chrisvoncsefalvay/vaers-outcomes huggingface dataset:
big chills; sweating; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (big chills), HYPERHIDROSIS (sweating) and PAIN IN EXTREMITY (Sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included No adverse event. Concomitant products included LOSARTAN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Mar-2021, the patient experienced CHILLS (big chills) and HYPERHIDROSIS (sweating). On 10-Mar-2021, CHILLS (big chills), HYPERHIDROSIS (sweating) and PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM taken for anxiety, depression; TRAZODONE. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive, notes: the + line became lighter. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Oct2023 to 07Oct2023 .  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328775 Same reporter/patient, different drug, different event;
Itching, mild erythema & induration 4cm area at injection site. BENADRYL, triamcinolone cream prn.
Chills fever for 36 hours. Sever sinus headache 36 hours. Flu-like body pain 36 hours. In-bed for 36 hours. Nausea, no appetite.
Moderna COVID-19 Vaccine EUA. The patient received the vaccine on Friday 6/4/2021 and the next morning (Saturday 6/5) she noticed her hands and ankles were swollen. Her wedding ring does not fit at all with the swelling. Today, 6/7/2021, the patient's hands and ankles are still completely swollen and has not decreased since it started. The patient also noticed this morning, 6/7/2021, that her fasting blood glucose levels are around 210 when they are usually around 130. The patient says the only thing she has done differently lately is getting the COVID vaccine. She is going to contact her primary healthcare provider today to have the side effects checked out.
Diagnosis: BELL'S [ALSY. Presented on 05/13/2021 as "prickly" feeling above upper lip. Within a few houre, feeling of paralysis in facial muscle on right side of face extending from forehead to jawline, from nose across to ear, leading to drooping face; eye and mouth definitely sagging, eye swollen, difficulty in drinking, eating, speaking; unable to smile, blink/close eye, or raise eyebrow; inner ear feels swollen; headache. Doctor's visit within 24 hours with diagnosis of BELL'S PALSY. Took blood sample and ordered chest x-ray. Prescribed medication: 2 week course of corticosteroids, 1 week course of antiviral drug, eye drops (to prevent dry eye). Six days into treatment.
Pt with vasovagal reaction immediately after vaccine. Near syncope. No loss of consciousness. Patient with immediate dizziness, lightheaded, feeling of near fainting, nausea and dry heaves. Given water, snack. Vitals stable throughout. Laid patient down with feet elevated. Ice pack to back of neck and cool compress to forehead. Denied any SOB, chest discomfort, or difficulty breathing at any point. Observed x60 min with near resolution of symptoms. Discharged to home with friend as driver. Instructed not to drive and to seek emergency medical attention if new or worsening symptoms at home.
Sore arm and headache shortly after injection. Chills and body aches 6-8 hours later. Upper body rash to include face and neck ~12 hours later. Fever and tachycardia next morning. All symptoms are currently unresolved.
Mother specifies that adolescent has pain and itchiness on the left arm, hardened area and swelling in the area of the HPV vaccination on 2/26/19.
Heart racing won?t stop (this happened for my first shot too) I just didn?t report it.
Pt. had swelling and redness at injection site. Fever reaching 102 degrees. Pain in left arm.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-APR-2018 and 14-JUN-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively (Incorrect product storage). The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
My sister received the Janssen vaccine on March 13, 2021.  One week later, March 20, 2021, she started complaining of severe headaches, dizziness and vomiting.  This continued so she visited the ER on Wednesday, March 24, 2021, where she suffered a cerebral venous sinus thrombosis.  She was pronounced brain dead on March 27, 2021, which is also the same day she was pronounced dead.
chondritis or polychondritis; chondritis or polychondritis; my nose and right ear swelled up; my nose and right ear swelled up; dose number=1: administration date=28Dec2020/dose number=2: vaccine date=08Jan2021; dose number=1: administration date=28Dec2020/dose number=2: vaccine date=08Jan2021; This is a spontaneous report from a contactable nurse reported for herself. A 65-year-old female patient received the second dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number EJ1686) via intramuscular on 08Jan2021 into left arm at a single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID 19. The patient got allergies to bentyl, codein, flagyl and got Hx diverticulitis, ileitis, hypothyroid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included levothyroxine, metoprolol and diazepam. The patient previously took the first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, lot number EK5730) via intramuscular on 28Dec2020 12:00 into left arm at a single dose for covid-19 immunisation. On 11Jan2021 04:00, the patient nose and right ear swelled up. On 05Feb2021, per ENT, it was chondritis or polychondritis. Refer to rheumatologist pending, for further diagnostics. The adverse event resulted in doctor or other healthcare professional office/clinic visit and received treatment included amoxicillin, labs drawn, then prednisone tx, more labs drawn, more prednisone prescribed on 05Feb2021. Since the vaccination, the patient has tested for COVID 19 named saliva test on 03Feb2021 and got negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided, it is unlikely that chondritis or polychondritis is unlikely related to suspect product. Case will be reassessed as and when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
?Covid arm? red, slightly itchy, firm patch appeared on arm. Slowly spread over the next few days until it was approximately 3? x 2? Finally faded after four days
Local reaction on right deltoid area, edema & erythema measuring 30 mm x 30 mm. Increased temperature on same area. Pt c/o no other symptoms.
Injection in left upper arm, left upper arm and shoulder swelling to the point of being un-moveable , hard to the touch and very red around the edges of the swelling (from shoulder to midpoint of shoulder and elbow) Took 440mg. Naproxen and applied hot compress in the evening. By morning the swelling had subsided by about half. By end of 2nd day the swelling had subsided completely but was still tender to the touch.
got COVID-19 after her first shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID-19 after her first shot) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID-19 after her first shot). At the time of the report, COVID-19 (got COVID-19 after her first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
See Attached email copy of message body I reported in person to clinic personnel on 9/25/2020, upon return to office as never received call back from anyone so emailed to VAERS what occurred on day 2021 after learning never reported so gave again to date, but incident report filed today - 11/9/21 by nurse on duty as no documentation entered last year  Good morning  I have previously contacted your office in regards to clinic reporting my 2020 adverse reaction to TDAP and/or ppd vaccines administered last September by clinic nursing staff. It was advised by your customer service department this was never done and that the information on my vaccine record is incomplete and does not specify manufacturer name or ndc information, but has generic code information which is inadequate.  FYI, this incident was reported in real time directly upon my return to see the RN who read my ppd. She observed an inflammatory response to my right deltoid with raised large Indentation/bubble with redness, itchiness at site and rash to upper area of my body and at the injection site, I also advised my enlarged/swollen glands under my throat 24-48 hours post administration. No physicians were physically present in building die to covid and so the RN informed she will report it and send over to MD. During my visit, I also informed the RN that I took Benadryl and applied cool compress to the site to help with swelling, rash and itchiness, and never have had reaction to any vaccine until then.  The RN advised she would report via VAERS, but your company still does not have and it's been more than a year and per my vaccine record the manufacturer name and ndc code of drug was not entered and says TDAP per your office rep the code on my form is generic and is not valid and I need to have specific manufacturer information, etc. to file the form myself.  I have reached out to the clinic several times including leaving messages with its staff, and to date no call back and no update to your office on record. About 3 weeks ago, I spoke with a representative from your office, whose name I wrote down but do not have with me at the moment, advised she would mail me the paper version so that I may submit that form with a copy of my vaccine record and for your office to investigate, but I have not received this form to date.  Please if you will send the form so that I can send in this information as clinic is not cooperative and failed me as a health consumer.
Severe headache, sore throat, ear ache/ear pain, coughing, fever, chills, arms ache. Feel horrible.
Vaginal infection/rash. Puss discharge from right nipple. Headache. Nausea.
Fatigue, nausea, fever, body aches I took Tylenol and it relieved body aches and fever
After second dose of vaccine, experienced body aches, chills, body pain. This lasted for about 36 hours. At the site of insertion: redness, swelling, warmth, and pain. This also lasted for 36 hours but now site is still red, bruised, and itching.
Terrible pain in both legs and hands; Hasn't been able to get out of bed for two days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Terrible pain in both legs and hands) and DYSSTASIA (Hasn't been able to get out of bed for two days) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DYSSTASIA (Hasn't been able to get out of bed for two days). On an unknown date, the patient experienced PAIN IN EXTREMITY (Terrible pain in both legs and hands). At the time of the report, PAIN IN EXTREMITY (Terrible pain in both legs and hands) and DYSSTASIA (Hasn't been able to get out of bed for two days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sxs started on 7/18 with red bumps that look like white fluid at the site (Left upper thigh) (area about 2x4 inches). - No redness, no induration, had low grade fever after Immz, nothing higher than 100.
Swelling, spreading rash, itchy, painful, hot to touch. Began 1 day post vax #5. Erythema 19x15cm, induration 7x9cm.
After receiving the vaccine  at 10:30AM . around 10:45AM  my tongue swelling, throat swelling began after 15 minutes, a foul taste in my mouth and general discomfort started to move down into my chest. The pharmacy staff was giving me Benadryl 25mg 11:23AM and at 11:40AM 25mg Benadryl again.  12:15PM inner ear feels swollen, 01:00PM drowsiness, 01:23PM  01:30PM - 06:00PM passed out for about 5 hours and then woke up, 09:40PM felt like throat was bruised, and left eye continued to twitch. This morning 01/14/2022 Fatigue, muscle soreness, no fever, it feels as if I have a hangover. Headache is mild and across my forehead, overall body aches as well.
Arm sore for a couple of days; Headaches every day, all day.; Terrible pain in the back of the neck and head; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 12:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included Vitamin D, Multivitamin, and Bupropion all for unknown indications from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 14:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 08:00 the patient experienced arm sore for a couple of days, headaches every day, all day. Terrible pain in the back of the neck and head for the past several days and was not subsiding. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm sore, headaches, terrible pain in the back of the neck, and head was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
My arm got hot, red and swollen. I had significant chills and felt very ill. My physical therapist saw my arm and told me to have it checked ASAP. The next morning I told my nurse practitioner that it was still red and swollen on day four and seemed to be getting worse and spreading further down my arm. I was also in a great deal of discomfort. She examined it and explained that I had developed cellulitis .  I was put on a course of antibiotics which appears to have cleared the infection although I am continuing to have pain in the upper arm.  I have a follow up tomorrow.
This case was reported by a pharmacist and described the occurrence of injection site induration in a 59-year-old male patient who received FLUARIX (batch number L5E9G, expiry date 30th June 2015). The patient's past medical history included no adverse event. Previously experienced adverse reactions included no adverse event. (The patient had no adverse event following previous vaccinations). On 21st October 2014 14:30, the patient received FLUARIX .5 ml. In 2014, an unknown time after receiving FLUARIX, the patient experienced injection site induration and injection site pain. On an unknown date, the outcome of the injection site induration and injection site pain were not recovered/not resolved. It was unknown if the reporter considered the injection site induration and injection site pain to be related to FLUARIX. Additional information received on 14 November 2014: The patient didn't take any concomitant medications, and previously, he had not received any flu shots. The patient, an employee working at the pharmacist, still had soreness in the muscle at the injection site and had a knot in the muscle like the medicine was still in there.
passed out; felt lightheaded; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included hypertension, hypothyroidism, high cholesterol. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 25Jan2021, the patient felt lightheaded since vaccine. On 02Feb2021, the patient passed out. The patient has never passed out before. He went to the cardiologist on 04Feb2021 and had EKG and review of BP readings and HR readings etc., all checked out ok. Today was 08Feb2021 and still lightheaded. The cardiologist suggested we call you but cannot get through. We were extremely concerned about getting the 2nd vaccine because of reports of worse symptoms with that one. We cannot get through to you and do not know what to do. The 2nd vaccine was scheduled for 15Feb2021.The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not recovered from the events. Treatment was received for the event passed out and ordered Exam-EKG-Holter Monitor. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
chills and body aches starting a couple hrs after the vaccine. also developed fatigue, "winded" several days later and that are persting.  Also had a L swollen lymph node under arm that appeared the next day. mild cough and runny nose which have since resolved.
This spontaneous report as received from a register nurse concerning a patient of unknown age and gender who on 21-AUG-2012 was vaccinated with a expired dose of M-M-R II, (lot number reported as 1059Z, expiration date 11AUG2012). No adverse events were reported. Additional information has been requested.
approx 1-2 minutes p/vax pt became completely limp & difficult to arouse; had a strong pulse & nl resp; p/several minutes, pt aroused w/stimulation; pt vomited 10min later; pt had fine rash; dx vasovagal rxn, drop BP;
After 3 hours  of get the vaccination,  I felt  my throat like stuck and I felt  pain in my throat too.The next day  I felt  headache and felt   heat in some parts of my body.
Vaccine administered in right arm,there has been continuous discomfort, and more significant burning sensation with use, in the muscle injected. No improvement noted, possibly getting worse. Otherwise healthy and active individual, pain limiting activity.
Swelling, redness, hot to touch for more than 2 weeks after injection. Met with provider and injection site was still red, raised and warm to the touch. Prescribed 10 day antibiotic. Currently on day 8. Injection site visibly better but very dry. Still slightly warm to the touch.
pt began w/sz activity during noc or 16JUL96;taken to ER by parents & had 2 more sz episodes & adm;to see pediatric neurologist;
Called received from mother 8-25-2022 - return call to mother @ 3:40 pm  - stating that daughters arm is painful, tender and swollen after receiving a TDAP vaccine on 8/24/2022. Mother states having numbness and tingling down to her fingers and pain in the arm since 4 am 8/25/2022. States the nurse from school notified her of the issue of the painful arm during school on Thursday. Mother states having pain from shoulder down to wrist and is painful and tingling from elbow to wrist stated at 3:30 am this morning. Red from shoulder/collar bone to tips of fingers. No hair ties or constriction on the area. Applied alternating ice and hot at 4 am for 15 minutes at a time. Messaged the area yesterday. She has a good pulse in the wrist and fingers move. Nail beds were purple this AM at 3:30 and they are now pink and equal. At 3:30 AM the pain was a 9. The swelling went down after 45 minutes of alternating ice and heat. Swelling is now a 2 and tingling at school was an 8 ? it is now a 4. The tingling gets worse off and on. Can only move her arm a quarter of the way up ? like a chicken wing.  Encouraged to take to ER, walk in clinic or provider for further evaluation.  Follow up call 8-26-2022 Doing well - no complaints and did not take child to ER or walk in clinic  Follow up call 8-30-2022 Doing better - muscle is still sore.  Only tingling in wrist when move arm too much.