chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose 8 to 10 months ago and had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 8 to 10 months ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable to this report. The pharmacist reported late second doses of Shingrix and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter had no information regarding the age or gender of the patient nor the exact date of the administration and expiration or lot number of the first dose. No further events were reported. The reporter consented to follow up. This case was linked to US2021AMR163652 and US2021163008, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR163652:Same reporter US-GLAXOSMITHKLINE-US2021163008:Same reporter
Loss of taste and smell for 48 hours after the shot. Took a COVID PCR test to confirm I wasn't sick and it was negative.
KINRIX and IPOL were given together, KINRIX was to be given, but IPOL was given as well, resulting in patient receiving 2x the recommended dose of polio vaccine.
missed the second dose window; A spontaneous report was received from a female patient concerning herself who received Modern's COVID-19 vaccine (mRNA-1273) and missed the second dose window.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 13 Jan 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration and at an unknown anatomical location for prophylaxis of COVID-19 infection.   On an unknown date, the patient missed the second dose appointment and was again scheduled to get the second dose on 08 Mar 2021.   Action taken with mRNA-1273 in response to the events was not reported.   Outcome and causality are not applicable.; Reporter's Comments: This report refers to a case of missed d second dose for mRNA-1273, with no associated AEs. Causality for this medication error is not applicable
nauseous; fatigue; stomach pain; can not breathe; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), DYSPNOEA (can not breathe), NAUSEA (nauseous) and FATIGUE (fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02G(?)L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and DYSPNOEA (can not breathe). On 02-Feb-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced NAUSEA (nauseous). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), DYSPNOEA (can not breathe) and FATIGUE (fatigue) had not resolved and NAUSEA (nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
patient was diagnosed with cancer; beyond 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of NEOPLASM MALIGNANT (patient was diagnosed with cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (patient was diagnosed with cancer) (seriousness criteria hospitalization and medically significant) and INTENTIONAL PRODUCT USE ISSUE (beyond 42 days). At the time of the report, NEOPLASM MALIGNANT (patient was diagnosed with cancer) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (beyond 42 days) 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.   Concomitant medications and event treatment information were not provided by the reporter.  Company comment: Limited information regarding the reported cancer has been provided at this time and a causal relationship cannot be excluded although if the diagnosis was made after the first dose but before the second dose was due it is likely the cancer was present prior to first injection of Moderna vaccine.  Per report the patient was hospitalized and then diagnosed with cancer.  Query created to ascertain the reason for the hospitalization and new event may need to be added dependent on the response to that query.  The report also includes an event of missed second dose with no associated AEs; Sender's Comments: Limited information regarding the reported cancer has been provided at this time and a causal relationship cannot be excluded although if the diagnosis was made after the first dose but before the second dose was due it is likely the cancer was present prior to first injection of Moderna vaccine.  Per report the patient was hospitalized and then diagnosed with cancer.  Query created to ascertain the reason for the hospitalization and new event may need to be added dependent on the response to that query.  The report also includes an event of missed second dose with no associated AEs
Post vax, the pt developed urticaria on trunk and back. Symptomatic treatment with Benadryl.
Injection site is reddened and raised. Circumference is approx. 2 inches in diameter.
Lost left are strength capacity by 50%, after 10 days developed intense nerve pain.  Persistent for 6 weeks and continuing.
Patient was administered vaccine around 11:15 am. patient was seated for about 10 minutes then when he walked over in front of the pharmacy counter, we heard a sound that appeared to be the sound of someone falling. I along with my technicians walked outside of the pharmacy and found the patient lying face down on the floor and bleeding from a cut on his chin that happened as a result of the fall. patient remained on the floor until EMTs arrived about 10 minutes later
Patient is 89-year-old female had a mechanical fall while using her walker and injured her left wrist primarily.  Had some left arm pain so x-rays were obtained.  Patient was hung in finger traps and a sugar-tong splint was placed.  She is neurovascularly intact.
Hives over body, concentrated on the limbs, in spots on upper arms down to fingers, across chest, around waist and upper thighs, and in heavy large blotchy raised rash areas on tops of feet/ankles, knees, and elbows.
12/31/21 presents to ED for "speech/word finding difficulty". PMHx of "HTN"
Patient given an HPV immunization (Gardasil) at a school based immunization clinic.  A few minutes after the injection she c/o feeling funny and light headed.  Patient was directed to lie down on the cot in the nurses room.  Patient rested for about a half an hour then stated she felt well enough to go back to class. Patient ended up going home from school early that day and felt poorly with aching hips and legs, tingling in her legs, a headache behind her eyes, and some dizziness. Patient went to the doctor the next day (01/18/13) at which time she was reassured and no other actions taken.
Patient described allergic reaction such as eye swelling, throat closing, itchy. He said he "felt sick". He reported a delayed onset, occurred late in evening. He did not report site irritation or any left arm problems. Patient "thinks" he took diphenhydramine to combat symptoms. He reported missing work the next day. He did not seek medical attention, and reported it resolved.
Patient had received Moderna at Pharmacy as first Covid vaccine. Patient self-scheduled to received second dose. Patient was inadvertently given Pfizer Covid vaccine as a second dose. No adverse events resulted.
Foggy feeling in head; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy feeling in head), FATIGUE (Fatigue) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Foggy feeling in head), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Foggy feeling in head), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment of these events were not provided.
Patient fainted when received vaccine.  She was unconscious for about a minute. We placed patient on the floor and patient parent lifted patient legs. We called EMS and they were there within 5 minutes. They evaluated her and suggested to the parent that she either speak with her primary care immediately or go to the ER since her blood pressure was low. Patient parent decided to just go home and contact her primary care after the evaluation. Patient left about 45minutes after receiving the vaccine. Called to follow up with patient tonight, however no answer on the phone.
Pain at injection site located high on left hip. Pain continued throughout the evening and resulted in inability for child to sleep through the night, basically awake in pain all night. The following morning, painful to move/bend her leg at the hip joint and not able to walk. Warm skin at the injection point and clammy skin throughout the evening. Have given Tylenol AM of 8/24/16. Tried cold compresses. Have been advised to bring child to clinic if condition worsens or is still the same on 8/25/16.
Extreme pain, numbness, crippling, weak paralysis comes and goes, seems to be getting worse, feet, legs, hands, arms, lose control writing, use 2 canes, shaking.
pt. rcvd 3rd dose of hepatitis B vac & developed nausea,vomiting & coughing.
Fever, joint and muscle pain, vomiting, headache, chills, red blotches  ?Covid arm?, swelling, hot and red Took Tylenol and aleve. Lasted 3 days except for arm which is still sore , hot and swollen
Sore arm; Fever of 104.9F; Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 104.9F), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 104.9F), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 104.9F), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 39-year-old male. On an unknown date, the patient received Influenza virus vaccine (manufacturer and batch number not provided). On an unknown date, immediately following influenza vaccination, the patient developed left shoulder pain. On an unknown date, two months following the vaccination, the patient presented at the clinic with prolonged, increasing left shoulder pain. The physical examination was normal. On laboratory assessment, leukopenia was noted on CBC (3-4,700 on serial tests for 4 months) without defined source, although counts were otherwise normal. ESR was normal. BMI was recorded as 25.7 kg/m2. The MRI of the shoulder was performed three months following vaccination. It showed Magnetic resonance imaging showed oblique coronal image and oblique sagittal fat-saturated T2 weighted image which showed focal subcortical bone marrow edema-like signal within the greater tuberosity, without associated obvious cortical destruction. The subcutaneous fat thickness was measured to be 4.7 mm on oblique coronal T1-weighted sequences. Hyperintense T2 signal along the periosteum indicated periosteal reaction. There were periosseous soft tissue inflammatory changes and small subacromial/subdeltoid bursal fluid. Laboratory testing did not support any infectious etiology. The patient was not actively anti-coagulated. Sagittal T1-weighted imaging showed hypointense bone marrow signal. The patient was treated conservatively with non-steroidal anti-inflammatory agents for 2 weeks and had complete resolution of symptoms after 5.5 months of observation. Outcome was reported as recovered. Authors comment: A causal relationship between vaccine administration and deltoid bursitis has been formally established. It has been reported that unintentional injection of vaccine antigen into subacromial/subdeltoid bursa can trigger an inflammatory reaction. Due to variable body habitus and muscle size, the optimum point for vaccine injection may vary among individuals. An improper angle of approach of the needle or increased needle length may result in bursal or cortical penetration, particularly in those with low BMI.
Initial unsolicited report received from a consumer on 19-Oct-2015. This case involves a 66 years old female patient who was vaccinated with a dose of FLUZONE HD via intramuscular route (manufacturer: Sanofi Pasteur, batch number: UI456AA, expiry date: 26-Apr-2016, dose details and site of administration was not reported) on 08-Oct-2015. The patient had no illness at time of vaccination. She had a history of Follicular lymphoma and kidney damage due to chemotherapy. Concomitant medications were not reported. On 09-Oct-2015, one day post vaccination, the patient had a kidney stone. On 15-Oct-2015, about 7 days after vaccination, she experienced body aches, fever as high as 102.8 degree F, poor appetite, her mouth was dry; her body was shaking when she had fever and when she did not. She was shaking so much that she could not hold her pills in her hands. There was no laboratory investigations done and corrective treatment was not reported. The kidney stone passed in a day or two while other events had not yet recovered. Upon internal review this case was considered serious due to important medical events: had a kidney stone. List of documents held by sender: none.
large local rxn w/swelling w/in 4hrs & itching & redness that spread to elbow; itching, soreness, & redness lasted 2wks; no tx other than ice; arm still aches
Pt had flu like symptoms the day following a combination of fluvirin and pneumovax given on Oct 21, 2008, both in the right arm.  Her flu like symptoms were aches/pains, fever, chills.  2 days following the vaccines, she presented to her MD with swollen lymph nodes on her right side that were both visible and swollen to touch according to the patient.  1 week after receiving the vaccines, she has no symptoms and is feeling back to normal.  Patient has had previous Flu vaccines in past.  This is her 1st pneumonia vaccine.
pt recv vax 21JUN96 & 11JUL96 pt devel induration & redness of 1.5cm @ inj site;pt recovered;
Information has been received from a medical assistant and medical records concerning a non-smoking male patient with no known allergies and history of prior transurethral resection of the prostate, a left inguinal hernia repair, tonsillectomy, and adenoidectomy who on 03/09/00 was vaccinated with Pneumococcal vaccine 23 polyvalent. Concomitant therapy included Bisoprolol (+) hydrochlorothiazide (ZIAC). On 03/10/00, the patient presented to a walk in clinic because he experienced a reaction on the arm of the injection which was described as a reddened area involving the upper arm on down to the elbow (also described by the medical assistant as being swollen). The patient was not admitted to the hospital but was given a shot of Rocephin and advised to take Benadryl. That night, the patient took on dose of Benadryl and the following morning he again presented to the walk in clinic because he had increasing redness, but no fever or shortness of breath. A white blood cell count was drawn at the clinic and the result was within nml range. The patient was the referred to the ER for evaluation. A physical exam revealed a well nourished, well developed male with a normal physical exam exam except for marked erythema of the lateral aspect of the right upper arm down the elbow. The area was not indurated or tender to palpitation. The patient's temp was 97.2 and a pulse ox was 97%, showing no evidence of hypoxia. The patient was placed on therapy with prednisone. He was advised to use moist heat on his arm, and to follow up with his physician within two to eight days, or with the walk in clinic. On 04/02/01, the medical assistant reported that the patient's experience was "an allergic reaction" and he was noted to be "fine". It was also noted that the patient had received Pneumococcal vaccine once before and did not have a reaction. Upon internal review, allergic reaction was considered an Other Important Medical Event. Additional info is not expected. The reporter also provided info regarding the experience of the patient's wife following vaccination with Pneumococcal vaccine polyvalent. Additional info has been requested. Addt'l info received states this was an allergic reaction, pt now fine.
BODY ACHES; JOINT ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 30 year old male. 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: 041A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced joint aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, joint aches, fever, headache and chills was not reported. This report was non-serious.
Started feeling chills/dizziness/fatigue with fever 8 hours after vaccination with elevated heart rate that continued for 12 hours until heart rate came down, fever and fatigue persisted for another 16 hours. Still feeling weakness and dizziness as of 4/8 but otherwise no other persistent effects.
HISTORY OF PRESENT ILLNESS Patient is a 69 y.o. male who presented to the ED via EMS with a right ankle injury that he sustained while experiencing a syncopal event while in the shower.  He is being admitted to the Hospital. He has medical comorbidities including, but not limited to, nonischemic cardiomyopathy, LV ejection fraction 30%, bradycardia/complete heart block status post ICD, atrial fibrillation/flutter on Eliquis, hypertension, obstructive sleep apnea, minimal coronary artery disease by angiogram 2011, medically complicated obesity, and history of clostridium difficile causing hypovolemic shock.     Today patient was taking a shower and experienced a syncopal episode with complete loss of consciousness and awoke to find that he had sustained a right ankle injury.  He denied other injury, but is anticoagulated.  In the ED he was hemodynamically stable and conversant with an obvious deformity to the right ankle.  Bedside interrogation of pacemaker/ICD revealed two episodes of ventricular tachydysrhythmia within the past 24 hours, one corresponding to his syncopal event during which he received appropriate antitachycardia discharge.  Available EGM appears to show VT at a rate of 185-210 bpm, rate eventually sustained long enough for device to start therapies.  Device delivered (1) unsuccessful ATP and then a 41J shock with a type I break.  Device also reported 6 VT episodes that occurred on 10-23-21 between the times of 3:27am to 4:20.  Ventricular rates ranged between 171-183 bpm which were under detection therapy rate.  Longest episode was 31 seconds which appears to show no conversion of VT but just going below monitor zone of 171 bpm. Dr. was notified and  VT-1 zone was programmed at 160 bpm with ATP and shocks at max outputs. Monitor zone was programmed at 140 bpm.    Radiographs of the right ankle demonstrated a fracture dislocation of the tibiotalar joint with lateral dislocation of the talus relative to the tibial plafond with frank diastasis of the tibiofibular syndesmosis. Ortho was consulted in the ED and he was placed in a plaster splint, his leg should be elevated above the level of the heart for 23 out of 24 hours each day to assist with reduction of swelling and preparation of the soft tissues for surgical intervention.  He will be contacted by ortho with a cast room appointment in 1-2 weeks and should arrive at that appointment fasting in order to be prepared for surgery if indicated.  Strict nonweightbearing on the injured extremity   Upon arrival to the PCU, patient is resting comfortably in bed, denies any chest pain or shortness of breath.  Reports a cold with congestion that began last Monday, Wednesday was the worst day and since then has improved.  He has been taking Mucinex DM (guaifenesin and dextromethorphan).  Denies any fevers.  His right ankle is in a soft cast and toes are pink and warm. He reports at home he sleeps flat on one pillow, he takes torsemide only as needed.  He does not weigh himself but does not feel he has gained any weight or is retaining fluid.
ventricular fibrillation cardiac arrest.  Witnessed collapse.  Bystander CPR performed.  Paramedics performed ACLS with defibrillation x 6 before ROSC
Shortly after receiving the vaccine, it felt like the vaccine was burning down my arm. Then 45 minutes later my legs became extremely scratchy. 2 hours later I felt delirious and felt like my throat was closing. I called my doctor and was told to wait a little while. Afterwards, I started feeling a little better.
My lymph were swollen the next day. For two weeks I had the same problem, then I went to the doctor and they gave me medication. They thought it was because of the medication. The rash was gone after two weeks. My lips burned and they still have this burning sensation. Since the vaccination, I have allergies to the things I never had before.