chrisvoncsefalvay/vaers-outcomes huggingface dataset:
01/20/2022-I had an appointment with my dermatologist for an annual follow up. The found a small mole, it was a different color, the size of a pin point, it was really small on my left arm. The did a biopsy on it and found it was  very early melanoma.  Next Tuesday, 01/08/2022,  they are going to widen the margins and sew it shut and they are going to have me come in every 6 months for observation.
Patient reports that at 7 pm on the evening of receiving vaccine she had fever, chills, body aches, wheezing.  At 1:30 am on 11/08/2012 awoke with hives on chest, arm pain and swelling at site of injection. On awakening later in the day had no symptoms. Denies any problems at this time.  Did not see physician or take any meds.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 (Lot number, expiration date, route and dose were not provided). Concomitant medication were not reported. The physician stated that, within 6 months of the first dose, the patient was administered a second dose of PNEUMOVAX 23 (Lot number, expiration date, route and dose were not provided). Then, after second dose, the patient experienced swelling at the injection site. The outcome of injection site swelling was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX 23 to injection site swelling. Additional information is not expected because the physician had no further information to provide.
High Blood pressure, COVID arm, swelling/itching at injection site, facial redness and swelling
About 29 hours after receiving my shot I had a migraine. I had a headache on and off throughout the day. Took ibuprofen which helped it out.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates or on 01-AUG-2016, some patients among these multiple unspecified patients were vaccinated with improperly stored ROTATEQ (lot # M019690, expiration date 02-NOV-2017, oral, dose not reported). On 21-JUN-2016 or 14-JUL-2016 or 03-AUG-2016 or 09-AUG-2016, another some unspecified patients were vaccinated with the same improperly stored vaccine (lot # L033543, expiration date 30-MAY-2017, oral, dose not reported). On 14-JUL-2016, another some unspecified patients were vaccinated with the same improperly stored vaccine (lot # K022995, expiration date 22-JUL-2016, oral, dose not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the reporter.
Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VALTREX, start date: Feb2019, stop date: 16Dec2022. Past drug history included: Ciproflaxin, reaction(s): "known allergies: Ciproflaxin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medications in 2 weeks. Patient treated with Paxlovid for Covid-19 from 14Dec2022 to 16Dec2022. Further stated that Feeling like she was in a slightly altered state - like she had taken a small amount of illicit drugs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received TDAP, HEP A, MENACTRA  1-20-09. Mom called this am 1-22-09 states he is out on town on basketball trip and called c/o stiff neck, started vomiting last night 1-21-09 and was running temp of 102 this am - instructed mom to have RN with basketball team to take him to ER - Mom states has already told them to take him to ER- will call back and report outcome to us.
joint aches; muscle aches; aches primarily in areas below the waist, in the hips, knees and lower legs.; This case was reported by a nurse via call center representative and described the occurrence of joint pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th May 2019, 2 days after receiving Shingrix, the patient experienced joint pain, muscle pain and leg pain. On an unknown date, the outcome of the joint pain, muscle pain and leg pain were recovering/resolving.   It was unknown if the reporter considered the joint pain, muscle pain and leg pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient experienced pain in areas below the waist, in the hips, knees and lower legs. The patient contineusly experienced the issues and for that seeing the nurse practitioner. Emergecy room visit was required.
Fever, achy joints. Onset around 11:30 pm (approx 9 hours after vaccination). Symptoms worsened around 10:30 am the following day. OTC flu relief was used, followed by OTC pain relievers a few hours later. All symptoms showed signs of lessening by 5:00 pm.
When asked how she was doing she reported that her "heart rate was fast".  Asked if she wanted to lie down, she said "yes" and was walked to the designated cot.  Her blood pressure was 124/90.  She also reported not eating all morning.  She laid down for about 45 minutes and was provided a bottle of water; a snack (crackers) was offered but she refused.  She left for home feeling better.
INFANT WAS A LITTLE JERKY AND SOME FEVER WITHIN 24 HOURS THEN WITHIN 48 HOURS OF RECEIVING HER 4 MONTHS VACCINES SHE HAD PERSISTENT, INCONSOLABLE CRYING. PARENTS TOOK INFANT TO ED AND THEY DID NOT FIND ANY REASON FOR THE CRYING.
felt lethargic; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic), PYREXIA (fever) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy to antibiotic (Antibiotic which the patient cannot recall) and Allergy (Allergy to Voltaren gel). Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced LETHARGY (felt lethargic), PYREXIA (fever) and CHILLS (chills). At the time of the report, LETHARGY (felt lethargic), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided. Action taken with respect to mRNA-1273 was not applicable. Additional information was provided that patient had not took OTC medication for cough drop.
Death  5/29/2021 Causes of death listed on death certificate: 1. pneumonia  2. COVID 19  3. coronary artery disease, hypertensin, Non insulin dependant diabetes
Patient admitted as observation on 11/5 due to pneumonia due to COVID-19 virus. Patient was tested for COVID-19 and was positive on 11/5.  Upgraded from Observation to Inpatient because he has a current diagnosis of COVID-19 pneumonia, which has not improved enough to allow for a medically safe discharge despite receiving appropriate treatment.  58-year-old male with known multiple sclerosis on ocrelizumab, OSA on CPAP presenting with increasing dyspnea on exertion and falls.  COVID positive 10/22/2021.  On admission no signs of secondary bacterial pneumonia or VTE.  Started on dexamethasone and remdesivir on admission.
dose was given after expiration date; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (dose was given after expiration date) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (dose was given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vaccine was placed in refrigerator on 17-Nov-2021. There was no temperature excursion. No adverse event was reported. No treatment information was provided.
Weakness; Deep muscle chills; Fever; Muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (Deep muscle chills), PYREXIA (Fever), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 026A21A) for COVID-19 vaccination.     No Medical History Reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (Fatigue). On 05-May-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Deep muscle chills), PYREXIA (Fever) and MYALGIA (Muscle aches). At the time of the report, ASTHENIA (Weakness), CHILLS (Deep muscle chills), PYREXIA (Fever), MYALGIA (Muscle aches) and FATIGUE (Fatigue) was resolving.            No relevant concomitant medications were reported. No treatment information was reported.
Red rash on upper arm above and wrapping around shoulder on arm of injection site. Rash was raised and slightly itchy. Rash was there for only a couple of days after it appeared which was about 2 days after vaccine.
Lymph nodes swollen I?m arm breast neck , fever, 101.2 , headache, body aches , pain in heart area , nausea , diriah
Red, warm, swollen R deltoid, measuring 2" in diameter. Temp of 99 deg with Tylenol. Swelling in axilla. AH symptoms began 10/22/03j am and ended by 10/24/03 am.
I helped facilitate scheduling for his COVID vaccine and received notification from his wife that he passed away unexpectedly this morning. She reported he had  been experiencing a rheumatoid arthritis flare and was on steroids.  His diabetes was not well controlled as a result.   He did not have any reactions in the days immediately after the vaccine.
Approximately 13 minutes after pt received her first dose, she got my attention as I was walking by and notified me she felt like her tongue was swelling, she had a bad taste in her mouth, and it was getting hard to swallow. She was very calm, and her breathing was normal. Rapid Response initiated. The doctor assessed the pt, they gave her oral Benadryl, and the pt was able to walk out about an hour later after additional monitoring by the UC nurse.
Severe swelling, redness, heat at vaccination site approx 8-12 hrs after receiving shot. Seen at outside urgent care, treated with clindamycin and diphenhydramine -> worse overnight, referred to med ctr, rx IV abs and diphenhydramine.
Tingling in face, swelling of face and tongue. Tongue was sore. Went to Dr and got shots and take antihistamine. Recovered patient states no, face feels semi numb.
3/9 (Tues): Sore arm, red 3/10 (Wed): Sore arm, increased redness; Wed p.m. - chills, nausea 3/11 (Thurs): increased redness, chills in evening 3/12 (Fri): increased redness with area (12cm x 8cm). Treated with cephalexin, cellulitis Will recheck 3/15; allergy eval prior to next dose
17 year old patient was given 1 dose of Moderna COVID19 vaccine. No signs or symptoms during 15 minute post vaccination period. Called father of patient and left message for him to call back.
Patient received Pfizer Dose #1- 1/19/2021 Dose #2- 2/3/2021 and received Dose #3 on 7/31/2021 of Pfizer. VAERS completed for dose #3 administration.
My reaction started 17 hours after my injection (except for the sore arm, it started 3 hours after).  The side effects started with the following and lasted the following:  12/27/20 @ 2pm my body started aching like I had the flu.  Lasted until 12/28/20 until 8am, except the back pain lasted until 6:30 pm. This side effect did make me very tired and irritable.   12/27/20 @ 3:30pm my joints started hurting to the point I felt like I could not stand long (ankles hurt terribly bad as they did the day I came down with actual covid). Lasted until 12/28/20 until 11am.  12/27/20 @ 4:15pm I started running a fever of 100.4 and it lasted until 12/28/20 @ 3am. I did have chills but feels like it was due to the fever and went away when the fever did.  12/28/20 @ 8am I had a bad headache that lasted pretty much all day.  12/29/20 I woke up with no side effects like it never happened.
Pt developed fever, rash, running nose, and cough the night after receiving the 4 month series vaccine.
Woke up at 12:30 am with severe chills and shaking. Headache, muscle aches, sweating and sore arm
Client was in observation for 30 minutes after vaccination. At 29 minutes client had near syncope event with shortness of breath. On-site EMS evaluated and called for transport and client was transferred to nearest emergency room.
Red round rash at administration site, itchiness to site, get itchiness all over body but only rash at administration site.
Bruising on left hand that looks like a blistered splotch appeared about 5-6 days after vaccination and then another similar but smaller spot on lip about a week after the first bruise was noticed followed 2 days later by 2 more eraser sized bruises again in the spot of the 1st bruise on hand. Saw my primary care today because I've never had any issues with bruising and these bruises aren't like any other bruise I have ever had.  She has ordered blood work fasting for tomorrow but asked me if I had reported the reaction. So I am reporting this experience. Also having dizziness when lying flat and then rolling side to side or standing.
was given and vaccine was 1 day expired; This case was reported by a consumer via interactive digital media and described the occurrence of expired vaccine used in a patient 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 expired vaccine used. On an unknown date, 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: 01-Aug-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The reporter reported that if a Bexsero was given and the vaccine was 1 day expired dose. The reporter asked that the dose need to be repeated. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired dose used. The follow-up could not be possible as no contact details were available.
fever to 101 w/genl tonic/clonic sz, no treatment, labs nl;
Patient reported on 7/22/21 the following incident: On 7/17/21, the day after receiving the second Pfizer vaccine, the patient fainted and hit his head to the floor. He was taken to the ER. Doctor performed MRI to make sure if there was any internal injury, which did not show internal injuries at the time. Patient was advised to see his family doctor and then discharged after a few hours. Patient saw his family doctor on 7-22-21, which referred him to cardiologists and neurologist. Patient is currently waiting for appointments from the specialists. Patient seemed to be feeling well at the time of talking to the pharmacist and did not have any health complain at the time.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. At the time of his death, patient had long existing comorbidities including, CKD stage 4, anemia of chronic renal failure, advanced age, leukemia, DVT, HLD, emphysema, HTN, obesity, thrombocytopenia. Patient was 88 and died on 2/6/21. No documentation detailing the circumstances of his passing or his cause of death.
Pt reports within 24 hours developed red raised area at site of injection, very itchy - 7x5cm. No other problems.
After receiving HPV vaccine child passed out in the exam room, then recovered within seconds. Examined by physician.
Increased weakness, shortness of breath, falls, dyspnea and orthopnea, acute kidney injury, bilateral lower extremity swelling, nausea, abdomen pain. Treated at ER 3/10/2021 - discharged home so patient could recieve dose 2 on 3/11/2021. Admitted 3/20/2021 for worsening of all symptoms and Cardiac cathe performed. Discharged to rehab facility 3/30/2021
Caller reports multiple doses of VAXELIS administered since temperature excursion; This non-serious spontaneous report was received by partner (reference number 02197725) on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.  The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Patient came back to pharmacy with a small bruise and redness on arm. she said the redness and swelling was goung down on her arm. She feels okay but wanted to come back. she will take benadryl and use an ice pack. If not better, she will go see a doctor.
Got the vaccine at 10:30am on 4/5/21 and felt ok all day. About 10:30pm when trying to go to bed I started having severe body aches, extremely high fever, all over and uncontrollable body shaking (thought I was having a seizure), racing heart, severe headache, very sensitive and sore injection site.  This lasted through the night, for a good 6 hours.  As of 10:30am on 4/6/21 I still have a very bad headache and mild to moderate body aches and an extremely sore injection site.
pt recv vax; lt arm reddened, swollen, firm; non tender; ice to arm & apap given;
Generalize fine rash, c/o burning sensation all over, c/o itching severe all over, sent home from work.
Developed oral herpes simplex starting just hours later. Don't remember if I had any more outbreaks March - October but don't think so. Got the booster on Oct. 28, 2021, and have had THREE outbreaks since.  I had not had an outbreak in years & think the Moderna vaccine triggered the virus
Heart rate increased (sitting heart rate jumped to at least 110), breathing felt slightly more labored. Visited emergency room and underwent tests, no specific treatment given. Outcome is heart rate slightly lower, but still appears to be higher than previously observed.
Tinnitus. A high pitched ringing sound in my head. I have been to many doctors, taken steroids and supplements and have had no improvement since the onset.
Chest Pain started within 24 hours intesity of 4/10 with increases to 8/10 and lasted for 6 days. Had normal Troponin, crp and ECK on 6/16/2021
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient experienced swelling of tongue sensation but no difficulty breathing or hives. Gave 50mg of Benadryl
Pt came in to the pharmacy requesting the new bivalent pfizer covid booster dose but patient was inadvertently given the pfizer covid monovalent vaccine.
Pt developed mild maculopapular and vesicular rash on about 10% of her body with less than 50 lesion, subsequent to receiving the varicella virus vaccine live.
With in 5 minutes of receiveing the vaccine, the patient developed shock-like symptoms. Patient presented with pale, cold, clammy skin. Then her vision became blurry and her arms shook when she moved them.  After 15 minutes she began to feel better and the symptoms completely resolved after 30 minutes.
At the time of the vaccination, he was surrounded by several people taking photos at a vaccine training and media event. He was apprehensive, as he typically is before a vaccination, but the group added to the emotional component of the event. After the vaccination, within 1 minute, the patient became pale, diaphoretic and lightheaded. He did not lose consciousness. We sat him back in a reclining chair, got cold towels, provided juice and talked him through the situation. He recovered in approximately 10 minutes without problem. No medications were administered.
Dizzy, achy muscles, upset stomach, headache, fever of 102 at 4:00 PM, chills at 7:00 PM.  Advil 600 mg helped a bit.
Child has red, swollen and warm area on left buttock where DTaP was given IM on 12/15/04. Advice to apply cold pack. Give Advil and Benadryl to recheck here with nurse on 12/20. To call doctor if worse.