chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was stored in refrigerator on 16 Jun 2022 and administered on 18 Jul 2022; Vaccine administered 30 days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16 Jun 2022 and administered on 18 Jul 2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16 Jun 2022 and administered on 18 Jul 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16 Jun 2022 and administered on 18 Jul 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient had received second booster on 18 Jul 2022.  Number of doses and vials were reported as 6 doses from the same vial 3. The vials were stored in refrigerator on 16 Jun 2022. The vial did not undergo any temperature excursions.  No treatment medication was reported by reporter.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Medical history, concomitant medications and drug reactions or allergies for the patient involved were not reported. The medical assistant reported that on unspecified dates an unspecified number of patients received improperly stored doses of the vaccines listed below: ROTATEQ lot number: M043838 (expiration date: 18-FEB-2018), orally, for prophylaxis (strength and dosage schedule were not provided). RECOMBIVAX HB lot number: N002914 (expiration date: 04-NOV-2019), for prophylaxis (strength, route and dosage schedule were not provided). GARDASIL 9 lot number: N000326 (expiration date: 14-OCT-2019), for prophylaxis (strength, route and dosage schedule were not provided). The storage characteristics were the following: Temperature: 32 F to 35 F (33.69 F) for 601 hours and 47F to 77F (55.63 F) for 15 minutes.  Previous temperature excursion: No. There was digital data logger involved. No adverse effects were reported. Follow-up information was received on 10-JAN-2018 from the medical assistant. The reporter reported that no additional information was available in reference to the event. Additional information is not expected. This case was previously considered valid but per current process it was determined to be non-valid as no patient identifier, therefore it is being sent to distribution for the last time to notify all recipients.
Broken out in hives  all over the body, It was everywhere, big "welts" and is miserable; Itch; Allergic reaction/allergist due the reaction from the shot; Cannot wear clothes, Cannot go out; Rash is severe, Rash is all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broken out in hives  all over the body, It was everywhere, big "welts" and is miserable), PRURITUS (Itch), ALLERGY TO VACCINE (Allergic reaction/allergist due the reaction from the shot), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot wear clothes, Cannot go out) and RASH (Rash is severe, Rash is all over the body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METHOTREXATE, FOLIC ACID, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and TRIAMCINOLONE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Broken out in hives  all over the body, It was everywhere, big "welts" and is miserable), PRURITUS (Itch), ALLERGY TO VACCINE (Allergic reaction/allergist due the reaction from the shot), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot wear clothes, Cannot go out) and RASH (Rash is severe, Rash is all over the body). The patient was treated with PREDNISONE for Itch, at an unspecified dose and frequency and HYDROXYZINE for Itch, at an unspecified dose and frequency. At the time of the report, URTICARIA (Broken out in hives  all over the body, It was everywhere, big "welts" and is miserable), PRURITUS (Itch), ALLERGY TO VACCINE (Allergic reaction/allergist due the reaction from the shot), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot wear clothes, Cannot go out) and RASH (Rash is severe, Rash is all over the body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased (High) Prednisone shot her blood sugar up.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    The patient had a schedule appointment with her allergist due the reaction from the shot. She stated that rash was severe and was an allergic reaction. The rash was all over the body such as scalp, armpits, ears and everywhere on the body except for her feet.The patient reported that it was everywhere and went to dermatologist who started patient on prednisone and cream for her itch; She stated that her symptoms went away and came right back. She stated that she is diabetic, so prednisone shot her blood sugar up. Lab data included  biopsy and blood test with no result.   This case was linked to MOD-2021-254144 (Patient Link).
pt recvd vax 22JUL94 & has been crying & c/o arm pain, t102, c/o stomach ache; pt c/o discomfort of lt deltoid, 9PM vomiting x 2, t102, refused to eat; 23JUL93 c/o stomach ache & refused to eat, t101; Saturday afternoon t104; taken to ER;
Two different issues: swellings and rashes, not to be confused with each other. Swellings: Beginning the evening of patient's first MMR shot (the only first-dose vaccine she had that day), she's had sporadic swellings on various areas of her body. The swellings are puffy, sensitive to pressure, and warm/hot to the touch. She can feel them coming with an itchy sensation that goes away once the swelling appears. The swellings typically last for several hours each, with no residual affects apparent. The locations of the swellings do not include joints or lymph node locations, and seem to be surface-level only; they've shown up on her feet, near her wrist, on a finger, around her hips, on her rear end, etc. Rashes: Seperately from the swellings, she also had a rash show up on her thighs three days after the vaccine. The rash waxes and wanes in feel and appearance and is still evident 2 months later. A similar rash came and went on her knees and inside shins, but isn't still visible. The rashes are/were mild ... tiny red dots you can see and feel, itchy.
Urticaria upper 1/3 of the humerus Triceps 1"x2" enlarge red bump left arm with both swelling and itching c minimal pain. Treatment: HCTC 1% apply tid. Mom gave son Benadryl which help c the swelling in the am also.
Parents had concerns for behavior - very active, racing around, then tipping, "bumping into walls", sleeping a lot, low normal temps in 48-72 hours after vaccines. Pt examined on 1/8, 1/10, 1/13 with normal exams - full PE exam and fully normal coordination, gait, engagement. No studies. No intervention without discussion with immunization dept and reassurance and anticipatory guidance.
Approximately 2 weeks post vax, pt was playing at home then laid on floor unresponsive; eyes rolled up; glazed ; knees drawn up; no jerking at all; lasting for 1 minute.  Pt confused for 1 minute after.  No incontinence, no vomiting. Pt back to normal in few minutes and slept on the way to hospital.
Day 5-6 she had itching all over her body and that has since stopped. Symptoms started on 1/21 with all-over itching and progressed to left-arm itching and redness on 1/22; Circular Rash with diameter of 9 cm  at vaccination site  Left-arm is tender and sore. No fever. Feels slightly chilled and fatigue; Treatment included Benadryl 25 mg and course of Cephalexin 500 mg for 5 days.
10 minutes after receiving vaccine patient fainted.  patient was doing better but then appeared to possibly have a seizure and faint again about 15 minutes after initial event.
1st Dose: No reaction 2nd Dose (Booster): Nausea - Dizzy, could not stand for several hours. Severe Headache, Full body muscle pain. 3rd day symptoms cleared up 85%
Stomach ache; Felt like I had the flu; Sore throat; Feeling hot without having a fever; Nausea; Tiredness; Headache; Hives all over chest; V-shaped rash on both sides of her neck near her lymph nodes; Tight throat; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over chest), RASH (V-shaped rash on both sides of her neck near her lymph nodes), THROAT TIGHTNESS (Tight throat), ABDOMINAL PAIN UPPER (Stomach ache) and INFLUENZA LIKE ILLNESS (Felt like I had the flu) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced URTICARIA (Hives all over chest), RASH (V-shaped rash on both sides of her neck near her lymph nodes) and THROAT TIGHTNESS (Tight throat). On 01-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), INFLUENZA LIKE ILLNESS (Felt like I had the flu), OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Feeling hot without having a fever), NAUSEA (Nausea), FATIGUE (Tiredness) and HEADACHE (Headache). On 01-Jan-2021, URTICARIA (Hives all over chest), RASH (V-shaped rash on both sides of her neck near her lymph nodes) and THROAT TIGHTNESS (Tight throat) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), INFLUENZA LIKE ILLNESS (Felt like I had the flu), OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Feeling hot without having a fever), NAUSEA (Nausea), FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Tylenol (paracetamol),Sudafed (pseudoephedrine) and ibuprofen. No relevant concomitant medications were reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had a really sore throat, fatigue, headache and muscle aches. I took three Covid-19 tests all of which came back negative. My husband was testing positive though.
This spontaneous report was received from a pharmacist via a field representative, concerning an adult female patient in her 60's. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On approximately 11-AUG-2017 (reported as "6-8 weeks ago"), the patient was vaccinated with ZOSTAVAX (lot #, expiration date, strength, dose, route of administration, an anatomical location were not provided), for prophylaxis (reported as "vaccination"); and developed diffuse redness at the injection site, an inch to an inch and a half in diameter, and there the skin was elevated. No treatment was given for the events and it was unknown if laboratory diagnostic studies were performed. No product quality complaint (PQC) was involved. The outcome of the injection site erythema and the skin disorder was unknown. The causal relationship between the injection site erythema and the skin disorder with ZOSTAVAX was not provided. This is one of two reports received from the same source. Sender's Comments: US-009507513-1710USA004038.
8 x 7 cm warm, slightly tender red rash at injection site on left deltoid
38 year old female with no relevant past medical history, currently pregnant G2P0 38 week of gestation came in to the ED complaining of 1 week history of lower extremity weakness. Described as ascending progressive weakness of the lower extremities associated with feet numbness, tingling as well as bilateral hand tingling and left-sided facial weakness for the last three days. She endorses being vaccinated for Influenza, Tetanus and after vaccination had 3 days of self-limited flu-like symptoms. She denies fever, chills, headache, dizziness, visual loss, syncope, SOB, chest pain, palpitations, cough, dysuria, hematuria, abdominal pain, diarrhea, vomiting or any other symptom. 38-year-old right-handed woman with past medical history as listed below who presented to the emergency room complaining of 2-day history of left-sided facial weakness.  She states symptoms came on suddenly.  And she noted that she was having difficulty closing her left eye and smiling on the left side.  She also endorses over the last few days increasing tingling in her feet which is affecting her walking.  She is having trouble ambulating and generally feels weak.  She has also noted some paresthesias in her hands.  She mentions that about 2 weeks ago she had a mild viral syndrome although recovered well.  She has had no recent diarrhea, fevers, or chills.  She denies any radicular pain from her cervical neck region or lumbar region into her hands or feet.  There has been no dysarthria, loss of vision, weakness in her upper extremities, fasciculations, bowel or bladder incontinence, or saddle anesthesia.  She denies any significant breathing difficulties. Patient receiving IVIG with plans to transfer to another hospital for higher level OB care later
first dose, her blood pressure went sky high and it continued to be high; first dose, her heart rate was up; tired; Blood pressure continues to fluctuate daily; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (age at vaccination: 70-year-old) received the first dose of bnt162b2 (BNT162B2, lot EN6198), via an unspecified route of administration in left arm, on 25Feb2021 16:00 as SINGLE DOSE for Covid-19 immunisation. Medical history was none. There were no concomitant medications. On 27Feb2021, her blood pressure went sky high and it continued to be high (reported as medically significant, disability) ending up in urgent care. She doubled her blood pressure medication which she did, she took Carvedilol and she could only take 2 of the double dose at night because she took 2 in the morning. On 27Feb2021, her heart rate was up (135) and felt tired. Her blood pressure continued to fluctuate daily (Feb2021). The patient underwent laboratory tests and procedures which included blood pressure measurement: high, 178/109, 168/98 on 25Feb2021, blood pressure measurement: went down to 60 on unknown date, blood test: negative on heart attack and everything came back negative, blood test: ok on 26Feb2021, blood test: ok on 27Feb2021, echocardiogram: ok, electrocardiogram: ok on 26Feb2021, electrocardiogram: ok on 27Feb2021 (all urgent care to check for blood enzyme for heart attack), heart rate: was up (135) on 25Feb2021. The outcome of the events was unknown.  Information on the lot number was already obtained.
Patient was given vaccine by a different pharmacist on 9/24/17. Patient returned 5 days later complaining of pain in her arm. When asked to show us her arm there was significant bruising with black and blue discoloration. The penetration site of the needle had a sizeable hole much bigger than the needle that was used to give the injection. She also complained of pain when moving her arm around. I asked the patient if she was on any blood thinners which she denied. I informed the patient to seek medical attention if the situation got any worse. I also informed them that they may take OTC ibuprofen for the pain.
Patient received 2 vaccinations on 1-29-2013. Hepatitis A in the right arm and MCV4 in the left arm. Pt stated weakness and swelling in her knee. She stated no injury or slipping or jarring her knee.  Went to therapy (02-1-2013) because there was previous injury to the knee and patient stated the muscle was tight and there was still swelling. He advised to contact PH to report.
Full of energy/has been much better; Full of energy/has been much better; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported for a 66-year-old female patient received the first dose of BNT162b2 (lot: EL3302), via an unspecified route of administration in left arm on 14Jan2021 at single dose for COVID-19 immunization. Medical history included Multiple Sclerosis for 39 years, past few months she has had difficulty walking and moving around. There were no concomitant medications. Last Thursday, 14Jan2021, she received the COVID Vaccine. She woke up the next day full of energy. She went for a walk. She has been much better since having the shot. The events were occurred on 15Jan2021. She would like to say she was hesitant about getting the vaccine. With Multiple Sclerosis, putting foreign invaders in the immune system is risky. The body goes to fight off the invaders and gets confused and fights against the myelin sheath around the nerves and creates damage. She is very careful about vaccines. She does not do well with flu shots. It is pretty incredible how she is feeling since she got the COVID Vaccine. Patient stated it will be hard to get the second dose as things are all messed up there. No further details provided. She has heard of some people getting a whole bottle versus not. She heard some bottles have 1, 2, or 3 doses in them. The outcome of events were not recovered.
This spontaneous report was received from a consumer refers to a person (patient) of unknown age (gender unspecified). On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot number, expiration date and route was not reported). No concomitant medications were reported. On an unknown date, the patient experienced light case of shingles after vaccination with ZOSTAVAX. The outcome of light case of shingles was unknown. This is one of the several reports from the same reporter. Additional information is not expected.
weakness; burning sensation in face and lymph nodes; burning sensation in her eyes; intense headache; pain in ears; body aches; Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 11Apr2021 (at the age of 40-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included endometriosis, hysterectomy, ovaries removed, surgeries (clarifies she actually had 4 total surgeries), severe allergies (had her epi pen with her at the time of the vaccination but everything was fine). The patient concomitant medication included estradiol (ESTROGEL) cream (applies cream every 2 days, intravaginally) via vaginal route taken for oestrogen replacement therapy (had endometriosis and had ovaries removed last year) from on an unspecified date in Feb2020 and ongoing. On 12Apr2021, the patient experienced body aches, chills, fever. On 14Apr2021, the patient experienced burning sensation in her eyes, intense headache, pain in ears, burning sensation in face and lymph nodes. On 15Apr2021, the patient experienced weakness. Calling because she got vaccine on Sunday, 11Apr2021, stated she has been having some reactions, wants to know how long will they last. The next day after the vaccine, she had body aches, chills, and fever. Stated the next day she started out feeling the same and then got a little better, states yesterday 14Apr2021 she had burning sensation in her eyes and lymph nodes and intense headache, stated it's not like a normal headache but it is hard to explain, stated she had pain in her ears, then felt a little better, in the evening yesterday felt the same. Cannot work due to symptoms. Product information: NDC, expiration date and dosage were unknown. Patient stated she does have severe allergies and had her epi pen with her at the time of the vaccination, but everything was fine. No further information provided. Stated previously she did have endometriosis and had ovaries removed, clarifies she actually had 4 total surgeries, had hysterectomy as well, everything prior to vaccine. The patient received acetaminophen and ibuprofen as treatment medication for all the events. Outcome of the event weakness was not recovered, and outcome of remaining events was recovering.  No follow-up attempts are needed. No further information is expected.
No Additional adverse effect reported.; RECOMBIVAX HB and VAQTA that experienced a temperature excursion were administered.; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-JUN-2021, the patient was vaccinated with improperly stored doses of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot #T025374 has been verified to be a valid lot number, expiration date 25-JAN-2023 (dose, route of administration, anatomical location were not reported) and hepatitis a vaccine, inactivated (VAQTA) lot #T036739 has been verified to be a valid lot number, expiration date 22-APR-2022 (dose, route of administration, anatomical location were not reported); both for prophylaxis. Administered doses of vaccines were stored above 9 degree Celsius (9.1 C) for 46 minutes. There was no previous temperature excursions reported. The digital data logger was involved. No adverse effects were reported.
Pt reports rash on right arm and upper torso, as well as peri orbital swelling. Pt was advised to take Benadryl 25mg and visit the emergency room for evaluation.