chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a 75 year old male patient with lung cancer who on an unspecified date was vaccinated with pneumococcal vaccine (MSD) injection subcutaneously, (lot number, vaccinated date, dose not reported). Other concomitant therapies included Influenza virus vaccine (manufacture unknown). On an unspecified date, in Hospital, the patient was vaccinated with PNEUMOVAX NP, subcutaneous and influenza vaccine at the same time. On an unspecified date, the patient went to the Hospital at first and he was hospitalized for only one day there. At that time, as creatinine phosphokinase (CPK) increased to around 20000 (the patient developed CPK increased), the patient was transferred to the reporter's hospital where the lung cancer was treated. On an unspecified date (about 3 days after vaccination), injection site swelling was found. When the blood test was performed, the patient was found that CPK decreased to 15830, C-reactive protein (CRP) was 17.6 (the patient developed CRP increased), white blood cell was 17700 (the patient developed white blood cell increased), procalcitonin and troponin T were positive, and pyrexia of 40 degree centigrade, so he was hospitalized. On unspecified date, the patient obtained an electrocardiogram for inquiring heart diseases such as cardiac infarction etc., but no special cardiogenic lesion was found. On an unspecified date, the patient developed weakness of the extremities. There was no strength of the whole body's muscle. When he lay down, he was unable to get up. About the injection site, compared with the site of influenza vaccine, the site of pneumococcal vaccine was more considerably swollen. On an unspecified date, the patient was on the way to recovering gradually (the patient was recovering from the injection site swelling, CPK increased, CRP increased, white blood cell increased, procalcitonin positive, troponin T positive, pyrexia and weakness of the extremities). The reporter's comment: the adverse effects which were occurred seriously may be caused by simultaneous inculcation, but the level of CPK value was considerably high. The reporting pharmacist considered that the CPK increased, CRP increased, while blood cell increased, procalcitonin positive, troponin T positive and pyrexia were serious due to hospitalization. The reporting pharmacist did not assess the seriousness of the injection site swelling and weakness of the extremities. The reporting pharmacist did not assess the relationship of injection site swelling, CPK increased, CRP increased, white blood cell increased, procalcitonin positive, troponin T positive, pyrexia and weakness of the extremities to pneumococcal vaccine. Additional information was not expected as the reporter did not wish to be contacted.
Information has been received from a physician concerning a 10-year-old male who was vaccinated with a dose of Varivax. Subsequently, the patient experienced "a lot of soreness in the arm after injection". Unspecified medical attention was sought and the physician indicated that everything was fine after ibuprofen and a cold pack. No further information was available at the time of this report. Additional information has been requested.
24 hours after vaccine, baby woke up paralyzed on left side. 5 days later seizures and bleeding in the brain. Hospitalized for 5 weeks. Given steroids and seizure meds. Diagnosed with ADEM.
patient was due to receive the second monovalent vaccine to complete initial series but received a bivalent pfizer instead. pt shows no ADE
Next day after vaccine: chills, headache, muscle pain Not capable of functioning normally 5 days after: hives along left lower back to side of buttock
Clinic (walk-in) visit with complaint of rash to forehead and anterior/posterior trunk on 4-30-2021.  Inmate reported rash began on 4-29-2021.  25mg Benadryl administered PO and pt referred to provider for follow up.
after 1/2 hour, had numbness that went up my left arm, shoulder, neck and face.  Lasted for about an hour.  within a week it felt like I had aged 10 years.  Joint pain all over.  Started having heart palpitations every few days.  Felt like I was having a heart attack.  After I got my second shot on 04/29/2021 (Moderna .5ml, lot 019B21A, right arm) it was worse.  Same thing happened with the numbness and the next day I couldn't get out of bed.  Heart thing happened more frequently.   Very painful.
Within hours of vaccine receipt, he developed a headache. The headache got worse and peaked the next afternoon. (mild pain - 2-3/10 - but tightness/pressure type pain around his head was intense). The a.m. of 10 Oct he noted difficulty finding words and felt like his speech was slow. No slurring or difficulty understanding words. No other accompanying symptoms. Symptoms have now resolved. Seen by neurology on 10/17/07. No history of headaches.
extensive swelling of vaccinated limb; raised red area around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 5JX9Z, expiry date 5th November 2021) for prophylaxis.   On 21st July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The pharmacist reported that the patient received Shingrx and experienced raised red area about 4 inches in diameter around the injection site. There is discrepancy between the vaccination date reported in the structured field (22nd July 2019) and the vaccination date reported in the source document (21st July 2019).
Extreme fatigue - days 2-7 after vaccine  Prolonged dizziness - comes and goes - not only from standing up too quickly - starting 4/14 - can be anything from momentary to 30 minutes.  Occasionally fainting. Fainting - starting 4/14 - following dizziness - has happened 4 times  Tinnitus - starting 4/14 - comes and goes - severity/loudness increases before dizziness
the reporter stated that an unk number of patients devel an inj site rxn, including rash @ inj site, p/vax;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  An 84-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "known allergies: Xarelto" (unspecified if ongoing). There were no concomitant medications. No other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 02Aug2023 to 06Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Additional Details: He said he was so exhausted he slept through  the night which is not normal for him.
This spontaneous report was received from a medical assistant, refers to 4 year-old patient of unknown gender. Medical history and current conditions were not reported. Concomitant medications include sterile diluent. On 18-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, exp. date: 24-APR-2018, albumin status: rHa; M044719, exp. date: 07-MAY-2018, albumin status: rHa) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccines were stored under temperature from -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. Previous temperature excursion included: -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. The outcome of events was unknown. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA001467: US-009507513-1709USA005542: US-009507513-1709USA006806: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1708USA001338: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820:
Pain in my upper right arm, shoulder, and into my neck; Pain in my upper right arm, shoulder, and into my neck; Pain in my upper right arm, shoulder, and into my neck; Soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness around the injection site), PAIN IN EXTREMITY (Pain in my upper right arm, shoulder, and into my neck), ARTHRALGIA (Pain in my upper right arm, shoulder, and into my neck) and NECK PAIN (Pain in my upper right arm, shoulder, and into my neck) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Soreness around the injection site). On 19-Sep-2021, the patient experienced PAIN IN EXTREMITY (Pain in my upper right arm, shoulder, and into my neck), ARTHRALGIA (Pain in my upper right arm, shoulder, and into my neck) and NECK PAIN (Pain in my upper right arm, shoulder, and into my neck). The patient was treated with HYDROCODONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Soreness around the injection site), PAIN IN EXTREMITY (Pain in my upper right arm, shoulder, and into my neck), ARTHRALGIA (Pain in my upper right arm, shoulder, and into my neck) and NECK PAIN (Pain in my upper right arm, shoulder, and into my neck) outcome was unknown.            No relevant concomitant medications were reported.
Mother called 4/15/11 at 11:05am & states "(L) leg (outer thigh) red area (size of baseball). Warm to touch at injection site of KINRIX given on 4/13/11. Recommend BENADRYL 3/4 tsp bid x 1 week. Warm bath or compress & alternate cool compress for 5-10 min. TID. Also follow up on Monday or ASAP if site does not improve. Verbal understanding acknowledged.
Heart palpitation and flutters for several months. No treatment. Stopped after several months.  I sent a message to the primary care doctor and they suggested monitoring at home if no shortness of breath.
Patient reports he felt nauseous and dizzy after 1st dose.  He drank water and after 15 minutes, he felt better.    On the 2nd day, he felt better.
I gave the patient 2 immunizations, Pneumovax 23 and Shingrix, in the same arm.  While injecting the Pneumovax 23, it felt like I hit something going in so I slightly withdrew the syringe.  A very small amount of vaccine (clear solution) squirted out.  The patient started bleeding immediately after I withdrew the syringe.  About 30-60 minutes later, the patient's daughter called and stated she had a hematoma the size of a quarter.  Patient did receive some Tylenol for her slight pain and has been putting cold compresses on the site.  No other adverse reaction were noted.
Pt received INFLUENZA in right deltoid, PNEUMOVAX in left deltoid. Provider noted reaction in right arm. Requested ADR be filed to PNEUMOVAX. Redness, swelling, warm to the touch. Diphenhydramine 1 tab at bedtime.
Second dose: left facial numbness; Second dose: tired; Second dose: pain in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 16:00 (Batch/Lot number: unknown) 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 number-1), for Covid-19 immunization, reaction(s): "she was a little bit tired", "she experienced some soreness of the left side ". The following information was reported: FATIGUE (non-serious) with onset 21Apr2021, outcome "unknown", described as "Second dose: tired"; PAIN IN EXTREMITY (non-serious) with onset 21Apr2021, outcome "unknown", described as "Second dose: pain in her arm"; HYPOAESTHESIA (non-serious) with onset 27Apr2021, outcome "unknown", described as "Second dose: left facial numbness". The events "second dose: tired", "second dose: pain in her arm" and "second dose: left facial numbness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoaesthesia.  Additional information: Caller explains she had the second dose of the Pfizer Covid-19 vaccine on 20Apr2021. One week later, she felt numbness on the left side of her face. She had to go to the doctor last week to get some medications. The doctor asked her to call Pfizer and report it.  She feels a little bit of numbness now but she was trying to see if its getting better. She has never experienced this kind of issue before. She clarifies the next day after receiving the second dose, she felt regular side effects- she felt tired and had pain in her arm, that's about all. She confirms she got better. After one week, she clarifies, starting on 25Apr2021, she had left facial numbness. She went to the doctor on 26 Apr 2021 and got some medication. She clarifies she was prescribed Prednisone only for 3 days. Attempted to clarify dose and frequency in which it was prescribed and the caller explains she was prescribed 2 doses each day. When probed for the outcome of the left facial numbness, caller explains it got better last week. She has a little bit of numbness again this week. She has a little bit of numbness this morning and she is looking to see if it has gotten better or not.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3-5 min (R) focal seizure 7 hrs. after vaccines. PE showed T 101.4 (was 102 at daycare), blistery pustular pharyngitis. Probable first febrile seizure.
Day 2 started having extremely dry eyes and eye pain. Day 3 dry eyes, extreme bloodshot right eye, eye pain in both eyes, sore left arm. Day 4 bloodshot eye gone. Lymph edema in left arm, eye pain both eyes, dry eyes. Day 5 lymph edema left arm. Eye pain both eyes. 6:00 PM started seeing streaks of light in peripheral vision of right eye. Day 6 went to my primary care doctor and lymph edema was confirmed. I was referred on an ophthalmologist for flashes of light in right eye. Day 7 was diagnosed with Posterior Vitreous Detachment. Woke up the next day with extreme light sensitivity and eye pain which lasted all day and night. Doctor could not explain what happened.
Per pt, she stated to person vaccinating that it was too high as she was applying alcohol swab on her shoulder.  Person vaccinating said it was in the right spot and proceeded to administer flu shot.  Pt states vaccination was very painful.  Pt has had to go to physical therapy since she still has pain and is unable to move/lift her arm like normal.
09-20-06 Immunization with Prevnar, Pediarix, Ped VAX.  09-21-06 Developed elevated temperature 101.9.  Severe irritability, uncontrolled crying for 24 hours.
25APR91 @ 1030PM approx 48 hrs post vax pt taken to ER sx of crying, t104; Dx sl ear infect; tx Ceclor TID; Fever broke pt recovered; Mom reported 3MAY91;
Syncopal episode in bathroom when trying to get into shower.  Felt dizzy,fell,hit top of head on sink, LOC for approx 45 seconds.  Arrived at office dizzy and hypotensive.  Drank 2 Liters of gatorade, observed for 1 hour, felt better and BP increased to 102/65.  Discharged home.  F/U later in evening doing well, no temp or dizzyness.  10/14/09 Received medical records. Date of Service 10/6/09. Dx:  Severe Vaccine Reaction. Presenting sx:  Pt. woke up and experienced dizzyness in the bathroom.  He had an episode of syncope and hit his head on the sink.  He presented with a headache, paleness,  fever, and unstable hypotension.  He drank 2 Liters of Gatorade and was walking and feeling good at time of discharge from physicians office an hour and 20 minutes later.
Patent had nausea, vomitting, shortness of breath, and dizziness ,,, adverse events occur a few minutes of getting shot. and adverse reaction lasted for 5 minutes. and after that she was feeling fine. And also patient said that adverse reaction may be due to low blood sugar.
Pain in arm started a couple of hours after the shot. Continued for 2 more days. Very painful, barely able to raise arm or rest on the right side of body. Achy bones, chills, and fever began several hours after the shot and continued for the next day. Fever of 100+ during the first night and partly through the next day. Intense nausea the first night and the day after the shot, including throwing up. Symptoms alleviated with tylenol.
Patient up to date on Moderna COVID vaccinations who was mildly symptomatic for COVID at home - but admitted for GI bleed.  Provider d/c note below:  "49 YO female with PMH of PUD, multinodular goiter and GERD who presented to hospital's ED for evaluation of recurrent syncopal episode and melena. However, on Friday, she developed symptoms of mild sore throat, nonproductive cough, coryza and nasal congestion. The patient also had a low-grade fever of 99.8° F and some chills.  She also notes that her epigastric pain has worsened and has become more constant in nature.  She did a home kit for COVID and came back positive. She reports she started having melena on 05/27 and went to an ED where she was evaluated.  She presented to them that time the stool that she saved.  She was found to have an acute blood loss anemia but hemodynamically stable with H&H at 9.8 g and 29.4% hematocrit. After she left the hospital, she had 2 episodes of syncope, after the second one, she ended up in the tub but she did not have a major injury as the husband was right there.  She apparently was out for a good 2 minutes. The husband described that at both times that she passed out 1 after the other, she was very pale, clammy and just did not look good. She was then brought to the emergency room by EMS after her 2nd syncopal episode. Upon arrival, her blood pressure was 91/43, heart rate of 79, respirations of 20 and temperature of 36.4° C. ED labs showed Hgb 6.7 and  She received 1 unit transfusion and hospitalist service asked to admit patient for further monitoring. GI consulted and EGD revealed clean based ulcers without evidence of active bleeding or old blood seen. Small hiatal hernia also seen.  She received 5 units pRBCs and hemoglobin stabilized. A head CT was completed which revealed no acute abnormality.Telemetry was normal sinus rhythm. She was evaluated by our therapy teams and deemed to go home independently.   She is to start iron supplementation every other day. She is to continue BID PPI for 8 weeks with close up with doctor for repeat EGD and continued monitoring. She is discharged home in stable condition.  She is to obtain CBC prior to her upcoming PCP appointment."
Seen ER 2/7/22 by Dr, sudden onsent of pleuritic chest pain, positional , sharp stabbing left side check with numbness radiating into left arm, hurts when pushes on chest or takes deep breathe, no previous history of or of pericarditis, long history of abdominal pain for few years, CXR no acute findings, beside ultrasound shows no pericardial effusion, troponin mildly elevated, D-dimer negative, EKG shows no new ischemia, case discussed with cardiology Dr, no regional beds available to admit, discussed with pt, fiance and mother, discharged with close follow up, Toradol IV given with decrease pain, outpt. echo in next day or two, trend toponins as outpatient, ibuprofen for pericarditis,