chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started with a headache. Then, I started getting drainage down my throat. I was coughing. That went on for about a week before I stared having chills. I felt feverish, but I did not have an actual fever. I was taking COLDSNAP, vitamin C, and zinc to keep it at bay. After about a week, it moved into my sinuses. My sinuses were dry and bleeding. I started wearing a mask. While I was away on a trip, I continued to cough. The last day of my trip, I got a bad ear infection. It was painful. I went to the doctor. She examined me and said I had a bacterial infection. She gave me an antibiotic to cover both. I started taking that Monday. I came to work on Tuesday. I felt sick so I stayed home Wednesday. I slept ten hours. I'm back at work today. I'm still taking antibiotics.
Pt.'s face and neck turned red following her vaccination. She reported feeling hot and having tingling in her back. The symptoms spontaneously resolved after 10 minutes.
I was feeling fine after my shot. 3 days later I was at home and I standing in bathroom and I was in ambulance after my fiancé found me on the ground. I have never had any history of seizures before.
Hospitalized with cerebral venous sinus thrombosis from  1/26/2021-1/29/2021. Presented with severe headache. Treatment included anticoagulation initially with heparin infusion, followed by oral anticoagulation with Eliquis. She required prescription medications for management of headache. Discharged home with ongoing headache.
Moderna Dose 1 2/12/21 (016M20A) Moderna Dose 2 3/12/21 (029A21A) COVID Positive 7/15/21  7/15/21: 72-year-old male with hypertension, CKD stage 3, hyperlipidemia and  type 2 diabetes mellitus presented with fever and nausea.  Patient history obtained through a translator with sometimes patient answering.  Patient reports he has been sick for the past couple days with dry cough, nausea and fever up to 102.  He is also complaining of muscle aches and joint pain, no shortness of breath, dizziness or lightheadedness.  He denies any chest pain or abdominal pain, no diarrhea.  Denied any urinary symptoms or sick contacts.  He received post COVID vaccinations, does not recall if he was vaccinated for influenza.  In the ED he had T-max of 101.5° with heart rate of 95 normal blood pressure.  Remarkable labs creatinine 3.56 it was 1.9 in 2018, sodium 126, WBC normal at 5.2, urinalysis negative for UTI, influenza a and B negative.  Chest x-ray on remarkable for acute abnormalities.  CT stone protocol reported no stones.  Blood cultures were obtained and patient received 2 g of IV ceftriaxone, COVID-19 pending at the time of admission.  7/30/21: 72-year-old man who presented with complaints of cough, fever, shortness of breath and myalgias. He was found to have acute kidney injury, admitted to the hospital and was subsequently found to be positive for COVID-19 infection. He continued to show worsening respiratory status with increasing oxygen requirements culminating in requirement for intubation mechanical ventilation. Hospital course was complicated by oliguric acute kidney injury which subsequently required renal replacement therapy. He was also noted with fluid volume overload and pulmonary edema for which she required diuresis. Following extubation on 07/24 he has continued to make sustained clinical improvement. Despite improvement in urine output, renal function and laboratories have continued to worsen in between dialysis sessions. He has been recommended for ongoing outpatient hemodialysis for which an outpatient chair has been obtained. He has been discharged today in stable medical condition.
pt recv vax 9SEP96 & 17SEP96 exp muscle pains in back which were untreated;sx persists as of 20SEP96;
U07.1 - COVID-19 virus infection U07.1 - Lab test positive for detection of COVID-19 virus
Patient experienced vasovagal syncope about 4 to 5 minutes after vaccine.  Patient was unresponsive for about 50 seconds and then came back for a minute then was unresponsive for 10 seconds and then came back for good.  the paramedics we called and patient was checked out.  they gave her the ok to leave.
PT came in to pharmacy this morning stating that she had received her 1st Shingrix last week (7/25/20). She did not have any reactions until 2 days after the vaccine was administered. She states a rash about the 1"x2" appeared ~1.5" below the injection. She denies having any fever.  She did confirm that there is itching where the rash is. The rash increased in size today (7/31/20) which is why she came in to notify us. The rash was about 2.5"x4" below the actual injection point (per pt).
Anxiety. Lasted approximately 1 week seemed to resolve than about a week later had another episode which lasted approximately 1 day. Took .5 mg ATIVAN 4 days into the reaction and took it for 3 days. It relieved the symptoms.
sore swollen arm with rash and redness, 4 inches, naseau, fever
chills; very tired; sore arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "unknown", described as "very tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that the events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
soreness in left arm; bruising left arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 497D9, expiry date 11th September 2021) for prophylaxis.   On 15th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th June 2019, 14 days after receiving Shingrix, the patient experienced injection site bruising. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and injection site bruising were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left arm. The patient experienced soreness in the left arm. On Saturday, less than month after vaccination, the patient developed bruising on the left arm . The outcome of injection site pain and injection site bruising were reported as not recovered/not resolved in the Argus however in source document, it was mentioned as recovering/resolving with sequel.
Lack of drug effect; Post Vaccination caught Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Post Vaccination caught Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B01A and 012A21) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced COVID-19 (Post Vaccination caught Covid-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Post Vaccination caught Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test: positive Positive.         No concomitant medication information was provided. No treatment product information was provided.   Patient tested positive for Covid-19 two weeks ago Monday.3OCT2021. Patient was not hospitalized.; Sender's Comments: This is a spontaneous case concerning a 68 -year-old  male patient with no relevant medical  history reported who experienced  The non serious and AESI event of COVID-19 approximately 6 month after the second dose of a proper vaccination schedule with spikevax. Additional event of drug ineffective was added. Rechallenge is not applicable for these events. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: oxicodone, trazidone, dextromethorphan hbr allergy, and chronic severe headaches (treated with botox injections, tylenol, and advil). The patient was previously treated with covid-19 vaccine ad26.cov2.s (Dose Number in Series 1) (suspension for injection, route of admin not reported, batch number: 1816022, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 12-JUL-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose Number in Series 1)  The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 02-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 47 years old.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2)  The patient additionally received non-company suspect drugs included: (Spikevax) Moderna bivalent booster (elasomeran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: AS7143C, expiry: UNKNOWN) dose was not reported, administered at right arm on 01-NOV-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). Concomitant medications included botox injections (botulinum toxin type A), Advil (ibuprofen), Tylenol (paracetamol) for chronic severe headaches, Cold Relief (acetylsalicylic acid/chlorphenamine maleate/phenylephrine bitartrate), (guaifenesin), and (pseudoephedrine hydrochloride). On unspecified date in 2022, the patient experienced suspected covid-19 infection (Dose number in series 3) and received non-company suspect drug Paxlovid for treatment of covid-19 (form of admin, route of admin were not reported, batch number: unknown expiry: UNKNOWN) dose was not reported, administered from 05-DEC-2022 to 10-DEC-2022.  On 15-DEC-2022, the patient was sick (Dose number in series 3). Although he felt pretty good at the end of the Paxlovid treatment, a few days later he became extremely sick again and that lasted for over a week. He spoke with the physician and was told that this could happen for the next few months. Very slowly he began feeling better, but 2 days ago it started getting worse again. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with paxlovid was drug discontinued. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N010108, expiration date: 20-MAR-2019, for prophylaxis (dose #, route and anatomical location of administration were unknown). The dose was stored from -14 Celsius degrees (C) to -10 C (-14.1 C) for 76 minutes, from -9 C to 8 C (-8.7 C) for 103 minutes, and from -14 C to -10 C (-11.2 C) for 11 hours. The temperature excursion was detected by a data logger. The sterile diluent (manufacturer unknown) used for reconstitution was properly stored. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1711USA011997: US-009507513-1712USA006541: US-009507513-1712USA006542: US-009507513-1712USA006543: US-009507513-1712USA006545.
PATIENT JUST REPORTS SORE ARM SINCE VACCINATION - HAD FOLLOWED UP WITH PCP WHO ADVISED TO USE AN ICE PACK.
FEVER STARTED ON 5-17-16 ALMOST IMMEDIATELY, THEN ON 5-18 HIS NOSE STARTED RUNNING, BY 5-19 HIS EYES WERE RED AND SWOLLEN, HIS NOSE WAS POURING AND HE HAD EXCESSIVE DROOL....BY 5-20, HIS EYES WERE ALMOST SWOLLEN SHUT AND VERY RED, HIS NOSE SEEMED SWOLLEN INSIDE AND WAS POURING AND HE WAS DROOLING SO BADLY IT WAS AS THOUGH HE WAS HAVING TROUBLE SWALLOWING....AT THIS POINT I GAVE HIM BENADRYL FOR THE ALLERGIC REACTION HE WAS HAVING. WITHIN AN HOUR HIS EYES WEREN'T RED AND RUNNING AND HIS NOSE STOPPED POURING.  HOWEVER...LATER IN THE EVENING HE THEN BROKE OUT IN TINY RED BUMPS FROM HEAD TO TOE...LIKE I HAD DOTTED HIM WITH A PEN (THIS IS THE SAME WAY HE REACTS WHEN HE EAT PEANUT PRODUCTS OR TAKES PENICILLIN) I HAD TO GIVE HIM BENADRYL AGAIN....BY THE NEXT MORNING HIS EYES/ NOSE AND DROOL WERE MUCH BETTER AND HE KEPT THE RASH FOR ANOTHER DAY.
At injection muscle spasmed, nurse stated never seen that before.  Within 1-2 hours had runny nose and felt stuffed up, thought it could be allergies or something and didn?t really attribute to vaccine.  4-5 hours  after injection felt something across the top of my brain ... felt as though something had been stuck in a blood vessel and became unstuck allowing blood to shoot through.  Was certainly freaked out by this, but was at an event and head of the ER department of the local hospital was also attending - so figured I had quicker access to medical care there if needed, than at home.   30-60 minutes later congestion completely cleared up.  9-12 hours after vaccination had extreme chills.  Day after vaccination had pain below the injection site... injection was 2? above pain.  Also neck pain. Day 2-8 since vaccination, on/off muscle pain or injection site pain. Today, day 9, have muscle pain in wrist of injection arm.
pt recvd vax & exp rash, hives, welts & angioedema; pt subsequently hosp due to angiodema; meds given; 30sep94 welts & rash persisted;
One day post vax, on 2/14/00 the pt experienced significant local swelling (twice as big), hot to the touch, redness, pain and tenderness at the injection site as well as fussiness and fever. The swelling was localized on the left thigh and persisted 1-2 days. Benadryl and Tylenol were administered and they relieved swelling after a "couple" of doses. He was treated by his mother with cold compresses with a resolution of symptoms in 24 hours. The most recent information received on 3/14/00 reports the outcome of the pt as resolved.
DTaP given right deltoid IM 12/20/2001. Mother noticed arm swollen and red 12/12/2001 and had him come in. Are on deltoid warm, red and swollen 3 by 4 inch tender with pressure. Tx: Ice, Tylenol and Benadryl.
Pt called Saturday 1/5 stating that he felt that he had an adverse reaction to the flu shot. He stated that he felt tired, lower blood pressure, difficulty standing/walking on his own (stated that he had to use his walker more frequently), and reported nodules/knots in his leg. When asked, he did NOT report fever, swelling, SOB, rashes, pain, or soreness.
Viral synd followed by extreme persistent irritability; mom describes character change, hair pulling persists to this time, screaming etc;
This spontaneous report was received from a 66-year-old male patient. Current conditions included high blood pressure (reported as manufacturer and dosage unspecified), high cholesterol and allergy to sulfur drug. On 02-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiration date not reported), subcutaneously. Other suspect therapies included PNEUMOVAX 23 (manufacturer unspecified) on the same date. Since 09-APR2013 (reported as since that time) the patient had been tired and had lack of energy. The patient stated that he was experiencing chest pressure and coughing on an unknown date in April 2013 (reported as now experiencing). The outcome of the reported events were unknown. No treatment was rendered for the events. It was unspecified whether laboratory diagnostic tests were performed. The patient sought medical attention by contacting the physician via telephone. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 19-JUN-2014 the patient was vaccinated with third dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J009788, expiry date: 17-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012657, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Daughter woke up on 10-17-09 with sore throat, congestion and very weak. She was unable to go to school for two days. It took four days before she was better.
bleeding under the skin; it was green on the top part like a bruise and the darker part of blood is down by the elbow; leaking capillary; Bruising; lump that is movable in front of the deltoid.; This case was reported by a pharmacist via call center representative and described the occurrence of hemorrhage subcutaneous in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   Previously administered products included Shingrix. Concomitant products included warfarin sodium (Coumadin).   On 13th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, 7 days after receiving Shingrix, the patient experienced hemorrhage subcutaneous (serious criteria GSK medically significant), injection site discoloration, capillary hemorrhage, contusion and skin mass. On an unknown date, the outcome of the hemorrhage subcutaneous and capillary hemorrhage were not recovered/not resolved and the outcome of the injection site discoloration, contusion and skin mass were unknown.   It was unknown if the reporter considered the hemorrhage subcutaneous, injection site discoloration, capillary hemorrhage, contusion and skin mass to be related to Shingrix.  Additional information was provided as follows: The case US2019172828 was found to be duplicate of case US2019172814 . Hence case US2019172828 would be deleted and all the information of this case will be added in case US2019172814 which is the case of record for this patient. The patient received Shingrix on left deltoid. The pharmacist reported that that she might have hit or nicked a capillary while administering Shingrix to a patient taking warfarin. It was leaked/bleed under the skin for some time and now it was down past the elbow. There was no blood at the injection site. It looks like it stopped. It was green on the top part like a bruise and the darker part of blood was down by the elbow. It started the following week after receiving Shingrix. He also reported a lump that is movable in front of the deltoid. The pharmacist was not sure if this was due to the Shingrix injection given its location. The reporter consented to follow up.
Onset redness at sight of SQ varicella inj (warm to touch) - 12/28/07.  Cont.  redness increasing in size with swelling approx size 11.5 cm x 14.5 cm.  Seen by Dr. on 12/31/07.  Placed on Keflex 500 tid.  1/1/08 symptoms resolving per patient mom.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On 14-AUG-2015, ROTATEQ lot# L008034; expiration date 05-AUG-2016 was improperly exposed to 70 degrees Fahrenheit for 2 minutes and to 28 degrees Fahrenheit for 10 minutes. Then on unspecified date in August 2015, a patient received orally the improperly stored dose of ROTATEQ, dose was not specified. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
My whole body got tingly and then I was freezing and had a fever of 105 my head hurt so bad it made me nauseous I was weak I couldn't even keep my balance to walk I couldn't sleep I woke up every 15 minutes because I was so uncomfortable
w/in 15min of vax pt c/o soreness, redness & swelling noted;mom stated pt has hx of allergy to PCN & cinnamon;pt had similar response to DT-was told was allergic;pt to ER given DPH;4x4 area over deltoid red & hot;dx cellulitis;
Muscle aches for 24 hours, chills on and off during that 24 hour period, fever and severe nausea overnight. Ended up taking ibuprofen to help ease muscle aches. Helped briefly. At the 24-hour mark (from when symptoms started), there was a sudden relief of all symptoms.
headache with in 30 mins, 3 days later GI upset diarrhea, SOB LAsting  3days. now 17 day later petechiae on abdomen abd burning pain (lymph nodes) in right underarm.
4 days later after vaccination,  nausea, vomiting, fatigue, chills, 101 temp, headache Took Tylenol, rested, and hydrated with water and electrolyte drinks Took 3 days to feel better