chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored VAQTA (lot # M011116 and expiration date 17-JUN-2017; lot # K008333 and expiration date 10-MAR-2017, dose and route of administration were not reported). The maximum temperature of excursion was 22.7 Celsius degrees with the time frame of 3 hours and 48 minutes. The minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 31 hours and 1 minute. There were no known adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Swelling and redness of left thigh starting about 2 days before.  Seen in urgent care center and given prescriptions for acetaminophen liquid and diphenhydramine liquid.
Had initial shot 4.29.21 and 2nd shot 5.21.21.  5.22.21 started having severe diarrhea which lasts to this day.  2-3 months later was dx with Graves disease    First Pfizer injection on 4/29/2021, second Pfizer on 5/21/2021. Next day started intestinal problems, diarrhea, large amounts of mucus, spasms, and lack of control. Began losing weight. Saw PCP, referred to Gastroenterologist, who performed all common stool tests for infection and parasites, and a colonoscopy, with negative results on all tests. Also tests for Celiac. Have recently had abdominal CT Scan with dye, again no negative results. Tried IBS diets, low FODMAP, and other dietary changes with no change of results. Since this started in May, I have dropped from about 175 pounds to a bit under 150 pounds. Have good appetite, and eat a well balanced diet.  I am recently experiencing reduced range of motion in mostly knees shoulders and elbows, and marked loss of strength. I feel that my general health is gradually getting worse. Nothing like this has ever happened before, and all symptoms started and have continued to progress to present. I'm now over 5 months into this situation, no one has found anything wrong or suggested anything that has helped.
4 Imz given: Dtap, Ipv, Hib, Prevnar (15mo) all 4 reacted with swelling, some transient redness (ie 4 bumps 1-1 1/2 cm each) pain, red gone x 24hrs, lumps persist. Unusual-generally only Dtap.
Her left arm went numb; then like 20 minutes later whole left side of her body went numb; it didn't go away, it got worst; This is a spontaneous report from a non-contactable consumer (Parent). This is the second out of two cases.     A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733), via intramuscular route of administration on 01Apr2021 at 18:30 (at the age of 25-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 01Apr2021 at 18:45, 15 minutes after the first dose of vaccine, the patient's left arm went numb; then like 20 minutes later whole left side of her body went numb; it didn't go away, it got worst. Patient visited emergency room and did a basic neurological exam to make sure that she didn't have a stroke. But it wasn't a stroke. The event didn't go away, it got worst. The next morning, the patient visited doctor. Doctor said it was not a stroke. Patient did not take any treatment for the adverse event. The patient underwent lab test and procedure which included neurological examination: not stroke, on 01Apr2021. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Immediate swelling at injection site along with nausea, and sweating. This lasted for about 1/2 hr.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild
Exacerbated asthma symptoms; chest pain, difficulty breathing; using inhaler on an as-needed basis (typically every 2-3 hours).
FELT A LITTLE FUNNY; SLEEPY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 08-MAR-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 MAR-2021, the subject experienced felt little funny. On MAR-2021, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt little funny and sleepy was not reported. This report was non-serious.
Within a few weeks Severe leg and feet swelling in one leg, then it spread to both legs every day Severe fatigue Tingling in fingers/hands Tingling in feet and calves Nerve pain in legs and feet Discolorization in calves and feet Blood work shows extremely low platelets - 63,000 then down to 59,000 one week later Forced to go part time at job due to physical impairment
Pruritic rash over R arm and back starting 48hrs after first dose, then spreading to trunk, chest, both arms, neck, and face.
COVID vaccine breakthrough case. Pfizer 1/28/21 EL9265, 2/18/21 EM9810, 11/1/21 FE3590, 4/30/22 FJ4989
My sister is permanently damaged from Mdrna shots; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (My sister is permanently damaged from Mdrna shots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (My sister is permanently damaged from Mdrna shots). At the time of the report, IMMUNISATION REACTION (My sister is permanently damaged from Mdrna shots) outcome was unknown.            Relevant concomitant medications were not reported.  It was reported that patient got permanently damaged from Moderna shots.  Treatment information was not provided.  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.
Fever to 101.1, chills, joint pain, occipital neuralgia pain, fatigue, pain and swelling at injection site
Patient is 4+ weeks pregnant and recieved smallpox vaccination on 20 March 2003.
I woke up worse than I was prior to the injection. My cheeks were red, rash like, no itching. No fever. My sinus were stuffed up, could not breathe, muscle pain, joint pain, general weakness, headache, diarrhea, sore throat, eye pain, sneezing, and cough. I also now lost my taste but can smell.  I have alternate chills and sweats, still no fever. Symptoms have faded other than the cough, loss of taste and off and on sweats and chills.
Sore throat; cough; difficulty in breathing; tiredness; sleepiness; myalgia; arthralgia; headache; metallic taste in the mouth; burning in the eyes; chills; shaking; This is a spontaneous report from a contactable physician, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection on 24Dec2020 at 09:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no relevant medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 25Dec2020 at 07:00, the patient experienced sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking which lead to doctor or other healthcare professional office/clinic visit. Treatment was provided for the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking with NSAIDs. The outcome of the events sore throat, cough, difficulty in breathing, tiredness, sleepiness, myalgia, arthralgia, headache, metallic taste in the mouth, burning in the eyes, chills, and shaking was not recovered. Since the vaccination, the patient has been tested for COVID-19 on 30Dec2020 via Nasal Swab and Antigen test and both were negative.
Patient arrived to clinic for COVID-19 Vaccine (Moderna), passed pre vaccination checklist for COVID-19 Vaccines.  Oversaw age, due to patient passing screening and fitting into criteria for vaccinating phase. No adverse side effects have been stated up to current date. reported sore arm (area of injection), and chills, which are expected after COVID-19 vaccine administration.
no adverse effect; 53-old female received one dose of gardasil 9; This spontaneous report as received from a pharmacist refers to a 53 year old female patient.    On 2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis.       On 2019 the patient experienced product administered to patient of inappropriate age.  On an unknown date the patient experienced no adverse event.    The outcome of product administered to patient of inappropriate age and no adverse event is unknown.
Pt seen in office 8/15/06. Dx: shingles. Pt received Varivax 12/4/04.
death U07.1, J12.82 - Pneumonia due to COVID-19 virus J96.01 - Acute respiratory failure with hypoxia
Became pregnant after first dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PREGNANCY (Became pregnant after first dose of Moderna vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Became pregnant after first dose of Moderna vaccine). At the time of the report, PREGNANCY (Became pregnant after first dose of Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.   This case was linked to MOD21-075585, MOD21-075618 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No New Information Added.; Sender's Comments:  MOD21-075585:Cross-linked case MOD21-075618:Cross-linked case
Itchiness, redness, slight swelling of injection area; No treatment; Has continued for 3 days following initial reaction
Patient was initially presented on 1/3/2022 with atrial fibrillation RVR as well as acute hypoxic respiratory failure due to COVID-19 infection. Patient was admitted for cardiac management. Patient was started on Dexamethasone as well as Remdesivir  given her hypoxic respiratory failure.
Had mild fever 7-14-07. Not aware of fever on 7-15. Had seizure 7-15. Went to hospital ER diagnosed with "febrile seizure". Had normal C.B.C. and B.M.O. On 7-17, came to my office for follow up. Rash first noted then. Macular or flat spots especially on trunk, less on neck and extremities.
ACT-HIB was reconstituted with store water instead of the diluent it came with, no reported adverse event; Initial information received on 12-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00809033.  This case involves a one years old female patient who was received HAEMOPHILUS TYPE B (HIB) VACCINE[ACT-HIB] (product preparation error).  The patient's medical history, past medical treatments, vaccinations and family history were not provided..  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX)  and WATER FOR INJECTION (STERILE WATER) for Immunisation.  On 12-Oct-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot number: UJ525AAB and expiry number:11-JUL-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of an actual medication error due to Wrong solution used in drug reconstitution (latency: same day).  At the time of reporting, 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 holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
sore arm; itchy eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (itchy eye) and MYALGIA (sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced EYE PRURITUS (itchy eye). On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, EYE PRURITUS (itchy eye) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
Noted after giving that the expiration date for the Men A portion of the vaccine was 3/2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA466A, expiry date 31st March 2022) for prophylaxis.   On 20th April 2022, the patient received Menveo. On 20th April 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's comments: The registered nurse reported that Meningococcal ACWY vaccine was given to patient and it was noted that Men A portion of the vaccine was already expired. The nurse was wondering if they need to call this patient back in to revaccinate them. The Men CYW portion of the vaccine had an expiration date of October 2022. When asked for the patient's demographics, nurse stated that he/she could not give. The reporter disconnected after asked if follow up could be made, so permission was not granted or denied.  Email address were provided. Additional Supportive Information: The use of Menveo dose which was already expired on 31st March 2022, which led to expired vaccine used.
Headache, dizziness, lightheadedness. Diarrhea, stomach pain. Pain, swelling, and redness at injection site
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Unknown number of improperly stored GARDASIL (dose, route, lot # not reported) were administered to patients. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Headache, Myalgia, Arthralgia, Diarrhea, chills Narrative:  Employee has multiple comorbid conditions including ehlers danlos, DM, possible POTS, etc unsure if reactions were due to medication side effects, chronic issues or vaccine related
Patient did not tell that he was not feeling well.  Later that day, he had to go to ER for heart related fluid  issues.  He stated that he was give medicine to get the fluid off his chest and that he had difficulty breathing.  His doctor stated that this was most likely not related to vaccine.
Day 1: 3PM Sore throat, 11PM facial swelling, 4AM panic attack Day 2:  2PM, lasting for 3+ hours:  Nausea, dizzy/faint/weakness, rapid heart rate (120-150 BPM), elevated blood pressure, chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus ; 5PM chills, temp up to 101.5, intense lower back pain, headache, anxiety Day 3:  intense headache, lower back pain Day 4: Mild headache, depression and fever blister later in the day Day 5:  Deep depression, feeling of impending doom Days 6-16: Elevated anxiety,  chest pain and pressure, bronchoconstriction, pharyngeal constriction, sore throat, burning tongue, tinnitus, GERD, esophageal spasms
Information has been received from a RN concerning a 15 year old female pt who on 05/04/2001 was vaccianted with varicella virus vaccine live. On 06/11/04 the pt had a titer done which was reported as "too low". The titer was ".40". No other information was available at the time of this report. There was no product quality complaint reported. Unspecific medical attention was sought. Additional information has been requested.
On January 11, 2023, I had a terrible headache and a cough with congestion. My chest began to feel heavy and had a low-grade fever. I tested positive for COVID-19. The next day I was feeling worse with heavy tight chest with wheezing. I contacted my doctor the next day. I was prescribed LEVAQUIN and prednisolone. I was advised to use my nebulizer with albuterol. I was sick for about 4 more days.
Itchy red patches on arm shoulder, neck and torso on same side as the injection site.  Red bumps on opposite arm.  Advised to report to after hours care.  Did not report to Dr.  Medicated with OTC drugs Benadryl 2 pills twice daily for 3 days.
Experience tired/achy and postnasal drip; Experience tired/achy and postnasal drip; Experience tired/achy and postnasal drip; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 the patient experienced tired/achy and postnasal drip. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events experienced tired/achy and postnasal drip was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
suspected vaccination failure; I got them shortly after I got the shot; Still having bad nerve damage pain; Still having bad nerve damage pain; Worse pain ever; This case was reported by a consumer via media and described the occurrence of  suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia, nerve damage and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia, nerve damage and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, nerve damage and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingles vaccine and shortly after experienced shingles. It has been 2 years and the patient was still having bad nerve damage pain and stated worse pain ever. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
patient was fine for 3 days then she state she had arm pain that progressed to full body pain, muscle spasms and lung pain and believes it was tied to vaccine
Information has been received from a physician concerning a 36 month old black male with no past medical history and no concurrent conditions who in 2001 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. The child had an upper respiratory infection at the time of vaccination. Concomitant medications administered on 09/14/01 included a first dose in the right thigh of MMRII (Lot # 634222/0606L) and a fourth dose in the right thigh of hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (Lot # 638581/21668K). On 02/28/03 the pt presented at the MD's office with a fever and a few lesions on both arms. The physician indicated that it was chickenpox breakthrough. The evening of 02/28/03 the child went to the ER and had "more lesions", but the pt was not treated and was released. The physician indicated that "she did not know why they took the child to ER since this was a chickenpox breakthrough". Unspecified medical attention was sought. There was no product quality complaint. No relevant diagnostic tests or lab data were reported. There were no adverse events following prior vaccinations. Follow up information indicated that on 02/27/03 the child developed a varicella rash. The reporter noted that the pt recovered. No further information is expected.
Morning after vaccination, patient developed sore throat, vomiting, fever. Seen at clinic that afternoon, had fever (forehead temp 101) but otherwise well-appearing on exam, well-hydrated. Prescribed ondansetron and acetaminophen PRN. Followed up with parent by phone today (~ 48 hours from vaccination), patient's symptoms improved. No one else sick at home per dad including brother who got COVID vaccine same day as patient.
Patient experienced his typical angina pectoris at rest shortly after receiving his shot.   Pain was a heaviness and was L sided above his nipple and radiates to his neck, back and some down his arm.   Symptoms progressed without SOB, nausea or diaphoresis.   He did not bring his NTG with him.   Hx of CAD, 2 MI's, 4 stents, DM, HTN
Pain at injection site within hour after injection Felt spread down arm to elbow & up arm to neck It felt tender for a couple of weeks  On 2/15/21 started feeling burning pain at back of injection arm & in scapula radiates down to wrist & small finger
cough initially then migratory urticarial rash w/wheal & flare on abd, chest, face, legs, back;