| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2870565 | 7 | M | NC | 11/04/2025 |
FLU3 |
SANOFI PASTEUR |
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Blister, Oral mucosal eruption, Pyrexia, Rash
Blister, Oral mucosal eruption, Pyrexia, Rash
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MOTHER STATES SON RAN HIGH TEMPERATURE NEXT DAY 103F AND DEVELOPED BLISTERS/RASH ON HANDS, ARMS, TOR...
MOTHER STATES SON RAN HIGH TEMPERATURE NEXT DAY 103F AND DEVELOPED BLISTERS/RASH ON HANDS, ARMS, TORSO, MOUTH. wENT TO ER, WAS OUT OF SCHOOL FOR SEVERAL DAYS. SXA SLOWLY RESOLVED. MOM STATES SEEMS THIS MAY BE RE OCCURRING
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| 2870566 | 48 | F | MI | 11/04/2025 |
COVID19 COVID19 COVID19 FLU3 FLU3 FLU3 |
MODERNA MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
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Blood test, Computerised tomogram, Eye pain, Facial pain, Facial paralysis; Head...
Blood test, Computerised tomogram, Eye pain, Facial pain, Facial paralysis; Head discomfort, Headache, Ocular discomfort, Pain, Pain in jaw; Scan with contrast, Swelling of eyelid, Tenderness; Blood test, Computerised tomogram, Eye pain, Facial pain, Facial paralysis; Head discomfort, Headache, Ocular discomfort, Pain, Pain in jaw; Scan with contrast, Swelling of eyelid, Tenderness
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Within 6-8 hours of receiving the MNexSpike Covid vaccine, I noticed pain on my left eyebrow and lef...
Within 6-8 hours of receiving the MNexSpike Covid vaccine, I noticed pain on my left eyebrow and left temple area. The entire area was tender to the touch and very sore. Within 12 hours I was noticing severe pain at the base of my skull, left side. These were sharp, shooting pains and unlike any muscular pain I'd ever felt. The tenderness and pain in left temple continued to get worse by the day, progressing to extreme, constant, sharp, stabbing pain 24 hours a day from the base of my skull on left side, to the left side of my head, jaw, temple and eye. There also feel like there is a lot of pressure behind my left eye and temple. I am unable to bend forward or lie on either my left or right side, without severe pain and pressure in the left temple and eye area. Left eyelid has also become drooping and swollen on a regular basis. I'm also experiencing jaw pain on the left side when chewing/eating.
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| 2870567 | 45 | M | OR | 11/04/2025 |
COVID19 |
PFIZER\BIONTECH |
EL1283 |
Arthralgia, Arthritis, Trigger finger
Arthralgia, Arthritis, Trigger finger
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Joint pain and inflammation leading up to surgery just a few months after vaccination. Trigger fing...
Joint pain and inflammation leading up to surgery just a few months after vaccination. Trigger finger both middle fingers
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| 2870568 | 77 | M | AR | 11/04/2025 |
COVID19 COVID19 FLU3 FLU3 PNC20 PNC20 VARZOS VARZOS |
MODERNA MODERNA SEQIRUS, INC. SEQIRUS, INC. PFIZER\WYETH PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
8146670 8146670 407268 407268 MA2488 MA2488 NY2AT NY2AT |
Blood test, Coagulation factor, Haematology test, Injected limb mobility decreas...
Blood test, Coagulation factor, Haematology test, Injected limb mobility decreased, Injection site bruising; Injection site pain, Platelet count decreased, Ultrasound scan normal, X-ray limb normal; Blood test, Coagulation factor, Haematology test, Injected limb mobility decreased, Injection site bruising; Injection site pain, Platelet count decreased, Ultrasound scan normal, X-ray limb normal; Blood test, Coagulation factor, Haematology test, Injected limb mobility decreased, Injection site bruising; Injection site pain, Platelet count decreased, Ultrasound scan normal, X-ray limb normal; Blood test, Coagulation factor, Haematology test, Injected limb mobility decreased, Injection site bruising; Injection site pain, Platelet count decreased, Ultrasound scan normal, X-ray limb normal
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Per caregiver: 10-8-25: bruising occurred in left arm about 2 inches below vaccine administration si...
Per caregiver: 10-8-25: bruising occurred in left arm about 2 inches below vaccine administration site along with pain and trouble lifting arm. Around 10-23-25: issue was reported to pharmacy to RPh. Patient was referred to ER, Urgent Care, or PCP and advised to follow up if applicable for VAERS report submission. Patient went to office approximately 10-28-25 to 10-30-25 due to worsening of symptoms (bruising spread down arm and has spread to back). Patient went to hospital on 10-31-25, and then went to another hospital on 11-3-25 for the same reason.
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| 2870569 | 70 | M | MN | 11/04/2025 |
COVID19 |
NOVAVAX |
6315mf002c |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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RN, writer, administered the vaccine with 1'25G needle on prefilled Nuvaxoid syringe, into Righ...
RN, writer, administered the vaccine with 1'25G needle on prefilled Nuvaxoid syringe, into Right deltoid of patient. Prior to administration, anatomy was confirmed and was seen to be WNL. Writer administered, and within a few seconds, the patient's arm, specifically where the vaccine was administered, was shown to have increased swelling with erythemia. Right deltoid area, looked as though a 'bubble' was underneath the skin. Vaccine was given with needle being fully insereted into arm, therefore, in the intramuscular area, as to ensure that administration was correctly given. Rph was also notified of adverse event, observed the area inwhich patient had unusual swelling, to draw a line around the swelling when he returns home for observation, and patient was advised to wait and additional 10 minutes in order to ensure patient safety. Patient was educated by Rph, when to seek further medical attention, if his symptoms prolonged or worsened. Patient reported understanding of direction and that he felt well at time of exit.
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| 2870586 | F | CA | 11/04/2025 |
RAB RAB RAB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
unknown unknown unknown |
Abdominal pain upper, Chest pain, Circumstance or information capable of leading...
Abdominal pain upper, Chest pain, Circumstance or information capable of leading to medication error, Dizziness, Flushing; Neurological symptom, Product storage error, Rash pruritic, Sinus congestion, Swelling face; Vaccination failure
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The patient concerned that the vaccination failed; a stabbing kind of chest pain after first and sec...
The patient concerned that the vaccination failed; a stabbing kind of chest pain after first and second dose of RabAvert; flushing, like was going to feel faint after first and second dose of RabAvert; could feel it hitting lymph nodes after first, second and third dose of RabAvert; sinuses swelled after first and second dose of RabAvert; itchy rash after first and second dose of RabAvert; stabbing stomach pain after first, and second dose of RabAvert; pretty significant neurological side effects 48 to 60 hours after each dose of RabAvert; A little bit of swelling in face, after first and second dose of RabAvert; flushing, like was going to feel faint after first and second dose of RabAvert; RabAvert vaccine was kept two hours at room temperature prior reconstitution; RabAvert vaccine was kept two hours at room temperature prior reconstitution; RabAvert vaccine was kept two hours at room temperature prior reconstitution; Nurse being confused regarding her administrating the vaccine; Case reference number US-BN-2025-001729 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-000437) on 24-Oct-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient had contact with a bat. On an unspecified date, an unknown amount of time after contact with a bat, the patient received the first dose of RabAvert vaccine, along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) for an unknown dose, route or site of administration, for indication post-exposure prophylaxis. On an unspecified date, five minutes within the vaccination with the first dose of RabAvert, the patient experienced an episode of little bit of swelling in face, reportedly like sinuses swelled, some flushing, feeling faint, a stabbing kind of chest pain as it went through patient's lymph system, then later, an itchy rash and a stabbing stomach pain. On an unspecified date, reported as 48 to 60 hours after vaccination with the first dose of RabAvert, the patient experienced an episode of significant neurological side effects. On an unknown date, an unknown amount of time after the first dose and an unknown amount of time after contact with a bat, the patient received the second dose of RabAvert vaccine, along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) for an unknown dose, route or site of administration. On an unspecified date, five minutes within the vaccination with the second dose of RabAvert, the patient experienced another episode of little bit of swelling in face, reportedly like sinuses swelled, some flushing, feeling faint, a stabbing kind of chest pain as it went through her lymph system, then later, an itchy rash and a stabbing stomach pain. On an unspecified date, reported as 48 to 60 hours after vaccination with the second dose of RabAvert, the patient experienced another episode of significant neurological side effects. On an unknown date, an unknown amount of time after the second dose and an unknown amount of time after contact with a bat, the patient received the third dose of RabAvert vaccine, along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) for an unknown dose, route or site of administration. It was reported that the vaccine was kept at room temperature for two hours prior to reconstitution. (coded explicitly as 'Product storage error', 'Product administration error' and 'Product temperature excursion issue'). On an unspecified date, an unknown amount of time after vaccination with the third dose of RabAvert, the patient felt a little bit of it going through lymph system. On an unspecified date, reported as 48 to 60 hours after vaccination with the third dose of RabAvert, the patient experienced another episode of significant neurological side effects. On an unspecified date, an unknown amount of time after vaccination with of RabAvert, the patient was concerned that the vaccination failed (coded explicitly as 'vaccination failure'). On an unspecified date, an unknown amount of time after vaccination with of RabAvert, the patient received HRIG (generic name: human rabies immune globulin) at unknown dose, route or site of administration for an unknown indication. On unspecified date, as reported both nurses who administered vaccine๏ฟฝone of them said she had never given vaccine before, and was really confused, and didn't understand it. (coded explicitly as 'Potential for medication error') At the time of the initial report, it was unknown whether the patient recovered from the events 'felt faint', 'flushing', 'facial swelling', 'sinus swelling', 'chest pain', 'itchy rash', 'stomach pain' and 'lymph node pain' after first and second dose of RabAvert and 'neurological symptoms NOS' after each dose or RabAvert, and 'vaccination failure'. The reporter did not provide seriousness assessment for the events of 'felt faint', 'flushing', 'facial swelling', 'sinus swelling', 'chest pain', 'itchy rash', 'stomach pain' and 'lymph node pain' after first and second dose of RabAvert and 'neurological symptoms NOS' after each dose or RabAvert, and 'vaccination failure', However, the event of 'vaccination failure' was assessed as serious due to the seriousness criteria of medical significance. The reporter did not provide causality or seriousness assessment for the events. No further information was received.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of swelling in face, reportedly like sinuses swelled, flushing, feeling faint, chest pain as it went through patient's lymph system, itchy rash and stabbing stomach pain on an unspecified dates, reported as five minutes within the vaccinations with the first and with the second dose of RabAvert for post-exposure prophylaxis, and the event of neurological side effects reported as 48 to 60 hours after each vaccination. On an unknown date, an unknown amount of time after the second dose and an unknown amount of time after contact with a bat, the patient received the third dose of RabAvert vaccine. It was reported that the vaccine was kept at room temperature for two hours prior to reconstitution, which is considered as product storage error, product administration error and product temperature excursion issue. An unknown amount of time after vaccination with the third dose of RabAvert, the patient felt a little bit of it going through lymph system. Also, reported as 48 to 60 hours after vaccination with the third dose of RabAvert, the patient experienced another episode of significant neurological side effects. On an unspecified date, an unknown amount of time after vaccination with RabAvert, the patient was concerned that the vaccination failed, which is considered as vaccination failure (medical significance). On unspecified date, as reported both nurses who administered vaccine๏ฟฝone of them said she had never given vaccine before, and was really confused, and didn't understand it, which is considered as potential for medication error. Dizziness is listed and expected for RabAvert per CCDS v6 and USPI, whilst chest pain, flushing, lymph node pain, sinus congestion, rash pruritic, abdominal pain upper, neurological symptom and swelling face are unlisted and unexpected. Vaccination failure, product storage error, product administration error, product temperature excursion issue and circumstance or information capable of leading to medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering compatible temporal relationship, theoretical biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for all the reported events is assessed as related to the suspect vaccine. Vaccination failure, product storage error, product administration error, product temperature excursion issue and circumstance or information capable of leading to medication error are not related to the suspect vaccine. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered reportable.; Sender's Comments: A female patient of unspecified age experienced non-serious events of swelling in face, reportedly like sinuses swelled, flushing, feeling faint, chest pain as it went through patient's lymph system, itchy rash and stabbing stomach pain on an unspecified dates, reported as five minutes within the vaccinations with the first and with the second dose of RabAvert for post-exposure prophylaxis, and the event of neurological side effects reported as 48 to 60 hours after each vaccination. On an unknown date, an unknown amount of time after the second dose and an unknown amount of time after contact with a bat, the patient received the third dose of RabAvert vaccine. It was reported that the vaccine was kept at room temperature for two hours prior to reconstitution, which is considered as product storage error, product administration error and product temperature excursion issue. An unknown amount of time after vaccination with the third dose of RabAvert, the patient felt a little bit of it going through lymph system. Also, reported as 48 to 60 hours after vaccination with the third dose of RabAvert, the patient experienced another episode of significant neurological side effects. On an unspecified date, an unknown amount of time after vaccination with RabAvert, the patient was concerned that the vaccination failed, which is considered as vaccination failure (medical significance). On unspecified date, as reported both nurses who administered vaccine๏ฟฝone of them said she had never given vaccine before, and was really confused, and didn't understand it, which is considered as potential for medication error. Dizziness is listed and expected for RabAvert per CCDS v6 and USPI, whilst chest pain, flushing, lymph node pain, sinus congestion, rash pruritic, abdominal pain upper, neurological symptom and swelling face are unlisted and unexpected. Vaccination failure, product storage error, product administration error, product temperature excursion issue and circumstance or information capable of leading to medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering compatible temporal relationship, theoretical biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality for all the reported events is assessed as related to the suspect vaccine. Vaccination failure, product storage error, product administration error, product temperature excursion issue and circumstance or information capable of leading to medication error are not related to the suspect vaccine. This case is considered as serious due to medical significance. For regulatory reporting purposes, this case is considered reportable.
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| 2870587 | F | 11/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Arrhythmia, Cardiac monitoring, Pain in extremity
Arrhythmia, Cardiac monitoring, Pain in extremity
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Arrhythmias; Pain in arm; This serious case was reported by a consumer and described the occurrence ...
Arrhythmias; Pain in arm; This serious case was reported by a consumer and described the occurrence of arrhythmia in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included trigeminal neuralgia, blood pressure, restless legs syndrome and atrial fibrillation. Concomitant products included apixaban (Eliquis), metoprolol fumarate, flecainide, rotigotine (Neupro) and gabapentin. On 02-OCT-2025, the patient received Shingrix. In OCT-2025, an unknown time after receiving Shingrix, the patient experienced arrhythmia (Verbatim: Arrhythmias) (serious criteria GSK medically significant) and pain in arm (Verbatim: Pain in arm). The outcome of the arrhythmia and pain in arm were not resolved. It was unknown if the reporter considered the arrhythmia and pain in arm to be related to Shingrix. The company considered the arrhythmia to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix. Additional Information: GSK receipt date:29-OCT-2025 The reporter mentioned waiting for results from heart monitor and review by electrophysiology. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Arrhythmia, an unknown time after receiving Shingrix, in a 74-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factors (Concurrent medical conditions included blood pressure and atrial fibrillation).
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| 2870588 | 11/04/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Cerebrovascular accident, Pain in extremity, Pyrexia, Visual impairment
Cerebrovascular accident, Pain in extremity, Pyrexia, Visual impairment
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Stroke; partial blindness; occasional sore arm; fever; This serious case was reported by a consumer ...
Stroke; partial blindness; occasional sore arm; fever; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced stroke (Verbatim: Stroke) (serious criteria GSK medically significant and life threatening), unilateral blindness (Verbatim: partial blindness) (serious criteria GSK medically significant and life threatening), pain in arm (Verbatim: occasional sore arm) and fever (Verbatim: fever). The outcome of the stroke, unilateral blindness, pain in arm and fever were not reported. The reporter considered the stroke and unilateral blindness to be related to RSV vaccine. It was unknown if the reporter considered the pain in arm and fever to be related to RSV vaccine. The company considered the stroke and unilateral blindness to be unrelated to RSV vaccine. It was unknown if the company considered the pain in arm and fever to be related to RSV vaccine. Additional Information: GSK Receipt Date: 30-OCT-2025 This case was reported by a patient via interactive digital media. The patient had Respiratory syncytial virus vaccine. It literally almost killed; it caused to have a massive stroke which then led to partial blindness. The reporter knows some people were against vaccines, but get all possible vaccines now. Other than an occasional sore arm, maybe a slight fever had not really had any problems with the vaccines.; Sender's Comments: A case of Cerebrovascular accident, Blindness unilateral, an unknown time after receiving RSV vaccine, in an unknown aged and unknown gender patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
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| 2870589 | F | 11/04/2025 |
MEN |
UNKNOWN MANUFACTURER |
UNK |
Death
Death
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aunt died of this/died; This serious case was reported by a consumer via interactive digital media a...
aunt died of this/died; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced unknown cause of death (Verbatim: aunt died of this/died) (serious criteria death and GSK medically significant). The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death to be related to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device. The company considered the unknown cause of death to be unrelated to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device. 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: 31-OCT-2025 This case was reported by a patient's family member via interactive digital media. The reporter's grandchildren had this vaccine. The batch number was not provided and we are unable to contact the reporter.; Sender's Comments: A case of Death, unknown time after receiving Bexsero and Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE in a female patient. Based on the available information a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.; Reported Cause(s) of Death: Unknown cause of death
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| 2870590 | 11/04/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Chest pain, Dyspnoea
Chest pain, Dyspnoea
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shortness of breath; chest pain; This non-serious case was reported by a pharmacist via sales rep an...
shortness of breath; chest pain; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of shortness of breath in a specified number of patients who received Flu Seasonal TIV Quebec (Flulaval) for prophylaxis. On an unknown date, the patients received Flulaval. On an unknown date, an unknown time after receiving Flulaval, the patients experienced shortness of breath (Verbatim: shortness of breath) and chest pain (Verbatim: chest pain). The outcome of the shortness of breath and chest pain were unknown. It was unknown if the reporter considered the shortness of breath and chest pain to be related to Flulaval and Flulaval Pre-Filled Syringe Device. It was unknown if the company considered the shortness of breath and chest pain to be related to Flulaval and Flulaval Pre-Filled Syringe Device. 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: 09-OCT-2025 Healthcare professional reported 2 cases where 2 individuals (patients) experienced shortness of breath and chest pain following the administration of FluLaval. HCP said these adverse events were reported to VAERS already and HCP did not want to report again. The batch number was not provided, and unable to contact the reporter.
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| 2870593 | CO | 11/04/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Product storage error
Product storage error
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Potential administration after a temperature excursion; Potential administration after a temperature...
Potential administration after a temperature excursion; Potential administration after a temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) for prophylaxis. On an unknown date, the patient received Fluarix 2025-2026 season. On an unknown date, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Potential administration after a temperature excursion) and product storage error (Verbatim: Potential administration after a temperature excursion). The outcome of the circumstance or information capable of leading to medication error and product storage error were 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: 21-OCT-2025 Registered pharmacist had a general question if there was a timeframe that the Fluarix vaccine could be out of the fridge at room temperature and after could be returned to the fridge and a stated that some patients were not aware if the vaccine can be left out of the fridge and if it can be returned to the fridge afterwards because they were not aware if it was okay to do so. No vaccination dates, no vaccine details and no patient demographics were provided. Adverse event was raised due to the risk scenario of potential administration after a temperature excursion. The reporter did not reactively confirm any specific real case scenario.
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| 2870605 | 53 | M | KY | 11/04/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
4795R |
Expired product administered
Expired product administered
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an expired dose of Flulaval vaccine was administered by mistake to a patient; This non-serious case ...
an expired dose of Flulaval vaccine was administered by mistake to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4795R, expiry date 30-JUN-2025) for prophylaxis. On 20-OCT-2025, the patient received the 1st dose of FluLaval 2024-2025 season. On 20-OCT-2025, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced expired vaccine used (Verbatim: an expired dose of Flulaval vaccine was administered by mistake to a patient). 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: 20-OCT-2025 On 20 October 2025, a nurse called to get assistance after an expired dose of Flulaval vaccine was administered by mistake to a patient. The vaccine administration Facility was the same as Primary Reporter.
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| 2870606 | F | 11/04/2025 |
COVID19 |
MODERNA |
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Pain in extremity
Pain in extremity
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Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurre...
Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the left arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (1st dose was Pfizer in 2021) in 2021, Pfizer (3 weeks later another Pfizer, Dose 2) in 2021 and Pfizer (Dose 3) in September 2021. Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Asthma and Blood pressure high (Elevated). On 10-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in the left arm). At the time of the report, PAIN IN EXTREMITY (Soreness in the left arm) outcome was unknown. Concomitant medication use information was not provided by reporter. The current age of the patient was reported as 72 years old. It was reported that the left arm was sorer than in previous experiences with the COVID-19 vaccines. The patient did not experience any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-790544 (Patient Link).
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| 2870607 | F | 11/04/2025 |
COVID19 COVID19 FLUX |
MODERNA PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site warm...
Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site warmth; Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site warmth; Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
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sore arm where the shot was given, and it is red and warm to the touch; sore arm where the shot was ...
sore arm where the shot was given, and it is red and warm to the touch; sore arm where the shot was given, and it is red and warm to the touch; feels tired; sore arm where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (sore arm where the shot was given, and it is red and warm to the touch), VACCINATION SITE ERYTHEMA (sore arm where the shot was given, and it is red and warm to the touch), FATIGUE (feels tired) and VACCINATION SITE PAIN (sore arm where the shot was given) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication and Influenza vaccine for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form, dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (sore arm where the shot was given, and it is red and warm to the touch), VACCINATION SITE ERYTHEMA (sore arm where the shot was given, and it is red and warm to the touch), FATIGUE (feels tired) and VACCINATION SITE PAIN (sore arm where the shot was given). At the time of the report, VACCINATION SITE WARMTH (sore arm where the shot was given, and it is red and warm to the touch), VACCINATION SITE ERYTHEMA (sore arm where the shot was given, and it is red and warm to the touch), FATIGUE (feels tired) and VACCINATION SITE PAIN (sore arm where the shot was given) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. She had received COVID shots twice a year since they had been offered. She received Pfizer at the beginning but then switched to Moderna since she thinks she had a better response from the Moderna product. The patient definitely felt the effects of the vaccine and if this was what the vaccination was like, she really did not want COVID. The patient had noticeable effects every single time she received a COVID vaccination, and it didn't 'slam her' but it woke up her immune system and, like it said, 'pay attention', which means it was really working. The patient experienced a sore arm where the shot was given, and it was red and warm to the touch. She did not experience a fever, but felt tired, but was still fully functionable. She experienced these effects for the first 48 hours and considered these to be "normal side effects." Her experience wasn't any different to her than every other COVID shot she's had, nor was it different from every other flu shot she's ever had. It's nothing extreme; she was not passing out or having extreme reactions. The reporter declined to provide any additional details. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. This case was linked to MOD-2025-790527 (Patient Link). Reporter did not allow further contact
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| 2870608 | 86 | M | VT | 11/04/2025 |
COVID19 |
MODERNA |
3052087 |
Extra dose administered, No adverse event, Syringe issue
Extra dose administered, No adverse event, Syringe issue
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No adverse event; When I was pushing the plunger, the vaccine leaked out of the joint between the ne...
No adverse event; When I was pushing the plunger, the vaccine leaked out of the joint between the needle and syringe; administer another mnexspike vaccination to the patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (When I was pushing the plunger, the vaccine leaked out of the joint between the needle and syringe), EXTRA DOSE ADMINISTERED (administer another mnexspike vaccination to the patient.) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052087) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection (batch no. 3052087) for COVID-19 prophylaxis. No Medical History information was reported. On 23-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 23-Oct-2025, the patient experienced SYRINGE ISSUE (When I was pushing the plunger, the vaccine leaked out of the joint between the needle and syringe) and EXTRA DOSE ADMINISTERED (administer another mnexspike vaccination to the patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (When I was pushing the plunger, the vaccine leaked out of the joint between the needle and syringe), EXTRA DOSE ADMINISTERED (administer another mnexspike vaccination to the patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that, during the administration of a mnexspike vaccine dose, a significant amount of the vaccine had leaked from the joint between the needle and the syringe while pushing the plunger. It was observed that the majority of the dose appeared to be lost due to this leakage. After a phone conversation with a relevant support team, the healthcare professional had proceeded to administer another mnexspike vaccine to the patient, based on the guidance received. The support team had later forwarded the email sent by the healthcare professional and had requested a credit, suggesting that the issue might have been caused by a fault in the plastic component or the pre-filled syringe. Needle Type: Easy Point needle, Lot Number: K153A, Expiration Date: 03/28/2030 The Device problem code for pre-filled syringe include FDA code 1670, code A23 which included Use of Device Problem. The Device problem code for pre-filled syringe include FDA code 1250, code A050401 which included Fluid Leak. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Oct-2025: Upon internal review on 24-Oct-2025, it was identified that the case MOD-2025-790555 (US-MODERNATX-MOC20251024000019) was created inadvertently as an initial case instead of adding follow up to the already existing case MOD-2025-790551. Hence, all the information from the case MOD-2025-790555 (US-MODERNATX-MOC20251024000019) has been added and merged into the retained case MOD-2025-790551 as a follow-up. The case MOD-2025-790555 (US-MODERNATX-MOC20251024000019) will be deleted from the safety database. Live non-significant follow-up received: Reference ids added. On 28-Oct-2025: Live follow-up received contains No New Information.
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| 2870609 | 71 | M | MA | 11/04/2025 |
COVID19 |
MODERNA |
3052733 |
Chills, Discomfort, Hyperhidrosis, Malaise, Nausea
Chills, Discomfort, Hyperhidrosis, Malaise, Nausea
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Sick; Followed by sweats; Terrible chills; Nausea; The discomfort was disabling; This spontaneous ca...
Sick; Followed by sweats; Terrible chills; Nausea; The discomfort was disabling; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (The discomfort was disabling), MALAISE (Sick), HYPERHIDROSIS (Followed by sweats), CHILLS (Terrible chills) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052733) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052733) for COVID-19 prophylaxis. The patient's past medical history included COVID-19. Previously administered products included for COVID-19 prophylaxis: SPIKEVAX 2024-2025 (Got Moderna 2024-2025 COVID-19 vaccine 12 plus year. Dose was 0.5ml) in December 2024, Spikevax 2023-2024 formula (Previously received Moderna 2023-2024 on October 23rd (did not provide year). Dose was 0.5ml) and Spikevax NOS; for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse effect with Pfizer, SPIKEVAX 2024-2025, Spikevax 2023-2024 formula and Spikevax NOS. On 22-Oct-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In October 2025, the patient experienced DISCOMFORT (The discomfort was disabling), HYPERHIDROSIS (Followed by sweats), CHILLS (Terrible chills) and NAUSEA (Nausea). On 22-Oct-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced MALAISE (Sick). In October 2025, HYPERHIDROSIS (Followed by sweats), CHILLS (Terrible chills) and NAUSEA (Nausea) had resolved. On 24-Oct-2025 at 9:00 AM, MALAISE (Sick) had resolved. At the time of the report, DISCOMFORT (The discomfort was disabling) outcome was unknown. Concomitant medication use information was not provided by reporter. This week, the patient received the Moderna vaccine. The reaction to that shot was the worst they had ever experienced with Covid vaccines. The patient received Covid vaccines since they were first available. The patient had severe side effects including terrible chills, followed by sweats and nausea. It lasted for about 24 hours or so. However, the discomfort was disabling. Nothing like that was ever wanted to be repeated. The patient's age was over 65. The reporter wondered if the new vaccine with a smaller dose might be a better choice and inquired about the potential for fewer side effects with a smaller dose vaccine. The patient felt as bad as having COVID, even if it was only a day. The mNEXSPIKE dose was absolutely brutal for the patient. Despite previous positive experiences with COVID vaccines, the patient now hesitated about future vaccinations. The reaction was awful, unlike anything ever experienced before, and the patient had been getting them all along, either Pfizer or Moderna. This one, the effect seemed over a minor loginess the day after. The patient had gotten Moderna COVID-19 vaccines before. This was awful. The patient would never go through this again and had COVID before. This was as bad as having COVID, although it was only for a day. The patient was sick starting in the evening of 22-Oct-2025 until about 9 a.m. on 24-Oct-2025. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2025: Live follow up received that contains significant information includes added historical vaccines in medical history and historical condition, updated suspect product coding, added suspect product details (start date, batch lot number and dose details), added feeling sick as additional event and narrative was updated.
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| 2870610 | 35 | F | NJ | 11/04/2025 |
COVID19 |
MODERNA |
026L2CA |
Atrial tachycardia, Multiple sclerosis
Atrial tachycardia, Multiple sclerosis
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MS symptoms, brain demyelination and lesion, balance issues, dizziness, atrial tachycardia, positive...
MS symptoms, brain demyelination and lesion, balance issues, dizziness, atrial tachycardia, positive for 2 matching oligoclonal bands in serum and CSF indicating systematic inflammation, headaches, neurological issues; Atrial tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS symptoms, brain demyelination and lesion, balance issues, dizziness, atrial tachycardia, positive for 2 matching oligoclonal bands in serum and CSF indicating systematic inflammation, headaches, neurological issues) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2CA) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 07-Jan-2021, the patient experienced MULTIPLE SCLEROSIS (MS symptoms, brain demyelination and lesion, balance issues, dizziness, atrial tachycardia, positive for 2 matching oligoclonal bands in serum and CSF indicating systematic inflammation, headaches, neurological issues) (seriousness criterion medically significant) and ATRIAL TACHYCARDIA (Atrial tachycardia). At the time of the report, MULTIPLE SCLEROSIS (MS symptoms, brain demyelination and lesion, balance issues, dizziness, atrial tachycardia, positive for 2 matching oligoclonal bands in serum and CSF indicating systematic inflammation, headaches, neurological issues) and ATRIAL TACHYCARDIA (Atrial tachycardia) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication use information was not provided by reporter. The current age of the patient was reported as 38 years. It is unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter.; Reporter's Comments: Company Comment: The benefit-risk relationship of product is not affected by this report.
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| 2870611 | 76 | M | 11/04/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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COVID-19; COVID-19
COVID-19; COVID-19
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Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ...
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 76-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On 01-Sep-2025, the patient experienced COVID-19 (Covid-19). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) in September 2025 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) was resolving. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications provided by the reporter. It was reported that the patient never had COVID in the last five years. However, on 01-Sep-2025 the patient got the COVID at the beach. The patient was a little sick. The symptoms were not like a typical cold sore throat and then the patient had a tight chest. The patient did not experience sneezing or coughing, but the patient had a tight chest. The patient received treatment of Paxlovid, and the patient symptoms get better after 7 days. The patient believed this COVID-19 infection must be very mutated interaction. Because the patient received every single vaccine that was ever been offered. Like with example Some were moderna, some were Pfizer, and the patient traveled to seven countries and four continents, and he never had COVID-before.
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| 2870612 | 64 | F | 11/04/2025 |
COVID19 |
MODERNA |
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Vaccination site reaction
Vaccination site reaction
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COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINAT...
COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm) in a 64-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 11-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2024, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, VACCINATION SITE REACTION (COVID arm) outcome was unknown. No concomitant medications provided by the reporter. It was reported that when the patient received Moderna COVID-19 vaccination then post vaccination the patient experienced the symptom of COVID arm. The patient did not report the incident in the past, and the patient was aware of COVID arm from online. No treatment medications provided by the reporter.
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| 2870613 | M | 11/04/2025 |
COVID19 |
MODERNA |
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Chills
Chills
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bad chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS ...
bad chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (bad chills) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (Patient have always chosen the Moderna Covid-19 vaccine in the past and she never having had any side effects.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. In April 2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CHILLS (bad chills). At the time of the report, CHILLS (bad chills) had resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) were reported as unknown. Patient have always chosen the Moderna Covid-19 vaccine in the past, he never had any side effects. No concomitant medication was reported. Patient had bad chills once after taking Spikevax in Apr-2024 (no other side effects and this was not an issue to them, they stated). Patient was senior with no health conditions and would then like to know which vaccine would be better for the patient. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.
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| 2870614 | M | 11/04/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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Back pain, Headache, Insomnia; Back pain, Headache, Insomnia
Back pain, Headache, Insomnia; Back pain, Headache, Insomnia
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lower backache; couldn't sleep; terrible headaches; This spontaneous case was reported by a con...
lower backache; couldn't sleep; terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower backache), INSOMNIA (couldn't sleep) and HEADACHE (terrible headaches) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower backache), INSOMNIA (couldn't sleep) and HEADACHE (terrible headaches). At the time of the report, BACK PAIN (lower backache), INSOMNIA (couldn't sleep) and HEADACHE (terrible headaches) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that the patient had a bad reaction to all the Covid vaccines that he has gotten before (that includes the Moderna and the Pfizer Covid vaccines) with terrible headaches, lower backache was so bad for the patient and the patient unable to sleep. So, the patient always dreaded going to get a Covid vaccine. The patient never had any reaction to any vaccine except the Covid vaccines. No treatment medications were reported. This case was linked to MOD-2025-790814 (Patient Link).
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| 2870618 | 11/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Post-acute COVID-19 syndrome, SARS-CoV-2 test
COVID-19, Drug ineffective, Post-acute COVID-19 syndrome, SARS-CoV-2 test
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COVID; COVID; long COVID; This is a spontaneous report received from a Consumer or other non HCP. Ot...
COVID; COVID; long COVID; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790418 (Moderna), US-MODERNATX-MOC20251017000007 (Moderna), MOC20251017000007 (Moderna), US-MO-MOC20251017000007 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (ongoing); "childhood asthma" (unspecified if ongoing), notes: exacerbated by the flu; "flu" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose number unknown, single), administration date: 2020, for COVID-19 immunization; Moderna covid-19 vaccine (Dose number unknown, single), administration date: 2021, for COVID-19 immunization. The following information was reported: POST-ACUTE COVID-19 SYNDROME (hospitalization, medically significant) with onset 2025, outcome "recovered" (Oct2025), described as "long COVID"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 18Sep2025, outcome "recovered" (Oct2025) and all described as "COVID". The patient was hospitalized for drug ineffective, covid-19, post-acute covid-19 syndrome (start date: 2025). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2025) Positive; (2025) Negative, notes: home tests and nose swabs. Therapeutic measures were taken as a result of drug ineffective, covid-19, post-acute covid-19 syndrome. Clinical course: patient wants to know how soon should get the COVID-19 booster after first shot. Patient has severe asthma and was caught unaware, getting sick from work and the back-to-school season. The reporter stated that the patient "nearly died" from COVID this past month. Has high-risk severe asthma and became severely ill on 18Sep2025, leading to hospitalization. Felt the illness was life-threatening. The reporter states that would have gotten the vaccine had known that COVID was in high circulation in Aug, but the reporter states that was caught completely unaware. The reporter states that started getting sick 28Oct2025 but tested positive for COVID on 18Sep2025 via PCP test, as home tests and nose swabs came back negative and states that nearly died from it. The reporter stated that because of the home/nose tests not working was treated with antibiotics, but they did not work, was also treated with Paxlovid but they didn't work because started them past the 5 days and also tried steroids with nebulizer. The reporter states now have long COVID, and it is debilitating that cannot work. The reporter equates COVID to "death row with an alligator" and states that it went through everything, throat and chest. The reporter states that the medical field in area is not aware of what to do with COVID or long COVID, but states that did own research online and googled that the COVID vaccine actually helps with long COVID based on the studies. After conducting own research, discovered that the vaccine helps with long COVID, which experienced, and it did help received the vaccine on 15Oct2025, and wants to know how soon should get a booster shot. The patient received a dose of mNEXSPIKE 10mcg/0.2mL and states that it has been the only thing that helped alleviate it and is the only reason is still alive. The reporter states it made a marked difference, yesterday was crawling on all fours yesterday thinking was going to die from the fatigue and experiencing breathing issues to walking around today. The reporter also states that throat feels a little bit better. The reporter states that gave COVID, but that "kicked" it in 4 days. The reporter states that had received Pfizer COVID vaccine but refused to provide any further details; no other details provided. The reporter researched online and saw that getting a vaccine could help, and it did help had severe COVID and now has long COVID, and the vaccine helped within a day. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2870619 | 11/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Allergy to vaccine
Allergy to vaccine
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Patient had allergy to COVID 19 vaccine; This is a spontaneous report received from an Other HCP fro...
Patient had allergy to COVID 19 vaccine; This is a spontaneous report received from an Other HCP from medical information team and a sales representative. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Patient had allergy to COVID 19 vaccine". Additional information: Patient had allergy to COVID 19 vaccine. Provider was prescribing Bactrim 800 mg -160 mg, mupirocin 2:1 topical. Red flag came up stating severe interaction. Provider overrode the flag but would like more information about this red flag.
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| 2870620 | 31 | F | CA | 11/04/2025 |
COVID19 COVID19 COVID19 FLU3 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. |
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Condition aggravated, Ear pruritus, Eye pruritus, Headache, Hypersensitivity; La...
Condition aggravated, Ear pruritus, Eye pruritus, Headache, Hypersensitivity; Lacrimation increased, Nocturnal emission, Pain, Rhinorrhoea, Sinus pain; Sneezing, Throat irritation, Upper-airway cough syndrome; Condition aggravated, Ear pruritus, Eye pruritus, Headache, Hypersensitivity; Lacrimation increased, Nocturnal emission, Pain, Rhinorrhoea, Sinus pain; Sneezing, Throat irritation, Upper-airway cough syndrome
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nightfall on the day; my allergies also worsened that night; sinus pain; headache; mild body aches; ...
nightfall on the day; my allergies also worsened that night; sinus pain; headache; mild body aches; chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip; chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip; chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip; chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip; chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip; chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip; chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip; chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip; This is a spontaneous report received from a Consumer or other non HCP. A 31-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 27Oct2025 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 27Oct2025 as dose 1, single, in left arm for immunisation. The patient's relevant medical history included: "Asplenia (total splenectomy in 2011)", start date: 2011 (unspecified if ongoing); "itchy throat" (ongoing); "itchy ears" (ongoing); "itchy and watery eyes" (ongoing); "itchy and watery eyes" (ongoing); "sneezing" (ongoing); "runny nose" (ongoing); "post-nasal drip" (ongoing); "chronic alllergies" (ongoing). There were no concomitant medications. Past drug history included: Cefalexin, reaction(s): "Hypersensitivity". The following information was reported: HYPERSENSITIVITY (non-serious), THROAT IRRITATION (non-serious), EAR PRURITUS (non-serious), EYE PRURITUS (non-serious), LACRIMATION INCREASED (non-serious), SNEEZING (non-serious), RHINORRHOEA (non-serious), UPPER-AIRWAY COUGH SYNDROME (non-serious) all with onset 27Oct2025 at 18:00, outcome "not recovered" and all described as "chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip"; HEADACHE (non-serious) with onset 27Oct2025 at 18:00, outcome "not recovered"; PAIN (non-serious) with onset 27Oct2025 at 18:00, outcome "not recovered", described as "mild body aches"; CONDITION AGGRAVATED (non-serious) with onset 27Oct2025 at 18:00, outcome "not recovered", described as "my allergies also worsened that night"; NOCTURNAL EMISSION (non-serious) with onset 27Oct2025 at 18:00, outcome "not recovered", described as "nightfall on the day"; SINUS PAIN (non-serious) with onset 27Oct2025 at 18:00, outcome "not recovered". Therapeutic measures were taken as a result of nocturnal emission, condition aggravated, sinus pain, headache, pain, hypersensitivity, throat irritation, ear pruritus, eye pruritus, lacrimation increased, sneezing, rhinorrhoea, upper-airway cough syndrome. Additional information: Vaccine: Comirnaty, Facility where vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine and did not taking any other medications within 2 weeks of the event starting. The patient have chronic alllergies year-round, characterized by itchy throat, itchy ears, itchy and watery eyes, sneezing, runny nose, and post-nasal drip. Since 2022, patient took OTC Zyrtec and Calritin pills daily, and Azelastine nasal spray at night as needed to manage my allergies. By nightfall on the day I got my flu and covid-19 vaccines, she had very sore arms, body aches, and malaise, all of which she typically experience every year since 2020 following vaccination. However, my allergies also worsened that night and none of my usual medications have helped. 3 days later, she still have all of her allergy symptoms, worse than they usually are, sinus pain, headache, and mild body aches. She thought the covid-19 vaccine this year amplified her current allergies as a result of the immune response but she could not find literature on this online. Treatment received for the adverse event was OTC Zyrtec, Claritin, Azelastine nasal spray. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2870621 | 81 | F | PA | 11/04/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Chills, Fatigue; Chills, Fatigue
Chills, Fatigue; Chills, Fatigue
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She came down with chills; She also felt tired on both days; This is a spontaneous report and receiv...
She came down with chills; She also felt tired on both days; This is a spontaneous report and received from Consumer or other non HCPs. An 81-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 28Oct2025 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 28Oct2025 at 10:30 as dose 1, single, in right arm for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing), notes: Cholesterol and maybe others based upon the Rx medications listed. Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; AMLODIPINE; HYDROCHLOROTHIAZIDE. The following information was reported: FATIGUE (non-serious) with onset 28Oct2025, outcome "recovering", described as "She also felt tired on both days"; CHILLS (non-serious) with onset 28Oct2025 at 20:00, outcome "recovering", described as "She came down with chills". Therapeutic measures were taken as a result of chills. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). The patient had no known allergies. Reporter stated that administered Flu and COVID-19 Vaccine at same visit (in separate arms) on Tuesday, 10:30. My mom was the patient. She was pretty sure the COVID-19 vaccine that was administered was Comirnaty from Pfizer. She received the vaccines at 10:30. About 8PM that night, she came down with chills. The next day, she took Advil, then chills manifested again late on Wednesday. She also felt tired on both days. I am an employee of Pfizer and learned that my mom had these adverse events this morning (Thursday). The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2870622 | F | 11/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Fatigue, Maternal exposure timing unspecified, Vaccination site pain
Fatigue, Maternal exposure timing unspecified, Vaccination site pain
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pregnant; Pain/soreness at injection site and feeling run down; Pain/soreness at injection site and ...
pregnant; Pain/soreness at injection site and feeling run down; Pain/soreness at injection site and feeling run down; This is a spontaneous report and received from Consumer or other non HCPs. An adult female patient (pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Unknown, reaction(s): "Allergy". The following information was reported: VACCINATION SITE PAIN (non-serious), FATIGUE (non-serious) all with onset Oct2025, outcome "recovered" (Oct2025) and all described as "Pain/soreness at injection site and feeling run down"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "pregnant". It was unknown if therapeutic measures were taken as a result of vaccination site pain.
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| 2870623 | 63 | F | SC | 11/04/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Malaise, Pyrexia
Chills, Malaise, Pyrexia
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Chills; Fever; Malaise; This is a spontaneous report received from a Pharmacist. A 63-year-old fema...
Chills; Fever; Malaise; This is a spontaneous report received from a Pharmacist. A 63-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Oct2025 at 18:00 as dose 1 , single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Mixed Connective Tissue Disorder" (unspecified if ongoing); "Cramping and Fasciculitis Syndorme" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE, start date: Dec2014; NIFEDIPINE, start date: Dec2014; PANTOPRAZOLE, start date: Feb2014; ATORVASTATIN, start date: Aug2011; CYCLOBENZAPRINE, start date: Jun2016. Past drug history included: Penicillins, reaction(s): "Hypersensitivity"; Sulphonamide, reaction(s): "Hypersensitivity". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3(BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 30Oct2025 at 14:00, outcome "recovered" (31Oct2025); PYREXIA (non-serious) with onset 30Oct2025 at 14:00, outcome "recovered" (31Oct2025), described as "Fever"; MALAISE (non-serious) with onset 30Oct2025 at 14:00, outcome "recovered" (31Oct2025). Therapeutic measures were taken as a result of chills, pyrexia, malaise. Additional information: The reported that patient experienced Chills, fever, malaise started approximately 2pm day after vaccines. The patient had been taking other medications within two weeks prior to the onset of the event. To treat the symptoms, the patient took Tylenol, which provided relief. The patient received unspecified suspect drug on 29Oct2025, Right arm. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2870624 | 11/04/2025 |
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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got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP. Other ...
got COVID; got COVID; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790422 (Moderna), MOC-2025-1020000010 (Moderna). A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "flu" (unspecified if ongoing), notes: started late that January; "low-grade fever" (unspecified if ongoing), notes: for seven solid days; "it went kind of to digestive tract" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: spikevax nos (DOSE 4, SINGLE; 9 and 12 hours after the shot), administration date: 11Sep2023, for Covid-19 immunization, reaction(s): "fever", "shaking chills", "feel lousy", "shoulder to elbow turned beet red and itched", "shoulder to elbow turned beet red and itched"; Spikevax nos (DOSE 1, SINGLE), administration date: Feb2021, for Covid-19 immunization, reaction(s): "red spot at the injection site"; Spikevax nos (DOSE 2, SINGLE, Intramuscular route), administration date: 2021, for Covid-19 immunization, reaction(s): "24 hours have shaking chills", "fever"; Spikevax nos (DOSE 3 (BOOSTER), SINGLE), administration date: 2022, for Covid-19 immunization, reaction(s): "Chills", "fever", "arm got the shot in hurt for months/arm being so sore for month after". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: got COVID, an actual, did test. Clinical course: The patient received Pfizer shot. On Jun2024, the patient "got COVID, an actual, we did test" (as reported). The patient had fever and chills. The patient did not want to get COVID but got COVID when he had a shot (Pfizer). 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-202500214764 same patient/suspect vaccine; different dose event;
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| 2870625 | M | UT | 11/04/2025 |
FLU3 |
SANOFI PASTEUR |
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Death, Guillain-Barre syndrome
Death, Guillain-Barre syndrome
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died of complications; Guillain Barre; Initial information received on 28-Oct-2025 regarding an unso...
died of complications; Guillain Barre; Initial information received on 28-Oct-2025 regarding an unsolicited valid serious case received from a physician. This case involves Elderly male patient who had guillain barre and died of complications after receiving influenza USP trival A-B high dose subvirion vaccine [fluzone high dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date the patient developed guillain barre (guillain-barre syndrome) and died of complications (death) (unknown latency) following the administration of influenza USP TRIVAL A-B high dose subvirion vaccine. Action taken was not applicable. It was not reported if the patient received corrective treatment for the events (Guillain-Barre syndrome). At time of reporting, the outcome was Unknown for the event guillain barre and was Fatal for the event died of complications. It is unknown if an autopsy was done. The cause of death was reported as unknown. Seriousness criteria: These events were assessed as medically significant and the event death was leading to death.; Sender's Comments: Sanofi company comment dated 03-Nov-2025: This is an initial report of a serious listed event with fatal outcome. An elderly male patient (specific age unknown) developed Guillain-Barr๏ฟฝ syndrome (GBS) with unknown TTO after vaccination. The patient subsequently died of unknown complications. Temporal association cannot be assessed due to lack of vaccination and event onset dates. No medical history or concomitant medications were provided. No information regarding clinical course, diagnostic confirmation of GBS, or specific complications leading to death was reported. The cause of death was reported as unknown, and no death certificate or autopsy information was provided. The role of the suspect vaccine cannot be assessed due to lack of information. More complete information is needed regarding vaccination date, event onset, medical history, clinical course, diagnostic confirmation of GBS (per Brighton Collaboration Case Definition criteria), and specific cause of death. Based on the limited information provided, this case is classified as "Reported GBS with insufficient evidence to meet the case definition" according to the Brighton Collaboration Case Definition. Known potential risk of GBS is monitored by routine PV activities, SET meetings and PBRERs; Reported Cause(s) of Death: died of complications.
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| 2870626 | 3 | F | IA | 11/04/2025 |
UNK |
UNKNOWN MANUFACTURER |
406986 |
Circumstance or information capable of leading to medication error, Skin lacerat...
Circumstance or information capable of leading to medication error, Skin laceration, Underdose
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Just a little cut; Half dose was administered; This spontaneous case, initially received on 20-Oct-2...
Just a little cut; Half dose was administered; This spontaneous case, initially received on 20-Oct-2025, was reported by a health professional and concerns a female child patient. The concomitant medication and medical history was reported as unknown. Administration of company suspect drug: On 18-Oct-2025, the patient received Flucelvax (TIV) for indication Not reported, Dose regimen: 0.5 ml, Route of administration: Not reported, Anatomical location: Not reported, Lot number: 406986, Expiry date: 04-May-2026. No additional suspect drugs. Adverse reactions/events and outcomes: On 18-Oct-2025, the patient experienced Just a little cut (outcome: Unknown), Half dose was administered (outcome: Unknown). Pharmacist called and stated that while administrating a vaccine to patient, the patient brought the hand over and took the needle of him arm. Pharmacist stated that just a half of dose was administered and also the patient had little cut and put a band aid. Treatment: band aid. Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter did not provide seriousness and causality assessment.; Reporter's Comments: The event Just a little cut is related due to chronological plausibility and Half dose was administered was not related due nature of event (special situation).
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| 2870628 | 65 | F | PA | 11/04/2025 |
COVID19 |
PFIZER\BIONTECH |
na0589 |
Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransfe...
Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased
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patient experienced extreme intense stomach pain - called an ambulance and went to the ER - was admi...
patient experienced extreme intense stomach pain - called an ambulance and went to the ER - was admitted for observation. she had extremely elevated liver enzymes- AST and ALT over 300 when it should be between 10-35. they monitored her and didn't really give any medication that she remembers but had IV fluids
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| 2870629 | 51 | F | ND | 11/04/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EN6199 30145BA |
Blindness unilateral, Optic ischaemic neuropathy; Blindness unilateral, Optic is...
Blindness unilateral, Optic ischaemic neuropathy; Blindness unilateral, Optic ischaemic neuropathy
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Ischemic Optic Neuropathy - Permanent vision loss in right eye. Verified by [withheld] Clinic and D...
Ischemic Optic Neuropathy - Permanent vision loss in right eye. Verified by [withheld] Clinic and Dr. [withheld name].
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| 2870645 | 65 | M | NY | 11/04/2025 |
FLU3 PNC21 |
SEQIRUS, INC. MERCK & CO. INC. |
409608 Z010457 |
Cellulitis; Cellulitis
Cellulitis; Cellulitis
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Came back to pharmacy to show that his left arm exhibited what seem to be cellulitis reaction. Patie...
Came back to pharmacy to show that his left arm exhibited what seem to be cellulitis reaction. Patient left before I could walked them through all the steps for adverse reaction care. Called his cell number & got his wife. The wife is aware of the reaction & will provide continual care such as icing area as needed. Ibuprofen given him oral / Benadryl. Is informed to consider having patient taken to see doctor or ER if condition continues to worsens.
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| 2870646 | 21 | F | VA | 11/04/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052736 U8832AA |
Loss of consciousness; Loss of consciousness
Loss of consciousness; Loss of consciousness
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mNEXSPIKE was administered first then Flublok in Left Arm with in 15 seconds patient passed out Tr...
mNEXSPIKE was administered first then Flublok in Left Arm with in 15 seconds patient passed out Treatment: assisted patient to floor, while technician called 911, elevated legs, placed cold packs on chest and back with in 15-30 seconds patient became alert, checked BP was within normal range. Slowly changed her position to sitting on floor to chair. She remained in chair for 20 minutes and felt fine. When EMS arrived (20 minutes later) she denied treatment and felt comfortable to leave pharmacy
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| 2870648 | 70 | F | TN | 11/04/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781DA |
Injection site pain, Shoulder injury related to vaccine administration
Injection site pain, Shoulder injury related to vaccine administration
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Patient received an immunization at our store and on 9/27 she then came back on11/4 picking up medic...
Patient received an immunization at our store and on 9/27 she then came back on11/4 picking up medications to help with a shoulder injury related to vaccine administration. She reports pain around the site and was prescribed medication to assist with this.
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| 2870649 | 77 | F | TN | 11/04/2025 |
FLU3 |
SEQIRUS, INC. |
407269 |
Dizziness, Hypoaesthesia, Pain
Dizziness, Hypoaesthesia, Pain
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Radiating pain and numbness on the left side of the body, and severe dizziness
Radiating pain and numbness on the left side of the body, and severe dizziness
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| 2870650 | 38 | F | WA | 11/04/2025 |
FLU3 FLU3 |
SEQIRUS, INC. SEQIRUS, INC. |
Lot Number: 409 Lot Number: 409 |
Arthralgia, Back pain, Injection site pain, Loss of personal independence in dai...
Arthralgia, Back pain, Injection site pain, Loss of personal independence in daily activities, Pain; Pain in extremity
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Received flu vaccine from our Employee Health Flu Vaccine Clinic around 9am on 9/26/25 at our [withh...
Received flu vaccine from our Employee Health Flu Vaccine Clinic around 9am on 9/26/25 at our [withheld] Campus. Our employee received her shot in the right arm (deltoid). She indicated that she could feel the vaccine go in - caused pain radiating through her shoulder into her back. She felt like the injection was placed higher up on her muscle more than normal. On the following morning the employee noticed more significant pain in her right arm - more than her typical pain in previous years. She realized that her arm was more sore than usual. She noted that she had significant level of pain when trying to put a coat on or lift her arm above her head. Did not note any redness/ swelling to the location. By October 10th she was packing for a trip and she noticed that she had soreness for much longer than normal. She has since had dull pain having difficulty taking her shirt off and other activities, but still notices the pain. She noted has improved with rest. Has not been taking any pain relievers for this pain - she prefers not to take pain medication in general. She has had pain now for almost 6 weeks.
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| 2870658 | 77 | F | FL | 11/04/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
ut8781da ut8781da |
Chills, Fatigue, Gait inability, Immunodeficiency, Musculoskeletal disorder; Ren...
Chills, Fatigue, Gait inability, Immunodeficiency, Musculoskeletal disorder; Renal impairment
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patient stated on Thursday after vaccines tired and chills, on Friday woke up and could not walk, le...
patient stated on Thursday after vaccines tired and chills, on Friday woke up and could not walk, legs did not work. Went into hospital, doctor wanted to do testing but kidney function was not at its best. Doctors told her due to covid infection two weeks prior to vaccines and pneumonia in6/25 , she was immunocompromised and it could have triggered this type of reaction
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| 2870661 | 46 | F | WA | 11/04/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
014F21A 014F21A 014F21A 014F21A 014F21A 014F21A 014F21A 014F21A 014F21A |
Amnesia, Aphasia, Arteriogram carotid, Asthenia, Balance disorder; Blindness tra...
Amnesia, Aphasia, Arteriogram carotid, Asthenia, Balance disorder; Blindness transient, Brain fog, CSF protein decreased, Cognitive disorder, Computerised tomogram head abnormal; Coordination abnormal, Dysarthria, Dysgraphia, Ear discomfort, Facet joint syndrome; Fall, Fatigue, Gait disturbance, Head discomfort, Idiopathic intracranial hypertension; Impaired driving ability, Impaired work ability, Intervertebral disc protrusion, Loss of personal independence in daily activities, Magnetic resonance imaging head abnormal; Magnetic resonance imaging spinal abnormal, Memory impairment, Micturition urgency, Muscular weakness, Neuralgia; Neurological symptom, Pollakiuria, Primary stabbing headache, Pseudopapilloedema, Scan with contrast abnormal; Scoliosis, Slow speech, Spinal stenosis, Tremor, Vision blurred; Walking aid user
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Reaction Summary: Within 24 hours of receiving the second Moderna COVID-19 vaccine dose, I began exp...
Reaction Summary: Within 24 hours of receiving the second Moderna COVID-19 vaccine dose, I began experiencing severe neurological symptoms. These escalated rapidly and persisted for months, leading to functional disability and ongoing neurological issues. Detailed Symptom Timeline (October?December 2021): October 13?14, 2021 (~24 hours after second dose) Severe weakness, near inability to walk Slurred, labored speech; difficulty forming words Vision disturbances: cloudy vision, trouble focusing, ?white-out? episodes lasting minutes Eyes did not improve with contact lenses or glasses Slowed processing and severe fatigue October 15?16, 2021 Cognitive dysfunction: forgot common names, typed and wrote inaccurately Mixed up words (e.g., ?Jennifer? instead of ?Joseph?) without realizing Used a cane to walk due to instability Severe coordination issues Emergency Room visit due to suspected stroke; CT scan showed possible idiopathic intracranial hypertension Follow-up referral initiated for MRI and neurology October 18?28, 2021 Increasing hand tremors Intermittent vision loss and cloudy eyesight Difficulty focusing, speaking clearly, and processing basic thoughts Difficulty writing and typing (formerly typed 60+ WPM error-free) Inconsistent walking ability: some days with cane, some without Extreme fatigue and pressure sensation in head/ears Balance and driving became unsafe October 31?November 2021 Continued balance problems and near-falls (including two falls while on vacation) Daily headaches, brain fog, slurred speech, and "mental unplugging" Memory lapses for important dates and people Required assistance with paperwork and errands MRI completed: Report suggested small vessel disease and follow-up recommended November?December 2021 Persistent neurological deficits: leg weakness, speech issues, and cognitive dysfunction Ophthalmologist noted optic disc elevation consistent with pseudotumor cerebri Lumbar puncture performed 12/29/2021 ? revealed low CSF protein levels Urinary urgency/frequency and fatigue became daily issues Recurrent ?ice pick? headaches in left temple area Diagnosis of idiopathic intracranial hypertension strongly suspected by multiple providers Ongoing & Residual Effects (2022?Present) Persistent nerve pain, hand weakness, visual processing issues Cognitive issues and fatigue continue to interfere with work and daily life Continued monitoring for MS, IIH, and other autoimmune or neurodegenerative disorders Important Notes: I had no history of this level of neurological impairment prior to the second Moderna dose. The rapid onset, severity, and duration of these symptoms strongly correlate to vaccine timing. I have extensive medical documentation of these symptoms and test results (CT, MRI, LP, ophthalmology, PCP, and ER notes).
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| 2870662 | 50 | F | NV | 11/04/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
u8832ba z003579 |
Hypertension, Malaise, Syncope; Hypertension, Malaise, Syncope
Hypertension, Malaise, Syncope; Hypertension, Malaise, Syncope
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Patient stated that she did not feel well the next day and then on Monday she wanted to go to work. ...
Patient stated that she did not feel well the next day and then on Monday she wanted to go to work. She stated she fainted at the bus stop. She stated she went to the hospital and she had to stay there until her blood pressure, that was too high, was under control.
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| 2870663 | 36 | M | MD | 11/04/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
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Bell's palsy, Blood glucose, Facial paralysis
Bell's palsy, Blood glucose, Facial paralysis
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Sudden left side facial paralysis. Noticed suddenly while driving around 4pm. Went to the ER to rule...
Sudden left side facial paralysis. Noticed suddenly while driving around 4pm. Went to the ER to rule out stroke around 9pm and was diagnosed with Bell's Palsy. It got worse over the next few days. As of 11/4/25, still no movement at all and complete facial droop and paralysis on left side of face.
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| 2870664 | 0.5 | F | MO | 11/04/2025 |
DTAPHEPBIP MNQ |
GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS |
9C295 N4TY2 |
Diarrhoea, Pyrexia, Vomiting; Diarrhoea, Pyrexia, Vomiting
Diarrhoea, Pyrexia, Vomiting; Diarrhoea, Pyrexia, Vomiting
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My daughter was not supposed to receive the menveo vaccine as it is not approved for children under ...
My daughter was not supposed to receive the menveo vaccine as it is not approved for children under 10. Approx 18 hours after administration Child developed a fever ranging from 103-104, despite tylenol administration. Friday, 10/31/25 she also had diarrhea and vomiting (after feeds). Saturday morning she woke up with a bloody nose. Her pcp was made aware. Current day, 11/4/25, Child is still having diarrhea and some vomiting.
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| 2870673 | 73 | F | MA | 11/04/2025 |
FLU3 |
SANOFI PASTEUR |
U8859AA |
Erythema, Peripheral swelling, Pruritus
Erythema, Peripheral swelling, Pruritus
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Patient started getting itchy about an hour after the vaccine at the injection site. Then the next m...
Patient started getting itchy about an hour after the vaccine at the injection site. Then the next morning her arm was swollen and red.
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| 2870674 | 2.67 | M | PA | 11/04/2025 |
COVID19 |
MODERNA |
3052549 |
Incorrect dose administered
Incorrect dose administered
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Wrong dose given pt was given a 0.5ML dose instead of a 0.25ML dose.
Wrong dose given pt was given a 0.5ML dose instead of a 0.25ML dose.
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| 2870676 | 59 | F | IN | 11/04/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
2L353 |
Gingival swelling, Lip swelling, Lymphadenopathy, Swollen tongue
Gingival swelling, Lip swelling, Lymphadenopathy, Swollen tongue
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Swollen glands under tongue, swollen tongue, lips and gums. Patient too Zyrtec.
Swollen glands under tongue, swollen tongue, lips and gums. Patient too Zyrtec.
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| 2870678 | 78 | M | TX | 11/04/2025 |
FLU3 |
SEQIRUS, INC. |
407251 |
Pain in extremity
Pain in extremity
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The patient reports pain to his left arm that started shortly after receiving the flu vaccine. He ha...
The patient reports pain to his left arm that started shortly after receiving the flu vaccine. He has used ice with some relief. The pain is slowly resolving.
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| 2870024 | 56 | M | CA | 11/03/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
ER8731 ER8736 FJ8757 |
Cerebrovascular accident, Myocardial infarction; Cerebrovascular accident, Myoca...
Cerebrovascular accident, Myocardial infarction; Cerebrovascular accident, Myocardial infarction; Cerebrovascular accident, Myocardial infarction
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While finishing my morning meeting with my Software Engineering program, I had a stroke (my second) ...
While finishing my morning meeting with my Software Engineering program, I had a stroke (my second) and a third heart attack. I was given TPA at the emergency room and I spent about three weeks in the hospital till I was moved to a rehab hospital where I went through two months of rehab. The following shows the first two batches were labeled "high toxicity". The hearing at this URL confirmed that the government hid the vaccine's potential to cause myocarditis; especially when I already had that condition. The state outlawed any research that tried to research why so many people were dying. I just now found out how to make this report to VAERS.
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| 2870025 | 86 | M | OR | 11/03/2025 |
COVID19 |
MODERNA |
3052784 |
Gait inability, Muscular weakness
Gait inability, Muscular weakness
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Patient had flu and covid vaccines at the same time. Patient's wife said he very weakness in th...
Patient had flu and covid vaccines at the same time. Patient's wife said he very weakness in the legs and cannot walk and required home health care. He also have an iron infusion because of low iron. She was not sure the low iron and combination of vaccines given at the time were the problem. Patient's wife wanted me to report the issue. Patient is ok now and walking fine after 2 weeks.
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| 2870031 | 72 | F | 11/03/2025 |
COVID19 |
MODERNA |
3042879 |
Hot flush, Hypersensitivity, Pain in extremity, Rash erythematous
Hot flush, Hypersensitivity, Pain in extremity, Rash erythematous
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bright red, very hot face; soreness in the left arm; red rash; hypersensitivity reaction; This spont...
bright red, very hot face; soreness in the left arm; red rash; hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (bright red, very hot face), PAIN IN EXTREMITY (soreness in the left arm), RASH ERYTHEMATOUS (red rash) and HYPERSENSITIVITY (hypersensitivity reaction) in a 72-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3042879) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3042879) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (1st dose) in 2021, Pfizer (3 weeks later another Pfizer) in 2021, Pfizer in September 2021 and Pfizer in 2023. Past adverse reactions to the above products included No adverse effect with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Asthma NOS and Blood pressure high. On 14-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 14-Oct-2024, the patient experienced HOT FLUSH (bright red, very hot face), PAIN IN EXTREMITY (soreness in the left arm), RASH ERYTHEMATOUS (red rash) and HYPERSENSITIVITY (hypersensitivity reaction). On 14-Oct-2024, HOT FLUSH (bright red, very hot face) had resolved. In October 2024, PAIN IN EXTREMITY (soreness in the left arm) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash) and HYPERSENSITIVITY (hypersensitivity reaction) had resolved. No concomitant medications were reported. The patient had no other vaccines in the past 4 weeks before receiving the Spikevax 2024-2025. She had always waited at least 2 weeks for flu vaccine, so she received Fluzone for age 65 years old and up with a label that said "HD 65+" on 01-Dec-2024 which was received 6 weeks after the Spikevax 2024-2025. She had very bright red, very hot face on the same day she had received the Moderna Spikevax 2024-2025 by the time she got home and stayed that way until she went to bed which lasted until about 10 pm or 11 pm and lasted roughly for 10 to12 hours despite using cold compress continuously. She had soreness in the left arm than previous experiences with COVID-19 vaccines, a red rash that spread across her upper arm and a little bit below where the shot was and straight across the outside of her arm, emphasizing that the rash appeared across the whole arm following the administration but could not exactly remember when it started but remembered it lasted for about 6-7 days post administration. She took a photo of her left arm 3 days after the reaction in that area started, to show to her doctor. She had a hypersensitivity reaction. It was her very first-time experiencing reactions following administrations of COVID-19 vaccines. She did not have that rash reaction before. The next day post administration, her face was okay, but the arm was sore, and she thought that it was rather typical. The patient did not experience any additional symptoms/events. No treatment information was provided. This case was linked to MOD-2025-790546, MOD-2025-790547 (Patient Link).
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| 2870032 | F | 11/03/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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Caller said she got Covid about 6 months after her second vaccine she got Covid. She feels the vacci...
Caller said she got Covid about 6 months after her second vaccine she got Covid. She feels the vaccine saved her life; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller said she got Covid about 6 months after her second vaccine she got Covid. She feels the vaccine saved her life) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller said she got Covid about 6 months after her second vaccine she got Covid. She feels the vaccine saved her life). At the time of the report, COVID-19 (Caller said she got Covid about 6 months after her second vaccine she got Covid. She feels the vaccine saved her life) had resolved. Concomitant medication was not provided. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.
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