chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/28 12-15 hours later - low grade temp, achy and tenderness at injection site. 9/29 - achy, low grade fever. 9/30 - Tongue thickening, rash - hives on neck - dense and spotty anterior and posterior thorax.
Pruritic burning rash on bilateral arms and legs. Given prednisone by provider.
Patient sought evaluation of chest pain with onset about 9 days post receipt of smallpox vaccination. Had experienced some chills, and body aches starting around 9 Apr, but on 13 Apr, sharp, shooting pains were noted on left side of chest. No changes with deep breaths or position changes. No dyspnea or palpitations. No /n/v or diaphoresis. SPV vaccine site progressing normally. In emergency room patient was evaluated for chest pain. She was afebrile and had negative ECG and normal troponin levels. ER physician thought pain was probably musculoskeletal and prescribed NSAIDs.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 18-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Within 15-20 minutes of immunization 3-4 cm of maculo-papular pink, non tender dermatitis at vaccination site on both left and right thighs. Without any systemic symptoms. Rash disappeared within 5 hours with no generalized symptoms.
Mild body aches later the night of the injection.  I took my emgality shot the next day, woke up the next morning with severe body aches, especially in legs, knees and back to the point was difficult to walk for 3 days. Used pain meds, ice packs, hot bath,   massage. Started to ease some on friday, still same Saturday (today), and now today also very nauseous. If any worse will be going to er and user my family dr on Monday (2days from today)
Sore throat, cough, congestion, fatigue/ lethargic, fluid in ears, headache,  low grade fever, loss of taste and smell.  Treated with  Prednisone and promethazine-dextromethorphan , doxycycline.  Prednisone and doxycycline did help.  Almost 2 weeks later started having symptoms of SOB or feeling "winded" with exertion, would have to take a deep breath  and stop what I was doing . I am still having this symptom and the cough.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with and improperly stored dose of GARDASIL 9 injection,  lot # N010497, expiration date 15-JAN-2020 and also, the patient the patient was vaccinated with and improperly stored dose of RECOMBIVAX HB injection, lot # M022077 expiration date 10-MAR-2019 (also reported as 10-MAY-2019) both for prophylaxis (route and anatomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1803USA006513; US-009507513-1803USA009619; US-009507513-1803USA009620; US-009507513-1803USA009622; US-009507513-1803USA009623; US-009507513-1803USA009624.
Heplisav-B given for first dose, Engerix-B was given for second dose; Initial Report Received on 04-Dec-2020  A pharmacy manager reported that a 63 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for the first dose of hepatitis B immunization and received ENGERIX-B for the second dose.  No medical history included penicillin allergy.  No concomitant medications were reported.  On 08-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot # 934259, expiration date 25-Sep-2021 and NDC # not reported) to the left deltoid at the pharmacy.  On onset 19-Nov-2020, the patient was given ENGERIX-B (Lot # 5NY2K, expiration date 29-May-2022 and MDC # not reported) to the right deltoid at his doctor's office.  The patient did not report any adverse reactions to either vaccination.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
FOR TWO DAYS FOLLOWING THE 2ND DOSE THERE WAS VOMITING. SWELLING AT THE INJECTION SITE LASTED APPROXIMATELY 2 WEEKS.  SEVERE DIZZINESS AND OFF BALANCE BEGAN TWO DAYS AFTER 2ND INJECTION. THE PATIENT IS NOT ABLE TO WALK WITHOUT A CANE OR SOMETHING TO SUPPORT HERSELF. THIS CONDITION HAS NOT RESOLVED AS OF THIS DATE. SHE HAD EXPERIENCED BPPV AFTER CONTRACTING COVID IN 2019 AND WE WERE DEALING WITH THAT BY PERFORMING THE EPLEY MANUEVER AS NEEDED. WHEN THIS NEW CONDITION STARTED THE EPLEY MANUEVER HAD NO EFFECT AND THERE IS NO NYSTAGMUS ASSOCIATED. HER PHYSICAL THERAPIST WHO TREATED FOR THE BPPV HAS STATED THIS CONDITION IS NOT BPPV.
Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 76 years old female patient who experienced mild facial edema, a raised red rash, itching and broke out in hives, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Aug-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number UJ000AA, expiry date: 28-Mar-2019, route of administration was not reported) in the right deltoid. On 31-Aug-2018, the patient developed a non-serious raised red rash (rash), itching (pruritus) and broke out in hives (urticaria), one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also reported that the rash and the welts spread to her trunk and to her right leg. On an unknown date, the patient developed a non-serious mild facial edema (face oedema), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was broke out in hives, itching, a raised red rash and mild facial edema. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) every 4-6 hours, HYDROCORTISONE Cream, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and RANITIDINE HYDROCHLORIDE (ZANTAC). The patient was recovering from the events. List of documents held by sender: none.
DTaP-IPV Component was administered to a patient without the ActHIB component, with no reported adverse event; Initial information regarding this unsolicited valid non-serious case via  Medical Information (Reference number- 00436605) was received from a physician and transmitted to Sanofi on 19-Jan-2021.  This case involved a patient of unknown age who administered dtap-ipv component without the acthib component (off label use), while patient received vaccines DIPHTHERIA/ TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Past vaccination(s) included MMRVAXPRO.  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received DIPHTHERIA/ TETANUS/5 HYBRID AC PERTUSSIS/ IPV (MRC5) /HIB(PRP/T) 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, patient administered dtap-ipv component without the acthib component (off label use) (latency: unknown) following the administration of suspect vaccine.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  There will be no information available regarding batch number in this case.
Patient reports "not feeling well" on 10/23/19; went to his PCP and was given Amoxicillin.  The next day 10/24/19 he reports the development of a rash.  Describes as bumps; was seen by the nurse at his job on 10/24/19 and was informed that it looked like "he was having a reaction to the Chickenpox vaccine".  On 10/25/19 the patient reports that the "bumps" are all over his body, including his trunk and scalp; they are blister like bumps. Pt. presented to an urgent care facility on 10/25/19 at 3:55 pm with Diagnosis of Varicella without complications and Cellulitis Right Lower Leg.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received 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 (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received 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 medications were reported.  The reporter stated that the facility where she worked, there had been temperature excursions with freezer. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 degrees Fahrenheit and minimum minus 18.9 degrees Fahrenheit. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.  The vials were stored in frozen state. The visual inspection did not noted any vaccine state change.   No treatment information was reported.
full body inflammation; affecting her white blood cells; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (148871). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization; Bnt162b2 (2nd dose), for COVID-19 Immunization. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "full body inflammation"; WHITE BLOOD CELL DISORDER (non-serious), outcome "unknown", described as "affecting her white blood cells". Additional information: Patient took Ibrance experienced full body inflammation, stated it started about 1 month ago after getting her COVID booster shot. Also felt like it affected her white blood cells similar to what she felt on Ibrance in the past. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shoulder joint pain/inflammation of rotator cuff. Treatment limit the rotation/rest. Duration has been greater than 2 weeks now.
Case number PHEH2012US016114 is an initial spontaneous report received from a physician on 10 Aug 2012. This case refers to an adult age group male patient. He was given only MenCYW-135 liquid conjugate component of MENVEO (batch number: X10132) intramuscularly on 10 Aug 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this administration error. No other information was available.
Two patches of hives appeared on patient's back. The patches are on the midsection of the right side of the patient's back.   Hives appeared on January 7 and are still present to date - January 11.
Began having fever up to 101.4 and seizures that required admission and anticonvulsant therapy. MRI normal. EEG results pending.
This spontaneous report was received from a pharmacist refers to an adult patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the adult patient was vaccinated with PROQUAD (lot, expiry date and dosing regimen were unknown). No adverse effects were reported. No product quality complaint (PQC) was filed. Additional information has been requested.
Patient described headache and scalp pain/tenderness in the upper-left quadrant of his face and head, including his left eye socket. He reported that this is the same area and pain he experienced when he had a shingles infection in the past. This started days after administration and persisted over the weekend of 4/12/19. He tried taking Tylenol OTC and had no benefit. The pain/headache got so bad it was causing him to be nauseous and he vomited the evening of 4/13/19. He also reported fatigue and related oversleeping throughout the weekend. His symptoms are steadily improving now but are still very bad. I recommended that he seek care from his primary care physician to be further examined.
patient developed severe back spasms, muscle spasms under rib cage. Pain with deep breathing and motion
This case was reported by a consumer (the subject's daughter) and described the occurrence of arm pain in a 92-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included breast cancer, dementia and hypertension. Concurrent medications included Lisinopril, HCTZ, ZETIA, KCl, Atenolol and Anastrozole. On an unspecified date in October 2011 the subject received a dose of FLULAVAL (unknown route, right arm). In October 2011, less than one month after vaccination with FLULAVAL, the subject experienced right arm pain, injection arm pain, right shoulder pain and difficulty lifting right arm. The subject's physician was contacted and at the time of reporting the subject planned to follow-up with her physician. At the time of reporting the events were unresolved.
Itchy red hives covering the entire body, virus-like illness following the rash. Doctors were unsure whether the vaccine or the virus was the cause, or possibly both.
I did not have an adverse reaction to the vaccine. I was recently diagnosed with bladder cancer on 11/2022. I am currently in treatment.
Information has been received from a literature article concerning a 17 year old male who on 1/00 was vaccinated with hepatitis B vaccine recombinant. After the first vaccination, the patient developed weakness of the legs. Seventeen days later, the patient received a second dose of the vaccine. Seventeen days after the second injection of the vaccine, low grade fever, a pruritic maculopapular rash appeared and weakness of the legs recurred. The patient was initially treated with topical diphenhydramine cream 1% thrice daily and received IV fluids in order to induce a good urine flow. He was discharged five days after admission. The day of discharge, the total creatinine kinase was 2,271 U/L, and leg weakness persisted. Four weeks later, he had recovered full strength of his lower extremities, the rash had disappeared, and the enzymes had normalized. Administration of the third dose of hepatitis B vaccine was thought unadvisable. Subsequently, the patient recovered from generalized myalgia, low grade fever, and pruritic maculopapular rash on thighs, abdomen, and arms. No further information is available. It has been noted that the patient was hospitalized. The article mention polymyositis. A copy of the published article is attached as further documentation of the patient's experience.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.    No Medical History information was reported.   On 19-Nov-2021 at 4:52 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 4:52 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The patient was given dose from vial that were stored in an ultracold freezer which was colder than they should have been. The facility had a temperature excursion for the Moderna COVID-19 vaccine and the patient was administered the vaccine underwent temperature excursion.  Excursion duration was 1 month; on 19-Nov-2021, the vial moved from super cold freezer to the refrigerator; 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator; no vaccine state changes were noticed; none of the vials were punctured and no previous temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
830am vaccinated, 12pm mild-mod headache and fatigue (sore arm at inj site),  persisted, 10pm worse headache, fatigue, mild body aches started at shoulders and upper back and neck, able to fall asleep by 11pm, woke up at 1am in severe pain, migraine, head pressure, joint pain of every joint in my body, hands were swollen, felt like my joints were pulsating, very painful to bend or move any of my joints, muscle aches so bad any tiny movement hurt, even lying still hurt my back because of the pressure onto my back, even my spine felt tender, stiff neck I could barely look down or up but i could turn head left and right, stomach ache and nausea, my arm that was given vaccine was severely in pain  and tender to touch and swollen at area of inj.  There was light headed sensation w/ movement and position, pressure in my head felt like my head was going to explode and my eyes were burning.  Because so severe, I took 1000mg tylenol, lathered by entire body in eucalyptus oil and peppermint on my hands, I was able to fall asleep at 3am but it was restless sleep I kept waking up because any movement I made in bed I'd have severe pain.  6am I felt moderately better all symptoms 50% improved, applied eucalyptus oil on again, started work at 730am I could barely function at work I have brain fog, just thinking focusing eyes concentrating makes migraine worse, +photopphobia, phonophobia, just typing is very hard to do because it hurts my joints, the vertigo worsened and the slightest looking down to the keyboard while typing causes lightheaded sensation.  No improvement and it's now almost 1pm.  I didn't take any pain medication or apply any essential oils.
Pt received Varivax 4/29/04 and had break through of 5 lesions after exposure.
Two days post vax, the pt developed a high fever of 103.4 degrees, seizures and experienced difficulty breathing.
localized rxn rt thigh very swollen, red, & large, hard knot;very irritable & inconsolable x 2 days;
Client scheduled and receive Pfizer vaccine after previously getting Moderna Dose 1. Client reported to clinic that they had not received any COVID vaccine previously and system did not have capability to check this. on 5/13/2021 client received the second dose of Pfizer erroneously as well reporting that was their second dose.
Patient reported at time of second shot, 11.24, that he received swelling under armpit after first dose (8.23).
Fever, drowsiness, muscle soreness around 10-12 hours after vaccine was administered. Took ibuprofen the next morning, then acetaminophen around 3pm the next day. Symptoms were very mild the next day until 9pm, when fever and muscle soreness came back. Took another ibuprofen, fell asleep, and so far symptoms are gone.
Severe and uncontrollable shaking through the night 102 degree temperature Severe headache and muscle cramps Joint pain Nausea
This spontaneous report as received from a Register Nurse refers to a 11 year old patient, of unknown gender. Medical history and concurrent conditions were not reported. On 03-OCT-2041, the patient was vaccinated with RECOMBIVAX HB lot # J009051, expiration date 26-MAR-2016 (dose, strength, route and frequency were not reported). The patient was vaccinated with improperly stored RECOMBIVAX HB. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.