| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2863897 | 65 | F | SC | 10/07/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
3052154 3052154 3052154 |
Abdominal pain, Chills, Dizziness, Dysphagia, Dyspnoea; Fatigue, Lethargy, Nause...
Abdominal pain, Chills, Dizziness, Dysphagia, Dyspnoea; Fatigue, Lethargy, Nausea, Pain, Sleep disorder; Throat tightness, Vomiting
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Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tig...
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Nausea-Medium, Systemic: Unable to Sleep-Medium, Systemic: Vomiting-Medium, Other Vaccines: VaccineTypeBrand: Fluzon High Dose 2025-2026; Manufacturer: Sanofi; LotNumber: U8859DA; Route: Intramuscular; BodySite: Left Arm; Dose: N/A; VaxDate: 09/29/2025
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| 2863898 | 57 | F | MA | 10/07/2025 |
FLUR4 |
PROTEIN SCIENCES CORPORATION |
tfaa2502 |
Chills, Injection site erythema, Injection site swelling, Pyrexia
Chills, Injection site erythema, Injection site swelling, Pyrexia
|
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, ...
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Additional Details: patient was treated on 9/27 for cellulitis after receiving vaccine 9/26. Patient reported that the technician followed proper aseptic technique protocol since she informed the technician that this has happened to her before after vaccines in the MD office. Technician cleaned area with swab and wore gloves Patient is following up with MD to try to find out why she is getting this type of reaction after vaccinations
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| 2863899 | 23 | F | IN | 10/07/2025 |
COVID19 |
MODERNA |
8146367 |
Dizziness, Fall, Syncope
Dizziness, Fall, Syncope
|
Systemic: Dizziness / Lightheadness-Mild, Systemic: patient fainted and fell down-Mild, Additional D...
Systemic: Dizziness / Lightheadness-Mild, Systemic: patient fainted and fell down-Mild, Additional Details: after giving the flu and covid shot patient fell forward and i fell with her ,we called 911 every thing is ok ,she did not go with 911 just sitting resting til a relative comes and pick her up, Other Vaccines: VaccineTypeBrand: flucelvax; Manufacturer: ; LotNumber: 407000; Route: im; BodySite: left arm; Dose: 1; VaxDate: 10/01/2025
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| 2863900 | 10/07/2025 |
COVID19 |
MODERNA |
|
Palpitations
Palpitations
|
had heart palpitations with the other; This spontaneous case was reported by a non-health profession...
had heart palpitations with the other; This spontaneous case was reported by a non-health professional and describes the occurrence of PALPITATIONS (had heart palpitations with the other) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (had heart palpitations with the other). At the time of the report, PALPITATIONS (had heart palpitations with the other) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not reported. It was reported that patient had inquired whether they can receive Novavax instead as the patient had experienced heart palpitations with the other. Treatment medication was not reported.
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| 2863901 | 74 | M | PA | 10/07/2025 |
FLU4 FLU4 FLU4 FLU4 FLU4 FLU3 FLU3 FLU3 FLU3 FLU3 |
SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR |
U8830DA U8830DA U8830DA U8830DA U8830DA |
Asthenia, Cardiac disorder, Chest discomfort, Chest pain, Chills; Dizziness, Dys...
Asthenia, Cardiac disorder, Chest discomfort, Chest pain, Chills; Dizziness, Dyspnoea, Headache, Injection site pain, Pain; Tachycardia; Asthenia, Atrial fibrillation, Chest pain, Chills, Headache; Heart rate increased, Hypotension, Malaise, Tremor; Asthenia, Cardiac disorder, Chest discomfort, Chest pain, Chills; Dizziness, Dyspnoea, Headache, Injection site pain, Pain; Tachycardia; Asthenia, Atrial fibrillation, Chest pain, Chills, Headache; Heart rate increased, Hypotension, Malaise, Tremor
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Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body A...
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe
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| 2863902 | 69 | F | NY | 10/07/2025 |
FLU4 |
GLAXOSMITHKLINE BIOLOGICALS |
ld9y5 |
Injection site pruritus
Injection site pruritus
|
Site: Itching at Injection Site-Mild
Site: Itching at Injection Site-Mild
|
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| 2863903 | 72 | M | OH | 10/07/2025 |
COVID19 |
MODERNA |
3052030 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient states the injection site began to swell, get red and become painful about 1 week after injection. Prior to that the patient did not experience any issues. Patient also stated the area was warm to the touch. I suggested he reach out to his primary care physician for consultation.
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| 2863904 | 34 | F | MA | 10/07/2025 |
COVID19 |
NOVAVAX |
6315mf002c |
Dizziness, Injection site pain, Nausea, Syncope, Unresponsive to stimuli
Dizziness, Injection site pain, Nausea, Syncope, Unresponsive to stimuli
|
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Un...
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild
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| 2863905 | 62 | F | CA | 10/07/2025 |
PNC21 |
MERCK & CO. INC. |
z006076 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
More
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Inject...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Other Vaccines: VaccineTypeBrand: arexvy; Manufacturer: gsk; LotNumber: 2293b; Route: IM; BodySite: left arm; Dose: 1; VaxDate: 09/23/2025, VaccineTypeBrand: flublok; Manufacturer: sanofi; LotNumber: tfaa2504; Route: IM; BodySite: right arm; Dose: 1; VaxDate: 09/23/2025
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| 2863906 | 76 | F | CA | 10/07/2025 |
FLUA4 |
SEQIRUS, INC. |
407244 |
Oral pruritus, Paraesthesia, Pruritus
Oral pruritus, Paraesthesia, Pruritus
|
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Tingling (specify: fa...
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: as per Patient, itching start shortly after the vaccine, itching in the head and face, around the rim of the mouth. started at 09/27/25. called the pharmacy at 11:30am at 10/01/2025, complaining of persistent itching and tingling in the head area, face and head, but not as sgnificant as previous days. no visible rash, not anywhere in the body.
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| 2863908 | 56 | F | WA | 10/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
9L944 |
Unevaluable event
Unevaluable event
|
Site: Pain at Injection Site-Mild, Systemic: NONE-Mild, Additional Details: NOT an adverse vaccine r...
Site: Pain at Injection Site-Mild, Systemic: NONE-Mild, Additional Details: NOT an adverse vaccine report. Record charting error: vaccine question about using diluent was marked "no" in error. Vaccine was mixed with diluent appropriately and given appropriately per manufacture guidelines.
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| 2863909 | 94 | F | PA | 10/07/2025 |
FLUA4 FLUA4 |
SEQIRUS, INC. SEQIRUS, INC. |
407264 407264 |
Injection site bruising, Injection site erythema, Injection site pruritus, Injec...
Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth; Pruritus, Rash
More
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Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Inject...
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: patient is not sure which vaccine gave her this reaction, she recieved 2 shots within 4 days of each other. was referred to go to urgent care or pcp for follow up. brusing/redness/swelling of arm that is slightly warm to touch with itch, Other Vaccines: VaccineTypeBrand: mnexpike; Manufacturer: moderna; LotNumber: 3052734; Route: im; BodySite: left arm; Dose: 1; VaxDate: 09/25/2025
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| 2863910 | 72 | F | FL | 10/07/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
NA4452 NA4452 |
Injection site erythema, Injection site induration, Injection site mass, Injecti...
Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling; Pruritus
More
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Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection...
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Hard red lump below injection site formed
More
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| 2863911 | 71 | F | RI | 10/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
7hz93 |
Joint injury
Joint injury
|
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe
|
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| 2863912 | 34 | CA | 10/07/2025 |
FLUC4 |
SEQIRUS, INC. |
406983 |
Dizziness
Dizziness
|
Systemic: Dizziness / Lightheadness-Medium, Additional Details: pt had reported experiencing dizzine...
Systemic: Dizziness / Lightheadness-Medium, Additional Details: pt had reported experiencing dizziness from vaccines before. still was ok to get the vaccines. pt felt dizzy post vaccination. pharmacsits was present. offered to call EMS but pt denied stating they will feel better shortly. provided water, pt had a family member get them a chocholate bar. pt felt better and was ambulatory and decided to leave. , Other Vaccines: VaccineTypeBrand: Comirnaty 25-26 covid vaccine; Manufacturer: pfizer; LotNumber: na0587; Route: left arm; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2863913 | 61 | M | NY | 10/07/2025 |
COVID19 |
PFIZER\BIONTECH |
my9548 |
Arrhythmia, Cardiomyopathy, Fatigue, Lethargy
Arrhythmia, Cardiomyopathy, Fatigue, Lethargy
|
Systemic: Exhaustion / Lethargy-Mild, Systemic: cardiomyopathy, arrhythmia-Mild, Additional Details:...
Systemic: Exhaustion / Lethargy-Mild, Systemic: cardiomyopathy, arrhythmia-Mild, Additional Details: patient called on 09/30 to confirm symptoms expereinced after vaccine and to gather information about the vaccine to foward to MD
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| 2863914 | 30 | M | PA | 10/07/2025 |
COVID19 |
MODERNA |
8146367 |
Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope, Un...
Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope, Unresponsive to stimuli
More
|
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Det...
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: covid vaccine was 3rd given and pt became unconscious almost immediately after administration. regained consciousness after approx 45 sec to 1 min. pt has had similiar reactions to vaccine in the past due to severe phobia. we had pt remain seated on the floor for approx 10 min after regaining consciousness, then pt felt well enough to move to chair. pt remained seated in pharmacy area for approx 30 more minutes., Other Vaccines: VaccineTypeBrand: tdap (Boostrix); Manufacturer: gsk; LotNumber: 4ya34; Route: im; BodySite: right delt; Dose: 1; VaxDate: 10/01/2025, VaccineTypeBrand: influenza (Fluarix); Manufacturer: gsk; LotNumber: 2ca5m; Route: im; BodySite: left delt; Dose: 1; VaxDate: 10/01/2025
More
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| 2863915 | F | 10/07/2025 |
COVID19 |
MODERNA |
|
COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
|
mild case of Covid; This spontaneous case was reported by a consumer and describes the occurrence of...
mild case of Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (mild case of Covid) 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 dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (mild case of Covid). At the time of the report, COVID-19 (mild case of Covid) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive. No concomitant medication was reported. Patient got a mild case of Covid after previous vaccines. She had body aches but not as bad as the flu but was not feeling right. Patient bought OTC test and tested positive for Covid. Patient got the virus 6 to 7 months after the vaccines. It was unknown if the patient experienced any additional symptoms/events. Treatment details were not reported by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2025-789795 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789795:Wife case
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| 2863916 | 79 | F | MA | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
u8837ca |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
|
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec...
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
More
|
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| 2863917 | 69 | F | CA | 10/07/2025 |
COVID19-2 |
PFIZER\BIONTECH |
na0587 |
Injection site bruising, Injection site induration, Injection site pain, Injecti...
Injection site bruising, Injection site induration, Injection site pain, Injection site warmth, Pain
More
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: pa...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Additional Details: patient came into pharmacay following morning after vaccine adminstered and showed a tangerine size bruise at the site of injection and states that painful to lift arm , warm to the touch and skin stiffer at the bruised area when touched. she will monitor and will follow up with md if condition worsens
More
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| 2863918 | 11 | F | CA | 10/07/2025 |
COVID19 |
PFIZER\BIONTECH |
na0846 |
Fatigue, Incorrect dose administered, Injection site pain, Lethargy
Fatigue, Incorrect dose administered, Injection site pain, Lethargy
|
Site: Pain at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: patient...
Site: Pain at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Mild, Additional Details: patient received adult dose vs kids dose. patient will turn 12 in less than 2 months
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| 2863919 | 56 | F | CA | 10/07/2025 |
COVID19 |
MODERNA |
3052550 |
Injection site pain, Refusal of vaccination
Injection site pain, Refusal of vaccination
|
Site: Pain at Injection Site-Mild, Additional Details: gave vaccines patient didn't ask for.
Site: Pain at Injection Site-Mild, Additional Details: gave vaccines patient didn't ask for.
|
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| 2863921 | 64 | F | MD | 10/07/2025 |
FLU4 FLU4 PNC21 PNC21 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. |
7CF5M 7CF5M z009681 z009681 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Incorrect route of product administration; Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling; Incorrect route of product administration
More
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injectio...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: PER PATIENT INFORMATION, SHOT WAS GIVEN IN THE RIGHT ARM BUT DOCUMENTED LEFT ARM, PATIENT STATES SX STARTED LIKE 5PM THAT DAY. PATIENT RECEIVED ALL 3 VACCINES ONE SAME DAY., Other Vaccines: VaccineTypeBrand: SPIKEVAX 2025-26; Manufacturer: MODERNA; LotNumber: 3052741; Route: UNKNOWN; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: CAPVAXIVE; Manufacturer: MERCK SHARP & D; LotNumber: Z009681; Route: UNKNOWN; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN
More
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| 2863922 | 70 | F | PA | 10/07/2025 |
COVID19 |
MODERNA |
3052733 |
Extra dose administered, Fatigue, Lethargy
Extra dose administered, Fatigue, Lethargy
|
Systemic: Exhaustion / Lethargy-Medium, Additional Details: I accidentally gave her 2 Mnexpike. She...
Systemic: Exhaustion / Lethargy-Medium, Additional Details: I accidentally gave her 2 Mnexpike. She did say she normally gets sick on every covid vaccine. I told her I would expect her to have covid like symotoms for 24-48 hours in -6-12 hours. There are no issues at this time.
More
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| 2863923 | 60 | F | CA | 10/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
ZT93C |
Bone pain, Chills, Cough, Pyrexia
Bone pain, Chills, Cough, Pyrexia
|
Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Bone pain, strong cough-Severe, Additiona...
Systemic: Chills-Severe, Systemic: Fever-Severe, Systemic: Bone pain, strong cough-Severe, Additional Details: Patient reports that she had a strong reaction to Shingrix that lasted around 2 weeks. She experienced coughing, chills, fever, and bone pain
More
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| 2863924 | 32 | M | AR | 10/07/2025 |
COVID19 |
PFIZER\BIONTECH |
my9548 |
Chills, Flushing, Hyperhidrosis, Seizure, Syncope
Chills, Flushing, Hyperhidrosis, Seizure, Syncope
|
Systemic: Chills-Mild, Systemic: seizure-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-...
Systemic: Chills-Mild, Systemic: seizure-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Additional Details: patient states he has experienced fainting and seizure activity before after given vaccination or giving blood, Other Vaccines: VaccineTypeBrand: flucelvax; Manufacturer: seqirus; LotNumber: 406999; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
More
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| 2863925 | 67 | M | MA | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
u8830da |
Asthenia, Chills, Flushing, Hyperhidrosis, Pyrexia
Asthenia, Chills, Flushing, Hyperhidrosis, Pyrexia
|
Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weak...
Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe
More
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| 2863926 | 51 | M | CA | 10/07/2025 |
FLUR4 |
PROTEIN SCIENCES CORPORATION |
U8832AA |
Hypoaesthesia
Hypoaesthesia
|
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: He says half of h...
Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: He says half of his fingers started feeling numb the day after vaccine given
More
|
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| 2863928 | 64 | M | NY | 10/07/2025 |
FLUC4 |
SEQIRUS, INC. |
407009 |
Injection site erythema, Injection site pruritus, Injection site swelling, Injec...
Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
More
|
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at In...
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: red,warm,itchy-pt said possibly infected but md did not write for antibiotic
More
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| 2863929 | 16 | M | MA | 10/07/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
na0587 na0587 |
Confusional state, Dizziness, Foaming at mouth, Generalised tonic-clonic seizure...
Confusional state, Dizziness, Foaming at mouth, Generalised tonic-clonic seizure, Grunting; Nausea, Syncope, Unresponsive to stimuli
More
|
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespons...
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Mild, Systemic: Seizure-Medium, Additional Details: About 2 minutes after receiving vaccination, patient fainted and had a tonic-clonic seizure for about 10-15 seconds. Patient was grunting and foaming at the mouth during seizure. About 20 seconds later, he became fully conscious and was initially confused and felt nauseous. EMT arrived and mom decided not to bring son to hospital., Other Vaccines: VaccineTypeBrand: fluarix (flu); Manufacturer: glaxosmithkline; LotNumber: 2ca5m; Route: intramuscular; BodySite: left deltoid; Dose: 1; VaxDate: 10/02/2025
More
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| 2863930 | 73 | F | TX | 10/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
342xp |
Injection site bruising
Injection site bruising
|
Site: Bruising at Injection Site-Mild, Additional Details: 1 week post vaccintion patient reported s...
Site: Bruising at Injection Site-Mild, Additional Details: 1 week post vaccintion patient reported she was infected by shingles and was seen doctor the following day to be evaluated
More
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| 2863931 | 76 | M | IL | 10/07/2025 |
COVID19 |
MODERNA |
3052155 |
Arthralgia, Injection site pain, Mobility decreased
Arthralgia, Injection site pain, Mobility decreased
|
Site: Pain at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Me...
Site: Pain at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Additional Details: Possible Sirva, patient claims they can't lift arm and had been 2 weeks since vaccine was administered. Counseled to follow up with md, Other Vaccines: VaccineTypeBrand: fluzone Highdose; Manufacturer: sanofi; LotNumber: U8764dB; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
More
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| 2863932 | 73 | F | NC | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
UT8804AA |
Skin mass
Skin mass
|
Systemic: lump on right buttocks-Mild
Systemic: lump on right buttocks-Mild
|
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| 2863933 | 70 | M | FL | 10/07/2025 |
COVID19 |
MODERNA |
|
Immunisation reaction, Pain in extremity
Immunisation reaction, Pain in extremity
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sore arm; minor side effects/other small things; This spontaneous case was reported by a consumer an...
sore arm; minor side effects/other small things; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and IMMUNISATION REACTION (minor side effects/other small things) in an 8-decade-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and IMMUNISATION REACTION (minor side effects/other small things). At the time of the report, PAIN IN EXTREMITY (sore arm) and IMMUNISATION REACTION (minor side effects/other small things) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. Concomitant medication was not provided. Patient was at high risk and had never had a problem with health. It was reported that patient and the patient's husband received constantly the Moderna vaccine since the beginning of the pandemic from 2021 and was very satisfied as they had only some minor side effects, like sore arm and other small things that were tolerable. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789812 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2025: Live follow-up received and updated narrative and references.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789812:Same patient with different product (husband case)
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| 2863934 | 69 | F | GA | 10/07/2025 |
RSV RSV |
PFIZER\WYETH PFIZER\WYETH |
MN0307 MN0307 |
Dysphagia, Dyspnoea, Dyspnoea exertional, Injection site pain, Pain; Throat tigh...
Dysphagia, Dyspnoea, Dyspnoea exertional, Injection site pain, Pain; Throat tightness, Vision blurred, Visual impairment
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Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allerg...
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Shortness of Breath while walking, difficulty swalllowing, body aches, and her vision is hard to focus-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: on October1, 2025, pharmacy received a voice message from patient stating taht she had received the flu and the RSV vaccines and was having terrible adverse reactions. She wants the pharmacist to call her back to address and report the adverse reactions. The vaccines were given on September 29, 2025. On October 2, I called her and apologized for the adverse reaction that she had had for 2 days. I confirmed she has a history of COPD and the reactions exacerbate the breathing conditions., Other Vaccines: VaccineTypeBrand: Fluzone High-dose 25-26; Manufacturer: sanofi-pasteur; LotNumber: UT8829BA; Route: Intramuscular; BodySite: Left Arm; Dose: ; VaxDate: UNKNOWN
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| 2863935 | 15 | F | IN | 10/07/2025 |
FLU4 FLU4 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
JE74J JE74J |
Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope; Unresponsive...
Dizziness, Flushing, Hyperhidrosis, Loss of consciousness, Syncope; Unresponsive to stimuli
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Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flus...
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient got dizzy after shot and passed out momentarily. patient was assisted to lie down and feet up. EMT were called and she was monitored for blood pressure and breathing. Patient recovered and was able to walk out unassisted.
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| 2863937 | 66 | F | TX | 10/07/2025 |
COVID19 |
MODERNA |
3052034 |
Chills, Pyrexia, Rash
Chills, Pyrexia, Rash
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Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chills-Medium, System...
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chills-Medium, Systemic: Fever-Medium
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| 2863938 | 63 | F | CA | 10/07/2025 |
FLUR4 |
PROTEIN SCIENCES CORPORATION |
u8864ba |
Circumstance or information capable of leading to medication error, Exposure via...
Circumstance or information capable of leading to medication error, Exposure via skin contact
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Systemic: pt moved away from needle, and needle-syringe came out of arm and vaccine liquid squirted ...
Systemic: pt moved away from needle, and needle-syringe came out of arm and vaccine liquid squirted all over arm-Mild, Additional Details: Pt was getting a flu shot and when the needle was inserted/plunger was initially being pushed, pt moved away from needle, which caused the needle/syringe to come out of pt's arm prematurely, causing one dose to be squirted on pt's arm, instead of injected. a 2nd dose (same lot/exp) was given, as pt received almost none of the liquid from the first dose, and the 2nd dose was injected successfully. A note was left on the first syringe, instructing pharmacy staff to damage it out.
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| 2863939 | 86 | F | TX | 10/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4TY55 |
Injection site erythema, Injection site swelling, Rash, Rash pruritic
Injection site erythema, Injection site swelling, Rash, Rash pruritic
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic:...
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Pt came in with rash on her arm on the left arm, she said she noticed it today and that is was itching. She got three vaccines that day and from what I can gather, it seems like that one causing the problem is probably the RSV vaccine., Other Vaccines: VaccineTypeBrand: Fluad; Manufacturer: Seqirus, Inc; LotNumber: 407244; Route: IM; BodySite: Right Deltoid; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: Comirnaty; Manufacturer: Pfizer Pharm; LotNumber: MY9550; Route: IM; BodySite: Left Deltoid; Dose: ; VaxDate: UNKNOWN
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| 2863941 | 77 | F | CA | 10/07/2025 |
COVID19 |
MODERNA |
unknown |
Headache, Oropharyngeal pain, Pain in jaw, Pyrexia
Headache, Oropharyngeal pain, Pain in jaw, Pyrexia
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Systemic: Fever-Severe, Systemic: Sore throat on right side of throat, jaw pain-Severe, Systemic: He...
Systemic: Fever-Severe, Systemic: Sore throat on right side of throat, jaw pain-Severe, Systemic: Headache-Severe
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| 2863942 | 67 | M | CA | 10/07/2025 |
FLUA4 |
SEQIRUS, INC. |
407244 |
Hypoaesthesia, Joint injury, Paraesthesia, Radial nerve compression
Hypoaesthesia, Joint injury, Paraesthesia, Radial nerve compression
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Numbness (specify: fa...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Patient claimed md diagnosed patient with radial impingment but no paper work provided or contact by md. patient can move shoulder joint but has numbing and tingling from elbow down and cannot move hand. Patient give prednisone by emergency room doctor., Other Vaccines: VaccineTypeBrand: Comirnaty 2025-2026; Manufacturer: pfizer; LotNumber: na4452; Route: Intramuscular; BodySite: right arm; Dose: unknown; VaxDate: 10/01/2025
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| 2863943 | 50 | F | NV | 10/07/2025 |
FLUC4 |
SEQIRUS, INC. |
406984 |
Injection site erythema
Injection site erythema
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Site: Redness at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: comirnaty; Manufacturer: pf...
Site: Redness at Injection Site-Mild, Other Vaccines: VaccineTypeBrand: comirnaty; Manufacturer: pfizer; LotNumber: my9550; Route: im; BodySite: right arm; Dose: ; VaxDate: UNKNOWN
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| 2863944 | 51 | F | PA | 10/07/2025 |
FLUC4 FLUC4 |
SEQIRUS, INC. SEQIRUS, INC. |
407010 407010 |
Chills, Injection site bruising, Injection site erythema, Injection site inflamm...
Chills, Injection site bruising, Injection site erythema, Injection site inflammation, Injection site pain; Injection site paraesthesia, Injection site pruritus, Injection site swelling, Insomnia, Joint injury
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Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injec...
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Systemic: Chills-Medium, Systemic: Unable to Sleep-Medium, Additional Details: Patient came in 10/1 to get both covid and flu vaccines. She claims she requested vaccines be given by a pharmacist since she is a cancer patient. Paitent claims she received both vaccines on the same spot (noticing one band-aid). A soon as she received them, she felt pain and tingling on left arm (where she got both vaccines). She reports having pain and chills the past few days, with chils not being present today and pain being present upon touching the area. Area looks red, inflamed, swollen, Other Vaccines: VaccineTypeBrand: Spikevax Moderna COvid; Manufacturer: Moderna; LotNumber: 8146367; Route: IM; BodySite: Left arm; Dose: ; VaxDate: UNKNOWN
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| 2863945 | 70 | F | VA | 10/07/2025 |
FLU4 |
SANOFI PASTEUR |
u8862aa |
Injection site erythema, Injection site swelling
Injection site erythema, Injection site swelling
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Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details:...
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient states has a history of reactions to vaccine. She came in on 10/3/2025 to show us area about size of a tennis ball that was pink in color and said you could feel the area by touch. States this is improved from date of injection. States took benadryl night of immunization. Area is pink in color, not overly warm. States has been improving daily.
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| 2863946 | 50 | F | PA | 10/07/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
93N4J 93N4J |
Decreased appetite, Injection site pruritus, Nausea, Pruritus, Rash; Urticaria
Decreased appetite, Injection site pruritus, Nausea, Pruritus, Rash; Urticaria
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Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-M...
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Nausea-Mild, Additional Details: Pt reported loss of appetite hours after receiving the vaccine (resolved). Pt then experience nausea (resovled) the next day. Then 2 days ago noticed hives along the bilateral forearms.
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| 2863948 | 87 | F | IL | 10/07/2025 |
COVID19 |
PFIZER\BIONTECH |
na0738 |
Extra dose administered
Extra dose administered
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Systemic: none, just duplicate vaccine given-Mild, Additional Details: Patient was given a duplicate...
Systemic: none, just duplicate vaccine given-Mild, Additional Details: Patient was given a duplicate dose of covid vaccine on 10/3/25 at the (withheld name) nursing home. She received a dose from her doctor on 9/22/25 which was not documented in her chart, nor was billed to the insurance from the doctor on 9/22/25. The patient notified pharmacy after the shot was given because she did not remember before hand. It did not show up on the State registry. The primary physicin was called and notified of the duplicate vaccine. (withheld) was the contact at the office.0, Other Vaccines: VaccineTypeBrand: comirnaty; Manufacturer: pfizer; LotNumber: na0738; Route: im; BodySite: ; Dose: ; VaxDate: UNKNOWN
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| 2863949 | 67 | F | HI | 10/07/2025 |
COVID19 |
JANSSEN |
NA0739 |
Injection site erythema, Injection site pain, Injection site pruritus, Injection...
Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
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Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injectio...
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
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| 2863950 | 70 | F | FL | 10/07/2025 |
COVID19 |
MODERNA |
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Immunisation reaction, Pain in extremity
Immunisation reaction, Pain in extremity
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sore arm; minor side effects/other small things; This spontaneous case was reported by a consumer an...
sore arm; minor side effects/other small things; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and IMMUNISATION REACTION (minor side effects/other small things) in an 8-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and IMMUNISATION REACTION (minor side effects/other small things). At the time of the report, PAIN IN EXTREMITY (sore arm) and IMMUNISATION REACTION (minor side effects/other small things) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication information was not provided. The patient was in her 70s. Patient was at high risk and had never had a problem with health. The patient's husband reported that they received constantly the Moderna vaccine since the beginning of the pandemic and was very satisfied as they had only some minor side effects, like sore arm and other small things that were tolerable. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789812 (E2B Linked Report). This case was linked to MOD-2025-789818 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2025: Live follow up received that contains non-significant information includes reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789812:Same report (husband case)
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| 2863951 | 69 | M | CT | 10/07/2025 |
FLUA4 |
SEQIRUS, INC. |
407264 |
Arthralgia, Joint injury, Joint range of motion decreased, Periarthritis
Arthralgia, Joint injury, Joint range of motion decreased, Periarthritis
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Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: customer ex...
Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Severe, Additional Details: customer experienced frozen shoulder pain limited range of motion and followed up with an md
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| 2863953 | 52 | F | FL | 10/07/2025 |
RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
2293B 2293B |
Injection site bruising, Injection site erythema, Injection site mass, Injection...
Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling; Injection site warmth, Joint injury
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Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injec...
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Site: Shoulder Joint Injury (prolonged pain, tingling, etc.)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: THE PT PRESENTED TO THE PHARMACY WITH RED SWOLLEN AREAS ON BOTH ARMS WHERE VACCINATIONS WERE GIVEN. SHE STATES THAT SHE FIRST NOTICED ON WEDNESDAY NIGHT AROUND 11PM (APPROX 5 HRS AFTER INJ). SHE DID TAKE BENADRYL AND TYLENOL BUT NOT MUCH RELIEF WHILE AWAKE. THE AREAS WERE TENDER TO TOUCH, WARM, RED AND HAD KNOTS. THE RIGHT SHOULDER WAS MORE TENDER THAN THE LEFT. , Other Vaccines: VaccineTypeBrand: COVID - SPIKEVAX; Manufacturer: MODERNA; LotNumber: 8146367; Route: IM; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: PNEMONIA - CAPVAXINE; Manufacturer: MERCK SHARP; LotNumber: Z010457; Route: IM; BodySite: LEFT ARM; Dose: ; VaxDate: UNKNOWN, VaccineTypeBrand: FLU - FLUCELVAX; Manufacturer: SEQIRUS; LotNumber: 407009; Route: IM; BodySite: RIGHT ARM; Dose: ; VaxDate: UNKNOWN
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