chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I noticed some singular tiny itchy spots on random spots on my body (arm, leg, thigh, back) that looked like tiny hives. They would have itchy periods then not bother me, but I could still see them as little raised bumps. Sometimes they would become larger like the size of a mosquito bite. (I was inside and not near any bugs). They would reoccur at least once a day every day (almost 2 weeks now). Occasionally when I scratch an area the hives will get bigger and blotchy.  In two spots I got little purple bruise dots from scratching. I?ve been using topical Benadryl and it helps temporarily.
Patient's left arm at the site became increasingly itchy and week later hot and red wheel 2 inch in diameter was visible  and on January 15 th site developed a hot and hard lump. The lump has gone down but still red and itchy. Advised not to scratch or irritate the siye further.
Injection site redness and induration; Injection site redness and induration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 10:15 as dose 4 (booster), single (Lot number: GJ6742) at the age of 43 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 01Nov2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior to vaccination; "chronic autoimmune hives" (unspecified if ongoing); "ocular migraines" (unspecified if ongoing). Concomitant medication(s) included: ALLI; MVI [VITAMINS NOS]; CULTURELLE; CETIRIZINE; TYLENOL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset 02Nov2022 at 12:00, outcome "recovering" and all described as "Injection site redness and induration". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site induration.  Additional information: The patient had no known allergies. The patient first noticed the redness and induration at the injection site on left arm around noon on 02Nov2022. She can see it and feel the induration when touched. It is tender to the touch but did not feel the redness or induration prior to that. It is currently ongoing. There is mild sensitivity at the injection site only. The patient was not tested for COVID-19 post-vaccination.
a 6 years 5 months old female patient received a dose of Flublok Quadrivalent on 25SEP2019/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a six years five months old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] pre-filled syringe on 25-Sep-2019 lot QFAA1925, expiry date: 30-Jun-2020 via intramuscular route in the left deltoid.  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 inappropriate age at vaccine administration.  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 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.
Pain in arm; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and HEADACHE (slight headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016821A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE for Heartburn, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (slight headache) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-071238 (Patient Link).
Had new pneumonia shot on 03/23/2015 night I had whole body (muscle and joint) ache. 03/24/15 felt better but very weak. 03/26/15 my arm had site redness and itching until now. No redness but itching arm still feels itching.
chills, dizziness, lightheadedness, fatigue, fever (102), headache, injection site swelling x 2 days, itchiness in throat for one hour then dry cough, muscle aches/joint pain, pain at injections site,
Information has been received from a registered nurse, who was also a 61 year old female patient referring to herself. The patient had asthma, depression and reactions/allergies to ZITHROMAX. On 30-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX, which might had been given intradermally (incorrect route of drug administration) (lot#, expiration date and dose unspecified). Concomitant therapies included citalopram, SYMBICORT, PROAIR RESPICLICK and TYLENOL. On the same date ("later that evening"), the patient developed itching at the injection site, a headache and she had a hard time falling asleep. The patient took BENADRYL as treatment for the itching (since an unspecified date), however, it was not working. The patient stated the itching was still present and she was still having a hard time falling asleep every night since getting ZOSTAVAX, however, it was unspecified if the headache resolved. The patient did not seek medical attention and no lab diagnostics studies performed. Additional information has been requested.
Information has been received from a medical assistant referring to a 16 month old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Upon awakening on the 2nd day, she had a red spot on the white part of her right eye, which is not swollen.  It is not painful.   She still has the red spot, but no pain.
Employee reported chills, nausea, vomiting, rash on torso, aches
Dose 1 and 2 received on 01-JAN-2021 and 18-FEB-2021 More than 35 days apart; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 01-JAN-2021 and 18-FEB-2021 More than 35 days apart) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.  Concurrent medical conditions included Ankylosing spondylitis.  On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free (1 in 1 wk). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 01-JAN-2021 and 18-FEB-2021 More than 35 days apart) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and 2 received on 01-JAN-2021 and 18-FEB-2021 More than 35 days apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant products were not provided. Treatment medication were not reported.  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.  It was unknown if patient was enrolled in COVID-19 Vaccine trial.  The reporter's causality for the event (s) of WEAKNESS AND FATIGUE WITH FIRST COVID VACCINE onset in January 2021, WEAKNESS AND FATIGUE WITH FIRST COVID VACCINE onset in January 2021, STIFFNESS and PAIN was not provided.  This case was linked to MOD-2022-619944 (Patient Link).
severe headache-took Naprosyn and Maxalt with slight reduction in intensity but did not relieve-eased by 2nd day out from vaccine myalgias throughout both arms and legs-rest-eased by 2nd day out from vaccine
At 3:30 p.m. the patient turned flush and red on neck and upper chest area.  Pt waited in observation area for 30 minutes to monitor allergic response. pt was administered 50 mg diphenhydramine and recovered and left clinic at approximately 3:55p.m.
This spontaneous report was received from a health care worker refers to a female patient of unknown age (also reported age as 0.021918). No medical history was reported. On 21-DEC-2015, the patient was vaccinated with a dose of an improperly stored oral, ROTATEQ dose, route and frequency: unknown, lot number: L002042, expiry date: 28-JUL-2016). No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Expired Havrix  administered; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a adult female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 28th October 2022, the patient received the 2nd dose of Havrix. On 28th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's comment: The patient was around thirties and received the second expired dose of Havrix vaccine.  The reporter consent to follow-up by email.  Additional supportive information: The patient received Havrix vaccine, which was already expired, which led to expired vaccine used.
Round Pink Area; Warm to Touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Round Pink Area) and VACCINATION SITE WARMTH (Warm to Touch) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, 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 (Round Pink Area) and VACCINATION SITE WARMTH (Warm to Touch). At the time of the report, VACCINATION SITE ERYTHEMA (Round Pink Area) and VACCINATION SITE WARMTH (Warm to Touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sore arm - five or ten minutes after the shot - hurt right after but then it  kind of subsided. It took a full month for the pain to stop - especially if pressed on. After two weeks, the pain in the arm migrated to the central right back. I could sleep on my right side only. Lasted about two days and then subsided. About a week or so after that, I was getting a throbbing pain on my left calf. That lasted a couple of days where it would intermittently start throbbing. I called the doctor. When I went in the symptoms has subsided but the doctor  (on April 13) said to do an ultrasound if it returns. It didn't return so I have not had an ultrasound.
five year old patient received FLUBLOK QUADRIVALENT vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Health Authority (Reference number- 00322459) and transmitted to Sanofi on 19-Oct-2020.  The case was linked to cases 2020SA295722 and 2020SA295712 (same reporter).  This case involves a 5-year-old male patient who received 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (strength: standard, Lot: QFAA2051, expiry date: 30-Jun-2021) via an intramuscular route in the right arm for prophylactic vaccination (product administered to patient of inappropriate age) on 19-Oct-2020.  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  No other vaccines were administered.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  Pharmacist wanted to know if any adverse events related use of Flublok in patients under the age of 18 years and about re-vaccinated with an appropriate flu vaccine.   At the time of reporting, patient had not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reports she woke up this morning with a severe headache and feeling extremely nauseous. Then around 1pm she began experiencing a sharp stabbing pain on the left side of abdomen and threw up.
Patient states she developed rash/hives about three hours after receiving vaccine and is still bothered by it over three weeks later. States has intense itching, "all over" which is worse at night. She mentioned that there was two times during the night "her lips and mouth" had swollen up. She has been treating herself with OTC BENADRYL with only some mild relief.
Reporter indicated that 28 non-responders to Engerix-B vax; vax program back to late 89 & the total number of pts is not known;
Had nonstop high pitched crying with first set of shots at last visit. (6/30/08) nonstop crying for several hours.
Pt given PEDIARIX combination vaccine and also given Hepatitis B and Polio vaccines. These are components of PEDIARIX). No reaction reported/observed.
Starting on the day of the vaccine- nothing significant noted.  About a week later, I started getting headaches, fatigue and eye discomfort.  It gradually increased discomfort and eye pain.  I called my doctor and was sent to the hospital for a brain scan (CT scan) which came back normal.  My eye pain was severe and was sent to an eye doctor who also found nothing.  I was prescribed eye drops for eye pain.  About a week later, the eye pain improved.  I still get intermitten headaches which can last for days.  I take Tylenol to help with the pain.  I am still feeling very fatigued.
Oct89 pt vax w/ hepta B; 08Oct89 devel severe myalgia + fatigue + rash.  PT tx w/ steroids.  MD felt that reaction related to Tryptophan not hepta B.
Vacc. given 8/2/13 approx 8AM. 8/2/13 evening - musc. weakness and fever. 8/3/13 all day - fever, chills, all over musc. weakness. 8/4/13 - musc. weakness - fever broke. 8/5/13 No fever, musc. weakness lessened.
LIGHTHEADED AN HOUR AFTER THE VACCINATION; SHOOTING PAIN THAT WAS SO INTENSE THAT CAUSED HARD TIME TO SLEEP; This spontaneous report received from a patient concerned a 69 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: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced lightheaded an hour after the vaccination. On 24-MAR-2021, the subject experienced shooting pain that was so intense that caused hard time to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded an hour after the vaccination on 25-MAR-2021, and had not recovered from shooting pain that was so intense that caused hard time to sleep. This report was non-serious.
Developed itchy rash all over body about 8 hours after vaccine. Responded to Benadryl. No egg or other vaccine reactions have been noted prior to this incident.
Warm to touch; getting worse; Itchy; Upper arm is red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), CONDITION AGGRAVATED (getting worse), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Upper arm is red) and VACCINATION SITE SWELLING (Swollen) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO RELEVANT MEDICAL HISTORY).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), CONDITION AGGRAVATED (getting worse), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Upper arm is red) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), CONDITION AGGRAVATED (getting worse), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Upper arm is red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
No Adverse reaction. Misadministered vaccine. Given DTaP instead of TDaP.
Patient felt faint and nauseous 5 minutes after receiving vaccine. She was gently placed on the floor with knees up and given an ice pack for her head. She did not lose consciousness  at any point. When EMS team arrived, they took her blood pressure and pulse. She eventually started to feel better and signed refusal for transport for EMS.
swelling of the left armpit lymph node. Then consistent on and off swelling of both arm pits lymph nodes and of the L groin Lymph node.  After completing ultrasound they discover mm sizes of lymph node swelling for the R arm pit and the L groin area. My pcp unable to identify what is is other than since the swelling started around the time I got both vaccines that it can be possible a side affect from the vaccine. Till this day I still get swelling of my lymph nodes.
swollen right thigh due from vaccines. Seen as nurse visit on 9-20 and received DTaP/IPV in right thigh. Yesterday had redness, and swelling and pain in right leg. Was swollen to the right knee. It hurt to move right leg, could not bend it, had to be carried due to the pain. Last night dad gave Benadryl and used ice. Today the area has improved, much less swelling, can walk on it today.  To continue with the Benadryl every 6 hours if needed, to rest leg, elevate right leg, apply ice. If does not continue to improve or worsens, then needs to be seen    I spent 15 minutes on the date of the encounter: Preparing to see the patient, Obtaining and/or reviewing separately obtained history, Performing a medically necessary appropriate exam and/ or evaluation, Documenting clinical information in the EHR, Communicating results to the patient, family, caregiver, and Care coordination
Developed pain in left upper arm 19 days after pfizer covid vaccine first dose March 6th.   Had Doppler/Ultrasound of left upper extremities and new DVT in Jugular and Subclavian veins was there.      Have prior history of 1 DVT in October 2020, and diagnosed with Factor V Leiden mutation.   Have been off anticoagulants for almost 3 months.
Patient states that she got a severe headache within 15 minutes after receiving the 2nd moderna shot and was still experiencing headache.
Right side of her face was swollen; This is a spontaneous report from a contactable consumer.  This is report 2 of 2. A 49-year-old female patient received BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EP7534) dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 14:00 (at the age of 49-years-old) as dose 1, single for covid-19 immunization.  Medical history included Thyroid problem and cancer and they removed her thyroid about 10 years ago. Concomitant medication included levothyroxine taken for thyroid disorder from 2011 and ongoing.  Prior to vaccination, the patient did not receive any other vaccines within 4 weeks.The patient was driving around after the vaccination; when she came back to her friend's house her friend told her that the right side of her face was swollen, which was maybe about 5 hours after she was administered the PfizerBioNTech COVID-19 Vaccine. The patient underwent lab tests and procedures which included blood test on 11Mar2021, her blood test results had 1 abnormal result that was elevated , computerized tomogram with unknown results   performed because she was having headaches. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Patient was overdue for her 15 month old vaccines and was to receive PEDIARIX and was given KINRIX. No evidence of any reaction to dose or injection. The adverse event was a medication error.
Pt recv vax on 11/21/98; post vax pt exp swollen face, neck, chest &legs w/ itchy rash; tx=Benadryl & Prednisone
Administered Novartis H1N1 (4yrs and older) vaccine 0.25 mL IM right deltoid. Should have given Sanofi Pasteur H1N1 (6mo and older) 0.25 ml IM. No signs or symptoms of distress noted.