chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph nodes in the head and neck area; This case was reported by a other health professional via call center representative and described the occurrence of enlargement of lymph nodes in an unspecified number of patients 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.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was unknown.   It was unknown if the reporter considered the enlargement of lymph nodes 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 age at vaccination was not applicable for this report. The patient's received Bexsero and experienced swollen lymph nodes in the head and neck area. The health care professional enquired for information on any patients having symptoms more than 7 days. No further information was available. The reporter consented to follow up.
Fever, diarrhea,  vomiting,  chills, no smell or taste for 3 days and extremely lethargic (I literally could not get up off the floor).
so cold; feet feel like they are on fire; loose bowel, gone several times a day; has lost 15 lbs; very weak; Fatigued/Tired; headache, on and off headache; chills; very confused; felt like he was in a fog; pain in the kidney area, still pain in kidney area; barely breath; sort of mumbling; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (very confused), FEELING ABNORMAL (felt like he was in a fog), RENAL PAIN (pain in the kidney area, still pain in kidney area), DYSPNOEA (barely breath) and SPEECH DISORDER (sort of mumbling) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical History.  Concomitant products included METFORMIN, ATORVASTATIN, DONEPEZIL HCL, ANDROGRAPHIS PANICULATA, ASCORBIC ACID, ECHINACEA PURPUREA, OLEA EUROPAEA, ZINC CHELATE (IMMUNE DEFENCE), QUERCETIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced CONFUSIONAL STATE (very confused). 20-Apr-2021, the patient experienced FEELING ABNORMAL (felt like he was in a fog), RENAL PAIN (pain in the kidney area, still pain in kidney area), DYSPNOEA (barely breath), SPEECH DISORDER (sort of mumbling), FATIGUE (Fatigued/Tired), HEADACHE (headache, on and off headache) and CHILLS (chills). On an unknown date, the patient experienced FEELING COLD (so cold), BURNING SENSATION (feet feel like they are on fire), DIARRHOEA (loose bowel, gone several times a day), WEIGHT DECREASED (has lost 15 lbs) and ASTHENIA (very weak). At the time of the report, CONFUSIONAL STATE (very confused), FEELING ABNORMAL (felt like he was in a fog), DYSPNOEA (barely breath), SPEECH DISORDER (sort of mumbling), FEELING COLD (so cold), BURNING SENSATION (feet feel like they are on fire), WEIGHT DECREASED (has lost 15 lbs), ASTHENIA (very weak), FATIGUE (Fatigued/Tired), HEADACHE (headache, on and off headache) and CHILLS (chills) outcome was unknown and RENAL PAIN (pain in the kidney area, still pain in kidney area) and DIARRHOEA (loose bowel, gone several times a day) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Newevents added. Event outcome updated.
acute CVA, lt hemiparesis; dysphagia post; pt had flu vax 12OCT94; CVA-30OCT94; pt has hx of CVA w/ rt hemiparesis on 13OCT93; 2 wkd prior to CVA in 1993 pt had a flu shot;
bilateral swelling of area around eyes, rash, runny nose, sore throat, sneezing
Elevated blood pressure; This is a spontaneous report from a contactable Consumer (patient).   An 85-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as 1st dose, single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a pharmacist refers to a 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 26-APR-2016, one unspecified patient was vaccinated with an improperly stored dose of VAQTA, lot # L049953 (expiry date: 14-JAN-2017) (dosage not reported). The temperature excursion was -0.5 (unspecified units) for 7 days. No previous excursion was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within a few hours, I became flushed but no fever. Then later in the evening, symptoms include headache, body ache, fever of 101, aches in my bones and fatigue.
Onset within 10 minutes of vaccination beginning with vertigo without nausea, and numbness of tongue.  At no time was there "any difficulty breathing or heart palpitations."  This progressed over a 2 hour period to include numbness of body with pain in shot arm.  "It felt like I was shot up with novicaine everywhere and pain down my (left)arm and my left hand felt like it was smashed."  Client spoke with her physician by phone but was not seen.  The numbness and discomfort lasted approximately 24 hours.  This was followed by malaise for another 48 hours.  When contacted November 2, 2005, client stated that she felt completely recovered.  At no time did she check her temperature.
Dry mouth that last for 3 hrs.; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 37-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EN6198) via an unspecified route of administration, administered in left arm on 22Feb2021 14:30 (at the age of 37-years-old) as dose 1, single for COVID-19 immunization. Medical history was reported as none. The patient known allergies was reported as none. Vaccination facility type was reported as Health Department. The concomitant medications included emtricitabine, tenofovir alafenamide fumarate (DESCOVY) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the covid vaccination. Since the vaccination, the patient had not been tested for COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 22Feb2021 at 15:00, the patient experienced dry mouth that last for 3 hrs. The patient did not receive any treatment for the dry mouth. The outcome of the event was recovered on 22Feb2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
19FEB93 7PM lungs really sore, wheezing, inc temp 103, achy bones; 21FEB93 constant h/a, inc temp 99.5-100.5, cough w/yellow sputum;
This spontaneous report as received from a nurse refers to an approximately 15-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 16-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot#, and expiration date were not provided). On 31-AUG-2017, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot#, and expiration date were not provided). No adverse symptoms were reported.
Vision Problems with black spots, seeing bright colors and Tracers, Vomiting nausea headaches
Individual stated she had not received a previous vaccine after being asked various times orally and in writing.  It was later discovered that the individual had received a prior vaccine at a different location.  Individual was monitored and no adverse reactions were noted.
Child received Dtap, IPV and HIB on Jan 30, 07. He developed fever and seizure that evening and was treated symptomatically at hospital ER.
Tiredness lasted a day from the time injection; arm soreness; rectal bleeding-  diagnosis internal Hemorrhoid.
Axillary Lymphadenitis. Lymph node is hard and painful. Large amount of fluid swelling protruding outwards from armpit. Larger than a golf ball but smaller than a baseball. Aching sensation.
This spontaneous report as received from a physician refers to a 75 year old female patient with rheumatoid arthritis, sulfa and aspirin allergy and a history of Lyme disease. On 14-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX injection (route and dose not provided, lot  number J003483, exp. date 29-JUN-2014). The physician reported that in August 2013 the patient had a flare up of the rheumatoid arthritis following vaccination with ZOSTAVAX. The patient sought medical attention -contacted office. There was no treatment of adverse events. The physician reported that the patient was previously on ENBREL, but received the last injection of ENBREL in July 2013 (date unspecified). The ENBREL was stopped , but received the last injection of ENBREL in July 2013 (date unspecified). The ENBREL was stopped so the patient could receive the ZOSTAVAX vaccination. The physician also mentioned that the patient and his wife ached all over after receiving Lyme vaccine (date of administration and manufacturer of Lyme vaccine was unspecified), but were recovered (date not reported). None of lab diagnostics studies where performed. The outcome of event was reported as not recovered. Relatedness of the event of the ZOSTAVAX was not provided by reporting physician.  Additional information has been requested.
Patient passed out and hit head on ground about 5 minutes after recieving vaccine. EMS was called. Patient refused transport to ER.
After receiving the vaccine, I developed a very painful, golf ball size lump. It is located behind my left ear. I went to see my doctor the next day. They ran an x-ray and ultrasound. It was changing every day. One day it might be big and hard or small and even harder. I followed up with my doctor and she said that it's a lymph node. I can feel that it's still there today, but it's not painful.
Left arm rash/swelling at site of injection. Started 2 days post injection and symptoms getting worse as of 5/4/16.
Non-productive cough, shortness of breath, increase in blood pressure (170/90) and increased heart rate (85 bpm).  Symptoms began shortly after second dose of vaccine on 2/26/2021
Patient was given Flublok that should have only been given to patient 18 years or older.  Patient had no adverse reactions to vaccine.
had flu shot at 6pm.  10 pm felt throat itchy & woke up at midnight with swollen lower lip & tongue, some wheezing and loose BM. Took two motrin.  Some difficulty swallowing.  Went to local emergency room, given Benadryl 50 mg. IM and Zyrtec 10 mg po.  Dx angioedema after flu vaccine.  Observed for two hours.  No wheezing, itchy throat upon discharge.  Swollen lip continued till next day.  Sent home with medrol dose pack (6 days) XYZZL 5 mg.  No symptoms as of this writing except feeling tired.
This is the first of three reports. This is an initial spontaneous report received from a contactable medical assistant. A 4-year-old female patient intramuscularly received a dose of PREVNAR13 on the leg as routine vaccination on 12APR2011. The patient also concomitantly received a dose of measles, mumps, rubella and chicken pox vaccine on 12APR2011. There was no relevant medical history. Past vaccines included PREVNAR which was given when the baby was 2 month old. No vaccines were given within 4 weeks. On 13APR2011, the patient developed hardening of skin at the injection site, and also hives, little bumps and warmth at the site of injection. The events did not require an emergency room visit. Treatment was not provided. At the time of the report the clinical outcome of the above events was unknown. Follow-up (27MAY2011): Follow-up attempts completed. No further information expected.
Information has been received from a 66 year old female with PHENERGAN allergy who on 02-JAN-2009 was vaccinated SC with 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included atenolol and aspirin. On around 28-FEB-2010 the patient developed shingles diagnosed by her doctor. The patient was treated with valacyclovir hydrochloride. The patient's shingles persisted. The patient sought unspecified medical attention. Additional information has been requested.
No known side effect; Dose of unknown lot of ROTATEQ was administered to a patient after undergoing temperature excursion; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  03-JAN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot# and expiration date were not reported) for prophylaxis after undergoing temperature excursions (product storage error).    On 03-JAN-2022, the agent reported a temperature excursion for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) but did not know the lot number or expiration date therefore this agent was unable to perform a temperature evaluation. Vaccine reached (34.3F) and was out of range for 4 hours 23 minutes and 0 seconds and had no previous excursions. Other rotavirus vaccine, live, oral, pentavalent (ROTATEQ) which she had lot information for were evaluated and supported. Agent reported that a dose of unknown lot rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to a patient. Patient had no known side effects. No PQC reported.
Post vax, the pt's arm became very sore, paresthesia and slight skin atrophy. She was seen by a chiropractor several times. Seen on 3/21 with developing left shoulder arm syndrome. Pt started anti-inflammatories on 5/25. Per doc 198856, at the time of vaccination, patient was using her maiden name. On 11/07/2000, the patient states that for several months s/p flu vaccine, she was unable to move her arm. She could not raise it to dress herself for several months. Currently she can raise the arm about 1/2 way and continues with PT and anti-inflammatory treatment. Pt admits she is on the thin side. An Health care provider told her that her arm was frozen and that the flu injection damaged the nerve in her arm. He believed that the needle "went in too far". On 12/18/2000, closing case as no response from vaccine for lot#information. As patient's physician is the reporter and gave a diagnosis, test results. There is no need for further records to document this case.
Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In June 2022, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) was resolving. Not Provided          It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product reported by reporter. No treatment medication reported by reporter.
Information has been received form a nurse practitioner concerning a retired 68 year old white female with no medial history and no allergies who on 06OCT2003 was vaccinated IM with a second (previously reported as a first) dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 06OCT2003, within hours of the vaccination, the pt developed a serious local rxn with injection site redness, swelling and pain. The pt developed cellulitis of her arm from her elbow to her shoulder and was seen for follow up twice. She was treated with NSAID's and local ice. Subsequently, the pt recovered. The duration was reported as 6 hours to 4 days. No product quality complaint was involved. It was also reported that three other female patient's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and developed injection site redness, swelling and pain.
Extream high fever maced out at 105.2 for almost 12 hours.  Joints swelled and became very painful.  Still 3 months later joins still feel arthritic.  Been having frequent chest pains following last injection.
Pt vaccinated with DTP/OPV and developed fever of 100, episode of convulsions, encephalitis/encephalopathy w/abn lumbar puncture, and aseptic meningitis.
Patient given 0.5 mL as a booster dose instead of the recommended 0.25 mL; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient given 0.5 mL as a booster dose instead of the recommended 0.25 mL) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 016B21A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Renal cancer.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (Patient given 0.5 mL as a booster dose instead of the recommended 0.25 mL). On 26-Oct-2021, EXTRA DOSE ADMINISTERED (Patient given 0.5 mL as a booster dose instead of the recommended 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.
Fully vaccinated with Pfizer vaccine second dose on 2/5/21. Her Boy friend became positive for Covid 4/15 so she got tested and was positive but reports only slight congestion
Historical date, not actually seen at our clinic for dx relayed to provider. On 7/20/00 at 14:40, in for well child check; Mom states no concerns today, other than pt got chickenpox about 2 weeks ago on 7/6/00. Recovered from chickenpox without problems. Has matting eyes every AM,  resolving. No other upper respiratory symptoms. Prescribed Polytrim ophthalmic drops, Fluoride drops, Tylenol drops and chews.
Male, 18 months old, was given a fifth dose of PREVNAR 13. Fourth dose was given in June 2014. Physician stated that error occurred due to new Electronic Medical Record being implemented and the proper vaccine information was not in the EMR. In addition, the nurse failed to check the paper chart to ensure that the child was receiving the correct vaccinations. Contributing factor may have been that the child recently moved to the state and his vaccinations were not all given by this practice.
PATIENT HAD REDNESS AND HEAT AT INJECTION SITE OF ARM FOR A FEW DAYS.  IT WENT AWAY AND THEN 5 DAYS AGO FROM TODAY SHE STATED THAT SHE FEELS PAIN AGAIN AT HER ARM.
This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 51-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 17th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown. The reporter considered the localized erythema and local swelling to be probably related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX in left deltoid, the patient experienced red, swollen, bumps approximately two inches from where the needle punctured the skin. The reporter was unable to provide additional information.
Around 0320 on 12/20/20, approximately 12 hours after my vaccination, I experienced uncontrollable chills for an hour and had an onset of a headache, nausea and weakness that lasted until about 1500 on 12/20/20. Side effects have since resolved.
Fever 101 F onset approximately 12 hours post vaccination;  Concurrent Chills - Duration 5 hours thereafter Fever dropped to 99 and resolved with increased fluid intake  Onset 1Hr post vaccine: Inflammation and Regional Pain Left  Axial Lymph nodes; difficulty raising and extrnding left arm  (heavy feeling) not due to soreness - Resolved 36 hours
02/09/09, mother of Pt said that 02/22/09 Pt was taken to ED of medical center for respiratory illness by his father. Pt was arrested in ED and after resuscitation, transferred to a different medical center. Pt passed away 01/24/09.  3/11/09 Autopsy report received with the following DX: Large right pleural empyema-collapse of R lung with no evidence of pneumonia-small R pneumothorax-Gram (+) cocci present in fibrinopurulent coagulum from R pleural space.  Multi-focal acute bronchopneumonia of L lung (early?).  Focal hemorrhage, base of L lung. Left pleural effusion.  Tri-lobed left lung (with normal bronchial branching pattern).  Mild cardiomegaly with dilated tricuspid valve.  Moderate congestive hepatosplenomegaly. Findings c/w acute physiologic stress: Moderate to marked thymic involution, moderate lipid depletion of adrenal cortex, moderate arrest of rib growth plate.  Small pericardial and peritoneal effusions.  Small fragment of apparent old blood clot in bladder.  Myeloid hyperplasia of bone marrow, with left shift 4/6/09 Coroner's report received with COD: Acute Respiratory Insufficiency due to Empyema, Sepsis and presumed pneumonia
Patient presents to ER with cough, body aches, chills, and right sided headache onset Saturday.
16  mins into the shot Rash on chest and face, Fast heart beat, Face went numb for an hour and a half, dizzy and hard to breath Tachycardia started, (had heart test that morning showing sinus healthy heart )