chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flushed, inc pulse, SOB, BP @ 2:40 140/104, 96;2:37 138/100, P96;2:42 P120 SOB;2:45 150/100, P100;2:49 P116;rash belly-wrist;later went home had reaction to adrenalin  @ home w/SOB;
Patient was given a dose that was >6 hours from reconstitution therefore was considered an invalid dose.
Chest pain, upset stomach, elevated heart rate and blood pressure  Performed tests, gave them water and advised to drink electrolyte rich fluids and take Tylenol or Ibuprofen every 6 hours for discomfort.
Friday red streak across arm horizontally 3" in length 10/26/07 Friday excessive sleep nauseated/vomiting  10/26/07 fine on 10/27/07
Migraines, stomach aches, nausea, diarrhea, sinus congestion
Got home - rash in shot arm, up arm up face. 7pm. Anaphylactic symptoms - Shortness of breath, neck swelling at shoulder. Dizzy, nausea. Called ambulance. Twitching eye, neck pain.
This spontaneous report was received from a physician, referring to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 18-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # K007826, that had expired on: 03-FEB-2016) (route and dose were not provided). Concomitant medication was not reported. No adverse effect was reported. It was also reported that there was not product quality complaint involved. Additional information has been requested.
10 days after shot.  Rash, pain & swelling returned to injection site on left arm.  Pain and itching are mild.
pt w hx of vagal events with vaccinations and blood draws.  shortly after vaccine administration, became nauseated, pale, and dizzy.  improved after 30 minutes.
Fever up to 102 Severe headache for 24 hours Nausea Chills Severe joint pain - felt like I was in fire
get sick every time I get one; Initial information received on 29-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional (under reference number: US-SA-SAC20211201000749).  This case involves Adult and unknown gender patient who experienced get sick every time i get one (illness) after receiving INFLUENZA VACCINE.   The patient's medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.  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 unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event get sick every time i get one (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  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 of the event was reported as unknown
Pt recvd vax 21OCT92 & on the same afternoon as the vax pt exp dizziness;
PHYSICIAN ORDERED THE INCORRECT VACCINE.  NURSE GAVE A 3RD MONOVALENT DOSE INSTEAD OF GIVING THE PATIENT BIVALENT.
About 5pm started to feel bad.  By 10pm had headache, chills, weakness, muscle aches, difficulty with moving, keeping balance and heart palpitations.   Patient slept very poorly.   Patient woke up feeling better but arm was quite sore.  After 3 hours, patient overcome with weakness and fatigue; had to sleep for 30 minutes.  Seemed to be getting tired and tired as the day went on.  On Friday, was still feeling poorly, had chills and totally without energy.   On Saturday noticed redness around injection site 2x3 inch; arm was tender.  All day just felt like lying down and sleeping.  Noticed that there was increased flatulence, had trouble making decisions, chills like hot flashes, decrease in appetite and intermittent nausea.  On Saturday, called the pharmacy around noon about the arm redness since it was odd that it appeared days later.   On Sunday woke up with a moderate headache and about 3 hours later food did not taste goodthings that she loves to eat tasted terrible.  Patient had lack of energy and fatigue.  More bowel movements that are frequent started Saturday and continued to Sunday.  Redness in arm was gone when woke up but came back after shower.   Sunday morning had to lie down again because felt so tired and had no appetite.    On Monday morning felt well when woke up and by afternoon felt like mostly okstill does not feel back to normal.   The fatigue is much better; it comes in waves and not as frequent.   Food taste ok now.   Patient did not call the doctor at any time.  Patient has received the Flu High Dose vaccine for several years prior with no problems.
pt recv vax 13NOV98 1030AM  nurse gave the vaccine quickly & it burned badly as vaccine was entering arm;arm swelled & could not touch it for 2wk;still coughing, nose running & did not feel the immune system has strengthened;
one week after first dose of vaccine developed intense itching right arm with purpura  and swelling resulting from itching , itching continued to spread to all over body arms back legs torso neck. intensity would wake me up at night.  ice pack only relief.  have consulted 3 dermatologists, one internal medicine,  and one neurologist. 9 weeks of itching .
DTaP test; this am noted redness increasing in size and tenderness. No fever. Right upper arm with puncture area of redness below/around it. 4x4 cm, warm, indurated. No ax nodes.
All stages of symptoms that can occur from the vaccine throughout a person's entire body, only occurred in my left arm. About an hour after the shot, the site felt like a wasp sting, and around 1630 EDT a hard lump appeared at the injection site, that grew to about the size of a lemon, then I experienced swelling of the upper arm, pain in the whole arm, heat all over the arm, then chills in the arm, then inability to raise my arm - by evening my arm felt like I had severely injured a rotator cuff or other shoulder muscle, and it felt like it was made of lead (very heavy). These symptoms continued throughout the night, especially the chills, and I couldn't raise my elbow above waist high. This morning, all the symptoms have receded and I only feel moderate ache in my upper arm, but still have some difficulty lifting it.  I tried to find information on the internet about anyone else having experienced a range of symptoms only in the arm of the vaccination, and I haven't found any evidence of that, so I thought it was worth reporting.
10-16-09 mother brought pt into health dept 2 rash that she noticed this morning. No noted dyspnea or angioedema. Pale macular rash on trunk and arms. Pt denies any itching.
104.5°f fever. Spiked up within an hour of feeling ill. I Could not move my body I was too weak. Had a persistent cold and throat ache for about a month after the vaccine Terrible headaches only started since I got the shot and still affect me once in a while
5 1/2 hr p/vax pt c/o upset stomach, the next day pt had a h/a also, along w/ fever of 102;the inj site was swollen, warm & erythematous;pt was seen 2 days (48hr) later w/inj site swollen, erythema & 9x7.5cm, but no further systemic effects
Information has been received from a nurse practitioner concerning a 26 year old female patient with a history of abnormal papanicolaou smear prior to get the GARDASIL. On 20-AUG-2009 the patient was vaccinated with a dose of GARDASIL (lot #662519/0087Y). Concomitant therapy included CONCERTA (dose and indication unknown). The nurse practitioner reported that on approximately 23-AUG-2009 after the patient received GARDASIL in her left arm, the patient developed fever, the fever lasted for about 48 hours, she also had pain and numbness in her left arm from her shoulder to her elbow, she had nausea and vomiting for 48 hours, during which she vomited twice. The nurse practitioner reported that the patient's legs and toes were tingly for one day and also reported that the pain in her arm is gone now but she still had numbness off and on. The nurse practitioner reported that the patient developed a urinary tract infection and on 04-SEP-2009 the patient developed fever. The patient still had fever when she saw the nurse practitioner on 09-SEP-2009. Therapy with human papillomavirus vaccine was discontinued on an unknown date. At the time of this report the patient's outcome was recovered. The patient sought for unspecified medical attention. Additional information has been requested.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.
PVCs developed 3-4 days after 2nd Pfizer shot.  No treatment and has not gone away.  Cardiologist said they probably will never go away.
t105, lethargy started 14-16 hrs p/vax; In office @ 24hrs p/8AM APAP (10AM temp 101 ax);
The patient developed joint pain and swelling involving the hand, knees, elbows and feet within a few hours after receiving the vaccine. Pt has not recovered at the present time.
pt recv 12FEB96&26FEB96 pt exp chicken pox rash about 20 lesions on trunk;no further details were provided
Menactra given 8/28/07. 9/6/07 Necrotizing fascitis opposite arm from injection - organism Clostridium Septra resulting in amputation (R) arm, (R) scapula. 11/5/07-records received for DOS 9/7-9/26/07- DC DX: Right upper extremity necrotizing soft tissue infection. Seen in ED with 13 hours increasing pain, swelling redness and bruising RUE, inflammation began in posterior lateral arm prox to distal humerus and down to mid radius. Immediate surgical debridement included four quarter amputation and debridement and irrigation of chest wall musculature with clavicle excision.  Post op day 1 repeat debridement of necrotic tissue and amputation.  Per 60 day follow up: This young lady had Clostridium perfringens sepsis causing a necrotizing fascitis 1 wk after pneumococcal vaccination warranting R upper extremity amputation.
Approximately 18-20 hours after the second dose I started getting an "electric" feeling on the right side of my neck going up to the right/back side of my head, behind my ear. It lasted for the rest of the night. I was very tired and had no appetite. Later that night I started to get strong menstrual cramps that lasted about 2 days. I was not on my period.
Information has been received from a register pharmacist concerning a 70 year old female patient with no pertinent medical history and no drug reactions or allergies who on 26-JUL-2010, was vaccinated SQ with 0.65 ml once dose of ZOSTAVAX (Merck) (Lot# 665531/0698Z). The pharmacist stated that, the patient had a rash at the injection site on her arm after receiving ZOSTAVAX (Merck) on approximately 26-JUL-2010. The patient was seen at an emergent care facility and was given a prescription for VALTREX. At the time of the report, the patient had recovered. Additional information has been requested.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL3269), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Mar2023, outcome "unknown" and all described as "Covid". On 17Mar2023 the patient had the beginning of nasal symptoms and tested positive for Covid antigens. She had had the original 2 vaccinations using your product and 3 boosters as listed. Therapeutic measures were taken as a result of event. The patient used Paxlovid starting 17Mar2023 for 5 days.
2 hours after vaccination, there was approximately 1 inchX 0.5 inch redness half inch below the injection site.  The next day at 7 AM, I was having chills and frequent cough spells precipitated by PVCs and in the evening I developed worsening chills and a fever with temperature of 101.9 to 102.4.  Also, the redness on my arm increased in size to 3 or 4 times larger.  Its size once again incread significantly on 11/1/2020.  I went to an urgent clinic for evaluation and treatment. I am currently being treated with Cephalexin 500 mg 4 times a day for 10 days.  On 11/2/2020-seen at another medical facility to report adverse reactions.
very painful day of inj then began w/welts over deltoid area which lasted 2 days;cont to have bruised muscle sensation over upper arm;
Left arm interstitial edema.  Pain at injection site since vaccine administered.  Experienced severe pain in left shoulder , chills, and shaking since Friday night, 9/10/2021. Pain in biceps and deltoid region
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from nurse. This case involves a 3 months old female patient where hub of the needle was cracked and because of this the 0.5 ml dose of PENTACEL (lot C5552AA/C5409AA and Exp. Date 10-OCT-2019 via unknown route in the left thigh) leaked all down the patient's leg, on 28-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTATEQ and PNEUMOCOCCAL 13 VALENT VACCINE for Immunisation. It was as actual medication error case due to vaccine underdose and exposure via skin contact. It was reported that, the hub of the needle there was a crack and because of this the vaccine leaked all down the patient's leg. It wasn't the vial but the hub of the needle that caused the issue. It was a case of needle issue. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
SON REPORTED THAT PATIENT WOKE UP 4/7/21 WITH FLU LIKE SYMPTOMS AND STAYED IN BED ALL DAY.  PT DID NOT DRINK ANYTHING OR TAKE INSULIN ON 4/7/21.  WHEN DAUGHTER ARRIVED AT PTS HOME THAT EVENING, PT WAS INCOHERENT.  SHE CALLED 911 AND PT WAS TRANSPORTED TO THE HOSPITAL WHERE HE PASSED AWAY ON 4/9/21.
I had no reactions with the first dose. The next morning on the 28th I woke up and couldn't get out of bed. I tried to get out bed and couldn't my husband had to come help me. I could barely walk because I hurt so bad. He helped me to the bathroom and then to my chair in the living room. It hurt so bad I couldn't stay long. My husband helped me back to bed, I stayed in bed all day besides when I needed to go to the bedroom. Today I am shaky, my stomach is bothering me, I can walk today but I real tired and shaky and have to come right back to my chair to sit down.  I am better then I was yesterday.  If I don't feel better by noon I will call my doctor.
Information has been received from a healthcare student referring to a patient of unknown age and gender. Concurrent conditions and medical history of the patient were not reported. On an unknown date in 2011, the patient was vaccinated with the first dose of GARDASIL (lot#, expiry date, dose and route unspecified). The patient then received the second dose of GARDASIL (lot#, expiry date, dose and route unspecified) on an unspecified date in 2012. On 23-MAR-2016, the reporting day, the patient received the third dose as either GARDASIL or GARDASIL 9 (lot#, expiry date, dose and route unspecified). No adverse effects were reported. Additional information is not expected as we are not permitted to contact the physician.
Information has been received from a Registered Nurse referring to a 6 week old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 24-JUN-2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB (route not reported, lot # reported as K026532, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccination adverse reactions; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reactions). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. It was reported that patient experienced some adverse reactions with the Moderna vaccine.  The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
I had the covid disease via a PCR test on dec 24th, 2020 and receive first dose of vaccine resulting in dizziness and vertigo not resolved presently after 7days.  I will seek an Ent appointment next week if necessary
The patient presented to the emergency department with chest and back pain. Admitted the hospital and diagnosed with myopericarditis.
Pt recvd Engerix-B vax & exp anaphylaxis w/sx of swollen tongue, difficulty breathing & hypotension; tx Epi;
Tingling in feet and legs, back ache and pain, 10/6/10, severe pain onset, 10/9/10 ER visit, diagnosed with GUILLAIN-BARRE syndrome. Unable to walk, still has tingling and pain. Currently in hospital receiving treatment.
This spontaneous report was received from an office manager refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot #, expiration date, dose and route were unknown) that underwent unsupported temperature excursions and no adverse effects reported. Follow up information was received from the office manager who reported that on 01-AUG-2013 one patient was vaccinated with RECOMBIVAX HB (lot # 1106AA, expiration date 05-APR-2014). This is one of the several reports from the same source. Additional information is not expected.
W/in 3-4 hrs p/immun, pt exp approx 16-24 hrs of persistent unconsolable crying, cry was high-pitched & shrieking; Pt was afebrile; no inject site rxn or any other sx occurred;
Administer vaccine, expired two days prior; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th April 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 6th April 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 6 April 2022 Reporter's Comments: Nurse administer vaccine and upon documenting, the nurse realized that the vaccine expired two days prior. Additional Supportive Information: The patient received vaccine which was already expired which led to expired vaccine used.
Severe swelling at injection point. Entire arm and bicep area 2 1/2 times its original size. Area red and hot to the touch 24 hours later. Extremely painful the 24 hours later.
I had a horrible asthma flare up which made me tight in my chest and was painful in my chest.  It was terrible.  Each time I get this vaccine it makes me horribly sick. I cannot take ever getting another Moderna vaccine. These vaccines have been hell on earth.
pt recv vax 28FEB95 & 5MAR pt reported both legs were sore & noted a nodule on lt leg; felt tired, irritable, achy;had multiple nodules on both legs, very sore, swollen; 11MAR joints were swollen; SOB; felt weak; arthritic, couldn't bend
Parents reported blank stare and unrespoonsive after vaccine, lasting for 30 seconds.  Parents never sought medical attention after episode.
Information has been received from a certified medical assistant concerning a 61 year old male who on 11-OCT-2007 was vaccinated SC in the left arm with a dose of Pneumovax 23 (lot #656233/0200U). Concomitant therapy included influenza virus vaccine (unspecified). On 11-OCT-2007, the patient developed an "enlarging" lump with pain, fever and tenderness in the left injection site arm. On 12-OCT-2007, the patient presented to an emergency room, and subsequently, was hospitalized with cellulitis and possible abscess at the injection site of the left upper extremity. On an unspecified date, the patient was discharged. At the time of this report, the patient was recovering. A concern regarding the lot was reported. Cellulitis and possible abscess at injection site were considered to be disabling events. Additional information has been requested. The medical assistant also reported another patient who developed an adverse experience after vaccination with Pneumovax 23 (lot # 656233/0200U) (WAES #0710USA03567).
Pt. rec'd yellow fever and typhoid IM left delt at 2:25, then hepatitis A#2  in R delt. At 2:31 pt. experienced c/o peculiar pain in the middle of his r. palm. Hand pink with CRT 1-2 secs. Ice pack applied to injection site. Over the next 15 minutes pt. began to experience cramping in his arm. Benadryl 50 mg given orally.B/P 156/90. Pt. then had some cramping in the right side of his neck in trapezius region, and then cramping in right thigh and calf. 3:00 Pt sent to ER for evaluation and was seen by Dr. who gave him IV steroids and observed the patient. By 4:00, symptoms stopped progressing but were still persistent. The pt. was sent home on oral SOMA. Pt. feeling slightly better the next day, but still sore. 48 hours later, pt. was called and the symptoms had completely subsided.