chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of swollen axillary lymph nodes in a 40-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to sulfa drugs, contrast media anaphylaxis, seasonal allergy and skin ulcer. Concurrent medications included MVI, Antihistamine and Calcium. On an unspecified date in October 2010 the subject received 1st dose of FLULAVAL (unknown, right arm). On an unspecified date in October 2010, less than one day after vaccination with FLULAVAL, the subject experienced localized pain (injection site pain). One day after vaccination with FLULAVAL, the subject experienced facial swelling, axillary left swollen lymph nodes and inguinal right swollen lymph nodes that was tender to touch. At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site, injection site redness, hoarseness, malaise and swelling of face. At the time of reporting the outcome of the swelling of face and swollen axillary lymph nodes resolved within 24 hours; injection site pain injection site redness and injection site swelling resolved within 36 hours. The swollen inguinal lymph node that was tender to touch resolved in March 2011. The events of malaise, hoarseness were unspecified. The subject reported that she receive last year's seasonal FLULAVAL in October 2010 at the health department. She stated that she had a localized pain, swelling and redness at the injection site. She also developed systemic reactions of hoarseness, malaise, facial swelling, swollen left axillary lymph nodes and right inguinal lymph nodes. The inguinal lymph node continued to be tender to the touch until March 2011 when it seemed to completely resolve. The localized reactions seemed to resolve after 36 hours. The subject took BENADRYL and the facial swelling and swollen axillary lymph node resolved. The consumer reported another case, see A0948347A.
golf ball sized lump at injection site; golf ball sized lump at the injection site. it is warm and tender to the touch.; golf ball sized lump at the injection site. it is warm and tender to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown) via an unspecified route of administration on 17Mar2021 at 13:00 (at the age of 40-year-old), as a single dose for COVID-19 immunization. Medical history included diabetes, liver disorder and covid-19. Concomitant medications were not reported. The patient was diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. It's unknown whether the patient had any allergies. On 17Mar2021, the patient experienced golf ball sized lump at the injection site, warm and tender to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the reported events. The patient underwent lab test and procedure which included BMI with unknown result. The clinical outcome of the events vaccination site lump, vaccination site warmth and vaccination site tenderness were not resolved at the time of this report.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
low temp, felt very tired & 930PM woke up w/hives from bottom of feet up to waist, itching legs, swollen but could have been from scratching them;took 2 DPH & fell asleep;woke in morning feeling fine-no side effects;
Itchy eyes/ears - 2  Benadryl were given (50mg).
Patient presented for a vaccine at our clinic. According to her husband, three years ago, she underwent stem cell treatment for lymphoma and has had a history of reactions after obtaining various vaccines.   According to LPN, patient appeared anxious and asked several questions prior to being vaccinated. After the administration, patient asked what she should do if she felt post-vaccine sideaffects and expressed concern about going to a hospital due to COVID census being reported in the news. She ambulated to the observation area of the clinic under her own power and did not appear to have any problems.  Beginning approximately 15 minutes in the observation area, she notified clinic observation staff that she felt dizzy. Staff assisted her to a treatment cot and obtained vital signs. Patient as given juice and water to drink which she did, and rested.  Serial vital signs were obtained. At least another 15 minutes later, patient later complained of "a weight on her chest", and chills. She had her eyes closed and was slower to answer questions. EMS was notified and patient required assistance to be lifted onto the stretcher by EMS and clinic staff.  Patient was transported to Hospital for further treatment.
Information has been received from a nurse concerning a 13 year old female who was vaccinated with her first dose of Gardasil. Subsequently, the patient experienced tingling in her feet. It was reported that the patient recovered. Additional information has been requested.
Around July 15 I contracted Covid. I had common cold symptoms, no fever, tired. I went to an Urgent care facilty and tested positive for covid. I was placed on Paxlovid. After 6 days I tested negative. A couple of days later I had cold like symptoms and tested positive again. My doctor believes it was a Paxlovid rebound. It was about seven days before I tested negative again.
Patient received 2nd dose on 3/1 and self-reported experiencing fever and lethargy for 3 days. Two days post dose, patient complained of her left leg hurting to her daughter. Daughter inspected leg and did not notice any swelling or warmth. Two days after that symptom started (4 days post dose), patient's leg felt better but she now had shortness of breath which she claims worsened for two weeks before presenting to the hospital where patient was diagnosed with a pulmonary embolism.
Nausea, T 98.5. Observed-hydrated, rested in nurse's office.
expired dose of Kinrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9Y52, expiry date 31-JAN-2022) for prophylaxis.   On 01-JUN-2022, the patient received Kinrix. On 01-JUN-2022, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Kinrix was administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Oct-2023 The practice manager consented to follow-up via email. The patient received an expire dose of Kinrix, which led to expired vaccine used.
Patient started experiencing rash the morning after the first dose, she received the second COVID shot on 8/30 because the rash was not severe at the time. However the itchy rash progressed and she required ER visit and Dr office visit for medications to relieve her symptoms. As of 11/4/21 she still has not recovered from the side effects and currently still taking antihistamines.
This case was received from a physician from Center for Disease Control and Prevention and forwarded by Crucell Medical Affairs. An initial spontaneous report was received on 26-JUN-2014 and concerns an unidentified patient of unspecified age and gender, who received a dose of VIVOTIF (batch number not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unknown date, 1-2 hours after receiving VIVOTIF, the patient experienced hives and difficulty breathing. At the time of this report, the outcome of the events was unknown. Action taken with VIVOTIF course was unknown. The events were assessed as serious (medically significant). No additional information was reported.
Pt vaccinated with PNEUMOVAC/FLU developed chills & fever approx 5 hrs after inject - visited ER w/weakness & shaking all over E61 SMA 18, Chest x-ray, CBC & U/A all normal.
At the 4 month vaccine visit on 7/30/14, PENTACEL, PCV and ROTA were administered in a.m. Later in the afternoon ( few hours after vaccines given)-> pt developed 'shaking' like body movement, and full body rash and increased crying.
I'm 10 years post menopause. Vaginal bleeding began the day after injection with severe cramping. Bleeding continues as of this writing. Went to primary care doctor. She said this is the second person in their office who have had similar reaction. Doctor ordered pelvic ultrasound and advised me to see my GYN next week.
1st Hep B mild rash on arm and side of neck, 2nd Hep B burning at injection site with macular papular, rash local, then spread spread.
Symptoms: Empty Stomach, Heartbeat runs fast, Dizzy and Vertigo, headache, fatigue, sweating, sleepless and low blood sugar symptoms.  Time Course: It happens when I feel empty stomach, it is around 4 times a day. Signs: Heart palpitations, follows dizzy and vertigo and sweating, I have to drink apple juice or some kind of sweet to relief the symptoms.  Doctor Comment: Panic attack or Vasovagal reaction, she prescribed Hydroxyzine HCL 10mg every six hours as needed.  I take 1 pill a day before bedtime.   As of today, I am still feeling that symptoms around, and that was my first dose of shot. I went to urgent care twice and went thru all testing, and lab test results are Ok.  But the symptoms are really bother me. April 29, I will see the allergy doctor if I have any allergy related to the drug
Hospitalized;  COVID-19 positive (10.6.21);  Fully vaccinated. Admission Date: 10/6/2021 Discharge Date: Oct 9, 2021 PRESENTING PROBLEM: Hyponatremia  Hypophosphatasia  Encephalopathy COVID-19  Acute respiratory failure due to COVID-19  HOSPITAL COURSE: This is a 66-year-old gentleman with a history of progressing right chest mesothelioma, as well as type 2 diabetes mellitus.  He has had some progressive memory problems and word-finding problems over the past months, but developed acute worsening mental status in the 3 days prior to admission.  When he came to the emergency room he was found to have fever and was borderline hypoxemic.  He was found to have COVID-19 infection.  He had anemia with a hemoglobin of 10.4, and subsequent anemia workup revealed an iron saturation of 3% consistent with iron deficiency anemia, as well as of vitamin B12 level of 189 consistent with vitamin B12 deficiency.  He was treated with IV iron sucrose, of which he received 2 doses of 200 mg during his hospital stay.  He was also treated with 1000 mcg of vitamin B12 IM. For his COVID-19 infection he was started on remdesivir and dexamethasone.  He developed acute agitated confusion after admission requiring IV Haldol.  This was thought to be a steroid psychosis, and it resolved with discontinuation of the IV Decadron.  He is on oral Decadron 2 mg daily as an outpatient which was resumed.  He also seemed to develop some confusion from remdesivir dosing so this was stopped as well.  By discharge she was at his baseline mental status.  He was breathing comfortably without oxygen.   For his altered mental status he had a head CT on admission which was negative, and also an MRI of the brain with and without contrast which was normal except for evidence of small-vessel cerebrovascular disease. Discharge medications include the addition of ferrous sulfate 325 mg daily and vitamin B12 500 mcg daily. Follow-up recommendations include consideration Neurology consultation to evaluate cognitive dysfunction.  For his vitamin B12 deficiency and iron deficiency recommend follow-up complete blood count, B12 levels, and iron levels to determine if IM B12 maintenance is necessary or IV iron infusions are necessary.
There is no adverse event, but the patient received 2nd dose of Moderna vaccine on day 49 after 1st dose because she received the 1st dose at another site (healthcare clinic) and she had to travel out of state due to a family member's death.
Swelling, erythema and some pain to arm where vaccines were administered. Started on Keflex for cellulitis and early abscess.
Client received 1st dose of Moderna vaccine on 3/17/21. Client began experiencing itchy hives on his stomach and right side near his belt line on Friday 3/19/21. On 3/22/21 client is still experiencing these hives. Client reports the hives have remained the same. He has not had any worsening or spread of the hives. Client denies any shortness of breath or difficulty breathing. Client also reports experiencing an increase in his arthritis symptoms, but reports he missed his Celebrex dose on 3/20/21 which may also contribute to these symptoms.
No adverse event; The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The expiration date of the vaccine was on 12 Feb 2023 and the date of administration of the 6 doses was on 09 Mar 2023).    No concomitant medication were reported.  HCP did not have patients' information at the time of the call. No patients have reported adverse event. No treatment information was provided by the reporter.  This case was of patient 5 of 6 patients, as mentioned by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-719555 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719555:Master case
On 2-18-09 sudden onset of knot in left neck area, swelling from left neck to left arm & left facial swelling & twisting of face - 3/12/09 cont. high BP & pain & burning/stinging back of left neck - hospital given VICODIN for pain & METHY/PRED dose pack
Headache, chills, diarrhea for 5 days,  then better for a day, then it started again to a lesser extent.  Now 11 days out I am better.  Sometimes have mild headache.
pt recvd vax; 1jun95 devel episodic dry heaves which occurred at noc;neurological exam w/in nl limits;
1:30 AM on 4-1-2021 horrible chills for 4 hours; horrible headache most of the day of 4-1-2021; vomitting and diarrhea started in the evening on 4-1-2021; low grade fever on 4-1-2021 until 4-2-2021; stuffy nose. My sense of taste makes everything taste like metal. I also had Covid-19 in December of 202, with mild symptoms of low grade fever, fatigue, no taste or smell for 6 weeks.
Information has been received from a registered nurse concerning a 26 year old female with polycystic ovarian syndrome, a history of thoracic sympathectomy for excessive sweating, and not known drug allergies, who on 27-JAN-2009 was vaccinated with a 0.5 mL first dose of GARDASIL (lot # 1423X), intramuscularly. Concomitant therapy included MIRCETTE and prenatal vitamins (unspecified). That evening the patient had episodes of diarrhea, flu like feeling, fatigue, achiness and chills. The symptoms persisted and the patient stated that she started to develop tingling in her lower legs and feet on 29-JAN-2009. The registered nurse requested that the patient took her temperature and it was 98.4 degrees F. The patient sought medical attention through a phone call. At the time of this report the patient had not recovered. Additional information has been requested.4/8/09records received-presented in ED on 2/2/09 with C/O pins and needles in legs and hands s/p  gardasil vaccine. Paresthesia and weakness lower extremities. Mild shortness of breath. PE RLE 4/5 LUE 4/5. No actual motor weakness.   DX: Mild Guillain Barre secondary to vaccination.  This is in follow-up to report (s) previously submitted on 2/13/2009.  Follow up information received on 19-FEB-2009 stated that the patient received a first dose of GARDASIL (lot # 1423X), intramuscularly into the left deltoid on 27-JAN-2009 at approximately 12:00.  The patient had a sympathectomy in 1999 for excessive sweating.  It was also reported that the patient called to the physicians office on 29-JAN-2009 complaining of fatigue, diarrhea and flu like symptoms starting a few hours after administration of GARDASIL.  The patient also complained of "tingling of feet".  On 01-FEB-2009 the patient called for increasing numbness on legs, the patient went to E.R. on 02-FEB-2009 for numbness and saw the neurologist who prescribed NEURONTIN.  Follow up information received on 27-FEB-2009 from the physician's secretary; she provided the patient's last name.  It was also stated that the patient was in contact with the physician by phone on 24-FEB-2009 and she told the physician that she was going to a rehab center for physician therapy two times a week for about a month, to "get resolution of symptoms".  The secretary could not find the name of the neurologist in the chart, nor was there any mention of recovery for the other events.  No further information is available.
Patient was administered Gardasil 9 the subcutaneous route versus the recommended intramuscular route; This spontaneous report was received from a Licensed Practical Nurse concerning a 11-year-old patient. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.     On 20-OCT-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S031287, the expiration date: 08-APR-2022, subcutaneously route versus the recommended intramuscular route (Incorrect route of product administration)    for prophylaxis.    combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S031287; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
C/O itching @ site LD 8-28-15, redness & pain started 8-29-15, seen in work clinic 8-31 with 4x4 inch raised red oval area below injection site. Warm to touch, no streaking, pain decreased, temp WNL. No intervention from Pt (ice, Tylenol) seen by Provider given RX for Augmentin to start immediately and to F/U with ER if condition worsens.
Myocardial infarction due to complete blockage of distal end of left anterior descending artery. Cardiologist stated it was impossible to tell the exact cause of the blockage, but could have been an embolism or thrombosis and not able to rule out if it was caused by the COVID-19 vaccination. Unable to place stent due to distal location/tortuosity of blood vessel. All other blood vessels were normal and clear during catheterization and had no sign of atherosclerosis or vascular disease. No other risk factors. No fam history of cardiovascular disease at a young age (only later in life age 60-80).
This spontaneous report has been received from a licensed practitioner nurse referring to a 4 month old female patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 28-MAY-2016, the patient was vaccinated with ROTATEQ, orally, lot # M002254, expiration date 15-NOV-2017 (dose and frequency were unknown by the reporter). Concomitant therapies included ZANTAC. On the same date of the vaccination the patient vomited "almost the entire dose of ROTATEQ shortly after receiving it" (accidental underdose). The licensed practitioner nurse stated that the patient did not receive treatment for the event and also none lab diagnostics studies were performed. Product quality complaint was not involved. It was reported that the patient sought medical attention and was at the doctor's office at the time of the event. The outcome of vomiting "almost the entire dose of ROTATEQ shortly after receiving it" was reported as recovered on the same date of the vaccination. The relatedness between the event and ROTATEQ was not reported. Additional information has been requested.
Headache after the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 HEADACHE (Headache after the second shot). At the time of the report, HEADACHE (Headache after the second shot) outcome was unknown.            Patient asked can he take po for headache after the second shot.  Treatment medications were not provided.  Concomitant medications were not given.
pt recvd vax; high pitched screaming 3-4 hrs p/ vax;
bilat swelling below both ears, redness of the ear lob, low grade temp, bilat tender rx pred;cervical adenopathy 5cm below rt earlobe;
after vaccine working arm, all blood in head rushed to feet, lightheadedness, felt like she was going to drop or die, tremors, body felt like it was growing fur, lymph nodes under tongue, fingers, toes, started to swell.teeth chattering, restless legs, itching legs, sugar swings
DIZZY SPELLS; BAD HEADACHES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced dizzy spells, and bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy spells, and bad headaches. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.