chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ALLEGRA and VITAMIN D. On 12Mar2021 at 10:15 the patient experienced nausea, sore left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any therapeutic measure for the reported events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event nausea and sore left arm was resolved on an unknown date in Mar2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Mild erythematous pinpoint petechial rash around eyelids and mild intra orbital lid edema. No urticaria, no pruritus. Patient given one tsp of Benadryl and 2 tsp Prelone and monitored in office.
Received vaccinia 10/5/05, returned for arm check 10/12/05, major response. Returned to office 10/14 c/o fever, chills, arm tender, redness, swelling, tenderness (+) A axilla L streaks, fever at home 102.3 fatigue. Rx'd with Tegreln 400mg po qd #5, 10/15 RTC redness now increased by and original margins with streaking to L axilla (+) 2cm Lymph node, changed to ketele, see additional hospital notes and labs. 11/1/05 per review of medical records, additional symptoms included inability to sleep, stiff neck and back, increased thirst, nausea, left-sided chest pain, and sharp frontal headache. Diagnosis of cellulitis was confirmed. Verbal report by reporter indicates final diagnosis also included myocarditis. Per annual report-10/15/05 Telephone f/u with Dr. Arm symptoms noted on VAERS report were diagnosed as cellulitis.  He relates that this patient was give 15 sticks for his smallpox vaccination as the patient stated he'd had the vaccine in the past.  However, Dr. believes that history is now in doubt due to the patient's age and the lack of a scar from an earlier vaccine. 12/27/05 The discharge diagnosis for the 10/16/05 hospital admission was acute myocarditis. Review of medical records for rehospitalization on 10/24/05 indicates final impressions of atypical chest pain, murmur, mitral & tricuspid regurgitation, dyspnea, and mild dizziness.
Hives on face, arms, legs. Wheezing, cough, vomiting-several episodes.
dizzyness,heart palpitations,weight loss,blurry vission;loss appetite nausea
Pt complained of headache, feeling ill and nausea, onset 1-2 hours, post vax. Had petechial rash at site of vaccine. Atraumatic injection. Treatment with Motrin and Benadryl.
Mom reports pt had high fever and then broke out in rash, rash eventually covered entire body.
sweating, nausea, vomiting, and has been feeling sick.; sweating, nausea, vomiting, and has been feeling sick; sweating, nausea, vomiting, and has been feeling sick; sweating, nausea, vomiting, and has been feeling sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating, nausea, vomiting, and has been feeling sick.), NAUSEA (sweating, nausea, vomiting, and has been feeling sick), VOMITING (sweating, nausea, vomiting, and has been feeling sick) and MALAISE (sweating, nausea, vomiting, and has been feeling sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating, nausea, vomiting, and has been feeling sick.), NAUSEA (sweating, nausea, vomiting, and has been feeling sick), VOMITING (sweating, nausea, vomiting, and has been feeling sick) and MALAISE (sweating, nausea, vomiting, and has been feeling sick). At the time of the report, HYPERHIDROSIS (sweating, nausea, vomiting, and has been feeling sick.), NAUSEA (sweating, nausea, vomiting, and has been feeling sick), VOMITING (sweating, nausea, vomiting, and has been feeling sick) and MALAISE (sweating, nausea, vomiting, and has been feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Medical office consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Approximately 20 minutes after dose was given, patient started complaining of red rash and hives on chest as well as itchy. Patient given 60 mg of Claritin. Patient observed for additional 15 minutes without any other complaints.
Day two fist size hard, warm swelling left deltoid.  Improved for several days Day 7 redness and swelling increased with itching.   It is again gust size, not hard but itchy with blanching No fever, no medication taken but area of redness is getting bigger
Pt called ECDH on 6/24/08 to c/o back pain and muscle aches along w sore throat, swollen tongue, and unable to swallow saliva.Pt spoke clearly. Pt directed to nearest ER for care. Pt voiced concerns over having no health insurance.Reinforced need to go to ER w her complaints.
Fever to 102 degrees at 10 pm.  Followed by chest pain and dizziness per patient's mother.
This spontaneous report was received from a licensed vocational nurse, and refers to four unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. It was reported that, on 29-JUN-2017 and on 30-JUN-2017, the unspecified patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M040271 with expiration date 30-APR-2018 (dose and frequency were not reported), for prophylaxis. No adverse effects were reported. The temperature excursion lasted 15 minutes at a temperature frame of 33°F, recorded by a digital data logger. No previous temperature excursions were reported.
Swollen feet and legs, chest pains, white feet, arm red and swollen, loss of vision.
This spontaneous report was received from a registered nurse regarding an unspeicifed number of patients of an unknown age and gender. The patients medical history or concurrent conditions were not provided. On 27-MAY-2015, the unspecified number of unspeciifed patients received doses of PROQUAD (intramuscualr, lot numbers involved in the temperature excursion were K020750 expiration date 30-APR-2016 and lot number reported as L00400 expiration date 15-AUG-2016) (it was unspecified what lot numbers were administered to patients), that were improperly stored. No adverse experiences reported. This is one of two reports from the same source (MARRS # 1505USA015039). Additional infromation has been requested.
Patient immediately slumped over and then fell off the table. Patient landed on his head and started experiencing tonic clonic movements. Patient urinated on himself. When patient stopped having the tonic clonic movements and came to, he was unaware of the events that had happened leading up to him passing out. He did not know how he got on the floor. 911 was called immediately. Paramedics arrived and patient was transported.
Chills, fever, nausea and vomiting 3 times, myalgia.
After 2 day period of initial soreness at injection site, some mild stiffness in the shoulder but no pain.  Then, starting around noon on Sunday the 14th (1 week  +1day post injection) noticeable soreness and itching of site.  There is a pink/red rash in a circle/oval about 3 inches in diameter. The rash is not obvious but visible.  I applied 1% hydrocortisone cream to the area 1 x The evening of the 14th, again the evening of the 15th.  There is still a knot in the muscle at the injection site though it continues to improve.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (received on an unknown date). Previously administered products included ZOVIRAX. Concomitant products included SHINGRIX. On 19th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 19th February 2019, several hours after receiving SHINGRIX, the patient experienced shingles and pustule. On an unknown date, the outcome of the shingles and pustule were not recovered/not resolved. It was unknown if the reporter considered the shingles and pustule to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX in left arm on 16th December 2018. The patient received 2nd dose of SHINGRIX in left arm. The patient stated that she received the 2nd dose in the morning and later on that same evening, she noticed shingles on the back of her left thigh. The patient stated that her husband could see little pustules on the back of her thigh. The reporter consented to follow up.
Headache, CoughWheeze, Syncope, Joint pain, cough chills Narrative:
Fever, Tmax 101.2, lasting  48 hours. Chills; severe fatigue, still present (it has been over 48 hours). Abdominal pain, still present *for over 48 hours now). Nausea - starting after 24 hours of taking the vaccine and lasted 12 hours.
Sore throat next day. 3 days later. Temp of 103, laryngitis, and sore throat.
Received vaccine at 5:20pm on Wednesday 10/27/21 and got a headache that night. On 10/28/21 at 11am i had to leave work as I felt dizzy, fever, headache, body aches, and fast heart rate. Friday 10/29/21 i woke up about 6am with complete numbness of my lips and my right foot was in severe pain.  Sunday 10/31/21 my heart rate and palpatations were extremely high. Monday 11/1/21 high heart rate and palapatations continued. Tuesday 11/2/21 left work at 3pm to go to Urgent care as I had severe chest pain. When checking in my pulse was elevated and my blood pressure after 3 tries was still high with the lowest at 173/106. Was given high blood pressure medication which I have never received prior as my blood pressure has always been low
21Nov89, 19Dec89 & 22MAy90 pt vax; exposed to needle.  Titer revealed non responder.
Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Patient's symptoms had a very quick onset (of about 2 minutes post-vaccination), and lasted for about 10 minutes before he felt better.
Within the first week of having the vaccination, I noticed handfuls of hair loss.  Within the 4 weeks after the injection so much hair loss, hair breakage and thinning resulted in me having to purchase a full wig.  For 6-8 weeks after the injection I also experienced excessive coughing,  and difficulty breathing that my rescue inhale could not handle so I was using a nebulizer to get relief.
- Ringing in my ears started after 1st dose. - Ringing WORSE after 2nd dose. - The ringing in my ears is horrible. It's very loud and piercing.  - Painful ear ache on the 2nd night. - Tingling in feet. ***Ringing is my ears is sssssooooo bad that I can't sleep. I have to keep the TV on to drown out the ringing. It's absolutely horrible. I really hope this is not permanent. This is torture. I can't even think straight. There should be more transparency on the side-effects, as this is life altering and psychologically damaging.***
RED RING (ABOUT 4-5 INCHES) AT SITE OF INJECTION, STILL THERE ON 3/10
Wrong vaccine administered. The patient received a bivalent Moderna vaccines as their first COVID vaccine. A monovalent Pfizer vaccine was ordered but the only one available in the inpatient pharmacy was the Moderna bivalent vaccine. The pharmacy staff had not been trained on COVID vaccines.
Vaccine reconstituted and drawn up into syringes at 11:00am on 8/9/2021 and expired on 8/9/2021 at 5:00pm. Those syringes were not disposed of at the end of the clinic day and 1 dose was mistakenly given the following morning, after the expiration time. The patient has had no adverse reactions or symptoms and will be revaccinated in the opposite arm today per CDC guidance.
Noted sore throat, malaise, fatigue, dizziness, pain in left arm, "tingling" in arms and legs.  Approximately 1 week later noted 1-2 day history of dyspnea and chest discomfort.
An event of drug administration error when vaccine was administered to an 85-year-old female. The report was received from a registered nurse. No medical or drug history information has been reported for this patient. The woman received a dose of FLUMIST intranasally. On 15-Oct-2007 the reporter indicated an elderly woman was inadvertently administered FLUMIST. The reporter indicated the nurse who dosed the woman was new and not aware of the age restriction for dosing FLUMIST. The reporter stated no adverse events were observed. Outcome: the woman had no ill effects. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable
pt recv vax & exp large swelling from the site of inj down to mid forearm;redness from site of inj down to the elbow;pt given med;pt was adm to hosp on 20OCT98;inj site erythema, 1-5cm diameter mild tenderness w/in24hr;
I had a goose egg on the left arm at the site of the injection. It went away after 24 hours. 1/24/2021 - ringing in my right ear high pitched ringing at 06:00 pm. Never experienced it before. I took OTC allergy medication, and it didn't go away. I saw Dr. 1/27/2021 and the Dr. did not find any fluid or anything wrong, but she gave me- antibiotic and drops Cipro. Those did not help with the ringing. About 2 weeks later, the ringing had not gone away after finishing the meds. At this appt, doctor recommended I go to an ENT. February 17th or so I saw Dr. I met with an audiologist that did a hearing test. And they confirmed that in my right ear that I had mild hearing loss associated with Tinnitus. Then when I saw the ENT, he did a complete exam didn't find an infection or fluids or anything in my outer ear that would create tinnitus. He ordered an MRI.  Had the MRI done the last week of February.  I still have the ringing it never stops. No other treatment after initial treatment from first Dr appt. I did have the second vaccine - 2/25/2021.
Information has been received from a physician concerning a 15 year old patient, who on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella vaccine live (Oka/Merck) (Lot number 657751/0779U). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection sit reaction on the upper arm. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
NO ADVERSE EVENT; a patient was administered improperly stored PROQUAD; This spontaneous report as received from a medical assistant regarding a 2-year-old patient with unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were not provided. On 19-SEP-2019, the patient was administered with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live,rHA (recombinant Human albumin)(PROQUAD) vaccine injection (Lot# S013715, Expiration date: 01-NOV-2020) (dose, dose number and anatomical location were not provided) which was reconstituted with properly stored sterile diluent for prophylaxis use. No adverse event reported. The temperature and time frame were reported as 5 degree Fahrenheit to 46 degree Fahrenheit (17.6 degree Fahrenheit) for 6 hours and 15 minutes. There was no previous temperature excursion. No data logger was involved. No product quality complaints (PQC) were involved.
Patient was giving to many doses of Hep A and Hep B. ALERT was not checked prior to giving this immunization.
Several hrs p/recvd DPT, pts temp went up 105; mom call MD who ordered Pediaporfen which brought temp down;
29OCT91 pt noticed soreness in mouth while eating breakfast; pt went to work @ hosp; @ lunch pt couldn't eat; seen in ER by MD who noted "severe lymphadenopathy & mouth ulcers; pt described raised, pinkish lumps in mouth; sore throat;
9JAN92 pt recvd Engerix-B & 10JAN92 felt very fatigued, felt like hot flashes, forehead, cheeks & chest had fine red rash, t99.4; pt consulted MD, took DPH & recovered; over weekend pt devel pruritus, rash got worse & appeared on abdomen;
ALLERGIC REACTION; SWOLLEN EYELID; VERTIGO; RASH ON NECK; NAUSEA; EYES PUFFY; ITCHY EYES; EAR CLOGGED; EARACHE; RINGING IN EAR; SLEEPY; TIRED; HEADACHE; This spontaneous report received from a patient via Social media concerned a 45 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and pneumonia, and concurrent conditions included asthma, and high cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNNOWN) dose was not reported, administered on 08-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced sleepy. On 08-MAR-2021, the subject experienced severe headache. On 08-MAR-2021, the subject experienced tired. On 21-MAR-2021, the subject experienced earache. On 21-MAR-2021, the subject experienced ringing in ear. On APR-2021, the subject experienced ear clogged. On 05-APR-2021, the subject experienced eyes puffy. On 05-APR-2021, the subject experienced itchy eyes. On 12-APR-2021, the subject experienced swollen eyelid. On 12-APR-2021, the subject experienced vertigo. On 12-APR-2021, the subject experienced rash on neck. On 12-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced allergic reaction. Treatment medications (dates unspecified) included: triamcinolone, ibuprofen, ciprofloxacin/dexamethasone, azithromycin, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ringing in ear, was recovering from earache, and nausea, had not recovered from, swollen eyelid, rash on neck, tired, and headache, and the outcome of vertigo, eyes puffy, allergic reaction, sleepy, ear clogged and itchy eyes was not reported. This report was non-serious.
COVID-19 Breakthrough case. 8/21/21: patient presents to the emergency department complaining of progressively worsening shortness of breath for the past 5 days associated with cough, generalized malaise, generalized body aches and progressively worsening weakness. Has become so severe that she is severely short of breath with minimal exertion.  This prompted her to go to an outpatient clinic where she tested positive for COVID 19 today and was administered Regeneron. Admitted 8/21/21. Note: PFizer Covid-19 vaccine given on 12/21/20 & 1/12/21. Diagnosed and treated for covid-19 pneumonia and acute hypoxic respiratory failure.   9/3/21: discharged Admitted 8/21/21. Tested positive for covid in hospital on 8/23/21. Covid vaccine on 1/12/21. Diagnosed and treated for covid pneumonia and acute hypoxic respiratory failure.  8/3/21: dischaged
Follow up information received from the physician included additional events, medical history, patient date of birth, vaccines received within four weeks, and illnesses at the time of vaccination. Information regarding Flumist nasal solution was received from a healthcare professional regarding a 13 year old female patient who experienced a stuffy nose, a runny nose, abdominal pain, fever, and a sore throat. The patient also received product that was stored at a temperature that was higher than allowable and was not frozen. At 13 years of age, the patient received a dose on 10/18/03. The patient had no relevant medical history. Indication for Flumist was immunization. Product was administered on 10/18/03. Dose regimen was 1 dose 1 time per day (IN). Patient was not taking any concomitant therapy. The patient experienced a stuffy nose, a runny nose and abdominal pain on 10/19/03. She was treated with Triaminic. The patient also developed a temperature of 100.2 degrees F. The physician indicated that the patient received product that was stored by the pharmacy at a temperature that was higher than allowable and was not frozen.
Urticaria - head to toe. 3.75 mL BENADRYL Q12h x 3 days.
Patient screamed for over 8 hours, uncontrollably. Otherwise happy baby. Breastfeeding, Tylenol, rocking would not soothe. Very irritable and in obvious pain. When not screaming, was asleep but woke with night terrors and pain.
Vaccines administered after temp excur; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 30-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 334RL, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   On 1st March 2022, the patient received FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Boostrix. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device and Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter reported that Flulaval and Boostrix underwent above temperature excursion with high 67 Fahrenheit for 14 days and was administered to a patient, which let to Incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040251:Same reporter US-GLAXOSMITHKLINE-US2022040253:Same reporter US-GLAXOSMITHKLINE-US2022040254:Same reporter US-GLAXOSMITHKLINE-US2022040248:Same reporter US-GLAXOSMITHKLINE-US2022040246:Same reporter