chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is first of the two reports. This is an initial spontaneous report from a contactable consumer via a Company representative. A 4-year-old female patient was administered a dose of PREVNAR 13 on an unknown date in the left thigh. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day included were reported as hepa varicella on the right thigh. On 29Mar2011, (after vaccination) the patient experienced swelling and redness at the site of injection on the left thigh which turned into cellulitis on 01Apr2011. Therapeutic measure taken as a result of cellulitis included treatment with SEPTRA and the patient was also taken to emergency room. Relevant lab data was not reported. The patient had not recovered from the events at the time of this report. Reporter does not know the prescribing/primary physician information.
Day 1-4, red, swollen, painful, warm to touch left thigh. Fever first 3 days. Days 4-8, decreased redness and warmth and pain. Hard lump 1 inch x 1/2 inch remains in area of injection. Patient is improving.
Had excessive crying at the time of the injection; This non-serious spontaneous safety report, with case number 02270452/02270446, was received by partner, on 18Oct2022 and forwarded on 19Oct2022 from a consumer.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Crying".  Further information is expected.
Pt received DT 4:30pm and awoke 2:30 am next day with shaking, rigors, fever 101-102 and palpitations with Hr ~ 100-105, near syncope, dizzy, nauseous, aching all over. No rash and no eryhtema. At shot site-shortly resolved over 15 hrs.
Soreness at injection sight (left arm) for approx. 24 hours after injection.; Soreness in arm pit of left arm, feels swollen, but upon examination and touch it is not swollen; just uncomfortable.; Dose number 3; Dose number 3; This is a spontaneous report from a contactable consumer or other non hcp.  A 57-years-old female patient received bnt162b2 (BNT162B2, Solution for injection; Batch/Lot Number: EW0164; Expiry date: Unknown), dose 3 via an unspecified route of administration, administered in Arm Left on 29Sep2021 (Batch/Lot Number: EW0164) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient did not have any allergies. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 12:00 (Batch/Lot Number: EM9809) and second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 02Mar2021 at 9:00 (Batch/Lot Number: EN6202) as SINGLE for covid-19 immunisation. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported. On 30Sep2021, the patient experienced soreness at injection sight (left arm) for approx. 24 hours after injection, soreness in arm pit of left arm, feels swollen, but upon examination and touch it is not swollen, and just uncomfortable. The patient did not receive any treatment. The outcome for the events soreness at injection sight (left arm) for approx. 24 hours after injection, soreness in arm pit of left arm, feels swollen, but upon examination and touch it is not swollen, and just uncomfortable was not recovered.   No follow-up attempts are possible. No further information is expected.
Patient received the Menactra vaccine and shortly after about 15 minutes felt dizzy and weak.  Patient was pale and almost passed out. No signs or symptoms of allergic reaction.
Patient came in today (11-6) and showed me her arm - it had several red patches (not just at injection site) and then looked mildly swollen. Patient said it had not gotten worse, was not itching, was no longer hurting, no other symptoms, etc. She just was not sure if this was a normal reaction to the vaccine or not since it was red at more than just the direct injection site. Told her to use compress, but due to allergies she cannot take anti-inflammatories. Told her to follow-up with us if does not go away or gets worse and also to talk to her primary care physician about it.
Low grade fever and achiness starting 30 hours after vaccine. Lasted for 12 hours.
mouth sores; bad rash on her face and neck where she had her radiations; lymph nodes swelling; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (mouth sores), RASH (bad rash on her face and neck where she had her radiations) and LYMPHADENOPATHY (lymph nodes swelling) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0096B21A) for COVID-19 vaccination.     The patient's past medical history included Radiation therapy. Concurrent medical conditions included Cancer in remission.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced RASH (bad rash on her face and neck where she had her radiations) and LYMPHADENOPATHY (lymph nodes swelling). On 26-Mar-2021, the patient experienced ORAL PAIN (mouth sores). At the time of the report, ORAL PAIN (mouth sores), RASH (bad rash on her face and neck where she had her radiations) and LYMPHADENOPATHY (lymph nodes swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking unspecified concomitant medications. No treatment medications were given.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received and contains No new information.
52 patients should have received the bivalent formulation of the COVID vaccine but were given the original formulation in error.  Stores were unaware of the new guidelines at the time of administration.  All patients have been contacted and made aware of the error.
Patient had Severe rash on both of his arms (welts/hives) Started Sunday or Monday After injection on Saturday and reported the adverse event on Wednesday 5/1 to the pharmacy
This initial spontaneous report was received from a physician referring to a 8 week-old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 11-SEP-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Pt fanning self complaining of feeling dizzy and faint. I supported torso as he went limp for 15 seconds, then he sat back up. Face pale, sweaty, escorted by wheelchair to EMS room. Pt states felt hot, has history of delayed vasovagal response. Encouraged him to request EMS room for follow up shot. Water, Rest, Snack. Exited 18:15.
Severe joint pain dx'd as palindromic rheumatoid arthritis. Aggressive medical treatment with Azulfidine and prednisone. Requires follow-up blood tests to check for liver and kidney damage. Also had 2nd Lymerix on unspecified date. Per doc 205104, 60 Day follow up, patient has been diagnosed with palindromic Rheumatism which is the result of taking lymerix. The annual follow-up states that "this patient has not recovered from effects of LYMErix vaccination. His condition has seriously deteriorated in the past year. Three physicians, one his primary care physician and two rheumatologists, have diagnosed his condition as palindromic rheumatism that is causing increasing pain, swelling and disability. He can walk only short distances, is unable to do most physical work and cannot enjoy and physical recreation. He is also suffering the effects of prolonged use of Prednisone taken for severe joint inflammation. The medications he takes, and has previously reported for treatment of rheumatoid arthritis, require monthly blood tests to determine if any liver of kidney damage have occurred."
Very sore and weak arm that got the injection; Weak arm that got the injection; Body aches; Sniffles; Sore throat; Tired; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780), via an unspecified route of administration in the left arm on 29Jul2021 at 15:00 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history included barrett's esophagus, anemic, restless leg syndrome and major depression. 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. Concomitant medications included unspecified medications from an unknown date for unknown indications. The patient previously took metronidazole (FLAGYL) on unknown date for an unspecified indication and experienced drug allergy. On 29Jul2021 at 17:00, the patient experienced very sore and weak arm that got the injection, body aches, sniffles, sore throat and tired. 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 events very sore and weak arm that got the injection, body aches, sniffles, sore throat and tired were resolving at the time of reporting.
Pain and swelling at site for 7 days, fatigue x 2 days Narrative:
Patient is a 83 y.o. male with a history of HTN, CAD, hyperlipidemia, aortic stenosis, HFpEF who presented to a HCF 3/6/2023 with worsening shortness of breath and found to have covid with CTPA c/w covid with possible edema. NTBNP 1.8K up from 574 in 2020. Cardiology followed. Patient required oxygen and completed remdesivir and steroid ,when weaned off of oxygen and vitals were stable , ambulating without oxygen , was discharged home.   1. Acute hypoxic respiratory failure: In setting of  covid.  Continued on remdesivir and steroids.  Last dose of remdesivir will be 3/11/2023.   Weaned to room air on 3/10/2023.  Continued supportive treatment, and spirometry. 2. Acute on chronic diastolic heart failure: No edmea but increase in bnp with some lung findings on CTPA. Dry lung strategy with covid. Repeat echo with EF of 50 to 55% with mild to moderate paravalvular aortic regurgitation without stenosis. IV lasix has been switched to p.o Lasix..  Cardiology followed.  Not volume overloaded 3. COVID19 Pneumonia: Symptoms for 1 day. Positive 3/6/23, isolation through 3/17/23. Required oxygen on admission.  Started on remdesivir and steroids , continued.  Supportive treatment. 4. Bradycardia: Patient heart rate was in 40s on 3/9/2023.  Heart rate between 50-60 after reduction of atenolol dose from 100 mg to 25 mg/day, will be continued as patient blood pressure is a stable and have clinically no symptoms at all.  Per patient his baseline heart rate is in 50s.   Telemetry and electrolyte. Was discharged on low dose of atenolol, and was instructed to follow PCP as an outpatient. 5. Constipation: Patient with no bowel movement for last 3 to 4 days.  KUB on 3/11/23 with no obstruction. Had BM .  Resolved. 6.  Generalized weakness: Likely in setting of above.  PT/OT followed. 7. CAD: DES to LAD 1994. No current chest pain, trop normal.  8. Aortic stenosis: S/p TAVR 11/2018. Repeat echo as above.   9. HTN: Home mds.  Continued home medications.  Cardiology following. 10. Hyperlipidemia: Statin continued.  11. HFpEF: Echo 2020 with ef 50% functional TAVR with mild regurg grade 1 diastolic dysfunction, unchanged from previous.
over the course of the week following the vaccination, tiredness, swelling of hands/fingers/wrist/palms that moved to mouth/throat/eyes, itchiness, soreness
1 years old received / adult dose; 1 years old received / adult dose; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HAV (Havrix adult) (batch number y29kl, expiry date 21st February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 8th July 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: Nurse reported that 1 year old patient received a Havrix adult dose during this Thursday, which led to adult product administered to child and overdose. The reporter consented to follow-up.
"covid arm"  red itchy rash about 2 inches in diameter at the injection site, first noticed about 8 days after vaccination
Bubble up under the skin; Hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE VESICLES (Bubble up under the skin) and VACCINATION SITE PAIN (Hurts) 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 VACCINATION SITE VESICLES (Bubble up under the skin) and VACCINATION SITE PAIN (Hurts). At the time of the report, VACCINATION SITE VESICLES (Bubble up under the skin) and VACCINATION SITE PAIN (Hurts) outcome was unknown.        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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves 80 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI885AB, expiry date: 29-MAY-2018 via intramuscular route in the right arm on 10-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
marked redness & swelling to muscle w/pain-itching @ inj site;ice applied & temp-golf ball size to grape size resolved completely in 4 days only in rt deltoid;
Pain at injection site, numbness from injection site to fingers, tingling in fingers (all of the vaccine arm only).
Sore injection site 2/26-2/28. Red/swelling injection site 2/26-2/28, Fever 2/27, Nausea 2/26, Muscle aches 2/26-2/27, Brain fog 2/26-2/28, Fatigue 2/27, Fast heart rate 2/26-2/28.
Patient received vaccines HPV - MENVEO. Sat for 1-2 minutes. Felt fine. Then stood up and fell face first on floor. Fell against sister's knee on way down. Hit (R) side of top of head. Bit (R) lower lip - inner and outer aspects. Ice bag. Eyelids twitched. Slight seizure like movements. BP - 129/78, P - 52.
Shortness of breath and swelling of the throat. Treated with epi shot, Benadryl shot, and prednisone.
This spontaneous report received from a consumer via a company representative concerned a 20 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced sickness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and sickness. This report was non-serious.
Miscarriage; Received vaccine when pregnant; A spontaneous report was received from a 34-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) when pregnant and experienced a miscarriage.  The patient's medical history included three prior pregnancies, with two live births and one miscarriage. Products known to have been used by the patient, within two weeks prior to the event, included prenatal vitamins and doxylamine succinate/pyridoxine hydrochloride.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) on 30 Dec 2020. On 27 Jan 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  At 7 weeks gestation, the fetus had a normal heart beat. She reported that she had no complications with the pregnancy.  On 08 Feb 2021, the patient had a miscarriage. Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The events received vaccine when pregnant and miscarriage were considered recovered.; Reporter's Comments: This report concerns a 34-year-old, P2G4 who experienced miscarriage 1 month 9 days post administration of first dose and 12 days after the last dose of mRNA-1273 vaccine. There is not enough information such as the last menstrual period, estimated date of conception and delivery and gestational age at the time of miscarriage. In addition, the patient's detailed medical history including any trauma  and reason for previous miscarriage is lacking. Vaccine exposure during pregnancy is assessed as not applicable.
Patient presented to the ED with shortness of breath and was subsequently hospitalized for elevated troponin, pneumonia and palpitations. She was in the ICU for 9 hours before being transferred to the cardiology floor.
pt recv vax & exp arm pain;the reporter felt that there was a possible problem w/the lot of vax;
Patient reported shingles shortly after receiving the first series of the SHINGRIX vaccine. Patient received VALTREX from our pharmacy on 5/18. Patient reported lesions and pain lasting multiple weeks.
Day 1: first hour slight euphoria -- hours 2-8 felt like a surge of epinephrine, speedy when speaking, stammering occasionally Day 2 - 4: felt like final day of having flu, achy, weak, overall off Day 5-8: extreme fatigue Day 10-11: slight fatigue, brain slow Day 12-14: strange subtle brain sensations, flow of blood to the head shifting, occasional lightheadedness, vision worse, nervous system a bit jerky
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 68-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Mar2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Jan2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (27Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Paxlovid rebound - Sunday Jun 19-27. On the 27th I tested negative. I had low fever, fatigue, upper respiratory cough and thick throat, taste off. The metallic taste in my mouth that started with the pills is still here on 30Jun. If treatment ae was no. No Other medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was having coughing, shortness of breath, and fatigued. This lasted for about a day and a half until I could get in to see my doctor. The doctor said it was a respiratory infection I was given an antibiotic, cough medicine and in haler. I sleep for the next few days and then I started to recover.
Extreme redness, swelling, soreness that has continued and is present 5 days later. Redness includes hotness at the area) and swelling is larger than the size of my palm.
mom reported on 8JUn that p/1st inj 6APR the following occurred approx 30" p/inj; pt cried 1-2 hr, then began whimpering off & on into the evening; noted to be very sleepy, would not nurse well; twitching was noted through the noc; t102;
Ringing in the ears, Headache, Lethargy, Swollen neck, Runny nose.