chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really sick for 48 hrs; still has no energy,feels spaced out with no energy; feels sick to her stomach; feels off balance; Feels like on the ocean rocking; arm was really sore; nauseas; Lymph nodes at base of neck was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick for 48 hrs), ASTHENIA (still has no energy,feels spaced out with no energy), ABDOMINAL DISCOMFORT (feels sick to her stomach), BALANCE DISORDER (feels off balance) and DEPRESSED MOOD (Feels like on the ocean rocking ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Past medical history not provided).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (really sick for 48 hrs), ASTHENIA (still has no energy,feels spaced out with no energy), ABDOMINAL DISCOMFORT (feels sick to her stomach), BALANCE DISORDER (feels off balance), DEPRESSED MOOD (Feels like on the ocean rocking ), PAIN IN EXTREMITY (arm was really sore), NAUSEA (nauseas) and LYMPHADENOPATHY (Lymph nodes at base of neck was swollen). At the time of the report, ILLNESS (really sick for 48 hrs), ASTHENIA (still has no energy,feels spaced out with no energy), ABDOMINAL DISCOMFORT (feels sick to her stomach), BALANCE DISORDER (feels off balance), DEPRESSED MOOD (Feels like on the ocean rocking ), PAIN IN EXTREMITY (arm was really sore), NAUSEA (nauseas) and LYMPHADENOPATHY (Lymph nodes at base of neck was swollen) outcome was unknown.            Concomitant medications taken by the patient were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
pt recv vax 17OCT95 & 18OCT95 30hrs p/vax pt devel swelling, induration, abscess, tenderness & erythema @ inj site;pt afeb;MD felt that site may have been infected & tx w/med;
woke up in middle of night after receiving vaccine because I was experiencing heart palpitations, PVCs, chest pain, shortness of breath, lightheadedness, and increased pulse rate.  Admitted to emergency room late morning.  discharged later that day still experiencing the same symptoms.  Received potassium chloride and Tylenol.  32 days later, which is when I am submitting this, I am still experiencing intermittent chest pain and some heart palpitations/PVCs.
The first day all I had was some soreness and by Wednesday it had faded.  Thursday night 1/7 I started getting chills off and on. I felt like I couldn?t get warm.  No fever.  Took 800 mg of Ibuprofen l, went to bed.   Still felt like I couldn?t get warm.   At about 2:00 am I suddenly awoke to severe nausea and thought I was going to vomit, but it didn?t come up.  Then, I felt like I was going to have diarrhea.  No BM.  Went back to bed eventually and continued to have chills and hot sweats back and forth. Nausea and stomach turning feeling  off and on.  No fever.  Normal temperature.  1/8 stayed home from work due to nausea.  Off and on during the day today and some light chills about 5 times so far.  Some headache and possible shoulder stiffness.
pain behind eye; Blister; This case was reported by a pharmacist via call center representative and described the occurrence of pain behind eyes in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain behind eyes and blister. On an unknown date, the outcome of the pain behind eyes and blister were unknown.   It was unknown if the reporter considered the pain behind eyes and blister to be related to Shingrix.  Additional details were received as follows: The patient experienced pain behind eye and a blister.  The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2019234407, reported by the same reporter.
Extreme chills; Extreme nausea; Body aches; Fever of 101.6; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Extreme chills), NAUSEA (Extreme nausea), MYALGIA (Body aches) and PYREXIA (Fever of 101.6) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested positive) on 04-Jan-2021.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (Extreme chills), NAUSEA (Extreme nausea), MYALGIA (Body aches) and PYREXIA (Fever of 101.6). At the time of the report, CHILLS (Extreme chills), NAUSEA (Extreme nausea), MYALGIA (Body aches) and PYREXIA (Fever of 101.6) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 101.6 (High) 101.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
On an unknown date, the patient began post exposure treatment with the rabies immune globulin and rabies vaccine and subsequently developed a large (11 x 14 cm) local reaction (erythematous, hot, and pruritis) to dose #4. This patient then switched to another rabies vaccine and experienced a smaller (3 cm) reaction (erythematous, hot, and pruritis) to dose #5. The event was treated with Tylenol and the patient recovered in 3.5 days.
Local erythroderma, warmth and painful touch, but no evidence of infection (right and left mid thigh, anterior aspect). Tender x 24h.
Upon administration of Covid 19 vaccine, needle accidentally dislodged from syringe causing zero to a miniscule amount of vaccine be administered.  OK to redose vaccine, and to report to VAERS.  Patient was then administered Covid  vaccine and tolerated without any complications or incidents
(9/24/2021) 7 days after the last (second) dose  of Pfizer was received, I started having a rash on my left arm and then it proceeded to spread to the rest my shoulders, right arm, chest and stomach. Since then it has remained and continued to spread. Today it has spread to my legs and feet. The rash look like many small bumps. It is itchy and at times turns into red patches.    (9/26/2021) 9 days after the last (second) dose  of Pfizer was received, I started sneezing repeatedly.  I also had congestion, runny nose, and sore throat.   Today (9/29/2021) I started having a productive cough with green phlem, but nose is still dripping clear.  Sneezing continued until yesterday (9/28/2021), but all other symptoms persist.
after 3rd day shoulder joint pain in left arm .after 10 days both arms moved to elbow. swollen lymph nods. also weakness in legs . still feel fatigue.
ADACEL was administrated post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 65 years old male patient to whom experienced diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administrated post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient was administrated  0.5 ml dose 1 of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (lot U7461AA Exp.date: 12-JUL-2024) via intramuscular route in the right arm for immunization post excursion with no reported adverse event (poor quality product administered).  Action taken : not applicable.  Outcome : Unknown.   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.; Sender's Comments:  01266747: 01266903: 01266768: 01266921: 01266924: 01266780: 01266792: 01266974: 01266976: 01266978: 01266980: 01266982: 01266985: US-SA-2022SA372080:
painful that it would take away breath; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Agency and transmitted to Sanofi on 02-Dec-2021.  This case involves 75-year-old female patient who experienced painful that it would take away breath (pain) while receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious painful that it would take away breath (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
On 9/14/00 had hives and chickenpox from vaccines, especially on lips. On 10/10/00, had persistent hives, joint stiffness, treated with Decadron and Depo-Medrol. On 10/13/00, was give prednisone. On 11/16/00, continued with hives, especially on face. On 1/09/01, had hives all over and was treated with Decadron and Depo-Medrol. Doc 215203 states the following: "I have called x2 & not received a return reply to my message. Spouse answered phone but was unaware of any problems associated with the 12's.
Had a reaction to every dose; Received a full dose instead of a half dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a reaction to every dose) and ACCIDENTAL OVERDOSE (Received a full dose instead of a half dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 393906, 044921A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic asthma (Asthma induced with allergies).   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received a full dose instead of a half dose). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a reaction to every dose). At the time of the report, VACCINATION COMPLICATION (Had a reaction to every dose) had resolved and ACCIDENTAL OVERDOSE (Received a full dose instead of a half dose) outcome was unknown.            No concomitant medications were provided. The caller reported that they had a reaction to every dose when they got them and it went away in a day or two. They did not take any medications for any reactions. No treatment medications were reported.   This case was linked to MOD-2021-307233, MOD-2021-307462, MOD-2021-307152 (Patient Link).
Arm sore within 2-3 hours Within 18-20 hours feel terrible. Constant headache, chills and a bit shaky, no fever but goosebumps all over, all of skin is uncomfortable when touched or clothes rub too hard, jaw sore and feels uncoordinated, aches and pains come and go all over body (legs, lower back, neck, arms), nausea, send ivory to light and sound
Pt. was given a DTaP on August 6th at 1430.  On 08/18/09 his mother called the clinic.  She stated that his arm was swollen from the injection site to his hand.  Pt. complained of pain when using his arm.  Mom took pt. to the doctor on Friday August 7th and was instructed to ice the injection site.  Mom states that is arm is still swollen and there is a bump at the injection site.  Encouraged mom to call her physician if the symptoms persist.
Developed chest pain 6 days post vaccination, no SOB, + fatigue, + nausea, + palpitations.  Currently no chest pain, but continues to note occas palpitations.  Symptoms: Chest Pain, sub-sternal, Fatigue, Malaise <60 Days, Tachycardia.  DX: myocarditis, paroxysmal SVT, VT.  6/10/08 Reviewed medical recods & vaccine records.  Patient was re-vaccinee & developed chest pain 6 days s/p smallpox & anthrax #4 vaccination.  Patient also experienced fatigue, nausea, palpitations. While hospitalized, experienced SVT & asymptomatic VTach, elevated troponin.  Cardio clinic 1/2008 w/ECG normal; treadmill test WNL; thallium WNL; echocardiogram WNL; Holter monitor revealed abnormalities.
After receiving the HEP B and ROTAVIRUS vaccine patient's respiratory illness became a lot worse. He was diagnosed with Bronchiolitis and possibly some other viral sickness. He was prescribed a Nebulizer with Albuterol, which inflamed his symptoms and caused him from going from no fever to 103.6 within one hour of time. Doctor was called and was prescribed Amoxicillin without being seen in the doctor's office. After a few days fever went away but respiratory issues were still severe. Patient went back to doctor on 01-02-2010, he was then prescribed Prednisolone Sodium Phosphate, which made him eat more and sleep maybe an hour a day. Did not seem to help with his respiratory issues. 01-05-2010, patient back at doctor, chest x-ray done and blood work. X-Ray showed mucous in his bronchial area and blood work reported back okay. 01-11-2010, patient was admitted to hospital for observation. Nothing changed and was dismissed the following day. 01-18-2010, patient went to doctor for post-hospital check up. Patient was still sick, asked for a referral to see a specialty doctor in Pediatric Pulmonology. 01-20-2010, seen Dr. An x-ray was taken of patient's chest. Dr. reported back that there was bronchi that were plugged with mucous and that patient's breathing sound worse that some of the kids in the hospital. Patient was admitted to Hospital on 01-20-2010 for observation. Patient was discharged on 01-21-2010. His lungs sounded better. Patient's wheezing and congestion will fluctuate throughout the day/night. At times patient will sound good and other times he is having hard time breathing. To this date 01-27-2010 patient is still sick.
my eyelid hurts; back hurts really bad; fever 101.5degF; every piece of my body hurts; had the worst headache of my life; also have chills; my throat was bothering me; Not feeling good; really dizzy; arm started hurting and killing me; felt like I was going to fell; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me) and FEELING ABNORMAL (felt like I was going to fell) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and Lot# 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me) and FEELING ABNORMAL (felt like I was going to fell). On 02-Apr-2021, the patient experienced EYELID PAIN (my eyelid hurts), BACK PAIN (back hurts really bad), PYREXIA (fever 101.5degF), MYALGIA (every piece of my body hurts), HEADACHE (had the worst headache of my life) and CHILLS (also have chills). At the time of the report, OROPHARYNGEAL DISCOMFORT (my throat was bothering me), MALAISE (Not feeling good), DIZZINESS (really dizzy), PAIN IN EXTREMITY (arm started hurting and killing me), FEELING ABNORMAL (felt like I was going to fell), EYELID PAIN (my eyelid hurts), BACK PAIN (back hurts really bad), PYREXIA (fever 101.5degF), MYALGIA (every piece of my body hurts), HEADACHE (had the worst headache of my life) and CHILLS (also have chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101.5 f.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details include ibuprofen. OK for safety to follow up with caller via phone.
At 15 hours after vaccine- I became nauseated and vomited repeatedly. Several hours later, I was still nauseated and unable to hold anything down and my torso and stomach was in pain. I dealt with the pain for 2 more days and eventually went to the ER on Sunday 2/6. After a blood test and a CT scan, I was informed that I had an inflammed pancreas (pancreatitis).
Missed second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided
After approximatly two weeks I started to see little "floaters" in my left eye. More like little hair moving toward the periphery of the eye and disappearing after blinking, but then appearing again.
Tdap and varicella given and seconds after varicella given to child his body fell back in chair with head jerk (fainted). This lasted about 30 sec. wet his face and fanned him and improved in seconds. Instructed mom to follow up with dr.
*may or may not be relevant to flu vaccine.:within 1 week of vaccine-severe headaches, nasal congestion, tired, within 4th week after vaccine:pain behind right ear, cold sore on outside left lower lip, 10/25/07-sudden numbness to left cheek, rt of mouth dropped causing drooling, no blinking from rt eye, rt side of face flattened, lt side of face swelled, visited er for fear of stroke, Dr diagnosed with Bells' Palsey after CAT Scan cleared, then requested to keep lubricating eye with lacri-lube at night, and prescribed steroids, and and antiviral medication with referral to nose ear throat speacialist, 10/26/07-front top of tongue tingly and numb, some foods taste different, trouble eating and drinking from a cup, need assistance drinking by using straw and holding lips closed aroung straw, MD appointment with ENT Specialist- gave me same advice as Dr, and lenghtened medicatin use for up to 2 weeks; also had audioaulogy testing for any loss of hearing, 10/27/07-words with b,f, or p are difficult to pronounce, vision now blurred to rt eye, must wear patch and keep lubricationg with artificial tears, worked this day causing emotinal distress because of peoples reactions to my face, symptoms have progressively gotten worse and more difficult, 10/28/07- rt nostril has drooped causing less airway, and more dificulty breathing when eating or drinking, 10/29/07-saw family physician for third opinion, and said to expect it to get worse, but the Bell's Palsey will reach it's peak depending on the person, then improve very slowly, may take a couple of weeks to several months at least, prescribed anitbiotic and pain med for uti and pain for headaches and right ear cramps, hearing to rt ear is extra sensitive to loud noises, or lound bong sounds (feels like a thick needle piercing throught my right ear causing so much pain my body trembles and i cry (:<)). 12/1/07- no change lots of ear pain and blurred vision on rt side. Advise Bell's Palsey is still an unknown disorder (not knowing the culprit that causes this, but have linked to possibly be cause by a virus)  12/4/07 Reviewed vax record from HD which provided Sanofi Lot# U2452A & corrected date of vax to 10/26/2007.  12/4/07 Reviewed ER medical records of 11/25/2007 which reveal patient experienced sudden onset right facial droop, left side numbness & HA x 1 day.  Tx w/antivirals & steroids. FINAL ER DX: Bell's Palsy. 12/7/07 Reviewed pcp medical record of 11/29/07 which reveal patient experienced facial numbness & HA since 11/25/07.  Also c/o dysuria.  Given additional antiviral & eye ointment & patch.  Already scheduled to see ENT.  FINAL DX: Bell's palsy, dysuria, UTI. 1/22/08 Reviewed ENT medical records which reveal patient initially seen 11/26/07. Dx right Bell's palsy.  Tx w/steroids/antiviral & eye protection. Returned 2/18/07 & experienced extreme sound sensitivity & gen discomfort worsening.  Facial weakness remained.  Returned 2/28/07 s/p MRI which revealed maxillary sinusitis.  Tx w/antibiotic.  Bell's palsy improved. FINAL DX: right Bell's palsy but w/increased right ear pain & sound sensitivity; maxillary sinusitis.