chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 YO M with no PMH who presented on 4/27 with left arm pain after covid vaccine on 4/15. He reports he developed left arm swelling and redness that was progressive following the vaccine. He is now s/p I&D at El Camino on 4/28. Patient with multiple apparent debridement sites 3x around elbow and 1x left deltoid. Continues to have pain and swelling around elbow and in shoulder. No sensation changes, compartments are soft. He was subsequently taken to the OR on 5/4 for debridement with return trips on 5/5, 5/6, and 5/7 with vac placed on 5/7. He tolerated bedside vac change to left deltoid and WTD to 3 sites around elbow. He lives at home alone and is unable to do dressing changes by himself. Wound vacs were placed on all wounds and home health was arranged for MWF visits. In addition, he will follow up in wound care clinic as outpatient. He understands he needs to complete course of oral antibiotics and will have pain meds for vac changes. He was stable upon discharge
when got out of bed the next morning after the injection it felt like electrical shocks in right foot. Can't walk well due to pain that is continuing and has gone up to calf and into hip and back.
July 3-meningitis, dTap, and chicken pox vaccine administered.  July 6 - chest hurts,fast heartbeat, sore throat, body aches, headache, fatigue.  July 7 - fever 102, sore throat, body aches, dry cough, fainting, paleness.  Took to urgent care; strep test negative.  Given amoxicillin.  July 8 - hives begin to appear that resemble chicken pox.  Took to urgent care.  Stopped amoxicillin.  Chest x-ray confirmed pneumonia.  Z-pac started.  Fever 103.  By 10pm, spots (hives) worsen, and itchy.  By 3am, spots covering whole body and itchy.  Given ibuprofen, z-pac, Benadryl, and applied Caladryl to spots.  July 9 - spots worsen, itchy; new sympton - swollen lips appear.  Fever down to 98.  Vomited on 7/8 at 10:30 pm.
1) Body aches, whole body experienced beginning morning of day after vaccination. Some relief with ibuprofen. Persisted approx. 12-14 hours and resolved. 2) "Severe" nasal congestion/swelling experienced beginning morning of day after vaccination. Persisted into overnight hours and resolved before next morning.
Beginning the day after the shot, I started having chills in the afternoon and then would get a fever.  Also had a sore throat, cough got worse.  I was tired  and didn't sleep well.  Fevers were as high as 101. 5 and my body temperature is usually lower than 98.6.  This continued for over a week and on the 28th, I went to hospital for a covid test, chest x-ray  and blood work.   All tests were negative and blood work was find.  About two weeks after I received the vaccine, the symptoms stopped.
A female consumer, with a medical history of hypersensitiviy to penicillin and erythromycin, received an injection of Tetanus toxoid adsorbed, purogenated (manuf unknown). She subsequently experienced anaphylaxis. Anaphylaxis was considered medically important. No further info was available at the date of this report.
Moderna COVID- 19 Vaccine EUA: one day after vaccination patient reported increasing fatigue after flying on an airplane to a high altitude destination. Two days after vaccination patient fell out of bed overnight and awoke confused with a temperature of 104 degrees Fahrenheit. Patient was transferred to another hospital by ambulance, admitted, received antibiotics, but developed acute hypoxemic respiratory failure. Eight days after vaccination patient transferred to intensive care unit at current hospital with acute respiratory distress syndome and bilateral pulmonary infiltrates requiring intubation and mechanical ventillation three days after arrival.  Patient remains in the intensive care unit receiving antimicrobials and steroids.
Headache, body aches, fever, fatigue started 4 days after vaccination and has continued for 5 days, still on going.
Dizzy, trouble walking, stomach pain, nausea, 100.9  fever for 8 hours, confusion, bones all paining in back, chills.
COVID-19 Vaccine. I had redness, soreness, and itchiness in the injection area. The redness was a rectangular area measuring three inches across (horizontally) and one and seven-eighths inches vertically. The redness and itching began on 01/21/2021 and lasted through 01/25/2021.
Minor:  Headache  - 1 day.  Joint pain - about a week  April 7. Sudden onset of Dizziness, Nausea , inability to walk straight, chest pressure   After 4 hours went to ER. Kept overnight for observations   Diagnosed BPPV with recommendations for Neuro consult and Cardiac Stress Test
Soreness under left arm - possibly lymph nodes occurred almost a week after the vaccination in addition to redness and swelling not previously present (24-48 hours after injection). The sore/tender underarm and redness persist (3rd day)
Pt recv vax on 6/21/97; on 12/14/98 pt exp atypical varicella
Redness and itchiness at injection site (L deltoid), extending from top of L arm to just above L elbow - Admin BENADRYL 25mg po.
Bad headache 3 days after; Up to 102 fever; Aches all over; Chills; Extreme fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On 01May2021 at 16:30, the patient experienced up to 102 fever, aches all over, chills and extreme fatigue for 24 hours starting 8 hours after vaccine. On the same day, the patient underwent body temperature test and the result was up to 102 (unspecified units).  On 04May2021, the patient experienced bad headache 3 days after. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme up to 102 fever, aches all over, chills and extreme fatigue was resolved on 02May2021 and bad headache was resolved on an unknown date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Edema, tissue induration, redness, swelling, tenderness, heat, approx 4 inches at vaccine site on right arm.
The patient experienced no symptoms.; an improperly stored dose of ROTA TEQ  was administered to a patient; This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. Concomitant therapies, current conditions, medical history and historical drugs were not provided.   On 11-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1660939, expiration date 26-OCT-2020, orally for prophylaxis (strength, dose and frequency were not reported).  Temperature excursion was reported as 27°F for 3 hours. It was reported that there was not previous temperature excursion.  The call was made due to a digital data logger. The patient experienced no symptoms; no additional adverse effect reported.
Mom reports that a small red area appeared a little while after injection was given and has enlarged to the size of a baseball, is red, raised and warm to touch.
Dizziness, chills, sweats, nausea, exhaustion, weakness, dry mouth
Mother noticed red rash on face as leaving clinic after shot. In evening mother noticed rash (macularpapular pinpoint pruritic) on chest and abdomen. No meds given. Mother brought child back to clinic this AM. No other symptoms.
medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; medical assistant did not mix the two vials together, so the patients only received the DTaP-IPV portion and not the HIB portion with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient whose medical assistant did not mix the two vials together, so the patient only received the Dtap-Ipv portion and not the Hib portion with no reported adverse event , it involved vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 15-Sep-2022, the patient received dose of 0.5m once of  suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE , with an unknown formulation and strength, (lot: U7311AA ; expiry date: 09-Sep-2023) via intramuscular route in the right thigh for immunization.  It was reported that on 15-Sep-2022, the medical assistant did not mix the two vials together, so the patient only received the Dtap-Ipv portion and not the Hib portion with no reported adverse event ,  (single component of a two-component product administered, product preparation error) (latency: same day).   Action taken: not applicable for both the events.  Outcome: unknown for both the events.   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.
This spontaneous report was received from a nurse practitioner referring to a 19 years old patient of unknown gender. The concomitant medication and pertinent medical history of the patient were not reported. On an unknown date, the patient was vaccinated with a pediatric dose of VAQTA (dose detail, strength, route of administration, lot# and expiration date were not reported) for prophylaxis (Incorrect dosage administered). No adverse symptoms were reported.
MORE ANXIETY; OVERALL PHYSICALLY AND MENTALLY IMPROVEMENT; HEADACHE; BODY ACHE; VOMITING; This spontaneous report received from a parent via a company representative concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, and hormonal monthly symptoms.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, vomiting, more anxiety, overall physically and mentally improvement, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, vomiting, and headache, and the outcome of more anxiety and overall physically and mentally improvement was not reported. This report was non-serious.
My daughter tested positive the Sunday before. She was in a play, and I was with her and her family. Sunday, she checked in to a hotel to isolate herself and I came over to take care of her children and masked when I was with them. I took my mask off when they were in bed or napping. Her husband did the same. On Wednesday of that week, her husband tested positive. I had been spending the night there because he was on call. Their daughter who is 4 slept late and woke up late and she had symptoms as well. They contacted the pediatrician and didn't test her because they assumed she had it. I was still asymptomatic and the 18 month old as well, I brought him home to my house. Then Friday night, I noticed I had a bit of chest tightness. Wheezing like and had to use my inhaler. Took some NyQuil then went to bed. I woke up the next day and felt better then started to feel the same feeling again midday. I tested myself at home around 1PM and it tested positive. I called my doctor to see about Paxlovid for people with underlying health conditions. The on-call doctor prescribed Paxlovid and picked that up on my way to my daughter's house. My husband stayed home. I had a shortness of breath one night, headache, cough that was productive, nasal drainage, sore throat for a morning after the day I tested positive, and some fatigue. I still have a slight cough, nothing major, a little productive. I've felt worse before with bronchitis and influenza, so it seemed to be a milder case overall.
I felt like a shitcocles fucjtangles for 12 days after the vaccine. I had a fever for 3 days, chills for 12, excessive body aches for 12 days,--incredible brain fog for 12 days which got worse, not better, on day 12--congestion, runny nose, and congested chest with crushing pain, wheezing, lack of appetite, night sweating.
I have tinnitus in both ears that was manageable but a few days after getting vaccination the ringing in my ears was so much louder.  It is unbearable now.
Menstruation changed, period used to only be 3 days now lasting 9-10 days
Day 3 started experience facial tingling, and it has persisted to now day 5.; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EN6199, and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 04Mar2021 at 07:45 (at the age of 32-year-old, non-pregnant) as dose 1, single for COVID-19 immunisation. Medical history included chronic headaches and anxiety. The patient's known allergies were unknown. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. The patient's concomitant medications were not reported. On 06Mar2021 at 12:00, day 3, the patient experienced facial tingling, and it had persisted to now day 5. The patient did not received treatment for reported event. The outcome of the event was not resolved.    No follow-up attempts are possible; No further information is expected.
body aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever). At the time of the report, MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter informed that patient is fine now and provided email ID
pt recv vax; had swollen, hot lt arm; 2" swollen area surrounding inject site;seen in er; put on motrin for arm; also C-chor for sore throat;
soreness at injection side; lately incredible red site at injection site; headache; Severe nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection side), VACCINATION SITE ERYTHEMA (lately incredible red site at injection site), HEADACHE (headache) and NAUSEA (Severe nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Asthma, Allergy to antibiotic (sulfa) and Allergy to antibiotic (cephalosporins).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at injection side), VACCINATION SITE ERYTHEMA (lately incredible red site at injection site), HEADACHE (headache) and NAUSEA (Severe nausea). At the time of the report, VACCINATION SITE PAIN (soreness at injection side), VACCINATION SITE ERYTHEMA (lately incredible red site at injection site), HEADACHE (headache) and NAUSEA (Severe nausea) outcome was unknown.            No concomitant medication was provided by patient. No treatment information was provided by patient.   This case was linked to MOD-2021-365089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Non-Significant follow up appended-Contact info updated
Pt recvd vax & devel migraine h/a; pt took 1 cafergot suppository which relieved sx; 4OCT93 3AM devel another migraine took another cafergot suppository to relieve sx; 6OCT92 devel a severe migraine which led to vomiting, dizziness & impair
PREVNAR 13 Vaccine syringe broke into two pieces when the needle was screwed onto the syringe; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 07Apr2022, this case now contains all required information to be considered as valid.  This is a spontaneous report received from a contactable nurse from product quality group.  A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13), as dose number unknown, single (Lot number: EW2019, Expiration Date: Dec2023) for immunisation, Device Lot Number: EW2019, Device Expiration Date: Dec2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "PREVNAR 13 Vaccine syringe broke into two pieces when the needle was screwed onto the syringe".  Additional Information: PREVNAR 13 vaccine syringe broke into two pieces when the needle was screwed onto the syringe. The glass is still connected to the vaccine. The nurse clarified it as the area where the neck of the syringe screws into the vaccine is connected to the needle. The syringe had all the PREVNAR 13 medicine in it and broke at the seal in the tube. This occurred with two PREVNAR 13 Vaccines from the same box. The sample of the product is available to be returned, if requested. The nurse confirms there was no patient involvement.  No follow-up attempts are needed. No further information is expected.
I developed Vertigo as a result of the vaccine, it started after the second dosage on November 5, 2021. Most recently I had another bout of vertigo most recently on 19 January 2022.
Red rash around injection site 6 inches diameter and hard underneath; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Red rash around injection site 6 inches diameter and hard underneath) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE RASH (Red rash around injection site 6 inches diameter and hard underneath). At the time of the report, INJECTION SITE RASH (Red rash around injection site 6 inches diameter and hard underneath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Lymph nodes under the arm where shot was given swelled up and were quite painful especially with arm movement.
Patient received vaccine on 5/1/18. On 5/3/18 patient returned to pharmacy and complained of arm redness and itching and "tingling around the head". Redness was visualized about 4 inches from site of injection. Patient was advised to take an oral antihistamine (either Claritin or Benadryl) and to go to urgent care/doctor visit. No update from patient as of yet.
erythema, induration, itching @ inject site, eyes itchy began 24 hrs post vax;
3 falls within a short period of time. Last fall hit her head, requiring ED visit to evaluate with CAT scans, UA, and lab work. Benign workup and patient back to baseline over few days.
pt recv vax 14OCT97 & same day pt exp instantaneous swelling @ the inj site & redness @ the inj site;
Patient received Small pox vaccination on 7/27/05. Presented to Medic in the field on 8-3-05 with c/o headache, chills, fever. Temp was 102.4 at 1730. Was given IV fluids by medic and Tylenol to decrease temperature. Temperature improved to 98.7 by 2200. Patient followed up at the Medical Clinic on 8-4-05, temperature was 99.3 at time of visit and patient had continued c/o headache, fever and myalgia. Local reaction noted to injection site on the left arm.
Mother stated patient had redness around the injection site and swelling in the right leg 2 day after the injection. The swelling and redness subsided after 2 days. 17 days after vaccine, patient started complaining of not being able to extend right leg. The following day, the patient started crawling and holding onto furniture or items to help her walk without putting pressure on her leg. There is a knot where the injection site is that has been present since injection. Patient has no pain, but states her leg feels as if it is asleep.
Presented to E.R. on 7/26 evening with hx of crying, irritability and bilious vomiting 15 x's approx. 10-12 hrs. Workup/CT abd revealed intussusception 5-6cm. A.M. of 7/27 pt. was transferred to hosp. via ambulance. Barium enema performed and intussusception resolved without surgery. D/c'd home on 7/28/14.
3 hrs after injection - "throat tightening" lasted 18 hrs "mucuousy eyes"? - flu symptoms next day. Sore throat/runny nose/ persistent cough/ increased mucous production lasting approx. 10 days.
family members who are 73 and 75 years of age were administered Adacel last week with no reported adverse event; Initial information received on 24-May-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Inquiry number: 00612961).  It was reported that DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Suspension For Injection) was administered to patients who were 73 and 75 years of age on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event 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.  There will be no information available on batch number for this case.; Sender's Comments:  00612908: