chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the consumer is not able to gain weight, has fallen below the 'failure to thrive threshold'; diarrhea; This spontaneous report as received from a family member via a company representative refers to a 5-month-old male patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number, expiration date, dose and route of administration were not provided).  On 14-AUG-2020, the patient experienced side effects. He was not able to gain weight, fell below the failure to thrive threshold and experienced diarrhea.  The outcome of failure to thrive and diarrhea was unknown.  The relatedness between the vaccine and the events of failure to thrive and diarrhea was not reported.  Upon internal review, the event of failure to thrive was determined to be medically significant.
Initial misuse report received from a healthcare professional on 22 May 2013. A 0.5 ml dose of ADACEL was administered to a patient intradermally (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
headache; stiff neck; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (also reported as "on Tuesday") at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter's uncle (patient) experienced bad headache and stiff neck on an unspecified date. The outcome of the events was unknown. Information on the /batch number has been requested.
Patient came in for yearly check and parent wanted to give the Moderna Covid vaccine this was the patient's first dose. The dose that was given was 0.2 mL from the vial with the pink cap which was the bivalent dose. That was also the only vial we had for the 6month-5year age group. the patient should've been given 0.25 mL from adult via.
20MAR97 mom took pt to clinic stated pt had been vomiting & having diarrhea almost immed p/vax;pt temp 103;was dehydrated;adm to hosp 20MAR97;mom states had vomited 1x in morning a/vax that afternoon;
pt recv vax & pt awoke w/ 10-20 vesicular lesions;some had already broken open & scabbed;pt had greater than 150 lesions all together;
Information has been received from a nurse concerning an 18 year old female patient who on unspecified dates was vaccinated with the first and second dose of GARDASIL (lot number not reported). On 19-OCT-2009 the patient was in the office for the third dose of GARDASIL (lot number not reported). The patient was currently on long term COUMADIN therapy after a blood clot in her lungs 3 weeks ago (September 2009). The patient's COUMADIN levels were stable. Unspecified medical attention was sought. At the time of the report, the outcome of the patient was not reported. Upon internal review, blood clot in lungs was determined to be an other important medical event. Additional information has been requested.
Rash on back, stomach, scratching arms. Given Benadryl to relieve symptoms.
started that evening with dizziness/fever 101/ chills/ muscles body aches. headache(bad) nausea (vomiting the next day) severe exhaustion, brain fog.  These symptoms persisted 3 days, seemed to be getting better then another round of teeth chattering chills on day four with recurring fever, headache same symptoms as day 1.  Day 5 better but still  feeling extremely tired muscle aches lingering headache low grade fever 99.5.  Day 6: same as day 5.  Tomorrow will be day 7
Extremely swollen left breast, the same side of vaccination. Breast is double the size and double the weight and extremely painful. Lymph nodes are NOT swollen, right breast is NOT swollen. Swelling started shortly after vaccination and have continued 3 days later.
Am vaccination IM per RD. Immediately felt flu like sx and had R axillary node enlargement. T to 101.6
fever 101.50; chilling; little dificult to breath; Like flu symptoms; Like Covid symptoms; very intense coughing for 4 days; This is a spontaneous report from contactable consumer, the patient. A 36-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the right arm on 26Apr2021 at 15:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were none, the patient did not receive any other medications within 2 weeks of the vaccine. The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On an unspecified date (reported as 07Apr2021), the patient experienced COVID like symptoms, very intense coughing for 4 days, fever 101.50, chilling, a little difficult to breath, flu-like symptoms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of COVID like symptoms, very intense coughing for 4 days, fever 101.50, chilling, a little difficult to breath, flu-like symptoms was unknown.
Shoulder/arm (left arm) sore/stiff MD put patient on prednisone 11-18-2014 and physical therapy.
Patient developed an itchy red rash on his upper torso. No vesicles present. Also had URI with sore throat. Did have contact with chlorine at amusement park and he has sensitive skin. Resolved on own.
1015 c/o chest heaviness, scratchy throat, heart racing states injection site feels warm. taken to cot to monitor VS 173/86 P 126  RA100  States worked last night, drank Monster drink, tired and little anxious.  1020  states sx are decreasing VS 143/85  94 100 RA  sitting up drinking juice and eating granola no distress noted 1035 states throat is little scratchy still given Bendadryl 25 mg PO per VO Dr. no distress noted, very calm states some chest heaviness 1/10 pain scale denies any other sx at this time sitting on edge of bed  1048 BP130/73  87 100RA  pain 1/10 chest discomfort decreased, denies HA, SOB, states throat still little scratchy but not bad at this time denies any pain at site. Site is warm to touch denies any pain at site no redness noted at this time 1100 BP 125/79 82 100 RA denies pain 0-1/10 sitting up states feeling much better denies pain in chest, minor scratchy throat but relieve 1115 Monitored for 60 minutes  released to girlfriend  given instruction to go to ER if any other sx.
My vocal chord on left side is paralyzed.  I became hoarse about a week after vaccine and went to Dr a month later when voice had not returned.
After vaccination client immediately turned pale with bilateral hand clenching.  Client laid down on the floor while concious AOx4, legs raised, 4 sets of vital signs taken, ice packs used.  No swelling of the face or tongue.  Clients hands massaged to relieve cramping.  EMS called and arrived on site at 5:05pm.  At that time client was able to sit up in chair no complaint of dizziness.  Clients hands unclenched was able to move fingers on command, able to stand and without assistance and verbalized no shortness of breath or pain.  EMS took vitals and fingerstick. EMS recommended follow up lab work at the hospital.  Legal guardian and patient refused.  Signed AMA form.  Client walked out with legal guardians, EMS and nurse to their car to go home in no visible in distress.
Later the day of dose 2 the patient developed a hard knot in the right upper inner arm. The know lasted several days. There was no redness, warmth or swelling.  After the knot resolved the patient experiences moderate to severe pain in the right deltoid.
Chest discomfort left side sharp in nature for about 2 weeks following vaccine. Worse with activity. Went away before second shot then returned for a shorter time (about one week) less severe following second shot
This spontaneous report was received from a medical assistant and refers to a 31 year old patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 05-JUN-2018, the patient was inadvertently vaccinated with an expired dose of PROQUAD subcutaneously, lot # M044720 and expiration date: 07-MAY-2018 (dose and frequency were not reported). No adverse event was reported. The outcome of events was unknown.
Approximately 30 hours after receiving a vaccine series, the patient had a 20-30 second episode of "eye blinking" and drooling as well as "jerking" arms and legs. The episode was self limited, with no obvious sequelae.
Hives/Urticaria.  Occurred after first shot and booster, but not second shot
post 2nd pfizer dose, in observation, ct developed few red patches <1/2" in diameter on throat, denied all-SOB/swelling lips/tongue/face, denied all-N/V/D, ct reported ' this happens to me periodically w/ no known cause and resolves on own within an hour. 04/16 & 4/23-attempted to call, no ans, left msg to call back, not yet heard back from ct.
Developed left subclavicular lymph node 2 weeks after vaccines that is still present, but smaller. Also developed left subclavicular lymph node after her smallpox vaccine in 2006 that remained for several months. Seen by General surgery which believed the node to be low risk and deserved watchful waiting.
Hospitalized;  COVID-19 positive;  Fully vaccinated (J&J x1 dose);  started Pfizer series (only 1 dose prior to J&J);  no booster Discharge Provider: MD Primary Care Provider at Discharge:  DO  Admission Date: 2/16/2022 Discharge Date: 2/23/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute on chronic respiratory failure with hypercapnia (HCC) [J96.22] HOSPITAL COURSE: Patient is a 67 y.o. male with medical history of stroke without residual deficit suspected possible TIA, cardiomyopathy, heart failure with both systolic and diastolic component, chronic obstructive pulmonary disease, gout, morbid obesity, and is currently in AFib with RVR  presents today with from home with bleeding in his left ear.  He states he felt something wet in his ear and his home healthcare nurse sent him to the hospital.  Ear was inspected and there was just a small excoriation.  When probed deeper, patient stated that he has been progressively worse lung function and difficult time standing to even do self-care.  While speaking to the emergency room physician, he lost peripheral view in the left side.  Stated that this has happened to him the past and resolved.  Consulted Neuro.  Hospital group accepted patient for TIA workup and acute on chronic respiratory failure with hypercapnia in the setting of COVID-19 positive,  acute on chronic heart failure, and a flutter with RVR. Reports that while in the ER, the patient lost left-sided peripheral visual field leaving him with an and NIHSS score of 1. Upon assessment, he had no deficit in vision.  He stated this has happened to him multiple times in the past and quickly resolved.  Working diagnosis, possible TIA in the setting of a history of a CVA without residual effects.  MRI imaging unobtainable related to severe Orthopnea and body habitus.  Carotid Dopplers were performed which did not reveal any significant stenosis.  Follow-up CT scan was negative as was  CTA head and neck.  Neuro felt he may have had a TIA.  Echocardiogram showed reduced ejection fraction.  He was diuresed with intravenous Lasix and made steady improvement.  Oxygen was able to be weaned down to 2 L which is his baseline. His renal function improved. Regarding his COVID he was treated with steroids; he was outside the window for treatment with remdesivir.  It was felt his respiratory symptoms were more likely related to COPD and CHF exacerbations.  It was felt that he needed aggressive diuresis.  Lasix was increased and fluid restriction increase to augment diuresis.  His edema steadily improved and his respiratory function also improved. Patient was discharged home on oral Lasix 40 mg 2 times a day increase from his home dose in stable condition after adequate diuresis.
Information has been received from a 65 year old female with sinus problems, reactions to steroids, antibiotics and certain vaccines, and allergies to aspirin, NAPROXEN and environmental allergy and a history of "getting sick" for 3 weeks on the flu shot (manufacturer unspecified, who on 29-JUL-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included estrogens (unspecified) (hormone replacement therapy-HRT). On 30-JUL-2008 the patient experienced sneezing, coughing, sore throat, flu symptoms, headache, arm redness, joint pain, achiness ant hurting. The patient did not seek medical attention. At time of reporting, the patient was recovering. This is one of two reports from the same source. No further information is available.
After getting the ZOSTAVAX INJ to prevent shingles, on Jan 29, 2016 - I suddenly lost vision due to what may be "Macro Pucker". Symptom in the right eye became solid blocking a quarter percent of the upper right quadrant of the eyes vision. This became permanent after 3 weeks following the injection as a possible immune reaction in the eyes defense.
These symptoms were all for 24 hours:  Fever (started in the morning at 100.5, rose to a high of 101.5 throughout the day and night), headache, muscle aches, joint pain,  eyeballs were sore, site injection pain, sweats, chills, could barely move, loss of appetite.  Those symptoms have gone away now on Friday morning around 9:30am and I feel exhausted.
she felt her heart pounding; she felt fatigue currently; Initial information received on 21-Dec-2020 regarding an unsolicited valid non-serious case from other health care professional.  This case involved a female patient of unknown age who felt her heart pounding (palpitations) and she felt fatigue currently (fatigue), while she received vaccines INFLUENZA VACCINE.  Medical history included Drug hypersensitivity (Penicilin, ampicillin- rash mussels, bronco constriction, Pruritus (Itch figs- nausea, vomiting, dizziness, elevated heart grass- welts), Asthma [asthma environmental triggers (flower, perfume, chemicals, soli, grass)]( and Breast cancer in 2005 [breast cancer left (had radiation and tamoxifen)].  Past vaccination(s) included INFLUENZA VACCIN in 2010.  Past medical treatment(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) patient felt her heart pounding (palpitations) and she felt fatigue currently (fatigue) following the administration of suspect vaccine.  Relevant laboratory test results included: Blood pressure measurement - on an unknown date: 151/113 [units unknown]; on an unknown date: 151/112 [after 10 mins]; on an unknown date: 125/68 [recheck at 20 mins] and Heart rate - On an unknown date: 158 [units unknown]; on an unknown date: 126 [units unknown]; on an unknown date: 88 [units unknown].  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
The shot was very painful.  My arm was sore after receiving it.  That same day my arm continued to get sorer.  As days went by, the pain got worse radiating up and down my are from the site of the injection.  My arm kept hurting worse.  It moved up my arm and into my shoulder and has now gotten to the bottom of the back of my neck.  It is a terrible throbbing pain and keeps me up at night and interferes with almost everything I do.  My arm has become very weak.  I have gotten to the point where is is very hard for me to drive.  I cannot park my car in my designated parking spot where I live.  I cannot open and close my car door with the arm I am writing about.  I have trouble dressing because raising my arm makes the pain unbearable.  I can move it in some directions without pain.  The pain is getting worse and not better.  It is progressively whittling away at my ability to carry on daily responsibilites.  I have seen my doctor and been in physical therapy.  The therapy has not done any good.  I go back to see my doctor tomorrow.  I think she will order and MRI and send me to an Orthopedist.  That is what she mentioned at my last visit.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012718 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Pt returned to site of clinic with c/o "I don't feel good". It was warm and she had a fleece jacket on. Evaluated for s/s. No difficulty breathing. No redness at site. BP 110/60 P68 Reg and strong. At 4:15 Left feeling better. cold pack to site and 1 to take with her.
Patient takes COUMADIN within a day following the vaccination, the patient's arm bruised across the entire upper arm becoming bluish-purple in color. Her arm was very sore for several days. Patient went to PCP & nurse told her that the VA should have used a shorter needle & did not hold the needle in the arm long enough right arm.
HAD SEVERE PAIN IN ARM, SHOULDER, AND  INTO NECK AND NUMBNESS ANDFT INGLING IN ARM ALL NIGHT ABOUT 6 HOURS AFTER GETTING THE VACCINE. WAS NOT ABLE TO SLEEP, MOVE THE ARM WITHOUT PAIN, AND IT WOULD WAKE ME UP. TOOK IBUPROPHEN 400 MG EVERY 12 HOURS, DID NOT HELP. ALSO RUBBED DEEP RELIEF ESSENTIAL OIL ON THE AREA, TO HELP WITH PAIN. HEADACHE ACCOMPANIED THE SHOULDER/ARM PAIN, AND NAUSEA THE FOLLOEING DAY AND FOGGY HEAD, FATIGUE.
Patient had administered the Moderna Covid 19 vaccine after temperature excursion; Patient had administered the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had administered the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient had administered the Moderna Covid 19 vaccine after temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient had administered the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had administered the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had administered the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient had administered the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022.Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion.and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and No vaccine state change was observed.  No treatment medication were reported.   This case was linked to MOD-2022-591989 (Patient Link).
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient states that she received flu shot 10/27 and waited in clinic after it (while getting x-rays).  She states she "passed out" in car on the way home and got into a motor vehicle accident.  She has not been examined since then-declined office visit and refused triage.  I'm not sure about if she sustained injuries in the MVA.
Sore arm at injection site for 2 days post vaccine. Large red, raised rash extending from the upper right arm (injection arm) down to the elbow, wrapping around the outer part of the arm appeared on Day 8 (4/13/21) at approximately 1845. By 0700 on 4/14/21 the rash was about 1/4 of the size, focused closely around the injection site. The rash was still raised, red and now itchy.   An additional and perhaps related adverse event was the start of menstruation approximately 3-4 days before the normal start date.   As both of these reactions are still on going, I can not report the outcome.
Pt recvd vax & had apneic episode & was cyanotic, given 02 & revived; mins later had 2nd episode; pt intubated; HCT 18; pt transfused; extubated 27MAY93;
became "really sick."; This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by the friend of the patient. The age at vaccination was not reported. The reporter stated that, the patient received the Shingrix vaccine and the flu (unknown manufacturer) vaccine and became really sick. No patient identifiers were provided. The reporter did not consent to follow up.  The reporter declined to provide health care professional information. This is US2021170654 linked  case, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170654:Same reporter