chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 14Nov2021 17:00, outcome "recovering", described as "Headache"; PYREXIA (non-serious) with onset 14Nov2021 17:00, outcome "recovering", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pyrexia.  Additional Information: The patient was a child. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Antibiotics medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has been tested for COVID-19. The patient underwent nasal swab test on 15Nov2021, results were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Did not receive dose 2 as of yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received in November 2019). Concurrent medical conditions included lymphoma.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Did not receive dose 2 as of yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Apr-2023 This case was self reported by the patient.        The patient received first dose of Shingrix in November 2019.  The patient started chemo shortly thereafter for history of lymphoma.  The patient did not receive dose 2 as of yet.  The education provided, referred to healthcare professional. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Information has been received from a registered nurse concerning a 6-month-old male with no pertinent medical history and no drug reactions/allergies who on 01-JUN-2007 was vaccinated PO with a 2mL third dose of Rotateq (lot number not provided). There was no concomitant medication. On 04-JUN-2007 the patient experienced contant irritability. On 05-JUN-2007 the patient was cranky and did not eat or sleep. He was taken to the hospital suffering from diarrhea, vomiting, and possible blood in stool. It was not known if the child was admitted as an inpatient. There was no product quality complaint. Upon internal review, blood in stool was considered to be an other important medical event. Additional information has been requested.
swollen throat; stinging in throat; Fast Heart Beat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast Heart Beat), PHARYNGEAL SWELLING (swollen throat) and OROPHARYNGEAL PAIN (stinging in throat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M00A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (She hasdseasonal allergies and uses an inhaler, not using it now.). Concomitant products included LEVOTHYROXINE and PARACETAMOL (TYLENOL REGULAR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced TACHYCARDIA (Fast Heart Beat) and OROPHARYNGEAL PAIN (stinging in throat). On 15-Feb-2021 at 6:00 AM, the patient experienced PHARYNGEAL SWELLING (swollen throat). On 15-Feb-2021, TACHYCARDIA (Fast Heart Beat) and OROPHARYNGEAL PAIN (stinging in throat) had resolved. On 15-Feb-2021 at 11:00 AM, PHARYNGEAL SWELLING (swollen throat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Heart rate: 120 (High) she had a fast heart beat at 120/BPM.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient also stated she uses sporadic while exercising but rare; she used the inhaler when she was exercising.  Patient stated she had zero reaction to the 2nd vaccine and declined having any lingering effects.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR received-  Dose-1 event outcome and dose-2 info updated.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 31-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M031651 with expiration date of 30-MAR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
hot burning sensation left elbow and to a lesser degree, both wrists. Could not use left arm for weeks. Prednisone resolved issue.
Tender, swelling at site that developed into 1 1/2? raised red & hard over next 12 hours. Whole body  Arthralgias, myalgias,; diaphoretic w low grade fever.  Severe headache from base of skull radiating up over whole head x 15 hours. Nausea & emesis x1  at hour 15 from time of injection.  Systemic symptoms resolving in 24-29 hours.    *** I had same symptoms w first dose 12/2018 that lasted over 48 hours. The injection site was very high on R arm/ shoulder & I believe likely hit the axillary nerve: sharp pain followed by tingling & numbness & loss of muscle strength in arm. Unable to lift arm for 2-3 days without intense pain & loss of strength on abduction.
sweaty all over body; soreness in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) and HYPERHIDROSIS (sweaty all over body) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 17-Mar-2021, the patient experienced HYPERHIDROSIS (sweaty all over body). On 17-Mar-2021, HYPERHIDROSIS (sweaty all over body) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm) 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.   Reporter did not allow further contact
15 minutes after injection patient became dizzy and diaphoretic. Patient very pale and nauseated. No emesis noted. Patient able to regulate self after rest, water, and zyrtec.
@ 15:28 Patient receives Pfizer 5 - 11 y/o Covid-19 0.2mg after receiving clearance from vaccine director for administration since the patient was on Xolair treatment regimen for Asthma. 15:45: Patient complaints of tightness of chest with on site provider confirming wheezing w/o any further systemic symptoms. 16:00: patient provided with albuterol followed by administration of epinephrine 0.3mg 1:1000 after patient states no sign of relief of symptoms. 16:14: on-site EMS decide transportation to emergency room after receiving clarification of vaccine director since the patient denies improvement of symptoms.
Pt coughing/SOB. Pt hx of asthma that became symptomatic after vaccination. Pt triaged and assessed by MD. No audible wheezing. MD decided to escalate to ER for further evaluation.
On either 5/10/2023 or 5/11/2023, I noticed welts on both of my arms, extending up to my neck. I waited a day and then went to the urgent care on 5/12/2023. At the urgent care, I was told that it looked like I had had an allergic reaction to something. I was prescribed oral Benadryl, prednisone, famotidine, and mometasone furoate cream. She told me that the medicines would clear up the symptoms, but I still needed to see an allergist in order to find out what could have caused the hives. Since I have been taking the meds, the hives have cleared up on my neck, but I still have hives on both forearms. I am due to see an allergist in a few months.
1 wk & 1 day following DTP #4, pt presented w/red, hot, swollen knot on lt deltoid; Area of induration 5x5 cm; macular rash in center of induration area; Consulted w/MD by phone;
Day 7 post vaccine developed hives and  angioedema on face chin and forehead
My left leg, mostly below the knee, was INTENSELY sore. It got to the point that I could barely walk on it and almost fell down the stairs.  the pain started to dissipate around 7pm and was gone this morning when I got up at 6am.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable consumer. A 41year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) intramuscular, in the left arm, at the age of 40-year-old on 30Apr2021, as  dose 1, single then BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unknown date, as  dose 2,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and had undergone PCR test. On 12Oct2021(also reported as 08Oct2021, the patient experienced Covid-19.The patient underwent lab test and procedures which include nasal swab(PCR) on 12Oct2021 which showed positive result.  The prednisone/atarax were given as a therapeutic measure. The outcome of the event was recovering at the time of report. The event was assessed was consumer by non serious.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient having muscle ache to elbow & around shoulder area for over a week.  He went to chiropractor saying it was bothering him & chiropractor stated he was out of alignment but that he had heard flu shot was causing more muscle pain.  He is also having issues gripping things very well.  It has not worsened but is not getting better very quickly per his wife.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Itchy throat, needing to cough & swallowing would hurt chest. Face & eyes swollen. Took OTC BENADRYL as directed (1) tab. All within an hour of receiving injections. Went to ER - they gave a shot of BENADRYL in (R) hip & steroid in the left hip. Vaccines given around 4:40 pm. At ER at 6:30.
Pt was discharge by the facility with no follow up instructions or their vaccination card. Pt is lost to followup
Dizziness, NauseaVomiting, Injection site soreness, malaise, stomach cramps Narrative:
Red circle & warm with thickness. Started cephalexin liquid 3 times a day for 10 days.
Right  deltoid with swelling, redness and tenderness 34 hour post DTaP administered. Mortrin every 6 hrs, ice every 4 hours and return in 24 hours.
This RN injected the Influenza vaccine (adult) into a Newborn baby boy's R Thigh, by error. Error was not noted until at approximately 5:10 PM & injection was given at approx 1:38 PM on same date(11/21/2022).
14DEC92 pt had nausea/vomited & diarrhea w/in 4 hrs of receiving Hep B vax;
02/21/2021 I had normal soreness in my arm, a fever about 102 and lethargic, did not feel well for about 48 hours, ?I felt like crap? in the next two weeks I started having intense pain in my brachial plexus area, it was almost like a shingles pain, that got debilitating and that is when I saw my family doctor. One of the initial sx I had was a large amount of swelling in my shoulder from there to my spine, it was so sensitive to touch, I could not touch it, or let the shower hit it, no clothing or anything could touch it. I though that it really felt like shingles (I had experienced shingles on my leg before). I did physical therapy for most of the summer, Then I went to pain management In October and in November & December I had pain block injections in C-5 & C6. After that I really did not have any relief from those procedures. I returned to Pain Management, and I went back to PT in January and February 2022, we tried dry needles to see if that would help desensitize the nerves. I still did not have any relief from any of this. I was started on Gabapentin for about 6 months with no relief so I stopped taking it. After the PT they suggested they could come in and do a nerve ablation 3 times and I said no. I have not recovered, it is better, I can be perfectly fine and it comes on suddenly and it feels like a knife in my shoulder. It's like intermittent on it's own terms.
Patient is a 52 y.o. male who was seen at COVID Vaccine Clinic today for his first dose of the COVID 19 vaccination.    He denied any history of previous adverse reactions to vaccines.   He was given the Moderna vaccination in the right deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience lightheadedness.  He denied difficulty breathing, difficulty swallowing, throat tightness and facial swelling. He denies eating or drinking anything today.   This provider was notified of patient reaction and he was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms.
This spontaneous report was received from Novartis and was assigned manufacturer report # PUS2012US134816 refers to an approximately 70 years old female patient. The patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) on an unspecified date.No other co-suspects were reported. No concomitant medications were reported. About a year ago, in approximately December 2011, the patient experienced reactions to the zoster vaccine live (manufacturer unknown). The patient felt she had shingles after getting the vaccine. At the time of the report, the patient's outcome was unknown. The relatedness for felt she had shingles after getting the vaccine was unknown for zoster vaccine live (manufacturer unknown). This was originally reported by a consumer. This is one of several reports received from the same source. Additional information has been requested.
Pt. received BOOSTRIX (LA) and pneumonia/PREVNAR 13 (RA) and minutes after receiving the vaccines she experienced chills, nausea, vomiting, fever, headaches, palpitation and weakness. The ambulance was called and I notified her doctor of what took place and spoke to nurse manager at Dr's office.
swelling, fever to 100.5, pain @ site of Td inj;induration of 5x5cm;no flatulence or lymphangitis;
mom relates pt not wanting to bend lt arm,moves it ok; period of staring lasting 2-5minutes; no temp today; felt warm day of vax; PC to MD who advised to see MD; seen by MD 5JUN92 dx vax reaction;
June 8,2022. I had gotten lab work done a few days earlier. My doctor called and said my A1C was through the roof. They prescribed insulin and metformin. I modified my diet significantly. My latest A1C is much lower.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date the unspecified number of patients were vaccinated with GARDASIL (Lot # J007354 and expiry date: 20-FEB-2016, reported as 12-FEB-2016) which was improperly stored. No adverse events were reported. No product quality complaint was reported for GARDASIL. Reporter provided that there have been no reported adverse events following administration of the vaccinations. There has been no need for revaccination. This is one of the several reports from the same reporter. Additional information has been requested.
Experienced redness, swelling, hot to the touch extended to the elbow crease within a week of receiving the vaccine. Dx and tx with cellulitis by urgent care.
This spontaneous report was received from a registered nurse referring to a currently 16 years old female patient. The patient has none pertinent medical history, drug reactions or allergies reported. On 20-JAN-2016, the patient was vaccinated with the first dose of GARDASIL 9 (Lot # L019297, expiration date 18-AUG-2017) (route, anatomical location and dose were not provided). It was reported that this vaccine was the only one she had received since 2011. There was not concomitant medication reported. On 29-APR-2016, the patient's mother visited the office and stated that the patient did not feel well (malaise), her appetite was down (decreased appetite), she experienced weight loss and shortness of breath. The reporting nurse stated that a blood work was taken at time of office visit and results showed aplastic anemia, the patient was admitted to the hospital from 30-APR-2016 to 02-MAY-2016. The patient had received 2 transfusions, platelets and aspiration of bone marrow on unspecified dates since diagnosis and she had received many unspecified medications as part of the treatment, there were additional admissions to the hospital on 25-MAY-2016 and 19-JUN-2016. The nurse stated that additional doses of GARDASIL 9 had not been pursued, the patient had received many unspecified blood work completed. At the time of the report, the outcome of the adverse events was reported recovering/resolving (also reported as "the patient was doing better"). Upon internal review the adverse events were considered as serious adverse events (medically significant) due hospitalization and disability. Additional information has been requested.
Pt was in for well child check and needed immunizations, I the MA drew up 4 vaccines instead just the 2 that were needed, then administered all 4. After mom and pt left I realized my mistake and reached pt to inform that pt was given 2 extra vaccines.
Light headed, nauseous, metallic taste in mouth, dull/numbing pain in entire arm except burning sensation at injection site.
Started 30 minutes after shot Lightheaded  Rash\hives Heart racing  Nausea and vomiting  Aches and pains Fever and chills thru the night  Extremely tired   Took Benadryl, Tylenol, pushed fluids and rested  Still tired with some nausea
Initial report received on 03 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3545AB received on 27 January 2010, lot number number C3555AA received on 08 April 2010 and lot number C3602AB received on 28 June 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 06 July 2012, approximately two years after the last dose. On 15 July 2012, the subject developed a cough and paroxysms began on 23 July 2012. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 24 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 24 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 30 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
The pt developed a high-pitched scream, very irritable and inconsolable for several days. He had a variable fever after 2nd set of vaccines.. The pt had a similar reaction, after his 1st set of vaccines, but lasted only hours afterwards.
Varivax administered right arm 8/13/08; returned to office with complaints of scattered excoriated papules/vesicules on right arm and scalp; few scattered enlarged tender nodes-neck.  Varicella vaccine rx + 1-2 inch infection.  Tx: keep clean and dry.  Altabax Bid x 5 days, Keflex x 500mg BID x 10 days.
pt recv vax 30APr99 & began having swelling & pruritus/pain 5MAY99;treated for cellulitis w/dicloxicillin;
Injection site reaction that was 3 inches by 3 inches,  the site was red, warm to the touch, swollen and sore.  This is the same reaction that she had during the first dose and reported it when receiving her second dose.  She stated that the first time it lasted 6 days.
About 13 hours after the vaccination, I developed chills and a fever.  This persisted, along with body aches and fatigue for about 13 hours.   I felt back to normal about 48 hours after the vaccination.
pt recv vax 27SEP96 & 30SEP96 & devel a rash;4OCT96 pt recovered from the experience;
On 3/12/21 developed pain in left calf area. Pain continued to progress and became extremely painful by April 2, 2021. April 3rd went to urgent care for assessment. Sent from urgent care to Lab for ultrasound of left calf which came back positive for DVT.  Sent to ER and started on IV heparin. Also received CT Scan of Chest and Abdomen which showed PE in right lower lobe of lung. Admitted to Vascular unit. Doctor ordered an upper Endoscopy to check for bleeding due to low HGB and FE. The Scope was negative for bleeding.  Lab work was ordered on 04/06/21 and due to very low HGB and FE patient was given an FE (iron) infusion the evening of 4/06/21 and again the morning of 04/07/21.  The patient also received a unit of blood the morning of 04/07/21 prior to being discharged from the hospital.  Patient was started on Eliquis 5mg 2x a day, Ferrus Sulfate 325mg 1x a day and Omeprazole 20mg 1x a day as discharge medications.
A few minutes after vaccine administration pts companion came to tell the pharmacy that she was not feeling well.  the pt was seating in the waiting area and was pale, sweaty, and breathing fast.  Her father stated that she was very nervous about getting the vaccine.  she was given water and some saltine crackers.  they stayed and was monitored until pt felt better.