chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 5:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 5:10 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient was given doses from a vial that were stored in an ultracold freezer which is colder than they should have been.  It was reported that the vaccine was at frozen storage condition at the time of the temperature excursion. Excursion duration was one month.  On 04-Nov-2021, the Moderna COVID-19 vaccine vial went from the super cold freezer to the refrigerator. The vaccine was returned to the freezer/refrigerator/ultra cold freezer, or maintained at room temperature.  No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2022: Follow-up received  included no new information.
pt recvd vax 19NOV92 & 19NOV92 lt arm became swollen & sore, it was red, moderately tender & hot to touch; could not move arm; there was no fever;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-OCT-2016, the patient was subcutaneously vaccinated with an expired 0.5 ml dose of M-M-R II injection, expiration date 26-AUG-2016 (site of administration, lot number and albumin status were not reported). No adverse events were noted. Product quality complaint was not involved. Additional information has been requested.
Patient received her first dose of Shingrix and experienced some side effects including blurry vision, lethargy causing her to miss a day of work, and patient reports she 'felt like [she] was on drugs'.  She had a 5 inch welp across the injection site.  Patient managed symptoms at home including watchful waiting and rest
Pt recvd last Typhoid vax 26JUL91 & began fine, raised rash on trunk & upper extremities 27JUL91; Pt called clinic 29JUL91 to report rash; States rash is resolving;
approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.
Passing out; Rash over entire body including inside mouth throat nose and eyes; Rash including inside mouth; Rash including throat; Blurred vision; Headaches; Aching; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (Batch/Lot Number: EW0182), via an unspecified route of administration, administered in arm left on an unspecified date (also reported as on 22Apr2021 09:00 AM) at the age of 44 years as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot Number: EW0161) administered in arm left on an unspecified date (also reported as on 22Apr2021). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. On 18May2021 12:00, the patient experienced rash over entire body including inside mouth, throat, nose and eyes; blurred vision, headaches, aching and passing out. No hospitalization prolonged. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included steroids. Outcome of events were not recovered.
Patient was walking to the bathroom when she became dizzy. Patient provided with chair on her walk to the bathroom and made aware that we needed her to be stable before getting up again. Patient took a 5 minute rest and felt better. Patient guided to the bathroom but once she came out of the bathroom she became dizzy again. Patient was provided with a chair again but started to become frantic so we provided her with a cot and laid her down but patient started to become very short of breathe. Medics called and provided with hand off.
Pt felt dizzy and had dry mouth/throat, pt c/o feeling "sort of out of it" - x1 hr. Resolved completely with rest/feet elevated.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient reports swelling, a "hard knot" at injection site that causes intense itching
Patient was given Kinrix off label.  The parameters for Kinrix are 4-6 years and the patient was only 2 months old.
3 days following vaccine injections, a mild rash developed on inner thighs and legs. Rash continued at different levels of severity for several days. On July 2, child was unable to walk without falling for much of the evening. Rash was still present. On July 4, the rash progressed to her entire body, appearing more patchy.
Information has been received from a wholesale representative and a nurse concerning a male who on an unspecified date was vaccinated with Pneumovax 23 (lot # 655290/0959F).  Subsequently the patient experienced pain, soreness to touch, redness, warmth, and swelling in the injection site arm.  The patient complained that it "hurt so bad he could not lie on it".  The patient also complained that he "felt lopsided".  Unspecified medical attention was sought.  At the time of this report, the outcome of the events was unknown.  Additional information has been requested.
pt recv vax 20SEP96 & 21SEP96 pt had pain in lt arm jaw to fingers & temp of 101.2 oral;resolved by 23SEP96 w/APAP;
Severe headache, nausea, vomiting, shivering, facial and head numbness. Still having severe headaches despite medication
Swelling entire neck-hard to swallow-cannot breath at night, feels like choking. Seen in clinic a few days later and had improved with BENADRYL. No rash, no hives, no swelling oropharynx. Add non-sedating antihistamine, continue prednisone BENDRYL HB.
Localized redness, swelling, pain that began 6-8 hours after injection of PNEUMOVAX.
Spoke with patient he states he took a home test, he is going in employee health this afternoon for rapid test  Pt states symptoms began 09/08/21
Patient is a 28 y.o. female patient of CNP with history of asthma, anemia, presented to local Medical Center with shortness of breath.   Covid-19 Virus Infection Multifocal pneumonia  Date of onset of symptoms: Before 2/1. Symptoms present on admission: Cough, congestion, shortness of breath Date of covid positive test: 2/7 Vaccination status: vaccinated Imaging: CTPA shows multifocal GGO likely infectious vs inflammatory process, no PE Baseline oxygen requirements prior to admission: Room air Current oxygen requirements: Required 6 L on admission, now on 2L  Medical therapy: remdesivir and steroids Consultants following: Pulmonology Anticipated special isolation end date: 2/11 if symptom onset truly started before 2/1   Acute respiratory failure with hypoxia-resolved Acute Asthma exacerbation  VCD (Vocal Cord Dysfunction) Likely exacerbated by COVID (see above)  Hypoxic and requiring 6 L/min with a baseline of RA CT showed multifocal GGO likely infectious vs inflammatory process, no PE Duonebs, and steroids On RA at rest and on ambulation 2/10 Pulm following   Right middle lobe atelectasis Noted on CT Repeat CT chest in 6 to 8 weeks   OSA Cpap per RT
One week after the injection , Thursday, February 18,  I woke up in the middle of the night with itching at the site of the injection.  When I looked in the mirror, there was a rash (or redness) measuring  4.5 inches long and 2.5 inches across around the injection site. It remains very itchy and feels  slightly warm to the  touch.  It remains this way today, Friday, 2/19/21.
On 7/19/2022, I started feeling not generally unwell, coughing, throat congestion. I took a COVID-19 home test on 7/20/22, within 30 seconds I got the black, black marks on the test. It was clearly positive. I was with a friend on a road trip. My friend was a retired medical doctor. He brought home test with him, and we both tested positive. And within a couple of hours of testing we both had prescriptions for PAXLOVID on 7/20/2022. I was substantially better on 07/21/2022. I tested positive on 8/3/2022 and I had symptoms till 8/13/2022.
This spontaneous report was received from the registered nurse regarding a 9 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 03-DEC-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
One week after after receiving the COVID vaccine, a raised circular rash appeared 1cm below the injection of the COVID vaccine. It was itchy and warm.
Pt returned to pharmacy 2 days after receiving vaccine w/ red & swollen arm. Required PCP visit.
Chills aches  that lasted 48 hours then severe joint pain in joints of fingers, toes and knees that lasted for three months finally got better but never really went away.  Had second dose and the severe joint pain in toes and knees reoccurred.
Patient reported feeling lightheaded, dizzy and tingling in fingertips on right hand.  Patient was observed scratching arms, head and chest.  Benadryl given.  30 mins after injection, itching was better.
Started to develop some chest pain in the middle of my chest. It's almost like a precordial catch that won't go away. Haven't seen a Dr yet but plan to if symptoms didn't pass.
vaccine given was the adult dose instead of the pediatric dose.  Report given on event to Provider, who states that there should be no adverse reaction to the event, and RN nurse manager.
Severe pain, swelling and redness at the injection site followed by all over body aches, fatigue, severe headache, fever, chills. At 4:00 AM on 03/12/2010, I took 800mg Ibuprofen which successfully broke fever and reduced pain and discomfort enough for sleep. Symptoms were greatly improved upon waking.
15 minutes after receiving the vaccine i got into my car and immediately got a headache and my ears began ringing and has not stopped since
My daughter doesn't feel good; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced my daughter does not feel good. Reporter stated, "I need to know I am trying to make sure I am calling to right place. I have some questions about side effects (Further clarification unknown hence captured as verbatim) from the Covid vaccine the second dose at about 20 days. I am trying to figure out if it would be the vaccine or if it is possible to be something else." Reporter stated, "I think I was on there; I mean the symptoms are so broad and big and most of the symptoms that listing on there that would match this, it looks like it happened with him like two to five days after the shot and it's been 20 then actually 21 days." Reporter stated, "No, I don't know I would have to go get my card to give. It is really bad time. My daughter does not feel good (Further clarification unknown hence not tab) I am trying to figure out if she needs to go to the hospital or not so I am going to hang up and see if I can get hold of somebody." The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.
Seven days after Injection, I was lifting 5 pound weights 36 times, and suddenly my injection site got red and itchy and swollen and hot within 30 minutes. The next day I went to the walk-in clinic where I had a 3? x 3? swollen red injection site and was given prednisone.  The next day it was 3? x 6? in size  and after 3 days on Prednisone it was 75% cleared up.  Prednisone was stopped at three days due to adverse reaction. It has been  11 days and there is STILL some rash left on the arm.  It is now 17 days since the injection.  It was diagnosed as a subcutaneous leak from the muscle one week after injection, and 4 days after all common initial injection site reactions had passed.  I was told I could just move on and not worry about it at this point? But it is still there somewhat. I am checking NO where it asks if I am recovered because it is still on my arm.
Expired Bexsero administered; 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 16-year-old female patient who received Men B NVS (Bexsero) (expiry date 28-FEB-2023) for prophylaxis.   On 05-APR-2023, the patient received Bexsero. On 05-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). 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: 06-APR-2023 The medical assistant reported that a patient was administered a dose of Bexsero and afterwards it was realized the dose had an expiration date. The reporter was unsure if this was the patient's first or second dose in the series.   The reporter did not had the lot number of the product and did not had patient initials.  At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient was administered an expired dose of Bexsero, which led to expired vaccine used.
Patient received DTaP on right arm; slightly swollen, red, occurred shortly after receiving immunization. By the next was resolving spontaneously. Ice, Tylenol.
Myalgia & NauseaVomiting Narrative:  sore arm at injection site for 3 days. nausea on the first day,   Other Relevant History:
received lot number involved in the Recall; received lot number involved in the Recall; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B) (batch number CP23D, expiry date 31st December 2023) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pediatric office receptionist reported that between 18th July and 25th August 2021, the patient received recall Engerix-B lot, which led to recalled drug administered and drug dispensing error. The reporter consented to follow up. This case was 1 of 20 linked cases, reported by same reporter for different patients.
Pt received vaccine 13:50. At 16:45 pt described itching to inflamed ears, rash on abdomen and chest, and some lip/tongue swelling. No SOB. Pt was instructed to take diphenhydramine 25 mg PO. After administration pt had some relief of symptoms.
Dose two in two dose series administered prior to recommended waiting period. Administered at day 7.
Initial and follow up information has been received from a consumer concerning a potential varicella outbreak in a 5 year old female child who was vaccinated, on an undisclosed date, with a second dose of varicella virus vaccine live (Oka/Merck). On an unreported date, the child developed a fever of 100 degrees, a sore throat and one pimple/blister on her face, which resolved in three days. The illness was considered mild and treated with Advil and Tylenol for mild fever. The pediatrician of the child asked that the child not be brought into the office, since they felt that he was contagious. The original source of the illness was thought to be a woman in the reporter's neighborhood who had a bad case of shingles and did not restrict her contact with others, however the physician indicated that several cases were seen in the school system prior to the summer break. The product quality complaint unit was not involved. Additional information is not expected. The consumer also provided information regarding other patients' experiences while on treatment with varicella virus vaccine live (WAES #0706USA03851, 0706USA04140, 0706USA04141).
Pt developed hives to arms, legs, chest 15 minutes post vaccine. Given Benadryl 50 mg PO with no improvement after 30 minutes. Hives continued to appear and pt c/o headache, left arm pain. Pt taken to ER at medical center. Per mother of pt, he developed SOB, tight chest after arrival at ER and was given Epipen x 2 dose and oral steroids. Admitted overnight for obs and d/c 4/25/21. On 4/26/21, developed hives again and taken with ER.
significant pain and swelling at injection site, chills without fever, mild headache, slight cough, diarrhea
Headache, Myalgia, Arthralgia, Fever, very fatigued Narrative: Temp was 98.7F
Flu vaccine 12-05-12 pm; knew I was sick 12-09-12 pm; recovering 12-17-12. Started with pain across lower back & abdomen, fever 103 degrees, chills, shivering, then hot & perspiring, could not use muscles normally. Could not get out of bed, stumbled in walking; frequently could not answer the phone. 12-12-12 husband took me to Urgent Care. Diagnosis: viral infection. Weak; could not use muscles normally. Could not get out of bed most of the time. Sometimes got up after much effort, stumbled in walking. (Example: As I was trying to walk back to bed, holding on to a door facing, I went down head first into a wooden chair that had a cane seat. All my weight was on my forehead against the wood and rough cane seat. I was alone and could not use my arms or legs to get out of the painful position. Finally, I went to my knees to get the weight off my head. After much effort to get up, I stumbled to bed. I have never had this problem before. Sometimes I could not answer my cordless phone and cell phone that were on the bed with me. I had to change my gown and underwear frequently as it was wet with sweat. On Wednesday, Dec. 12, 2012 pm, my husband got me out of bed, dressed me, held me up to walk, and took me to Urgent Care, they swabbed my nosed to test for flu, took blood, and a urine specimen. They said the results were good. The doctor said I had a viral infection, needed to get the fever down, drink lots of liquids, try to eat, and drink chicken soup. I was too sick to tell him what was happening to me. They gave me a steroid shot in one buttocks and an antibiotic shot in the other buttocks. The steroid injection helped my walking, and I could get out of bed that night after the injection. The illness lasted approximately a week - until Monday, Dec. 17, 2012. On Dec. 17, 2012, I got out of the house and drove even though I had to gain more strength after that, but I felt I was recovering. I have never had symptoms like this. I do not take Flu shots until this time (12-05-2012). I don't think I will ever take another one. I am a healthy person, do not take any prescriptions, and do not have any medical problems.
Chills, fever, cold sweats, nausea, diarrhea, headache. All lasting @ 48 hours.
Shingles injection sight was large and swollen. Became ill three weeks later with shingles for months. Existing infectious disease Dr. who routinely does labs said my labs showed all viruses had returned after shingles shot and to report this for your records.
2 hours later after vaccination, patient started feeling uncomfortable.  She felt better the next day, but started having persistent symptoms on 06/30/21 with difficulty to take deep breath and felt uncomfortable in the throat as well.  Patient also felt dizziness on 07/01/21 - not anymore on 07/03/21. Provider scheduled a F/U visit on 07/05/21.  On 07/05/21 televisit, patient  chest discomfort persistent but stable; prev episodes of shortness of breath, throat discomfort, and dizziness still recurring intermittently. Provider recommended immediate evaluation; patient declined. Provider scheduled a F/U visit on 07/06/21.  On 07/12/21 televisit, chest discomfort persistent but stable. Patient was no show on 07/06/21 and self reported to ER. Patient stated that  easily fatigued and needing to take deep breaths; denied palpitations, LOC, MS change, or other neuro/cardio/pulmonary symptoms. Provider referred patient to F/U with cardiologist.