chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 days after getting the vaccine I started with intense itching at injection site accompanied by redness of about 4 inches in diameter and slight warmth and swelling. After about 16 hours it began to subside.
Slight fever, chills, body aches, constant headache (triggered migraine), fatigue, injection site soreness.
STORAGE OF VACCINE VIAL OUTSIDE OF THE RECOMMENDED  TEMPERATURE RANGE; POOR QUALITY VACCINE ADMINISTERED; MUSCLE ACHE; This spontaneous report received from a pharmacist concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: UNKNOWN) dose was not reported, 1 total administered on MAY-2021 for prophylactic vaccination (Dose number in series 1). Later, (date not specified) the patient experienced muscle ache (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 10-DEC-2021 for prophylactic vaccination (Dose number in series 2) from a vial that was stored outside of the recommended temperature range (incorrect product storage). 2 doses were drawn from the vial and placed back in the fridge, then the next day another 2 doses were drawn and were given to the patient (poor quality vaccine administered). No concomitant medications were reported.  In DEC-2021, the patient experienced muscle aches (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the storage of vaccine vial outside of the recommended temperature range, muscle ache and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211233061, 20211233514 and 20211233937.
Several hours later I started to shake due to horrible chills, than my fever spiked to 102.8, my whole body became extremely painful to the point even laying down was horrible. Now the following day I can?t get up without becoming dizzy, and my head hurts to the point that it feels as if it will pop.
Pt experienced wheezing, tightness of chest and tongue jerking. Parent initiated two breathing treatments with some relief of tightness of chest. Tongue continued jerking. Pt taken to ER and Decadron injection was administered, breathing treatment given. Pt given a prescription for Prednisone and discharged.
This is an 82-year-old male with a history of CAD with previous CABG x2 5/2017, PAF on Eliquis, HTN, T2DM, dyslipidemia, history of PPM in 2010, OSA, history of TIA 2021 originally presented to the ER on 8/18/2022 due to abnormal LFTs.  Patient was noted to be having complaints of fatigue and recent 5 pound weight loss.  There was concern for biliary tree obstruction.  He went for ERCP on 8/22/2022 with dilation and stent placement.  Repeat ERCP was performed on 8/26/2022.  Patient now may require to go to the OR due to left-sided bile duct occlusion with possible left hepatectomy and Roux-en-Y reconstruction. Discharged home.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Hyperventilation-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Student reported to School Nurses office C/O dizziness for the previous  1 Hr. C/o headache at 11:50 AM. Dizziness ceased at 12 noon. Stepfather states patient has history of migraines. Patient transported to local ER by stepfather per Dr. instructions.
I did not know this could possibly be a side effect of the vaccine until my school nurse alerted me to the possibility and advised me to report my reaction. I developed sinus congestion that I did not think was serious in the weeks after the vaccine. I had headaches and nasal congestion. many weeks after the vaccine, I sniffled and a large mass went down my throat, again I thought nothing of it. Last weekend, I got a very painful headache behind my other eye. I massaged my brown-bone and a large walnut sized and shaped mass, brown and red in color, shaped exactly like a shelled walnut with lobes came out of my nose. My school nurse told me this sounds like it was a sinus blood clot and to alert the clinic. The  clinic in town where I got my vaccine said because I am not ethnicity, I had to report it myself on VAERS.
Got the rash around where the vaccine was administered. It measured 3 inches by 2 inches and is sore if she pushes on it.
rash - itching and redness on the arm where the vaccine was given, 1 week later treated with small amounts of benedryl, ice it comes and goes
Arthritis; Bronchitis; The patient have PREVENAR 13 almost yearly; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients (mother and herself). This is 1st of 2 reports.   A 69-year-old female patient (reporter) receive pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date at single dose (once every year) for immunisation.   Medical history included pneumonia in the past. The patient's concomitant medications were not reported.   The patient experienced arthritis (non-serious) on an unspecified date with outcome of unknown, bronchitis (non-serious) on an unspecified date with outcome of unknown.   The patient and her mother have PREVENAR 13 almost yearly. They do it themselves, not through an organization, not recommended by physician.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019282907 Same reporter, product, similar event/ different patient
Broke out with chicken pox lesions 5 + 2 weeks after Varivax #1.
OBSTRUCTIVE SLEEP APNEA 3/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
lightheaded with fainting episode from seated position hitting head on ground, unconscious about 10 seconds, evaluated by EMS, recommended transport but refused
headache front and back and neck,  face feels flushed and hot,  slight cough,  breathing is slightly labored, chest feels tight. Some body ache's. Tylenol given.
I got pneumonia shot on 4/18/18. (PNEUMOVAX 23) My shoulder hurt a lot that night. The next day/night I had an itchy rash inside my arm (opposite the area on the outside where I was injected) and was awakened off and on all night with horribly itchy feet. I wouldn't say this was terribly serious, but it was certainly uncomfortable, especially the itchy feet.
Normal menstrual period ended on April 2nd. On April 10th I started bleeding again. As of today April 27th I am still bleeding.  If it continues beyond this week I will have to see my doctor about it.
This case was reported by a consumer via patient support programs and described the occurrence of chest tightness in a adult female patient who received Flu Seasonal QIV Dresden for prophylaxis. Previously administered products included FLOVENT HFA (220 mcg per spray, was started taking the product more than 10 years). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced chest tightness. On an unknown date, the outcome of the chest tightness was unknown. It was unknown if the reporter considered the chest tightness to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. This case was reported by a consumer via vaccine patient support programs. The patient had chest tightness due to reaction to flu shot. The caller had been informed that they had reported an experience with a GlaxoSmithKline product that needs to be shared with GlaxoSmithKline. The reporter had agreed to had GlaxoSmithKline safety team follow-up with them via postal mail. This event did not include the product complaint.
Pain at injection site - immediate and increasing for about 48 hours. Swelling to size of large lemon (small orange) at site. Red color at site. 24 hours after injection: fever 101.6, dizziness, some confusion, lethargy, fever, responded to Motrin.
felt like passes out; face turned bright red; sweating; shivering; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, face turned bright red/erythema, sweating/ hyperhidrosis, shivering/shivering, felt like she would pass out/loss of consciousness, blood pressure was 88/66/ hypotension.  The patient's medical history was not provided. Concomitant medications reported was valsartan.  On 4 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010AZIA) in the left arm intramuscularly for prophylaxis of COVID-19 infection.  On 4 Mar 2021, the patient after she received mRNA-1273, she waited for 30 minutes and was okay. She drove about half an hour, and her face turned bright red, sweating, shivering, felt like she would pass out. The event felt like she would pass out was assessed as serious as per IME list. She pulled to the side of the highway to wait, it got worse. She called 911 and they transported her to the hospital. She went to the ER from 2:30 to 5:30pm. They did a lot of tests; blood test, heart test, EKG, everything was normal. They put her on saline bags. When the ambulance first got there her blood pressure was 88/66, when she left the hospital it was back to normal.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events face turned bright red, sweating, shivering, felt like she would pass out/loss of consciousness was not reported whereas event blood pressure was 88/66 was resolved on 4 Mar 2021.; Reporter's Comments: This case concerns a 63-year-old female who had a serious unexpected event of loss of consciousness along with nonserious unexpected hypotension, erythema, hyperhidrosis, and expected chills.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
11/6/09 3:20p.m. PC from child's grandmother. States child received injection at approximately 3:30 pm on 11/5/09. She states child began to nod his head and blink his eyes about 2-4 hrs after inj, c/o eyes burning- not constant, but more after this evening. Advised to phone pediatrician immediately. She agreed at this time. We phoned this nurse after speaking with clinic's nurse. States she was told this nodding and blinking should not be a result of the H1N1 injection. Advised grandmother to call physician's emergency service again if any changes and go to ER if concern continues. Grandmother will phone clinic 11-9-09 with report of how child did this weekend.  She states child's mother travels with her job and will be home soon. Grandmother to report this conversation to child's mother who (she states) is aware of this problem. 11-9-09 PC to mother for update on child's condition. She stated that on Fri 11/6/09- child's teacher had phoned her to ask if she was aware that child was jerking head and his eyes would roll back. She states that Friday eve when she got home she phoned pediatrician at his home and he told her to give the child BENEDRYL through the nite. She states on Sat am 11/7/09 she took him to hospital and saw pediatrician. They kept him all day and did tests. He was sent home Sat eve on BENADRYL 1 1/2t q 6h prn. She states on Sun a.m. he seemed better but was sleep and same movement continued. He went to church and mostly slept. She states he played outside a little Sun pm, but continues to do same movement. She sent him to school today with BENADRYL. States he continues to have same movement of the head, eyes, and now lower jaw. Pt is to see pediatrician at his office this morning. Mother states she will phone nurse with result of appt. States pediatrician told her he did not know if these sx are a result of H1N1 injection.
Flu-like symptoms; Red raised welt with rash on arm at injection site of vaccine; Body aches; Fever (100F)/High fever of 102F; Chills; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via unspecified route of administration in left arm on 08Apr2021 at 11:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patients medical history included latex allergy. The patient did not receive any medication within 2 weeks of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced fever (100F), chills, body aches, nausea, headache within first 48 hours of vaccine then resolved, but then all came back again 10 days later along with red raised welt with rash on arm at injection site of vaccine and high fever of 102F, somewhat resolved, and came back again over two weeks later along. Flu-like symptoms were intermittent but continued over two weeks later. No therapeutic measures were taken for the events. On 18Apr2021, the patient underwent the nasal swab (helix) and result was negative. The clinical outcome of the events fever (100F)/ high fever of 102F, chills, body aches, nausea, headache, red raised welt with rash on arm at injection site of vaccine and flu-like symptoms was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
I was having a lot of congestion, problems breathing and sore throat. No fever but I did have body aches and was really tired. Went to the doctor and they tested me for Covid as soon as I came in but it was negative. The doctor provided me steroids' & antibiotics, I then started to feel better after 3-5 days but still have on going mucus in throat.
fever; CHILLS; soreness of arm; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (CHILLS), PAIN IN EXTREMITY (soreness of arm), NAUSEA (Nausea) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (CHILLS), PAIN IN EXTREMITY (soreness of arm), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (CHILLS), PAIN IN EXTREMITY (soreness of arm), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Pt was administered Moderna Covid-19 2nd dose 10.22.21. Vial had an expiration date of 10.21.21, which was extended by Moderna to expire on 12.21.21 on 10.22.21 (via e-mail from management). This morning new guidance was received stating only vials that were frozen are to be used with new expiration date. The vial used for patient was previously thawed-out.
Incorrect dose administered (Incorrect dose administered) A non-serious, spontaneous report was received from a nurse involving the administration of one-half dose of FLUMIST to an eight month-old female patient.  There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
pt recv vax 4JUN95 & approx 5wk later, pt exp an unspecified mild rxn to the vax;21DEC96 pt devel full blown chickenpox w/a fever;sx lasted 5-7 days;
achiness; Chills; Fever; Patient also experienced pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Patient also experienced pain at the injection site) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patient had history of reaction to other prior vaccines.   On 16-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced PAIN (achiness), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Patient also experienced pain at the injection site). In September 2022, PAIN (achiness), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Patient also experienced pain at the injection site) had resolved.            No concomitant medication information was provided. It was reported that patient recovered without visiting a healthcare professional. No treatment medication were provided.
Within 3 hours of receiving my first COVID pfizer vaccine on 10/2/21, I developed ear pain, bilaterally, greater in my left ear. I also at this time had sudden onset of hearing loss, bilateral ears. This has since progressively worsened with passage of time.    Treatment listed below in item 19
Developed shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Developed shingles) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 04-Feb-2021, the patient experienced HERPES ZOSTER (Developed shingles). At the time of the report, HERPES ZOSTER (Developed shingles) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
PATIENT DEVELOPED RINGING IN EARS ABOUT 48 HOURS AFTER RECEIVING HIS SECOND DOSE OF SHINGRIX.  THE ADVERSE EVENT DISAPPEARED IN ABOUT 3 DAYS.
Sore all over body, very tired and felt weak. No fever was reported. Pt had to take off one day of work to rest. Pt felt bad for 2-3 days.
A third dose of Moderna Monovalent COVID-19 vaccine 6months to 5 years old was administered as a booster to a 2-year-old patient.
Client states she developed severe headache and weakness about an hour after receiving vaccine.  The following morning she awoke with nausea, vomiting, sore throat.  She reports feeling better today, though not completely well. Client states she called and reported to CDC.
Generalized myalgia, severe for 24 hour with headache. No fever or respiratory symptoms. Myalgia was moderate for 24 hours more and headache lessened. Myalgia and headache waned over following 24 hours. Weakness and fatigue lasted till four days after vaccine.  I was in bed for three days. I took Aleve and Tylenol and stayed well hydrated. If I had fever, I would have thought it was a severe case of flu.
sore arm; little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (Dose 2), for Covid-19 immunization, reaction(s): "sore arm", "little fever". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever".  Additional information: My wife and I took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. We also had one bivalent booster. We experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. We are eligible for the second bivalent booster however, my wife started taking Miralax for digestive problems one or two 17gram capsules a day and it is pure polyethylene glycol. She might have developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. We think there is a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine, does it contain Polyethylene glycol?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/patient/product/AE, different dose;
Got the shot on 4/8/2021 . That night I experience chills, a little fever, spams, intense fatigue, no appetite , muscular aches, this sinthoms started to disappear after 4 days. After about 10 days I started to noticed small involuntary movements on first my left arm , then my right arm , then both , then my legs,  neck . This started to happened at night during sleeping . I didn't know what to think at that time . the week after that all those movements started to be very intense. For no apparent reason  I started to have all this movements so intense that I had to keep my body in bed till the episodes stopped . sometimes lasted second , sometimes , minutes, sometimes hours. I went to a urgent care . they made me a blood test that it was normal. all my other vital signs were normal. i feel no pain when this happened besides the soreness on my extremities as a result of such , fast and repetitive movements. The day after I went to see a Neurologist . I had a normal MRI and a normal EEG. Visited another Neurologist that diagnose Functional Movement Disorder . She also recommended me a Physical therapist and a Psychologist . After several sessions with both of them ,they got in the conclusion that my problem is not related with stress or any kind of anxiety disorder as the neurologist has suggested . My family who has been