chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent left arm soreness, muscle ache. Symptom present from date of administration and continues to date. Apply Lidocaine patch for symptom control.
I came home and I was dizzy and my arm was sore. At 1am my armpit was swollen the size of a baseball and my left breast. Very painful. I broke out in hives on my arms, legs, face. Heavy vaginal bleeding started and lasted 24 hours. Also, headache and body aches. Several acid reflux.
My menstrual bleeding started a day after getting my shot, and it didn?t stop for over 4 months straight.
On 04/08/2021, I noticed a blistering rash on the back of my right thigh.  About 4? x 2?.  I went to the Dr. on 04/09/2021; diagnosis Shingles.  I was given a steroid shot, Valacyclovir tablets, and Clotrimazole and Betamethasone Dipropiinate Cream (1%).  On 04/18/2021 I noticed new rash patches; the fronts of both thighs (6? x 4?), on my back (3? x 1?) and the backs of my hands.   I returned to the Dr. on 04/19/2021 and was prescribed another round of Valcyclovir, Prednisone 20 mg tablets, Hydroxyzine HCL 50mg, Gabapentin 300 mg capsules.  The rash seems to have stopped spreading as of 04/20/2021.
Day after I got the vaccine the injection site was red, swollen and very hot to the touch.  Also very itchy. 1 week later the symptoms were still there. Sought medical attention at dermatologist and was told that my arm was infected and showed signs of cellulitis.
Headache/lightheaded, weak, face was feeling hot, dizzy. 1st ever flu vaccine.
2wk p/vax papular eruption @ inj site-has persisted x 3mo-resolving w/topical steroids;
tested positive for COVID; Lack of efficacy; had minimal side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had minimal side effects), COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (had minimal side effects). In November 2021, the patient experienced COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, VACCINATION COMPLICATION (had minimal side effects), COVID-19 (tested positive for COVID) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided. No treatment medications were provided.  The patient took no medication for COVID disease. The physician reported that if the patient did not take medications, the patient would be fine and others told the patient to wait for 90 days.  Company comment: This case concerns a 67-years-old female patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 9 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient did not require treatment for the event.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Significant follow up: Patient information (demographics) updated.; Sender's Comments: This case concerns a 67-years-old female patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 9 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient did not require treatment for the event.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This non-serious spontaneous case, was initially received from other non-health care professional on 02-Oct-2017, concerning a 10-year-old, male child patient. The patient's historical conditions included: severe allergic reaction to polymyxin-b and neomycin. The patient has not received any concomitant medications. On 28-Sep-2017, the patient was vaccinated with FLUCELVAX QUADRIVALENT(dose: 0.5ml, Lot no: 195125, route of administration and anatomical location: not reported). On 29-Sep-2017, after one-day of vaccination, the patient developed a very tiny (size of pencil tip) raise red bumps on his upper back and chest. The symptoms of bumps get reduce with 25 mg dose of BENADRYL. At the time of this report, the patient was completely recovered from event. The reporter assessed the report as non-serious. Follow-up received from the reporter on 11-Oct-2017: Non-significant information received. The patient's mother stated that the patient takes no concomitant medications. Narrative amended accordingly. Non-significant case correction received with 02-Oct-2017: Batch number (195125) was added on the screen. The narrative was amended accordingly.
Fatigue, Tiredness, No energy, Chills, Weakness, Multiple times of vomiting
chills, fever, sore arm, rash, bodyaches, nausea , vomiting
APRIL 26, 2021, APPROXIMATE 9:00PM. BOTH ARMS INSIDE THE ELBOW THE FLESH PART I DELEVOP A RASH THAT ITCH, TODAY I GOT SOME CREAM FOR THAT ITCH FROM MY VA CLINIC.
No additional AEs were reported; patients received improperly stored vaccines; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 24-MAR-2022, the patient received one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally, lot # 1741817, expiration date 30-JUL-2022 or lot # U026664, expiration date 24-FEB-2023 (strength, dose and frequency were not reported) for prophylaxis, and one dose of improperly stored haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # U026217, expiration date 02-NOV-2023, (strength, dose, frequency and route of administration were not reported) for prophylaxis (product storage error). The nurse did not know which specific lot of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient. There were no additional adverse events reported or product quality complaint reported. Administered doses of vaccines experienced the temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There were no previous excursions reported.
UPON RECEIVING THE IMMUNIZATION, PATIENT REPORTED FEELING LIGHT HEADED. HE WAS GIVEN WATER AND REMAINED SEATED. AFTER A COUPLE MINUTES HE BEGAN TO PERSPIRE AND WAS PALE. ROUGHLY 5-7 MINUTES AFTER RECEIVING THE VACCINE, THE PAINTED FAINTED AND DID NOT RESPOND TO HIS NAME FOR 90 SECONDS. HE DID ALSO HAVE SOME  BRIEF SHAKING MOVEMENTS OF HIS ARMS. UPON WAKING UP, THE PATIENT REMAINED SWEATY AND PALE. HE WAS ASSESSED IN THE PHARMACY (LOCATED IN A HOSPITAL) BY AN EMERGENCY ROOM PHYSICIAN AND WAS CLEARED TO LEAVE WHEN HE WAS COMFORTABLE.
4inch lnch X 2.5 inch wide hot, itchy red area at injection site
I got my first dose of the Moderna vaccine on 4/8/2021. On 4/10/2021, I began having cognitive symptoms. I definitely had impaired working memory and impaired concentration; I had difficulty maintaining conversations and staying on topic. The cognitive impairments lasted for about a week. I had difficulty with alternating attention and working memory, most especially. On 4/11/2021, I had vaginal bleeding, which was unusual, as I had just finished my period. My periods are normally very regular, but the breakthrough bleeding lasted about 5 days. It was a very light-flowing breakthrough, and I was able to use just pantyliners for protection. On the same day, I had a nosebleed. It was odd, as I didn't bleed much, but it took a long time to coagulate. I have a history of nosebleeds, and they usually produce a heavier flow, though they coagulate much sooner. On 4/12/2021 or 4/13/2021, I began having cardiac symptoms. I had difficulty tolerating working, as I had significant fatigue; this is unusual, as I'm athletic and active. I had chest pains, palpitations, shortness of breath. These symptoms escalated over the following few days. One evening, I had chest pains and difficulty breathing; I should have gone to the ER, but I didn't. My cardiac symptoms included arrhythmias, shortness of breath, heart palpitations, significant fatigue. These lasted for about 6 months before they tapered off. I have also had an abnormally fast heartrate since my vaccination, and this continues at the time of writing.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 22-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 528 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
RED SWOLLEN INJECTION SITE WITH PAIN THAT INCREASED A FEW DAYS AFTER THE INJECTION. SHE WAS GOING TO GIVE IT A FEW MORE DAYS AND IF IT DIDN'T GET BETTER OR GOT WORSE SHE WOULD THEN CALL HER DR.
Felt chills when I went to bed. Got up had emesis after drinking water. Fever 101.7. No energy or appetite until 7pm last night.
Pt c/o nausea/ vomiting/ coughing. 1220 - 125/82,119. 19, 98%; Wheezing  L Upper/ Lower lobes; coughing c/o "something in throat" - Benadryl 50 mg po given.1230 - symptoms not relieved by benadryl, EMS called. 1237 - 130/80, 99, 18, 100% EMS here. Pt states improving - refused transport. 1250 - sleeping 128, 87, 16. 99%. 1300 - awakened, coughing respiratory distress, diff breathing, SpO2 - 83%, NO air movement lower lobes, 1310-Epi 0.3 mg r thigh. 1317-138/81, 96, 100%,  EMS returned- strongly encouraged transport ot ED. Pt agreed. 1325- transported to
not enough diluent was withdrawn to reconstitute the pfizer vaccine  as a result patient received higher concentration of vaccine than the normal dose . no unusual side effects were reported
started 3/15/22 with migraine, continued with increased sx throughout the night of chills, shaking, nausea, into 3/16 all sx including fever 102. getting better into 3/17 but not recovered, still with headache. arm at injection site is bright red and swollen. also with period spotting.
Red rash down her arm; Red rash down her arm; Swelling of arm at injection site; Fatigue; Headaches; Nausea; Fever; Heated at injection site; Sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (Heated at injection site), PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red rash down her arm), RASH (Red rash down her arm) and VACCINATION SITE SWELLING (Swelling of arm at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heated at injection site), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Swelling of arm at injection site), FATIGUE (Fatigue), HEADACHE (Headaches), NAUSEA (Nausea) and PYREXIA (Fever). On 12-Mar-2021, the patient experienced ERYTHEMA (Red rash down her arm) and RASH (Red rash down her arm). At the time of the report, VACCINATION SITE WARMTH (Heated at injection site) and VACCINATION SITE SWELLING (Swelling of arm at injection site) outcome was unknown and PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red rash down her arm), RASH (Red rash down her arm), FATIGUE (Fatigue), HEADACHE (Headaches), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products also included Fomamox for an unknow indication.  The patient stated that she had swelling of arm, and heated at injection site. She also had a red rash down her arm, and sore for a couple of days. According to the patient, she had fatigue, headaches, nausea and fever for 2 days. No treatment information was provided.
This spontaneous report as received from internet referred to a female student (patient) of unknown age. On an unknown date the patient was vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were unspecified). Patient said she collapsed and was left paralysed for six hours after being injected. "I couldn't move at all. There were girls dropping like flies, basically". Patient also said she had been vaccinated in the past (Lot#, dose/frequency, route and duration were unspecified) but her reaction to GARDASIL was different. At the time of reporting the outcome and relationship were unknown. But "authorities believed the reactions were likely to be related to having an injection not the vaccine itself." Upon internal review, paralysed was considered as other medical significant event. This is one of several reports that received from the same source. Additional information has been requested.
This case was reported by a physician and described the occurrence of swelling of underside of arm in a 58-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included high blood pressure. Concurrent medications included Ramipril. ON an unknown date in September 2009 the subject received a dose of FLUARIX (unknown, left arm) at work. On an unknown date in September 2009, less than one month after vaccination with FLUARIX, the subject experienced swelling of underside of left arm ("left arm swelling in axillary region") and frozen left shoulder. At the time of reporting the events were resolved.
Patient presented with rash from elbow to wrist and received prednisone prescription for it on 11/6/2017.
Rash over torso, underarms and on chest.  Visited dermatologist for steroid cream to treat.   Also painful swollen lymph nodes under arm where vaccination was received.
Covid + even though 2 doses vaccinated. One dose missing in the record. Advise to up to date at injection clinic with vaccine record
Redness; Swollen injection site; Tenderness; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed redness, swollen injection site and tenderness.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 07 Jan 2021, approximately eight days prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced side effects which included redness, swollen injection site and tenderness. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, redness, swollen injection site and tenderness was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
7/27/21: Patient transferred to hospital from outside facility with COVID-19 infection, pneumonia and pulmonary embolism, acute hypoxic resp distress. Patient was diagnosed with COVID on 7/17.  Note: Patient was previously vaccinated with Pfizer COVID-19 Vaccine, last dose in April 2021.  8/9/21: Patient is still admitted at the time of this report submission. Please note: Patient received First dose of Pfizer COVID-19 vaccine on 3/23/2021, followed by the second dose on 4/13/2021.
Case number PHEH2013US022539 is an initial spontaneous report received from a medical assistant on 24 Oct 2013. This report refers to a 13-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated intramuscularly only with Men A lyophilized powder component of MENVEO (batch number: X12127) reconstituted with sterile water and did not receive MenCYW-135 liquid conjugate on 16 Oct 2013. No adverse event were reported following the administration error.
Started with chills in early evening, but unable to sleep at all with crazy ? headache?, sweats,  chills, slight nausea  Slept all the next day and night, used Tylenol, no high fever however.  2/5 noticed peeling skin on chin, feeling improved
Dull head pain located at the front of the head to the temples, almost like when you have a fever but without a temperature.  Severe night sweats, and have had hot flashes around the ears a few times. This has been going on since the evening of  my vaccine. The head pain is constant and the night sweats have occurred almost every night. On night one the head pain was moderate.
SEVERE BODY CHILLS ALTERNATING WITH BY FEVER AND BODY ACHES. SKIN SENSITIVITY AND SWEATING. ONSET ABOUT 4 HOURS AFTER INJECTION. SYMPTOMS OCCURED FOR ABOUT 24 HOURS.
The pt developed swelling on left deltoid from shoulder to mid upper arm with intense redness (15cm length).
hives & swelling on face; rash on limbs & trunk; low grade fever; 12 to 24 hrs;
right ankle and calf became swollen; right ankle and calf became swollen; puffiness in face; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm  on an unknown date in May2021 at 15.45 hours (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included deep vein thrombosis (DVT), pulmonary embolism (PE), and family history of diabetes. The patient have not reported any allergies to food, drugs or medication.  Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), ascorbic acid (VITAMIN C), elderberry (MANUFACTURER UNKNOWN) taken within two weeks of vaccination for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination it was unknown whether the patient had not been tested for COVID-19. On 21May2021 the patient experienced right ankle and calf became swollen once the patient returned home. That was three days ago and the patient still had the swelling, the left ankle was swollen but not as much, the patient also noticed puffiness in face. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the event right ankle became swollen (swollen ankles), calf became swollen ( calf swelling), puffiness in face (puffiness face)was not resolved at the time of the report.    No follow-up attempts are needed. No further information is expected.
runny nose; swelling on my arm; hot areas on my arm; headache; chills; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), RHINORRHOEA (runny nose), PERIPHERAL SWELLING (swelling on my arm), FEELING HOT (hot areas on my arm) and HEADACHE (headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A212) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SNEEZING (sneezing), PERIPHERAL SWELLING (swelling on my arm), FEELING HOT (hot areas on my arm), HEADACHE (headache) and CHILLS (chills). On an unknown date, the patient experienced RHINORRHOEA (runny nose). On 31-Mar-2021, CHILLS (chills) outcome was unknown. At the time of the report, SNEEZING (sneezing), RHINORRHOEA (runny nose), PERIPHERAL SWELLING (swelling on my arm), FEELING HOT (hot areas on my arm) and HEADACHE (headache) outcome was unknown.            No concomitant medication provided. No treatment medication provided.
Myocarditis; This is a literature report for the following literature source(s): "One year follow up for case series of myocarditis following mRNA vaccination against SARS-CoV-2.".  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". Comments: myocarditis, 4 patients.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event myocarditis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300060530 Same article/drug/event and different patient;
Patient was given this vaccine in error.  Patient was to have received PCV-23. Patient was given PCV-13 first in error, and then physician requested that PCV-23 still be given during the same visit.
Shot was at 1:50. At 8:00PM I started getting chills and body continues to shiver. Was able to fall asleep and got up to use the restroom around 2:00AM and had dizziness, headache, Nausea and felt faint. Same occurrence happened around 4:00AM as I got up to use the restroom again.   By 8:00AM I could slowly get up and move around with out feeling faint or nauseous. Left with fatigue
positive covid test on admission 4/4 for small bowel obstructtion Narrative: hospitalized for unrelated SBO when the asymptomatic test results were obtained