chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was given cloudy, the vial was still frozen or not thawed properly; A spontaneous report was received from a consumer concerning a 58-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that the vaccine given was cloudy, still frozen and not properly thawed at the time of the administration.  The patient's medical history was not provided. Concomitant medications were not reported.  On 13 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 13 JAN 2021, the patient received first dose of vaccine and reported that the vaccine given was cloudy, still frozen and not properly thawed at the time of the administration. The patient also stated that the pharmacist warmed up the new vial in his hands for couple of minutes.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, the vaccine given was cloudy, still frozen and not properly thawed at the time of the administration, were considered recovered.; Reporter's Comments: This report refers to a case of Product preparation issue for mRNA-1273, lot # 028L20A. There were no reported AEs associated with this case of Product preparation issue.
Patient called clinic at 11:30 AM and reported to nurse practitioner she was experiencing numbness on the left side of her face. NP advised patient to go to Emergency Department. Patient stated she has history of idiopathic anaphylaxis.
The minute I stood up after the vaccine around 5 mins post injection leg felt like I was gonna collapse. I tried to walk couldn't make it found a chair. I saw one of my coworkers there helped me get a wheelchair. I immediately went to the ER Oxygen level was fine, BP elevated and exp heart palpitations. That  afternoon I was able to go home.
pt recv vax  FEB94 & same day pt to ER w/elevated blood pressure, rt side numbness, & muscle weakness;it was reported that muscle weakness resolved in 24hr, but inc BP persisted;1996 pt devel arthritis & in1998 underwent a total hip replace
Patient received oral typhoid vaccine x 4 doses. 48 hrs. after last dose developed chills, felt feverish with sweats, myalgias. Developed rash on trunk today - feels "irritated".
Neuropathy in both feet and right forearm and hand. Substantial memory loss and lack of cognitive function.
Pt was administered 4yr old shots early. Pt was accidentally mixed with sibling. Parent informed staff. Verified that patient wasn't having any kind of reaction. Per immunization tool kit, pt shouldn't have any adverse reactions.  Explained adverse reaction symptoms, ER protocol if needed. MOP was informed that she should follow up with pt's pcm as needed. Pt had no reaction in the clinic. A note was placed in pt's IMR.  Technician is aware of the mix up, and has been briefed on protocols/operating instructions.  It will not happen again.
3 days post vax pt c/o flu-like symptoms; generalized rash 7/28, rash started on neck and went to face; c/o pain in rt ear & jaw; rash extended to trunk; pt recovering
No adverse event; vaccine administered after the published expiry date or 30-day Use by Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after the published expiry date or 30-day Use by Date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after the published expiry date or 30-day Use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered after the published expiry date or 30-day Use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine administered after the published expiry date or 30-day Use by Date).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 15-Nov-2022. The vial did not undergo any temperature excursions. The date of vaccine administration were reported as 11-28, 12-02-22, 12-05-22,12-06-22, 12-08-22.  No treatment drugs were reported.
Information has been received from a physician concerning a 11 year old female with no pertinent medical history, drug reactions or allergies who on 18-JUN-2008 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot #660389/1968U).  There was no concomitant medication.  On 18-JUN-2008, within a minute of receiving the vaccination, the patient experienced a seizure like episode.  While sitting on the examination table the patient became very stiff and her eyes rolled back into her head.  The patient then fell backwards, from the sitting position, onto the examination table.  The patient recovered within two minutes.  The patient was at the office.  Upon internal review, the "seizure-like episode" was determined to be an other important medical event.  Follow-up information was received via phone call from a nurse on 18-JUL-2008.  She reported that no labs were performed.  The patient recovered.  She had no further information to add.  Additional information is not expected.
Bell's Palsy; Enlargement of lymph node; No appetite; High fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol (Tressor for cholesterol), Stress (Takes "stress pills") and Drug allergy (azithromycin (Zithromax)).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever). On 10-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On 05-Mar-2021, LYMPHADENOPATHY (Enlargement of lymph node), DECREASED APPETITE (No appetite) and PYREXIA (High fever) had resolved. At the time of the report, FACIAL PARALYSIS (Bell's Palsy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 10-Apr-2021, she experienced right-sided facial paralysis and was unable to keep her eyes closed. Her doctor subsequently diagnosed Bell's Palsy.  The patient inquired if there were patients who have experienced the same thing.  Action taken with mRNA in respect to the events was not applicable. Concomitant medications included stress pills and tressor for cholesterol. Treatment included prednisone, unspecified antiviral medication and eye drops for the right eye.  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.
My blood pressure was 144/ 75 with a pulse of 122; in evening my blood pressure was still 129/71 with my pulse up to 114 and then say at 11:22 it was 115/ 72 and my pulse this morning was 88; Ringing in my ear; Unable to focus and confused; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Lot number: EW0183, Expiration Date: Nov2021) at the age of 61 years as dose 3 (booster), single for covid-19 immunization.   Relevant medical history included: "I suffered a stroke a brain bleed" (unspecified if ongoing); "I usually have low blood pressure" (unspecified if ongoing). There patient received different concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single), administration date: 2021, for COVID-19 immunization, reaction(s): "very tired", "I was hot", "not feeling good"; Bnt162b2 (dose 2, single), administration date: 2021, for COVID-19 immunization.  The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious) with onset Nov2021, outcome "unknown", described as "My blood pressure was 144/ 75 with a pulse of 122; in evening my blood pressure was still 129/71 with my pulse up to 114 and then say at 11:22 it was 115/ 72 and my pulse this morning was 88"; TINNITUS (non-serious) with onset Nov2021, outcome "unknown", described as "Ringing in my ear"; CONFUSIONAL STATE (non-serious) with onset Nov2021, outcome "unknown", described as "Unable to focus and confused"; IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "booster". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No investigation assessment were done. Regarding prior vaccination (4 weeks): Consumer stated, that she did the first two and then this one. It was over 8 months. No other vaccines. Consumer stated that she took different medication and she does not know them all. Consumer stated, "The reason that she was concerned because she suffered a stroke a brain bleed (history) and usually had low blood pressure, her numbers were usually low for it to be this high. It really concerns because that's not good for her. So, that was her main concern.   Follow-up attempts were completed. No further information was expected.
pt recvd vax; unconsolable crying w/ screaming from 10 am to 6:30pm off and on;difficult to feed;apap given w/out effect;both shot sites extremely tender;no fever;mom called Ped & he feels pt had rxn;
Information has been received from an office manager and a physician concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in October 2016 (reported as "since 01-OCT-2016"), the patients were vaccinated with improperly stored ROTATEQ (dose and route were unknown; lot # L033693 with expiration date 31-MAY-2017 and lot # M012495 with expiration date 09-OCT-2017). The vaccines were exposed under temperature of 30.6 degrees Fahrenheit for 29 hours 30 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax & on next exam 1 1/4" circular depressed area dx as fat & sub Q tissue necrosis due to DTP;
Patient is a 66 y.o. male patient of, MD with history of hypertension hyperlipidemia diabetes mellitus and degenerative joint disease, is known for chronic kidney disease stage III with baseline creatinine 1.4-1.5 and GFR 35-40, previous back surgery, benign prostatic hypertrophy chronic obstructive pulmonary disease, history of psoriasis and erectile dysfunction and is status post left knee replacement is here due to shortness of breath was found to have COVID positive about 2 days ago, hypoxic on arrival to the emergency department today with oxygen saturation at 75 at room air, will maintain oxygen saturation at 4 L nasal cannula, chest x-ray showed no acute findings, noticed also rising creatinine up to 2.0   Acute hypoxic respiratory failure COVID-19 respiratory infection with pneumonia Onset 4 days ago.  Reports being vaccinated x2. CTPA reviewed no PE patchy bilateral nodular groundglass infiltrate noted. Required 2 L O2 while here. Was treated with Decadron and remdesivir, renal dose. Ultimately he was taken off oxygen after 3 days and did well ambulating. Okay to discharge home today, continue isolate for total 10 days since symptom onset.   Acute kidney injury on CKDb Prerenal azotemia COVID mediated Baseline creatinine around 1.5.  Creatinine on admission 2.08. Improving with some hydration. Resume Benicar and hydrochlorothiazide at discharge.    Hypertension Resume Benicar hydrochlorothiazide, amlodipine and carvedilol   Hyperlipidemia On statin therapy   Diabetes mellitus On metformin   Benign prostatic hypertrophy On Flomax
The patient states that the day following the vaccination, she experienced some slight nausea and chills. Within 2 days her face became red, swollen and itchy. The patient's ear lobes and complete bilateral ears became red and swollen after 1 week. The patient was treated with Prednisone.
Got vaccinated, now I have it; Now I have it; I don't sleep; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had strongly about 15 years before).   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: Got vaccinated, now I have it) (serious criteria GSK medically significant), shingles (Verbatim: Now I have it) and insomnia (Verbatim: I don't sleep). The outcome of the vaccination failure was unknown and the outcome of the shingles and insomnia were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and insomnia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and insomnia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-Apr-2023. the patient vaccinated every certain time they had to get vaccinated. The patient got it very strongly about 15 years ago and now he/she had it again. The patient did not sleep, and already took the medications. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
flu; Initial information received on 26-Jan-2023 regarding an unsolicited valid Social-Media Non-serious case received from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who experienced flu  after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In 1984, the patient received a  last dose of suspect Influenza vaccine produced by unknown manufacturer (strength ,dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event Flu (influenza) (unknown latency) following the administration of Influenza vaccine.  It was reported Had 3 Flu shots in my 24 year career 1971/95. Got the flue 3 times once 24 hour once 3 weeks on my back and once put me in the hospital for several days. Last flu shot 1984 last case of flu 1984. Keep your shot, i will stay healthy.  Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
aching all over/ I have a lot of pain, lots of pain; I can hardly move my neck and it goes across my shoulder to the top; I can hardly move my neck and it goes across my shoulder to the top; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 (Lot number: 3-1358A) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Restless legs" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1; Lot number: EL3246; Anatomical site of administration: Left), administration date: 01Feb2021, when the patient was 76 years old, for COVID-19 immunization; Bnt162b2 (Dose 2; Lot number: EL9262; Anatomical site of administration: Left), administration date: 22Feb2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset Oct2021, outcome "not recovered", described as "aching all over/ I have a lot of pain, lots of pain"; MUSCULOSKELETAL DISCOMFORT (non-serious), MOVEMENT DISORDER (non-serious) all with onset Oct2021, outcome "not recovered" and all described as "I can hardly move my neck and it goes across my shoulder to the top". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, musculoskeletal discomfort, movement disorder.  Additional information: The patient called to report side effects from the booster he had yesterday. He was aching all over and can hardly move his neck and it goes across shoulder to the top and all just he has a lot of pain, lots of pain. Patient takes unspecified medications for restless legs. Weight reported as 281 (Further Clarification Unknown). He underwent lab test couple of weeks ago (reported as of the blood whatever that is, they run all the test). No prior vaccination. Expiry Date of COVID 19 Vaccine was Unknown. Reporter seriousness for events was unspecified.  No follow-up attempts are possible. No further information is expected.
Very big bruise on upper arm on the site of injection; This is a spontaneous, reported by pharmacist to Med Communications (reference number: SEQ19-02669), and initially received on 13-Sep-2019, concerning a female patient.   The patient's medical history and concomitant medication were not provided.  On 08-Sep-2019, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, batch number: P100115959, expiration date: 17-Jun-2020, anatomical location: upper arm, route of administration: not reported] for influenza prophylaxis.   On 09-Sep-2019, one day after vaccination, the patient developed a very big bruise on her upper arm at the site of injection. It was not reported whether the patient received any corrective treatment for the event.  On 13-Sep-2019, the patient recovered from the event.  The reporter assessed the case as non-serious, while the causality assessment was not provided.  Company comment: A female patient has experienced injection site bruising associated with Afluria Quadrivalent. Chronology seems plausible. The patient's medical history and concomitant medications were not provided. Route of administration was also not reported. The cause of the event could be attributed to the way the needle was inserted into the muscle of the patient and/or to the expertise of the qualified personnel. Also medical history of the patient could provide more reasonable casualty for the event. With information provided causality is assessed as not related to the product.; Reporter's Comments: Company comment: A female patient has experienced injection site bruising associated with Afluria Quadrivalent. Chronology seems plausible. The patient's medical history and concomitant medications were not provided. Route of administration was also not reported. The cause of the event could be attributed to the way the needle was inserted into the muscle of the patient and/or to the expertise of the qualified personnel. Also medical history of the patient could provide more reasonable casualty for the event. With information provided causality is assessed as not related to the product.
Vaccine Error Kinrix only approved for age 4-6 years old Per the mother: Had 102*F fever for 3 days after the vaccine  Since having the vaccine the infant continues to have the following: Appears more fussy; Sleeping a lot less; No fever currently but feels warm; Seems overall uncomfortable;
Pt was extremely nervous (possible panic attack) about getting the vaccine, then after administration pt reported blacking out, pale skin, blood pressure was low/difficult to take, hyperventilating, tx was sitting and drinking water several minutes. afterwards was able to walk out on his own
Right upper swelled, turned red & hot to touch (vaccines was administered in this arm); hives developed on forehead, chest, & under right arm. Pt fainted swelling was extreme. Went to ER. IV steroids given - symptoms quickly resolved. Mild swelling persists on 6/14.
This spontaneous report was received from a medical assistant via Poison and Drug Center and refers to a female child patient of unknown age. She had no past drug history. The patient's concurrent conditions included allergic rhinitis and asthma. On an unknown date, the patient received first dose of M-M-R II strength reported as "25 mcg neomysin/dose", 0.5 ml, subcutaneously (lot # and expiration date not reported) for her well child check. No information about the patient's concomitant medications was provided. On 23-APR-2016, the patient was vaccinated with the second dose of M-M-R II 0.5 ml, subcutaneously, lot # K005574, expiration date 17-APR-2016. No relevant tests or laboratory data was provided. Additional information has been requested.
Injection was administrated on 6/29/2021. Pain started immediately and continued to grow worse as the days went by. By day 8, 7/7/2021,  I experienced the worst of the symptoms and contacted the Dr.s office.   List of symptoms: sharp stabbing pain while moving arm, unable to lift arm above head and other limited motions, unable to internally rotate arm with out pain, dull pain while not moving, occasional shooting pain down the inner arm with tingling/pins and needles. Extreme soreness at site of injection when touched.   The dr. did not examine or even look at the arm or the area of injection. When I walked in the door she immediately said "there is nothing we can do, this happens all the time because we cant see under your skin and often times we tear a nerve while injecting. It just takes time to heal". She offered no other advice other than ice and over the counter pain killers. When I asked how long I should wait until I get concerned her response was several weeks to months. When I explained that I was a yoga teacher and could not wait several weeks to be able to lift my arm above my head, she had no response. I then told her that I was going to get a second opinion from my pain management specialist, at this point her attitude changed and she wrote me a prescription for max dose Gabapentin. I left feeling like my voice was not heard and that medication was thrown at me to shut me up.   When returning home to write a review of the dr, I pulled up my appointment and it said I was there for a testicle ultrasound. I don't have testicles thus they input another patients information into my medical portal.