| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2718159 | 56 | F | NY | 11/27/2023 |
FLU4 FLUX |
GLAXOSMITHKLINE BIOLOGICALS UNKNOWN MANUFACTURER |
h4297 |
Arthralgia, Pain, Pain in extremity, Palpitations; Mobility decreased, Musculosk...
Arthralgia, Pain, Pain in extremity, Palpitations; Mobility decreased, Musculoskeletal discomfort, Product administered at inappropriate site
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pt states she experienced heart palpitations and a very sore arm with pain radiation to her knee.
pt states she experienced heart palpitations and a very sore arm with pain radiation to her knee.
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| 2870000 | 72 | F | ME | 11/02/2025 |
COVID19 PNC21 |
PFIZER\BIONTECH MERCK & CO. INC. |
NA0589 Z006076 |
Injection site bruising, Injection site haemorrhage, Injection site pain; Inject...
Injection site bruising, Injection site haemorrhage, Injection site pain; Injection site bruising, Injection site haemorrhage, Injection site pain
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EXCESSIVE BLEEDING AND BRUISING AND EXTREME PAIN UPON VACCINATION
EXCESSIVE BLEEDING AND BRUISING AND EXTREME PAIN UPON VACCINATION
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| 2870001 | 10 | M | DE | 11/02/2025 |
COVID19 |
MODERNA |
3052579 |
Syncope
Syncope
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CLIENT HAD A SHOT OF SPIKEVAX PEDIATRIC 2025/2026 (0.25ML) DOSE. HE WAS VERY FINE AND STABLE WHILE ...
CLIENT HAD A SHOT OF SPIKEVAX PEDIATRIC 2025/2026 (0.25ML) DOSE. HE WAS VERY FINE AND STABLE WHILE WAITING FOR OTHER 3 MEMBERS OF HIS FAMILY TO GET THEIR SHOTS . HE FAINTED OUTSIDE IN THE PARKING LOT ACCORDING TO HIS FATHER WHO RAN INTO THE STORE TO ALERT US. I ASKED HIM TO CALL EMS OR TAKE HIM TO EMERGENCY ROOM FOR OBSERVATION. WHILE IN THE ER, I FOLLWED UP WITH PHONE TO THE MOTHER .
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| 2870005 | 67 | F | 11/02/2025 |
COVID19 |
MODERNA |
3052082 |
Injection site pruritus, Injection site reaction, Injection site warmth
Injection site pruritus, Injection site reaction, Injection site warmth
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ADVERSE REACTION TO MNEXSPIKE COVID VACCINE FROM FRIDAY 10/31 /25: REDNESS FROM ABOVE ELBOW TO TOP O...
ADVERSE REACTION TO MNEXSPIKE COVID VACCINE FROM FRIDAY 10/31 /25: REDNESS FROM ABOVE ELBOW TO TOP OF SHOULDER. FRIDAY NIGHT 10/31/25 - ITCHINESS SO TOOK BENADRYL. REDNESS STARTED SATURDAY NIGHT. WARM, STILL ITCHY. SAME AMOUNT OF REDNESS NO CHANGE.
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| 2870007 | 37 | F | NC | 11/02/2025 |
FLU3 |
SANOFI PASTEUR |
U8832DA |
Muscular weakness, Pain in extremity
Muscular weakness, Pain in extremity
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Persistent pain in left arm. Relieved by analgesic. Weakness on lifting if pain is present. Reporte...
Persistent pain in left arm. Relieved by analgesic. Weakness on lifting if pain is present. Reported 11/02/2025.
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| 2870008 | 75 | F | NM | 11/02/2025 |
FLU3 |
SANOFI PASTEUR |
u8874aa |
Eye pruritus, Paraesthesia, Paraesthesia oral
Eye pruritus, Paraesthesia, Paraesthesia oral
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patient came to the pharmacy today to report "she experienced tingling on the face and tongue o...
patient came to the pharmacy today to report "she experienced tingling on the face and tongue on the drive home and itchy eyes on 10/18/25 but it clears up by the next day. She did not take anything for the reactions. She did not contact us nor her primary care physician; however, she came by the pharmacy today to get the information needed to report to the vaccine adverse event reporting system (VAERS). She think that b/c it is the FLUZONE HD that why it cause the rxn but she not truly allergic to flu-shot. STC showed she had a Fluzone HD 9/15/20 @ her provider.)
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| 2870009 | 75 | F | GA | 11/02/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
U8859BA U8859BA |
Erythema, Hyperhidrosis, Pain, Pain in extremity, Peripheral swelling; Petechiae...
Erythema, Hyperhidrosis, Pain, Pain in extremity, Peripheral swelling; Petechiae, Product administered at inappropriate site, Rash, Tenderness
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Patient said she woke up around 10:30 or 11:00 pm the night she received the vaccine (Wednesday) wit...
Patient said she woke up around 10:30 or 11:00 pm the night she received the vaccine (Wednesday) with throbbing, shooting pain in her arm. She began sweating profusely. She said she continued to have pain in the area until Saturday when she came to the pharmacy to show me the area. There was a large (approximately 8 inches in diameter) red area. She said it had reduced in size, and it had previously been raised. There were petechia present in the rash area as well. Patient said the rash was still tender, but not painful as before. In addition, it appears the vaccine was given too low and to far interior. It is unclear whether the reaction is due to the potentially improper location or if the reaction would have occurred anyway.
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| 2870010 | 38 | F | NY | 11/02/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Constipation, Gastrointestinal pain, Impaired gastric emptying, Injection site b...
Constipation, Gastrointestinal pain, Impaired gastric emptying, Injection site bruising, Pyrexia; Renal pain, Urinary retention, Vomiting
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Bruising at injection site still present 11/2 (have photo), fever and urinary retention for 72 hours...
Bruising at injection site still present 11/2 (have photo), fever and urinary retention for 72 hours following vaccine. For 5 days following vaccine had severe kidney pain, vomiting, and severe intestinal spasms and worsened gastroparesis and constipation
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| 2870018 | 79 | F | WA | 11/02/2025 |
COVID19 |
MODERNA |
3052733 |
Arthralgia, Contusion, Product administered at inappropriate site, Soft tissue i...
Arthralgia, Contusion, Product administered at inappropriate site, Soft tissue injury
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The patient complained the shot was given too high up to her shoulder area which caused 7 out of 10 ...
The patient complained the shot was given too high up to her shoulder area which caused 7 out of 10 severe pain which started about one hour after the shot that she had to take strong pain killer. She had to go to see a physical therapist who said the vaccine caused soft tissue damage. She confirmed there is no local swelling or redness except for a bruise mark. She said her pain is getting better.
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| 2870019 | 33 | M | NM | 11/02/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC. |
NA4457 NA4457 409415 409415 |
Back pain, Blood test, Culture throat negative, Gait disturbance, Malaise; Stoma...
Back pain, Blood test, Culture throat negative, Gait disturbance, Malaise; Stomatitis; Back pain, Blood test, Culture throat negative, Gait disturbance, Malaise; Stomatitis
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patient developed lower backpain that made walking difficutl. Patient was seen at an urgent care and...
patient developed lower backpain that made walking difficutl. Patient was seen at an urgent care and recieved lidocain patches. Patient had sores on right side of tongue that was treated with oral lidocaine. Patient reports general malaise.
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| 2870020 | 66 | F | 11/02/2025 |
COVID19 FLU3 |
MODERNA GLAXOSMITHKLINE BIOLOGICALS |
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Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa...
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm
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patients arm was red and swollen about 1-2 days after vaccine. it was warmer only in the area where...
patients arm was red and swollen about 1-2 days after vaccine. it was warmer only in the area where red. area was about 3 inches in diameter. she received two vaccines that day but it was on her left arm , the arm she received the covid moderna. it was a booster
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| 2870021 | 71 | F | CA | 11/02/2025 |
FLU3 |
SANOFI PASTEUR |
UT8794CA |
Injected limb mobility decreased
Injected limb mobility decreased
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Forty-eight hours after receiving vaccine, patient reported experiencing a limited range of motion i...
Forty-eight hours after receiving vaccine, patient reported experiencing a limited range of motion in left arm. Minimal pain reported. The limitation has persisted since then. She visited urgent care on 10/25 who reported no findings. When she followed up with her PCP on 10/28, her physician said there may be a tendon issue.
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| 2870022 | 76 | F | MA | 11/02/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Confusional state, Fall, Gait disturbance, Muscular weakness, Retrograde amnesia...
Confusional state, Fall, Gait disturbance, Muscular weakness, Retrograde amnesia; Tooth fracture
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The evening following flu vaccine administered, Patient experienced confusion, lower extremity weakn...
The evening following flu vaccine administered, Patient experienced confusion, lower extremity weakness and subsequent fall, striking her face and chipping a tooth. Lower extremity weakness, gait disorder and retrograde amnesia lasted into the following day.
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| 2869932 | 79 | M | IL | 11/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Laboratory test
COVID-19, Drug ineffective, Laboratory test
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Had all his shots, still got covid; Had all his shots, still got covid; This is a spontaneous report...
Had all his shots, still got covid; Had all his shots, still got covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 80-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 79 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure", start date: 1970 (unspecified if ongoing), notes: Date of diagnosis: back in 1970s, took medicine/one small tablet for that; "Thyroid problem", start date: 1970 (unspecified if ongoing), notes: Date of diagnosis: back in 1970s. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete.), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Oct2025, outcome "unknown" and all described as "Had all his shots, still got covid". The patient underwent the following laboratory tests and procedures: Lab test: PSA everything, everything comes out good, notes: past days everything comes out good. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: The patient stated "I was at my doctor, I went for my infection. I had a lot of problems coughing and breathing, and different things, and they did the test to find my test came back, that I have COVID. Even though I have all my shots and everything else, I still got it from somewhere. So I need to buy the medicine Paxlovid". The patient stated he had an infection, had a lot of problems coughing and breathing, took all of his COVID shots, boosters and caught covid. The patient never had covid before, this is the first time. The patient stated, "I had all my Pfizer shots, all my booster shots. I have everything done over the years." However, the manufacturer was never confirmed for the COVID shots or Boosters. 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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| 2869933 | M | 11/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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It killed my dad; This is a spontaneous report received from a Consumer or other non HCP from medica...
It killed my dad; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A male patient received BNT162b2 omicron (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: DEATH (death, medically significant), outcome "fatal", described as "It killed my dad". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical details: The wife stated it killed her mom, her dad, her two older sisters, her husband had relatives die, they've had friends die and no one takes it off the market. It's got a whole bunch of stuff in it that is toxic to the body and it has the spike protein which causes harm to the body. (withheld) has had several conferences with these people that have gotten the covid jab and they almost died and a lot of them have died and they're, like, crippled now and they have heart disease and nobody's doing jack about it. 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-202500213507 Same reporter/vaccine/event, different patients;; Reported Cause(s) of Death: Unknown cause of death
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| 2869934 | 8 | M | UT | 11/01/2025 |
COVID19 FLUX |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
NA0846 948409 |
Pruritus; Pruritus
Pruritus; Pruritus
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patches of itchy skin; This is a spontaneous report received from a Consumer or other non HCP. An 8...
patches of itchy skin; This is a spontaneous report received from a Consumer or other non HCP. An 8-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 28Oct2025 at 12:00 as dose 1, single (Lot number: NA0846) at the age of 8 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 28Oct2025 at 12:00 as dose number unknown, single (Lot number: 948409), in left arm for immunisation. The patient's relevant medical history included: "Strawberry (mild skin rash)" (unspecified if ongoing), notes: mild skin rash; "toothpaste" (unspecified if ongoing), notes: some toothpaste if not rinsed off skin around mouth cause mild skin rash. Concomitant medication(s) included: TYLENOL, start date: 23Oct2025, stop date: 26Oct2025. Vaccination history included: Pfizer-biontech covid-19 vaccine (2023-2024 formula) (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "less severe itchy rash". The following information was reported: PRURITUS (non-serious) with onset 29Oct2025 at 02:00, outcome "unknown", described as "patches of itchy skin". It was unknown if therapeutic measures were taken as a result of pruritus. Additional information: At around 2 AM (about 14 hrs after shot), reporter's son broke out in patches of itchy skin. He got a flu and covid shot at his paediatrician office - one in each arm. The last time he got the same (about 2 years ago), he also broke out in a less severe itchy rash, about 1/2 hr to an hour after getting them. Reporter reported it to Pfizer at the time. Reporter called his Drs office when they open tomorrow (30Oct2025). The patient was taking other medications within 2 weeks of the event starting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. At Doctor's office/urgent care facility where vaccine was administered.
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| 2869935 | M | CA | 11/01/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Blood glucose increased, Malaise, Pain in extremity
Blood glucose increased, Malaise, Pain in extremity
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he felt a little bit ill; sore arm; his glucose levels were still really high; This is a spontaneous...
he felt a little bit ill; sore arm; his glucose levels were still really high; This is a spontaneous report received from a Pharmacist from medical information team. A 33-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 25Oct2025 as dose 1, 0.3 ml single (Lot number: NA0589, Expiration Date: 23Jun2026) intramuscular, in right arm for covid-19 immunisation, Device Lot Number: NA0589, Device Expiration Date: 23Jun2026. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMALOG subcutaneous taken for type 1 diabetes mellitus. The following information was reported: MALAISE (non-serious) with onset 2025, outcome "recovered" (2025), described as "he felt a little bit ill"; BLOOD GLUCOSE INCREASED (non-serious) with onset 2025, outcome "not recovered", described as "his glucose levels were still really high"; PAIN IN EXTREMITY (non-serious) with onset 2025, outcome "recovered" (2025), described as "sore arm". Therapeutic measures were taken as a result of blood glucose increased. Additional information: Pharmacist went to the site just to look at the side effects that patients could have after they get the vaccination and then one of my patients reported a side effect that she did not see there. But she was wondering if you had any idea if anybody else had it because she was not sure if it was related to the vaccine or if it was maybe just due to something else, and it was maybe a coincidence and timing. The patient was a type 1 diabetic, and then he noticed that, basically, so after he received the Comirnaty vaccination he had his usual side effects where he felt a little bit ill sore arm, but then he said about maybe 5 or a couple of days later he noticed that like no matter how much insulin he was using like his glucose levels were still really high, have you heard any of that?. We usually had an insulin pump, but then he was saying that he was just using more insulin than he usually does. He thought he was almost becoming resistant to the insulin. He asked his doctor as well and thinks his doctor was aware of this. The patient was not sure if it was a side effect so that was why pharmacist called and wanted to ask if it was a side effect that was known and when she looked it up online she didn't find anything. Patient didn't know if it was related to the vaccine. He received Comirnaty on 25Oct2025. Indication: Thinks he gets his annual flu shot and got the covid shot. He did not mention any treatment to her regarding him feeling a little bit ill and his sore arm. She was assuming it was his right arm that was sore but he didn't tell her which arm was sore. Glucose levels really high outcome: States this was ongoing as of yesterday afternoon but she had not called him today and needs to call him.
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| 2869936 | M | UT | 11/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Rash pruritic
Rash pruritic
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The last time he got the same (about 2 years ago), he also broke out in a less severe itchy rash; Th...
The last time he got the same (about 2 years ago), he also broke out in a less severe itchy rash; This is a spontaneous report received from a Consumer or other non HCP. A 6-year-old male patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Strawberry (mild skin rash)" (unspecified if ongoing), notes: Strawberry (mild skin rash); "toothpaste (mild skin rash)" (unspecified if ongoing), notes: some toothpaste if not rinsed off skin around mouth cause mild skin rash. The patient's concomitant medications were not reported. The following information was reported: RASH PRURITIC (non-serious) with onset 2023, outcome "unknown", described as "The last time he got the same (about 2 years ago), he also broke out in a less severe itchy rash". Additional information: The last time he got the same (about 2 years ago), he also broke out in a less severe itchy rash, about 1/2 hr to an hour after getting them. Reporter reported it to Pfizer at the time. Reporter called his Drs office when they open tomorrow (30Oct2025). The patient was taking other medications within 2 weeks of the event starting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. At Doctor's office/urgent care facility where vaccine was administered. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
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| 2869946 | 67 | F | FL | 11/01/2025 |
FLU3 |
SANOFI PASTEUR |
ut8781da |
Burning sensation, Contusion, Pain
Burning sensation, Contusion, Pain
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Initially there was an aching post vaccine, bruise developed next day and an achy burning sensation ...
Initially there was an aching post vaccine, bruise developed next day and an achy burning sensation started in upper shoulder moving down into the deltoid . Brusing was severe, dark purple. Patient kept waiting took Motrin for symptoms. Sensation and pain still remains day 9 but bruising has got better.
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| 2869949 | 88 | M | MI | 11/01/2025 |
FLU3 |
SEQIRUS, INC. |
407273 |
Device connection issue, Underdose
Device connection issue, Underdose
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Patient presented to vaccination clinic for high dose (HD) flu and covid vaccine 12+. While attempti...
Patient presented to vaccination clinic for high dose (HD) flu and covid vaccine 12+. While attempting to administer HD flu, the white vaccine fluid leaked from luer lock. Needle removed from patient's arm as fluid leaked out. Spoke with MD on site who agreed ok to give a new dose. FYI sent to PCP via chart. Reviewed with patient and daughter who agreed to receive HD flu as a third poke. Advised patient and daughter to call with any concerns, as there are nurses available 24/7.
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| 2869950 | 74 | F | WA | 11/01/2025 |
COVID19 FLU3 |
MODERNA SANOFI PASTEUR |
3052030 u8830DA |
Arthralgia, Pain in extremity; Arthralgia, Pain in extremity
Arthralgia, Pain in extremity; Arthralgia, Pain in extremity
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Patient states that she has had joint pain in wrists, fingers, feet, ankles, toes and hips since get...
Patient states that she has had joint pain in wrists, fingers, feet, ankles, toes and hips since getting the covid and flu vaccines in September. She said that she had arm pain the day following the vaccine and then the joint pain started soon after and has continued since. She had not reported to her doctor as of 10/31/2025.
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| 2869956 | 14 | M | IN | 11/01/2025 |
COVID19 |
MODERNA |
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Loss of consciousness, Pallor
Loss of consciousness, Pallor
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Technician administered the vaccine to patient. Upon receiving vaccine, the patient passed out for a...
Technician administered the vaccine to patient. Upon receiving vaccine, the patient passed out for a few seconds and his skin became very pale. The pharmacist then came in the room and checked the patients blood pressure and HR which were both below normal limits. After drinking some fluids, the patients vitals stabilized and his skin color returned to normal as well.
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| 2869957 | 62 | F | FL | 11/01/2025 |
FLU3 |
SANOFI PASTEUR |
u8823aa |
Bell's palsy, Facial paresis, Vision blurred
Bell's palsy, Facial paresis, Vision blurred
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Patient seen in hospital and given initial diagnosis of Bell's Palsy with associated symptoms s...
Patient seen in hospital and given initial diagnosis of Bell's Palsy with associated symptoms such as blurred vision and one sided facial weakness.
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| 2869959 | 32 | F | IA | 11/01/2025 |
ADEN_4_7 ADEN_4_7 HEPA HEPA IPV IPV MNQ MNQ TDAP TDAP VARCEL VARCEL |
TEVA PHARMACEUTICALS TEVA PHARMACEUTICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
100043652 100043652 EY57A EY57A y1d03p1 y1d03p1 537LH 537LH H4K3S H4K3S Z008427 Z008427 |
Feeling cold, Gait disturbance, Headache, Hypoaesthesia, Mobility decreased; Pai...
Feeling cold, Gait disturbance, Headache, Hypoaesthesia, Mobility decreased; Pain, Paraesthesia, Respiration abnormal, Visual impairment; Feeling cold, Gait disturbance, Headache, Hypoaesthesia, Mobility decreased; Pain, Paraesthesia, Respiration abnormal, Visual impairment; Feeling cold, Gait disturbance, Headache, Hypoaesthesia, Mobility decreased; Pain, Paraesthesia, Respiration abnormal, Visual impairment; Feeling cold, Gait disturbance, Headache, Hypoaesthesia, Mobility decreased; Pain, Paraesthesia, Respiration abnormal, Visual impairment; Feeling cold, Gait disturbance, Headache, Hypoaesthesia, Mobility decreased; Pain, Paraesthesia, Respiration abnormal, Visual impairment; Feeling cold, Gait disturbance, Headache, Hypoaesthesia, Mobility decreased; Pain, Paraesthesia, Respiration abnormal, Visual impairment
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Sept. 18 about 13:30 am vaccines administered. Around 9:05 pm, left arm started going numb. Sept 19...
Sept. 18 about 13:30 am vaccines administered. Around 9:05 pm, left arm started going numb. Sept 19, went to MC, unable to feel left arm properly. Was prescribed ibuprofen. Did nothing. Sept 20 around 8:30-10 am left hip and butt cheek went numb i staggered before getting balance after standing from a sitting position. Went to hospital and given a toradol injection at 11:03 am. It helped for a few hours, but by 4 or 5 pm I was getting pins and needles again. About 5:30-6 pm, from the left side of top of my head down to my left butt cheek, went numb with pulsing and throbbing and I couldn't move my left arm at all. Happened briefly and for a few hours it happened at regular intervals of 15-30 minutes. Sept. 21 started to get holes in vision. Bouts of minor to more serious numbness happened more frequently, for longer durations. Sept 22 vision holes became more frequent and fractured. Numbness more frequent. Headaches. The Worst episode of Numbness, unable to move at all. Sept. 23 Headaches, Numbness, fractured vision, all day in different locations and severity, all between the left side top of my head and left hip/butt cheek. Throbbing and pulsing occasionally has brief ebb of a breath to a few seconds. Happens a few times. Toradol pill prescription does nothing. Sept. 24 more of the same Sept. 25 same symptoms, addition of icy feeling occasionally in left arm and side. 6:02-6:15am, last episode of pulsing and throbbing, with an ebb at 6:08, 6:10, and 6:13. Around 2pm, IV administered at MC. Around 2:44 pm, IV administered in ambulance. From Sept. 25, administered IVs to 10/3, symptoms improve before stopping completely.
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| 2869960 | 53 | F | CA | 11/01/2025 |
FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR |
UT8817KA UT8817KA |
Headache, Immediate post-injection reaction, Injection site bruising, Injection ...
Headache, Immediate post-injection reaction, Injection site bruising, Injection site pain, Injection site pruritus; Injection site swelling, Nausea
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Was given IM inj to left deltoid. Pt immediately felt unusual pain, with bruising and itching. Swell...
Was given IM inj to left deltoid. Pt immediately felt unusual pain, with bruising and itching. Swelling was noted the next day with tenderness. Here today in clinic 4 days later with resolving bruise and resolving swelling. Reports nausea and headache subsequently after her vaccination,
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| 2869961 | 72 | F | MA | 11/01/2025 |
COVID19 |
MODERNA |
3052583 |
Injection site rash
Injection site rash
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Patient stated that she got a rash around the site of injection and patient went to urgent care 2 da...
Patient stated that she got a rash around the site of injection and patient went to urgent care 2 days after receiving vaccine to receive treatment. Patient received a prescription for doxycycline for 7 day course.
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| 2869962 | 61 | F | 11/01/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
U8832DA Z009681 |
Dizziness, Injection site erythema, Injection site swelling, Injection site warm...
Dizziness, Injection site erythema, Injection site swelling, Injection site warmth; Dizziness, Injection site erythema, Injection site swelling, Injection site warmth
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Patient experienced redness, swelling, and fever at the injection site . Patient stated she felt diz...
Patient experienced redness, swelling, and fever at the injection site . Patient stated she felt dizzy.
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| 2869964 | 39 | F | MI | 11/01/2025 |
FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
KL47G KL47G |
Dyspepsia, Immediate post-injection reaction, Malaise, Paraesthesia, Paraesthesi...
Dyspepsia, Immediate post-injection reaction, Malaise, Paraesthesia, Paraesthesia oral; Photopsia
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Flu Vaccine given at 1341. Pt immediately c/o not feeling right. Felt indigestion, seeing stars, ton...
Flu Vaccine given at 1341. Pt immediately c/o not feeling right. Felt indigestion, seeing stars, tongue and jaw tingling. VS stable, 1347: 130/73 P91 R20. Repeated VS 1400 126/76 P74 R16. Pt given juice and she refused crackers. A&O x3 throughout. Symptoms continued. Offered pt to go to the ED for evaluation. Pt agreed and wished to go. AT 1410 EMS called. Left with EMS at 1433.
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| 2869965 | 61 | M | NY | 11/01/2025 |
COVID19 UNK |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
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Ear pain; Ear pain
Ear pain; Ear pain
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Continuing minor ear ache in one ear. Antibiotic and steroid have not helped.
Continuing minor ear ache in one ear. Antibiotic and steroid have not helped.
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| 2869966 | 45 | F | TX | 11/01/2025 |
FLU3 FLU3 FLU3 UNK UNK UNK |
SEQIRUS, INC. SEQIRUS, INC. SEQIRUS, INC. UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
410514 410514 410514 Z006076 Z006076 Z006076 |
Carditis, Chest X-ray, Chest pain, Chills, Electrocardiogram abnormal; Erythema,...
Carditis, Chest X-ray, Chest pain, Chills, Electrocardiogram abnormal; Erythema, Feeling abnormal, Hyperhidrosis, Peripheral swelling, Pneumonitis; Pyrexia, Skin warm, Vomiting, X-ray abnormal; Carditis, Chest X-ray, Chest pain, Chills, Electrocardiogram abnormal; Erythema, Feeling abnormal, Hyperhidrosis, Peripheral swelling, Pneumonitis; Pyrexia, Skin warm, Vomiting, X-ray abnormal
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Patient said she started feeling bad the day after the shot. She had fever, chills, sweating, chest ...
Patient said she started feeling bad the day after the shot. She had fever, chills, sweating, chest pains and vomiting for several days. Her left arm was red, hot and swollen. She went to her primary care provider who sent her to the ER. At the ER she had an electrocardiogram done and X-ray. She said they told her she had "inflammed avioli of the lungs and inflammation of the heart." They told her they believed it was due to the vaccine. As of today patient is still not feeling well and has an appointment with a cardiologist for a heart evaluation.
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| 2869968 | 67 | M | GA | 11/01/2025 |
FLU3 PNC21 |
SANOFI PASTEUR MERCK & CO. INC. |
UT8781DA Y013009 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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Localized reaction around site of injection, arm red and swollen. No pain reported.
Localized reaction around site of injection, arm red and swollen. No pain reported.
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| 2869969 | 55 | F | PA | 11/01/2025 |
COVID19 |
MODERNA |
3052583 |
Injection site erythema
Injection site erythema
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Patient got Covid 19 (Moderna Spikevax) on Tuesday 10/28/2025. She said it turned redness at inject...
Patient got Covid 19 (Moderna Spikevax) on Tuesday 10/28/2025. She said it turned redness at injection site (Left Arm) on Wednesday 10/29/2025.
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| 2869970 | 12 | F | FL | 11/01/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
305258 409413 |
Dyspnoea, Pain in extremity; Dyspnoea, Pain in extremity
Dyspnoea, Pain in extremity; Dyspnoea, Pain in extremity
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Patient and father had come to the pharmacy. Patient had stated she had trouble breathing and arm wa...
Patient and father had come to the pharmacy. Patient had stated she had trouble breathing and arm was sore. Provided advil 200mg and took blood pressure. 129/82 and pulse of 70
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| 2869971 | 60 | F | VA | 11/01/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
MY9550 U8823da |
Injection site pain, Injection site reaction, Injection site warmth; Injection s...
Injection site pain, Injection site reaction, Injection site warmth; Injection site pain, Injection site reaction, Injection site warmth
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Patient developed injection site reaction on right arm in area that vaccines were given the morning ...
Patient developed injection site reaction on right arm in area that vaccines were given the morning after vaccination. The area around the injection was sore, red, and warm to the touch in an approximate 5 inch diameter circle. Recommended patient watch the area to make sure it has not spread, and if it does not improve to contact her PCP to discuss treatment options.
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| 2869972 | 72 | F | NJ | 11/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8862AA |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Redness and swelling a few inches below the injection site.
Redness and swelling a few inches below the injection site.
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| 2869974 | 77 | F | NY | 11/01/2025 |
FLU3 |
SANOFI PASTEUR |
U8837BA |
Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity
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Patient said her arm hurt. She had trouble raising her arm above her side.. Patient came in and told...
Patient said her arm hurt. She had trouble raising her arm above her side.. Patient came in and told me her problem, I asked her to go to the urgent care in town. The urgent care didn't have a provider so they sent her to hospital ER. The hospital gave her cyclobenzaprine. Patient took the muscle relaxer and said she was feeling better
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| 2869975 | 26 | F | VA | 11/01/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EK4176 EK5730 |
Amenorrhoea, Breast mass, Dysmenorrhoea, Lymphadenopathy, Ultrasound breast; Ame...
Amenorrhoea, Breast mass, Dysmenorrhoea, Lymphadenopathy, Ultrasound breast; Amenorrhoea, Breast mass, Dysmenorrhoea, Lymphadenopathy, Ultrasound breast
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Developed difficulty with amenorrhea, painful periods after the vaccine; this was noticed by the nex...
Developed difficulty with amenorrhea, painful periods after the vaccine; this was noticed by the next menstrual cycle. Developed axillary lymphadenopathy and a right breast lump approximately 6 weeks after the second vaccine.
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| 2869977 | 14 | F | CA | 11/01/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Chills, Fatigue, Fungal infection, Pain, Pyrexia; Rash, Rash pruritic
Chills, Fatigue, Fungal infection, Pain, Pyrexia; Rash, Rash pruritic
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The night of I had chills and body aches. The day after I had fatigue, body aches, and a fever (whic...
The night of I had chills and body aches. The day after I had fatigue, body aches, and a fever (which is normal for me). The day after that I woke up with an unorthodox yeast infection. There was no smell, and no white discharge, but just these sensitive hard bumps. It was itchy and it gave me sharp stabbing pains. It wouldn?t go away with drugstore creams, so I had to go to urgent care. About a week later I got the flu, and the yeast infection came back. They gave me a pill to treat it.
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| 2869980 | 84 | F | VA | 11/01/2025 |
COVID19 |
PFIZER\BIONTECH |
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Acoustic stimulation tests abnormal, Deafness neurosensory, Deafness unilateral,...
Acoustic stimulation tests abnormal, Deafness neurosensory, Deafness unilateral, Sudden hearing loss
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Total hearing loss in left ear
Total hearing loss in left ear
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| 2869646 | F | CA | 10/31/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
J9493 |
Exposure during pregnancy, Product administered to patient of inappropriate age,...
Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
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HCP administered AREXVY to a pregnant patient; HCP administered AREXVY to a pregnant patient; Inappr...
HCP administered AREXVY to a pregnant patient; HCP administered AREXVY to a pregnant patient; Inappropriate age at vaccine administration; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number J9493, expiry date 01-NOV-2025) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: HCP administered AREXVY to a pregnant patient), product use in unapproved population (Verbatim: HCP administered AREXVY to a pregnant patient) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the vaccine exposure during pregnancy, product use in unapproved population and inappropriate age at vaccine administration were not applicable. Pregnancy exposure: Gestation time at first exposure (Arexvy): 32 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK Receipt Date: 27-OCT-2025 Pharmacist reported another healthcare professional administered Arexvy to a pregnant patient. Pharmacist didn't have delivery date but states patient is 32 weeks pregnant.
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| 2869647 | 70 | F | IA | 10/31/2025 |
COVID19 COVID19 |
MODERNA UNKNOWN MANUFACTURER |
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Death; Death
Death; Death
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passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH ...
passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product COVID-19 vaccine for an unknown indication. Concurrent medical conditions included Smoker. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of COVID-19 vaccine (unknown route) 1 dosage form. Death occurred on 02-Dec-2024 The patient died on 02-Dec-2024. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was reported. It was stated that patient passed away on 02-Dec-2024, that her death was unrelated to Moderna Covid vaccines, but she did take all of the Moderna vaccines in the past, except for the final booster. It was stated that her last shot was either in 2023 or 2024. It was unknown if the patient experienced any additional symptoms/events No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788898 (E2B Linked Report).; Reporter's Comments: Essential details such as the exact date and cause of death, medical history, concomitant medications, and the clinical course leading to the event are missing. Additionally, the temporal relationship between the last vaccine dose and the fatal event is unclear. Further information has been requested. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788898:Son's case; Reported Cause(s) of Death: Unknown cause of death
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| 2869648 | IA | 10/31/2025 |
UNK |
UNKNOWN MANUFACTURER |
No batch number |
Syringe issue, Underdose
Syringe issue, Underdose
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Vaccine leaked during administration; Partial dose administered; This spontaneous case, initially re...
Vaccine leaked during administration; Partial dose administered; This spontaneous case, initially received on 17-Oct-2025, was reported by a health professional and concerns a patient of unknown age/gender. Concomitant medication and Medical history were reported as unknown. Administration of company suspect drug: On an unknown date, the patient received Fluad (TIV) for an indication not reported, Dose regimen: Not reported, Dose 1, Route of administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient had Vaccine leaked during administration (outcome: Unknown), Partial dose administered (outcome: Unknown). They had a patient who was going to need their Fluad vaccine repeated as the first vaccine leaked during administration. Partial dose administered. Treatment measures associated with event were unknown. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter provided seriousness assessment for events Vaccine leaked during administration, Partial dose administered as unknown and did not provide the causality assessment.; Reporter's Comments: Events Vaccine leaked during administration, Partial dose administered are not related due to nature of events (special situation).
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| 2869671 | 16 | M | 10/31/2025 |
FLU3 MENB MNQ |
GLAXOSMITHKLINE BIOLOGICALS NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
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Dizziness, Headache, Loss of consciousness; Dizziness, Headache, Loss of conscio...
Dizziness, Headache, Loss of consciousness; Dizziness, Headache, Loss of consciousness; Dizziness, Headache, Loss of consciousness
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Post-vaccine administration, patient became lightheaded and lost consciousness for approximately 20 ...
Post-vaccine administration, patient became lightheaded and lost consciousness for approximately 20 seconds. Possible fall? Reported headache after, but also noted that he hadn't eaten all day. Unclear if symptoms were hypoglycemia vs vaccine related ADR.
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| 2869672 | 9 | M | PA | 10/31/2025 |
FLU3 HPV9 |
SEQIRUS, INC. MERCK & CO. INC. |
407001 Z008262 |
Hyporesponsive to stimuli, Pallor, Presyncope, Skin discolouration; Hyporesponsi...
Hyporesponsive to stimuli, Pallor, Presyncope, Skin discolouration; Hyporesponsive to stimuli, Pallor, Presyncope, Skin discolouration
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Onset of near syncope (decreased responsiveness, pallor, dusky lips) approximately 5 minutes after r...
Onset of near syncope (decreased responsiveness, pallor, dusky lips) approximately 5 minutes after receiving vaccinations and while witnessing sisters receive multiple vaccines. Symptoms resolved completely over several minutes with elevation of legs, ice pack, and drinking sips of juice. Normal activity at discharge from the office.
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| 2869729 | 63 | F | OK | 10/31/2025 |
FLU3 FLU3 FLU3 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
33CM4 33CM4 33CM4 |
Asthenia, Burning sensation, Condition aggravated, Decreased appetite, Facial pa...
Asthenia, Burning sensation, Condition aggravated, Decreased appetite, Facial paralysis; Fatigue, Gait disturbance, Herpes zoster, Malaise, Neuralgia; Post herpetic neuralgia, Rash
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Oct 17, 2025, beginning apprx 24 hrs post flu vaccine administration, noticed weakness, extreme fati...
Oct 17, 2025, beginning apprx 24 hrs post flu vaccine administration, noticed weakness, extreme fatigue, generally feeling ill, followed by increase in PHN pain/burning/searing (R), rash starting over dermatome areas affected by the shingles in June (R), facial palsy (R), and difficulty walking d/t nerve pain, decrease in appetite, over the next few days. As it worsened, I inquired about it with an RN at work who suggested that I probably should have opted out (tho I had no way of knowing) and recommended I reach out to my PCP, which I did, and she prescribed Valcyclofir (again as I had in June from hospital physician). My intent/hope of this report is to increase awareness of this potential, promote research (which I would be willing to participate in), so that possible resolutions may be obtained and implemented
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| 2869731 | 5 | M | MI | 10/31/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
33CM4 |
Injection site pruritus, Injection site rash, Injection site urticaria, Injectio...
Injection site pruritus, Injection site rash, Injection site urticaria, Injection site warmth
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Patient developed a deep red circular rash over the entire bicep region of where the shot was admini...
Patient developed a deep red circular rash over the entire bicep region of where the shot was administered. Hives initially presented before turning to a deep red. No pain, but was warm to touch and itchy for multiple days. Patient was utilizing claritin and advised to use a dose of benadryl and pepcid to help with local reaction. Was able to stay at home.
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| 2869733 | 37 | F | OK | 10/31/2025 |
COVID19 |
PFIZER\BIONTECH |
EN6207 |
Bell's palsy, Facial paralysis, Pain, Paraesthesia oral
Bell's palsy, Facial paralysis, Pain, Paraesthesia oral
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Within 24 hours after getting the COVID vaccine I experienced tingling in my lips and tongue. Then ...
Within 24 hours after getting the COVID vaccine I experienced tingling in my lips and tongue. Then the left side of my face quit moving. I went to my primary care facility and was diagnosed with Bells Palsy and started the anti viral medication. Over the next month I was seen again by my primary and also with ENT and my eye doctor. All monitored the progress of my Bells Palsy. I continue today (10/31/2025) with facial paralysis from this event along with pain. I have to see a specialist and physical therapy.
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| 2869734 | 53 | F | NJ | 10/31/2025 |
FLU3 FLU3 FLU3 PNC20 PNC20 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
5R4CY 5R4CY 5R4CY MG7418 MG7418 MG7418 |
Burning sensation, Chills, Decreased appetite, Fatigue, Headache; Injected limb ...
Burning sensation, Chills, Decreased appetite, Fatigue, Headache; Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site warmth, Loss of personal independence in daily activities; Pain, Peripheral swelling, Sleep disorder; Burning sensation, Chills, Decreased appetite, Fatigue, Headache; Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site warmth, Loss of personal independence in daily activities; Pain, Peripheral swelling, Sleep disorder
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In the evening, I felt tired and had lost my appetite. Late in the afternoon, I had chills, a headac...
In the evening, I felt tired and had lost my appetite. Late in the afternoon, I had chills, a headache, body aches, and swelling in my arm. I could not move my arm at all. It was burning inside. I took 1000mg of Tylenol and could not sleep due to severe pain. In the morning, the symptoms were still there. I took 400mg of Ibuprofen. I slept the whole day. I could not function. Late in the evening, I took 1000mg of Tylenol. I woke up during the night with a headache. 36 hours later, in the morning, my arm was warm, red, and itchy in the area of the injection, and I had a headache. I was tired. Today, my arm is still painful, red, and swollen. I woke up during the night with a headache again. I am still tired.
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| 2869736 | 80 | M | FL | 10/31/2025 |
FLU3 PNC21 |
SEQIRUS, INC. MERCK & CO. INC. |
407267 Z006889 |
Dizziness; Dizziness
Dizziness; Dizziness
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Patient reported to rph on 10/31/25 that after his flu and pnuemonia vaccine on 10/15/25 that while ...
Patient reported to rph on 10/31/25 that after his flu and pnuemonia vaccine on 10/15/25 that while driving home (30-40mins after administration) he felt that he was going to pass out during driving. When he arrived home he stated he took his bp and it was normal. Since then he reports having 2-3 other spells like this. Pt not sure if it is being caused by vaccines, his current heart condition (reported recent heart cath and stress test), or his ongoing neck injury (reported injury since 2014).
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| 2869737 | 71 | F | FL | 10/31/2025 |
FLU3 |
SANOFI PASTEUR |
U8862CA |
Erythema, Pain, Skin warm, Swelling
Erythema, Pain, Skin warm, Swelling
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Localized erythema, swelling, warmth and pain approximately 5 inches in diameter within 24 hours of ...
Localized erythema, swelling, warmth and pain approximately 5 inches in diameter within 24 hours of vaccine administration. Possible cellulitis vs differential of allergic drug reaction. Treat with Benadryl 25mg BID, Ibuprofen 800mg BID and Augmentin 875mg BID x 1 week
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