chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; Error resulting in administration of expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Its not reported that how long the vaccine was stored at refrigerated prior to the administration.   The concomitant medications information was not reported. Treatment information was not provided.
Headache, Myalgia, Fever, NauseaVomiting,  injection site pain
Slight difficulty swallowing, then disappeared at time of injection. Within the hour, tongue felt swelled, irritated. Within a couple of hours had intermittent trouble swallowing again. Irritated, itchy tongue and throat to date.
Dates 1/1 - 1/4 experienced arm soreness and pain Dates 1/6-1/11: 1/6 experienced onset of soreness and tenderness around L axillary lymph node. 1/7 lymph node began swelling up. 1/8-1/10 experienced swelling and tenderness of lymph node, fatigue, GI upset including abdominal pain and diarrhea, and general malaise, along with redness and itching where the injection site was the week prior. Every symptom except the swollen lymph node faded after 1/11, and the lymph node has gradually and steadily decreased in size up to today. It is still slightly swollen.
tested positive for COVID-19; tested positive for COVID-19; Fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 03Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "tested positive for COVID-19"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever". The patient underwent the following laboratory tests and procedures: pyrexia: (Jan2022) 101.4; sars-cov-2 test: (Jan2022) positive. Clinical information: Reporter son received first dose of Pfizer COVID-19 vaccine on 03Jan2022 and 9 days after the first dose he had only fever of 101.4 and 7 days after he had fever he tested positive for COVID-19, and his second dose is due on 24Jan2022 can he get his second dose or he has to wait, if he has to wait , how long does he have to wait before he gets his second dose. by the way he does not have fever or any other symptoms for the las 9 days.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
12/10/21 presents to EC ED for "tachycardia and shortness of breath". PMHx of " T2DM"
Mild urticarial from neck to waist beginning 3 hours following TWINRIX. After evaluation felt likely not r/t immunization.
The day after receiving  the second dosage of the Shingles vaccine, I develop chest pains with radiating pain to my right shoulder blade.  It continued through Sunday when I developed jaw pain and went to the ER the morning on Monday January 18th
RN  responded to a call for help in the observation room at about 1115. The pt was found to be on the ground next his chair and diaphoretic. Someone was supporting his head and his eyes were open. The pt was was responding and A&Ox4. His initial vitals were 96/49, 42bpm, 96% on RA. The pt remained alert and said that he was trying to sit down in his chair, and then found himself on the ground. He had recently walked over from getting his Pfizer covid vaccine. He was unsure he if he had LOC or hit his head. The pt said he felt "a little dizzy," but he denied any pain, including head, neck, back, and chest. He denied feeling SOB. The pt was able to sit up with minimal assistance, and then was able to get himself on to a cot that was placed next to him. He vitals were checked and can be found below. He continued to remain alert and respond appropriately. He said he "felt better." EMS was called due to the pt's dizziness, 61/40 BP, and 31 bpm pulse. AMR and a fire crew arrived at 1131, placed the pt on their gurney and monitoring equipment, and brought the pt in to the ambulance. The pt remained alert and was able to transfer himself to their gurney. Report and care of the pt was given to EMS personal.    1117: 96/49, 42bpm, 20RR, 96% RA 1120: 81/31, 47bpm, 18RR, 95% RA 1123: 61/40, 31bpm, 18RR, 95% RA 1125: 110/53, 53bpm, 18RR, 94% RA 1127: 100/61, 57bpm, 16RR, 94% RA 1131: 113/62, 66bpm, 16RR, 95% RA
Approximately one week after the vaccine she developed sudden worsening of her eczema. Approximately 2.5 weeks after her vaccine, she started experiencing breakthrough hives on her torso and lower back.
A few days after my shot I started itching  a lot.  I didn't think anything of it; maybe dry skin.  Yesterday (04/10/2021) undressing to bathe I noticed a slight red bumpy rash on my back in there area that I scratched the most.  (And yes, I am well aware that my timeline just says I need to bathe more.  It's COVID... er, and I'm conserving water :)  I started to notice the red rash a bit on my arms and legs but not as bad as my back. Today (4/11/2021)  the rash is considerably worse.  My back is now completely covered.  It has spread to my arms, legs, abdominal area, breasts, sternal region and my face and ears are starting to itch and appear red as well.  Just today I have been putting Cortizone-10 on the effected areas to lessen the itching and have taken 2 Wal-Dryl (Walgreen's version of Benadryl).  I'm still itchy and there are not many signs of it getting better.  Granted, it has only been like two hours since taking the Wal-Dryl.
SWOLLEN INJECTION SITE, REDNESS, AND PAIN THAT LASTED NEARLY A WEEK.
Severe swelling, redness, very hot at site, 6 red lumps, arm stiffness for 3 days, size of symptoms increased in size to 19.5 mm on 11/05/2001 (right humerous).
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This was link case to 2018SA291866. (Same reporter). This case involves a patient of an unknown demographics (age reported as > 65 years) who received an expired dose of vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date in Aug-2018, which was from last year. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was case of actual medication error due to expired vaccine used. No adverse event was experienced. 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. List of documents held by sender: none.
Patient received vaccine on 03/04/2021 and on 03/05/2021 developed fatigue, headache, muscle/body aches that lasted 72 hours.
side effects he had: nausea; side effects he had: "warm"; side effects he had: "feel lousy"; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if he could take Tylenol or Motrin to treat his side effects after receiving his 1st dose of the vaccine. The side effects he had included: nausea, "warm", and "feel lousy". The reporter said that the vaccination location told him that most people experience the symptoms that he was feeling. The reporter said he already spoke with another nurse. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
Patient received Pfizer vaccine at 1426. Shortly after, patient began complaining of dizziness and nausea. Patient observed and vital signs were monitored. O2 remained 100% RA. BP and HR as follows--BP 196/97 HR 84; BP 202/106 HR 84; BP 235/113 HR 89. Patient denies rash, hives, tongue or facial swelling, difficulty breathing or shortness of breath. Patient denies history of hypertension. Patient taken to ED for further evaluation of BP.
Patient was 12 years of age and received a pediatric dose of Pfizer instead of the 12 yr and older dose of Pfizer. Patient received 0.2 ml of Pfizer instead of 0.3 ml.  Patient had no prior medical history noted at the time of the event and or reported.  No adverse signs and or symptoms noted at the time of event and or after. No treatment noted or necessary at this time or at the time of the event.  No further orders/instructions were given per Branch Director, Incident Command and Program Administrator,  and or health care provider.
Tdap 3/10/11. 3/12/11 - redness, swelling at site, feverish/chills. Redness worsened. Examined 3/15/11 -> local cellulitis, no abscess. Afebrile.
one of vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL; one of vials was accidentally diluted with 2mL of diluent/2 people were vaccinated with it; one of vials was accidentally diluted with 2mL of diluent/2 people were vaccinated with it/received vaccine that was diluted with 2mL instead of 1.8mL; This is a spontaneous report from a contactable pharmacist reported similar events for 2 patients. This is 1st of 2 reports. This Pharmacist reported for a 61-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. and expiry date not reported NDC number of COVID-19 Vaccine: 59267100001) , via an unspecified route of administration on 03Feb2021 at a single dose (diluted the COVID-19 vaccine with 2mL instead of 1.8mL) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first dose of BNT162B2 intramuscular (hopefully it was in the arm) as covid-19 immunization. On 03Feb2021, one of vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL, he used a whole 2mL. 2 people were vaccinated with it. Patients received vaccine that was diluted with 2mL instead of 1.8mL. The caller explained she was calling because one of her pharmacists diluted the COVID-19 vaccine with 2mL instead of 1.8mL. The pharmacist did inject two patients and it was their second dose. Caller is calling because she wants to know what the next steps are with the patients. Should they get another dose or what?  Prior vaccinations were reported as unknown. The vaccine was given in a Pharmacy.   Information on the lot/batch number has been requested.; Sender's Comments: The company deems there is not a reasonable possibility that the reported event is related to suspect product BNT162b2. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021126750 same drug/reporter, different patient/AE
I felt a cold shock on the left side of my head like brain freeze right after injection then started seizing for the first time of my life 20 minutes later.
-Started off with soreness at injection site then as each day passed pain increased to a point where she cannot lift her hand past a 90 degree angle position. She said the 9th day after getting vaccine was the worst pain. - There is so swelling or redness detected.
Fever, rash, acute renal failure with hematuria, localized site reaction. 10 days. ER on 11/05/14 then my Doctor on 11/07/2014. SMZ-TMP DS/FLUCONAZOLE/ETC.
Daughter was translating in another language to her mother, who has dementia. Nurse spoke to patient prior to giving vaccine. Patient moved her arm as soon as the needle pierced the skin and the vaccine went rolling down patient's arm.  Nurse immediately called her contact at the facility and she stated she would find out what should happen next. Facility nurse called nurse at site and quoting guidelines stated immediately following this another dose may be drawn up and given. Patient was successfully vaccinated.  Nurse and screener stayed in home 25 minutes longer to be certain of no apparent side effects.
Vaccination administration Error - This was the patient's second dose of the Covid Vaccine. He was given Moderna and should have been given Pfizer.  His first dose on 2-26-21 was Pfizer.  We feel the mistake was due to carelessness by the pharmacy staff.  No one seems to know the safety and efficacy of receiving a single dose of two different Covid vaccines.  Thus  far, 3-18-21 the patient has had no adverse effects except for a sore left arm which was the site of the injection.
Information has been received from a physician concerning a patient who has vaccinated with a dose of ROTATEQ vaccine live (human-bovine) (no lot numbers available). Subsequently the patient experienced diarrhea. Medical attention was sought at the physician's office. As a result, the parents of the patient requested the ROTATEQ vaccine live (human-bovine) series not to be continued. It was noted that by the physician that a "couple of patients out of hundred doses" at the office have experienced diarrhea. The recovery status was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
The patient is very petite/ thin and prefers injections in her buttock.; No adverse effect reported; This spontaneous report has been received from a medical assistant regarding to a currently 26-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, lot #, expiration date and route of administration were not reported) in her buttock (laterally unspecified) for prophylaxis. The patient had received 2 doses of the vaccine and stated that since she was very petite/thin, she preferred the injection in her buttock. It was reported that the vaccine therapy was continued.No adverse effects reported.
Headaches that lasted most of the day and left the patient debilitated. Headaches were not relieved by normally effective medications  nor over the counter). Headaches lasted 6 days starting the day after injection, and similar headaches have recurred since then.
Swollen arm, Jaw, Back bone, Nausea, Diarrhea, also caused a seizure.
Patient received his first dose of Moderna at 1:45pm.  Pt walked to the waiting area and sat down. At 1:46pm patient passed out and hit his head.  I received a call at 1:47pm. When I arrived on scene, MCIP and EMT1 had the patient in the EMT room on a gurney.  Patient was awake and oriented. 1:53pm vitals were 140 BP by palpitation, 98 O2, 62 HR, 139 blood sugar. MCIP had patient sit up and attempted to take his BP. Upon pumping the cuff, patient passed out with seizure like activity, after about 10 seconds he came to. patient complained of being hot and sweaty.  No complaints of trouble breathing or itchiness. At 2:00pm vitals were 152/80 BP, 97 O2, 59 HR.  EMS arrived on scene. At 2:09pm EMS had patient try to stand. At 2:12pm patient was complaining of lightheadedness and being sweaty. EMS had patient lay down. Vitals were 115/70 BP, 53 HR, 97 O2.  At 2:15pm EMS loaded patient up and took him to the hospital.
Pt received FLUVIRIN vaccine 9/28/09. She said her arm started to hurt after 1 hour. Went to doctor on 10/15/09 since she said her arm was too sore to move in certain positions. Patient received medication but said her arm is improved but still bothering her.
This spontaneous report as received from a pharmacist refers to a 61 year old male patient. On 25-APR-2014 the patient was vaccinated with ZOSTAVAX (route, lot number and expiration date not reported). On 25-APR-2014, the patient received less than a full dose of ZOSTAVAX. Pharmacist stated that the syringe leaked upon administration of the ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Moderate to Severe pain in left shoulder due to improper placement of the needle. Limited mobility due to inflammation and pain.
Severe lower back pain, causing dull achy numbness and pain in legs. Severe headache in left temple every time I stood up. Throat pain. Body aches. Chills.
Cleint reported general soreness, sore throat. Temp elevated to 102' 6/10/11.  Seen by nurse practitioner, advised probable influenza, but since coincided with vaccine, suggest VAERS also.
On October 1st, I was running in a Cross Country race (I have been doing this since I was 8 years old), and when I was 25 meters to the finish, my entire body seized up and I fell to the ground. I started crawling to the finish and while I was crawling, I lost consciousness. The medics said I was throwing up while this happened. I have no recollection of what happened for the next 30 minutes. My memory came back after half an hour, and my pulse OX was low, my resting pulse was high (in the 120s--stayed here for a total of an hour), and I was hyperventilating. My skin was extremely pale, and I was throwing up. Dehydration and heat were not a factor. Ever since, I have not been able to run without my heart spiking above 200 bpm (usually it will be in the 140s - 150s), I am dizzy, I have chest pains and palpitations, brain fog, and easily out of breath. I have not been able to tolerate running without getting extremely dizzy and my eyes blurring and my heart rate spiking. These symptoms get worse with stress, or if my heart rate gets very low (low 40s). This is still a problem to this day (December 8th, 2021).
This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 14 years old female patient with prophylaxis and incomplete right bundle branch block was vaccinated IM into right arm with first dose of GARDASIL (lot # 669794/1400AA, expired date 11-OCT-2013) on 03-APR-2012. No other co-suspects were reported. Concomitant medications included ADACEL (lot# U4088AA) and MENACTRA (lot# U4099AA). On 03-APR-2012, 3 minutes after vaccination, the patient fainted and slump slowly down from sitting position. The patient was layed down on table. Patient was loss of consciousness about 10-15 seconds with brief seizure activity towards last 5 seconds. Smelling salt was put under patient's nose and she immediately awoke. Patient was monitored for 15-20 minutes afterward. On internal review, lost consciousness and seizure activity were determined to be an other important medical event. The original reporting source was not provided. No further information is available.
6FEB swollen gland-sl fever, very tired-losing weight since DEC96;went to MD blood tests for anemia none-negative WBC inc;10FEB other side of neck swollen, nausea, vomiting;
Received flu shot in LD on  10-3-16 at 2:20PM. Received call from grandma that left upper arm is swollen and twice its size.
Pt recvd 3 doses of Engerix-B 15OCT90, 2JAN91 & 2MAY91 & reporter indicated that pt did not respond;
Information has been received from a nurse practitioner and a medical assistant concerning a 41 year old female with asthma, diabetes, and allergies to FLAGYL, who on 09-JUN-2008 in the morning was vaccinated IM with a first dose of PNEUMOVAX 23 (Lot# 658555/0694U). Concomitant therapy included "thyroid." On 09-JUN-2008 post vaccination the patient developed an injection site reaction. The patient had a 4 inch area around the injection site that was hard, indurated, and painful with a red rim. The patient was unable to lift her arm. She returned to the office in the afternoon on 09-JUN-2008. The patient was treated with ice packs and DEPO-MEDROL. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. The injection site reaction, involving a 4 inch hard, indurated, and painful area with a red rim and the not being able to lift her arm was considered to be disabling and medically significant. Additional information has been requested.
Narrative: Patient is a 60 year old MALE, Covid vaccinated with Jansen vaccine on 07/2021, hypertension, CAD with prior non-STEMI, chronic troponin elevation/chronic angina, SVT, hypertrophic obstructive cardiomyopathy s/p AICD, chronic kidney disease stage IIIa, HRpEF EF 65-70% (5/2019), hyperlipidemia, Hashimoto's thyroiditis with secondary hypothyroidism, PTSD, bipolar disorder, GERD, active smoker recently tested Covid positive 11/23/2021 associated with symptoms of cough with increased phlegm production than his usual with no fever, no diarrhea, no nausea or vomiting, mild change of sensation of taste but otherwise appetite is good. Patient is being admitted secondary to elevated serum troponin although no symptoms of chest pain,need to r/o ACS. Patient was admitted to Covid floor. He did not require supplemental oxygen. O2 sat range between 97% on room air. Chest x-ray showed focal patchy airspace consolidation at left superior lung. He recovered and was discharged to home.
Nausea 12 hrs after initial dose; severe cramps, vomiting, diarrhea 20 hrs after initial dose.  Continued for additional 24 hours, weakness persisted for 3 days. First dose taken with water 1 hour prior to dinner.  Did not continue the remaining 3 doses.
Telephone call from pt's mom; states that left thigh is red slightly swollen. Denies fever. State that child has been fussy.
Mother reports baby rolling her eyes backward and not responding to mother and that she took baby to the ER but nothing was noted to be wrong.
Patient received Hep A vaccine around 0900. At 1400 she was presented to me by her squad leader and I noticed several hives only affecting the arms of the PT. I instructed her to take 50mg of BENADRYL every 8 hours and to immediately report to the nearest ER if she noticed any difficulty in breathing otherwise report back to me in the morning. She reported back around 0900 with no improvement. I told her to continue BENADRYL and to report to the ER if her symptoms worsened. At approximately 1400 on 11 Feb I was informed that she was taken to the local ER as the hives were becoming increasingly painful. I called the patient at 1000 on 13 Feb and she reports that she is doing fine now and was given a steroid shot in the ER and was also told to continue BENADRYL.