chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Potassium was low (3.5); Bilirubin was high (1.1); WBC High; RDW High; Still a visible knot and tenderness; Still a visible knot and tenderness; Painful swelling of my lymph node on my left collarbone area/ Lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Aug2021 18:00 (Lot number: EW0180) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "seasonal allergies" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing). Family history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol and high BP runs in family; "High BP" (unspecified if ongoing), notes: High cholesterol and high BP runs in family. Concomitant medication(s) included: ZYPITAMAG; EZETIMIBE. Past drug history included: Keflex, reaction(s): "Known Allergy: Keflex", notes: Known Allergies: Yes, some antibiotics - Keflex; bad reaction to Epinephrine.; Epinephrine, reaction(s): "Bad reaction to Epinephrine", notes: Known Allergies: Yes, some antibiotics - Keflex; bad reaction to Epinephrine. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Aug2021 08:30, outcome "recovered" (2021), described as "Painful swelling of my lymph node on my left collarbone area/ Lymphadenopathy"; TENDERNESS (non-serious), MASS (non-serious) all with onset 11Aug2021 08:30, outcome "recovering" and all described as "Still a visible knot and tenderness"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "Potassium was low (3.5)"; BLOOD BILIRUBIN INCREASED (non-serious), outcome "unknown", described as "Bilirubin was high (1.1)"; WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "WBC High"; RED BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "RDW High". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, tenderness, mass.  No follow-up attempts are possible. No further information is expected.
ERROR: Age- UNAUTHORIZED AGE GROUP (17 years old, Moderna EUA approved only for adults 18 years and older. Patient signed consent form with incorrect DOB indicating age greater than 18yo). Event discovered and forwarded for VAERS reporting. Signs and symptoms: None known Diagnosis and treatment: None known Outcome: No adverse reaction reported
Serious increase in tinnitus since vaccination. Can?t sleep. Tinnitus started when contracting COVID in December. Had that with vertigo. Vertigo has passed.  Tinnitus is a 4out of 5 and is debilitating.
Pt presented to the clinic for evaluation of a localized reaction to the varicella vaccination which she recd 5/8/15. She reported 3 hours after the immunization she noted a "small rash" to the area, when she woke up the next day she c/o warmth and itching to the area. She stated on 5/11/15 her skin at injection site felt like it was "on fire". Pt advised to take BENADRYL, PRN, NEOSPORIN 3x day to site and stop scratching area.
A physician reported that a pt received vaccine on4/7/00, on 4/10/00 pt developed a 18cm by 10cm area of redness and was treated and recovered. Follow-up info received from the physician on 04/02/2001 indicated that this pt has a medical history inclusive of hypertension. The pt remained recovered.
Patient received 1st dose of COVID 19 vaccine. Patient received vaccine with no issue. At 15 minute mark patient stated that she was feeling a little lightheaded. Patient stated that she had hiked 14 miles prior to coming into the shot and was visibly sunburned patient stated that it was most likely due to the that. Patient did not want to wait an additional 15 minutes. Patient left. I followed up with the patient at 5:20pm and she stated was doing well with no issues.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 22-FEB-2016, the patient was vaccinated with an improperly stored PEDVAXHIB, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Menstrual cycle has become much more irregular and heavier; Menstrual cycle has become much more irregular and heavier; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 22Mar2021 at 09:00 (at the age of 24-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0161) via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. Medical history included brain cancer and allergy to fresh frozen plasma. 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 vaccination. Concomitant medications included levetiracetam (KEPPRA) and vitamin K (MANUFACTURER UNKNOWN); both for unknown indication from unknown date and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) and ciprofloxacin (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in Apr2021, the patient's menstrual cycle became much more irregular and heavier. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event menstrual cycle has become much more irregular and heavier was not resolved at the time of reporting.  No follow-up attempts are possible. No further information is expected.
IM influenza vaccine was mistaken for "Flu Mist" and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.
Pt received the Hepatitis A and Influenza vaccine on 11/1/07 and started getting swelling on the face 11/5/07, has given Benadryl. Was seen in office by Dr on 11/5/07 he has vaccination reaction from vaccines told pt to use Benadryl
Developed a rash/hives at site area of injection the next day. Rash/hives in area near injection were blotchy, somewhat raised and itchy. Subsided third day and about gone on fourth day.
Patient called today (7/8/21) complaining of shortness of breath and rapid heart rate
FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Day after getting vaccine, fever, pain, nausea, headache, joint pain, this improved/resolved over course of week. Initial Covid infection in December resulted in loss of smell/taste, with mild improvement over following months, August COVID resulted in loss of smell/taste with some improvement noted within 4 days after vaccine. Nausea, headache and stomach discomfort have continued since day after vaccine, with new onset chemical and soap smell since Saturday October 9th, it is overpowering, overbearing. Headache pain has remained about the same over course of week (improved from very severe headache day after vaccine), but around a 3/10 for pain wise. The new onset chemical smell and taste sensation  is constant in nature
felt like fainting; Blood pressure dropped very low; pain and redness on the injection site; pain and redness on the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-027323 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna (1st dose (Lot# 011J20A)), administration date: 17Jan2021, for COVID-19 immunization; moderna (2nd dose (lot# 042L20A)), administration date: 19Feb2021, for COVID-19 immunization; moderna (First Booster dose (Lot# 014F21A)), administration date: 21Oct2021, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "felt like fainting"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "Blood pressure dropped very low"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "pain and redness on the injection site". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported that after the 2nd primary shot and after the first Moderna Booster and after Pfizer Booster, within 24 hours after the shot, her Blood pressure dropped very low and she felt like fainting. She also had pain and redness on the injection site. The events were reported non-serious. Prior to the Bivalent vaccine, she had antibody testing done and the result was more than 150. But she did not know what that means. After Bivalent booster (Moderna COVID-19 Vaccine on 19Oct2022 (Lot# 055F22B & MFG Exp. Date 20Oct2022)), she had absolutely no side effects.  No follow-up attempts are possible. No further information is expected.
Received Pfizer vaccines on  2/23, 3/16/21 COVID-19 positive by PCR on  1/13/22 admitted to hospital on 1/15/21 d/t COVID 19 pneumonia; known h/o pulmonary HTN, CHF, home O2, severe restrictive lung disease
Staff had her 2nd vaccine on Friday 1/15/2021.  On Saturday 1/16 Started to have asthma flare up.  Monday and Tuesday; cough and asthma.  Called PCP got inhaler.  Staff used inhaler to control her asthma through out the week.  Today again, cough, congestion.  Took day off.  Has an appointment this morning.  Her 1st vaccine had allergy reaction too.  COVID testing every 2 week
w/in a few hrs devel sl dry irritating cough w/face & lip swelling, achiness, chills & fatigue;lasted a few hrs & started to resolved;flu shot in past w/o problem
SIDS 30 hours after 2 mos immunizations autopsy pending. DTaP, IPV, Comvax, Prevnar.
Day after first shot both of my thighs felt sore like I had done lunges/squats when I had not exercised. I told the person giving the 2nd shot about the soreness and said I should report to my primary Dr. I did and was told if not gone in 2 weeks call back. I had 2nd shot Wednesday 2/10/21. I started feeling worse on the 28th. Tuesday 03/02/2021 had great difficulty getting out of bed and great difficulty walking also my upper arms hurt. I saw the Dr. that morning and she thought I had polymyalgia rheumatica PMR and took a blood sample. I also had a fever. The results came back positive for PMR and put on prenisone 15mg for 3 weeks. I am now on 4 weeks of prednisone tapering down from 10mg to .5mg. I do not tolerate
Fever, chills, flu-like symptoms. Middle of the night (4 AM) woke with rapid heart rate.
Fever (102), Chills, Dizziness, blurred  vision, body pain, hearing issues, sever headache
Right side tingling past 10 days. Reports tingling to right face and right arm feels like intermittent pins and needles. Received Janssen COVID vaccine on 4/12/21 at an outside facility.  Diagnostic workup revealed Cerebral Vascular Accident (CVA).
flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included fibromyalgia (patient diagnosed with fibromyalgia in July 2021), pain, stomach pain, back pain, difficulty breathing (feelings of not being able to breath), energy decreased, muscle atrophy (atrophy of the muscles) and difficulty in standing (not able to stand for long periods of time).   On 8th October 2020, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 8th October 2020, 1 hr after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced influenza-like symptoms. On 13th October 2020, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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 as follows: The case was reported by patient's mother. The patient was diagnosed with Fibromyalgia in July 2021. The reporter reported that, since being diagnosed with Fibromyalgia, the patient continued to be sensitive to pain, has stomach aches, back aches, feelings of not being able to breath, low energy, not able to stand for long periods of time, hypermetabolic and atrophy of the muscles. The reporter stated that, the patient's health care professional had decided not to treat her for Fibromyalgia at this time because she was so young. The patient received  Bexsero vaccine in the right deltoid  and experienced flu-like symptoms about an hour after receiving the Bexsero vaccine that resolved 5 days later. No further information available. The reporter did not consented to follow up. For tolerance of 2nd dose refer case US2021176187, reported with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021176187:Same reporter
This spontaneous report as received from a physician via company representative refers to an approximately 44 year old female patient of unknown age. The patient's medical history included autoimmune condition. On 03-APR-2014 the patient was vaccinated with ZOSTAVAX, 0.65 Microlitre, subcutaneous. On an unknown date in approximately 2014 the patient experienced reoccurring minor breakout of a rash on their left shoulder. The patient sought medical attention for the event. Patient was treated with acyclovir (manufacturer unknown). There was no  intervention to prevent serious criteria. The caller could not confirm if the patient has rash at the time of report. Product quality complaint was not reported. The outcome of reoccurring minor breakout of a rash on their left shoulder was unknown. The causality of event with ZOSTAVAX was unknown. Additional information has been requested.
Dizzy; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 05Mar2021 13:00 (Batch/Lot number: unknown, Expiration Date: 31Jul2021) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "Dizzy"; HEADACHE (non-serious) with onset 05Mar2021, outcome "recovered" (06Mar2021), described as "Headache". Additional information: It was reported that the events occurred about an hour or two after the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given an oral vaccine by intramuscular route. (Rotavirus) Mom was educated on signs and symptoms to be aware of as well as what actions need to be taken in the event that the baby was to have a reaction. Patient was monitored in clinic for 20 minutes without any reaction.  Patient was also contacted the same afternoon to check on status.
Patient reported bruising at injection site then hot, red, inflamed skin from site towards elbow. Patient saw doctor who administered a cortisone shot and an antibiotic (AUGMENTIN). Doctor didn't want to use BENADRYL due to a heart condition patient has.
I started getting palpations and shortness of breath in March 2021. It was not consistent and I had episodes and they would subside. As the months went by, the episodes were more frequent and lasted longer. I went to an urgent care and they preformed an EKG that was abnormal. They made an appointment for a cardiologist. I went to the cardiologist I had an EKG and an echo was abnormal. I was sent to the ER. While at ER, I had a chest x-ray, EKG, echo, and blood work. I was diagnosed with Pericarditis. I was prescribed Colcrys and Ibuprofen. I have had other tests done as well and a nuclear stress test. I was still experiencing shortness of breath. I was referred to a pulmonologist. The pulmonologist admitted that he didn't know what to do. I was put on a steroid for another month. After the one month, a pulmonary function test was performed that was abnormal. But I was still having shortness of breath. I went to a different pulmonologist. Then I developed COVID-19. I had harsh symptoms of COVID-19. I was placed back on steroids and had 3 different inhalers. Then I seen another pulmonologist. He placed me on oxygen because my O2 was in the 80s. I had referrals for different doctors. I ended up having 2 biopsies on 3/2022 and was inclusive. I was then referred to a thoracic surgeon and on 4/6/2022, a wedge was taken from my right lung. I had a diagnoses of PVOD. I have been out of work since April. I remain on 3 liters of oxygen and am waiting a lung transplant.
Pt reports post 10 minutes of vaccine he felt funny, throat dry, burning in chest. Pt was able to breathe, no swelling noted, called 911.
She is due for shot day 7 today. We forgot to order it; Case reference number US-BN-2021-002005 is a spontaneous case initially received from a pharmacist via regulatory authority (reference number: USBAV21-0272) on 11-Jun-2021 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication were not provided.  On 01-Jun-2011, the patient was vaccinated with the first dose of RabAvert (inactivated rabies virus vaccine, batch number not provided) at unknown dose or route of administration, for post exposure.  On 04-Jun-2011, after three days, the patient was vaccinated with the second dose of RabAvert (inactivated rabies virus vaccine, batch number not provided) at unknown dose or route of administration, for post exposure.  On 11-Jun-2021, the third dose of RabAvert was scheduled, but the provider forgot to placed the order for the third dose to be delivered on time (explicitly coded as 'Missed dose').  At the time of initial reporting, it was unknown if the patient experienced any adverse event.  Additional information received from regulatory authority on 11-Jun-2021 included new information: Updated reporter's phone number.  No further information was provided.; Reporter's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received two doses of RabAvert and the third dose was scheduled, but the order was forgotten to be placed on time. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.; Sender's Comments: Product dose omission issue is listed by convention. Reportedly, the patient received two doses of RabAvert and the third dose was scheduled, but the order was forgotten to be placed on time. No adverse events were reported. Product dose omission issue is not related to the suspect product but to a human action.
Patient had fever and redness and swelling about 4 inches in diameter around the injection site.  PNEUMOVAX and FLUARIX were given in the same arm, unable to determine which vaccine cause the adverse event.
Lightheaded, sweaty, elevated blood pressure, brain fog, skin turned red, shaking.
Horrible aching up and down right arm, especially under armpit, down arm, side of breast and 1/2 way across back. Sunday, temp of 100.3 with chills.
Headache, Myalgia & NauseaVomiting Narrative:  1/11/21 redness and swelling at injection site, slight headache (which has been on-going since contracting Covid) 1/12/21 body and joint pain along with nausea and fatigue 1/13/21 fatigue and body ache gradually subsided No fever detected throughout course. Prescribed Meloxicam was taken the evening of 1/12 and 1/13.
Injection Site Soreness (began less than hour after injection and is ongoing/resolving 3 days later); ~6.5 hours post injection Chills began (lasted ~2 hours); then Fever  100 F (~24 hours);  and Tiredness (~36 hours); and Headache (~40 hours)
I had a breakthrough case of Covid-19 I had a horrible headache I experienced dizziness and light head with diarrhea and abdominal cramping and pain with clay colored stool I was lethargic with a general feeling of being unwell with brain fog.  I also experienced some coughing nasal drainage and congestion I was prescribed Paxlovid.
My son broke out in hives all over his body the day after vaccines on the 2nd or 3rd day the hives were so bad I called the doctors office and was told to give tylenol and benadryl and a warm bath he had marks that look like bite marks he immediately started to regress and started doing circles in the floor, extreme tantrums and non stop crying I knew it had to be the vaccines because it was the only thing we had done in those days, there were no new foods or anything like that. He also stopped eating he only wanted milk.
Mother states that immediately after injection patient had burning, tingling and itchy. About an hour later the injection site swelled to the size of golf ball, was red and hot to touch, painful and burning.
L thigh with erythema, swelling, warmth to touch area of erythema 9x9 inches.
Information has been received from a nurse concerning an unspecified patient of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 26-JAN-2016, the patient received a dose of improperly stored RECOMBIVAX HB (lot # L044707 with expire date 06-OCT-2018; dose and route not reported). The temperature/time frame was Cumulative 34.1 F for 135 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had syncope approximately 10 minutes after administration of GARDASIL (second in series). Had syncopal episode after administration of vaccines (Tdap, MENACTRA, GARDASIL #1) on 8/25/10. Did not report because we felt it was due to setting 3 shots at once.