| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2842582 | 89 | F | 05/24/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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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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Patient had extreme swelling, redness, pain and itching a few inches below injection site starting t...
Patient had extreme swelling, redness, pain and itching a few inches below injection site starting the day after immunization. As of a week later she still had some redness and a little swelling.
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| 2842583 | 23 | M | IL | 05/24/2025 |
TDAP |
SANOFI PASTEUR |
U8122AA |
Cold sweat, Dizziness, Hyperhidrosis, Loss of consciousness
Cold sweat, Dizziness, Hyperhidrosis, Loss of consciousness
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After donating plasma, donor was given Tdap. He went to observation area and about 3 minutes later ...
After donating plasma, donor was given Tdap. He went to observation area and about 3 minutes later her passed out. He was assisted to the floor by his girlfriend. He was clammy, sweaty and LOC was 20 seconds. His vitals were adequate BP 88/48 Pulse 54, He felt better over 15 minutes with BP 108/70 Pulse 49 and he got up in a chair where he passed out again for 30-40 seconds. He was assisted to floor again in supine position. EMS was called due to his persistent symptoms of dizziness, light headedness. He was transported to a local Hospital He was subsequently was treated and released in the ER. I spoke to him today and he states he is back to his normal self. Alert & Oriented and doing well.
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| 2842584 | 72 | F | CA | 05/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA MODERNA MODERNA |
031M20A 031M20A 031M20A 031M20A 031M20A 031M20A |
Asthenia, Atrial fibrillation, Back pain, Blood cholesterol increased, Blood pre...
Asthenia, Atrial fibrillation, Back pain, Blood cholesterol increased, Blood pressure increased; Blood test, Cardiac imaging procedure, Cardiac monitoring, Cardiac stress test, Condition aggravated; Dizziness, Echocardiogram, Electrocardiogram abnormal, Exercise tolerance decreased, Fall; Fatigue, Headache, Heart rate increased, Hypercholesterolaemia, Malaise; Muscular weakness, Musculoskeletal stiffness, Myalgia, Pain, Palpitations; Paraesthesia, Poor quality sleep, Somnolence, X-ray
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Weakness of whole body especially my legs, headaches, light headed, tingling of my muscles, sleepy, ...
Weakness of whole body especially my legs, headaches, light headed, tingling of my muscles, sleepy, fatigue, body aches, no energy, heart beating faster, and stronger, heart palpitations. My BP was also high. After 7 days, I went to urgent care at facility because I was not feeling well and feeling all the side effects. After the EKG the doctor told me I have AFIB and sent me to ER and was confined for 24hrs. to do more heart test. I asked the attending cardiologist, if the vaccine cause the irregular heart beat because I did not have that before. His reply was it is possible because it is a new vaccine. The cardiologist put me on a 48hrs. heart monitor, did an EKG also. He told me "(redacted) you might be right" I have constant body aches, tingling, light headed, headaches,weakness, fatigue, no energy, muscle pain especially on my legs, arms, and back. One hour after my vaccine, my legs became stiff and felt too weak to carry my body. I also keep falling. My BP is always high and feel my heart beating. I keep going to the ER and many times stay in the hospital for 24 hrs. because of my BP and AFIB. I never had a good night sleep because of my body aches and pain and feeling my heart beating. I cannot take my statins or increase my BP medications because the aches and pain becomes worst and and now my cholesterol is also higher. I have tried different medications and the pain gets worst for months. I was on these medications for almost 20 years without side effects. Now I can have a heart attack anytime. I used to walk almost everyday for about 1 hour but now I cannot do it anymore because I might fall and get tired easily.
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โ | โ | ||||
| 2842585 | 36 | F | NJ | 05/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4n222 |
Incorrect route of product administration
Incorrect route of product administration
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vaccine was given intramuscularly instead of subcutaneously.
vaccine was given intramuscularly instead of subcutaneously.
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| 2842586 | 73 | M | CA | 05/24/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Confusional state, Fatigue, Feeling abnormal, Headache, Pain in extremity; Tremo...
Confusional state, Fatigue, Feeling abnormal, Headache, Pain in extremity; Tremor
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Uncontrollable shaking, confusion, headache, unstable on feet, excessive tiredness, sore arm
Uncontrollable shaking, confusion, headache, unstable on feet, excessive tiredness, sore arm
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| 2842587 | 54 | F | TX | 05/24/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FF2589 FF2589 FF2589 FC3183 FC3183 FC3183 |
Asthenia, COVID-19, Cardiac stress test, Catheterisation cardiac, Chest pain; Di...
Asthenia, COVID-19, Cardiac stress test, Catheterisation cardiac, Chest pain; Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram, Laboratory test; Memory impairment, Post-acute COVID-19 syndrome; Asthenia, COVID-19, Cardiac stress test, Catheterisation cardiac, Chest pain; Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram, Laboratory test; Memory impairment, Post-acute COVID-19 syndrome
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The very night of 9/13/2021 I had chest pain for the first time in my life and it lasted intermitten...
The very night of 9/13/2021 I had chest pain for the first time in my life and it lasted intermittently for over a year with shortness of breath, dizziness and weakness.
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โ | โ | ||||
| 2842588 | 39 | M | NJ | 05/24/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4n222 |
Incorrect route of product administration
Incorrect route of product administration
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vaccine was given intramuscularly instead of subcutaneously.
vaccine was given intramuscularly instead of subcutaneously.
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| 2842589 | 38 | F | KS | 05/24/2025 |
COVID19 |
MODERNA |
3043838 |
Burning sensation, Rash, Rash pruritic
Burning sensation, Rash, Rash pruritic
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patient called 5/24/25 to inquire if her rash on legs, back, rib cage, neck now, lower back upper ba...
patient called 5/24/25 to inquire if her rash on legs, back, rib cage, neck now, lower back upper back, itching/burning rash, has seen the doctor and doctor thought it was environmental before the vaccine, took benadryl but switched to zyrtec, Had rash before the vaccine but new rash(different presentation-per prescribers(same office) whom she saw before and after the vaccine) appeared the same day or the day after getting the vaccine. Patient says had Pfizer covid shots in past without reaction, and this was the first time to get Moderna. reffered patient back to page her doctor because getting worse or go to urgent care (er if more severe symptoms)
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| 2842590 | 13 | F | PA | 05/24/2025 |
HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 TO27784 |
Abdominal distension, Abdominal pain upper, Acne, Alopecia, Altered visual depth...
Abdominal distension, Abdominal pain upper, Acne, Alopecia, Altered visual depth perception; Amnesia, Arthralgia, Back pain, Blood pressure decreased, Blood test; Brain fog, Chest pain, Cyanosis, Disturbance in attention, Dysarthria; Dysmenorrhoea, Dysphagia, Dysphonia, Dyspnoea, Echocardiogram; Electrocardiogram, Electroencephalogram, Endoscopy, Exaggerated startle response, Excessive eye blinking; Eye pain, Fatigue, Flank pain, Furuncle, Gastrointestinal microorganism overgrowth; Hallucination, visual, Head discomfort, Headache, Hydrogen breath test, Hyperacusis; Hyperhidrosis, Hypoaesthesia, Hypotension, Increased need for sleep, Limb discomfort; Loss of consciousness, Loss of personal independence in daily activities, Lymph node pain, Lymphadenopathy, Magnetic resonance imaging head; Magnetic resonance imaging spinal, Monoplegia, Muscle spasticity, Musculoskeletal stiffness, Myalgia; Nausea, Neck pain, Neuralgia, Obsessive-compulsive disorder, Pain in extremity; Pain of skin, Palpitations, Parosmia, Photophobia, Postural orthostatic tachycardia syndrome; Presyncope, Respiratory disorder, Sciatica, Seizure, Sensitive skin; Sensory loss, Skin discolouration, Sleep study, Speech disorder, Staring; Stomatitis, Swallow study, Swelling face, Syncope, Tenderness; Tunnel vision, Ultrasound biliary tract, Ultrasound spleen, Unresponsive to stimuli, Vertigo; Vision blurred, Weight fluctuation, X-ray
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Beginning in August 2022, she began with syncope and presyncope, sweating for no reason, toes turnin...
Beginning in August 2022, she began with syncope and presyncope, sweating for no reason, toes turning purple, extreme fatigue, low blood pressure, nausea, stomach pain and bloating, headaches, etc. . After seeing numerous physicians, she was diagnosed with POTS and SIBO in March 2023. As time went on, fatigue had worsened to the point that she would fall asleep in random places - soccer games, family events, school, etc. She could not be active like a "normal" teenager. She could no longer play sports or make plans with friends. Her life completely changed. In December 2024, she had a respiratory illness and following that, things got so much worse. Since January 2025, she has had episodes of blurry vision, tunnel vision, and pain when moving her eyes. She is sensitive to lights and sounds and has vertigo constantly. She started to faint but not from changing position. Sometimes she gets dizzy sitting. She has had episodes of leg paralysis lasting 20 minutes, she has nerve pain, joint pain, and all over muscle pain. It hurts her to be touched, even gently. She has had staring episodes and recently her first seizure. I have a complete list. ? Extreme Fatigue- Became SOOOOO Much Worse o wiped out after minimal effort- literally cannot walk or stand more than 5 minutes; cannot get dressed, walk upstairs, make food without taking a break. ? Fainting More Frequently and not from changing positions with POTS, not due to low bp or dizziness, literally just collapses o Salt no longer helping ? Chronic Pain o Sore and Achy Back and Neck Pain ? Says There is Never a Time When She is Not in Pain ? Walks Around Like Little Old Lady ? Vision Issues o Blurry Vision, Tunnel Vision, Vison Altered, Seeing Things o `Pain Moving Eyes Up & Down, Back & Forth o Depth Perception seems off o Seems like Walls are Moving in and out ? Vertigo (ER Dr said she had nystagmus 02/25/25) ? Staring Spells More Frequently, 15 plus a day ? Sleep crashes- will fall asleep anywhere and within seconds o soccer game, bedroom doing craft, car after event, home after school ? Paralysis episodes o Feeling like a bar between legs and back, Unable to speak, Unable to raise hand o Two scary episodes of not being able to move her legs from waist down for 20 minutes- could feel me touching her but could not make her legs move ? Swallowing issues o sometimes she feels like her throat is not wide enough o Sometimes she feels like her brain will not tell her to swallow o Sometimes she feels like she doesn?t have enough strength to swallow ? Sensory overload; Sensitive to lights, sounds, smells o Easily overstimulated ? Startles When Being Woke ? Random pain that moves around ? Low Back Pain, tender to touch o Flank Pain- had sharp pain on low right side 03/02/2025 ? Chest Pain; episodes of pain through her upper abdomen to her back ? Nerve pain ? Extreme menstrual pain o recently with some Sciatica pain (02/15/2025) ? Numbness and pain in feet, hands, legs- but hurts ? Dangerously low bp at ER after IV (75/49) saline didn?t improve- was still low when we left (02/25/25) o ER Dr said Normal with POTS (her blood pressure was never this low) ? Heart palpitations ? Purple extremities (usually when cold but had at ER and will just have randomly at home) ? Blue lips at ER ? Bloating (SIBO history) but foods and Salt make her bloated ? Nausea- usually forces herself to eat then feels worse after ? Weight fluctuations o Seems like her weight changes daily ? Frequent Mouth Sores ? Swollen face (Looked puffy 05/01) ? Swollen lymph node in neck (not sure if lymph node but she says it?s been there forever and sometimes it?s tender) ? Medicine sensitivity o Everything makes her feel worse ? Brain Fog/Concentration issues ? Memory Loss- Can?t remember things that just happened ? Hair loss ? Acne and Boils on Face ? Sweating (for no reason; ongoing) ? Can?t feel temp of water with hands; often burns fingers ? Feet super sensitive to temp- feels like boiling water when getting in tub despite being warm) ? Slurring Words (episodes) ? Severe Head Pressure ? Having episodes of OCD (Clicking pen certain number of times, feels like certain things needs to happen) ? Complains of Air Hunger ? Spasticity? Can?t bend fingers to seal Ziploc bag (April 2025) ? Leg Paralysis ? episodes for 20 minutes where can?t move legs from waist down, can feel me touching her but can?t move, says has happened before but not as long 04/08 and 04/13 ? Hurts when gently touched, hugging is often painful ? Touching her scalp gently sends ?shock? down her spine- ? Can?t speak- doesn?t have energy or strength to get her words out , will not respond 05/10/2025 (says this happens often during episodes) ? Says legs are like heavy weights when standing at church ? Having pinching in her knee ? Allodynia- hurts to be touched on skin, gently caressing her and her head sends pain down her back ? Extreme menstrual cramps that caused nerve pain down her back and legs ? Seizure 05/17- nausea, blacked out, followed by convulsions; eyes blinking rapidly, fingers bending/unbending ? Pain worsening- hurts to pick up her phone, hurts to play guitar, hurts to be touched, she ran vacuum on small rug in living room and just pushing it, exhausted her and she felt like she had been lifting weights
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| 2842591 | 19 | M | CA | 05/24/2025 |
VARCEL |
MERCK & CO. INC. |
Y014181 |
Syncope
Syncope
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Syncope,
Syncope,
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| 2842592 | 49 | AZ | 05/24/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Acute myocardial infarction, Coronary arterial stent insertion; Acute myocardial...
Acute myocardial infarction, Coronary arterial stent insertion; Acute myocardial infarction, Coronary arterial stent insertion
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I suffered an NSTEMI Myocardial Infarction days after the second Moderna COVID vaccine was received....
I suffered an NSTEMI Myocardial Infarction days after the second Moderna COVID vaccine was received. A stent was placed into my Widow Maker artery once several consecutive bags of IV Heparin finally caused the cardiac event to stop.
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โ | โ | |||||
| 2842593 | 29 | F | ID | 05/24/2025 |
COVID19 |
PFIZER\BIONTECH |
FH8028 |
Abortion spontaneous, Blood gases, Echocardiogram normal, Heart rate increased, ...
Abortion spontaneous, Blood gases, Echocardiogram normal, Heart rate increased, Muscle spasms
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Chest cramping pain, muscle cramping everywhere even though I drink water, heart beat going up to 18...
Chest cramping pain, muscle cramping everywhere even though I drink water, heart beat going up to 180 bpm just walking to one side of the room, I am an athlete that had just completed a half marathon and full Ironman days & months prior. I lost multiple pregnancies before proper detox, have spent thousands of dollars to try to heal my body, and still dealing with some things, though more livable now.
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| 2842594 | 15 | F | ID | 05/24/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Abdominal pain, Autoimmune disorder, Autoimmune thyroiditis, Biopsy stomach, Con...
Abdominal pain, Autoimmune disorder, Autoimmune thyroiditis, Biopsy stomach, Constipation; Gastrointestinal motility disorder, Hypersensitivity, Malnutrition
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extreme abdominal pain, allergies, could no longer pass stool, paristalsis in my intestines stopped,...
extreme abdominal pain, allergies, could no longer pass stool, paristalsis in my intestines stopped, I now have other autoimmune diseases, hoshimotos, I eat super clean and always chronically nutrient deficient because my stomach doesn't seem to absorb anything.
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| 2842395 | FL | 05/23/2025 |
HPV9 |
MERCK & CO. INC. |
Y015180 |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
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the patient involved did not experience any medical concerns after the GARDASIL 9 was inadvertently...
the patient involved did not experience any medical concerns after the GARDASIL 9 was inadvertently administered; The wrong vaccine was pulled from the refrigerator and administered because of human error; a 2 month old patient was inadvertently administered a dose of GARDASIL 9 today, 5/5/2025, during a routine vaccination appointment when the patient was ordered to receive a dose of VAXNEUVANCE; This spontaneous report was received from an administrator (also reported as "health business professional [HBP]") concerning a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 05-May-2025 (also reported as "today"), the patient was inadvertently administered a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), batch/lot number Y015180 has been verified to be a valid batch/lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration date reported and upon internal verification established as 28-Jan-2027, dose number 1, 0.5 mL administered as prophylaxis (anatomical location and route of administration were not reported) during a routine vaccination appointment when the patient was ordered to receive a dose of 15-Valent Pneumococcal Conjugate Vaccine (CRM197) suspension for injection (VAXNEUVANCE) 0.5 mL as single or four dose series (wrong product administered). Reporter confirmed the patient involved did not experience any medical concerns after Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was inadvertently administered (no adverse event). It was also stated that "the wrong vaccine was pulled from the refrigerator and administered because of human error" (product selection error.) No additional information provided.
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| 2842396 | 05/23/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Stress, Vaccination failure
Herpes zoster, Pain, Stress, Vaccination failure
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Suspected vaccination failure; I got the vaccine and I still have flare ups; Stress brings mine on; ...
Suspected vaccination failure; I got the vaccine and I still have flare ups; Stress brings mine on; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (I have had so many flare ups). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got the vaccine and I still have flare ups) and stress (Verbatim: Stress brings mine on). The outcome of the vaccination failure, shingles and stress were not reported. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and stress to be related to Shingles vaccine. Additional Information: GSK receipt date: 19-MAY-2025 This case was reported by a patient via interactive digital media. Patient indicated that he/she would not wish Shingles on anybody. Patient have had so many flare ups. Patient know when the pain starts. Patient got the vaccine and still had flare ups. Also indicated that they don't last as long and are less painful than before the shot but they were still painful. Patient stated that stress bring patient's on. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles, insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2842397 | MD | 05/23/2025 |
DTAP HIBV |
SANOFI PASTEUR SANOFI PASTEUR |
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No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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inadvertent administration of ActHib and Daptacel to patient after temperature excursion with no rep...
inadvertent administration of ActHib and Daptacel to patient after temperature excursion with no reported adverse event; temp. excursion of ActHib and daptacel occured at 9.6 C for 4 hrs with no reported adverse event; Initial information received on 19-May-2025 regarding an unsolicited valid non-serious Courtesy case received via Merck national service center from a other health professional. This case involves an unknown age and unknown gender patient who had inadvertent administration of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] And Hib (Prp/T) Vaccine [Act-Hib] after temperature excursion at 9.6 c for 4 hrs, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-May-2025 the suspects acthib and daptacel were exposed at 9.6 celsius for 4 hrs with no reported adverse event (product storage error) and on 19-May-2025 patient received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site and on same day patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (strength: not reported) (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization), with no reported adverse event (poor quality product administered) (latency: same day). Information on batch number and expiration date corresponding to the one at time of event occurrence could not be requested. Action taken : not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2842398 | 0.33 | M | NJ | 05/23/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK023AA |
Expired product administered, No adverse event
Expired product administered, No adverse event
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reports that the Pentacel was given to patient past the expiration date with no reported adverse eve...
reports that the Pentacel was given to patient past the expiration date with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from other health professional. This case was linked to other case US-SA-2025SA146684. This case involves a 4 months old male patient who received expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] date with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 14-May-2025, the patient received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (Unknown strength) with lot UK023AA and 30-Apr-2025 via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (Latency same day) Reportedly, the pentacel was given to 3 different patients past the expiration date. The first injection occurred on 30-Apr-2025, the second on 12-MAY-2025 and the last injection was on 14-MAY-2025. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA146684:
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| 2842399 | 0.5 | M | NJ | 05/23/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK023AA |
Expired product administered
Expired product administered
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administration of expired vaccine with no reported adverse event; Initial information received on 15...
administration of expired vaccine with no reported adverse event; Initial information received on 15-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 6 months old male patient who administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-May-2025, the patient received a dose of 0.5 ml of expired suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK023AA and expiry date 30-Apr-2025) (strength not reported) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered) (Latency: same day). Reportedly, Caller reported that pentacel was given to 3 different patients past the expiration date. The first injection occurred on 30-Apr-2025, the second on 12-May-2025 and the last injection was on 14-May-2025. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA142769:
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| 2842400 | MO | 05/23/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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No adverse event, Product preparation issue
No adverse event, Product preparation issue
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administration of diluent from the pentacel without the dry mix/lyophilized component with no report...
administration of diluent from the pentacel without the dry mix/lyophilized component with no reported adverse event; Initial information received on 19-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who administrered diluent from the diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] without the dry mix/lyophilized component with no reported adverse event. Information on the batch number was requested corresponding to the one at time of event occurrence The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of diluent of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization and without the dry mix/lyophilized component with no reported adverse event (single component of a two-component product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, The patient also got the HIB vaccine that same day. Caller asked about re-vaccination of pentacel or recommendations after only diluent was administered. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2842401 | 12 | M | CT | 05/23/2025 |
MEN |
UNKNOWN MANUFACTURER |
U7939AB |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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administration of a menquadfi dose too early with no reported adverse event; Initial information rec...
administration of a menquadfi dose too early with no reported adverse event; Initial information received on 20-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who received meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] too early with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis a vaccine and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation. On 13-Sep-2023, the patient received a dose 1 of suspect meningococcal a-c-y-w135 (t conj) vaccine, and on 14-May-2024 also received an extra dose 2 of same vaccine, both with formulation:Solution for injection, lot U7939AB,expiry date :31-Mar-2026, lot number : U7827AD,expiry date: 30-Sep-2025, strength :standard, frequency: twice, via unknown route in unknown administrative site for immunization, too early with no reported adverse event (extra dose administered) (latency: same day). Reportedly, The first MENQUADFI dose was given on 13-Sep-2023 and then the second one was administered on 14-May-2024. Physician assistant asks if they still needs to give a third dose to the patient or if that second one already counts the full series. Both dose of vaccine were administered by different providers. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2842402 | CA | 05/23/2025 |
HIBV |
SANOFI PASTEUR |
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No adverse event, Product preparation error
No adverse event, Product preparation error
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received the injection that had sterile water instead of diluent with no reported adverse event; Ini...
received the injection that had sterile water instead of diluent with no reported adverse event; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) Vaccine [Act-Hib] that had sterile water instead of diluent with no reported adverse event while receiving vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization, that had sterile water instead of diluent with no reported adverse event (product preparation error) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2842444 | 34 | F | IN | 05/23/2025 |
HEP HEPA TDAP VARCEL |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. |
945660 2345B X449Y Y015558 |
Abdominal distension, Infrequent bowel movements; Abdominal distension, Infreque...
Abdominal distension, Infrequent bowel movements; Abdominal distension, Infrequent bowel movements; Abdominal distension, Infrequent bowel movements; Abdominal distension, Infrequent bowel movements
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Per phone call from patient she is experiencing bloating causing her stomach to come over the waistl...
Per phone call from patient she is experiencing bloating causing her stomach to come over the waistline of her pants and decreased bowel movements since approximately March 30, 2025.
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| 2842445 | 34 | F | IN | 05/23/2025 |
VARCEL |
MERCK & CO. INC. |
Y015558 |
Abdominal distension, Infrequent bowel movements
Abdominal distension, Infrequent bowel movements
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** Please note that Item 5 would not allow me to enter the date the patient reported because it was ...
** Please note that Item 5 would not allow me to enter the date the patient reported because it was before this vaccine. She reported that she noticed the bloating about two weeks after the first vaccines one 3/18/2025 and about two weeks before the second appointment on 4/22/2025, so I entered 4/2025.** Patients reports bloating causing her stomach to come over the waistband of her pants and decreased bowel movements.
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| 2842446 | 2 | M | NC | 05/23/2025 |
MMR |
MERCK & CO. INC. |
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Antibody test, Body temperature increased, Urticaria
Antibody test, Body temperature increased, Urticaria
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Hives all over body, lasted on and off for a month. Was given steroid injection twice, daily Benadry...
Hives all over body, lasted on and off for a month. Was given steroid injection twice, daily Benadryl/Zyrtec. Was prescribed an Epi pen just in case. It started around his forehead with an elevated temperature then it spread.
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| 2842447 | 15 | F | NJ | 05/23/2025 |
COVID19 |
MODERNA |
3043023 |
Underdose
Underdose
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Minor was administered COVID 19 vaccine for 6 to 12 years old dose; minor received half a dose.
Minor was administered COVID 19 vaccine for 6 to 12 years old dose; minor received half a dose.
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| 2842448 | 0.5 | M | MI | 05/23/2025 |
UNK |
UNKNOWN MANUFACTURER |
9D25P |
Wrong product administered
Wrong product administered
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Patient was due for DTAP and was given a combination vaccine. No treatment needed, and patient'...
Patient was due for DTAP and was given a combination vaccine. No treatment needed, and patient's parents were notified
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| 2842449 | 61 | F | WI | 05/23/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
E754F |
Lip swelling, Malaise, Pain, Pyrexia
Lip swelling, Malaise, Pain, Pyrexia
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Experienced high fever on the evening of the vaccine around 6 pm and took aspirin to treat pain and ...
Experienced high fever on the evening of the vaccine around 6 pm and took aspirin to treat pain and fever. On the following day, the patient experienced swelling of the lips and malaise.
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| 2842450 | 18 | F | FL | 05/23/2025 |
MNQ |
SANOFI PASTEUR |
U8361AA |
Chest discomfort, Swelling of eyelid, Urticaria
Chest discomfort, Swelling of eyelid, Urticaria
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patient developed hives, eyelid swelling, chest tightness that occurred the morning after the vaccin...
patient developed hives, eyelid swelling, chest tightness that occurred the morning after the vaccination
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| 2842451 | 74 | F | PA | 05/23/2025 |
PNC20 |
PFIZER\WYETH |
LK6655 |
Injection site rash
Injection site rash
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Patient ended up with a rash on left shoulder cap; above injection site
Patient ended up with a rash on left shoulder cap; above injection site
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| 2842452 | 60 | F | FL | 05/23/2025 |
TD |
SANOFI PASTEUR |
U8492BA |
Confusional state, Dizziness, Loss of consciousness, Syncope
Confusional state, Dizziness, Loss of consciousness, Syncope
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On the evening on May 5, 2025, the donor began to feel lightheaded and had a syncope episode. Donor ...
On the evening on May 5, 2025, the donor began to feel lightheaded and had a syncope episode. Donor was unsure of what time or how long she exactly was unconscious for. Donor stated she woke up on the floor and was confused as to what happened. Donor did not have any injuries related to this event, and did not call 911 or receive any outside medical care. Donor stated she felt fine afterwards and continued as normal. Donor was evaluated on May 10, 2025, no injuries or symptoms were present. The donors' immunization injection site appeared to be healed, with no signs of swelling, infection, or bruising. Donor did not have any pain on the injection site. Donor later stated that she has a history of syncope episodes. however, she was unsure if previous syncope episodes were caused by donations or other unrelated factors.
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| 2842453 | 90 | F | NC | 05/23/2025 |
COVID19 |
MODERNA |
3042914 |
Hypoaesthesia, Mobility decreased
Hypoaesthesia, Mobility decreased
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NUMBNESS IN LEFT HAND/FINGERS, NO PAIN, DIFFICULT TO MAKE FIST, STARTED SAME DAY AS VACCINE
NUMBNESS IN LEFT HAND/FINGERS, NO PAIN, DIFFICULT TO MAKE FIST, STARTED SAME DAY AS VACCINE
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| 2842454 | 49 | F | CO | 05/23/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect route of product administration
Incorrect route of product administration
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Vaccine administered IM rather than SQ as recommended.
Vaccine administered IM rather than SQ as recommended.
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| 2842455 | 45 | M | MN | 05/23/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA MODERNA |
038C21A 038C21A 038C21A 038C21A |
Back pain, Balance disorder, Blood testosterone free, Blood thyroid stimulating ...
Back pain, Balance disorder, Blood testosterone free, Blood thyroid stimulating hormone, Brain fog; Differential white blood cell count, Disorientation, Electrocardiogram, Full blood count, Glycosylated haemoglobin; Headache, Lipids, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test; Neck pain, Scan with contrast, Ultrasound Doppler, Vision blurred, Vitamin B12
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Loss of balance, brain fog, vision issues (inability to focus when moving), headache, spatial disori...
Loss of balance, brain fog, vision issues (inability to focus when moving), headache, spatial disorientation, Neck/back pain
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| 2842457 | 48 | F | 05/23/2025 |
COVID19 |
MODERNA |
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Headache, Pain
Headache, Pain
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Severe body pain and headache
Severe body pain and headache
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| 2842458 | 4 | M | CA | 05/23/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5G23D |
Extra dose administered
Extra dose administered
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Father came in with patient to receive 4 year old vaccines to start school. Pulled up Vaccine Regist...
Father came in with patient to receive 4 year old vaccines to start school. Pulled up Vaccine Registry and reviewed due vaccinations. I mis- interpreted a date on the vaccine schedule. During the visit I read and interpreted needing 4th dose of polio, 5th dose of Dtap, and 2nd dose for MMR and Varicella. I did not properly check that last dose of Dtap was given 2/21/25. I gave child 5th dose of Dtap too close to prior dose resulting in an invalid dose. I was not sure why Vaccine Registry was not counting the vaccine, it was not until I verified with a resource that I understood where I had made my mistake. Contacted parent and advised that an additional dose will be needed to complete the series.
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| 2842459 | 73 | M | FL | 05/23/2025 |
PNC21 RSV TDAP VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y013009 AE435 7KD5B MG5s9 |
Meningitis; Meningitis; Meningitis; Meningitis
Meningitis; Meningitis; Meningitis; Meningitis
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patient's family came back after about a month and saying that patient was admitted to a hospit...
patient's family came back after about a month and saying that patient was admitted to a hospital for a week and was discharged the day before. Patient's family member believed that the patient got meningitis because he received 4 vaccines at the same time a month prior to
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| 2842460 | 4 | F | VT | 05/23/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Product preparation issue
Product preparation issue
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Was given triple the dose that was recommended and it was not diluted
Was given triple the dose that was recommended and it was not diluted
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| 2842461 | 37 | M | CO | 05/23/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Anaphylactic reaction, Rash
Anaphylactic reaction, Rash
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anaphylaxis, diffuse rash,
anaphylaxis, diffuse rash,
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| 2842462 | 75 | F | FL | 05/23/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EN6205 EN6205 |
Blood test, Condition aggravated, Electromyogram, Epstein-Barr virus infection r...
Blood test, Condition aggravated, Electromyogram, Epstein-Barr virus infection reactivation, Fatigue; Neuropathy peripheral, Oral herpes
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Herpes lesions upper lip and mouth and extreme fatigue the next day. Activation Epstein Barr diagn...
Herpes lesions upper lip and mouth and extreme fatigue the next day. Activation Epstein Barr diagnosed April 8, 2025. Severe neuropathy diagnosed April 23, 2025.
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| 2842463 | 70 | F | CT | 05/23/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
93N4J 93N4J |
C-reactive protein, Full blood count normal, Injection site mass, Laboratory tes...
C-reactive protein, Full blood count normal, Injection site mass, Laboratory test normal, Metabolic function test normal; Paraesthesia, Tremor
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When seen on May 22, 2024, almost one month from the date of vaccine, patient still has a visible ra...
When seen on May 22, 2024, almost one month from the date of vaccine, patient still has a visible raised nodule at the site of the vaccine, approximately 3x3 cm (photo taken). She also has had tingling and a fine tremor below her left eye and of her left arm from shoulder to fingers that began about 2 weeks after vaccine administration
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| 2842464 | 25 | F | TX | 05/23/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
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No adverse event, Underdose
No adverse event, Underdose
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No adverse events noted.
No adverse events noted.
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| 2842465 | 35 | F | CO | 05/23/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0591 |
No adverse event
No adverse event
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SHE HAD NO ADVERSE SYMPTOMS WHEN WE CHECKED WITH HER.
SHE HAD NO ADVERSE SYMPTOMS WHEN WE CHECKED WITH HER.
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| 2842466 | 79 | F | OK | 05/23/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
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Injury associated with device
Injury associated with device
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Needlestick injury due to incorrect use of safety device after administration. Individual immunizing...
Needlestick injury due to incorrect use of safety device after administration. Individual immunizing was the only one injured.
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| 2842467 | 20 | M | WA | 05/23/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
U8665EA U8665EA |
Chest X-ray normal, Chest pain, Electrocardiogram ST segment abnormal, Electroca...
Chest X-ray normal, Chest pain, Electrocardiogram ST segment abnormal, Electrocardiogram ST segment elevation, Headache; Sinus bradycardia, Troponin, Visual impairment
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Experienced sudden onset L side chest pain radiating down L arm, and L eye vision changes at around ...
Experienced sudden onset L side chest pain radiating down L arm, and L eye vision changes at around 0630 in the AM after receiving Southern Hemisphere Flu shot the afternoon prior. SX intermittent. He had a concerning EKG showing sinus bradycardia and nonspecific changes. Repeat EKGs were consistent. He went to the ER twice for these SX. on 20MAY and 22MAY. He went back the second time due to added SX of headache. Chest Xray was unremarkable. Troponin 18-- >13. Given these findings consulted cardiology who evaluated patient and advised symptoms are most likely due to benign ventricular repolarization, with pertinent J point elevations and concave ST segments present. Cardiology recommended follow-up with PCP and if symptoms are persistent to consider outpatient cardiac work-up including Holter monitor, stress test, and echocardiogram.
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| 2842468 | 24 | F | AZ | 05/23/2025 |
HPV9 |
MERCK & CO. INC. |
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Extra dose administered
Extra dose administered
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Client had a foreign IZ record; I missed HPV immunization entry during the allotted time for this ap...
Client had a foreign IZ record; I missed HPV immunization entry during the allotted time for this appt. I believed the entries on the record were correct; then I looked to the foreign record and then I realized that the client had already two doses. Client was notified at that moment and verbalized understanding.
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| 2842469 | 46 | F | WA | 05/23/2025 |
COVID19 FLU3 VARZOS |
MODERNA SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS |
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Injection site cellulitis, Injection site induration, Injection site pain, Injec...
Injection site cellulitis, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth; Injection site cellulitis, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth; Injection site cellulitis, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
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Transient cellulitis (flesh swollen, painful, hot to touch, flesh hardened and inflexible) across an...
Transient cellulitis (flesh swollen, painful, hot to touch, flesh hardened and inflexible) across and surrounding all three injection sites and expanded out an additional 1.5" in all directions (upward and downward from the row of injection sites, and out laterally in both directions from the outside injection sites). Cellulitis developed in the space of a few hours, and remained painful for more than 10 days. Hardened area started moving downward from the row of injection sites (as if pulled downward through the tissues by gravity) after the third day, and gradually decreased in size (area at and under the skin slowly shrinking) until finally regaining normal tissue texture/flexibility, normal tissue color/temperature, and no longer causing discomfort by the 12th or 13th day.
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| 2842470 | 51 | F | CA | 05/23/2025 |
COVID19 |
MODERNA |
3043 |
Dyspnoea, Pain, Pain in extremity, Pyrexia
Dyspnoea, Pain, Pain in extremity, Pyrexia
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On 5/16/2025, the patient reports symptom of fever of 100.6 degrees Fahrenheit at 0200, which resolv...
On 5/16/2025, the patient reports symptom of fever of 100.6 degrees Fahrenheit at 0200, which resolved when they woke up for work at 0900. The patient reports symptoms of arm soreness and body aches. The patient also reports shortness of breath, which they described as "taking a breath that felt different than normal". The patient reports that the shortness of breath immediately resolved after the episode and that no other episodes occurred. On 5/17/2025, the patient reports that symptoms of arm soreness and body aches resolved without requiring medical intervention. The patient reports not taking any medications or seeking medical attention for symptoms. On 05/19/2025, the patient reports no other symptoms.
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| 2842471 | 31 | M | CO | 05/23/2025 |
TD |
SANOFI PASTEUR |
LN0591 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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THIS PATIENT HAD NO ADVERSE SYMPTOMS. ADMINISTERED COVID-19 VACCINE INTERVAL ONE WEEK APART 2ND DOS...
THIS PATIENT HAD NO ADVERSE SYMPTOMS. ADMINISTERED COVID-19 VACCINE INTERVAL ONE WEEK APART 2ND DOSE. THIS IS NOT RECOMMENDED DOSE.
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| 2842472 | 30 | M | WA | 05/23/2025 |
HEP MMR |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
T5D73 Y010046 |
Nausea, Syncope; Nausea, Syncope
Nausea, Syncope; Nausea, Syncope
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nausea, brief vasovagal syncope. Pt has experienced similar symptoms with blood draws/immunizations....
nausea, brief vasovagal syncope. Pt has experienced similar symptoms with blood draws/immunizations. Pt also noted to be in a fasting stage. Pt given water and food, recovered from symptoms very quickly
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| 2842473 | 24 | M | WA | 05/23/2025 |
JEV1 JEV1 UNK UNK |
INTERCELL AG INTERCELL AG UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
JEV23K07E JEV23K07E U8665EA U8665EA |
Chest X-ray normal, Chills, Electrocardiogram normal, Laboratory test normal, Mu...
Chest X-ray normal, Chills, Electrocardiogram normal, Laboratory test normal, Musculoskeletal chest pain; Pain, Pyrexia; Chest X-ray normal, Chills, Electrocardiogram normal, Laboratory test normal, Musculoskeletal chest pain; Pain, Pyrexia
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Developed left side lower chest wall pain on 22MAY that woke him up. Received southern hemisphere fl...
Developed left side lower chest wall pain on 22MAY that woke him up. Received southern hemisphere flu and JE-VC vaccines on 19MAY and had reported fever, chills and body aches since. Went to ER and had labs, EKG and chest Xray which were unremarkable. He was given Toradol injection and Lidocaine patch.
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