chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 YO AA F PRESENTED WITH A C/O AN ERYTHEMATOUS RASH ON HER LEFT NECK REGION (POSTERIOR TO HER LEFT EAR) AND MIDCHEST REGION POST VACCINATION. PT ADMITS TO SUN EXPOSURE THIS AM WHILE WALKING HER DOG WITH MID CHEST EXPOSED. SHE HAS A HX OF SENSITIVE SKIN.  VS @ 3:30 PM BP 109/68 HR 73 SpO2 97%  ON EXAMINATION, THE RASH WAS LOCALIZED, NONEDEMATOUS, WITHOUT PUSTULES/ PAPULES/WHEELS, AND NO PRESENCE OF HIVES. PT WAS INFORMED THAT THE ERYTHEMA MOST LIKELY RESULTED FROM SUN EXPOSURE AND INSTRUCTED TO CONTINUE MONITORING FOR ANY CHANGES IN SYMPTOMS. PT ALSO INSTRUCTED TO TAKE BENADRYL AT HOME IF SYMPTOMS WORSENED. PT VERBALIZED AGREEMENT AND THAT SHE FELT FINE. PT LEFT FROM OBSERVATION SITE DRIVING ALONE.
On 6/30/17, the day after receiving the vaccines; my baby developed extremely blood shot eyes. The whites of her eyes were red and swollen. She randomly would have a fever for the following week after injections. Also had moments where she was completely inconsolable. Screaming and crying not eating well and barely napping but also lethargic and not acting herself. Exactly 7 days after injections on 7/06/17 she woke up with a rash all over her face and neck. We took her to the Peds office and her Pediatrician was out of the office so we saw a different doctor, and she said it was likely a reaction to the MMR vaccine she had the previous week. Keep an eye on her and as long as she didn't get a high fever she would be fine. I believe it took about 3 days for the rash to go away and never spread past her neck.
Began on 08/02/21 at 10:45pm. Experienced pins and needles sensation in my left hand that travel up my left wrist and arm to my left shoulder. Felt loss of strength in my hand and arm, shoulder.  Pins and needles sensation left leg and foot. Facial hives developed on 08/03/2021. These symptoms continue  24 hours after first dose of the Pfizer vaccine on 08/02/2021.
5/15/10 Patient received ZOSTAVAX and 5/20/10 patient called stating she has a "red bump" and itching at injection site, also patient had developed a cold sore which she indicated was bothersome.
Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine, at an unspecified dose and frequency; RIZATRIPTAN BENZOATE (MAXALT) for Prophylaxis, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Prophylaxis, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Prophylaxis, at an unspecified dose and frequency and TRAMADOL for Prophylaxis, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Excedrin ES, Excedrin Migraine, Maxalt, Tylenol, Aleve, tramadol. No Concomitant medications were provided
Pt had joint aches x 2 days followed by erythema & marked swelling below the area of inject in lt deltoid;
Itch in many parts of my body, feet, legs, ear; A spontaneous report was received from a consumer concerning a 82 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Itch in many parts of my body, feet, legs, ear.  The patient's medical history was not provided.    The patient was not taking any concomitant medication.  On 13-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 Batch no: 041LZ08 for prophylaxis of COVID-19 infection.  On 14-01-2021, The patient experienced the events Itch in many parts of my body, feet, legs, ear.  Laboratory details was not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Sender's Comments: 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.
pt brought to Er w/ 4hr h of crying, fever 103, swelling of lt thigh were shot given;
She felt right afterwards and a few hours later has been having an allergic reaction since. Her face is puffed up with blotches (may be hives) her eyes are very swollen and her stomach has been hurting her since. She also developed a dry cough. I am unable to go back as the Health Department is closed on Sunday and on Monday due to Holiday.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced URTICARIA (Hives). The patient was treated with ACRIVASTINE (BENADRYL OTC) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
My arm was sore for the first few days - couldn't lift it up over my head. On day 6 or 7, I experienced a few heart flutters/palpitations throughout the day but no dizziness or feeling faint.  On day 7, my arm was very itchy around the injection site and red and swollen and warm. On day 8, same situation with the arm.  Took a Claritin on day 9 and itching stopped but still red and swollen. Ttoday is day 10 - I just took another claritin although it's feeling much better today and redness and heat are almost gone.
fluzone hd qiv excursion this past weekend which brought the cumulative time of excursion to 112 hours with no reported adverse event; fluzone hd qiv was administered to 2 patients after a temperature excursion with no reported adverse event; Initial information received on 26-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves temperature excursion as fluzone hd qiv excursion this past weekend which brought the cumulative time of excursion to 112 hours with no reported adverse event and fluzone hd qiv was administered to 2 patients after a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, batch number and expiry date: unknown), administered to 2 patients after a temperature excursion with no reported adverse event (poor quality product administered) (latency same day). Information on the batch number was requested  On an unknown date fluzone hd qiv excursion this past weekend which brought the cumulative time of excursion to 112 hours with no reported adverse event (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 06-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U026664 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 13-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001582: US-009507513-2206USA001583: US-009507513-2206USA001584: US-009507513-2206USA001585: US-009507513-2206USA001586: US-009507513-2206USA001587: US-009507513-2206USA001588: US-009507513-2206USA001589: US-009507513-2206USA001590: US-009507513-2206USA001591: US-009507513-2206USA001592: US-009507513-2206USA001593: US-009507513-2206USA001594: US-009507513-2206USA001595: US-009507513-2206USA001596: US-009507513-2206USA001597: US-009507513-2206USA001598: US-009507513-2206USA001599: US-009507513-2206USA001600: US-009507513-2204USA001865: US-009507513-2204USA001998: US-009507513-2204USA002052: US-009507513-2204USA001952: US-009507513-2206USA001103:
I had congestion, fatigue, anorexia, and a dry cough. The fatigue was almost gone at day two. This lasted for about three days. I contacted my doctor and was prescribed PAXLOVID. This put a terrible taste in my mouth. I did not have a rebound case. Even though I did not test positive I am pretty sure I had COVID-19 because my wife and other family members had it.
This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequnecy unknown) from January 2013 to 16-DEC-2013 that may have had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific adminstrarion dates), concerning a patient of unknown age and gender. On 30-SEP-2013 the patient had received a dose of VARIVAX (Merck) (lot number #H018797, exp. date:24-OCT-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences was reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA011520; #1312USA011521; #1312USA011522; #1312USA011523; #1312USA008561; #1312USA011526). Additional information has been requested.
07/05/22 presents to Triage for 40w6d". PMHx of "Hypothyroidism"
Left arm started aching and turning red and has continued all these 10 days; now it is itchy and has spread across the arm; also other symptoms were fast heart beat, aching terribly  with body aches x 10 days also with headache x 10 days
Patient was administered a 4th Moderna vaccine. Patient was under the impression a 4th dose has been authorized. Patient reports no adverse reactions and is feeling well.
Pain at the injection site; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients (parents). This is second of two reports.   A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13, lot number and expiration date were unknown) via an unspecified route of on an unspecified date in 2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that his parents came in to be vaccinated and they experienced the typical pain at the injection site. This event occurred a year ago on an unspecified date in 2018. The pharmacist stated it was typical to experience pain at the injection site. The outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019433156 same reporter/drug/event, different patient
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for chest pain. Vaccination took place on 11/14/2007 and hospital admission was on 2/14/2008. According to the physician, relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.
11:45am: Patient feels faint and dizzy, pulse 70 regular, strong: pale, BP 98/62: patient sitting with head down.  12:00 noon: called 911 c/o tightness in neck, pale.  12:03pm: EPI 0.2 cc: assisted to another room.  12:08pm: scared, pulse 80 regular strong: skin dry: BP 110/68: color improving.  12:10pm: Life squad on scene, pulse 80: always verbal: color improving: wife called.  12:15pm: Transported to hospital.
Hours later, sore arm and fatigue.  Day two extreme fatigue, body and bone pain, headache, chills, went on into day three.  Day 4 headache and dizziness, still have headache.  Off work for two days
Blood clot; Destroyed her left lung / surgery for 3.5 hours; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (Blood clot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and RIVAROXABAN (XARELTO) for Anticoagulant therapy.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant) and LUNG DISORDER (Destroyed her left lung / surgery for 3.5 hours). The patient was treated with Surgery for Lung disorder. At the time of the report, THROMBOSIS (Blood clot) and LUNG DISORDER (Destroyed her left lung / surgery for 3.5 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient was off of her blood thinner for 2 weeks.She went into have a surgery for 3.5 hours so went off her blood thinner a week before and after surgery. She assumed it was caused by not taking the Plavix.  This case concerns a 80 year old female patient, with no medical history reported who experienced serious unexpected AESI of thrombosis after second dose of mRNA-1273. The event occurred 5 months after second dose of mRNA-1273. The re-challenge is not applicable since the event outcome unknown and occurred after second dose. Patient´s discontinue treatment with concomitant medication (Plavix) remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 80 year old female patient, with no medical history reported who experienced serious unexpected AESI of thrombosis after second dose of mRNA-1273. The event occurred 5 months after second dose of mRNA-1273. The re-challenge is not applicable since the event outcome unknown and occurred after second dose. Patient´s discontinue treatment with concomitant medication (Plavix) remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.
Swelling, redness x 3cm, itching, mild tenderness at injection site. Recommend Zyrtec 10mg. daily, take medrol dose pak if symptoms worsen in 24-48hrs.
heart felt like it was going to pouind out of his chest; This is a spontaneous report from a contactable consumer (patient) via sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 20Feb2021 as dose 1 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient received 1st vaccine on 20Feb2021. 2nd day "heart felt like it was going to pound out of his chest lasted 10 minutes than slowed down to a tolerable rate felt like he took a hit of speed" didnt do it until day after the shot wonders if he should get 2nd. I was just calling to let you guys know that I had a reaction through the first dose that I got. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt developed slight discomfort at the site of injection the next day, worsening a little each day. More pain when she lays on the side. No redness or edema.
This spontaneous report was received from a physician refers to a 10 year old male patient. The patient had no pertinent medical history or drug reactions or allergies. On 20-MAR-2013, the patient was intravenously vaccinated with a dose of 0.5 ml VARIVAX (Merck), (lot number, expiry date was not reported) in the deltoid muscle. No Concomitant medications were reported. The physician reported that when he withdrew the needle "there was lot of blood" he was concerned that he may have given the patient VARIVAX (Merck) intravenously. No adverse effects were reported. No laboratory tests were performed. The patient did not seek medical attention. Additional information has been requested.
Case number PHEH2014US025358, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 69 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the right deltoid on 16 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
The next day my left arm was very sore, which is to be expected. Even though the soreness went away, I noticed a large welp on my arm at the injection site that was red, inflamed, and hot to the touch. The welp stayed on my arm for about a week then disappeared, but the area is still warmer than the rest of my arm.
5-10 minutes after patient received vaccine became dizzy and was complaining that he was having a hard time breathing.  911 was called immediately and the Pharmacist on duty attended to the patient.  The RPh administered 1 dose of epi.  She then followed up by taking tha patients blood pressure which was 117/94 and his pulse which was 89.
Pfizer dose 1 administered to patient @ 9:30am. Approximately 5-10 minutes later patient had shortness of breath, redness of skin, and tongue inflammation. Pharmacist administered diphenhydramine 50 mg and ibuprofen 600mg to help combat reaction. Patient symptoms did not improve. EMS dispatched to check on patient. EMS transported patient at 10:05am
Received TDAP - Tuesday 6-8-10 before lunch 6-9-10 arms/legs wouldn't stop shaking - arm were red tight - c/o h/a - given liquid BENADRYL by PMD (lasted 5-6 hours) resolved by 8:00 pm.
chills, nausea, fever, dizziness, headache, sweating, weakness, no appetite Referred to primary provider if symptoms worsen, advised to drink fluids and to take pain reliever to tolerate headache.
HYPOXIA 11/12/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE  HYPOXIA 11/12/2022 SHORTNESS OF BREATH
This spontaneous report as received from a pharmacist refers to patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored ZOSTAVAX vial 19400 PFU (dose, route, lot # and expired date were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Vaccine expired on 03 Oct 2021 and placed in refrigerator on 04 Nov 2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03 Oct 2021 and placed in refrigerator on 04 Nov 2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 03 Oct 2021 and placed in refrigerator on 04 Nov 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03 Oct 2021 and placed in refrigerator on 04 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. HCP stated that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.It was mentioned that the vial was initially refrigerated on 04 Nov 2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events. No treatment medication was provided by the reporter.
Received 1.0 ml Flu vaccine IM. Complain of throat felt "scratchy" for 24 hours. Sore arm- more than usual 2-3 days. Headache for 2 days (went to bed used Tylenol).
Fever 102 degrees, headache, body ache, cough, fever onset: 9/27 at night. Pain in (L) arm.
Fever, weakness, altered mental state. CT head ? increased intracranial pressure. Admission, IV antibiotics. (+) for enterovirus on NP. CSF and blood encephalitis panels neg. Fully recovered.
Chills, fever, vomiting, nausea, weakness, severe unbearable pain from arm/shoulder/neck and upper back. Stiff shoulder, limited mobility. Treatment - morphine, VICODIN, ibuprofen, ICY HOT, BEN GAY, ice packs, heat packs.
Subsequent to receiving vax, the pt experienced a local reaction characterized by an area of 3 cm of redness.
The patient started having breathing issues and increased heart rate 5 hours after vaccine administration.  He was transported to Hospital where he later passed away.