SITE PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovering" and all described as "Muscle soreness/stiffness at injection site". Therapeutic measures were taken as a result of vaccination site pain, musculoskeletal stiffness. Additional information: the patient had no known allergy. The patient didn't receive any other vaccines on the same date as the vaccine or any other vaccines within 4 weeks PRIOR to the vaccine. Treatment included OTC painkillers. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2831554 | F | 03/14/2025 |
HPV4 |
MERCK & CO. INC. |
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Death
Death
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passed away shortly after receiving her third dose of Gardasil; This spontaneous report was received...
passed away shortly after receiving her third dose of Gardasil; This spontaneous report was received from a consumer or other non-health professional and refers to a 17-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), dose number 3, (lot # and expiration date were not reported). For prophylaxis. On an unknown date (also reported as shortly after receiving the third dose of vaccine), the patient passed away. Cause of death was not reported. It was unknown whether an autopsy was performed. The causal relationship between the event and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not provided. Additional information is not expected.
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| 2831556 | 81 | F | MN | 03/14/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Arthralgia, Chest pain, Headache, Loss of personal independence in daily activit...
Arthralgia, Chest pain, Headache, Loss of personal independence in daily activities, Muscular weakness; Neck pain
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Weakness in legs; pain in neck; head pain; shoulder pain; chest pain; This non-serious case was repo...
Weakness in legs; pain in neck; head pain; shoulder pain; chest pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness lower limb in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 19-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). In FEB-2025, an unknown time after receiving Shingrix, the patient experienced neck pain (Verbatim: pain in neck), headache (Verbatim: head pain), shoulder pain (Verbatim: shoulder pain) and chest pain (Verbatim: chest pain). On an unknown date, the patient experienced muscle weakness lower limb (Verbatim: Weakness in legs). The patient was treated with gabapentin, baclofen and paracetamol (Tylenol). The outcome of the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain were not resolved. It was unknown if the reporter considered the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain to be related to Shingrix. It was unknown if the company considered the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain to be related to Shingrix. Additional Information: GSK Receipt Date: 04-MAR-2025 Patient experienced muscle weakness in legs and pain going up both sides of head, shoulders, and chest. Patient stated the onset of muscle weakness was approximately 10-12 days following vaccination and the neck pain going up both sides of the head, shoulders, and chest presented a few days prior to the muscle weakness. The patient was self-treating the symptoms with Gabapentin, Baclofen, and Tylenol, the dose and frequency were not provided. The patient stated Gabapentin, baclofen and Tylenol were prescribed to her for a different diagnosis prior to vaccination with Shingrix. The patient had not been treated by a doctor for the adverse event after vaccination. The patient stated she was being treated by physical therapy but did not specify if the treatment was for a different diagnosis prior to vaccination with Shingrix. The vaccine was administered at Pharmacy. The patient stated she was very active and she hiked approximately 30 miles per week and she has been unable to hike due to the muscle weakness in her legs
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| 2831557 | AR | 03/14/2025 |
HEP MENB |
GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS |
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Incorrect dose administered; Incorrect dose administered
Incorrect dose administered; Incorrect dose administered
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requests stability data for Bexsero, Engerix-B stored at 33.5F for 15hours; This non-serious case wa...
requests stability data for Bexsero, Engerix-B stored at 33.5F for 15hours; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On an unknown date, the patient received Bexsero and Engerix B. On an unknown date, an unknown time after receiving Bexsero and Engerix B, the patient experienced product storage error (Verbatim: requests stability data for Bexsero, Engerix-B stored at 33.5F for 15hours). The outcome of the product storage error 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: 06-MAR-2025 A Licensed Practical Nurse requested stability data for Bexsero and Engerix B stored at 33.5 Fahrenheit for 15 hours which led to incorrect storage of drug. The reporter reported no prior excursions and no signs of freezing or slushing The unknown number of patients involved as excursion occurred on 05 December 2024.
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| 2831558 | M | CO | 03/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old...
covid; covid; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient have been getting the Pfizer COVID vaccinations every year since they were released. Patient used Paxlovid when he got covid, despite the vaccine. Outcome of the events was unknown. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500053626 same reporter/patient, different dose/AE;
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| 2831559 | F | FL | 03/14/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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had 4 vaccinations for COVID/I take the test and it's clearly positive; had 4 vaccinations for ...
had 4 vaccinations for COVID/I take the test and it's clearly positive; had 4 vaccinations for COVID/I take the test and it's clearly positive; This is a spontaneous report and received from Consumer or other non HCPs, Program ID. A 70-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Feb2024, outcome "unknown" and all described as "had 4 vaccinations for COVID/I take the test and it's clearly positive". The events "had 4 vaccinations for covid/i take the test and it's clearly positive" required emergency room visit. So although the patient was very sick Friday and Saturday, she really believed she had a sinus thing, the patient get sinus things, but Sunday morning she knew in her heart this was not a sinus thing, this was a whole bag of problems...The patient went to the pantry, got out a COVID test, she had never had COVID. The patient took the test and it's clearly positive, so she pretty much crawl to the emergency room. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500055311 same reporter, drug and event, different patient;
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| 2831560 | PA | 03/14/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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COVID-19, Disease recurrence, Drug ineffective; COVID-19, Disease recurrence, Dr...
COVID-19, Disease recurrence, Drug ineffective; COVID-19, Disease recurrence, Drug ineffective
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my second time having COVID. And I had all my shots; my second time having COVID. And I had all my s...
my second time having COVID. And I had all my shots; my second time having COVID. And I had all my shots; my second time having COVID. And I had all my shots; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 72-year-old patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "my second time having COVID. And I had all my shots". Clinical course: The patient's husband got COVID, then two or three days later, the patient had it too. This was their second time having covid and the patient had all his/her shots.
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| 2831561 | F | NY | 03/14/2025 |
COVID19 |
UNKNOWN MANUFACTURER |
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COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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I didn't even test positive until 4 o'clock; I didn't even test positive until 4 o�...
I didn't even test positive until 4 o'clock; I didn't even test positive until 4 o'clock; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 60-year-old female patient received BNT162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), in Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immune system" (unspecified if ongoing), notes: I have immune system issues. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "I didn't even test positive until 4 o'clock". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Positive, notes: I didn't even test positive until 4 o'clock. Clinical course: During this inbound call for financial assistance, the patient stated that she was very sick, and she was trying to get Paxlovid. The patient obtained the Paxlovid prescription through the city's sort of virtual care thing, and the doctor that saw her virtually prescribed the Paxlovid through the city hospital program. The patient later mentioned that she was very stressed out and anxious. She literally avoided this virus for four years at great cost and she was already angry, upset and very nervous. She just got a vaccine three weeks ago and she had all the boosters because she had immune system issues. After a brief hold, the patient stated that she is still there and just a little out of breath. When the patient was asked if they confirmed that the prescription had been sent, she stated that the hospital was doing this a long time ago and they called it in like within 30 seconds. She didn't even test positive until 4 o'clock. Toward the end of the call while on conference with the pharmacy representative, the patient stated that it's the difference between her going to the hospital or not since she had health issues.
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