chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Frozen shoulder, arm and lockjaw left side first night. Next Day, on top of expected fatigue and disorientation, Charly horses in calves. 2nd night legs started to swell. Day 3, swelling in lower legs moved to thighs. Night 3, lower ribs band sensation. Day 4 swollen thighs, abdomen and lower ribs. Day 5, legs and abdomen back to normal and only tightness in ribs. Afternoon of Day 6 all is well.
Muscle distress in left arm and shoulder, down to wrist. Achy all over my body.
One month following vax, pt's ALT (SGPT) was 169 and AST (SGOT) was 70. Pt had no symptoms. The abnormal labs were noted through routine bloodwork.
experienced headache, severe dizziness and Shortness of breath. Accompanied via Security officer and vehicle to the ED
She had emesis within 30 minutes of 2nd dose of vaccine.  Her nausea continued for 1 hour with abdominal and chest discomfort. She was taken to ED.  Her vital signs remained stable.  All work-up for cardiac event was negative. This was determined to be a vaccine reaction leading to nausea with 1 episode of emesis.
Right deltoid swollen, red area at the injection site, temperature 98.7 at 3:40 PM.  Patient complained of tenderness under the Right armpit.  Upon assessment no nodes noted under right armpit and patient denied pain upon assessment.  Injection site warm to the touch, red area 30 mm x 30 mm marked with a pen.  Instructed mother to apply cool compress to the injection site as well as under the armpit.  Instructed mother to give Ibuprofen or Tylenol to help reduce swelling.  Instructed mother to watch the red area, if area were to become larger, hot to the touch, pain is severe, or bleeding would occur to go to the Emergency Room for evaluation.  Patient and mother left the clinic at 4:00 PM  Mother more relaxed upon leaving the clinic.
Immediately after receiving the injection, I experienced a headache right behind my eyes (similar to sinus headache); after approximately 15 minutes, I experienced a ringing in my ears.  I told the attending person, but she said it was probably due to being anxious about getting the shot.  I left after being in the waiting area for 30 minutes and began driving home.  My face felt very warm, so I opened the car window.  I touched the side of my face and felt hives.  My tongue felt thick, but I did not feel hives going down my throat.  My torso started to itch and I had hives there as well.  There was no raised area at the injection site.  I became very itchy on my head, neck, and arms.  When I arrived home, I took a dose of benadryl.  Four hours later, I took a dose of zyrtec.  My hives subsided and my tongue returned to normal, but I was still itchy.  The next morning, I took a dose of claritin and called my doctor.  In the afternoon, I took benadryl.  In the evening, I took zyrtec.  I continued this for 2 more days.  The day after my vaccine, a node between my thumb and forefinger on my left hand was swollen and painful to the touch.  My hand was swollen and my finger joints ached.  I went to the doctor for an examination.  The swelling and pain in my hand continued to worsen during the day and overnight.  I kept ice packs on my hand and it felt better after 3 days.
Influenza symptoms (cough, fever) with positive nasopharyngeal test for influenza despite influenza vaccine (inadequate total # of immunizations).
severe muscle & arm soreness-unable to lift arm more than 40' Lasted about 2 days- I took aleve and lots of ice because of swelling of shoulder, bicep+muscle and a little into back.
patient who received a possibly expired vaccine, no adverse event; Initial information was received on 22-May-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves a child patient who possibly received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5202AA, expiry date 16-May-2019) via unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.   At the time of report, no adverse event was reported.  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.
mouth dryness; lymph nodes swollen; rash on face, arms, torso, backand thighs; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247) via an unspecified route of administration in left arm on 11Mar2021 at 11:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication includes unspecified vitamins (MANUFACTURER UNKNOWN) and biotin (MANUFACTURER UNKNOWN) taken for unspecified indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021, the patient experienced mouth dryness, lymph nodes swollen and rash on face, arms, torso, back and thighs. At the time of this report (since 5 days), the events were still persisting. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with ZYRTEC for rash and dry mouth. The clinical outcome of the events mouth dryness, lymph nodes swollen and rash on face, arms, torso, back and thighs were not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
Scond shot was bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (On an unknown date, received first shot of Shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: Scond shot was bad). The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that getting two shingle shots was a breeze compared to getting shingles.  The second shot was bad per say but well worth the protection. The follow up would not be possible as no contact details were provided.
Stiff shoulder, painful, wakes me up at night. Aches down my arm since injection.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-AUG-2014, the patient was vaccinated with an expired dose of M-M-R II (lot # H014989, expired date: 10-AUG-2014), (dose and route were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information is not expected since no consent to follow up.
improperly stored (6.7F for 46 hours) PROQUAD was administered to the patient; No adverse effects; improperly stored (6.7F for 46 hours) PROQUAD was administered to the patient; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided. Concomitant therapy included sterile diluent.  On 24-OCT-2018, improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R001540, expiration date 15-JUL-2019; strength, dose and frequency were not reported) was subcutaneously vaccinated to the patient for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot and expiration date unknown by the reporter). No adverse effects reported for the patient. The vaccine was store at temperature maximum of 6.7 F and the time frame was 46 hours which were detected by a data logger. There is no previous temperature excursion.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005465:
pt recv vax 2JUN96 & 26AUG96 pt was found to have elevated liver enzymes which resolved in OCT96;
Her injection site is red; Has rash on injected left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Her injection site is red) and VACCINATION SITE RASH (Has rash on injected left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Her injection site is red) and VACCINATION SITE RASH (Has rash on injected left arm). At the time of the report, VACCINATION SITE ERYTHEMA (Her injection site is red) and VACCINATION SITE RASH (Has rash on injected left arm) had not resolved.            The patient post receiving their vaccine reported that their injection site was red and had rash on injected arm.  No Concomitant product use was reported.  No treatment information was provided.
chills, nausea, vomiting, nasal congestion, headache, chills
Extreme arm pain. Can't lift arm. Hives on left arm. Body aches in low back, hips. Headache. Lethargic.
Swelling, seizure, rash, lethargy, bloody stool, fever, pain, weakness, lump at injection site.
Fever, swelling and crying nonstop for 30min at a time after DTaP.
RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 74 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (form of admin, route of admin, and batch number were not reported), 1 in total, dose was not reported (dose number in series was 1), for prophylactic vaccination. The reporter had not reported any adverse events following vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: 11-APR-2022) dose was not reported, (dose number in series was 2), 1 total administered on 01-DEC-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 01-DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the reporter mentioned that patient received less than 0.5 Milliliter (mL) of the vaccine as a booster dose approximately around 0.3mL of dose (vaccine underdose and off label use) (both events dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml (approximately around 0.3ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211209775, 20211209782, 20211209816, 20211212088, 20211212082, 20211210824, 20211210670, 20211210662, 20211210610, 20211210590, 20211210585, 20211210555, 20211210549, 20211210409, 20211210408, 20211210385, 20211210350, 20211210334, 20211210197, 20211210180, 20211210165, 20211210159, 20211210143, 20211210112, 20211210112, 20211210107, 20211209679, 20211209706, 20211209740, 20211209816, 20211210019, 20211210067, 20211210106, 20211210141, 20211210160, 20211210588, 20211209921, 20211209740, 20211209679, 20211210141, 20211210733, 20211210058, 20211209976, 20211209782, 20211209798 and 20211210058.
Information has been received from a consumer concerning her sister who on an unspecified date in October 2007, was vaccinated "by injection" with a 0.5 mL first dose of GARDASIL (lot # not reported). On an unspecified date in November 2007 the patient was vaccinated with a second dose of GARDASIL (lot # not reported). On an unspecified date in April 2008, the patient was vaccinated with a third dose of GARDASIL (lot # not reported). There was no concomitant medication. The consumer reported that "the patient experienced nausea, stomach ache, diarrhea, abdominal pain and rash after getting all three doses". It was also reported that the "patient's LMP was in November 2007 and did a pregnancy test but she is not pregnant". The patient sought unspecified medical attention. The nausea, stomach ache, diarrhea, abdominal pain, rash and amenorrhea persisted. Laboratory tests included a CT scan, blood test and urine test. The results of the CT scan, blood test and urine test were not reported. No further information is available.
Immediately after vaccine: arm soreness ? 10-14 days after vaccine: flu-like feeling ? headache, sore throat, fatigue, resolved after ~a week ? July 8, 2021: Headache, dizziness, nausea, shaking  upon exertion ? From then: Gradually increasing symptoms of ME/CFS: Severe fatigue; dyspnea; exercise intolerance; postexertional malaise; orthostatic intolerance/POTS; poor temperature regulation; worsened brain fog; trouble focusing eyes; dramatically reduced life function (tried part-time schooling Fall 2021, dropped out of school September 2021 due to severity of symptoms)  No symptoms or positive tests for Covid
Vomiting; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 5-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 09Jan2022 at 11:00 (Lot number: FK5618) at the age of 5 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Food allergy" (unspecified if ongoing), notes: Known allergies: Zucchini. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: FK5618, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 11:00), administration date: 19Dec2021, when the patient was 5 years old, for COVID-19 immunisation.  The following information was reported: VOMITING (non-serious) with onset 10Jan2022 at 02:30, outcome "unknown", described as "Vomiting". Therapeutic measures were not taken as a result of vomiting.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
The patient was given two Shingrix vaccines in 2021. However, she was given a 3rd shot on 7/20/2023 and currently there is no indication for a 3 dose of this vaccine. Currently, there are no adverse events reported so we are reporting the administration error.
Erythema, tenderness, pain and warmth to left anterior thigh with induration present. Approximately 8cm x 11cm in size.
This is submitted to replace the incomplete form submitted on 6-21-04.  Client reports "bumps" at injection site after receiveing injection.  Now rash the size of a "50 cent" piece.  No pain, redness, swelling.
Parent of child reported child developed a high fever 12 hrs after getting vaccines (DTaP, Hib, PCV). Parent gave child a fever reducer medication. Fever continued to raise. Child experienced a muscle spasm of all extremities. Parent called 9-1-1. Child taken to Hosp ER. Observed and released back home the same evening.
5 days after original shot I began having joint pain in my hands. This then moved to my elbows. Then to my feet and knees. After the second shot, I began having extreme fatigue, continuing joint pain, which has progressed to a burning pain in my rib cage.  I am also having numbness and tingling in my hands and feet. This has caused extreme anxiety and difficulty working. I have gone from exercising very vigorously 6 days a week to light walking with extreme fatigue.
Huge vertical long bulge/bulging lump to the left side of the her face in the jowl area/a quarter-sized round bulge/bulging lump on her right cheek; Huge vertical long bulge/bulging lump to the left side of the her face in the jowl area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-110221-25735 (RA).  A female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; poly-l-lactic acid (SCULPTRA AESTHETIC), since 01May2021 (Batch/Lot number: unknown) for plastic surgery to the face. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious) with onset 2021, outcome "unknown", described as "Huge vertical long bulge/bulging lump to the left side of the her face in the jowl area/a quarter-sized round bulge/bulging lump on her right cheek"; MASS (non-serious) with onset 2021, outcome "unknown", described as "Huge vertical long bulge/bulging lump to the left side of the her face in the jowl area". Therapeutic measures were not taken as a result of swelling face, mass. The lot number for bnt162b2 was not provided and will be requested during follow up.
Developed symptomatic COVID+ infection approximately four days after vaccine dose. Had confirmed exposure to COVID+ individual prior to vaccination. Was administered IV Bamlanivimab on 12/22/2020 at Hospital. Stayed in an isolation facility at Center for 9 days.
Pin prick feeling in right scalp, 1/23. pink patches on forehead, painful feeling in right eye, swelling eyelid.  much soreness on forehead and six inches into scalp during the next two days.  small blisters developing,    diagnosis - Shingles
I've suffered from Plantar warts covering the bottom of my entire right foot for 18 years.  About 2 months after my 2nd Covid vaccine, I noticed they were starting to turn black under my skin.  They are now ALL completely gone, 6 months after my 2nd vaccine.  I wanted to report this so research can be done on HPV and the response to the COVID-19 vaccine.  If it helped me, it could help others!
Fainted for few seconds. Laid back on exam table & applied cool cloths to forehead & neck B/P 110/70/5 min later 96/60; feeling fine within 5 min & left clinic ambulatory.
o Parent/Guardian attested multiple times that the patient?s date of birth. Also, she confirmed that patient was at least 5 years old. o I tried to correct DOB but wouldn?t allow it. Guardian did not want to provide birth certificate to submit change o Patient received the Pfizer 5-11 year old vaccine
Starting 4 days after first shot: Debilitating night sweats for 15 days straight, increased and large bowel movements (6-10 a day), headache, chest pain, abdominal pain, rapid weight loss, irregular appetite.  Night sweats stopped abruptly after second vaccine shot. Tested positive for Blastocystis Hominis. Started Metrozinadole 4/22/21, symptoms recurred immediately upon stopping 10 day course and 10 pounds lost in 2 days. Tinidazole take 5/5/21, symptoms recurred. Paromomycin prescribed 5/17/21 in progress.
Both thighs are burning; Spasm in left thigh; she thinks she had an allergic reaction; Sore arm; Whole face started to feel numb; Tounge started to feel numb; Fast heartbeat; Dizziness; A spontaneous report was received from a (Consumer) concerning a  50 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness, both thighs are burning, spasm in left thigh, she thinks she had an allergic reaction) list.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On 23-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the Left Arm for prophylaxis of COVID-19 infection.    On 23-JAN-2021, The patient experienced the events list (sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness). On 24-JAN-2021, The patient experienced the events list (both thighs are burning, spasm in left thigh)   Laboratory details was not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the event(s) (sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness) was unknown.   At the time of this report, the outcome of the event(s) (both thighs are burning, spasm in left thigh) was recovered.   The reporter assessed the event(s), [sore arm, whole face and tongue started to feel numb, fast heartbeat for 5mins, dizziness, both thighs are burning, spasm in left thigh], as related to study drug.
Patient has right thigh swelling, redness, and 1.5 cm nodule that was tender to palpation
Fever (101), chills, body aches, overly emotional/tearful. This began around 5:00am and has continued throughout the day. I am alternating Tylenol and aspirin to alleviate the symptoms.
Approx 5 min after vaccines given, pt developed 3-4 erythematous urticaria on lower legs and one on left forearm. BENADRYL cream applied. Urticaria completely resolved within 5 min. Developed facial swelling irritability at home that night and went to ER. Evaluated and monitored. Not treated. Symptoms resolved spontaneously.
I developed shingles left middle back after second dose 1 week later.  Coincidentally two other employees that work in the same facility developed shingles after first dose. We are all health care professionals. The other two developed shingles after first moderna vaccine. We received them at different locations and on different days.
Patient Vomited about 10 minutes after the Pfizer COVID-19 vaccine. We gave the mother a water bottle, asked how he was and he said he felt better. About 10 minutes later they left without checking back in with the staff. The RPh on duty was watching him for other reactions and he seemed fine.
Information has been received from a medical technologist concerning a 1 year old male who on 3/5/99 was vaccinated and on approximately, 4/6/99, he developed atypical rash and was seen by a physician on 4/7/99. The reporter expressed concern with the lot #. Two additional pts were reported with similar incident after having been vaccinated with the same lot #. Additional information has been requested.
Pt. noticed itching of lower right arm followed by several welts on her lower right arm.  No other problems reported.