chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Improperly stored of the improperly stored temperature excursion; This spontaneous report was received from a nursing assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported.   On 20-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, for prophylaxis, lot # S038698 and expiration date reported as 01-DEC-2021.  The temperature exursion was reported as -10.°C, on a time frame of 1 hour and 53 minutes. There was no previous temperature excursion.   A digital data logger was involved.   This is one of several reports received from the same souce.; Sender's Comments:  US-009507513-2008USA014798: US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015035: US-009507513-2009USA000113: US-009507513-2009USA000117: US-009507513-2009USA000132: US-009507513-2008USA014806: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014705: US-009507513-2008USA014757: US-009507513-2008USA014803: US-009507513-2008USA014825: US-009507513-2008USA014888:
On the 5th day, I started to feel like I had no control of my head, like I was falling to my left side. It was then explained  to me as strong vertigo. To the point where just turning my head a little bit would make me feel dizzy and overall discomfort. I was unable to concentrate, sleep and could barely work. At one point, I grabbed something from the floor and almost hit my head because I lost balance and went face down to the floor.
Rash at injection site,  Injection site sore,  itchy and warm to the touch. Patient used over the counter Benadryl and Hydrocortisone cream for the last 2 days. Patient went to Physician.  Diagnosis is undetermined.   Could be an allergic reaction, cellulitis or the body's reaction to fighting off a virus.  Patient prescribed Cephalexin, told to continue Benadryl at night and Hydrocortisone during the day.  If it continues to spread, call the office back or see their primary physician.
passed out; Chills; nauseated; fever; body aches; got a little sick; feeling tired; after the second shot for two weeks and three days she felt better from her arthritis and fibromyalgia; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 68-year-old female patient received second dose of bnt162b2 (Batch/Lot Number: EP7533; Expiration Date: 05Jul2033), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at age of 68-year-old as single dose for covid-19 immunisation.  Medical history included arthritis and fibromyalgia. The patient received first dose of bnt162b2 (Batch/Lot Number: EN6208), on 09Mar2021 at age of 67-year-old as single dose for covid-19 immunisation. No family medical history relevant to AEs. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No AEs following prior vaccinations. There were no concomitant medications.  She already had both doses of the Pfizer COVID vaccine. She got a little sick the night of the second dose, chills, body aches, when she got up in the morning she was so sick during the night. She wasn't drinking or eating. She felt very nauseated and called for her husband, he came in and grabbed her and she passed out, and her husband had to call the ambulance. Body aches was all through the night with the other symptoms. She had four blankets and had an electric blanket she was running a fever. Fever started in the evening of the shot 30Mar2021 around 5 or 6 o'clock. Her appointment was at 1 and then it was 2 or 2:30 she started feeling tired. No treatment was received. She was really sick for 2 days. She had chills lasted until the following day. She recovered completely. Two days later she noticed her arthritis was gone and she doesn't have it anymore and wanted to report that. She started drinking and eating a little bit. She clarified that for two weeks and three days, she felt better than she has felt for the last 20 or 30 years but then it came back. Caller clarified it was after the second shot for two weeks and three days she felt better from her arthritis and fibromyalgia. Vaccine Administered at Facility (Vaccination Facility Type). The AEs did not require a visit to Emergency Room and Physician Office. No relevant tests. The outcome of event "after the second shot for two weeks and three days she felt better from her arthritis and fibromyalgia" was unknown, of other events was recovered (reported as recovered completely).
A patient was positive for covid after receiving 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (A patient was positive for covid after receiving 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced COVID-19 (A patient was positive for covid after receiving 1st dose). At the time of the report, COVID-19 (A patient was positive for covid after receiving 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2021, SARS-CoV-2 test: positive (Positive) COVID-19 Positive..   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a female patient, unknown age, with no disclosed medical history, who experienced the non-serious, unexpected, AESI event of Covid-19. The event occurred  11 days after first dose of Moderna vaccine. The rechallenge is not applicable as patient only received first dose. The benefit-risk relationship of Moderna vaccine is not affected by this report.
pt recv vax & between 24 & 72 hr post vax pt exp fever, sometimes greater than 103, chills, & nausea;an ER or MD visit was required;lab work was ordered & pt was found to have an elevated LDH;
Red, swelling, sore arm that last several months. Patient talked to her doctor; was taking CLARITIN for allergic reaction. Arm in not swelling or red now but still sore.
A few mins p/vax pt stiffening of extremities & body, but no jerky movement or rolling of eyeball; lasted about a few mins.
14years old given flublock vaccine with no reported adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Global Media Information (under the reference 00839602).  This case involves a 14 years old male patient whom given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines.  On an unknown date, the patient received a dose of suspect FLUBLOK QIV ( oral suspension, once, lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication Inappropriate age at vaccine administration (same day latency).  It was reported "Pharmacist is asking why FLUBLOK is for 18 and over because a friend's child was administered it at 14 years of age? Caller declined to provide the street location of her pharmacy saying it wasn't given at their pharmacy. Pharmacist states she thinks the injection was given yesterday and the child looks 18 but is 14 and her friend's son."  At time of reporting, the outcome was unknown for the reported 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 by the regulatory authority. 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.  There would be no information on the batch number for this case.
Severe pain in shoulder and entire upper arm on the day of the injection (9/28), worsened through 10/1. Unable to touch upper arm or lift it, required assistance showering and getting dressed. Morning of 9/30 a large rash appeared on my upper arm, not at the site of the injection but about 5 inches below. Swollen, bright red, extremely tender to the touch, about the size of the palm of my hand. Evening of 9/30 the rash had doubled in size on my arm, still below the injection site. Notified my doctor so we could monitor over a digital platform, sent him pictures and descriptions. Morning of 10/1 the rash had again doubled in size covering half of my upper arm, now a darker red, still extremely swollen and very tender. Evening of 10/1 the rash had increased in size, covering over half of my arm. Pain and swelling the same. Evening of 10/2 the rash covered about 3/4 of my upper arm, but the swelling, red color and pain was not as intense as previous days. Morning of 10/3 the rash and pain appeared to be fading, continued to do so over the next couple of days until it ceased entirely on 10/7.
A non-serious spontaneous report of "we gave expired H1N1 to several patients" was received from a registered nurse/health professional concerning a four-year-old male out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date was 12-Feb-2010, that had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
7days p/vax pt vomit all day, that evening to hosp; x-rays dx intussusception; intussusception reduced by contrast enema
Local reaction at site. Large 10x10 cm circular, erythematous reaction on right thigh, warm to touch, swelling.
5min p/vax pt was sitting next to mom in waiting room & fell against her-unresponsive;mom called for help; color pin, resp WNL;unresponsive for 1 1/2min;woke screaming w/abd pain;resolved w/in 5min;
Patient arrived with her husband and both were administered the Pfizer Covid 19 vaccine at 3:16pm. Patient  expressed nervousness prior to getting the shot. A few minutes after getting the vaccine, patient complained of lightheadedness and dizziness and feeling hot. Pharmacist went out and elevated patient's feet and took her blood pressure which was elevated (147/111,and pulse 94). Patient was offered water and advised to take sips. Rph then put icepack on patient's forehead and wrists, which patient stated felt good.  Code white was called. About two minutes later, patient stated that she was feeling worse. Dizziness was getting worse and she was extremely lightheaded. At this point, patient became unresponsive to her name. EMS was called at this point. Pharmacist then lowered patient to the floor. Her pulse and blood pressure were taken again which were elevated even more (202/122). Patient started to respond after a few minutes to her name (husband was calling her name). EMS arrived and took over, taking patient away.
feel miserable; This case was reported by a consumer and described the occurrence of feeling miserable in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was unknown.   It was unknown if the reporter considered the feeling miserable to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received shingles shot and the patient felt miserable. For tolerance of Nucala, refer case US2020226625, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020226625:same patient
I received my first vaccine on 01-29-2021 and I experienced shingles two weeks after around 02-12-2021. My shingles were located in my back and below my breast. I can not wear a bra due to the pain I experience. My shingles were very bad that they had to postpone my second vaccine 16 days later of my original date. I also suffer from rheumatoid arthritis. I noticed with the first vaccine that my rheumatoid arthritis calmed down. I also developed a cold which was short lived and I felt very sleepy. I do not have lot# to provide.
Rash behind ears, neck, trunk rash started 5-3-15 approx 10 days after immunizations administered.
Swelling at the injection site, red rash area about 2 inches wide below injection site that nearly encircled the arm, itchy -- all lasting about a week; had no reaction to the first shot
Information has been received from a consumer concerning her 12 year old daughter with a penicillin allergy, who on 22-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot # 654272/0073x). There was no concomitant medication. On 22-FEB-2008, approximately one hour post vaccination, the patient developed hives or her legs. The patient sought unspecified medical attention. Diagnostic testing included testing for yeast allergy with no results reported. On 22-FEB-2008 the patient recovered. No product quality complaint was involved. Additional information has been requested.
Hair loss, hair feels thinner/Hair loss; Hair texture feels different, hair feel dryer; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss, hair feels thinner/Hair loss) and HAIR TEXTURE ABNORMAL (Hair texture feels different, hair feel dryer) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced ALOPECIA (Hair loss, hair feels thinner/Hair loss) and HAIR TEXTURE ABNORMAL (Hair texture feels different, hair feel dryer). The patient was treated with BETAMETHASONE SODIUM PHOSPHATE (BETAMETHASONE [BETAMETHASONE SODIUM PHOSPHATE]) for Hair loss, at an unspecified dose and frequency. At the time of the report, ALOPECIA (Hair loss, hair feels thinner/Hair loss) and HAIR TEXTURE ABNORMAL (Hair texture feels different, hair feel dryer) had not resolved.            Concomitant medication was not provided. The patient went to her doctor and her doctor ran batteries of tests associated with why her hair loss might be occurring. Everything came back normal, no thyroid issues or nothing.The only thing she can attribute it to was it started two to three months after her second shot. It has not resolved, she has never had this in her life. She attributes it to the vaccine.She was later prescribed Minoxidil, but she did not used it due to the expected side effects.   This case was linked to MOD-2021-358794 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Added reporter's details, patient DOB, age, suspect drug start date and updated events outcome from recovering to not recovered.
Difficulty swallowing began 15 minutes after injection was administered Pt. was given BENADRYL.  Patient's condition has improved
High fever for 48 hours, chills, slurring words, migraine, vomiting
24 Sep: Swollen Lymph nodes and pressure on right side of chest, visited ER at the Hospital, prescribed aspirin 24 Sep - Present: Chest pressure has occurred about 20 times and lasts for a few minutes before returning to normal. Saw cardiologist on 24 Nov, diagnosed with pericarditis, prescribed Colchicine (3 month supply) and Ibuprofen (4 week supply). Lymph nodes are still swollen.
Enlarged supraclavicular lymph node 5 days after receiving the vaccine, very painful and growing each day; Enlarged supraclavicular lymph node 5 days after receiving the vaccine, very painful and growing each day; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included cystitis interstitial, insomnia and known allergies to strawberries. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), montelukast sodium (MONTELUKAST) and daily multivitamin (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication. On an unknown date, the patient received rifampin (MANUFACTURER UNKNOWN) and bactrim (MANUFACTURER UNKNOWN) and experienced allergies for both. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 08Apr2021 at 16:30, 5 days after the vaccine, the patient experienced enlarged supraclavicular lymph node, very painful and growing each day. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with possible antibiotics, chest X-ray and blood work on an unknown date in Apr2021. On an unknown date in Apr2021, post vaccination, the patient underwent COVID-19 test and the result was negative. The clinical outcome of enlarged supraclavicular lymph node which was very painful and growing each day was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
About 4 hours I had a severe debilitating headache that lasted almost 4 days and no amount of over the counter pain med helped
Information has been received from a health professional concerning a female assisted living pt over the age of 65 who on 7/16/01 was vaccinated, IM, with a 0.5 ml dose of pneumococcal vaccine 23 polyvalent (lot 637369/1187K). On 7/18/01, the pt was taken to the ER for cellulitis with symptoms of swelling, redness and a warm to touch arm from the site of the injection down to her fingers. She was treated with IV ceftriaxone sodium (Rocephin) and was released back to the assisted living facility, hospital admission was not needed. It was reported that the pt has subsequently recovered. The reporter expressed a concern with the lot. It was reported that another pt (WAES 0107128) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent (lot 637369/1187K). Upon internal medical review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested.
mild dizziness on day 1; days 2-6 flu like symptoms, arm soreness and joint pain, unable to move arm and neck without pain. Day 10 -16 and ongoing have severe vertigo.
COVID; COVID; This is a spontaneous report received from a contactable Nurse. A 57-years-old male patient received first does of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included covid: positive on an unspecified date. On an unspecified date, the patient experienced covid. Patient was hospitalized in ICU with COVID after receiving Pfizer COVID vaccine. The clinical outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events DI and Covid 19 and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product 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.
Patient developed herpes in her eye 2 weeks after the vaccine.  The same thing happened after the first Shingrix dose. She is now on maintenance valacyclovir.
AT 28 MINUTES PATIENT BECAME ITCHY, BENADRYL 25MG GIVEN, T-98, 125/81, 85, MONITORED ADDITIONAL 15 MINUTES. 0851- CONTINUES C/O ITCHING, ESPECIALLY FACE, NO OTHER SYMPTOMS REPORTED. T- 98.3, 130/88, 80. 0900 25MG BENADRYL 0909 CONTNIUED C/O ITCHING. 0926 REDDENED SKIN AREAS ON HANDS AND FOREARMS, OCCASIONAL SOB WHEN TAKING A DEEP BREATH.
Information has been received from a healthcare professional concerning a 69 year old male who in 6/00 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. It was noted that the pt was schedules for surgery in 6/00 and that routine blood work revealed "anti-D (anti-RBC) antibodies". The pt did receive gamma-globulin. Additional information has been requested.
Fatigue after both. Massive lump/tumor in left arm and very painful 2 days after second shot. Also hot red skin around injection site that spread throughout the day on 2nd day after 2nd shot. Stopped getting my period for 3-4 month after vaccine. Period was SIGNIFICANTLY lighter and shorter for the rest of the year and occasionally would skip all together. Heart rate progressively increased throughout the year and I had multiple muscle injuries. Diagnosed with Graves' Diseases a year later but had symptoms of Graves' starting a month after vaccination.
Two minutes after vaccination, she reported itching at the site.  Upon assessment, red hives started to develop.  Dr. came and assessed patient.  Benadryl 50 mg. PO and 2 puffs Albuterol administered by Rapid Response Team  RN.  Tightness in chest, lightheaded, lungs clear throughout, itchiness in left arm.  Resolved within 15 minutes.
dizzness and feeling tired tightness in throat bp:97/72 hr:60 spo2:100%
Angioedema. Epinephrine 0.3 mg once, Diphenhydramine.
Large painful swelling of the lymph nodes on the lower anterior throat beginning the morning after the vaccination (approx 16hrs) and significantly getting worse until treatment in the ED that evening, extreme fatigue, and general soreness of muscles in arms and wrists.   Events resolved after 5 days of high-dose steroids and rest which involved time off work.