chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 2 month old female who was vaccinated PO with her first dose of Rotateq.  Concomitant vaccinations included "standard two month old vaccines."  Immediately after vaccination, the patient's body went limp and the patient stopped breathing.  The physician reported that they did not have to resuscitate the patient, and the patient was fine to leave the office that day."  Subsequently the patient recovered.  There was no product quality complaint.  The physician considered the patient's body went limp and stopped breathing to be life-threatening.  Additional information has been requested.
arm soreness; neck lymph node swelling; This is a spontaneous report from a contactable consumer (patient).  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3246, Expiration Date: 21Apr2021), via an unspecified route of administration, administered in Deltoid Left on an unspecified date at 08:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK5730, Expiration Date: 31Mar2021), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced arm soreness lasted for only 1 day. The patient experienced arm soreness, neck lymph node swelling lasting for only 1 day on an unspecified date. The outcome of events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Really stiff; Hurts a lot/it's been like a week and a half; Really swollen; 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 VACCINATION SITE INDURATION (Really stiff), VACCINATION SITE PAIN (Hurts a lot/it's been like a week and a half) and VACCINATION SITE SWELLING (Really swollen) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Really stiff), VACCINATION SITE PAIN (Hurts a lot/it's been like a week and a half) and VACCINATION SITE SWELLING (Really swollen). At the time of the report, VACCINATION SITE INDURATION (Really stiff), VACCINATION SITE PAIN (Hurts a lot/it's been like a week and a half) and VACCINATION SITE SWELLING (Really swollen) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received and AE information updated, event outcome updated as recovering/resolving.
Arm was just sore for a couple days after the shot at site of injection. It got better after a couple of days.  On Tuesday, July 13 at approx 9:30 pm the arm started hurting just below the injection site and felt warm in that one spot.  I had on a tank top and it was cool in the bedroom.  It is now Thursday afternoon and it is still sore and warm to touch in that spot and the arm is a slightly weak and sore feeling all over.  Not too bad.  It is not getting worse, just not any better.  I just went to the doctor and she is sending me to have an ultrasound just to be on the safe side to rule out a blood clot.
Metallic taste and swollen lymph node around the neck area below the jaw line (submandibular area maybe).
This spontaneous report was received from a Registered Nurse, referring to an unspecified number of patients of unknown demographics. No medical history nor concurrent conditions were reported. On unknown dates, unspecified number of patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L002419, expiration date 23-JUL-2015; lot # L005293, expiration date 17-AUG-2016; lot # reported as L008353, expiration date 11-SEP-2016 and lot # reported as L010142, expiration date 24-SEP-2016) (strength, dose, route and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
I ended up with COVID-19 in April 2002. It started Saturday morning with a headache. It got work. to a home test. Started coughing the next day the test was negative at first. I went to work that day and at night I felt worst. took another test and it came out positive. I am in quarantine in has been 2 days so far. I spoke to doctor over the phone. I have been resting and drinking fluids.
ringing in his ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in his ears) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Ringing in ears.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TINNITUS (ringing in his ears). At the time of the report, TINNITUS (ringing in his ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      Reporter did not allow further contact; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.
Approximately 8 minutes after receiving the first dose of the Pfizer-BioNTech COVID-19 vaccine, the patient reported feeling ?funny?.  She described symptoms including itching/tingling, sweating and increased heart rate.  She was immediately ushered into the counseling room of the pharmacy and a blood pressure monitor was attached to her arm.  At 2:09 p.m. her blood pressure was 166/78 and heart rate was 98 BPM.  At this time 25mg of diphenhydramine was given to the patient orally.  In addition to the subjective symptoms, the patient?s complexion had turned from neutral to red, and her face was covered in what appeared to be hives.  EMS was called, and while on the phone with a dispatcher, a subsequent reading found the patient to have a BP of 140/122 and HR 121 BPM (2:15p.m.). As instructed by the EMS dispatcher, 0.3mg was administered to the patient via auto-injector into the left thigh.  Paramedics arrived several minutes later and the patient was helped onto a stretched and subsequently escorted from the building for further observation and treatment.
Within 4 hours I had chills, fever, body aches, severe headache, nausea, vomiting, and a racing heart rate. At rest my normal heart rate is 55; but that night at rest it was 108 bmp
Itchy arms, drowsy, chills, rash on arms, hard raised surface at injection site, woozy head, body aches
2009 - cold sores (oral) 2 wk antiviral & topical med. 2010 - shingles - 2 wk antiviral tx.
Pt presented with swollen left biceps and chest area. Area was warm to the touch and spreading down arm. Started approx 1" below injection site and ended at elbow.
6 cm hot, red, indurated, painful area, increasing in size each day; low grade fever; fatigue; axillary pain
Patient states she received her second vaccine on April 13, 2021 and developed injection site pain same day. She states it was just like the pain she had with first shot except this pain never went a way. When she saw Dr. for her annual visit in June she mentioned it and at that time had a loss of range of motion + upper arm pain. Dr. diagnosed her with tendinitis of left rotator cuff and gave her some home exercises to do. Patient contacted Dr. in August 2021 and stated arm no better and asked for a referral to physical therapy. Dr. ordered physical therapy and the patient was seen on 8/16/2021. The physical therapist recommends skilled physical therapy in conjunction with a home exercise program to address the left arm pain and decrease range of motion. The following is a summary of what is captured in the physical therapist note:When looking at the range of motion assessment there is a difference between the right and left shoulder in the following areas:  Should Abduction, Shoulder Flexion, and range of motion of left shoulder. When looking at the palpable pain assessment there is pain in the deltoid muscle and areas surrounding it.
dizziness, nausea, chills, no fever. rested for 8 hours and symptoms gradually subsided
No adverse reaction from 1st dose. 14 hours after 2nd dose I fainted after waking up to go to work. I was unconscious for 13 minutes. My alarm goes off at 5:25am I went to the bathroom got undressed and the next thing I remember is opening my eyes and realized I was on the bathroom floor. I called for my husband and he got me up at 5:43 am. Estimating I was awake for 2 minutes before fainting and 3 minutes before I was able to call for my husband. I would say I was completely unconscious for close to 13 minutes. I still feel absolutely horrible today. I did not go the ER but now I?m thinking that was a mistake. My headaches are still very bad and still not able to stand up for long periods of time. The bump on my head and black eye are healing so I know that?s a good sign but I still overall do not feel normal. I want to report my experience to someone.
development of vomiting and purpura on 10/19, leg swelling/pain/difficulty bearing weight on 10/21, dx of HSP on 10/21
Chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient received bnt162b2 (BNT162B2), administration date 16Jan2022 11:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of chills, headache.  Additional Information: Additional Context: Reporter stated, "he is calling for his wife who had a shot this morning about 11 o'clock. And she is having chills and a headache. He stated, "Is there anything we can do other than, he gave her two Tylenol extra strength a half hour ago (treatment)." Reporter was suggested to visit the nearest Physician or ER in case of emergency. Further probing could not be done as the reporter was unwilling to share any further information. Hence limited information available over the call.  The lot number for [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Tested positive for covid; This is a spontaneous report from a contactable consumer.  A female consumer of an unknown age reported that received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9269) on 03Feb2021 at 0.3 ml single for COVID-19 immunization. Medical history and concomitant drugs were unknown. The consumer reported she got her first covid vaccine and she tested positive for Covid on 10Feb2021. She had minor covid symptoms. Caller thought she probably got covid from the OR since she worked in a hospital. Asking what manufacturer recommendation is for getting the second dose. Caller wanted to know if she should delay her vaccination.
No additional AE/no PQC.; Nurse reported AE related to improperly stored and administered PROQUAD; This spontaneous report was received from a Licensed Practical Nurse (LPN) and referred to a patient of unspecified age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 19-JUL-2023, the patient was vaccinated with an one (1) improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live s (rHA [recombinant Human albumin]) (PROQUAD) injection (strength, dosage, vaccination scheme frequency, dose number, route of administration and anatomical site of application were not reported; lot number W029543 with an expiration date reported and established as 14-MAR-2024) (product storage error) for prophylaxis.  It was stated that the suspect vaccine had a temperature excursion of 6.93 degree Fahrenheit (F) with a time frame of 1 hour 13 minutes. Also experienced a previous temperature excursions of  52.01 F with a time frame of 2 hours and 6 minutes; and 9.74 F with a time frame of 4 hours and 34 minutes.  No additional adverse event (AE) was reported.
This spontaneous report was received from a certified medical assistant and refers to multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored ROTATEQ lot# L046318 with expiration date: 28-SEP-2017, orally (dose was not reported). Administered doses of ROTATEQ underwent temperature excursions at 31 Fahrenheit degrees, for 189 hours (7 days and 21 hours) (2 cycles). There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
YF-VAX had an excursion and were administered to a patient, with no reported adverse event; YF-VAX had an excursion and were administered to a patient, with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received from a nurse. GMI number: 01270287  This case involves a 9-month-old male patient who had YELLOW FEVER VACCINE - [YF-VAX] after excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, nurse reported yf-vax had an excursion (product storage error).  On 07-Sep-2022, the patient received suspect YF-VAX vaccine post excursion at dose 0.5 ml once via subcutaneous route in the left leg (lot UJ563AA, expiry date: 23-May-2023) for prophylactic vaccination with no reported adverse event (poor quality product administered) same day latency. It was not the first time of product use. At time of report, product was not in use.  It was reported that "Nurse called to report that her YF-VAX had an excursion and were administered to a patient. Nurse also wants to know if they need to revaccinate and if they could return or reimburse the vaccines. Nurse also confirmed stability information just to make sure she has right info. Agent advised nurse to contact customer service with regards to replacement and reimbursement. Agent provided contact details."  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both events.  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 guidelines. 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.
pt recvd vax; 2 hrs later, devel v & d, lasted about 1 hr & resolved;
At an off site flu shot clinic today, I advertently administered the FLUZONE Intradermal twice to this client. I observed no redness or "wheel" at all. So I thought that this shot was invalid. When I reviewed the prescribing materials, it stated that redness and/or "wheel" might occur. It didn't say that it must occur. I then administered a second dose to the opposite arm.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 04-FEB-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J004319 and expiry date: 17-OCT-2014) which was improperly stored. Primary reporter was reported excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall support range of -58 F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Pain at injection site Diaphoresis, no fever chills body aches headache stiff neck upset stomach/nausea
rapid heartbeat; edema extended from her shoulder to her elbow (redness, swelling and edema at injection site); redness at the injection site; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist (caregiver).  This case involves a 51 year old female patient who experienced rapid heartbeat (tachycardia), redness at injection site (vaccination site erythema), edema extended from her shoulder to her elbow (swelling and edema at injection site) (extensive swelling of vaccinated limb), after she received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date in Oct-2020, the patient received a 0.5 mL dose (frequency once) of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (pre-filled syringe, lot number and expiration date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in Oct-2020, the patient developed a non-serious rapid heartbeat (tachycardia), redness at injection site (vaccination site erythema), edema extended from her shoulder to her elbow (swelling and edema at injection site) (extensive swelling of vaccinated limb), within few hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that the patient did not experience dyspnea. Reporter is concerned that patient may also react to the COVID vaccine and is asking for any available information  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The patient was recovered from all the events at the time of reporting.  There will be no information available on the batch number for this case.
Information has been received form a registered nurse concerning an unknown number of patients who were vaccinated with GARDASIL (lot number not reported). The nurse reported that the patients received GARDASIL (lot number not reported) that had been stored at 33 degrees F for 12 hours. No adverse effects reported. Additional information has been requested.
PATIENT DEVELOPED FEVER, WEAKNESS, DYSPEA, NAUSEA, VOMITING, DIARRHEA, WITH AN O2 SAT OF 80% ON ROOM AIR AND RESPIRATORY OF RATE OF 40.  PATIENT TESTED POSITIVE FOR COVID 19 AND WAS HOSPITALIZED, LATER PLACED IN ICU
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a adult male patient who received SHINGRIX. Concomitant products included allopurinol. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th April 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness, injection site hyperesthesia and pain in arm. On an unknown date, the outcome of the tiredness, injection site hyperesthesia and pain in arm were recovered/resolved. It was unknown if the reporter considered the tiredness, injection site hyperesthesia and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient reported that he felt little tired within hours of receiving the SHINGRIX vaccine. The patient's arm was sore (less than a day after vaccination) and it resolved within two days. The patient also experienced some sensitivity at the injection site (less than a day after vaccination). The patient had denied permission to contact their physician.
Severe Constant headache, throwing up, body aches, full left side of back in pain, cough, chest congestion, sinus congestion. I don?t want to get the second shot, is that ok?
Right arm - 2 spots - red next to each other swelling, parts of area raised, warm to touch, painful.
PATIENT STATES THEY STARTED HAVING REDNESS AND ITCHINESS AT SITE OF INJECTION STARTING IN THE MORNING ON 11/5.
Shingles as possible side effect; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles as possible side effect) in a 7-decade-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced HERPES ZOSTER (Shingles as possible side effect). At the time of the report, HERPES ZOSTER (Shingles as possible side effect) outcome was unknown.            No Concomitant and Treatment were reported.
chills, headache, tired, loss appetite for a weeks, tingling throughout entire left arm,
Nausea; Vomiting; Stomach cramps; Fever; Chills; Sweats; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8127) in the left arm on 26Mar2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to "all meat". The patient did not receive any medication within two weeks of the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 30Mar2021 at 05:30, the patient had experienced nausea, vomiting, stomach cramps, fever, chills, sweats and headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, vomiting, stomach cramps, fever, chills, sweats and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.