chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right Deltoid (RD) swelling, painful and with redness given medication for pain only.
Flu shot administered at  Approx 8:30 started feeling body aches, very tired. Went to bed, but unable to sleep: body aches, feeling bad. Took aleve, then ibuprofen. Threw up around 3am, sweating and body aches. Fever was 101.7. Took more ibuprofen. Fever went down to 100, then 99.5. Continued taking ibuprofen. Went to urgent care 10/9, fever and vitals all normal, negative rapid Covid test. Low fever all day 10/9, tired and body aches all day 10/9. Finally broke for good during night of 10/9. Woke up drenched, no fever.
This spontaneous report was received from a certificated medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On 02-NOV-2016 or 03-NOV-2016, the patients were vaccinated with a dose of improperly stored GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). There was no adverse effect reported. The call was made due to digital data logger. The dose of the administered vaccine was exposed to temperature of 9.5 degrees Celsius for 28 hours. The vaccine was exposed to previous temperature excursion. There was no product quality complaint involved. This is one of several reports received cases from the same reporter. Additional information has been requested.
Headache, pain in neck, arms, chills, hands, shaking, nausea, couldn't get warm, struggled getting washed up for bed. Went to bed in wollen scarf on neck, extra blankets, still shaking! Took 2 Tylenol before retiring symptom gone next day
enlarged lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300361224 same reporter/event, different patient/dose;
Left arm severe pain , Left shoulder severe pain limiting ROM, Left armpit pain and mass with enlarged lymph nodes and severe pain of Left breast (symptom persists today with superficial and deep palpation of area), more frequent tingling and numbness of upper and lower extremities with muscle weakness in general but worse in Left arm; chest pain , tachycardia and fluttering sensation as well as prickly pain of bowels radiating to bilateral hips and legs  since day one right after 3rd dose of Pfizer COVID-19 vaccine.  On the second week after the third Pfizer COVID-19 vaccine booster, a severe lower back pain appeared causing moderated difficulty walking and strong headache was accompanied by more noticeable tingling on the scalp, left side of face and also more frequent on alternate upper and lower extremities. Episodes of dizziness, weakness and fatigue were more frequent as well as muscle pain now generalized, and occasional shortness of breath. There were, and still are,  sensations of having the brain wrapped in a wet towel, sort of heaviness sensation of the brain as well as dizziness, generalized weakness and fatigue episodes, generalized and alternate muscles pain weakness and mild twitching of the muscle on the vaccination site. Second booster of the Pfizer COVID-19 vaccine caused mild pain in left arm and mild tingling of scalp and arm as well as muscle pain and tiredness in general, but symptoms got worse after third booster as described above.
This spontaneous report was received from a Licensed Vocational Nurse refers to a patient of unknown age and gender. On 02-OCT-2013, the patient was vaccinated with GARDASIL intramuscular (dose and indication were not reported) by the medical assistant, and while administering the GARDASIL, the medical assistant felt the GARDASIL leet out. The reporter stated that the "hub" was not on the needle of the GARDASIL "all the way" and that is the reason the GARDASIL leak out. The amount of GARDASIL the patient received was unknown to the nurse. No adverse effect reported. This is one of several reports from the same source.  Additional information has been requested.
Information has been received from a health professional concerning a 6 year old Hispanic female with no pre-existing allergies, birth defects, or medical conditions who on 20 Jan 1998 was vaccinated with a dose of Varivax (lot# 624722/1325E). There was no illness at the time of vaccination. Subsequently the patient developed a mild case of breakthrough chickenpox. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was available. There was no product quality complaint. Follow up information received from a medical assistant indicated that on 06 Jun 2001 the patient was vaccinated in the right deltoid with a second dose of Varivax. ( Lot # 635453/0756K). On 05 May 2006, the patient was diagnosed varicella, noted to be lesions to the body. The outcome was recovered on 15 May 2006. No additional information is expected.
54 y/o male alert and oriented x3 speaks clear in complete sentences received moderna vaccine and informed to wait 15 minutes for standard observation. Pt asked Nurse when he could consume alcohol after receiving vaccine. Per Provider Pt should wait at least 24 hours. I informed Pt, he agreed with plan. Pt reports he feels dizzy and drowsy after 15-minute observation period. Nurse assessed Pt alert and oriented x3 speaks clear in complete sentences. Pt reports drowsiness. Pt later reports an episode of dizziness that lasted a few seconds and resolved. Pt currently denies dizziness, CP, SOB, headache or change in vision. BP assessed 161/85, R18, P61, O2sat 97 %. Pt verbalized he has only had coffee this morning. Pt asked if he had any alcohol. Pt reports yes, had small shot liquor earlier this morning. Pt wanting to leave, stating he is going to eat. I informed Provider as noted above. He is cleared to leave any dizziness or other S&S check in to UC. Pt given ER/911 precautions any CP, SOB. Pt agreed with plan and verbalized understanding. RN
All around 2pm of the day i got the vaccine i got a fever, cold sweats, could not move, was very tired, and it hurt to touch my skin.
had a sore arm; huge local reaction; and just tired about 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced pain in arm, local reaction and tiredness. On an unknown date, the outcome of the pain in arm and local reaction were unknown and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the pain in arm, local reaction and tiredness to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent. Age at vaccination was not reported. The patient had a sore arm, huge local reaction and just tired for about 24 hours. The reporter commented that, his/her brother almost dies from meningococcal disease and that's why they chose to vaccinate their kids. The case had been linked with US2021AMR074584 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR074584:same reporter
HEADACHE; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (series 1 from unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination . The patient received covid-19 vaccine ad26.cov2.s (Janssen series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 08-DEC-2021 into left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-DEC-2021, around 11 PM, the patient experienced chills and fever. On 09-DEC-2021, in morning hours, the patient experienced headache (series 2 adverse events). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and headache was not reported.  This report was non-serious.
Headache, swollen itchy red patch at injection site (symptoms still present today, but not overly worrisome)
It has been two weeks ago today that I received the 1st dose of the Moderna vaccine.  On February 15th, 10 days after the vaccine, a rash started around the injection site on my right shoulder.  It has persisted through the week.  Sometimes the area is redder, other times it's less so.  Sometimes it solid in color, other times blotchy.  Today it is approximately 6cm X 4cm.  It doesn't itch and is not painful.  My temperature has been normal.
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022; The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) and EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 030L20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) and EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 02-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
The vaccine was injected into the wrong site. It was injected lower in the left arm below the deltoid  It was injected subcutaneously and not intramuscularly This resulted in severe swelling. Redness , warmth and tenderness as well as induration in the fat It was a foreign body reaction to vaccine injected subcutaneously. This resulted in severe pain x > 2 weeks. Photos are available and were shown to pharmacy staff. They agreed that the vaccine was injected lower than it was suppose to be injected at. We are reported primarily so that the provider may get necessary advice on proper injection technique and other px may not suffer unduly.
Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2012 the patient was inoculated with ZOSTAVAX vaccine by a physician for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-JUL-2016 the patient was treated by a physician for onset of a blistering vesicular rash, which was diagnosed as severe herpes zoster or shingles The patient was prescribed VALTREX and tramadol for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
pediatric dose of Engerix-B instead of an adult dose.; pediatric dose of Engerix-B instead of an adult dose.; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 61-year-old female patient who received HBV (Engerix B pediatric) (batch number L32D9, expiry date unknown) for prophylaxis.   On 12th November 2021, the patient received Engerix B pediatric. On 12th November 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were provided as follows: The patient received pediatric dose of Engerix-B instead of an adult dose, which led to underdose and adult use of a child product. The reporter consented to followup.
11-year-old male patient received BNT162B2; 11-year-old male patient received BNT162B2; My son had a seizure 4 hours after receiving his first dose of the Pfizer vaccine.; This is a spontaneous report from a non-contactable consumer (patient's father). An 11-year-old male patient (reporter's son) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 17May2021 03:00 PM (at the age of 11-year-old) as 1st dose, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Patient's father stated that his son had a seizure 4 hours after receiving his first dose of the Pfizer vaccine (onset date also reported as 17May2021 20:30). The event resulted in emergency room/department or urgent care visit. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved for "seizure" and unknown for the other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
IPol and Infarnix were administered to a patient, mixed in the same syringe; Initial information received on 17-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age male patient who received vaccines INFANRIX and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect IPV (VERO) lot number not reported via unknown route. On an unknown date, the patient received a  dose of suspect INFANRIX not produced by Sanofi Pasteur lot number not reported via unknown route.  It was of actual medication error case due to  Product compounding error.  No adverse event was reported.  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 and Module VI of the 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.  List of documents held by sender: none.
patient go her first dose of vaccine on 12/29. on 1/11 her arm started itching and  now have a wheal at the vaccine site. Rash lasted 2 and half days and now resolved
left eye stroke (blood clot), Central Retinal Vein Occlusion,  no treatment, vision foggy
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 16:00 as dose 5 (booster), single (Lot number: Ff2590) at the age of 59 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17May2022 at 16:00 as dose 4 (booster), single (Lot number: FM7553), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Feb2021 at 13:15 as dose 1, single (Lot number: EN6200), in left arm, on 14Mar2021 at 12:00 as dose 2, single (Lot number: En6208), in left arm and on 07Oct2021 at 15:00 as dose 3 (booster), single (Lot number: Ff2590), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive; (2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Having a rebound infection with positive Covid test after she discontinued paxlovid and had a negative Covid test.
Syncopal episode occurred at home . Head trauma sustained which resulted in visit to Urgent care center
? injection site pain  ? tiredness  ? headache  ? muscle pain  ? chills  ? joint pain  ? fever  ? injection site swelling  ? injection site redness  ? nausea  ? feeling unwell  A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions i.e. slept 2 days straight, missed work Increased asthma medication used rescue inhalers
Child brought to clinic by mother. Received DTaP, Hib, HPV in LLT on 5/8/02. Site approximately size of 1/2 dollar, swollen, red and tender to touch. Abcess noted at injection site. Parent states child has had fever. Obviously ill today.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. In November 2010 the patient was vaccinated with her first dose of GARDASIL (dose, route and lot number not provided). On MAY-2013 the patient was vaccinated with her second dose of GARDASIL (dose, route and lot number not provided) and was in the office to receive her third dose of GARDASIL (dose, route, and lot number not provided), on 28-AUG-2013. No adverse effect was reported. Additional information has been requested.
Patient developed severe arm pain 2 hours after injection. Unable to lift arm and went to ED for evaluation. Still symptomatic a week after when I saw her 8/30/17 in clinic and difficulty raising arm due to pain. Per patient, medical assistant gave vaccine "too high" (pointed to subacromial bursa) instead of usual deltoid space, so wonder if she inadvertently caused severe impingement symptoms with vaccine given in wrong location. Saw in clinic on 8/30/17 and provided subacromial corticosteroid injection with some relief.
c/o area of 3 1/2" x 4" red & warm & hard area around inj site;lt arm deltoid area;
Approximately 8 minutes after receiving vaccine patient complained of Difficulty breathing, grasping for air, tightness in throat and chest. Epi injection 0.3 mg  and Benadryl 50 mg  given. EMS transported to ER for further evaluation.
The patient presents with 64 year old female with hx of DM presents to the ED with c/o weakness, with associated fatigue, cough, fever, SOB, x2 weeks ago. Pt states she was diagnosed with Covid 2 weeks ago, and sx have been worsening the past 3 days. Per husband, her sx have been declining since she was diagnosed with Covid, but is worse the last 3 days. Pt is vaccinated for Covid. Pfizer. Pt is aaox4 but feeling very weak all over. No focal weakness. Pt denies cp, nausea, vomiting, abdominal pain, diarrhea .  Risk factors consist of diabetes mellitus.  Associated symptoms: shortness of breath, fever, fatigue , cough, denies chest pain, denies abdominal pain, denies nausea, denies vomiting, denies chills, denies HA
Beginning on 10/19, I noticed pain in the left deltoid which is where the shot was given. The pain gradually worsened and the area became extremely painful to the touch or to any movement. I can feel a hard lump in the muscle at the injection site. The area is warmer than the rest of my skin and slightly reddened. I called Dr's office 10/21 AM and was told to alternate cold and warm compresses, take Motrin, and call if it starts to swell or develop severe redness.
2 days after vaccination I was awakened by acute, sharp pains in my left thorax in the region of my heart. They steadily got worse over the next half hour.   I did not experience shortness of breath, swelling of extremities, or discoloration. The pains continued intermittently over the next several days with any exertion, lifting, etc. I started bed rest and limited activity and continued my hypertension and arrhythmia medication.  Note:    * I have not had any similar pains before this incident    * I am due for vaccination #2 on June 2    *  The Lot number above may be EUU0167. The handwriting on the card is difficult to determine L or U
Pt developed leg weakness and atrophy which was slowly progressive (left leg worse than right leg). This was progressive over 6 months to the point that she could no longer walk unassisted. She was admitted and dx'd with anterior horn cell lesion and received inpatient rehabilitation.
Headache, fever 100 F, sweating, muscle aches,  malaise ,
INCREASED BLOOD GLUCOSE.  NORMALLY RUNS AROUND 95.  READINGS DAY AFTER VACCINE WERE 172 AND 184.
Expired Product Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-month-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 01-MAY-2023, the patient received Infanrix. On 01-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-MAY-2023 Director of Operations of a community health center reported that patient was administered a dose of Infanrix which had an expiration date of 29Apr2023. Reporter was unsure which dose in the series this was for the patient. At the time of reporting, the dose has not been repeated. The reporter consented to follow up. The patient received a dose of Infanrix which was already expired, which led to the expired vaccine used.
Shortness of breath during five days after the first dose, palpitations during more than three weeks thst have improved through time but I still experience them and 6 day delay in my period