chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At which point in the process the medication error occurred: Storage in clinical Practice; No additional adverse effects; Expired dose of VAQTA was administered to a patient / Give vaccine 6 days expired; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-OCT-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot number U024378 has been verified to be valid for hepatitis a vaccine, inactivated [VAQTA], expiration date reported and confirmed as 22-OCT-2022) (dose and route of administration not reported) as prophylaxis (Expired product administered). No adverse event was reported.  This is a non-valid case due to the lack of patient identifiers  Follow-up information has been received from the physician on 25-APR-2023.  The patient was a male of an unknown age.  He was vaccinated at his deltoid (it was not specified which side). The point in the process the medication error occurred was reported as: Storage in clinical Practice (Product storage error). No intervention was needed due to the event, the reporter only contact the Company line.  The reporter considered the event of Expired product administered (previously reported) as medically significant.
Shaking in the left hand/actual hand shakes; Twitching/left arm twitching and shaking in certain positions; Numbness in her leg; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 24-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0198), via an unspecified route of administration, administered in Arm Left on 27Jul2021 (at the age of 24-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE) taken for an unspecified indication, start and stop date were not reported. Caller said that she has another med that she takes has another medication that was already approved by her eye specialist for an eye condition, and she approved for her to get vaccine and said that med was ok and CDC said approved. She said she does not think that the medication was relevant, it was Mycophenolate. No further details provided about this medication. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0198) via an unknown route of administration on 06Jul2021 (at the age of 24-years-old) as dose 1, single for COVID-19 immunisation. Consumer calling about Pfizer-BioNTech COVID-19 vaccine, who said she recently got her second dose on 27Jul, which was about 3 days ago. She said that last night or early this morning she noticed on Jul2021, her arm was twitching and shaking when she would hold it in certain positions, and that her actual hand shakes, and she has never experienced that before. Caller was asking for any recommendations on treatment. Caller said it seems like the twitching and shaking has stayed about the same. though it was twitching and shaking more frequently when she holds her hand in that position. She said it started now randomly in middle of the night or early this morning between 01:00 to 02:00. Therapeutic measures were taken as a result of shaking in the left hand/actual hand shakes, twitching/left arm twitching and shaking in certain positions. Caller further stated that she had done no treatment since she did not know what to do which was why she called. She said she has been taking Tylenol. No further details provided about this medication. The outcome of the events was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Physician Discharge Summary   Patient ID:   94 y.o.    Admit Date:  7/29/2022   Discharge Date: 8/2/22   Principal Dx/ Final Dx: Acute hypoxemic respiratory failure   Relevant Inpt Dx: Principal Problem:   Acute hypoxemic respiratory failure Active Problems:   Bronchiectasis without complication   Generalized weakness   COVID-19 virus detected       HPI:   Hospital Course:   This elderly woman was admitted with weakness.  She had cough and sob.  This was felt to be due to a combination of covid and a flair of bronchiectasis.  She was treated with remdesivir and steroids and antibiotics and is improved.  She still has some rhonchi today but air movement is better.  She will taper steroids and complete antibiotics orally.  Her oxygen saturation this am is 99% on 2 liters oxygen and she will be assessed off of oxygen before discharge.  Follow up with pcp.              Consults:   IP CONSULT TO SOCIAL WORK       Disposition:  SNF   Discharge Condition:  fair
I have never suffered from hives in the past and now I am getting them on a monthly basis, in addition I at first I had serious shingle belts across my body and arms, less so now but still present each month. It would appear that my immune system has been compromised as I now have allergies, which I did not have in the past.
Multiple satellite lesions to left arm.  Also had auto-inoculation to left ear.  Recovered without complications.
presented with n/v x 4 days; fatigue, weakness; Covid + in ED; admit with Covid PNA; tx with Vit C,  maxipime, actemra, rocephin, Vit D3, steroid, doxycycline, suppelemental O2; HD initiated 9/3; Disposition:She will be dischargedtommorrowtohome with home health
Redness and swelling below injection sight to elbow covering inside of arm from side to side ,   very warm to the touch.  Returned to  pharmacy where the druggist looked at it and said to take Benadryl and keep an eye on it.  She advised me to file the report.  Swelling and redness appear to be subsiding.
Information has been received from a registered nurse concerning a 30 month old male with no pertinent medical history and no known allergies who on 12-AUG-2006 was vaccinated with Vaqta (lot #654337/0510f) 0.5 mL intramuscularly in the left leg. There was no concomitant medication. This was the patient's first dose of Vaqta. On 15-AUG-2006 the patient presented to the doctor's office with red splotches over his body. The child did not seem to be ill or in distress and had no fever. Oral diphenhydramine hydrochloride (BENADRYL) was administered. The patient's red splotches over his body persisted at the time of reporting. There was no product quality complaint involved. The nurse reported that intervention to prevent serious criteria (Other Important Medical Event) was needed for the event. Additional information has been received from the physician indicating that the patient woke on 15-AUG-2006 with the splotchy red rash/urticarial rash and was not sick. The physician was unsure whether the rash was related to the Vaqta or "either food, drug, vital exposure." The patient recovered. It was now reported that the event did not require medical or surgical intervention to prevent serious criteria. Additional information is not expected.
Client received VARIVAX via intramuscular route instead of subcutaneous route when getting her Kindergarten shots. CDC hot line called. Public Health Specialist at CDC stated the dose would not have to be repeated. Client had no reaction to the shot.
Information has been received from a health professional concerning a female patient with chronic fatigue who on 07/21/2000 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  On 08/04/2000 the patient's diagnosis included photophobia, fever, macular body rash and mild congestion.  In October 1000, the patient developed aches, weakness, path of red rash and increased photophobia.  The physician diagnosed "no joint involvement, non-infectious measles reaction to the vaccine."  The patient started ibuprofen and rest and experienced gradual improvement over the next few days.  In January 2001, the patient developed dermatitis to the eye, and "the physician did not find vaccine involvement".  The patient continues to have symptoms/disease such as chronic fatigue.  Unspecified medical attention was sought.  Additional information has been requested.
Pt experienced swelling and rash on left side of neck and head. Rash spread towards the right side of head. Patient also experienced general weakness, diarrhea and could not sleep.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient did not received a complete dose of ZOSTAVAX lot # N009777, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). Some ran down to the patient arm. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored RECOMBIVAX HB lot # J004700, Expiry date, 20-NOV-2015, K019502, expiry date 04-FEB-2016. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Soreness of right arm, stiffness of muscles on the right side of my neck, headache on the back side of my head temperature as hi as 103.2  swollen lymph nodes in right armpit
very high fever 104 degrees/low grade fever (99/100 degrees); speech has been slurred; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 4-year-old male patient received BNT162b2 (BNT162B2), on 22Aug2022 at 17:00 as dose 2, single (Lot number: FT9142) at the age of 4 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: yes. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FT9142, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 01Aug2022, when the patient was 4-year-old, for Covid-19 immunization. The following information was reported: DYSARTHRIA (non-serious) with onset 23Aug2022 at 16:30, outcome "recovering", described as "speech has been slurred"; PYREXIA (non-serious) with onset 23Aug2022 at 16:30, outcome "recovering", described as "very high fever 104 degrees/low grade fever (99/100 degrees)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: It was reported that, almost exactly 24 hours after the shot his son had a very high fever 104 degrees and fever reducers (tylenol & advil) at times only brought it down to 103 so they had to use ice packs to lower his fever in addition to the fever reducers. His fever lasted 32 hours and he then had a low grade fever (99/100 degrees). they noticed the day after his fever that his speech had been slurred. Patient recieved treatment fever reducers. Patient had covid prior vaccination. Patient did not test covid positive post vaccination no. Patient has no known allergies. Patient had no other vaccine in four weeks. Patient had no other medications in two weeks.
Diarrhea; upset stomach; nausea; fatigue; fever; This is a spontaneous report from a contactable pharmacist, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: El3248), via an unspecified route of administration in the left arm on 19Jan2021 at 10:45 (at the age of 50-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none; the patient had no known allergies. The patient was not diagnosed with COVID prior to the vaccination. Concomitant medications included unspecified multivitamins. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Ek5730) on 30Dec2020 at 10:30 (at the age of 50-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks of the vaccination. On 19Jan2021 at 16:00, the patient experienced diarrhea, upset stomach, nausea, fatigue and fever. The patient did not receive treatment for the events. Since the vaccination, the patient was not tested for COVID. The clinical outcome of diarrhea, upset stomach, nausea, fatigue and fever was resolving.
ITCHY RASH, BURNING ON UPPER ARM. NO FEVER, FELT WEAK.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of with GARDASIL 9 from lot# M032650 with expiry: 31-MAR-2019; M041990 with expiry: 28-JAN-2019, and L043213 with expiry: 28-AUG-2017, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursion of -1.7 degree Celsius for 1 hour and 10.8 degree Celsius for 2 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001439.
Pharmacy sent the two vials of Shingrix up to the unit nurse to mixed up and administered to the patient. The nurse ignored directions labeled on the bag containing the vaccine when she was preparing to mix the vaccine. Instead of using the provided diluent, she drew up one milliliter of normal saline and used that to reconstitute the vaccine. She then drew up the vaccine which was improperly diluted with normal saline and administered it to the resident. The error was discovered when pharmacy staff was collecting medications to be relabeled or discontinued and noticed the diluent vial was still remaining in the fridge.
REDNESS AT INJECTION SITE; SWOLLEN PATCH AT INJECTION SITE; HEAT AT INJECTION SITE; FEELING UNWELL; DIZZINESS; TIRED; NAUSEA; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A211, and batch number: 206A211 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced feeling unwell. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced heat at injection site. On 13-APR-2021, the subject experienced redness at injection site. On 13-APR-2021, the subject experienced swollen patch at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, feeling unwell, tired, and nausea on APR-2021, and had not recovered from redness at injection site, heat at injection site, and swollen patch at injection site. This report was non-serious.
Starting three days after my second vaccine dose and lasting for three terrifying months, I had number of severe neurological issues, including migraines, swelling in my head, blurred vision, heart palpatations, and near daily panic attacks. I was completely debilitated and had no way of knowing if I would ever recover. After running a number of other tests to rule two conditions out, a doctor put two and two together with the vaccine date and told me there was essentially nothing she could do and not enough data yet to know what would happen next. I understand the government wanted to vaccinate as many people as possible against Covid, and of course also understand why they wanted to do that, but it was simply a lie to say that there would be no serious medical complications. Anyone with a medical background could have known that latent autoimmune conditions might be triggered by a vaccine designed to generate an immune response, and not disclosing this has made it completely and totally irrevocably and forever impossible for me to trust what any government body says.   And for people who never did trust what the government said and wouldn't get the vaccine? Instead of offering them *free doughnuts* try looking closer to home. You've developed a for-profit system that truly cares for almost no one and bankrupts people. I'm 34 and none of my friends or I would call an ambulance in an emergency because of the cost. People don't get surgeries they need because of the cost. And now you want people to trust this system?   There is zero excuse in this country for not using taxpayer money to give everyone health insurance. I am a freelance writer with fluctuating income and have attended two graduate schools for the past six years. The idea that I could even have a primary doctor is laughable. Everything that happened this summer was terrifying enough, but to do so in a country where I didn't 1. have a real relationship with a doctor, because I can't and 2. without knowing if I would bankrupt myself getting medical tests and care or calling an ambulance on the nights I thought I was having an aneurysm brought this summer into the realm of the dsytopian.
Bruising that grew at injection site with redness that developed into larger and larger slightly raised rash over upper arm - very tender and warm to the touch on skin and painful down into arm for several days. Rash was itchy as well from days 2 through 6. Bruising spread about 2.5 inches out and is yellow in color on day 6 - still slightly tender to the touch. Upper arm was stiff down to elbow joint if not moved enough over days 1 and 2.
31yo female presents to the ED for evaluation of elevated HR earlier today. Pt was given the 2nd Phizer vaccination today at the clinic here in the hospital and was sent to the for the tachycardia and feeling light headed. Denies prior vaccine reaction. No chest pain or SOB. Symptoms improved slightly on arrival. No nausea, vomiting or headache. Denies rashes or pruritus.  Assessment:  31yo female presents to the ED for evaluation of palpitations after 2nd dose of pfizer vaccine. 126/69  82  16  36.5C  Differential diagnosis:  Tachycardia, dehydration, stress reaction, vaccine reaction EKG Interpretation: normal sinus rhythm, no ischemic changes  ED Disposition: Discharge.
High platelets (over 1000; unit was not provided); This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for two patients. This is the first of the two reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had high platelets (over 1000; unit was not reported). The outcome of the event, high platelets, was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022206 same reporter/drug/events, different patient
High fever (up to 103.4). Patient refusing to eat any solid foods or take bottle, only wishing to nurse, for 2 days now.  Patient developed rash of tiny red dots all over her body on 08/18/2012.
Hot Feeling Radiating from Left Ear; Pain - Near the Injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot Feeling Radiating from Left Ear), VACCINATION SITE PAIN (Pain - Near the Injection site) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for COPD.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced FEELING HOT (Hot Feeling Radiating from Left Ear), VACCINATION SITE PAIN (Pain - Near the Injection site) and HEADACHE (Headache). At the time of the report, FEELING HOT (Hot Feeling Radiating from Left Ear), VACCINATION SITE PAIN (Pain - Near the Injection site) and HEADACHE (Headache) outcome was unknown.        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.   No Treatment information provided; 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.
Profound swelling, pain, headache, lethargy, shortness of breath. Unable to move arm without pain. Debilitating pain
Occurred after each Pfizer vaccination dates.  The first shot there was swelling and pain of the left arm, chest, neck and underarm area which lasted about 2 weeks. The last shot had the longer effects on left arm, neck, chest, underarm swelling (lumps) and pain which went away after 3 weeks.
her arm was a little sore; redness and swelling at injection site.; redness and swelling at injection site.; This is a spontaneous report received from a contactable consumer (patient). This 73-year old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration om 02Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient's arm was a little sore just like the flu shot was gone within a couple of days. On 08Mar2021 or 09Mar2021 the patient developed redness and swelling at the injection site. The patient's arm did not hurt as much now but the redness went down her arm to above her elbow. The outcomes of arm was a little sore and swelling at the injection site were unknown. The outcome of redness at the injection site was not recovered.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse (R.N.) concerning a 45 year old female patient with gastrointestinal discomfort and allergic reaction to losartan potassium (WAES# 1202USA02194), who on 16-SEP-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot # 669579/0595AA, expiration date 30-AUG-2012) in the left arm (dose and route were not reported). Concomitant therapy included FLUZONE (Sanofi Pasteur) in the right arm. It was reported that on 17-SEP-2011 the patient experienced the injection site reaction following vaccination with PNEUMOVAX 23. The injection site was described as swollen (Half dollar size), painful, tender and fever, body aches, chills and loss of movement in the arm. On 18-SEP-2011 the patient went to emergency room but was not admitted. On 20 and 21-SEP-2011 the patient missed work. On 28-SEP-2011 the patient was examined and the injection site reaction was then described as "indurated and tender". The nurse asked for a lot check for PNEUMOVAX 23 (lot # 669579/0595AA, expiration date 30-AUG-2012). No lab diagnostics studies were performed. On unknown date, the patient recovered from the adverse experiences. Injection site reaction described as swollen, painful, tender with fever, body aches and chills and loss of movement in the arm, induration and the patient could not work on 2 days were consider to be disabling, the patient missed work on two days. Lot check has been initiated. This is one of several reports received from the same source. Additional information has been requested.