chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen and painful lymph nodes under R armpit.; Painful lymph nodes under R armpit.; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 12Apr2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient reported no known drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Apr2021 at 00:00, the patient experienced swollen and painful lymph nodes under R armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event swollen and painful lymph nodes under R armpit was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
swelling around injection site, very red, hard not, sore to touch  this went away, but came back 5 days later with sever itching.  The more I scratch the worse it would itch, so tried not to touch.  Stop by pharmacy where I received the vaccine and she ask me to report this to you.  I did do benadtyl gel extra strength to injection site which helped a lot.  It is normal now.
I went to sleep and when I woke up I noticed that my arm was hurting and I had a bad headache, and it lasted for 4 or 5 days. My head hurt so bad that I was crying and my husband asked me if I needed to go to the ER. I also had body aches for about 4 days.
First day: Chills, then spiked fever to 101.3, muscle aches, painful upper left arm, some redness at injection site Second day: general lethargy, muscle aches, fever returned in evening
metallic taste in mouth soon after the injection, discolored tongue; rx mouthwash prescribed; new symptoms include headache, fatigue, continued arm pain, swollen glands in armpit
Constant crying and developed infantile spasms.  (Was not aware she was having spasms at that time but this is when they started. Her spasms look like she pulls her legs in, like gas pains only more jerky).
Received ROTATEQ 1/15/10. On 1/19/10 dev. vomiting and soft stools. Seen in office 1/20/10 - well hydrated and doing okay. Night of 1/20 taken to ER for vomiting. Tx'd with ZOFRAN IVF; sent home. 1/22 Back to ER for V/D so admitted. Later evening/early morning of 1/22-1/23 dev. abd. distension/bloating. X-ray c/w obstruction. Transferring to hospital for eve. bypass surgery. Had surgery (exploration) and abd. pain. Pt. passed Rotavirus and C. diff.
A report was received from a health professional on 10/16/02, concerning about 20 vaccinees between the ages of 6-35 months who were inadvertently administered Fluvirin in the vastus lateralis between 14-16 October 2002. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update (1) 12/27/02: A report received from a health care professional indicated that a 5 month old male vaccinee inadvertently received Fluvirin vaccination on 10/16/02. There were no adverse effects noted at the time of the report. See Ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300023, PJP200300025, PJP200300026, PJP200300027, PJP200300028, PJP200300029.
swollen, tender rt deltoid around DTAP inj site;erythema 4cm x 4cm;
Information has been received from a physician concerning a 19 year old female patient who was vaccinated with the first dose of GARDASIL on 12-JUN-2008.  Immediately post vaccination the patient fainted and had convulsions and seizure which lasted for approximately 1 minute.  The patient sought medical attention in the office.  At the time of the reporting the patient had recovered.  Upon internal review, convulsion was considered to be an other important medical event.  Additional information is not expected.
at 1430, pt. states she felt warm, went to screening station, temp was 99.5, went back to desk and felt warm.  States she started feeling pressure and warmth to her face with some itching. At 1500 she came to employee health.  RN gave her 25 mg liquid benadryl.  Her BP was 126/89, HR 87. No hives or swelling to Right arm noted. BP 117/80, HR 75.  at apprx 1520, bp 137/85, HR 67.  No other signs or symptoms noted.  1528, bp 121/82 At 1532, "patient states she feels good, almost back to normal".
complain of headache and muscle ache later diagnosed and treated for Guillain Barre syndrome
Starting around 9AM I began noticing a high heart rate while inactive. My heart rate was at 140 bpm (measured manually and with Watch). Normal for me is between 80-100 bpm. My heart rate remained high (between 120-140 bpm) for about 6 hours. I did not notice it go down to 100bpm until the next day. The high heart rate was never provoked by any physical activity. I rested in bed or in a chair all day and drank lots of water. Throughout the day I had fluctuating periods of feeling very hot and very cold. I took 1000mg of Tylenol every 4 hours throughout the day.  I also experienced expected side effects (chills, joint aches, muscle aches, nausea, headache, fever (100F w/ Tylenol)).
Tightening in the throat; Mild soreness in the muscles all over the body; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Tightening in the throat) and MYALGIA (Mild soreness in the muscles all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced THROAT TIGHTNESS (Tightening in the throat) and MYALGIA (Mild soreness in the muscles all over the body). At the time of the report, THROAT TIGHTNESS (Tightening in the throat) and MYALGIA (Mild soreness in the muscles all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Initial report was received on 17 September 2014 from a health care professional via company representative. An almost 80 year-old female patient (date of birth not reported) had received on an unspecified date FLUZONE (lot number not reported) and several hours later, experienced an allergic response. The patient's face swelled up she went to the emergency room. The patient's medical history and laboratory tests were not reported. The patient was fine the next day. Outcome was recovered. Documents held by sender: none.
Two days later passed away; difficulty breathing, shortness of breath; difficulty breathing, gurgling; Not feeling well; Achiness; Severe fever; Chills; A spontaneous report was received from a physician concerning a 56-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, chills, achiness, shortness of breath, gurgling and unresponsive.     The patient's medical history was not provided. Concomitant product use was not provided.  On 19 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   After receiving the vaccine on 19 Jan 2021, the patient experienced fever, chills, shortness of breath, gurgling and achiness. On 21 Jan 2021, the patient was found unresponsive. Emergency medical services were called to perform life saving measures however, they were unsuccessful. No further treatment information was provided.   The patient died on 21 Jan 2021. The cause of death was reported as unknown. An autopsy was planned.; Reporter's Comments: This case concerns a 56-year-old, female, who experienced a serious event of death, with many other events after receiving second dose of mRNA-1273 (Lot# 042L20A). Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history.  No known allergies. The patient did not receive other medication in 2weeks.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The patient received Paxlovid for COVID-19 as treatment from 09Oct2023 to 13Oct2023, while the patient rebound of symptoms of congestion, headache, Chills, mild fever since 17Oct2023. The patient was recovering. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
the first 24 hours were very complicated with a lot of fever, headache, body aches, fatigue, chills, great thirst, and shortness of breath, chest pain. On the third day the fever decreased to 40% and the body aches decreased to 20% but the headache continued and the shortness of breath also. The day was no longer fever, the muscle aches were somewhat better, but the headache, chest pressure and breathing problems continued and I went to  and was evaluated by a doctor and treated with some injections. The headache improved almost 100%, but I continued with breathing problems and for 2 days I presented as bruises on the body and face. Breathing and chest are definitely what worry me the most because I already have treatment and I'm not getting better.
patient had tingling at the injection site; arm hurt to lift it; red patch on the lower arm; felt warm to the touch; Initial information received on 10-Feb-2021 regarding an unsolicited valid non-serious case from a non-healthcare professional.  This case involves patient (unknown demographics) who had tingling at the injection site (injection site paraesthesia), arm hurt while lifting (pain in extremity), red patch on the lower arm (rash erythematous) and felt warm to the touch (feeling hot), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in the upper arm near the shoulder for prophylactic vaccination  On an unknown date, the patient developed a non-serious tingling at the injection site (injection site paraesthesia), next day of vaccination arm hurt while lifting (pain in extremity), red patch on the lower arm (rash erythematous) and felt warm to the touch (feeling hot) (Unknown latency), following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient got recovered from all the events on an unknown date as it reported that the patient was feeling much better and did not take any of the medicines as directed.
Redness - soreness at injection site. Pharmacist traced area - diag. cellulitis - RX Doxycycline. Pharmacist called and apologized (did not wear gloves or cleaned injection area). Area much improved by Sat 4/28.
A pharmacist reported that a received a vaccine on 7/2000, Pt subsequently developed cellulitis at injection site. Pt treated with antibiotics and recovered. Follow-up info received on 01/23/2001 from the reporter indicated that the pt was immunized on 07/25/2000. The cellulitis, requiring a physician visit, occurred the following day on 07/26/2000. The pt has a histroy of pcn allergy and allergy to "environmental agents."
After the first vaccine noticed tinnitus in both ears when second Pfizer shot given I waited til September 27,2021 got second Pfizer and the tinnitus got worse have seen ENT and had audiology testing no hearing loss and also CT scan of inner ear canal for vestibular reason also had a whole vestibular testing done by Dr including rotation chair and VESTIBULAR-EVOKED MYOGENIC Tests and caloric testing all findings normal  So I can only attribute this ringing to the Pfizer first and second shot very annoying
Fever followed by upper back pain, elevated heart rate, muscle pain and weekness, nerve issue with tingling and numbness in hands and feet.
pt recv vax & mom states sz began @ 215PM on 6/3/99;pt taken to hosp & transferred via ambulance to hosp;sz returned on 6/5/99 & pt placed on Tegretol per order of MD;
administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On an unknown date, the patient experienced OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.  No Treatment information  were reported.
She got her vaccine, it irritated her joints.  A lot of pain which she is still having.  She has had joint pain with all three vaccines that lasts from weeks to months.  She has gone to her PCP and has told her to take pain pills.  The reactions get worse with each reaction that she has gotten.
This spontaneous report as received from a consumer refers to herself: a 74 year old female patient. The patient's medical history included cholesterol, blood pressure and 'hypthyroidism'. In 2009 the patient was vaccinated with ZOSTAVAX in the arm for prophylaxis (lot number not provided). Concomitant medication was not provided. End May 2013 the patient experienced shingles. The outcome of shingles was not reported. Additional information has been requested.
The patient received vaccine.  Was 10 min. into monitoring period.  She started experiencing SOB, Heart racing, dizziness. She was taken to the ER to be check in.
pt calls w/ c/o soreness (aching) in lt upper arm since immun in JUL98;states it got better for awhile but now has worsened;can't sleep on that side;no redness or swelling noted;
Pt came to ER c/o weakness and fever for 1 week, SOB.
Noticed symptoms of numbness and tingling in my left arm and partial spots of my left face from my mouth all the way up to around my left eye. Later in the day, noticed numbness and tingling in my left foot. Took 1 tablet of ZYRTEC around 11:00 AM. Symptoms resided the next morning.
temperature excursion for Adacel/Temp: 48.2; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves 4 Adult female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was exposed to temperature (Temp: 48.2) for 8 hours.   The reported temperature excursion for Adacel/Temp: 48.2 occurred at unknown gestation period<<the gestation period at onset and gestation period at exposure data needs to be populated, if available>> The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had <<XX>> previous pregnancy/ies.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route.  It was of actual medication error due to  incorrect product storage.  No adverse event was reported.  Additionally, at time of reporting, the outcome of the pregnancy is unknown. <<Outcome of the pregnancy was reported as <Birth Type unknown> and fetal outcome was reported as 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 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.
patient is still due for 2nd dose after 42 days since first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient is still due for 2nd dose after 42 days since first dose) 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 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 (patient is still due for 2nd dose after 42 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient is still due for 2nd dose after 42 days since first dose) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: follow up added
This spontaneous report as received from a nurse refers to a 55 years old female patient with renal failure requiring peritoneal dialysis, diabetes, hypertension, right benign renal mass, atrial fibrillation and rheumatoid arthritis. The patient's medical history included left nephrectomy and chicken pox in childhood. The patient was accidentally vaccinated with a dose of VARIVAX (merck) instead of prescribed ZOSTAVAX on 29-OCT-2012. Concomitant medications included furosemide, folic acid and methotrexate. Historical drug included PNEUMOVAX 23 (lot # 671001/0843AA, exp. Date: 07-MAR-2013) one injection 0.5 ml in 2008. There was no relevant laboratory data. As of 29-OCT-2012, it was unknown if the patient continued to take VARIVAX (merck) and the status of the patient after accidental administration of VARIVAX (merck) was unknown. Additional information has been requested.
Got the vaccine, no problems with the arm, then about 3 hours later after had something to eat, and had a headache and took a nap.  She woke up and sneezed and her nose then started running and wouldn't stop.  She just felt that she was in lala land, fatigued, chills, scared her.  This continued for about 5 days.  She took some Benadryl, and also took some arthritis Tylenol.  Her feet are bothering her badly where they weren't that bad before, feel like sponges.  She has not notified her doctor.  Feels like it attacked her neuropathy.
26MAR91 mom found child face down in bath tub; Not sure poss unconscious; Pt limp, pale & disoriented; To ER- MD states probably shot related no tx; 27MAR91 pale not very active; 28MAR91 developed cough, runny nose, congestion & ear infect;
Rashes are itchy; Patient started to have rashes that look like blisters all over his body 2 weeks after first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rashes are itchy) and RASH (Patient started to have rashes that look like blisters all over his body 2 weeks after first dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH PRURITIC (Rashes are itchy) and RASH (Patient started to have rashes that look like blisters all over his body 2 weeks after first dose). At the time of the report, RASH PRURITIC (Rashes are itchy) and RASH (Patient started to have rashes that look like blisters all over his body 2 weeks after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Prednisone and a cream
The adverse side effects I'm experiencing at this time are :  slight  swelling, to left  upper arm,  left shoulder and below axillary.   Mild flushed at injection site and tender to touch.     Most pain noted under axillary site.   I have taken Tylenol as directed.   Tylenol ineffective.
Patient called pharmacy day after shot and was driving home complaining of fatigue,"loss of thought", fever, headache. RPH told her to go directly to ER or MD for evaluation. At the ER she was told her Blood Sugar was very low(26).  RPH followed up with phone call on 6/15/2016 and patient was doing much better,
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/25/2021, and 8/22/2021. Presented to ED on 12/31/2021 with complaints of shortness of breath, cough, and positive COVID test on 12/29/2021. Admitted 12/31/2022 for acute hypoxemic respiratory failure 2/2 Covid-19, intubated in the emergency department and transferred to the ICU. Patient was started on remdesivir and dexamethasone. On 1/10/2022 patient became progressively hypotensive and acidotic, developed septic shock. Expired 1/11/2022.
Extremely itchy hands lasting for about two weeks; debilitating chest/upper abdominal pain; intense esophageal issues; large amounts of constant saliva; frequent necessary ER visits; admission to hospital;  surgery and removal of cyst to determine if that was the source of the problem (which it was not) ; still ongoing issues - no remedy or conclusive diagnosis thus far; cannot eat regularly or consistently; practically bed ridden and cannot work or function normally because of the ongoing issues PCP 11/16/2021? Hospital admission: 11/20 through 11/29/2021 Hospital ER Visits General Hospital: 11/19/2021, 12/06/2021, 12/09/2021, 12/13/2021, 12/14/2021, 12/23/2021, 12/26/2021, 12/28/2021, 01/03/2022 Hospital ER Visit Hospital: 12/17/2021 Additional visits to Gastro Doctors; Outpatient Urgent care facilities; phone consults with doctors