chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented at 17:30 with itching of her face and eyes after being vaccinated with the J&J COVID-19 vaccine at 17:15. Doctor advised to administer Benadryl and discharge if improved after 30min.    Patient had no complaints of dizziness, lightheaded, patient's breath sounds were bilaterally clear. Patient had no stridor, no tightness of the throat or swelling of throat or tongue.   Patient was given 25mg of Benadryl at 17:35 and an additional 25mg of Benadryl at 17:50 due to continued itching and redness of the face, eyes, and forehead.   Patient improved after administration of Benadryl with reduced itching of the face and eyes. Patient's father is driving her home. Patient was advised that if her symptom worsen, or she feels swelling of the throat or tongue, or difficulty breathing to call 9/11. Patient's breath sounds were clear when discharged at 18:15 with no complaints of difficulty breathing, and no stridor.    VS 17:35    BP 151/87, HR 88, SpO2 98%    T 97.8   VS 17:50    BP 148/88, HR 81, SpO2 98%   VS 18:05    BP 141/91, HR 84, SpO2 100%  Patient went home and took a nap when she woke up, felt fatigued and tired w/ nausea/vomiting, vomiting while on call, shaking, tachy, p=110-120, and groggy, very weak  Non bloody. Was shaking at home. Possibly was anxious about how she was feeling.  Patient went to ED and was examined with no skin rash, no swelling, no sob. Patient was administered Ondansetron (4mg). Lactated Ringers IV Bolus (1,000 ml), and Acetaminophen (1,000 mg) and discharged.
rom:  To:  Cc:  Subject: Patient Concerns Date: May 29, 2021 6:42 PM  Dear Sir/Madam,  I would have liked to include her in this message but am not in possession of her official email address.   To recap the encounter on April 29, 2021  :  I went with my friend to the clinic,where we spent 12 most frustrating hours  I expressedly told the staff with my friend present, that I have been an extremely healthy individual, who has never seen a doctor,/ER/hospital in over 40+ years. I am happy to give you  my previous employers contact info to verify that I never missed a day`s work.  I told the staff I suddenly fell very ill 2 days ago 2-3 weeks after my 2nd CVID 19 vaccination. with sudden massive bilateral leg edema up to the groin and extensive lower leg blood staining and mottling of my skin.  The attending dr just called it Pedal Edema. He was not interested in my history (present and past), no examination, had to remove no clothes. My friend and later neighbors in the community where flabbergasted that he did not see the state of my legs. Obvious other symptoms such as abdominopelvic ascites was also present. Further tests were done and inexplicably suddenly pulmonary atelectasis and cirrhosis of the liver become important. Could that really make me so sick in two days?  Absolutely incomprehensible. there was an avalanche/cascade of blood destruction with destruction of RBCs, hemolysis, loss of platelets, obvious very high total  bilirubin, hypoalbuminemia and ascites. My bed sheets still show numerous blood stains where I bled from many of the skin lesions and scabs Those were all results due to one common denominator:: reaction to COVID vaccination. Forget about pulm atelectasis or liver cirrhosis making me so sick in 2 days i AM INTERESTED TO SEE YOUR EXPLANATION  A quick comment for her and her comment about compassion, She is probably unaware, that are quite a few nations in this world, where medical colleagues do not charge their colleagues/family and the pastor/family of their church, I lived/worked for a for a few years in another country. One night I was called to drive into one of the park's camps to attend to a colleagues wife who had an incomplete miscarriage and bleeding, This was quite a drive through the night back to the hospital, doing a D&C and the couple could happily continue their journey that afternoon. No charge by the hospital or me. That is compassion. Dr.
Systemic: muscle twitch-Medium, Additional Details: muscle in vaccinated arm began twitching about 1 hour after dose and has continued every 30 seconds since
Client reports on 8/29 at 9 am she noticed redness, discomfort  and swelling in R posterior arm. On 8/30 client came to public health at 3:30 PM to notify staff of reaction. I took her information of the event and assessed site where vaccination occurred- Right posterior arm- mild edema, erythema mild- measures 70 by 90 mm with a central area of moderate erythema which is firm on palpation. Site is warm to touch. Temperature 99.6. Client denies any SOB, no difficulty swallowing, breathing, no rapid heartbeat. Client worked today without any distress or difficulty. Client reports itching and discomfort of RPA today. She has taken no medications-she is  breastfeeding. I advised ice to site, increased fluids and advised f/u with medical care if fever or swelling, pain increases.  Recheck 8/31. Client is on no medications and is breastfeeding. On 8/31 at 1: 50 client returned for recheck of RPA. Edema minimal, mild erythema spread in distal pattern. Central area of moderate erythema, 3 cm size remains firm. Entire site warm to touch. T- 99. Due to spread of erythema and continued central firmness - advised client to followup with medical provider for evaluation. Client states she is going to  Acute Care today as she is not working today.
Patient states she had an allergic reaction within 14 minutes of getting her first Covid vaccine. Chest Pain, difficulty breathing, felt like her throat was closing and her lungs were caving in, had an abnormal cough sounding like the cough she makes when she is having an anaphylactic reaction. She used her Epi-Pen and is much better. Her neighbor is monitoring her and will continue to do so. After speaking with Dr., I told her that she needed to go to the ED immediately if she experiences worsening shortness of breath or if her throat feels like it is closing again. She voiced understanding.  I told her she may still feel flu like for a few days which is a normal side effect of the vaccine. She will let us know if she has any further concerns. I told her that we would report this to VAERS.
Pt administered the 6 month-4-year monovalent vaccine.  Should have gotten the 5 and older bivalent,
8 days later I had pain in my right knee and went up to my thigh. It got so bad that I had to get a cane because I could not walk on it. I went to the doctor and she did not know what it was. It took me about a month to recover.
itchy, sensitive at site of injection; sensitive at site of injection; Size of half a raisin -slightly raised and slightly swollen; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available at the time of the report), via an unspecified route of administration at the left arm (reported as left shoulder) on 31Jan2021 at SINGLE DOSE for covid-19 immunization. The patient had no allergies to medications, food, or other products and no other medical history. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19, since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included finasteride (reported as Generic form for Propecia: other medications the patient received within 2 weeks of vaccination). It was reported that itchy, sensitive at site of injection - started 24H after (reported onset on 01Feb2021) and still sensitive 48H after. Size of half a raisin -slightly raised and slightly swollen. Case/ events were considered non-serious. The outcome of the events was not recovered. No treatment was received.   Information on the lot/batch number has been requested.
Paxlovid: Treatment of COVID-19; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19".  Clinical course: Rebound, symptoms 10 days after medication. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of administered half dose, scratched the inside of nose and nose bleed has been received from a registered nurse/health professional concerning a four-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 22-Jan-2010, the patient received H1N1, Intranasal via nasal route for an unknown indication. On 22-Jan-2010, after inserting the syringe tip of the H1N1 LAIV into nose, the patient jerked her head back so hard that it scratched the inside of nose and it bleed. Only half dose was administered and the other nare was not dosed. There was no symptoms at the time of report. The outcome of the administered half dose was considered to be resolved and of scratched the inside of nose and nose bleed was resolved on an unknown date of Jan-2010.
A patient received DTaP #3, IPV #3, Comvax #1, on 02/21/01 during her well baby visit. The patient was found blue and unresponsive at home midday on 02/26/01. She was transferred to the ER unable to resuscitate. The ER Dr states the patient was secured in infant seat device to maintain upright position. The patient was found in infant seat turned on side , the foster mother had been out of the room approximately 10 minutes. ER doctor states "probable positional asphyxia"). The patient had been well prior to death.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. The patient's medical histories and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) lot # K020758 with expiration date: 31-OCT-2016 and lot number (reported as) L000453, expiration date: 06-JAN-2017 (administration route was not reported). No concomitant therapies were reported. The vaccine doses that were administrated were exposed to a support temperature excursion (+1C for 4.5 hours) on unspecified dates. No adverse events were reported. Additional information has been requested.
Local reaction, quarter sized erythema to arm.  Blanches, non tender, not raised.
Patient received an expired dose of fluzone QIV with no reported adverse event; Initial information was received  on 14-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 57 years old male patient received an expired dose of fluzone qiv with no reported adverse event after receiving influenza quadrival a-b multidose vaccine preserved [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Oct-2022, the patient received a dose of 0.5 ml suspect influenza quadrival a-b multidose vaccine preserved (suspection for injection) (Frequency: once) (lot number: UT7316NA,Expiration date:30-Jun-2022)(strength: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) .  On 12-Oct-2022 the patient received an expired dose of fluzone qiv with no reported adverse event (expired product administered) (latency: same day) following the administration of influenza quadrival a-b multidose vaccine preserved.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event patient received an expired dose of fluzone qiv with no reported adverse event.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Patient rec'd PPSV23 (state supplied) vaccine in her (L) upper deltoid on 1/17/17. On 1/18/17, pt. began to experience pain at the injection site along with some redness and swelling. Pt also reported "feeling feverish" overnight. Pt was seen in clinic on 1/19/17, (11:19am). Pt was prescribed BACTRIM DS 800-160mg. (1) tab PO BID for 10 days. Pt advised to call if not completely better. No call from Pt. RN 2/2/17
Dad notified school nurse that when student got home from school his back was bleeding. When parents looked at back, hives noted. Benadryl administered per parents.
On 7/11/01 at 21:00, pt had a fever of 101F and vomited. On 7/12/01 AM, pt had a fever of 101F, swelling of face and hives on face. The pt also, complained of a sore throat. Pt was seen by ER physician at 15:00 on 7/12/01 and he said that the pt had fluid in ears and tonsillitis. Antibiotics were given.
No additional AE reported; Inbound call from CMA who reports improperly stored MMR II was administered to 2 patients.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT).   On 15-JUL-2023,  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHa) (M-M-R II) underwent temperature excursion for 30 hours in above 14 degree Celsius (9C) (Product storage error). On 17-JUL-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHa) (M-M-R II) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).
Patient arrived to Pharmacy for his 2nd booster dose of the COVID-19 vaccine. Upon arriving to the pharmacy, the pharmacy intern checked the patient in for his appointment, but was not aware of the updated CDC guidelines that restricts the 2nd booster dose of the Covid-19 vaccine to those who are either 50 years old and older, or those 12 years old and older who have an immunocompromising condition. The patient received the vaccine, it was not until after the patient left the pharmacy that a pharmacist working at that location noticed the error and reached out to me for guidance.
About 12 hours after the vaccine, I awoke in the night, aching joints and muscles throughout the night, hard to turn over, had the urge to stretch and tense my muscles. In the morning I got in the hot tub, took Naproxen, and walked 3 miles to pump the pain out of my muscles. I began feeling better throughout the day, and 24 hours later I felt quite normal again with the exception of soreness in the injected arm. 48 hours later the soreness is nearly gone.
Patient receiving Moderna booster after having received 2 shot series of Pfizer COVID vaccines.  She felt feverish and fatigued the next day and then about 36 hours after administration, developed episodic non-positional dizziness associated with nausea, vomiting and fever.  She was unable to keep food down for about 2 days.  Her dizziness gradually abated and resolved by the 6th day after vaccination.
Information has been received from a physician concerning a 30 year old female with no known drug allergies who on 28 Dec 2000 was vaccinated with MMRII(Lot #637255/1380K) SC.  It was reported on 01/09/01, the "last night" the patient started developing some discomfort of her ears, particularly the right ear. On the morning of 01/09/01, the patient started experiencing some diccomfort of the left ear. The patient used Q-tips and there was some significant discharge on the tip. The patient had awareness, a discomfort, of both ears and she noticed some lumps particularly on the right posterior cervical area. The patient denied any sore throat, runny nose, shortness of breath, or any coughing. The patient did have a couple of papillar lesions on her skin and perhaps a little itchiness. The patient took acetaminophen (Tylenol Regular Strength) without any relief. The patient denied fevers and chills. The patient's blood pressure was 120/70, pulse was 68, weight 200 and temperature 37.2 C. The HEENT was essentially negative. The patient did have some erythema in the posterior pharyngeal area and a small definite mobile firm lymph node approximately .5 cm in diameter at the angle of the jaw on the right side. The patient also had what appeared to be two lymph nodes approximately 1 cm in diameter behind the right ear. They were almost confluent and she had one behind her left ear. There was fluid in both ears and her lungs were clear. The physician's reported impression was cervical adenopathy, bilateral serous otitis media, erythematous pharynx without any other symptoms. The physician reported that the symptoms were "probably related to viral infection." The physician was concerned enough about the adenopathy that it was "important for her to follow-up with her own PCP." The patient sought unspecified medical attention. No further information is expected.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 1st of 43 adult patients described by the reporter.
Client states area around vaccination site is red raised itchy and the size of 2 quarters side by side.  Advised to seek medical attention if worsens or is bothersome.
Face flushing, " rolling hot flashes", head fullness. This lasted about 10 to 15 minutes, intermittently then dissipated.
Vaccine  8 a.m.  felt funky at abt 4:00pm  and fever hit 5:00 pm102 fever until  abt 2 A.M , then headace, chill ,fatigue, are painful to touch.  rest of symptoms resolved at 11 a.am. next day except headache.
Tested positive symptomatic COVID-19 on 04Jan2021.; Tested positive symptomatic COVID-19 on 04Jan2021.; High grade fever up to 104F after booster dose on first 24 hours with headache; High grade fever up to 104F after booster dose on first 24 hours with headache; This is a spontaneous report from a contactable physician (patient). A 42-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot unknown: EK5730), intramuscularly on left arm on 23Dec2020 at 08:45 AM at single dose for COVID-19 immunization. Medical history included hyperuricaemia and hypertriglyceridaemia. Concomitant medication included fenofibrate and febuxostat. The patient was tested positive symptomatic COVID- 19 on 04Jan2021. Symptoms started 01Jan2021: recovered at home. High grade fever up to 104F after booster dose on first 24 hours in Dec2020 with headache. The patient received other vaccine same date (reported as) on 13Jan2021 as second dose on IM left. The patient did not receive any treatment from events. The outcome of events was recovered on unknown date.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 23Dec2020, and COVID-19 test positive on 04Jan2021. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.