chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On and off chills that were not severe; Had some discomfort in the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCOMFORT (Had some discomfort in the site of injection) and CHILLS (On and off chills that were not severe) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006(A/B)21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension (High) since an unknown date. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced CHILLS (On and off chills that were not severe). In March 2021, the patient experienced VACCINATION SITE DISCOMFORT (Had some discomfort in the site of injection). At the time of the report, VACCINATION SITE DISCOMFORT (Had some discomfort in the site of injection) and CHILLS (On and off chills that were not severe) outcome was unknown. Not Provided          Concomitant medication include Rivaroxaban for blood thinner, Thyroid medications for unknown use, antihistamine for unknown use Treatment information was not provided.   This case was linked to MOD-2021-068458 (Patient Link).
20 days p/vax pt became woozy @ school p/knee scrape pulse @ that time was reportedly 60;later that afternoon child fainted @ home;to local ER via amb then airlifted to Denver for pacemaker implant;
numbness and tingling of gums, jaws and face approximately 1 hour after receiving 1st dose. Has continued periodically since receiving 1st dose.
Information has been received from a healthcare student (Pharm D) concerning a patient (age and gender not reported) who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot# 655289/0958F) IM in the deltoid. The patient experienced swelling from the shoulder to the elbow and the swollen area was hot to the touch. On an unspecified date the patient recovered from the reaction within 24 hours of administration of the dose. No further information is available. Additional information has been requested.
5cm red, swollen area surrounding injection site. Pt's temperature was 99.5F at time of re-check.
Inadvertent administration of Moderna Vaccine past expiration and "good to use by" date.
Initial unsolicited report received from a consumer on 15 Dec 2016. This case involves a 45 years old female patient who was vaccinated with third dose of Imovax (batch number, expiry date, dose and site of administration- were not reported) intramuscularly and Imogam (batch number, expiry date, dose and site of administration- were not reported) intramuscularly on 04 Nov 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Any other vaccinations within 4 weeks of vaccination was not reported. The patient concomitant medications were not reported. On 12 Nov 2016, eight days following the vaccination, the patient experienced flu like illness, nausea, dizziness, abnormal feeling (reported as overall felt "really lousy"), she thinks she ran fever but didn't checked it and shooting pain throughout the body since vaccination anytime she had a drink (alcoholic). It was reported that patient refused 5th dose due to reaction. Laboratory investigations were reported as none. Patient's corrective treatment were not reported. The patient's outcome was unknown. List of documents held by sender: none.
This spontaneous report was received from a pharmacist regarding a 61 year old female patient with penicillin allergy and no pertinent medical history. On 19-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # H020844, expiration date 20-FEB-2014) (subcutaneous, dose and anatomical site not reported). No other suspect therapies were reported. There was no concomitant medications. The pharmacist reported that the patient developed a rash at the injection site, immediately following vaccination with ZOSTAVAX, which spread to the other arm. Pharmacist stated that the rash was starting to go away (had faded) and the patient left the pharmacy after an unspecified timeframe. At the time of the report the patient's present status was reported as recovering. No treatment was given for the rash at the injection site which spreaded to the other arm. No laboratory diagnostic studies were performed. Additional information is not expected.
Injected and felt burning immed in shoulder. HA in 30 min took 4 Advil. Feels LH, weak, nausea. No SOB, no tightening in chest. No prev rxn to vaccine. VS Rx adm (prior) Pepcid, Benadryl.
First shot March 5 th.  Some itching late that night....right arm.  Some soreness.  March 16th evening time....right arm red, itchy, hot to touch, redness size of 2 quarters side by side.  March 15 and 16th body aches, fatigue, tired.  March 17th headache.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was treated by a healthcare provider. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
2 days post 2nd vaccination developed severe pain in right lower molar tooth. This tooth had had a root canal and crown done approximately 20 years prior.  Seen by dentist 3 days after onset of pain (01/13/2021). He advised visit to endodontic specialist who performed a CT scan which indicated possible area of inflammation around root canal. Recommended antibiotics, pain medication and tooth extraction. Pain did not resolve. Returned to dentist (01/15/2021) who extracted the tooth. Pain resolved.
Pt received 4 yo health check on 2-19-08. Pt came back 2-21-08 arm was red and swollen. Referred pt to surgeon.
Information has been received from a healthcare worker (certified medical Assistant (C.M.A.)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 12-MAY-2015, the patient was administered with a dose of improperly stored ZOSTAVAX, lot# L002422, expiration date 23-APR-2016 (dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Swollen arm, severe headache, dizziness, sore leg started later that day and through the next day took TYLENOL, BENADRYL and iced the area.
Initial report was received 23 August 2011 from an allergist. A four-month-old female patient had received a second dose intramuscular injection of PENTACEL (lot number not reported) and an unspecified amount of time later, the patient developed a fever, her lips turned purple and she developed breathing problems. She was taken to the emergency room and received BENADRYL, prednisone, TYLENOL and a nebulizer as corrective treatment. The patient was seen by an allergist and had skin testing performed which showed delayed reaction. She had no concurrent illness and had not been taking any concomitant medications at the time of vaccination. Outcome was recovered. The patient had a past history where she experienced a similar event after receiving her first dose of PENTACEL at two months of age. This patient previously experienced a similar event captured in case 2011-07441. Documents held by sender: None.
Vaccine given 3/1/01. Varicella diagnosed 2/16/06.
Information has been received from a physician concerning a patient who in approximately 2000 was vaccinated. According to the physician, "a month or two later" she developed acute lymphocytic leukemia. Additional information has been requested.The physician questioned as to if there was a relationship between varicella virus vaccine live and acute lymphocytic leukemia. The physician also believed that the pt's experience was disabling. Additional info has been requested.
Patient developed 6x6.5 cm area of redness around injection site, left arm.
received a dose from a vial that was expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired) had resolved.        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.
urticaria dermatographism (1/27/2011); facial swelling, angioedema, urticaria dermatographism, abdominal pain (1/28/2011); required epinephrine on multiple occasions
Received dose too early. Second dose given on 9/21/2021. Should have waited until 9/28/2021.
red spots & flushed looking appearance on head & fore head w/5-6 spots looked like small blood vessels ruptured; redness lightened to pinkness p/5-6 mins;
Patient received shot b/t 10:30 and 11:00 AM. Went to eye doctor at 1PM for eye exam. B/t 1-3PM  pt developed a rash. Returned to our practice on Thursday and we sent her to dermatologist.
VERY SORE ARM BELOW INJECTION SITE. SOME SWELLING NO REDNESS.
The same day as the shot I had an extreme headache and arm was sore. Approx a week and a half later I noticed broken blood vessels over my body, went to my PCP had a blood draw and was informed I had a platelet count of 1. I was sent to the ER then to hematology. I received an very large  infusion and was put on 40 mg of Dexamethasone for 4 days. The next step is to get more blood work and see if I need another infusion. After the infusion I was really sick and passing out .
Hives surrounding the injection shot, started in small blotches and now is one big area about 2x6 inches on my upper arm
minor constriction in chest (but definitely  noticeable);10-20min p/vax;same evening required motrin & ice packs for soreness & onset of swelling;also very itchy;swelling hot, hard, sore , itchy moved from deltoid inj site to inner bicep;
Mild headache, injection site muscular soreness, body skin aches and tenderness, general fatigue.  All symptoms appeared between 16-24 hours post dose.  Headache and body aches resolved after administration of 1 tablet ibuprofen 200 mg.
Gradual onset fatigue< weakness and muscle pain. Severe headache on 1/17/12. Acute transverse myelitis on 1/19/12 with ascending paralysis.
I feel really dizzy after 2 weeks every time I take my blood thinner Lovanox it feel like my toes are numb pins sticking me all over my body my skin is crawling it feel like my veins are moving the back of both my calves are sore. Stopped my blood thinner it went away. Took my blood thinner again to see if that was the problem same symptoms again. I didn't have no symptoms until a few weeks after my second dose of the Pfizer.
Sudden exacerbation of asthma with chest tightness lasting 2 days, treated with intramuscular corticosteroid injection on second day
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. There was no pertinent medical history, drug reactions or allergies reported. On 12-FEB-2016, the patient was vaccinated with PEDVAXHIB (dose, route and site not reported) lot # L030867, expiration date 09-JUN-2018, that was improperly stored. It was noted that the PEDVAXHIB was expose to 34.2 F temperature for two hours and fifty minutes. The PEDVAXHIB was not expose to previous temperature excursion. There were not adverse effects reported. Additional information has been requested.
Every time child has received a DTAP vaccination she has had an adverse reaction that includes a fever of up to 105*.  The fever usually lasts about a week and I have had to miss alot of time from work.  I have reported it to the Doctor's office and no-one seems to think it is of big concern or that anything can be done about it.  I have a friend who says his daughter was the same way until they found that the mercury in the shot was what was causing his child to get sick.
No adverse event. Reporting vaccine administration error. DTAP was administered and patient was above the allowable age range for DTAP. Patient was over the age of 7yrs at the time of administration.
Moderna COVID-19 Vaccine EUA  4 days of fever - 99.9, heavy head, sore throat, headache and constant diarrhea and intense stomach cramping
Had a restless night - took temp this AM - approx 10 AM - Temp 103. Achey - Feels very warm to the touch.  Sleeping - staying in bed.  I am his mother -concern as he has asthma - moderate to severe.
Dizziness, nausea, fever, chills, HA, muscle aches, fatigue
swolling on face. Mild Facial Swelling, decreased sensation and pressure behind eyes x 2 weeks.  Pt states he received J&J vaccine on 10MAR21 and developed symptoms next day; swelling has since decreased but decreased sensation and pressure remains. Decreased sensation to bil cheeks; airway intact; Pupils PEERL Bil; NAD; steady and balanced gait.
PULSE RACING; BLOOD PRESSURE WAS UP; FELT ANXIOUS; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced felt anxious. On 27-MAR-2021, the subject experienced pulse racing. On 27-MAR-2021, the subject experienced blood pressure was up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulse racing on 2021, and had not recovered from blood pressure was up, and felt anxious. This report was non-serious.
red; hard; very sore; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red), INDURATION (hard), PAIN (very sore) and PERIPHERAL SWELLING (swollen arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ERYTHEMA (red), INDURATION (hard), PAIN (very sore) and PERIPHERAL SWELLING (swollen arm). At the time of the report, ERYTHEMA (red), INDURATION (hard), PAIN (very sore) and PERIPHERAL SWELLING (swollen arm) outcome was unknown.            No concomitant and treatment information were reported by the reporter
The day after my vaccination, my lymphdema was acute. I have had lymphedema since 2018 when I had a lymph node removed due to melanoma. Ever since my right leg and foot often swell up by the end of the day. Following the shot, the next day my leg and foot were swollen at the beginning of the day and all day and much more painful than usual. I did some exercises to relieve the pain and by Sunday felt better. I didn't think much of this but in light of the blood clot side effect that some have experienced I thought it might be helpful to mention this side effect I experienced.
Dose administered to minor in error. Family notified of incident. No adverse reactions as of 11/18/2020.
pt recv vax 21MAR96 & 15JAN97 pt devel chickenpox consisting of 10-15 pox;no fever was noted;f/u was recv from a MD which indicated the pt chickenpox was a atypical case;A visit to the MD was required;
Patient went to emergency room due to chest pain. she also has fever, headache, body ache, nausea and fatigue.
Constipation; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONSTIPATION (non-serious), outcome "unknown", described as "Constipation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia Pain/Discomfort at injection site, fatigue or tiredness Narrative:
almost flu like symptoms; headache/head hurt; tired; Felt achy; Sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness), INFLUENZA LIKE ILLNESS (almost flu like symptoms), HEADACHE (headache/head hurt), FATIGUE (tired) and MYALGIA (Felt achy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 048A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE, VENLAFAXINE and PRAVASTATIN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepiness), INFLUENZA LIKE ILLNESS (almost flu like symptoms), HEADACHE (headache/head hurt), FATIGUE (tired) and MYALGIA (Felt achy). At the time of the report, SOMNOLENCE (Sleepiness), INFLUENZA LIKE ILLNESS (almost flu like symptoms), HEADACHE (headache/head hurt), FATIGUE (tired) and MYALGIA (Felt achy) had resolved.            No treatment medications were reported.
patient received FLUZONE-HD QIV however they were under the age of 65 with no reported adverse event; Initial information was received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 30 years old female patient who received influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT] however they were under the age of 65 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine (lot U8135AA, Frequency : Total, Expiry date, strength, formulation was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient received fluzone-hd qiv however they were under the age of 65 with no reported adverse event (product administered to patient of inappropriate age) (latency : same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient received fluzone-hd qiv however they were under the age of 65 with no reported adverse 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.
pt devel spacey/staring; arms/legs shaking, jaw clenched, lasted about 10 seconds; post event was subdued acted tired but not limp x 30 mins; no fever; mild rhinonhea x 1 day;