chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warm surge through the body; Broke out in sweat; Tingling in tongue; Tingling of upper lip; Tip of tongue felt funny; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm surge through the body), HYPERHIDROSIS (Broke out in sweat), PARAESTHESIA ORAL (Tingling in tongue), PARAESTHESIA ORAL (Tingling of upper lip) and PARAESTHESIA ORAL (Tip of tongue felt funny) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Warm surge through the body), HYPERHIDROSIS (Broke out in sweat), PARAESTHESIA ORAL (Tingling in tongue), PARAESTHESIA ORAL (Tingling of upper lip) and PARAESTHESIA ORAL (Tip of tongue felt funny). At the time of the report, FEELING HOT (Warm surge through the body), HYPERHIDROSIS (Broke out in sweat), PARAESTHESIA ORAL (Tingling in tongue), PARAESTHESIA ORAL (Tingling of upper lip) and PARAESTHESIA ORAL (Tip of tongue felt funny) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
A 9-year-old patient was administered her second dose of the Pfizer Covid-19 vaccine today. The patient was incorrectly given an adult dose of the vaccine (0.3 ML). The patient did not have an adverse reaction to the vaccine after 15min grace period. The patient's mother is aware of the error and has been informed to watch for any adverse symptoms.
63YM whot presented to outside facility with a chief complaint of 3 months of hemoptysis.  Along with this he had shortness of breath.  He reportedly had Moderna COVID-19 vaccination 7 days prior to the onset of the symptoms.  At one point in time he was seen in the ED or urgent care and told he had pneumonia and was placed on antibiotics.  He later saw his primary care provider at some point in time.  A CTA of his chest was ordered, but due to an insurance issue he was unable to obtain this study until a later date.  Ultimately when CTA of the chest was performed, it identified bilateral pulmonary emboli with scattered infarcts.  Etiology for the VTE was not clear.  He indicated he had never had a colonoscopy and therefore will need to follow up with his primary care provider to ensure he is up to date.  Hypercoagulable panel is pending at the time of discharge.  He was seen in consultation by Pulmonology, who recommended lifelong anticoagulation.  He is being discharged on Eliquis therapy. Due to hypoxemia that is most prominent with exertion, he will be discharged on 3 liters nasal cannula continuously.  Anticipate his drive home to a lower elevation will result in improvement in his oxygen needs; however, to what degree it is not known.  Discharged home on 7/5/21
C/O red, swollen and painful at site started itching 1 hour after injection. C/O not feeling well such as joint aching and fatigue.
Patient developed facial tic. Patient now has persistent exaggerated eye-blinking tic throughout the day.
Patient developed herpes zoster (shingles) on right lateral thigh 2 days after vaccination with Varicella. He recovered well on Acyclovir treatment for 1 week.
Information has been received from a physician concerning two patients who were vaccinated with doses of ROTATEQ.  Within 72 hours of vaccination, the patients experienced a high fever and were both seen at the same emergency room.  Subsequently, the patients recovered.  There was no product quality complaint.  No further information was provided.  Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful.  No additional information is expected.
After 1st dose, patient only experienced small pain in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After 1st dose, patient only experienced small pain in the arm of injection) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01DA2ZA) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (After 1st dose, patient only experienced small pain in the arm of injection). At the time of the report, VACCINATION SITE PAIN (After 1st dose, patient only experienced small pain in the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
dose number=2 vaccine date=18May2021/ Dose number=1 Administration date=18May2021; Hypertension hard to control/Was on one pill now have to take 5 and it's still high; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 18May2021 at 13:30 (at the age of 48-years-old) in left arm as a single dose for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0217) via an unspecified route of administration on 18May2021 (at the age of 48-years-old) in left arm as a single dose for covid-19 immunization. Medical history included borderline high blood pressure (never triple digits top and bottom) from an unknown date and unknown if ongoing. The patient previously took codeine and experienced allergies. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient's concomitant medications included unspecified pill for hypertension. The patient received both doses 1 and 2 on 18May2021 (coded to overdose). The patient experienced hypertension which was hard to control on an unknown date in 2021. She was on one pill and had to take 5 and still it was high. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was treated with a lot of hypertensive medication. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date in 2021. The outcome of the event hypertension was not recovered and for overdose was unknown.  No follow-up attempts are possible. No further information is expected.
Sunday, September 11 nerve ending pain is bottom of feet and upper and lower tooth nerve pain  Monday, September 12 Extreme upper and lower tooth nerve pain, ear pain - both sides, and bottom of feet pain, September 13 early morning upper tooth nerve pain and continuing as of this writing.
how soon they can give another dose of MENACTRA to a patient that was given an expired dose today.; Initial information received on 04-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who experienced how soon they can give another dose of Menactra to a patient that was given an expired dose today while receiving vaccine meningococcal A-C-Y-W135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meningococcal vaccine b rfhbpa/fhbpb (Trumenba) for Immunisation.  On 04-Mar-2022, the patient received 0.5 ml of suspect meningococcal A-C-Y-W135 (d conj) vaccine(formulation unknown) via intramuscular route in the right deltoid (batch number: U6827BA and expiry date :18-Feb-2022) for immunization.   On 04-Mar-2022 (latency: same day)the patient developed a non-serious event of how soon they can give another dose of menactra to a patient that was given an expired dose today(expired product administered) following the administration of meningococcal A-C-Y-W135 (d conj) vaccine   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hives - redness, bumps, and itching on hands, back, chest, and face.
Approximately 8 days after 1st shot, my upper left arm started to get itchy. After another day, the area around the injection site was hot and hard to the touch. I thought it was a spider bite and the itching persisted. The affected area was red and approximately 4 inches in diameter. My doctor advised me to take Advil and give it a day or two. The itching, redness and swelling disappeared after two days.
Patient stopped at the health department on 3/18/21 and spoke with the secretary stating that he had a blood clot on 2/26/21  after receiving the covid vaccine. She took his information and RN followed up with him on 3/19/21. Patient states he had a blood clot in his left leg a few years ago and on the 26th he experienced the same pain as with his original blood clot. He said it was 10/10 pain in his left leg from just above the knee to right above the ankle around the whole leg. He states it felt warm. He did not speak with his doctor or seek any medical attention. He states he "suffered through it" and it went away after a couple days.
It was reported that a 41 year old female received Fluzone SV '99-'00 on 10/12/99. She experienced an elevated heart rate, jitters, nervousness and hives on the throat and neck area. She was seen in the ER. No further information is available at this time.
This spontaneous report as received from a consumer refers to her 75 years old husband with no drug allergy. The reporter had been traveling and thought perhaps the rash on her husband's face was due to a bug bite. The reporter said when they got back home her husband had visited his HCP and given a dose of ZOSTAVAX (lot#, dose and route unspecified) in the second week in August 2012. Concomitant medication included ibuprofen 3 every 6 hours. It was later determined he had shingles at the time of injection. The reporter stated the rash only lasted two weeks after the vaccine was given however the patient was experiencing extreme nerve pain on approximately 11-AUG-2012 ("2nd weekend in August"). The patient was treated with gabapentin 400 mg. The outcome of extreme nerve pain was unknown. The patient had sought unspecified medical attention. Additional information has been requested.
?Covid Arm? raised itchy rash/hives around  and including injection site.  Warm to touch.  Taking Benadryl and cold compresses  on rash.  Had redness and soreness initially but a week later began the itchy raised rash.  I?m 3 days in with rash.
10 days after vaccine developed RUQ pain and pain on the right side of the back at the base of the ribs.  pain progressed to be constant and relentless.  Pain is stabbing, constant and burning
mom reports 3 days p/vax pt devel small red bumps on shoulders, gradually inc to chest & legs;states lasted for 1wk;mom reports no treatment;
Neuropathy / tingling in body, so far lasting almost 3 weeks as of current reporting.  Started in left hand (vaccine arm)  then right hand, and then progressed over next days to all over arms and legs.  Intermittent /transient neuropathy.
Pale, weak, not herself, passive, sleepy, out of character; puked up lunch; fever 102.5; dizziness.
makes my arm hurt; arm is weak; ringing in the left ear; did move around my arm muscle, the left arm where I got the shot; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single (age at vaccination: 63 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient had the 1st dose of the Pfizer Covid vaccine 1 month ago and not taken the second dose, because if the 1st dose did this, he is afraid to see what the other one does. On an unspecified date, it was reported that a week after the first dose, my arm is not sore, it did not get sore, is not a pain, like a skin tag, or sharp pain, but it did move around my arm muscle, the left arm where I got the shot, and down my arm, and it makes my arm hurt, my arm is weak, and is not as strong as it used to be. I also had ringing in the left ear sometimes, not all the time and asked are these side effect common and how long will it take for this side effects to go away and how does the body get rid of the vaccine, does it just stay there where you get the shot, because its just affecting my left side. The caller is calling about the Pfizer covid vaccine. The caller needs to speak to someone in charge of all the stuff. The caller had a serious side effect and had some questions and needs to speak to someone. Can Pfizer tell the caller what to do and asked is this a common side effect, had a lot of people reported it. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was anxious before and after vaccine . Patient blood pressure dropped . Vitals taken multiple times . . BP increased  after 10 minutes .  Continued to monitor patient x 45 minutes.  Patient stated she felt better .
Patient came in on 09/08/16 and received a high dose influenza vaccination in accordance with the guidelines and due to the fact that the patient has received flu vaccination without any adverse reactions in the past. On 09/09/16 patient came to the pharmacy and her arm was bruised and red in the area where the vaccination was administered. Patient felt like she has a slight fever on 09/08/16 after receiving the vaccination but she took some acetaminophen and did not feel feverish since. No pain was reported. The patient was advised to continue with the acetaminophen if needed and diphenhydramine to see if it would help in case she was having an allergic reaction. She was also advised to see medical attention if the reaction got worse. Patient returned approximately 3 days later and reaction had significantly declined.
received a larger dose than recommended of the Pfizer Covid-19 vaccine with a purple cap; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 66 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 02Dec2021 (Lot number: FF2590, Expiration Date: Dec2021) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Hypertension" (ongoing); "Insulin resistance" (ongoing); "Eczema" (ongoing). Concomitant medication(s) included: FLOVENT taken for asthma (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma (ongoing); METFORMIN taken for insulin resistance (ongoing); LISINOPRIL taken for hypertension (ongoing); AMLODIPINE taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (Dose 01, Left deltoid, Intramuscular, EN6198), administration date: 03Mar2021, for Covid-19 immunization; Bnt162b2 (Dose 02, Left deltoid, Intramuscular, ER8732), administration date: 24Mar2021, for Covid-19 immunization; Influenza (Batch/Lot: 312875, Manufacturer: Unknown, Route: IM, Anatomical location: Left arm, No of previous dose: Unknown), administration date: 16Oct2021.  The following information was reported: OVERDOSE (hospitalization) with onset 02Dec2021 14:00, described as "received a larger dose than recommended of the Pfizer Covid-19 vaccine with a purple cap". The patient was hospitalized for overdose (hospitalization duration: 1 day(s)). The event "received a larger dose than recommended of the pfizer covid-19 vaccine with a purple cap" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of overdose.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the Hospitalized event Overdose and the suspect BNT162B2 cannot be excluded.
Menstrual  cycle different- April - missed five pills from my pack and took them the week my period was due. Period was late and messy. May- No period  June- No period
Student rec'd the influenza vaccine as listed in #17. Approximately 30 min later, she started to develop swelling and itching in the lower lip. There were no other reported symptoms or observed physical signs at the time of her examination in the Urgent Care. She was given Cetirizine 10 mg  and Ranitidine 300 mg orally and observed. She had no progression of symptoms or new physical exam findings and was subsequently discharged after observation for an hour.
pt recv vax 8JAN96 & 28MAY97 pt devel 45-50 lesions on first day of breaking out;
Light headedness and flush feeling to the face and left arm.  Client seen and assessed by EMT and vital signs are: BP 165/113, HR 98, O2 99.  Client denies any other symptom and voiced that his BP is usually high and that there is no need for concern.  Client advised to contact his PCP if symptoms worsen or go to ER.  Client verbalized understanding and was cleared to go home by EMT once he stated he felt a decrease in sensation.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Those patients' medical histories, concomitant medications and drug histories were unknown. On unknown dates, patients received GARDASIL (lot number reported as L004741 and expiration date 04-MAR-2017, dose and route of administration were unknown), that was not stored in proper storage conditions and not supported by stability data. The reporter stated that no patients reported any unwanted affects to her. Those patients' laboratory data were unknown. At the time of the report it was unknown if any of those patients still received GARDASIL. Additional information has been requested.
Slight numbness in L cheek and inner L lip, symptoms worsened on the way home, seen in the ED (6:23PM), MRI completed, diagnosed with Bell's Palsy, discharged home (10PM)
Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored RECOMBIVAX HB (lot # M007763, expiration 15-SEP-2017, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014500: US-009507513-1612USA014504: US-009507513-1612USA014502: US-009507513-1610USA013229: US-009507513-1612USA014499: US-009507513-1612USA014501:
Narrative: Patient received 2nd dose of COVID-19 vaccine (Moderna) in clinic and was not observed to have any reaction within the 15-minute initial observation period. According to clinic note, patient returned to clinic a couple after later complaining of nausea. At clinic visit, patient was observed to start to lean against right side of wheel chair with HR 45-48 and reported not feeling well. Np decided to give epinephrine to and call a code. Code team arrived and determined patient never loss consciousness; patient was alert and oriented - asymptomatic at that time w/ HR 60 and BP 100/60. Per note, "he reports that he was just stretching and communicated this to the staff but they didn't listen." Patient was transported to ED for evaluation and observation. In the ED, patient reported nausea has resolved, and patient asymptomatic. Patient subsequently discharged to home.
Information has been received from a health professional concerning a male child who was vaccinated with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  The patient's mother reported that her child developed autism immediately after receiving the vaccination.  A product quality complaint was not involved.  Upon internal review, autism was determined to be an other important medical event.  No further information is available.
pt recv ax 25JUL96 & 22JUL97 pt devel a mild case of chickenpox that consisted in 30 to 35 vesicles;it was reported that the pt had been exposed to a child w/zoster @ a camp;
This spontaneous report was received from a registered nurse via medical assistant and refers to a 13-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.