chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has a bump in her left arm; had diarrhea; felt tired; Had some cold; sore left arm that went all the way to the neck; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore left arm that went all the way to the neck), NASOPHARYNGITIS (Had some cold), PERIPHERAL SWELLING (has a bump in her left arm), DIARRHOEA (had diarrhea) and FATIGUE (felt tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Back pain and Cholesterol. Concurrent medical conditions included Diabetes.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm that went all the way to the neck). On 28-Jan-2021, the patient experienced NASOPHARYNGITIS (Had some cold) and FATIGUE (felt tired). On 01-Feb-2021, the patient experienced PERIPHERAL SWELLING (has a bump in her left arm) and DIARRHOEA (had diarrhea). On 28-Jan-2021, PAIN IN EXTREMITY (sore left arm that went all the way to the neck) outcome was unknown. At the time of the report, NASOPHARYNGITIS (Had some cold), PERIPHERAL SWELLING (has a bump in her left arm), DIARRHOEA (had diarrhea) and FATIGUE (felt tired) outcome was unknown.        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 spontaneous report as received from a healthcare worker refers to a 83 year old patient (first of 2 patients). On 20-NOV-2013 the patient was vaccinated with ZOSTAVAX vial of lot # J001729 and expiry date 20-OCT-2013, dose 0.65 ml, via subcutaneous route. The patient had received an expired dose of ZOSTAVAX. No adverse effect was reported. This is 1 of 2 reports received from same reporter. Additional information has been requested.
ARM PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included dizziness, numbness, and vitamin d deficiency, and concurrent conditions included hypertension, and chronic pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm pain was not reported. This report was non-serious.
Generalized, red, pinpoint, pruretic rash, blanches.  Myalgias, fatigue, Afebrile
Heart fluttering/palpitations within a couple of hours after second dose. Tightness/pain in chest, mostly left side/center, difficulty breathing/shortness of breath consistent two days following the second dose but got better on the third day. Took Tylenol but did not notice a difference.
Narrative:  Patient received one dose of covid vaccine. Passed 5 days later. Unclear if she had any medical history that would cause death or if this is related to covid vaccination. Reporting per Regulatory Authority instructions.
Nausea; Vomiting; Sick; some looseness in his stomach; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a male patient (reporter's son) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter reported that patient just took shot on Wednesday, he was sick. He took his shot on Wednesday and when he woke up Thursday with severe vomiting and nausea and he did that all night. He was better Friday except he had some looseness in his stomach but he didn't throw up. He woke up this morning and feeling that again. The outcome of the event "Stomach upset" was not recovered. The outcome of other events was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No menstrual cycle after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Aug2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Aug2021, the patient experienced no menstrual cycle after vaccine. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event no menstrual cycle after vaccine was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient recieved 1st dose of vaccine, however he was under minimum approved age of 18.  Patient was 16 years old.
Diagnosed with varicella disease on 5/31/12. Greater than 50 lesions. Received 2 prior doses of varicella vaccine.
Extreme joint stiffness and it continues today (almost 2 years later). Initially, I could barely get out of bed or stand up straight when getting out of a chair. It has lessened but not gone away completely. I'll take anti-inflammatory to help. I can be driving my car and my elbows will start aching. I can sit for awhile and then my hips will ache. On occasion, my eyeballs will swell. I have always been very energetic and basically a "tom-girl"; since having the vaccines, I am stiff and lacking flexibility.
some cellulitis at the site of injection.; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (some cellulitis at the site of injection.) and LYMPHADENOPATHY (Swollen lymph nodes) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALLERGY MEDICATION for Allergy, PROGESTOGENS AND ESTROGENS, FIXED COMBINATIONS for Birth control.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 14-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (some cellulitis at the site of injection.). At the time of the report, VACCINATION SITE CELLULITIS (some cellulitis at the site of injection.) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Thursday morning and afternoon from 9 am. - 5 p.m., fever (101.4 at its highest), intense shivering and chills, muscle pain, fatigue and weakness. I felt better by that evening but was sore and tired for a couple more days and arm was sore for four days.
PATIENT REPORTED FACE  AND TONGUE TINGLING. DENIED ANY   PATIENT REPORTED SHORTNESS OF BREATH AND TONGUE/FACE   TINGLING WITHIN 15 MIN OF COVID 19 VACCINATION IM.    OBSERVED BY RN. dR ON SITE AND INFORMED.  NO   FACIAL SWELLING OR DROOP.  BP TAKEN   167/108.BENADRYL 25MG LIQUID GIVEN ORALLY. PATIENT   SAID SHE FELT BETTER AFTER BENADRYL. OBSERVED ANOTHER   30 MINUTES.  FOLLOW UP BP WAS 140/91 AND HR WAS 72.    TINGLING RESOLVED.    Reported taking a steroid dose once at home from prednisone that was already prescribed to her.
Pt recvd vax & 12 hrs p/vax exp chills, abdo cramps, t104, h/a, sneezing, diarrhea, nausea & vomiting;
Pale, dusky color, decreased BP, decreased pulse, decrease resp, nausea. Epi 3cc 1mg/1mm given SQ right arm. 911 called
Exactly like having the flu. Fever 104, chills, fatigue, vomiting, severe body aches, shivering, Generalized weakness Worst part of the symptoms occurred approximately nine hours post vaccine until 48 hours post vaccine. With only my whole body aches, fatigue, weakness, nausea.
Pt given adult dose of GlaxoSmithKline Hep B instead of pediatric dose.
he had to have passed out; he defecated himself among other things; could not move; the fatigue.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a 76-year-old elderly male received the second dose of BNT162b2 (solution for injection; Lot EWO187 expiry information not provided) as a single dose via an unspecified route on an 19May2021 (at 76 years-old) for COVID-19 immunization. Relevant medical history included ongoing Type V hyperlipidaemia (12Aug2020), ongoing Coronary artery disease (31Oct2018), ongoing elevated Prostatic specific antigen (PSA; 10Jun2014), ongoing extradural extramedullary spinal tumor (04Apr2018), ongoing Dizziness (04Apr2018), ongoing Obesity (03Mar2021), Acute kidney injury (AKI), swelling of joint right upper arm, urinary tract infection associated with indwelling catheter (05Jun2020), pneumonia due to COVID-19 virus (hospitalized for two and one half months; 26Apr2020-02Jun2020), pneumonia due to COVID-19 virus (05Jun2020), restless leg syndrome, depression, and Atrial fibrillation (Afib), stent in his heart, and chest pain. Concomitant medications included pramipexole dihydrochloride for restless leg syndrome from unspecified date; venlafaxine hcl for depression from 1992; atorvastatin calcium (LIPITOR) for unspecified indication from unspecified date; SOTALOL for Afib from an unspecified date; tamsulosin hydrochloride (FLOMAX) for unspecified indication from unspecified date; apixaban (ELIQUIS) for unspecified indication from unspecified date; and esomeprazole magnesium (NEXIUM) for unspecified indication from 1998. The patient also received unspecified concomitant medications for the stent in his heart though he could not recall the name. The patient received the first dose of BNT162b2 (solution for injection; Lot EWO171 expiry information not provided) as a single dose in the left upper arm an 19Apr2021 (at 76 years-old) for COVID-19 immunization and experienced no adverse effect. The patient reported that on 19May2021 when he got home, he passed out and had to be taken by ambulance. When questioned, the reporter stated he had to have passed out. The patient reported that de does not really know, except he could not move; described as 'had a heck of a time moving'. The patient reported that he literally defecated himself among other things. The patient reported that his neighbor heard him screaming and called an ambulance who took the patient to the hospital, the emergency hospital and then the hospital itself. The patient reported that he was hospitalized from 21May2021 to 24May2021. The patient yawned and stated that this was another problem, the fatigue. The outcome of the events passed out, defecated himself, and could not move was recovering. The outcome of the fatigue was unknown.
Blood pressure increased dramatically 3 weeks later.  Went from 122/81 average to 136/98 average.  Chest tightening, shallow breathing, dizziness, headache.
Deep pain in left armpit starting around 7 days after injection.  Sore arm/shoulder for 2 days following injection.
approx 3yrs p/vax pt devel 14 spots on abd & legs
Encephalopathy, severe malnutrition and hairloss, ADD, ADHD, vitamin deficiency, memory loss, concentration problems, burning in head, acute "electric" pain originating in head and coursing through to feet, decreased states of consciousness, tunnel vision, breathing/heart murmurs, chronic headaches, chronic fatigue, severe depression, suicidal thoughts, bi-polarity, arnold-chiari brain malformation type 1 etc.
Patient had a vasovagal response to the shot. We advised her that she needed to remain seated for 15 minutes, but chose to get up and walk around after about 7 minutes. She was walking with her husband when she all of sudden felt faint and collapsed into her husbands arms. We raced out to her as he lowered her to the ground, she was talking, but was having problems seeing and when we checked her blood pressure it was 90/60 supine. We ran a cool bottle of water under her neck and that brought her around, when she was able to sit up and then move into a chair where her blood pressure returned to 112/60. The paramedics were called and patient was evaluated but she refused any further care.
Due to an error in date of birth on consent form, patient received the adult dose of Pfizer Covid-19 vaccine (0.3ml) instead of the pediatric dose, 0.2ml. DOB was corrected, but vaccine was still given in error. Pharmacy manager left voice mail for parent, but has not heard back yet. Error was discovered by corporate and emailed to us to investigate.
This was for the first COVID shot, A few days afterwards, I got a significant rash on my lower legs and ankles. Rash continued until my second vaccine on 05/03/2021.  After I took the second vaccine, the rash subsided on my legs but came back strong on my upper arms, back and neck. I have been taking Benadryl and applying hydrocortisone to treat the itching.
I received the high dose flu vaccine for those over 65. Two days later I began having sensitivity around my waist and then four days later and subsequently broke out with a shingles rash.
Syncopal episode that occurred within 15 minutes of vaccination.  Patient recovered after rest and snacks. No injuries noted from fall.  Discharged to home after evaluation and monitoring.
Pt. was given vaccine (MENVEO) at approx. 4:45 PM on 6/06/14. When pt. awoke on 6/07/14 he reported to his mom that his arm was sore. Mom states the (L) upper arm was red and warm to touch. Pt. c/o arm being sore. Spoke with mom on 6/10 and she stated that pt's arm is better except for slight redness.
This case was reported by a nurse and described the occurrence of expired vaccine used in a 4-year-old male patient who received KINRIX (batch number unknown, expiry date 23rd November 2014). On 4th December 2014, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Mr. does have a hx of epilepsy, though has not had a seizure since June of 2022.  This seizure presented ~5 hours post vaccination.   s/p seizure he was unresponsive whereas his previous postictal episodes resolved in <10 minutes; following a second seizure, he was sent to ED for evaluation with hospitalization recommended.  His family declined admission & he returned to the facility the following day with a recommendation for hospice & a dx of aspiration PNA.  PNA is being treated with IV Zosyn & seziure activity with SL Ativan & PR Distat.   He has remained somnolent, does not respond to verbal stimuli and has been NPO since his return(all are a noted change from his baseline).
1st event was a 102.4 fever with muscle aches, chills, weakness, headache, random bruising on hip, injection site soreness. 10/30/2021, chest pain on left side started and still going.
Fever, chills, muscle pain, chills, headache and fatigue lasting 2 days.
Starting 4 days after his second shot on 12/27/2021 Patient has experienced feelings of having a fast-beating, fluttering, or pounding heart. It has continued to this day and we are not sure what to do other than to find a heart doctor. His sister complained of similar heart issues over the past year which we now believe are attributed to her receiving the Pfizer shot last summer. We didn't make the connection until now. His mother is also experiencing a fluttering of her heart a few days a week this year (also a new condition) and she is vaccinated. We were on vacation when it happened so we only called a doctor and have not taken him in yet. We will look for a heart doctor for him and my daughter.
initially c/o pain & swelling in rt arm below inj site beginning 14APR96;p/further questioning states soreness & discomfort in rt arm began a couple of days p/inj;red, swollen & pt states it is painful
Fever, 101.3 degrees within 24 hours of vaccine. Pain- local. Fever, 99.6 degrees within 48 hours of vaccination. Pain- local 2 Tylenol 500 mg before sleeping. Local swelling 2 inches
Information has been received from a pharmacist and a registered nurse concerning a patient who on an unspecified date was vaccinated with PNEUMOVAX (Lot # 660717/0224X) and developed injections site reactions. The pharmacist stated that the reactions included joint pain and immobility and were "over and beyond soreness". The pharmacist reported that he was not sure if it was the first or the second dose for the patient. A lot check has been requested by the registered nurse. Follow up information was received via a telephone call from the registered nurse (R.N.) who reported that the patient was a male and he fully recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and were released. Additional information is not expected.
Case 0.5 cc Moderna IM - Not recommended until age 18 - 3/30/21 I spoke with patient's gaurdian. She reports today had a sore arm.
Patient received immunizations.  Sat in Injection Room for a few minutes while nurse completed the paperwork.  Appreared to be fine.  Walked out to the check out window and passed out while standing at the window.  Fell face-forward and cut his chin.  Patient had c-spine stabilized, oxygen placed via nasal cannula.  Chin dressed with sterile gauze and transported to Hospital per ambulance.  Patient received 7 stitches in chin and Xrays revealed jaw fracture.
getting yellow green puss coming out of his penis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PENIS DISORDER (non-serious), outcome "unknown", described as "getting yellow green puss coming out of his penis".  Additional information: Clinical course: It was reported that ever since the patient took the Pfizer Comirnaty vaccine, he was getting yellow green puss coming out of his penis. Patient wants to know is this a common side should the patient scrape some off and send it to Pfizer for us to look at. The patient wife thinks that he was having an affair on her because of this. The patient had to go to get Comirnaty because it was not offered in that country. Patient wants to know could Pfizer tell his wife that this is a side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Small rash with pimple-like inflammation an inch from the bruise marking the injection site.
days of left arm and 1 day of acute left side chest pain following 2nd administration of COVID-19 vaccine.   Patient reports that 3 days ago, he received the 2nd COVID-19 vaccination (Pfizer ) in his left anterior deltoid area.  Following this he developed diffuse body aches and headaches.   On day prior to admission, patient developed fever at home with T-max 101.8° F. after going to sleep, he was awoken with nausea.  Patient experienced episodes of vomiting, which he reported mostly consist of water, and also reported left arm and left chest pain at this time.  He reports the pain felt like pressure and was a severity of 9/10.  Patient also experienced numbness and tingling in his left hand.  He attempted to take Tums and Motrin at home with mild relief of symptoms.  Mother then brought patient in to Emergency Room.  Patient denies syncope, no palpitations, pain does not worsen with deep breathing, pain unchanged by position.. emergency department course:  Presented with temperature 99.7° F, heart rate 92, blood pressure 138/90, saturating 98% on room air.   Laboratory work revealed elevated troponin, elevated CK-MB, and elevated creatine kinase.  Chest x-ray was performed which was normal.  EKG revealed normal sinus rhythm.  Patient was transferred to our emergency room and subsequently admitted to the floor.       Hospital Course: He was evaluated in Hospital Emergency Room and admitted to the floor for more close monitoring.  His repeat labs showed elevated troponin and an echocardiogram was unremarkable.  In view of the elevated troponin was case was discussed with the cardiologist who recommended a cardiac MRI which was performed which did reveal myocarditis, pericarditis.  In view of this ICU service is consulted for admission closer monitoring further evaluation management.
Fine raised, red rash under left arm and around left upper chest and left arm pain. Small petechiae down both extremities with welt-like appearance. Red papular area with excoriation noted on the sacral area 3cm. Papular red scaley area noted behind left ear. Observed child scratching areas. Mother has been applying Calamine lotion and reports no temperature or changes in eating habits.
Slightly sore arm; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6203, Expiration date: Unknown) via an unspecified route of administration in left arm on 06Mar2021 at 08:30 AM (65-year-old age at vaccination) as UNKNOWN, SINGLE DOSE for covid-19 immunization. Medical history included diabetes type2 and high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included lisinopril, metformin, sitagliptin (Jenuvia), glimepiride and pimozide (Mozep). Patient has no known allergies. Patient did not receive any other vaccine in four weeks. Since vaccination, patient has not been tested for covid. On 06Mar2021 at 15:00, the patient experienced slightly sore arm. Patient has not received any treatment for the event. The clinical outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
13SEP91 pt recvd Engerix-B vax & 3 days p/recvd dose devel lightheadedness & weight gain & became tired & rundown; pt recvd no tx & is reported feeling better; late NOV91 went to MD dx low thyroid & a kidney infect;
The pt's father reported that his 10 week old son received an IPOL, a Tripedia and an ActHib vaccination on 8/9/02 and immediately, developed redness in his legs and anaphylactic shock. The pt was sent to ER and admitted to the hospital overnight. From additional telephone conversation with the pt's mother on 8/19/02, it was reported that the pt was vaccinated on 8/9/02 with the adverse event occurring immediately following. The pt was admitted to the hospital on Friday and discharged on Sunday. Treatment of Benadryl and Solu-Medrol IV was given. The pt recovered from this experienced.  Reported on 02/27/2003: "From follow-up (follow-up all received at Aventis Pasteur Inc. on 02/24/2003, it was reported that the patient received first doses of ACTHIB, UA647AA, given intra-muscular in the left leg.  Patient has a history of gastroesophageal reflux.  Patient had no illnesses or was taking any medication at time of vaccination.