chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 68-year-old female patient. The patient had no concomitant medications, medical history and concurrent conditions. On 18-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, lot # 103820 with expiration date on 06-MAR-2019 (dose and route of administration were not reported). On 19-OCT-2017, the patient experienced bicipital tendonitis in her left shoulder and a moderate left arm pain which was severe at first, however at the time of the report it was mild and worsening at night, when the patient was lying and with movement. On 15-NOV-2017, a physician performed a shoulder test and a Hawkins test and both were negative. There was no evidence of muscle atrophy and no other muscle abnormalities. The events were treated since 11-DEC-2017, with a course of prednisone, which was ongoing at the time of the report. The relatedness between the events and PNEUMOVAX 23 was not reported.
Developed sudden pulmonary embolism on 4/5/21.  No DVT.  Very active pt.  Unprovoked
The morning after I received the vaccine I woke up and could not breathe out of my nose I was completely clogged up. My body hurts so badly that I could not take my dog outside to use the bathroom. I was hobbling around like I was 80 years old and I?m only 30. I was very emotional and had bursts of crying episodes. I have never experienced body pain like this. I had chills like I had a fever. I slept the whole day into the night.
TC from mom of pt on 8SEP93; stated pt had MMR in lt arm on 7SEP93; w/in 10-15 mins pt c/o lt arm being numb, cold to touch, unable to move from elbow to & including hand; pt MD notified;
Adverse (possible allergic reaction) to Moderna Covid vaccine. Member with multiple drug allergies and states history of anaphylactic reaction to "shot" in past. Received Moderna vaccine to left upper arm at approximately 5:41 pm - at 6:04 pm began to C/O itching to area around injection site that then began to spread to left arm and left upper anterior chest wall.  No visible hives noted.  No respiratory difficulty or facial swelling noted - Pulse = 78, RA O2 sat = 97%.  Pt transported to ACC via W/C for further observation.  Pt with personal walker , also transported to ACC with member.
A report has been received from a Health Professional concerning an 8 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST QUADRIVALENT started on 17-Oct-2013. It was reported that while administering FLUMIST QUADRIVALENT on 17-Oct-2013, a patient jerked and not all of the FLUMIST QUADRIVALENT was administered into the second nostril, a portion of the FLUMIST went into the face and eye. Patient has not had any symptoms or complaints from eye exposure. The first nostril was successful. FLUMIST QUADRIVALENT was discontinued on 17-Oct-2013. The outcome of the event of PATIENT JERKED AND SOME FLUMIST WENT INTO THE FACE AND EYE and NOT ALL OF THE FLUMIST QUADRIVALENT WAS ADMINISTERED is unknown. The report was considered to be non-serious.
lupus; tested positive for syphilis, but tested negative during the confirmatory test/ false positive may have been due to lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (COMIRNATY), administration date 01Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus"; TREPONEMA TEST FALSE POSITIVE (non-serious), outcome "unknown", described as "tested positive for syphilis, but tested negative during the confirmatory test/ false positive may have been due to lupus". The patient underwent the following laboratory tests and procedures: blood test: unknown result; syphilis: positive; negative, notes: tested negative during the confirmatory test. Clinical course: Patient recently had her yearly gynecology appointment where she did a blood test panel for STI. Patient tested positive for syphilis, but tested negative during the confirmatory test. Patient stated that the same sample was used for the blood test and the confirmatory test. Patient was told that the false positive may have been due to lupus and other things. Patient did her research and found the letter from the FDA and CDC online in Dec2021 about false positive results with patients who received the Pfizer COVID-19 Vaccine within 5 months. Patient wanted to know if Pfizer had more information about it. Patient stated that it's possible that she may have been the first to report this since it's not a common test.  The lot number for bnt162b2 was not provided and will be requested during follow up.
no adverse event; temperature excursion on MMR II 10 degrees Celsius/ had been administered to a patient.; This spontaneous report was received from a nurse and refers to a 12-month- old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 26-APR-2021, the patient was vaccinated with incorrectly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type rHA, lot # S037503 with expiration date reported on 04-DEC-2021, but upon internal validation it was established as 20-NOV-2021 (exact dose, route of administration were unknown) for prophylaxis. The vaccine underwent temperature excursion of 10 degrees Celsius for 11 minutes. No adverse events were reported. Digital data logger was involved.
pt recv vax 22OCT97 & started to ache @ 3AM some sharp pains, some dull extremely sensitive to touch from just above lt elbow to shoulder area;no redness where inj but large amount of swelling;c/o low grade fever, nausea & h/a;3AM till 12N;
Itchy red raised blister-like rash to (L) forearm and (L) chest, flank area. Denies pain, fever. Denies contact with other meds. irritants. Denies N/V/D.
Dizzy; Weak; Weird Feeling; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak), FEELING ABNORMAL (Weird Feeling) and NAUSEA (Nauseous) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weak), FEELING ABNORMAL (Weird Feeling) and NAUSEA (Nauseous). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weak), FEELING ABNORMAL (Weird Feeling) and NAUSEA (Nauseous) outcome was unknown.            She mentioned she is taking concomitant medication but no concomitant medications were mentioned. No treatment drugs were reported.
Pt states that arm that PNEUMOVAX was given was in the left arm and was extremely swollen and red. Pt went to dr today who states she got cellulitus and was given an antibiotic.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 12:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 12:58 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 68.48.   Concomitant products were not provided.  On 03-Nov-2021 Excursion time was 10:00 A.M., temperature was 35 degrees Fahrenheit, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Horrible headache Body aches Diarrhea Left arm was  swollen in injection spot and my armpit swell up too.  I could not lift my arm.    Symptoms lasted for about 24 hours and then I was fine, except for my arm and armpit.  They were still swollen, but I could lift my arm again..  My arm pit did go down a bit, but was swollen for about three days.
not able to mobilize; developed sores in her mouth; She can't eat; This is a spontaneous report from Pfizer. A contactable consumer reported for a female patient(mother) that. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: Not reported), via an unspecified route of administration on 17Jan2021 as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medication was not reported. she reports that her mom is not having a good quality of life, her mom is not able to mobilize on an unspecified date. she does not know what to do. she reports that the HCPs they have seen don't know how to resolve symptom or fix it. she reports she is aware of a similar situation that happened to a person. she does not know how to handle this; she is looking for some assistance on what to do for her mom. she would like me to email or get a hold to someone to get research because of the vaccine that her mom received was from Pfizer, or it will be a lawsuit. she would like to speak to someone else that could give her more information. she was not satisfied with response to question above she reports that if someone doesn't follow up within 24 hours that she will go to social media. Possible duplicate AE. Upon callback, caller clarified that 40 minutes after receiving the Pfizer vaccine, her mother developed sores in her mouth. She can't eat, it hurts to speak (that's what was meant by her mother is not able to speak) and they are getting worse. They look like blisters and it's only in her mouth on an unspecified date. Her quality of life is poor. She has been to the emergency room three times and has been given antibiotics, steroids and several different things and nothing seems to work. It has been seven weeks. She thinks it is Pfizer's responsibility to come up with a way to treat this since she makes the vaccine. The seriousness criteria are Disability for the event not able to mobilize. The event outcome was Unknown  Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information? No  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
still get sharp pain at the vaccination sites/in both arms at different times, not continuous; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:   A male patient received BNT162b2 (BNT162B2), as dose 1. single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (had a flu vaccine which was heavy/sore arm for about week and then it went away), reaction(s): "Sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "still get sharp pain at the vaccination sites/in both arms at different times, not continuous"; VERTIGO (non-serious), outcome "unknown". Therapeutic measures were taken as a result of vertigo.  Additional information: the patient looked into the list and had seen there were many that were also getting pain at the injection site. He stated with all the many vaccinations he had over many years, this was the only one that had done this. The pain was like a dull pain and it started after a couple of weeks after the vaccinations and has been continuing on since then and had not gone away which was disturbing for him. After he discovered what was going on with the vaccines he decided to go against it, he was not pleased with the results of this vaccine. He had vertigo and he was treated like he was a hypochondriac. He did the alpine maneuver, which was little crystals in the ears. It was horrible but it was little crystals in your ear canals they start to form and then it falls and it all your hairs, ears, and it made you feel like you were spinning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300079920 Same reporter/patient/drug/event, different dose;
somnolence w/inability to arouse x 7 hrs-11JAN93; inconsolable crying x 3 hrs 12JAN93; vax administered about 2 hrs prior to onset somnolence & 20 hrs prior to onset crying; no treatment given;
Patient is an 82 y.o. male who presented from Care Unit on 12/8/2022 with generalized weakness, cough, syncope. Found to be positive for SARS-CoV-2   Discharge Diagnosis and Associated Hospital Course   Acute respiratory failure with hypoxia COVID-19 infection  -Reporting cough wheezing generalized weakness.  Also had COVID-19 in September. -On 2 L NC on arrival. Started on Decadron; continue for 9 days total    Asthma with mild exacerbation -Due to COVID-19 infection -Continue inhalers and steroids   Vasovagal syncope -Reportedly several episodes at nursing home, likely in setting of infection and dehydration -BP stable at this time.  CT head nonacute -Orthostatics, continue gentle IV fluids -PT/OT consulted   Acute encephalopathy -Has baseline dementia however patient restless and agitated pulling at lines likely due to above. -CT head stable without any acute findings.   Elevated troponin -Chronically elevated at baseline.  Currently 40. -No acute EKG changes. -Serial troponin, monitor on telemetry -No further work-up needed   Paroxysmal atrial fibrillation -Follows with EP, Dr. Has ILR in place but nonfunctional per notes. CHA2DS2-VASc  3, on apixaban -Echo 4/2022 EF 75% grade 2 diastolic dysfunction. -Continue home metoprolol, Eliquis, and amiodarone   Vascular dementia History of TBI   - Living at memory care facility, requires full assistance, bed/wheelchair bound - Stable since admission - Continue home Depakote
Her left knee to her hip is completely numb/ It is sending a numbness and tingling sensation and she can not pick her foot up; It is sending a numbness and tingling sensation and she can not pick her foot up; Hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Sep2021 (Lot number: EW0186) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose no: 1), when the patient was 60 years old, for COVID-19 immunization, reaction(s): "Hot flashes", "Her left arm felt like a water balloon". The following information was reported: HYPOAESTHESIA (non-serious) with onset 18Sep2021, outcome "unknown", described as "Her left knee to her hip is completely numb/ It is sending a numbness and tingling sensation and she can not pick her foot up"; HOT FLUSH (non-serious) with onset Sep2021, outcome "unknown", described as "Hot flashes"; PARAESTHESIA (non-serious) with onset 18Sep2021, outcome "unknown", described as "It is sending a numbness and tingling sensation and she can not pick her foot up". Additional information: Patient who was in very good health, beside her left ankle that she injured that has a plate in it and she was now disabled. She considers herself a healthy girl and only takes a stupid cholesterol pill. She was not a person who does this. She received her first dose of the Pfizer Covid-19 Vaccine. She was normal, she experienced no other side effect than her left arm felt like a water balloon, but that went away after 4 days. But in turn, she began to experience hot flashes. A good amount of them during the day. They did start at night, when one would come on, she would rip her clothes off and check her temperature, but this was all coming from her inside. She added that they have subsided but do continue. She has never had a hysterectomy. She received her second dose on 15Sep2021, and she asked to receive it in her right arm because she is left-handed. She continues with her hot flashes after the second dose, but on 18Sep2021, her left knee to her hip was completely numb. It began as the size of an orange that was numb, but now the area was the size of a watermelon. It now runs into her ankle and foot. It was sending a numbness and tingling sensation and she cannot pick her foot up. She wants to nip this in the butt and not second guess herself. Caller was asking if any of the symptoms she has experienced have been reported by others.  No follow-up attempts are possible. No further information is expected.
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Flu like systems, chills, headache , fatigue . Next morning I had a headache for the rest of the day .
No additional AE reported; consumer received their 1st dose of GARDASIL-9 on 11/19/2021 and their 2nd dose on 12/3/2021; This spontaneous report was received from a nurse, referring to a 28-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 19-NOV-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # T030746, expiration date: 16-MAR-2023, dose, strength and route were not provided) for prophylaxis. On 03-DEC-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # T030746, expiration date: 16-MAR-2023, dose, strength and route were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event reported.
This case was reported by a healthcare professional and described the occurrence of shortness of breath in a 32-year-old male subject who was vaccinated with hepatitis B vaccine with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. On 05 October 2006 the subject received unspecified dose of Engerix-B in the left arm. On 05 October 2006, less than one day after vaccination with Engerix-B, the subject experienced shortness of breath, hive and hot flash. The subject was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the events was not reported.
Patient's arm is hot, red and painful. Patient realized of symptoms when she woke up the morning after the immunization was given. Patient will take BENADRYL tablets, use Hydrocortisone cream and ice packs for now. Advised to seek medical attention if reaction gets worse.
Lingering soreness (or swelling)  in left arm. I still feel tingling throughout the arm even after a month later.  While my arm feels somewhat  better now, it is still not at 100 percent prior to the shot.
TENDERNESS IN LEFT ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced tenderness in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tenderness in left arm was not reported. This report was non-serious.
Left upper arm below injection site is red\swollen\hard\hot. Approximately 11cm in length and 9 1/4 cm across. Given BENADRYL and tx with antibiotic prophylaxis.
Reported by mother: Took only 6 oz formula after vaccination at 06:00 today. Urine has had pink tinge color. Haven't given Tylenol even though temp over 100. Had had a different high pitch cry. Doctor felt that mild reaction, low-grade fever and fuzziness.
Around 2:00 am on July 31st, the gland located under the left arm in the armpit area started to swell up and was painful. It continued to become more swollen and sore as the day progressed. As of this time, it is still sore and painful and has not went away.  Also, on July 30th around 4:30 pm (less then 2 hours after receiving the vaccine) hives broke out on both legs below the knees to the ankles. This went away within approximately 3 hours later. I contacted The Little Clinic on August 2nd approximately 3:55 pm and informed them of the above. They recommended I report the event and said to call back on  August 4th if the gland was still swollen and they would write me a rx for steroids.