chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm itched; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (arm itched) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Lyme disease, Food allergy (carries an Epipen) and Seasonal allergy. Concomitant products included EPINEPHRINE (EPIPEN), ONDANSETRON (ZOFRAN [ONDANSETRON]), PARACETAMOL (TYLENOL), ALBUTEROL [SALBUTAMOL] and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.   On 24-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) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (arm itched). On 25-Feb-2021, PRURITUS (arm itched) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-058859 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058859:
Generalized tonic-clonic febrile seizure lasting 3-5 minutes.
Patient is a 64 y.o. male patient of MD with history of  Hodgkin's lymphoma on chemotherapy via right chest Mediport( follows with Dr.) with last chemotherapy two weeks back, coronary artery disease status post CABG, hypertension, dyslipidemia, obstructive sleep apnea on CPAP and obesity who presents to Hospital with fever.   Neutropenic fever, resolved Bicytopenia Patient with known hx of Hodgkin's lymphoma s/p recent chemotherapy two weeks back Presented with fever and chills ANC 460, Hgb 12-13 CT Chest and urinalysis negative Suspect source of fever is due to COVID Blood Cx x 2 with NGTD MRSA Probe negative Received neupogen x 1 ANC improved to 3000 ID followed Cultures remain negative at 48h, will stop empiric IV antibiotics now that neutropenia resolved   Covid-19 Virus Infection Date of onset of symptoms: 9/14/23 Symptoms present on admission: fever, chills, cough, adbominal pain and shortness of breath Date of covid positive test: 9/21/2023 Vaccination status: unvaccinated Imaging: CT chest with no pneumonia Oxygen requirements on admission: 2L Current oxygen requirements: RA Medical therapy: Received remdesivir while hospitalized Consultants following: ID Anticipated special isolation end date: 9/24/2023 Continue supportive care for COVID Non-Hodgkins Lymphoma Follows with Dr., currently on chemo with ABVD therapy   CAD s/p CABG Continue home statin and BB   Dyslipidemia On stain, continue   BPH On flomax, continue   OSA on CPAP Resume nightly   Obesity Body mass index is 32.96 kg/m².
After the flu shot was given, the patient fainted twice, hit his head on the pharmacy bench, and looked like he was trying to have a seizure. The paramedics were called to the pharmacy to evaluate the patient. The paramedics gave the parents the option to take him to the hospital, follow up with urgent care or the pediatrician in the morning. The parents didn't have the paramedics take him to the hospital.
Since the 1st shot all my joints are. Swollen and soar. I am depressed and about 5 days after the injection the injection site turned red and hot and swelled up.
ZOSTAVAX given 8/1/2012 at 3 pm as per protocol. (L) posterolateral SQ. 8/2/2012 pm c/o itching, hardness at SQ site, painful to touch client denies rash, denied headache, denied fever site 9 cm x 6 cm red raised, warm to touch area.
Vaccine given too early, was due to be administered on or after 12/14/2023 but administered in error today 8/01/2023
has a rash, it is itchy; kind of like the shingles/thinks it may have caused her to have shingles; has a rash, has bumps or pustules; has a rash, has bumps or pustules; it made her sick; This is a spontaneous report from a contactable nurse (patient herself).  A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 02Mar2021 10:30 (at age of 73-year-old) (Lot Number: EL9262) at single dose for COVID-19 immunisation. Medical history (including any illness at time of vaccination) and family medical History was reported as none. There were no concomitant medications or prior vaccinations (within 4 weeks). The patient stated she got the shot on 02Mar2021 and had a rash at time of the report. Added she was going to get scheduled for the next dose but is asking if she should get it with this rash. Clarified she received the first dose of the Pfizer COVID 19 vaccine 02Mar2021 at 10: 30AM in the left arm. She didn't get the rash right away. All of the sudden a week after the shot she woke up in the night Monday (08Mar2021) with a rash; kind of like the shingles; it was itchy and had bumps or pustules. The rash was  located on her upper body; shoulders and arms. Added she could scratch her boot to hell. Stated she was an old nurse and she did a lot of things to try to stop the itching. Added it was so itchy. She treated her rash with Vicks vapor rub; Bag Balm; Greycaine powder to dry it up; and finally put diphenhydramine hydrochloride (BENADRYL) on it. She took aspirin; vitamin C; B12 and zinc. Added but this shot didn't work, it made her sick. Added she thought it may have caused her to have shingles and she had never had shingles before. She had not had the shingles vaccination. Added she was supposed to get the next dose of the Pfizer COVID 19 vaccine in three weeks. The events did not result in emergency room visit or physician office visit. Therapeutic measures were taken as a result of 'has a rash, it is itchy, has bumps or pustules'. The outcome of events was not resolved.
Woke up next day (12/30) with a hot red mark and bruising around injection site and soreness and pain. Later noticed lots of swelling in deltoid. Took the temperature of red spot that afternoon and it was 100.2 F. On 1/5 in the morning it appeared to be going away, but that night came back. 1/6 morning had soreness and now looks kind of like a bullseye
only the diluent portion of the Shingrix vaccine; only the diluent portion of the Shingrix vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9lt3g, expiry date 25th October 2022) for prophylaxis.   On 29th June 2021, the patient received Shingrix. On 29th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had administered only the diluent portion of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further events were reported. The reporter consented follow up.
This case is 1 of a cluster of 5 (previously reported as 6 unidentified) identified patients who experienced similar adverse events following vaccination with ADACEL. The events for the first patient was captured in case 2010-04334, second patient in 2010-04836, third patient in 2010-04837 and fifth patient in 2010-04839. Initial report received from a health care professional on 07 September 2010. A 45-year-old female patient received on 04 August 2010 an injection (route and site not reported) of ADACEL, lot number sanofi pasteur Ltd. C3314 and lot number sanofi pasteur Inc. U3082AA. The patient developed flu symptoms and arm pain. The outcome was reported as recovered. Documents held by sender: None.
Patient got a vaccine for Pneumovax23 and Fluzone HD in Left arm on  9/24/2020. Patient presented to pharmacy on 9/26/2020 with redness and localized swelling extending from her shoulder to her elbow. Referred patient to medical care to rule out cellulits and to be treated for possible allergic reaction.
Had a red rash/spot come on left arm at injection site nine (9) days after injection date.  It started about 2-1/2 inches x 3-1/2 inches and has grown to about 3 inches x 4 inches (maybe little more).  It has a darker red rim around it and has become lighter in the center .  It is a little bumpy where it grows and gets more red.  It might itch a little--not much.  I have been putting hydrocortisone cream on it.  My concern is that it is getting larger.
Redness and induration at injection site. Same day - mild, by  48h s/p immunization 3-4cm and redness approximately 10cm (+) warm, (-) lump. Patient o/w.
'pseudomonas infection; first dose of the Shingrix vaccine on 08/06/2019. She has not received the second dose; fever; Condition aggrevated; bronchiectasis flare up; pneumonia; This case was reported by a consumer via call center representative and described the occurrence of bronchiectasis in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included bronchioectasis.   On 8th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In January 2020, between 6 and 8 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant) and fever. In February 2020, the patient experienced bronchiectasis (serious criteria GSK medically significant) and condition aggravated. On an unknown date, the patient experienced pseudomonas infection (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the bronchiectasis, pneumonia and condition aggravated were recovered/resolved and the outcome of the pseudomonas infection was not recovered/not resolved and the outcome of the fever and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the bronchiectasis, pneumonia, pseudomonas infection, condition aggravated and fever to be related to Shingrix.  Additional details were provide as follows: This case was reported by patient herself. The patient had a pre-existing diagnosis of bronchiectasis. In early January 2020, the patient had diagnosis of pneumonia for two weeks and in February 2020 for 6 weeks she had a flare-up of bronchiectasis. In January and February of 2020, the patient had fever. The patient was still undergoing treatment of the pseudomonas infection and the patient stated as other infection, which patient did not want to disclose. Customer states had fever in January and February of 2020. Till the time of reporting, the did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow.
Pt recvd vax & w/in minutes following vax pt devel feelings of faintness, nausea, diaphoresis, & tachycardia; approx 45 mins later the sx resolved;
Two hours after didn't feel good, felt extremely tired. Had chest pain, breathing problems. Nurse line recommended to call ambulance. Ambulance took vital and were OK after severe diarrhea began, hiccups, horrible gas. At 7 P.M. vomiting attacks started, gagging. Problems continued until Monday 7th by 10/9 and 10/10 felt better. Completely recovered by Saturday !!
Patient received Immunizations Hep A and Influenza QUADRIVALENT 3/03/2015 and developed erythema 3-19-2015.
Sore, itchy, red  at injection site on upper left arm; swollen, firm (like a bump) under skin; resembled hive.     10 days after vaccine; Applied topical Benadryl ointment for itching.
Index had rash on her genital region which started on 12/05 and lasted for 8 days. Treatment: MD prescribed Nystatin cream, gave to index mother.
Systemic: Fainting / Unresponsive-Moderate, Additional Details: Skyler fainted after leaving immunization area and walking approximately 15 steps.  After falling down, she was alert, color pale, she rebounded over the next 10 minutes bp normal.  Called ambulance to be safe.  Patient went home after 45 minutes with no issue.
I started feeling very weak, tired and exausted, with any physical exertion I became weaker, got more exausted and I got very dizzy and tired.
headache; Fever; Fatigue; cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), HEADACHE (headache), FATIGUE (Fatigue) and PYREXIA (Fever) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced COUGH (cough). On 18-Jan-2021, the patient experienced FATIGUE (Fatigue). On 20-Jan-2021, the patient experienced HEADACHE (headache) and PYREXIA (Fever). At the time of the report, COUGH (cough), HEADACHE (headache), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
passed out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: 4 negative covid antigen tests; (unspecified date) Negative, notes: 4 negative covid antigen tests; (unspecified date) Negative, notes: 4 negative covid antigen tests; (unspecified date) Negative, notes: 4 negative covid antigen tests; (22Aug2022) Positive, notes: tested positive again; (Aug2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient stated that she was having tingling in her arms, chest was tight and legs were feeling heavy. The feeling started with her arms and then went to legs but didnt notice this until  she pulled her phone out and that she was having tightness in her chest. We took the patients vitals at  11:24 am heart rate 92, Blood pressure 132/80, o2 100, and then again at 11:30 am heart rate 69, Blood pressure 112/73, o2 99. I asked the patient how she was doing. Patient stated that legs still feel heavy and that the chest tightness is better. After the second blood pressure the patient stated that her chest tightness was completely gone. Patient also stated that her arms and legs were better. I released the patient home with mom and dad. She was released at 11:40 am.
Brain zaps like I feel when I miss my SSRI (duloxetine) a couple days. Then, fatigue, headache, achy.
GI issues after about 12 hours. Sent me running to the bathroom with diarrhea. Also had terrible cramps. This lasted for about 3 days.
Day after vaccination patient developed red, swollen, painful rash, body aches. Treating with clindamycin 300 mg TID for 10 days and BENADRYL 25 mg as needed.
Patient said within a couple hours his arm was quite sore.  He also reported loose stool, chills, and his lower back pain seemed to come back as though the nerve was aggravated.
Bruise, raised bruise at injection site Nausea  Low grade fever Chills/sweats Soreness at injection site Headache Sore throat Runny nose
Information has been received from a physician concerning a 15 month old female patient who was vaccinated with a dose of MMR (lot # not available). Eight days later, the patient experienced a febrile seizure. She was seen in the emergency room and released. No hospitalization was required. No treatment was required. Subsequently, the patient recovered from febrile seizure. Upon internal review, febrile seizure was determined to be an other important medical event. Additional information has been requested.
Child became pale, and limp in the chair following injection. He regained consciousness within a few seconds and then was sweating. Child was able to verbally respond and stated he felt light headed. He remained seated for 20 minutes following episode and was provided cold water to drink. He was able to leave on his own with mom following the event with no treatment needed.
64 yo female with vasovagal syncope ~5 minutes after receiving Janssen Covid-19 vaccine.  Patient was sitting on a bench with a friend after receiving the vaccine when noted to slump over suddenly and briefly lose consciousness. The patient?s friend helped ease her to the ground and called for help. Patient immediately regained consciousness and was helped to a supine position onto the bench by another PA and a medical assistant. I assessed the patient and noted that she was alert and oriented with SBP 120 (supine), regular pulse, respirations were non labored and O2 sat was 98%. She had a small superficial abrasion to her left forehead that was treated with antibiotic ointment by the medical assistant.  Patient admitted to a prior h/o syncope immediately after receiving a cortisone injection and a h/o anxiety with needles. She reported that she was not diabetic and had eaten a regular meal earlier that day.  She was monitored for an additional 30 minutes and then reassessed with BP of 135/84 (sitting), pulse 70, and O2 sat 99%. Patient was allowed to leave in the care of her friend after reporting that she felt fine and was ambulating without c/o lightheadedness, headache, or N/V.
Scratchy throat; flu like symptoms; Extreme fatigue; Felt badly; This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2021, the patient received the 1st dose of Shingrix. In September 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fatigue, feeling unwell and throat irritation. On an unknown date, the outcome of the influenza-like symptoms, fatigue and feeling unwell were recovered/resolved and the outcome of the throat irritation was unknown.   It was unknown if the reporter considered the influenza-like symptoms, fatigue, feeling unwell and throat irritation to be related to Shingrix.  Additional details were reported as follows: This case was reported by the physician for herself. The age at vaccination was not reported. The physician reported that she herself had received the first dose of the Shingrix vaccine on Friday night. On 18th September 2021, Saturday morning, woke up with flu like symptoms, extreme fatigue and felt badly for about six days. The patient stated that she did not check herself for other illnesses but less than a week after vaccination had a scratchy throat and felt badly. The reporter did not agree to follow up. This case had been linked with US2021AMR085370, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR085370:same reporter
Partial paralysis on the right side of face. Neck pain. Sensitivity to sound. Right eye watery and trouble blinking/closing eye
17-year-old patient was inadvertently administered Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was inadvertently administered Moderna Covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was inadvertently administered Moderna Covid-19 vaccine). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was inadvertently administered Moderna Covid-19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067198, US-MODERNATX, INC.-MOD-2021-067250, US-MODERNATX, INC.-MOD-2021-067645, US-MODERNATX, INC.-MOD-2021-067217, US-MODERNATX, INC.-MOD-2021-067547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067198:Cross link, same reporter US-MODERNATX, INC.-MOD-2021-067250:Cross link, same reporter US-MODERNATX, INC.-MOD-2021-067645:Cross link, same reporter US-MODERNATX, INC.-MOD-2021-067217:Cross link, same reporter US-MODERNATX, INC.-MOD-2021-067547:Cross link, same reporter
Pt noticed some itching at the site of injections the morning after the day of the shot. Apprx. 15 hours post injection. Pt's wife noticed a large red area extending from injection site down under elbow region. Pt observed48 hours later. Rxn started to fade.
Patient started with a rash C/W Erythema Nodosum that began just a few days after his flu vaccine; there were no other inciting illnesses. So far rash has been present for over 2 weeks.