chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient can not use arm much; They put it in the wrong place; Initial information was received on 31-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographic)who received INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown and reportedly inappropriate administration site for prophylactic vaccination on an unknown date (product administered at inappropriate site) and cannot use arm much after that (Injected limb mobility decreased).   Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient cannot received INFLUENZA VACCINE via reportedly inappropriate administration site (product administered at inappropriate site) and cannot use arm much after that (Injected limb mobility decreased) (unknown latency). Patient mentioned going to see an orthopedic surgeon. . It was a case of an actual medication error due to vaccine administered at inappropriate site (latency same day).  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  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 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.  At the time of reporting, the outcome of hypokinesia event was unknown.  There will be no information available on the batch number for this case.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GH9683) at the age of 39 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: QSYMIA, start date: 22Apr2021; MIRENA intra-uterine, start date: 18Jul2022; SPIRONOLACTONE, start date: 18Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & devel inject site rxn with redness, induration, warmth and soreness.
This spontaneous report was received from a registered nurse refers to a female patient in her 20's. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot #, dose, route not reported) in the arm. Other suspect therapies included ADACEL (lot#,dose,route not reported) in the same arm. No concomitant medications was reported. On an unknown date, the patient experienced tachycardia, swelling of the arm and fever of 103. Since then the symptoms resolved. No treatment was received. Patient sought medical attention(patient saw the nurse). The outcome of tachycardia, swelling of the arm and fever of 103 was resolved. The relatedness of the events with PNEUMOVAX23 and ADACEL was unknown. Additional information has been requested.
12:00 pm vax given, immediately after pt appeared faint. B/P was checked noted 90/50 the 1st time. Repeated B/P 90/50, checked again and unable to diastolic B/P. EMS notified B/P still 90/50 with no radial pulse.
This spontaneous report as received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history drug reactions or concurrent conditions. On 19-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N012619, expiration date 21-APR-2019) (dose, frequency and route of administration were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 to 14 degrees Fahrenheit for 30 minutes, as recorded by a data logger. The vaccine was reconstituted with a sterile diluent (manufacturer unknown) which was properly stored. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. On 31-JAN-2018, a call was received from the nurse, who stated that the patient had no adverse experience from receiving improperly stored vaccine dose. Nurse reported that physician would complete the form and he would place ''not applicable" for adverse event related questions on the form. Additional information has been requested.
Varicella vaccine on 6/8/10 - began to itch and swell on 6/9/10 - Now 6/10/ with redness, swelling, itching upper R arm.
Information has been received from a physician concerning a female who in approximately September 2007, also reported as about one year ago, was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). On 04-SEP-2008 the patient was vaccinated with a second dose of GARDASIL vaccine (yeast) (lot number, injection site and route not reported). No problems reported. No further information is available.
Within 10 minutes of injection, patient started to say her eyes were moving by themselves behind her eye sockets and she was feeling alot of "snapping" in her body.  Her blood pressure and pulse were higher than normal and she could not keep her eyes open well. She was observed by nurses for approx 30 minutes and those symptoms seemed to subside although she was not steady walking. Midway into our 30 minute drive home it all started again, this time she said she felt heaviness in her chest but was pointing to her throat.  I immediately drove her directly to the ER. Was monitored for 4 hours and was release to go home, be observed and follow up with Neurologist when possible.  Throughout the night, she continued to say she was shaking alot on the inside and her eyes were still moving involuntarily.   3/20/19 at 8:30 am I called her Neurologist to inform her patients symptoms were continuing.  I waited 8 hours and called back only to have her tell her service I was to call patients Primary Physician.  Which I did.  Dr. was on call and quickly  prescribed medication to help calm patients symptoms.  She prescribed Valium 2mg q 6 hours. 3/21/19:  Patient is still experiencing shakiness, involuntary eye movement and fatigue.  She does not have arm pain at injection site.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The date of vaccine administration was from 4-Jun-2022 until 26-Jul-2022. The vial did not undergo any temperature excursions. Patient received half dose. No treatment medications were reported.
Dizziness, Headache, Myalgia, CHILLS, FATIGUE, MILD COUGH, COLD SWEATS Narrative:
My COVID-19 symptoms started on 01/2023. I had low grade fever, muscles aches, and congestions. I felt like I had the flu. I probably tested positive for COVID-19 on 01/17/2023. I called my doctor and asked for Paxlovid for 5 days. My symptoms were moderate. I quarantined for 5 days.
Approx 3 hrs p/ immun-pt was @ restaurant w/ grandparent. Pt started a high ptiched cry, became limp & pale & would not bear wt on lt leg. Mom states pt did not have fever. Back to nl in another 1 1/2 hr.
14 hours after shot started having chills lasting for 24 hours. had soreness at injection site for 4 days.  fatigue started 12 hours after receiving shot and lasted for 18 hours.
Information has been received from a 23 year old female patient, for GARDASIL, a Pregnancy Registry product, who on 11-SEP-2009 was vaccinated intramuscularly with the third dose of 0.65 ml GARDASIL. Concomitant therapy included SYMBICORT and prenatal vitamins. The patient had been pregnant for 7 weeks when she was given her third dose of GARDASIL. Blood work was performed (result not reported). The patient's date of last menstrual period was approximately on 24-JUL-2009 and estimated delivery date was on 30-APR-2010. No adverse event reported. Medical attention had been sought. Follow up information was received from a registered nurse, for GARDASIL, a Pregnancy Registry product, which reported that on 11-SEP-2009, the female patient with asthma and with a history of 1 previous pregnancy and 1 previous full term delivery was vaccinated with the third dose of GARDASIL (lot # 663453/0249Y) while she was pregnant. Concomitant therapy included SYMBICORT, prenatal vitamins and PULMICORT. Her LMP was on approximately 24-AUG-2009, the estimated conception date was on approximately 07-SEP-2009, and EDD was on approximately 03-JUN-2010. On an unspecified date, the patient developed allergies. She was given EQUATE ALLERGY MEDICATION daily to treat allergies. On 15-OCT-2009, ultrasound was performed for dating which was ok, the patient was 6 weeks and 6 days of pregnancy and there was fetal heart rate (FHR). Additional information has been requested.
First shot gave me a tight chest and swollen throat right away day one about 40 minutes after receiving shot. That night I was woken up with burning ligament and tendon pain in my legs. This subsided after two days. Pain in all joints of foot, ankle, knees and elbows have been ongoing but not constant. The day after second shot tendons in  thumbs on both hands became painful and popping.  This hasn't went away and is constantly painful.
Patient received his first Covid 19 Pfizer booster at 3:00p on 4/23/22. He had received Pfizer for his original series with no issues. After 30 seconds of receiving the vaccine, he started complaining of becoming warm and became visibly sweaty. I gave him a water to sip on, an ice pack for his neck and checked his blood pressure at 305p which his reading was 78/49 with a pulse of 58. He did not complain of being dizzy or light headed, just warmness and some stomach issues which he attributed to the fast food he just ate. His blood pressure and pulse normally run low because he is a cardio fitness fanatic to his own admission. I rechecked his bp at 310p and it read 103/80 with pulse at 58. He said he felt about 25% better. I gave him a glucose tablet at that time. I rechecked his bp at 325p and it read 88/48 with pulse at 98. He was talking more and not sweating and felt better so I asked him to get up and move around and he felt good after that.
Rash on abdomen; low grade fever of 99; Asthma started getting bad; chest pain; Coughing; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHMA (Asthma started getting bad), CHEST PAIN (chest pain), COUGH (Coughing), RASH (Rash on abdomen) and PYREXIA (low grade fever of 99) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and METFORMIN for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced ASTHMA (Asthma started getting bad), CHEST PAIN (chest pain) and COUGH (Coughing). On 11-May-2021, the patient experienced RASH (Rash on abdomen) and PYREXIA (low grade fever of 99). At the time of the report, ASTHMA (Asthma started getting bad) outcome was unknown and CHEST PAIN (chest pain), COUGH (Coughing), RASH (Rash on abdomen) and PYREXIA (low grade fever of 99) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 99 (High) Low grade fever of 99.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment of event asthma aggravated included, albuterol inhaler, singulair. Action taken with mRNA-1273 in response to the events was not applicable. Products known to have been used by the patient, within two weeks prior to the event, included oral birth control medicine.   This case was linked to MOD-2021-118335 (Patient Link).
Injection site so sore couldn't sleep on arm first two nights following vaccination. Same first two nights such a severe burning sensation in cheeks and especially gums. Awakened from sleep. So fatigued two days after vaccination had to take several rests in bed during day. Mild feeling of nausea, diarrhea but no actual episodes. Some nose drippings, need to keep clearing throat from phlegm. On third day slight sore throat by fifth day, with injection site back to normal. All symptoms pretty much gone.
p/vax pt presented to ER w/chickenpox described as full blown;tx w/DPH & Zovirax;
Pt states she got her COVID vaccine on Wednesday 3/17 and  has been having nausea, vomiting, hoarseness, and fever since.
Decreased the INR to subtherapeutic level.  Dr had the patient increase the warfarin and is monitoring.
This spontaneous report was received from a healthcare professional referring to a 12 months old male patient. Information about the patient's medical history and concurrent conditions was not reported. On 21-SEP-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 60-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included low blood pressure. On 24th July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 14 hrs after receiving SHINGRIX, the patient experienced dizziness, pain in arm, fever and diarrhea. On an unknown date, the outcome of the dizziness was not recovered/not resolved and the outcome of the pain in arm, fever and diarrhea were recovered/resolved. It was unknown if the reporter considered the dizziness, pain in arm, fever and diarrhea to be related to SHINGRIX. Additional details were provided as follows: This case was not reported to anyone previously. The patient received SHINGRIX into left arm. The patient stated that, 14 hours after receiving the vaccine, he noticed that his left arm was sore. The patient stated that approximately 14 hours after receiving the vaccine; he also experienced dizziness, diarrhea and fever. The patient stated that the soreness in his arm lasted for 5 days before resolving. The patient stated that the diarrhea and fever resolved, however, the dizziness had not gone away.
The day I received the shot I started to have a lot of muscle pain. By evening I felt like I had the flu coming on. I took Tylenol and went to bed. I woke up at about 5 a.m. My heart was racing very fast, the middle of my upper lip was swollen and my arm hurt where I had my injection. I took Tylenol again and took Benadryl and went back to bed. When I woke up the second time to get ready for work, my face was bright red my chest was flushed, my pulse was racing and my upper lip and mouth Was swollen. My face became more puffy as the day went on. I called my drs office because my heart was racing & I was having anxiety because I couldn't get it to come down. That night I started to feel a bit better so I took benadryl and went to bed. I again woke up early in the morning with very fast pulse. First day I was 110 BPM resting and on Friday I was 127 BPM. At around 2pm I started felling palpitations and then a bit later I had pain in my chest starting in my sternum.  Symptoms calmed down a little at night so I went to bed. Waking up Saturday and Sunday I had an ache in my chest and the beginning of pressure like a 3 on the pain scale.  Monday I called my doctor & he believed I was having an anxiety attack and called me in  medicine. The Ativan seemed to calm me down but my pulse stayed high. The next day the pressure had increased in my chest and my heart was at over 130 BPM resting. the pain was radiating out from my center chest to below my collarbone and into my right arm I went to my moms & she took my blood pressure and it was 172/140. The pain stayed constant & I was getting a terrible headache on top of the pain. She immediately took me to the ER for treatment. My blood pressure finally started to stabilize after they gave nitroglycerine & it took away my chest pain. My pulse regularly stayed over 100bpm until 01/09/2014. Blood pressure went back to 122/80 on 12/24/2013. I have had bronchitis, pneumonia, high blood pressure, tachycardia, kidney infections with no microbes present since  having the shot. 2 ER visits & multiple doctor office visits. I'm still being treated for pneumonia.
Patient fainted and hit her head on the floor.  Once she came to she stated that she does faint sometimes after a vaccine.  We called 911 and the ambulance responded and transported her to the hospital.   I spoke with patient later in the day and she stated that she was feeling fine.
feeling anxious; Depressed state; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (feeling anxious) and DEPRESSION (Depressed state) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANXIETY (feeling anxious) and DEPRESSION (Depressed state). At the time of the report, ANXIETY (feeling anxious) and DEPRESSION (Depressed state) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6.         No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In January 2021, the patient experienced COVID and on an unknown date, COVID resolved. For HUMIRA, the reporter causality for the events of Feeling anxious and Depressed was no reasonable possibility and for the event of COVID was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.   Reporter did not allow further contact
Around 12:45p patient got his second dose of Moderna Covid-19 Vaccine. About 5 minutes into waiting outside the pharmacy sitting in a chair I heard a loud thud outside the clinical services room. I was alerted by pharmacy technician that the patient had fainted. We called 9-1-1 immediately. Patient was face down and unconscious for about 7-10 minutes. Patient also had some convulsions during this period. Patient regained consciousness but was very disoriented and did not know where he was. He then went in and out of consciousness for about another 7-10 minutes until EMTs arrived and began caring for patient.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 29-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J007208, expiration date 20-SEP-2014, dose, route not reported). The patient had not reported or demonstrated any adverse effects. Additional information has been requested.
Information has been received from a licensed practical nurse concerning a 25.4 week old female who on 17-AUG-2007 was vaccinated with her first oral dose of Rotateq. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information has been requested.
Initial surge of energy for about 9 hours, followed by brain/ body lack of coordination. By 4:30 am, fever was over 101, eventually rose to 102.4 before slowly receding over 24 hours Tues 6/29 woke up to discover my legs would NOT move on their own. My bladder was numb, leading to incontinence. I had to left each leg with my hands and move it to the floor and stand using upper body strength only. Knees would not bend. I basically lurched to and from bathroom and kitchen rapidly at about a 30 degree forward tilt. This lasted 12-18 hours, was 80% resolved by next day, legs cleared during sleep. Transitory Guillan- Barre would be my educated guess. Right knee remains not 100%, mostly when extremely fatigued. Chronic fatigue was triggered, and is still in flare, as is fibromyalgia to a lesser degree. Bladder now trickles urine, rather than a full empty, severity varies.