chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I began itching mainly in my arms, looked like mosquito bites, then I took off my shirt and realized I had  a rash on my entire body. It looks like I am sunburn, but I have not had exposure to sun.  It is very red and hot around my neck/upper chest area.
Immunization: FLUZONE and PNEUMOVAX at 4:31 pm 9/24/15 at 10 pm (9/24/15) pt start had sore then fever. Fever increased 102.4 on Sat 9/26. Patient took ADVIL 3 Q 6 hours, and APAP fever down to 98.2 on Sunday 9/27.
Very strong Ear ringing (Tinnitus) in left ear that has been 100% constant since April 16th 2021. Headaches have been intermittent also. Pre April 16th 2021 i was not experiencing any issues of tinnitus nor regular headaches.
2nd dose after 42 days of 1st shot of Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days of 1st shot of Moderna Covid-19 Vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Hypertensive.   On 18-Mar-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) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days of 1st shot of Moderna Covid-19 Vaccine). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days of 1st shot of Moderna Covid-19 Vaccine) had resolved.       No concomitant medication were provided. No treatment details were provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-049573 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: No significant information was received. On 22-Jul-2021: No new information added.
dizzy; had numbness in my feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization; Bnt162b2 (Dose 3, (Booster) Single), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "recovering", described as "dizzy"; HYPOAESTHESIA (non-serious), outcome "recovering", described as "had numbness in my feet".  Additional information: After the second booster I got Covid. Then I started being dizzy and had numbness in my feet. Those symptoms eventually decreased.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300104567 same reporter/patient, different dose/event;US-PFIZER INC-202300220101 same reporter/patient, different dose/event;
Shortness of breath and wheezing for three days - albuterol, IV Mag and prednisone given with improvement.
p/vax pt c/o h/a; abd cramps; less of appetite; seen in ER & given IV fluids & DPH for swelling of rt upper arm; symptoms resolved
I was weak, fatigued, out of breathe, bad headaches, ached everywhere. I was only able to walk about 20 yards without having to sit down to recuperate. even with the portable oxygen. Doctor has me using portable oxygen. I have now been pushed out of my job and forced into early retirement.
Chills at 1:00 am with fever of 101.3; severe headache, nausea, fatigue for the next 3 days.
Right leg red, hot to touch.  Right leg measured 29 3/4 inches, left leg measured 29 inches (per MD).  patient has no temperature.
CLL; DLBCL; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant), outcome "unknown", described as "CLL"; DIFFUSE LARGE B-CELL LYMPHOMA (medically significant), outcome "unknown", described as "DLBCL". Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, diffuse large b-cell lymphoma. Additional information: The patient reported having Chronic lymphocytic leukaemia (CLL) and Diffuse large B-cell lymphoma (DLBCL). He/She completed 6 cycles of R-CHOP in Nov2022 and 18 radiation treatments in Jan2023. He/she had a complete response DLBCL and the CLL is not active but will return.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300154339 same patient and drug, different vaccine dose/event;
Report number 2000027554-1 describes crying in an 11 year old pt who rec'd Engerix-B. Allergies, medical history, and concomitant medications are not specified. On 6/13/00, the pt rec'd the unspecified dose of Engerix-B. Following the vaccination the pt cried for 48 hrs, and her arm was swollen 2 inches larger than the other. Unspecified medical attention was provided. As of 9/7/00, the outcome of the swollen arm is unknown.
No additional AE reported; A vaccine coordinator reported PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 23-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose and route were not reported; lot # U022729, expiration date: 16-JAN-2023) for prophylaxis (product storage error).       It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes; Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.    No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
RUE pain - After COVID vaccine in L arm on 1/23 developed fever (tmax 104, could only get it down to 102 with apap and ibuprofen) and severe upper body myalgias.This resolved by 2 days later, but has had persistent RUE pain since. Describes she had to sleep upright x1.5 weeks and was nearly in tears due to the pain. Using peppermint oil with improvement.   Noticing pain with flexion >90 and scapular popping sensation. Weakness, while washing hair (has to prop her elbow on shower wall) and inability to cross arm across her chest. Also having difficulty lifting grocery bags. Was having R lower chest wall/inframammary/RUQ discomfort too. Talked about these sx with rheum, had shoulder xray which was normal and cspine xray which showed DJD. labwork showed brief elevation in LFTs which subsequently normalized.     Has persistent R flank pain since November, currently dull. Not limiting her, just constantly there . Some shooting pains up/down spine at times  +scapular winging on exam, subsequently seen by ortho and neurology given onset and acute nature of the scapular weakness (long thoracic distribution), most likely that this was neuralgic amyotrophy/parsonage turner syndrome, which is in general an idiopathic auto-immune disorder that affects all or portions of the brachial plexus, but very commonly the long thoracic nerve alone
Patient was told to come back for the 2nd dose after 9-10 weeks/1st dose was on 21-Aug-2022, no 2nd dose yet; they cannot find a facility where it is currently available; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient was told to come back for the 2nd dose after 9-10 weeks/1st dose was on 21-Aug-2022, no 2nd dose yet), PRODUCT AVAILABILITY ISSUE (they cannot find a facility where it is currently available) and NO ADVERSE EVENT (No adverse event) in an 11-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient was told to come back for the 2nd dose after 9-10 weeks/1st dose was on 21-Aug-2022, no 2nd dose yet), PRODUCT AVAILABILITY ISSUE (they cannot find a facility where it is currently available) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient was told to come back for the 2nd dose after 9-10 weeks/1st dose was on 21-Aug-2022, no 2nd dose yet), PRODUCT AVAILABILITY ISSUE (they cannot find a facility where it is currently available) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
the left arm went numb (the same arm that was administered), vomiting, body shakes, fingers and toes turned blue
p/vax pt devel hives for 2 days starting 8/18/99 in afternoon;
Same day, period started. Wasn't due yet. Full period for 8 days, now day 15 and still spotting. Usual period 3 to 4 days and is light.  Swollen, hot, itchy and painful injection site on the 4th day. Arm only ached overnight.  On the 12th of April, not sure if related, body itchiness.
First attempt of jynneos vaccine given in left arm with no elevation of the skin or wheal present after administering.  Second dose attempt of jynneos in left arm with a wheal formed.
Patient came in for first dose Shingrix vaccination. Patient was asked if had ever received a shingles shot and pt stated had received old vaccine many years ago. Vaccine was administered. Patient was then asked about pneumonia series and patient was unsure if completed. Reviewed system and saw that Shingrix vaccine series was already completed back in 2019 at two different pharmacies. Doses were confirmed with those two pharmacies as well.
Started getting dizzy at various times during the day and while doing normal activities. Had not had this problem befor getting the shot. Has not went to a health care provider. But is still having dizziness off and on during the day it is not severe enough to seek medical care at this time.
Pt stated they woke up @ 3am on 7/9/23 with a headache, fever, and chills.  They reported feeling gradually better throughout the day and felt back to normal by time of phone call around 5:15pm on 7/9/23
Left Deltoid with gray Vesicle surrounded by 8CM of red, warm, edematous skin with red streaking. (L) axilla with firm tender, enlarged lymph node. Had fever.
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2019SA081256 (same reporter). This case involves a 23 years old male patient who was vaccinated with 1 ml second dose of vaccine IMOVAX RABIES (lot N1K30M and Exp. Date 28-OCT-2019) via intramuscular route in the right arm on 21-Mar-2019. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to vaccine underdose, wrong technique in product usage process, exposure via skin contact and accidental exposure to product. As it was reported that, after pharmacist completed the injection to the patient, she removed the plunger from the syringe to discard it and some of the reconstituted product was still inside the barrel and it leaked onto the patient. Some of the vaccine got on the patient's arm and on his toe, also reported that the patient received less than the full 1 ml dose. It was unknown whether the patient 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. List of documents held by sender: none.
on 12/05/2022, I sore throat that escaladed to cough. I took a at home test and made sure it wasn't COVID-19. By a week ago, it hadn't gotten better. I would stay awake at night coughing. I then urgent Care and they told me I had an infection.  The recommended I take a cough syrup.
states "white bumps" which after 24 hours became "red Bumps". Initially started on bilateral ankle and proceeded cover arms and trunk
This spontaneous report was received from a nurse referring to a 5-year old patient (gender not reported). The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-OCT-2018, the 5-year old patient was administered with GARDASIL 9 (Lot: N035032; expiry date: 24-SEP-2020). No adverse effects reported.
None, dose expired on 4/14/2019, given on 4/16/2019. Given in error, no harm done.
This spontaneous report was received from a 74 year old female patient with diabetes, codeine allergy, hypertension, thyroid issues and sulfa allergy, who was reporting on herself. On an unspecified date in 2014, reported as about "3-6 months ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, lot number and route of administration were not reported). Concomitant medications included the medications the patient took to treat her diabetes, hypertension and thyroid issues (the patient stated that she didn't know the exact names of her concomitant medications). In approximately August 2014, reported as "about a month ago", the patient experienced burning, tingling, and numbness in her left groin and hip after being administered ZOSTAVAX. The patient also reported that "her symptoms were constantly there and that sometimes he pain was worse than others". No treatment was given for the events. No lab diagnostic studies were performed. The patient did not seek medical attention. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
pt recv vax & devel a fever w/virus & thinner & weaker hair (fine hair which pulls out of head very easily);
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On 13-FEB-2015 the patient was vaccinated with a dose of ROTATEQ oral, (dose and lot # not reported) that had undergone temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
facility thought this would be her 2 nd dose but upon getting back to bill the shot and checking the registry the patient received this dose as her 3rd shot. no ill effects so far.
redness around site that progressed to wrap around the right arm with warmth, pain, and a knot. Sought medical attention on Saturday dx with cellulitis. Seen MD for follow up given a longer dose of abx.
My verbal baby who would make sounds and say mama, dada, ball, nenna, and a few other words/sounds stopped talking. She recently started saying mama again and has been evaluated by Early Childhood Intervention and has an expressive speech delay. She will begin speech therapy for the next 6 months.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 83-year-old female patient who received SHINGRIX (batch  number 477FS ?, expiry date 30th January 2020, GSK note: the reported lot number did not match with any GSK lot number). Concurrent medical conditions included osteoarthritis. Concomitant products included omeprazole. On 15th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced erythema, pain in elbow, skin warm and pain in arm. On an unknown date, the outcome of the erythema, pain in elbow, skin warm and pain in arm were unknown. It was unknown if the reporter considered the erythema, pain in elbow, skin warm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient later developed redness, warmth to touch, and pain in her right elbow. This was not at the site of administration. The reporting pharmacist was not aware of any medical intervention taken, but stated that the patient wanted to visit the emergency room and the patient did not want to get the second does.
pt recvd MMR vax on 21NOV91 & pt devel a low-grade fever of 102 & a rash over body; ENT exam showed rhinitis & erythematous rash; w/in next 4 to 5 days pt recovered;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE UNSTABLE ANGINA ANGINA, UNSPECIFIED
This is a non-serious spontaneous case from a healthcare professional reporting that a medical support member had ACCIDENTAL EXPOSURE to FluMist while vaccinating military personnel. The reporter determined the events to be unrelated to FluMist administration. This case is submitted according to the VAERS accelerated reporting agreement for FluMist. A 54 year old female medical support member developed headache and scratchy throat after accidental exposure during FluMist administration. Investigation into these events resulted in "no definitive reason" why the FluMist was responsible for "these symptoms." HEPA filters were put into the environment and since then nobody has gotten sick.  The patient has recovered. The reporter believes army personnel that were vaccinated with FluMist were already sick and hence may have caused the individuals administering FluMist to have headache and scratchy throat. The reporter determined the events to be unrelated to FluMist vaccination. Further information has been requested. Additional informatio received on 05Jan05 and 19Jan05 incorporated into above narrative. Additional information received on 04May05; patient name, gender and DOB; vaccine lot number.
I initially had an injection site reaction. It went almost alway in about 3 days which would be  around the 13th. Today the same spot is hot to the touch, has a lump, and is very itchy.
No direct symptoms after initial vaccine.  3 days after second shot Hives developed. Never ever had Hives or any allergic reactions or being allergic to anything.
developed shingles and then additional spots all over body per client a week after the shingles started had J&J vaccine for her first dose 6-22-2021 lot #  204A21A, also right arm IM.
INITIAL DATE/TIME OF VIAL ENTRY WAS 8/30/21 14:30. DOSE WAS ADMINISTERED ON 8/31/21 07:44, APPROXIMATELY 17.25 HOURS AFTER FIRST ENTRY INTO VIAL AND 5.25 HOURS PAST THE MANUFACTURER'S RECOMMENDED BEYOND USE DATE/TIME.  THIS WAS HIS SECOND DOSE IN THE SERIES (FIRST DOSE REPORTED AS GIVEN 6/2/21 BY A DIFFERENT PROVIDER).  PATIENT HAS NOT REPORTED ANY OTHER ADVERSE EFFECTS SINCE RECEIVING THE DOSE. MANUFACTURER WAS CONTACTED FOR RECOMMENDATION TO REPEAT/COUNT THE DOSE, REPLY PENDING.
Severe pain in arm that vaccine was given, chills, hot/cold feeling, pain throughout body, neck pain, head pain.
Joint pain, nausea, rash started on left hand and forearm. very red and hot and itchy. Started getting hives and began to spread to both arms and both legs, torso. rash became very itchy. Dermo prescribed hydrocortisone 25mg- topical cream and tablet.
mother claimed son received HPV, DTAP and Meningococcal in the same arm at the same time to MA and then told me she received 2 shots and was unable to verbalize what they were. DNP FNP BC
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 655C21a) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Blood pressure. Concomitant products included VERAPAMIL for Blood pressure.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) had resolved.        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.   Patient did not take anything for treatment. Concomitant medication included allergy shots.
loss of color, LOC lowered to the floor, spontaneous return of consciousness;monitored x 20min;pt left w/mom to consult MD if problems;5NOV97 called pt doing fine no problems w/health;
4 1/2 mo old infant experienced inconsolable crying beginning 1 hr after imunization and lasted for 10 hrs; resumed 24 hrs later for 6 hrs, mild fever - 101. Treated with tempra
Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient experienced fever after receiving Shingrix. The patient did not consent to follow up.