chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness; Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised; Fever 100F; Body aches; Headache; Soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), LYMPHADENOPATHY (Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised), PYREXIA (Fever 100F), MYALGIA (Body aches) and HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Previously around one year ago, he was exposed to COVID.) in April 2020.    On 04-Mar-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (Redness), LYMPHADENOPATHY (Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised), PYREXIA (Fever 100F), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), PYREXIA (Fever 100F), MYALGIA (Body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness in the injection site) outcome was unknown and LYMPHADENOPATHY (Swelling of the lymph nodes under the armpit and near the chest about 3 inches long and 1 and a half wide, raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: (High) 100 F. On 17-Mar-2021, Inhibiting antibodies: (High) He did his test IGG antibody before first vaccine shot and result were under threshold. He did the second test 12 days after first shot and antibody tested at high level after it..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow-up information received on 02 Apr 2021.Added laboratory details, medical history and updated outcome of event.
Rec'd vac 4/4/08-site was warm with knot and sl. redness.  Have fever and headache which abated after several day.  Then developed pain over deltoid, triceps and shoulder region.  Occ. paresthesias radiating to fingers.  Denies weakness but has dropped objects.  Insomnia secondary to pain.  Seen by IM MD then refer to Neuro MD.  Advised to take ibuprofen but was told symptoms would resolve spontaneously.  Follow up if necessary--develop any worsening neurologic symptoms such as persistent paresthesias or weakness.  Prescribed Tramadol for pain.
I have an ear ache, nasal sensitivity, eye pain, slight headache all on the left side of head, shot was in left arm.
PT ON 11/19/22 CAME TO THE PHARMACY TENT ASKING FOR A 2ND MODERNA SHOT. HE CAME AS A WALK-IN AND NOT AN APPOINTMENT. PT SAID HE LEFT HIS VACCINE CARD IN THE CAR BUT MENTIONED THAT A STICKER CAN BE GIVEN TO HIM AFTER RECEIVING THE SHOT AND HE CAN PUT IT ON HIS CARD AT HIS CONVENIENCE. HIS NAME WAS CALLED, VERIFIED NAME AND DOB. ASKED PATIENT HE'S HERE FOR A MODERNA BIVALENT BOOSTER SHOT CORRECT HE SAID "YES". THE DOSE WAS GIVEN ON HIS LEFT ARM. PATIENT WENT TO HIS VEHICLE TO PUT THE STICKER ON AND CAME BACK INSIDE AND SAW THAT MODERNA "BOOSTER" BIVALENT WAS GIVEN AND HE SAID "OH, I THOUGHT I WAS GETTING THE SECOND SHOT". WITH HIS INTERPRETATION, WHEN HE CAME AND SAID HE'S HERE FOR A 2ND MODERNA (WHICH WOULD BE THE PRIMARY SERIES DOSE). LOOKED AT HIS VACCINE CARD AND HE GOT HIS FIRST SHOT. A SECOND SHOT WAS GIVEN AT THE SAME TIME AS THE BIVALENT (ON THE OTHER ARM). PATIENT NEEDED THE SHOT FOR WORK PURPOSES.  GUIDELINES DEVIATION APPENDIX TABLE D: Bivalent Moderna vaccine: Repeat 1 monovalent dose immediately (no minimum interval) because administration of the booster dose will result in a lower-than-authorized dose. THIS RECOMMENDATION WAS FOLLOWED.
Complete facial paralysis of the left side of the face. Went to the Dr 10/4/2010 and diagonised by Dr as having Bells Palsy. Started on eye drops and prednisone 20 MG tabs.
Patient felt light headed.  Fainted for a little bit. Patient was ok after a little while.
Since the time of vaccination, my medications have not changed, my routines have not changed, but I suffer from chronic fatigue now.  I live by caffeine while I am at work, and as soon as I get home from work, I am ready for bed.  I have been going to bed around 6:00 pm and waking up around 6 am.  Still, I am fatigued.  If I sit down and close my eyes for just one minute, I fall asleep.  This is not my normal baseline.
Presented with ulcerative and vesicular lesions. Dx with varicella. Had Varivax vaccine on 12/23/1997 at previous pediatrician
Pt reports the redness started in the evening of 6/17/14. Was getting worst the next day 6/18/2014-increasing redness, pain, swelling,warmth from left elbow to left shoulder. Pt was seen 6/18 by Dr. and was started on antibiotics.
ACHES/PAINS; Blood work levels high; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ACHES/PAINS) and BLOOD TEST ABNORMAL (Blood work levels high) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 24-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 12-Jan-2022, the patient received third dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (ACHES/PAINS) and BLOOD TEST ABNORMAL (Blood work levels high). At the time of the report, PAIN (ACHES/PAINS) was resolving and BLOOD TEST ABNORMAL (Blood work levels high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product reported by reporter. On an unknown date in 2022, patient had the event of aches/pains. No treatment medication reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality with respect to Humira for event of aches/pains was reported as probable and for event of blood work levels high was not reported.  The reporter causality with respect to JANSSEN COVID-19 VACCINE for blood work levels was reported as possible and for event of aches/pains was not reported.
This spontaneous report was received from a medical assistant regarding 2 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L019836/expiration date - 24-MAR-2017, 0.5 ml. No adverse event was reported. Temperature of excursion was 25-7 C (Celsius) and time frame was 57 hours. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Developed a runny itchy nose around 4pm. Also experiencing face flushing on forehead, cheeks, nose and ears. General discomfort.
This spontaneous report was received from a physician via a company representative refers to a 6 year old female patient. No drug reaction or medical history was reported. On an unknown date in 2007, the patient was vaccinated with dose 1 of 0.5 ml of VARIVAX (Merck) (lot #, route not reported). On an unknown date in January 2011, the patient was vaccinated with dose 2 of VARIVAX (Merck) (lot #, route not reported), 0.5 ml. No concomitant medications were reported. ON 08-MAR-2013, the patient broke out with shingles. Shingles are on her right arm, C6 dermatome. Patient sought medical attention. Child was taken to her pediatrician and at first they thought she had mosquito bites, so hydrocortisone was given as treatment. On 11-MAR-2013, shingles was confirmed and child was put on acyclovir therapy. No laboratory tests were performed. The child was recovering from shingles but the rash was running its course. Additional information is not expected.
Patient has/had about 9 quarter size red spots on arm between elbow and shoulder. No itching, a little swelling at spots, was checking to see if she had a fever and said would call back. Never got a return call.
Body aches, headache, vomiting, diarrhea, low grade fever developed in 1st 24 hours and lasted 2 days.
Jaw little swollen; top lip swelling/ lower lip  really swollen; a pink mark on her arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site redness in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included botulinum toxin type a (Botox) solution for injection for prophylaxis.   On 27th July 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient started Botox at an unknown dose and frequency. On 28th July 2022, 1 days after receiving Shingrix, the patient experienced injection site redness. In August 2022, the patient experienced jaw swelling and lip swelling. The patient was treated with methylprednisolone sodium succinate (Solu-Medrol) and benadryl (nos) (Benadryl). The action taken with Botox was unknown. In August 2022, the outcome of the jaw swelling and lip swelling were recovered/resolved. On an unknown date, the outcome of the injection site redness was recovered/resolved.   It was unknown if the reporter considered the injection site redness, jaw swelling and lip swelling to be related to Shingrix.     Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comments: The caller was the reporter and the patient.  The patient stated that the following day after vaccination she had a pink mark on her arm at the injection site that had resolved. In August 2022, 1 week after receiving Shingrix and unknown after starting Botox, the patient experienced jaw swelling and swollen lips.  The patient also reported that one week after receiving the Shingrix shot, she woke up in the morning with her jaw little swollen but it got worse at noon time with her top lip swelling and reaching the bottom of her nose and her lower lip was getting really swollen.  The patient further described it as a Botox injection gone really bad.  The patient went to urgent care around 1:30 PM same day, she was given Solu-Medrol injection in the hip and Benadryl tablets after which the swelling went away.  The consented to follow up was granted. The patient gave permission for safety follow-up with her health care professional (HCP). Patient states her HCP is not aware of this incidence. Additional supportive information: It was unknown if the reporter considered the jaw swelling and swollen lips to be related to Botox.
A physician reported that a female in her 60's with a history of arthritis, received an injection of TD Toxoids Adsorbed, Purogenated. She was receiving therapy with Mevacor at the time of the immunization. One to two days later, she developed myalgia of the proximal muscles in her extremities. She also developed an injection site reaction characterized by redness and tenderness.
This spontaneous report as received from a 66 year old male consumer refers to himself with no drug reactions or allergies. The patient's concurrent condition included diabetes and sleep apnea. The patient's medical history included heart ablation. On 14-JUL-2012, the patient was vaccinated with dose 1, 0.65 ml ZOSTAVAX (lot# unspecified) subcutaneously. Other co-suspects included BYDUREON. Concomitant medications included ALTACE, JANUMET, SINGULAIR, warfarin, SPIRIVA, metoprolol, CRESTOR, pantoprazole, hydrocodone and LOVAZA. After getting the ZOSTAVAX vaccine, the patient mentioned his heart had been acting funny. He was perspiring more and his pulse rate was up. He did not think it was the vaccine because he had heart problems prior to getting the vaccine and this did not start until a couple weeks ago. He thought it was an experimental drug, BYDUREON (manufacturer unknown), he was currently on. The patient called to HCP and his cardiologist put him on a heart monitor for 48 hours and has not yet heard the results. The patient was going to his cardiologist to discuss it. Unspecified treatment for the adverse events was given. At the time of reporting, the patient had not recovered from all reported adverse events. Additional information has been requested.
pt recvd vax;exp heart palpitations,tremors,flushing,shallow breathing & broke out in hives;tx w/ dph for 11 days;periodic episode of heart palpitations;depression & panic attacks that last for several days;tx w/ xanax;
Right arm was sore to move and had armpit tenderness the first week. At the end of the first week I started to notice some redness along the injection site. The armpit began to swell about midweek after the vaccine as well. I began to use ice and ibuprofen to relieve the symptoms however yesterday (1-26-2021) I noticed that the redness was really starting to get worse and contacted my physician. Sent pics via patient chart and he suggested to keep doing what I was doing. This a.m. (1-27-2021) the redness was more apparent (quite warm to the touch too) and starting to broaden down my arm. Called Dr, had a visit. He recommended prednisone on top of icing and ibuprofen. Suggested I let CDC know as well.
This spontaneous report was received fro a mother of the patient refers to a newborn male patient of unknown age. No concurrent condition or medical history was reported. On 23-SEP-2015 and 28-SEP-2015, the patient was vaccinated with RECOMBIVAX HB. No concomitant therapy was reported. On an unknown date in November 2015, also reported as in last couple weeks, the patient experienced diarrhoea, and was unable to gain or loose weight. The physician stated that the patient was below the height and weight chart. No treatment was given for the events. The outcome of the event was reported as recovering. The causality assessment was not reported. No product quality issue was involved. Additional information is not expected as reporter did not wish further contact.
On 5/4/2017 called complaining of extreme neck pain. Went to ER and was admitted with acute encephalopathy and bacterial meningitis. Patient is currently in the hospital.
7 year old patient recieved KINRIX; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 06-Feb-2023 Reporter's comment: The package insert stated vaccine should be given prior to the patient's 7th birthday. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix in right arm at inappropriate age, which led to inappropriate age at vaccine administration.
Auditorium COVID Vaccine Clinic  Upon staff member receiving vaccination, collapsed after getting up from chair. Rapid Response were called. Staff member was positioned supine with legs elevated. Blood pressure 147/88 HR 92.Po2 at 100% on room air. Complained of feeling faint and dizzy. Assessed by Rapid Response RM and MD. Escorted via cart to mid hallway for further evaluation. Patient symptoms continued to be concerning, transported to ED with MD escort.   Staff member was evaluated in ED.  fluids given, Zofran for nausea and Benadryl.  CTOH was completed and resulted as no abnormalities.  Staff member was discharged to home in stable condition.
Mailaise:  went away after normal 24 hours Fever headache light headedness Extreme muscle/Body aches: still have 3 months later some days are worse than others syncope/near syncope: two times in December  Otherwise extremely healthy individual, now dr is trying to diagnose me with fibromyalgia after many dr visits/tests/meds (including complete cardio workup after syncope, Vicoden, Darvocet, Tramadol, Ibuprofen 800mg) meds only take the edge off the pain
pt recvd vax; t of 102 intermittent since  vax given; very irritable; intense crying 21oct94;
had PPV vaccine administered approx. 1:45 P.M. on 11/04/08.  At 4:30 P.M. on 11/04/08 felt arm burning, redness, red lines and horrible swelling-applied ice-couldn't move arm-wheezing and coughing. 11/05/08 emergency visit to family physician. 11/6/08 swelling has improvement but still red and hot.
Within 10 mins of vaccines:  Dizziness  Weakness / fatigue  chills next day Sat 2022-11-05:  initially took my temp 98.5F , while I?m usually low 97F.  Fever.  Severe kidney pains on both kidneys, despite drinking lots of water & resting lots; urinating as normal, so severe it almost called for an ambulance/emergency. I just pained through it barely. I could barely get out of bed.  My friend stated that it was an ?aggressive immune response?, my immune system attacking itself which is deadly, ?Cytokine storm? which is fatal / organ failure. This was very scary and I don't want to die over a vaccine. In the future, I don't think it's the best idea for me to get these types of vaccines.  For at least 2 months following, lots of swelling and muscles out of sorts.  I had a very difficult time passing bowel movements, but now I am back to normal.  Still to this day Mar-2023, my right underarm front area is slightly swollen, specifically from 2 COVID vaccines.  Since the 11-04-2022 vaccines here, I have spent money in follow up doctor bills to check if my organs / body will be okay from this terrible ordeal. Plus having to take time off work; and losing time that I can't gain back from being so sick.  In my case, the cost to my body outweighed the benefits to getting the vaccines. My body cannot tolerate the COVID vaccine.
STROKE; CLOT; This spontaneous report received from a consumer via media via a company representative concerned a male of unspecified age, race and ethnicity. 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, batch number and expiry were not reported) dose, start therapy date were not reported, administered 1 in total for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced clot and then stroke. Reported as "J&J makes the "clot shot "father got his vex then the clot then the stroke, explicative your poison". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clot and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221033422-covid-19 vaccine ad26.cov2.s-stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20221033422-covid-19 vaccine ad26.cov2.s-clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Patient received 2nd Pfizer vaccination on 11/13/21.  He developed chest pain that evening which prompted him to go the ED on 11/14/21.  ECG without ischemic changes, high sensitivity troponin >1000.  Echo on 11/14 showed normal biventricular function without wall motion abnormalities.   Diagnosed with myocarditis
acute hypoxic respiratory failure; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Characteristics and outcomes of adverse events after COVID-19 vaccination. J2021;2:e12565     The patient's past medical history included Atrial fibrillation and Chronic kidney disease. Concurrent medical conditions included Hypertension and Congestive heart failure.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure. It is unknown if an autopsy was performed. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) to be possibly related.    Concomitant medications were not reported Treatment medications were not reported  This fatal literature-study case concerns a 90-year-old, female patient with medical history of Atrial fibrillation, Chronic kidney disease, Hypertension and Congestive heart failure who experienced the unexpected fatal event of ACUTE RESPIRATORY FAILURE. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge is not applicable The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.   This case was linked to MOD-2021-371537, MOD-2021-371538, MOD-2021-371539, MOD-2021-371540, MOD-2021-371541, MOD-2021-371542, MOD-2021-371543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received 03-Nov-2021 included an Email with FTA received from the team and  contains significant information.; Sender's Comments: This fatal literature-study case concerns a 90-year-old, female patient with medical history of Atrial fibrillation, Chronic kidney disease, Hypertension and Congestive heart failure who experienced the unexpected fatal event of ACUTE RESPIRATORY FAILURE. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge is not applicable The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure
I got my moderna booster shot and had excessive swelling in my armpit for two days. I did not experience that same swelling on prior injections. I also had tooth pain on that side of my mouth that coincided with the armpit swelling. They both went away after the third day
Decedent has a history of COPD and has been progressively getting worse, decedent passed on 12/202/2021.