| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2819633 | M | GA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
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Product storage error
Product storage error
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The physician is reporting that unknown number of patients received improperly stored vaccines. Temp...
The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007147. Further information is not expected.
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| 2819634 | M | GA | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7296AA |
Product storage error
Product storage error
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The physician is reporting that unknown number of patients received improperly stored vaccines. Temp...
The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C; This spontaneous safety report, with reference number 02708409 (interaction number: 02708405), was received by the partner on 02-DEC-2024 and forwarded to agency on 02-DEC-2024, from a physician. Due to the nature of the event, the causality between the event "The physician is reporting that unknown number of patients received improperly stored vaccines. Temperature: 8.7C" and Vaxelis was not applicable. This case shares the same event with the following companion cases: MCM-007147. Further information is not expected.
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| 2819635 | U | GA | 01/06/2025 |
DTPPVHBHPB HEP |
MSP VACCINE COMPANY MERCK & CO. INC. |
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Product administered to patient of inappropriate age; Product administered to pa...
Product administered to patient of inappropriate age; Product administered to patient of inappropriate age
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Caller reported a 2 month old was administered VAXELIS and RECOMBIVAXHB on the same day. Date of adm...
Caller reported a 2 month old was administered VAXELIS and RECOMBIVAXHB on the same day. Date of administration unknown.; Caller reported a 2 month old was administered VAXELIS and RECOMBIVAXHB on the same day. Date of administration unknown.; This serious spontaneous safety report with MSD reference number #02715884 was received by the partner on 03-DEC-2024 and forwarded to agency on 03-DEC-2024, from a healthcare professional. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event of "Caller reported a 2 month old was administered VAXELIS and RECOMBIVAXHB on the same day. Date of administration unknown". Further information is expected.
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| 2819636 | F | TX | 01/06/2025 |
DTPPVHBHPB PNC15 RV5 |
MSP VACCINE COMPANY MERCK & CO. INC. MERCK & CO. INC. |
U7907AA X022479 2032352 |
Incorrect dosage administered; Incorrect dosage administered; Incorrect dosage a...
Incorrect dosage administered; Incorrect dosage administered; Incorrect dosage administered
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Pt was given the incorrect dosage. The dosage ordered was l00mg/lmL and pt was administered 50mg/0.S...
Pt was given the incorrect dosage. The dosage ordered was l00mg/lmL and pt was administered 50mg/0.SmL; This non-serious spontaneous safety report was received by partner on 11-DEC-2024 with the following reference number: 2796962-1 and forwarded to agency on 12-DEC-2024 from a health professional The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event; "Pt was given the incorrect dosage. The dosage ordered was l00mg/lmL and pt was administered 50mg/0.SmL" No further information is expected.
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| 2819637 | U | IN | 01/06/2025 |
DTPPVHBHPB MEN UNK |
MSP VACCINE COMPANY UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
U7392AA |
Off label use, Product administered to patient of inappropriate age; Off label u...
Off label use, Product administered to patient of inappropriate age; Off label use, Product administered to patient of inappropriate age; Off label use, Product administered to patient of inappropriate age
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VAXELIS was inadvertently administered to a 13 year old.; This non-serious spontaneous safety report...
VAXELIS was inadvertently administered to a 13 year old.; This non-serious spontaneous safety report was received by MSD on 12-DEC-2024 and forwarded to agency on 13-DEC-2024 with Case ID: 02721599 from a nurse. Due to the nature of the event, the causality between the event "VAXELIS was inadvertently administered to a 13 year old" and Vaxelis was not applicable. Case was considered as off-label use due to the reported event of patient being administered Vaxelis at age of 13 years. Further information is expected.
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| 2819638 | F | IN | 01/06/2025 |
DTPPVHBHPB MEN MEN |
MSP VACCINE COMPANY UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
U7392AA |
Off label use, Product administered to patient of inappropriate age; Off label u...
Off label use, Product administered to patient of inappropriate age; Off label use, Product administered to patient of inappropriate age; Off label use, Product administered to patient of inappropriate age
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VAXELIS was inadvertently administered to a 16 year old. Patient also received MenQuadfi and Meningi...
VAXELIS was inadvertently administered to a 16 year old. Patient also received MenQuadfi and Meningitis B vaccine. No other information provided; This non-serious spontaneous safety report was received by agency on 12-DEC-2024 and forwarded to agency on 13-DEC-2024 with Case ID: 02721564 from a nurse. Due to the nature of the event, the causality between the event "VAXELIS was inadvertently administered to a 16 year old" and Vaxelis was not applicable. Case was considered as off-label use due to the reported event of patient being administered Vaxelis at age of 16 years. Further information is expected.
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| 2819639 | U | TX | 01/06/2025 |
DTPPVHBHPB HEP |
MSP VACCINE COMPANY MERCK & CO. INC. |
2CA52C1 W035402 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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2 month old inadvertently received both VAXELIS and RECOMBIVAX; 2 month old inadvertently received b...
2 month old inadvertently received both VAXELIS and RECOMBIVAX; 2 month old inadvertently received both VAXELIS and RECOMBIVAX; This non-serious spontaneous safety report was received by agency on 16-DEC-2024 and forwarded to agency on the same day with Case ID: 02723097 from a HCP. Due to the nature of the event, the causality between the event "2 month old inadvertently received both VAXELIS and RECOMBIVAX" and Vaxelis was not applicable. Further information is expected.
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| 2819640 | F | NY | 01/06/2025 |
DTPPVHBHPB FLU3 |
MSP VACCINE COMPANY SANOFI PASTEUR |
U7921AA |
Product storage error; Product storage error
Product storage error; Product storage error
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VAXELIS was administered to 1 patient after temperature excursion with negative disposition.; This n...
VAXELIS was administered to 1 patient after temperature excursion with negative disposition.; This non-serious spontaneous safety report was received by Sanofi with GPV Number: 2024SA373698 on 18-DEC-2024 and forwarded on 17-DEC-2024 from an HCP. Due to the nature of the event, the causality between the event "VAXELIS was administered to 1 patient after temperature excursion with negative disposition." and Vaxelis was not applicable. Further information is expected.
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| 2819641 | U | KY | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7907AA |
No adverse event, Product storage error
No adverse event, Product storage error
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administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No...
administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No symptoms reported.; This spontaneous safety report, with reference number 02725276 (interaction number:02725238), was received by the partner on 19-DEC-2024 and forwarded to agency on the same day, from a physician. Due to the nature of the event, the causality between the event "administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No symptoms reported." and Vaxelis was not applicable. Further information is expected.
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| 2819642 | U | KY | 01/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7907AA |
No adverse event, Product storage error
No adverse event, Product storage error
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administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No...
administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No symptoms reported.; This spontaneous safety report, with reference number 02725238 (interaction number:02725247), was received by the partner on 19-DEC-2024 and forwarded to agency on the same day, from a physician. Due to the nature of the event, the causality between the event "administered improperly stored VAXELIS on 12/19/2024, following a TE that occurred on 12/19/2024. No symptoms reported." and Vaxelis was not applicable. Further information is expected.
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| 2819643 | F | MO | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Device leakage, Needle issue, Occupational exposure to product
Device leakage, Needle issue, Occupational exposure to product
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the needle broke; It (Covid-19 vaccine) also splashed on the pharmacist; It (Covid-19 vaccine) also ...
the needle broke; It (Covid-19 vaccine) also splashed on the pharmacist; It (Covid-19 vaccine) also splashed on the pharmacist; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, 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: DEVICE LEAKAGE (non-serious), OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) all with onset 2024 and all described as "It (Covid-19 vaccine) also splashed on the pharmacist"; NEEDLE ISSUE (non-serious) with onset 2024, described as "the needle broke". Causality for "the needle broke" and "it (covid-19 vaccine) also splashed on the pharmacist" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction). Additional information: When reporter got the shot (Clarified as Pfizer Covid-19 vaccine) and then the needle broke and then, what was in the needle splashed on reporter's face and it splashed on the reporter and it also splashed on the pharmacist and so when that happened the pharmacist said, she does not want to give the reporter another shot because she does not know how much went in reporter's arm before the needle broke.
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| 2819644 | F | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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died; This is a spontaneous report received from a Consumer or other non HCP. A female patient rece...
died; This is a spontaneous report received from a Consumer or other non HCP. A female 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 (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: DEATH (death), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400335023 Same reporter/event, different patient;; Reported Cause(s) of Death: Unknown cause of death
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| 2819645 | F | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Endometrial cancer, Vaginal haemorrhage
Endometrial cancer, Vaginal haemorrhage
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I was diagnosed as endometrial cancer; heavy and abnormal vagina bleeding; This is a spontaneous rep...
I was diagnosed as endometrial cancer; heavy and abnormal vagina bleeding; This is a spontaneous report received from an Other HCP. A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine on the same date. No other vaccine in four weeks. No other medications in two weeks. No known allergies. Patient was in good health before. No medical conditions. The following information was reported: VAGINAL HAEMORRHAGE (disability, life threatening) with onset 2021, 2 days after the suspect product(s) administration, outcome "recovering", described as "heavy and abnormal vagina bleeding"; ENDOMETRIAL CANCER described as "I was diagnosed as endometrial cancer". Therapeutic measures were taken as a result of vaginal haemorrhage includes: surgery, chemo and radiation. Clinical details: Patient experienced heavy and abnormal vagina bleeding 2 days post dosing which she never experienced before. I was diagnosed as endometrial cancer. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The event vaginal haemorrhage is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. As there is limited information in the case provided, the causal association between the event endometrial cancer and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500000306 same reporter/patient, partial same event, different dose;US-PFIZER INC-202500000312 same reporter/patient, partial same event, different dose;
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| 2819646 | F | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Vaginal haemorrhage
Vaginal haemorrhage
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heavy and abnormal vagina bleeding; This is a spontaneous report received from an Other HCP. A 41-y...
heavy and abnormal vagina bleeding; This is a spontaneous report received from an Other HCP. A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient was in good health before. No medical conditions. Patient didn't have Known allergies. There were no concomitant medications. There was no other vaccine same date, no other vaccine in four weeks, no other medication in two weeks. Vaccination history included: Bnt162b2 (dose 1), administration date: 2021, for covid-19 immunisation, reaction(s): "heavy and abnormal vagina bleeding". The following information was reported: VAGINAL HAEMORRHAGE (disability, life threatening) with onset 2021, 2 days after the suspect product(s) administration, outcome "recovering", described as "heavy and abnormal vagina bleeding". Therapeutic measures were taken as a result of vaginal haemorrhage which included Surgery, Chemo and radiation. Clinical course: experienced heavy and abnormal vagina bleeding 2 days post dosing for all three doses which she never experienced before. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The event vaginal haemorrhage is conservatively assessed as related to the suspect drug BNT162B2 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202500000306 same reporter/patient, partial same event, different dose;US-PFIZER INC-202500000311 same reporter/patient, partial same event, different dose;
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| 2819647 | F | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Allergy to vaccine, Bell's palsy, Urticaria
Allergy to vaccine, Bell's palsy, Urticaria
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general bell's palsy; allergic to covid 19 vaccine; hives; This is a spontaneous report receive...
general bell's palsy; allergic to covid 19 vaccine; hives; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female 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. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "general bell's palsy"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "allergic to covid 19 vaccine"; URTICARIA (non-serious), outcome "unknown", described as "hives". Clinical course: The patient stated that she is allergic to COVID-19 Vaccine, she got general Bell's palsy and hives with the vaccine. 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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| 2819649 | 45 | M | WV | 01/06/2025 |
HPV9 |
MERCK & CO. INC. |
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Inappropriate schedule of product administration, No adverse event, Product use ...
Inappropriate schedule of product administration, No adverse event, Product use in unapproved indication
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no adverse event; Pharmacist called to report a patient who received their first dose of GARDASIL 9 ...
no adverse event; Pharmacist called to report a patient who received their first dose of GARDASIL 9 at 45 years of age missed their next two doses in the series and is now 46 years old. No symptoms reported. Consent to correspond was granted. See related request ca; Indication HPV; This spontaneous report was received from a pharmacist, concerning to a 45-year-old male. The patient's medical historry, concurrent conditions and concomitant therapies were not reported. On 03-MAY-2024, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered intramuscularly for Human Papillomavirus (HPV) (Product use in unapproved indication) (strength, lot #, expiry date, and indication were not provided), when he was 45 years old. He missed the next two doses and he was already 46-years-old. (Inappropriate schedule of product administration). No additional adverse event (No adverse event).
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| 2819650 | M | IL | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
FJ8757 |
Injury
Injury
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3 years later he is having more injuries; This Initial case was previously missing the following min...
3 years later he is having more injuries; This Initial case was previously missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 31Dec2024, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FJ8757, Expiration Date: 22Nov2021) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Xanax for anxiety. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0170), administration date: 30Apr2021, when the patient was 32-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot Number: EW0178, Expiration Date: 22Nov2021, Route of Administration: Intramuscular, Anatomical Location: Right Arm), administration date: 21May2021, when the patient was 32-year-old, for COVID-19 immunization, reaction(s): "Had a heart attack", "Heart raced up to 250 beats a minute; Heart rate was pounding for about a minute and half for no reason; Heart rate is over 200 beats per minute", "Migraine", "Chest pain; Used to wake up out of sleep with chest pains", "Palpitation", "Body ache/Pain", "Heart spasm", "GERD/Acid reflux; Acid reflux got out of control", "Sleep apnea", "GI issues; Sensitive to every food that he eats", "Heart fluctuation", "Short of breath", "Fever of 101", "sensitive to dust; If he inhales any amount of dust, he gets severely sick", "sensitive to dust; If he inhales any amount of dust, he gets severely sick", "heart rate gets so low when he sleeps and when he wakes up, it wants to speed up to catch up to his normal resting heart rate which is 55 and when he sleeps his heart rate is 33", "Night tremor", "Lost over 40 pounds", "having amplified his anxiety, 10 times", "Paralysis", "Chest pain; Used to wake up out of sleep with chest pains", "can't eat", "Stomach hurts", "nerve pain", "tachycardia". The following information was reported: INJURY (non-serious) with onset 2024, outcome "unknown", described as "3 years later he is having more injuries". The event "3 years later he is having more injuries" required physician office visit. Additional information: The patient stated he had covid in Jun of this year and it was, he had it when he was unvaccinated and then he had it after he was vaccinated and it was worse after he was vaccinated. So, he just does not get how that was even told the people that people would have a less severe side effects from it, when that is not true. Patient wanted to figure out how he could get compensation for this traumatic injury and he has been going to doctors and they are saying he is fine but that is a lie, they are not looking for what is really wrong. He is saying that from the vaccine injury that he received from taking a safe and effective vaccine (as reported). The patient told last time his heartbeat was over 250 beats a minute after his second dose, was after the second dose. He took a vaccine his first dose, his second dose to the vaccine, 2 days after his heart, he had tachycardia and that showed that the vaccine engineered his body to attack his own body. The vaccine, whatever they gave him a shot of, triggered his body to attack its own his cells and that is why his heart got tachycardia and 3 years later he is having more injuries and this could be from early onset of heart disease because the vaccine made him attack his own body.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400329270 same patient, different vaccine dose/event;US-PFIZER INC-202500000715 same patient, different vaccine dose/event;
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| 2819652 | 69 | F | FL | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Crying, Disturbance in attention, Insomnia, Muscle spasms, Tremor
Crying, Disturbance in attention, Insomnia, Muscle spasms, Tremor
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trembling and spasms right arm; trembling and spasms right arm; trouble sleeping; she couldn't ...
trembling and spasms right arm; trembling and spasms right arm; trouble sleeping; she couldn't concentrate; she's crying; This is a spontaneous report received from a Consumer or other non HCP. A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 14Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), TREMOR (non-serious), outcome "not recovered" and all described as "trembling and spasms right arm"; INSOMNIA (non-serious), outcome "not recovered", described as "trouble sleeping"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "she couldn't concentrate"; CRYING (non-serious), outcome "unknown", described as "she's crying". The events "trembling and spasms right arm" required physician office visit. Therapeutic measures were taken as a result of muscle spasms, tremor, insomnia. Additional information: The reported called in regard to the COVID-19 vaccine, the booster. They had a COVID booster at (pharmacy name withheld) on 14Nov2024. The patient got reaction a couple of days after. The patient wife's hand was trembling, the upper arm was trembling, having spasms; spasms in her right hand and right thumb, most of it comes from her right thumb. She almost lost it, she couldn't concentrate, she was fine until she got this, and it almost killed her, she is still going through it, and it is kind of bad and he does not know if it was muscle and partially the nerve. The reporter clarified it was the whole right arm. It mostly comes from the thumb. It got so bad last Thursday, had to go to urgent care. The patient was given muscle relaxer. Before couldn't even sleep. The reporter was trying to get help, trying to get a doctor. Has an appointment with an orthopedic doctor on 02Jan. The patient had taken Benadryl so she could sleep and that helped. The reporter verbalized going to a primary isn't going to help. The reporter stated he was going through hell because his wife's arm was trembling and spasming and would not stop and he was up all night with her and they did not know what to do and tried everything they could figure out. The reporter stated he gets nervous himself because he was trying to help her and feels so sorry for her because she was crying and it makes him cry because he does not know what to do. This has been going on for a week, wife is having trouble sleeping. It doesn't stop trembling and started getting worse and worse because she couldn't even sleep. Bought a brace and has been using it and the next morning stated wow that stuff is working pretty good, and he does not know if it was a lot better than what she was going through but it is still kind of bad but it's better. This is going on for over a week and they are going crazy, and she has trouble sleeping and it is better with the medication but is still serious and it all seems like it is coming from her thumb and kind of works through her fingers and her upper arm. 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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| 2819653 | M | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0588 |
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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her husband has covid/they received with Lot#LN0588; her husband has covid/they received with Lot#LN...
her husband has covid/they received with Lot#LN0588; her husband has covid/they received with Lot#LN0588; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LN0588, Expiration Date: 17Apr2025) 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), outcome "unknown" and all described as "her husband has covid/they received with Lot#LN0588". No follow-up attempts are possible.
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| 2819654 | F | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Vaccination failure
COVID-19, Vaccination failure
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Caller had Pfizer covid 19 vaccines last 20Sep2024, and on Nov caller was diagnosed with covid; Call...
Caller had Pfizer covid 19 vaccines last 20Sep2024, and on Nov caller was diagnosed with covid; Caller had Pfizer covid 19 vaccines last 20Sep2024, and on Nov caller was diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 75 and a half years old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 20Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: Feb-Mar she got COVID as well and took PAXLOVID. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Nov2024, outcome "unknown" and all described as "Caller had Pfizer covid 19 vaccines last 20Sep2024, and on Nov caller was diagnosed with covid". Therapeutic measures were taken as a result of vaccination failure which included Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2819655 | 70 | F | PA | 01/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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covid rebound; covid rebound; This is a spontaneous report received from a Consumer or other non HCP...
covid rebound; covid rebound; This is a spontaneous report received from a Consumer or other non HCP. A 71-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (PRIMARY SERIES COMPLETE, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2024, outcome "recovering" and all described as "covid rebound". Therapeutic measures were not taken as a result of drug ineffective, covid-19. 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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| 2819656 | 4 | M | NY | 01/06/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
42Y93 Y015355 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
|
Set of twins were given DTAP, PIV and MMRV on 12/24/2024 by LPN. As per nurse, parent denied childre...
Set of twins were given DTAP, PIV and MMRV on 12/24/2024 by LPN. As per nurse, parent denied children getting vaccines elsewhere. State System was not verified before administration. Staff received a call from NP from Pts' school to advise me that these vaccines were already administered by her on 12/04/2024, as per State System. Provider Dr advised. Provider stated no harm done and vaccines will be invalid. Nurse unable to contact parent on 01/03. Will try again tomorrow.
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| 2819657 | 32 | M | CA | 01/06/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
201A21A 201A21A |
Biopsy lymph gland, Chemotherapy, Colonoscopy, Depression, Diagnostic aspiration...
Biopsy lymph gland, Chemotherapy, Colonoscopy, Depression, Diagnostic aspiration; Haematochezia, Hodgkin's disease, Libido decreased, Lymphadenopathy, Suicidal ideation
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I had developed Hodgkin Lymphoma a year after the the vaccine. A few months before my lymphoid on my...
I had developed Hodgkin Lymphoma a year after the the vaccine. A few months before my lymphoid on my neck first became swollen, I experienced months of bloody stools. After diagnosis I had to go through several rounds of chemotherapy. Till this day I'm unsure if I'm able to reproduce due to the chemotherapy. Loss of sex drive, thoughts of suicide had occurred, depression; all after chemotherapy.
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โ | โ | ||||
| 2819658 | 81 | M | FL | 01/06/2025 |
COVID19 |
JANSSEN |
1808982 |
Death, Ill-defined disorder, Malaise
Death, Ill-defined disorder, Malaise
|
after my parents got that shot they became ill for a little over a month starting feeling a little b...
after my parents got that shot they became ill for a little over a month starting feeling a little better but then things went south for both of them. my dad found my mother bleeding out her rectum on the bathroom floor. i have all hospital reports and documents . They both died within days of each other. the only information I was told by the detective was he had a medical issue. A medical issue? I guess thats what its called. We need accountability for this insanity
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โ | โ | ||||
| 2819659 | 11 | F | FL | 01/06/2025 |
FLU3 |
SEQIRUS, INC. |
946614 |
Dizziness, Syncope
Dizziness, Syncope
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the patient had fainted, she felt lightheaded, she did not hurt herself, the mom caught her before h...
the patient had fainted, she felt lightheaded, she did not hurt herself, the mom caught her before hitting the ground. the paramedics were called on
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| 2819660 | 69 | F | MI | 01/06/2025 |
COVID19 |
MODERNA |
8081260 |
Diarrhoea
Diarrhoea
|
Patient reporting diarrhea the day following administration. RPh advised patient to increase liquid ...
Patient reporting diarrhea the day following administration. RPh advised patient to increase liquid intake and to take Immodium as directed by the package.
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| 2819662 | 11 | M | FL | 01/06/2025 |
MNQ TDAP |
SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
|
Fall, Head injury, Malaise, Nausea, Syncope; Fall, Head injury, Malaise, Nausea,...
Fall, Head injury, Malaise, Nausea, Syncope; Fall, Head injury, Malaise, Nausea, Syncope
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The child complained of not feeling well about 5-10 minutes after the vaccines. He said he started ...
The child complained of not feeling well about 5-10 minutes after the vaccines. He said he started feeling nauseous. He then fainted and fell to the ground. No one warned us that this might happen, so we were standing in a parking lot and he hit his head on the concrete.
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| 2819663 | 47 | F | GA | 01/06/2025 |
TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP TYP |
BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. BERNA BIOTECH, LTD. |
3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 3004063 |
Small intestinal obstruction; Abdominal X-ray, Abdominal adhesiolysis, Abdominal...
Small intestinal obstruction; Abdominal X-ray, Abdominal adhesiolysis, Abdominal distension, Abdominal pain, Anion gap increased; Biopsy small intestine abnormal, Blood bilirubin increased, Blood culture negative, Blood urea nitrogen/creatinine ratio increased, Carbon dioxide decreased; Chills, Computerised tomogram abdomen abnormal, Dehydration, Differential white blood cell count abnormal, Fat necrosis; Full blood count, Gomori methenamine silver stain, Haematocrit normal, Haemoglobin normal, Human chorionic gonadotropin negative; Induration, Intestinal dilatation, Laparotomy, Lipase normal, Mechanical ileus; Mesenteric haemorrhage, Metabolic function test, Mycobacterium test negative, Nausea, Neutrophil percentage increased; Pathology test, Platelet count normal, Shift to the left, Small intestinal resection, Vomiting; White blood cell count increased, X-ray abnormal; Small intestinal obstruction; Abdominal X-ray, Abdominal adhesiolysis, Abdominal distension, Abdominal pain, Anion gap increased; Biopsy small intestine abnormal, Blood bilirubin increased, Blood culture negative, Blood urea nitrogen/creatinine ratio increased, Carbon dioxide decreased; Chills, Computerised tomogram abdomen abnormal, Dehydration, Differential white blood cell count abnormal, Fat necrosis; Full blood count, Gomori methenamine silver stain, Haematocrit normal, Haemoglobin normal, Human chorionic gonadotropin negative; Induration, Intestinal dilatation, Laparotomy, Lipase normal, Mechanical ileus; Mesenteric haemorrhage, Metabolic function test, Mycobacterium test negative, Nausea, Neutrophil percentage increased; Pathology test, Platelet count normal, Shift to the left, Small intestinal resection, Vomiting; White blood cell count increased, X-ray abnormal; Small intestinal obstruction; Abdominal X-ray, Abdominal adhesiolysis, Abdominal distension, Abdominal pain, Anion gap increased; Biopsy small intestine abnormal, Blood bilirubin increased, Blood culture negative, Blood urea nitrogen/creatinine ratio increased, Carbon dioxide decreased; Chills, Computerised tomogram abdomen abnormal, Dehydration, Differential white blood cell count abnormal, Fat necrosis; Full blood count, Gomori methenamine silver stain, Haematocrit normal, Haemoglobin normal, Human chorionic gonadotropin negative; Induration, Intestinal dilatation, Laparotomy, Lipase normal, Mechanical ileus; Mesenteric haemorrhage, Metabolic function test, Mycobacterium test negative, Nausea, Neutrophil percentage increased; Pathology test, Platelet count normal, Shift to the left, Small intestinal resection, Vomiting; White blood cell count increased, X-ray abnormal
More
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employee this vaccine caused a small bowel obstruction
employee this vaccine caused a small bowel obstruction
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| 2819664 | 38 | M | MI | 01/06/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
Fc3527 Fc3527 Fc3184 Fc3184 |
Abnormal behaviour, Drowning, Fall, Heart rate increased, Hypersomnia; Seizure; ...
Abnormal behaviour, Drowning, Fall, Heart rate increased, Hypersomnia; Seizure; Abnormal behaviour, Drowning, Fall, Heart rate increased, Hypersomnia; Seizure
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Patient has two occasions of fast heart rate after the vaccine. His behavior changed and he slept a ...
Patient has two occasions of fast heart rate after the vaccine. His behavior changed and he slept a lot. Had first seizure on 5/19/2022 that caused his to fall into water and drown.
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โ | |||||
| 2819665 | 27 | F | FL | 01/06/2025 |
COVID19 COVID19 HEP HEP COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH DYNAVAX TECHNOLOGIES CORPORATION DYNAVAX TECHNOLOGIES CORPORATION PFIZER\BIONTECH PFIZER\BIONTECH |
LP1780 LP1780 |
Rash; Rash; Rash; Rash; Rash; Rash
Rash; Rash; Rash; Rash; Rash; Rash
|
Rash under and between breast, rash on the left part of the neck, behind the neck, and rash in the l...
Rash under and between breast, rash on the left part of the neck, behind the neck, and rash in the left inguinal area. Rash was self-limited
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||||||
| 2819666 | 14 | F | CA | 01/06/2025 |
COVID19 COVID19 FLU3 FLU3 HEPA HEPA VARCEL VARCEL |
MODERNA MODERNA GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
b0002 b0002 724L5 724L5 5JA57 5JA57 Y007955 Y007955 |
Carotid pulse normal, Dizziness, Hyperhidrosis, Mouth injury, Pallor; Unresponsi...
Carotid pulse normal, Dizziness, Hyperhidrosis, Mouth injury, Pallor; Unresponsive to stimuli; Carotid pulse normal, Dizziness, Hyperhidrosis, Mouth injury, Pallor; Unresponsive to stimuli; Carotid pulse normal, Dizziness, Hyperhidrosis, Mouth injury, Pallor; Unresponsive to stimuli; Carotid pulse normal, Dizziness, Hyperhidrosis, Mouth injury, Pallor; Unresponsive to stimuli
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Client (DOB: 08/xx/20xx) received 2nd dose of Varicella, seasonal COVID-19 (Moderna-Spikevax), Hepat...
Client (DOB: 08/xx/20xx) received 2nd dose of Varicella, seasonal COVID-19 (Moderna-Spikevax), Hepatitis A and seasonal flu shot (Flulaval) at 2:55 PM. At around 2:57 PM, client stated "I feel like I am going to faint". Staff guided client to the nearest chair. Client was observed to be diaphoretic and pale. At around 2:57 PM client became unresponsive for about 5-10 seconds. Staff assessed carotid pulse at this time. Pulse was regular and strong. Staff called RN who provided blue mat. At this time, client became responsive and Staff assisted client down to supine position. Client was given ice packs to apply on forehead. Client was also given emesis bag. At 3:01 PM, nurses took VS while client was lying down; HR 82, SPO2 100% RA, BP 94/64, RR 22. Client was alert and oriented to person, place, and event. Client denied experiencing any chest pain, shortness of breath, nausea, or headache, but reported she bit the inside of her cheek. Staff assessed mild errythema on the left buccal mucosa. Buccal mucosa was intact, no bleeding or additional complications were assessed. At 3:06 PM, VS were as follows HR 67, BP 104/71, SPO2 96% RA, RR 18. At 3:12 PM, client was able to sit up on mat by herself. VS were as follows HR 80, BP 101/83, SPO2 100% RA, RR 16. Client denied any dizziness, nausea, shortness of breath or pain. At 3:14 PM, client stated that she felt like she could sit up on chair. Staff observed client stand and sit in chair. Client denied any dizziness, nausea, shortness of breath or pain. At 3:17PM, client was able stand up on her own and denied experiencing any dizziness, nausea, shortness of breath or pain. Staff took another set of VS while client was standing. VS were as follows HR 91, BP 99/63, SPO2 100% RA, RR 18. Client stated that she felt comfortable walking and requesting to leave. Client's gait appeared steady and skin was normal for ethnicity. Client also confirmed and denied any concerning symptoms. Advised client and client's father to follow up with client's primary care doctor and to seek emergency care if symptoms return, or if client starts experiencing new symptoms.
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| 2819667 | 24 | M | WA | 01/06/2025 |
TD |
SANOFI PASTEUR |
y002061 |
Extra dose administered
Extra dose administered
|
On 10/8/24, pt received MMR vaccine (live vaccine) from store. On 10/13/2024, pt received another li...
On 10/8/24, pt received MMR vaccine (live vaccine) from store. On 10/13/2024, pt received another live vaccine, Varivax, from our store. Per CDC, "If 2 injected vaccines are administered on separate days, but administered <28 days apart, the second vaccine is invalid and should be re-administered >28 days after the invalid dose. The mistake was identified when patient came back to pharmacy on 1/6/25 to receive the second doses of MMR and Varivax. Patient was informed of the mistake. He understood the first dose of Varivax he got on 10/13/24 was invalid. Each dose of MMR and Varivax was given on 1/6/25 at the same time and patient agreed to come back for another dose of Varivax.
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| 2819668 | 74 | F | IN | 01/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Dysgeusia, Fatigue, Influenza like illness
Dysgeusia, Fatigue, Influenza like illness
|
Pt reports experiencing flu like symptoms and tiredness beginning 1-5 at 7pm, then reports a metall...
Pt reports experiencing flu like symptoms and tiredness beginning 1-5 at 7pm, then reports a metallic taste when drinking fluids this morning 1-6
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| 2819669 | 62 | F | TN | 01/06/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255T2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
|
Patient received AREXVY on 1/2/25 after receiving it previously 2 years prior. During patient intera...
Patient received AREXVY on 1/2/25 after receiving it previously 2 years prior. During patient interaction patient stated they had not received it prior, insurance allowed the claim to be billed, and our system did not recognize the vaccine being administered again. Further investigation of if the patient had received the vaccine was not pursued until later. Patient has had no adverse effects known-to-date from receiving vaccine again.
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| 2819681 | 70 | F | FL | 01/06/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SEQIRUS, INC. |
LM2216 388487 |
Injection site bruising, Injection site mass, Injection site pain; Injection sit...
Injection site bruising, Injection site mass, Injection site pain; Injection site bruising, Injection site mass, Injection site pain
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Pain, bruise and lump under the skin at injection site beginning 12/31/24. Lump described as larger ...
Pain, bruise and lump under the skin at injection site beginning 12/31/24. Lump described as larger than a half-dollar. As of 01/04/25, pain and size of lump have both decreased, but are still present.
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| 2819690 | 5 | M | CT | 01/06/2025 |
VARCEL |
MERCK & CO. INC. |
Y010374 |
Vaccination site erythema, Vaccination site induration, Vaccination site vesicle...
Vaccination site erythema, Vaccination site induration, Vaccination site vesicles
More
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24 hours after receiving Varicella, developed area of erythema and induration at the vaccination sit...
24 hours after receiving Varicella, developed area of erythema and induration at the vaccination site. Area examined 1/6, findings of approx. 2cm x 2cm area of discreet vesicles in annular distribution, mild induration.
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| 2819405 | 53 | F | TX | 01/05/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Dyspnoea, Pruritus, Swollen tongue
Dyspnoea, Pruritus, Swollen tongue
|
Severe itching on palms, feet, shoulders, sides and thighs. Tongue swelling and trouble breathing
Severe itching on palms, feet, shoulders, sides and thighs. Tongue swelling and trouble breathing
|
โ | |||||
| 2819406 | 55 | F | SC | 01/05/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR |
00069-2432-10 00069-2432-10 49281-0724-10 49281-0724-10 |
Erythema, Headache, Lethargy, Pruritus, Skin warm; Urticaria; Erythema, Headache...
Erythema, Headache, Lethargy, Pruritus, Skin warm; Urticaria; Erythema, Headache, Lethargy, Pruritus, Skin warm; Urticaria
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Larthagic,- slept , large welt (lump), itchy, redness, soreness, headache - took Advil midday on Fr...
Larthagic,- slept , large welt (lump), itchy, redness, soreness, headache - took Advil midday on Friday the 3rd. On Saturday 4th started getting redder and hotter, more itchy. Placed cold compress on in early evening and then ibuprofen at night. Jan 5th woke up still red no increase in size, still itchy, placed cold compress. Won't take further medication unless pain gets worse
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| 2819407 | 70 | F | NY | 01/05/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Asthenia, Syncope
Asthenia, Syncope
|
Extreme weakness resulted in fainting
Extreme weakness resulted in fainting
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||||||
| 2819408 | 68 | F | WV | 01/05/2025 |
RSV |
PFIZER\WYETH |
7090729604 |
Axillary pain, Injection site pain, Injection site swelling, Oedema peripheral
Axillary pain, Injection site pain, Injection site swelling, Oedema peripheral
|
Swelling at injection site, sore. Swelling and sore in left armpit
Swelling at injection site, sore. Swelling and sore in left armpit
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| 2819409 | 65 | F | LA | 01/05/2025 |
RSV |
PFIZER\WYETH |
LG9827 |
Asthenopia, Diplopia, Dizziness, Fall, Fatigue
Asthenopia, Diplopia, Dizziness, Fall, Fatigue
|
Double vision. Fell asleep at 8pm and woke a little after midnight with severe double vision , dizzi...
Double vision. Fell asleep at 8pm and woke a little after midnight with severe double vision , dizziness. Tried closing eyes to read on phone what could be wrong. Tried to rub eyes & pop ears, tried doing head maneuvers. Got up and fell bad but didn't bread anything. Made it to kitchen, drank water, rinsed eyes. Kept pressing eyes & refocusing eyes. Put warm compresses on them. Finally got sort of adjusted to single vision. Tired fell asleep very scared. Woke up with phone call at 8:30 - 9 am and no vision issue except eyes feel tired.
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| 2819410 | 62 | F | MI | 01/05/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
|
Arthralgia, Injection site pain, Injection site pruritus, Mobility decreased, Ne...
Arthralgia, Injection site pain, Injection site pruritus, Mobility decreased, Neck pain; Pain in extremity, Rash macular
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Extreme pain with injection. Still have pain in left arm on 1/5/52025. On Dec 15 went to Dr with re...
Extreme pain with injection. Still have pain in left arm on 1/5/52025. On Dec 15 went to Dr with red blotches up and down left arm and terrible pain in left shoulder and neck. Diagnosis possible shingles. Treated shingles ( only on left arm) still having issues lifting arm and had itching at site the last 2 days
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| 2819411 | 55 | U | 01/05/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
|
Axillary pain, Biopsy breast, Breast mass, Chest pain, Chest wall abscess; Compu...
Axillary pain, Biopsy breast, Breast mass, Chest pain, Chest wall abscess; Computerised tomogram breast abnormal, Mammogram, Pain, Ultrasound breast
More
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approx. 6 days after injection experienced severe soreness and pain under both arms radiating into s...
approx. 6 days after injection experienced severe soreness and pain under both arms radiating into sides of chest, this dissipated after 7-10 days then after approx. 6-8 days while showering found large lump in right outer breast I monitored this for approx 5-7 days when it didn't go away I went to urgent care, they sent me to the ER they did CT with contrast finding possible malignant growths in both breast radiating under each arm. They referred me to a cancer breast surgeon specialist who sent me for mammogram, ultrasound, and needle biopsy findings were "no malignancy detected" so not cancer. The surgeon is calling it a chest wall abscess I am scheduled for surgery 1/9/25 to have the fist sized mass removed.
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| 2819412 | 28 | F | WA | 01/05/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Chemotherapy, Chest pain, Philadelphia positive acute lymphocytic leukaemia, Rad...
Chemotherapy, Chest pain, Philadelphia positive acute lymphocytic leukaemia, Radiotherapy, Stem cell transplant; Tachycardia
More
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Presented to emergency department with chest pains and tachycardia, several tests performed resultin...
Presented to emergency department with chest pains and tachycardia, several tests performed resulting in a diagnosis of ph+ b cell acute lymphoblastic leukemia. Treatments included chemotherapy, radiation and stem cell transplant
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โ | โ | โ | |||
| 2819413 | 67 | F | TX | 01/05/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Full blood count normal, Hypertension, Laboratory test normal, Thyroid function ...
Full blood count normal, Hypertension, Laboratory test normal, Thyroid function test normal
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High blood pressure up to 175/102. Up until 08/15/2024 never had a blood pressure above 126/82 befo...
High blood pressure up to 175/102. Up until 08/15/2024 never had a blood pressure above 126/82 before.
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| 2819414 | 41 | M | FL | 01/05/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
x357e |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
|
Pt received 1st boostrix on 5/31/2024. Pt received the same vaccine again on 1/4/2025. The 2nd vacci...
Pt received 1st boostrix on 5/31/2024. Pt received the same vaccine again on 1/4/2025. The 2nd vaccine was not appropriate given guidelines
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||||||
| 2819415 | 46 | F | ME | 01/05/2025 |
PNC20 |
PFIZER\WYETH |
|
Dizziness, Fatigue, Injection site swelling, Peripheral swelling
Dizziness, Fatigue, Injection site swelling, Peripheral swelling
|
The patient started to experience arm swelling, light headedness and fatigue within 24 hours. The s...
The patient started to experience arm swelling, light headedness and fatigue within 24 hours. The swelling at the injection site became progressively more prominent over the subsequent days. Treatment was sought at an urgent care clinic. The patient was assured that she was not developing cellulitis.
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| 2819416 | 25 | F | OR | 01/05/2025 |
COVID19 |
PFIZER\BIONTECH |
LP1780 |
Injection site erythema, Injection site induration, Injection site pain, Injecti...
Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
More
|
A few hours after receiving the vaccine (1/3/25 at 10:30 am), the site began to itch, so I removed t...
A few hours after receiving the vaccine (1/3/25 at 10:30 am), the site began to itch, so I removed the Band-Aid, but the site was normal. The next morning (1/4/25 at 6 am) the injection site was red, hard, and tender. It is starting to heal as of today, 1/5/25 and is not as tender but still red and hard.
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| 2819417 | 69 | F | FL | 01/05/2025 |
PNC21 TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
y011819 253d2 |
Peripheral swelling, Pruritus, Rash, Skin warm; Peripheral swelling, Pruritus, R...
Peripheral swelling, Pruritus, Rash, Skin warm; Peripheral swelling, Pruritus, Rash, Skin warm
More
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Itching, rash, feverish arm, swollen arm
Itching, rash, feverish arm, swollen arm
|
||||||
| 2819418 | 64 | F | NM | 01/05/2025 |
RSV |
PFIZER\WYETH |
|
Fatigue, Nausea, Pyrexia
Fatigue, Nausea, Pyrexia
|
Fever for at least two days, tired, naseaous.
Fever for at least two days, tired, naseaous.
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