chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EMPLOYEE STATES THAT HE WENT TO SIT DOWN AFTER THE HEP B SHOT WAS ADMINISTERED. HE SAYS THAT 10 MINUTES LATER HE BEGAN TO FEEL LIGHTHEADED AND BEGAN TO SEE SPOTS. EMPLOYEE THAN NOTIFIED THE MSA. MSA HAD EMPLOYEE TO LIE DOWN ON BED AND BEGAN TO MONITOR EMPLOYEE. MSA APPLIED ICE PACKS TO THE NAPE OF NECK AND TO CHEST. AFTER 8 MINUTES OF LYING DOWN EMPLOYEE BEGAN TO FEEL BETTER AND TRIED GETTING UP. EMPLOYEE BEGAN TO INSTANTLY GET LIGHTHEADED AGAIN. MSA HAD EMPLOYEE TO LIE BACK DOWN AND CONTINUED TO MONITOR FOR AN ADDITIONAL 7 MINUTES. EMPLOYEE STATED THAT HE FELT FULLY RECOVERED AND RETURNED TO WORK.
Patients arm exhibited redness and swelling within 24 hours of vaccination.  Advised to seek care at walk-in clinic.  Was seen on 10/8/20 and prescribed doxycycline.
The patient presents with 78-year-old male presents emergency department via EMS.  Patient was sent over from local doctor's office with family stating that they were worried because he has had blood in his urine and he is complaining of back pain and hallucinating.  Patient states that his back on the right side hurts and his right lower quadrant.  Patient is unsure if there was blood in his urine at this time.  He just keeps complaining of back pain.  He is alert and oriented.  He denies any chest pain, shortness of breath, fever, chills, nausea, vomiting..  The onset was unknown.  The course/duration of symptoms is constant.  Location: Right abdomen Flank. The character of symptoms is pain.  The degree at onset was minimal.  The degree at present is minimal.  Risk factors consist of coronary artery disease.  Therapy today: none.  Associated symptoms: abdominal pain, back pain, denies chest pain, denies nausea, denies vomiting, denies shortness of breath, denies fever, denies chills, denies headache and denies dizziness.
patient reports vertigo starting day after dose 1 vaccine given and reports intermittent vertigo symptoms since then-most symptoms with position changes.  Patient returned for dose #2 on today 4/29/2021
Stabbing pain in R. neck and shoulder.  Also felt like needles pricking all around.  Has gone on for 2 1/2 weeks with no permanent relief.  Have tried extra strength Tylenol, naproxen sodium, ibuprofen with partial  temporary relief.  Used moist heat, massaging, etc.  Dr. is unfamiliar with any such side effects and dismissed it.  It feels like the shingles did when I had them about 5 years ago, but no rash or blisters.
Chills, Fever, Diarrhea, Dizziness, Aches. As of 09/13/2012 at 6:00 PM symptoms are still present.
Hives outbreak all over body since Nov 4th till now. I went to local Urgent care on Nov 4th and had been treated by Steroid oral (20mg/dose x twice/day) for 5 days, Benadryl & Famotidine for 7 days. I stopped taking all medication on Thurs 11/11 in order to see an allergist on Wed 11/17. I have no cord of being allergic to any type of food, medications, weather, pet dander, pollen, etc.
From telephone contact received on 06/17/2002, it was reported by the pediatrician's office that a 19 month old female received ACTHIB on 06/04/2002 to the right thigh.  Lot # UA704AA.  Patient's parent reported on 06/09/2002 to the pediatrician, Dr P, that there was redness and swelling.
Had the shot, got shingles/Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-MAY-2022 Reporters comment:  The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Fever, headache, chills, and nausea the day after the injection. Severe pain at injection site.  Diagnosed with COVID-19 on 9/24/2020
This spontaneous report was received from a Registered nurse regarding an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
After administration of the vaccine series the pt vomited one time in the office.  5 Minutes After the patient left the office the parents called to inform us that the pt vomited again and "passed out" briefly.  They were instructed to return to the office for exam/stabilization.  Pt returned ~12:15PM and was pale, diaphoretic, and clammy upon initial presentation. VS HR=120, RR=30, T=98.1    Pt was lethargic with eyes closed though he did arouse to painful stimuli. Patient vomited once more and fell asleep in his mothers arms. Respirations remained even and unlabored and color returned from its pallor, vital signs remained stable though he aroused only to painful stimuli.  He was monitored until he woke from his slumber and his condition stabilized/returned to baseline.
Approx. 6" x 3' area on each leg was very swollen and bright red. Patient did not complain of pain, but did complain of itching around 4th day. Redness/swelling decreased by 5th day but not gone.
approx 6mos p/vax pt presented w/zoster down leg & on back. addl info req
Throat felt very tight, cough and sore throat. difficulty swollening. took Tylenol sinus and steriods 4mg started 8pm on the 1/20/21
Pt bit on inner left forearm on 4/26/01 at 22:30; seen by health dept; no adverse symptoms; vaccinated on 5/3/01.
Big swollen red lump; like I have a injection site reaction; Big swollen red lump; like I have a injection site reaction; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) (PREVNAR 13, Solution for injection in pre-filled syringe Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on 06Oct2021 as DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient Medical history none. Concomitant medication included buspirone taken for an unspecified indication. It was reported that a big swollen red, had the Prevnar vaccine on 06Oct and yesterday noticed mp like had a injection site reaction, have no pain had nice big lump. Therapeutic measures were taken as a result of events vaccination site mass and vaccination site erythema included took Benadryl. The outcome of the events was unknown.  The information about Lot/batch number has been requested.
both test showed inactive antibodies/The patient was worried he didn't have any antibodies; This is a spontaneous report . A contactable consumer(patient) reported that a male patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration first dose on 23DEC2020 and second dose on 13JAN2021, at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported.  The patient got 1st COVID shot on23Dec2020. At 10 days ago the patient had the 2nd shot on 13JAN2021. He tested his antibodies after the 1st and 2nd dose of the vaccine and both test showed inactive antibodies. The patient was worried he didn't have any antibodies. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Spondylitis ankylosing aggravated; Ache; Sleep excessive; Cough; Fatigue; Illness; This is a Solicited report from FACILITATED COLLECT based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-3976955-00. A contactable consumer (patient) reported that a 54-year-old male patient received bnt162b2 (Batch/Lot number was not reported), first dose intramuscular on 20Apr2021 at the age of 54-year-old as single dose, second dose intramuscular on 20May2021 at the age of 54-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date and ongoing, at unspecified dose for ankylosing spondylitis. The patient's medical history and concomitant medications were not reported. The patient experienced spondylitis ankylosing aggravated, ache, sleep excessive, cough, fatigue, illness in 2021. Solicited report from the Regulatory Authority by a consumer of an adult male with events of non-serious ankylosing spondylitis flare up, achiness, illness/fatigue/slept for 72 hours and cough with adalimumab (HUMIRA). There was no reported medical history. On unknown dates, the patient experienced ankylosing spondylitis flare up, achiness, illness/fatigue/slept for 72 hours and cough. Pfizer BioNTech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. On 20Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 20May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. The action taken in response to the events for adalimumab was unknown. The outcome of events for cough was unknown, for other events was not resolved. The reporter's causality for the events of ankylosing spondylitis flare up and achiness with adalimumab was a reasonable possibility. The reporter's causality for the events of fatigue, slept for 72 hours, cough and was not provided. The reporter's causality for the event of illness with adalimumab was no reasonable possibility.   The reporter's assessment of the causal relationship of all events with the bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Spondylitis ankylosing aggravated, Ache, Sleep excessive, Cough, Fatigue, Illness and suspect drug BNT162B2 cannot be excluded.
rhinitis, sneezing, flushed;4PM sweating profusely,hot, beat red, eyelids swollen, swollen face generalized, sensitivity to touch, bumps resembling acne;630Pm sensitive to touch, swelling subsided, warm & red;hot flash;
Patient given vaccine before their first birthday (12 months). No s/s of adverse reaction at the time. No treatment was given, assessed by MD, MD stated will follow up.
Diarrhea with stomach cramps, lasted ~36 hrs, tx bland diet & rest
patient had no reaction while waiting for the 15mins wait time after the vaccine was administered  the MA that administered the vaccine to the patient called parents of the patient to inform them about the incident and that  patient needs to get re vaccinated dad understood about the situation and we asked if they wanted to come back and get the patient re vaccinated dad said we rather wait and will find a different place to get vaccinated. MA gave dad our contact information if they have and questions or concerns.
7x7cm redness/tenderness/swelling with small nodule at tetanus injection site.  pt was in clinic for a follow up on injury and was put on antibiotics.
This spontaneous report as received from a patient's mother refers to a 12 year old male patient with none pertinent medical history and no drug reactions/allergies. On 14-OCT-2013 the patent was vaccinated in an unspecified arm with a dose of GARDASIL dose, route and lot # not reported. There was none concomitant medication. Immediately after the administration of GARDASIL on 14-OCT-2013 the patient cried and experienced a horrible reaction described as very red, very hard and very painful area at the GARDASIL injection site. There were none lab diagnostic studies performed. The patient was given ADVIL for one week as a treatment. The outcome of adverse events was reported as recovered on 21-OCT-2013, (reported as one week after administration of GARDASIL). The relatedness between adverse events and GARDASIL was unknown. Additional information has been requested.
Around 10:00pm, went to bed about 11:00pm. Couldn't sleep but the pain got worse. Had aches all over. About midnight, too 2 Ibuprofen 800mg, and drank some milk. Next day felt better.
Patient was given Flu Blok Quad on 10/20/2020 and she reported redness below the injection site.
30SEP93 devel inject site react of erythema, tenderness, swelling (size 4" x 3") & low grade temp w/in 24 hrs of vax; seen in ER 2OCT; dx cellulitis; no cultures taken; rx'd w/Cipro; seen by MD 4OCT;
This spontaneous report was received from a consumer (patient's mother) reporting on her son who is currently 2 years old. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient was administered a series of vaccines (unknown) including PEDVAXHIB on an unspecified dates in July, September and November 2013 (reported as at ages 2, 4 and 6 months respectively) (inappropriate schedule of vaccine administered). On an unknown date, after receipt of the vaccinations, the patient was taken to an unspecified hospital because "he stopped breathing for a short time", "experienced seizures", and "cried for 6 to 8 hours". On an unknown date, it was also reported that the patient had developed "a lump on his leg" that lasted for several months. The patient had sought unspecified medical attention. The outcome of the events was unknown. The reporter did not provide the relatedness of the events with PEDVAXHIB. Upon internal review the event seizure was found to be medically significant. Additional information has been requested.
Upset stomach, swelling around mouth and then skin went scaley and weepy below lips after swelling gone.  Some upper airway wheezing also.  Took Benadryl and did a breathing treatment (Albuterol).  O2 sats and heart rate remained normal.  Bruise and swelling to injection site also.   Second dose of Benadryl taken.  No further treatment needed.
24 hours after administration pt noticed burning sensation, redness started small and spread to area 2 inches in diameter. Patient has also experienced a headache since administration. Burning sensation continues upon any contact to area. No treatment except ADVIL for HA.
Right arm soreness: onset 6-8h after vaccine -- > worsened to full body soreness/aches with point TTP over injection site (couldn't sleep on that side);   Injection site redness: No initial redness on day 0 or day 1 post-injection. Slight redness and TTP as above on morning of day 2.  Body Aches: began ~18h after vaccine, worsened throughout day 1 before bed; ~36h vaccine symptoms resolved  Fatigue: Started morning after vaccine (~18h post-vaccine) -- > peaked ~36h post-vaccine (went to bed early and simultaneously restless but also exhausted)  Headache: Moderate, primarily frontal headache (like a head cold with NO congestion); began ~24h after vaccine, continues today (~48h vaccine) but improving without intervention.  Fever: Began ~36h after vaccine at peak of fatigue symptoms (peak T: 100.2). No intervention, self-resolved by 48h post-vaccine
Patient experienced excessive pain and swelling radiating through the entire left arm from the injection site.  Patient had difficulty sleeping due to the pain and swelling. Patient stated she placed a Butrans on the injection site before speaking with a healthcare provider.  After contacting the provider administering vaccine, she was instructed to remove the Butrans patch, ice the area, and take OTC ibuprofen or acetaminophen for the pain. Patient stated at follow-up that the pain and swelling is much improved. She was advised not to receive the second dose of the Shingrix vaccine.
pt recvd vax & c/o joint stiffness; pain intermitent; rx'd w/ motrin & po pcn; joint pain resolved;
Patient was given a 5th dose of a COVID-19 vaccination when an additional dose was not required. The patient is not immunocompromised, nor was there an appropriate time interval. The geriatric facility lacked documentation of patient's 4th dose (2nd booster) given on 6/1/22. No adverse events reported per the center on 8/23/22.
1st dose administered 2/23/2021 with only mild arm pain and no side effects.  2nd does 3/23/2021 caused significant arm pain in the evening.  By morning feeling a little unwell and right ear congestion as well as continued arm pain.  No nasal congestion or signs of allergies.  By 2nd morning ear congestion was significant.  By 3rd morning 3/26/21 right ear hearing seriously impaired.  Saw General Physician on 3/27 and found no problems with ears physically and diagnosed with Sudden Sensorineural Hearing Loss.  Dr. declined to file as possible vaccine side effect.  On Monday 3/29 audiologist confirmed 35-40db loss above 750Hz, and board certified Otolaryngologist ENT confirmed ideopathic SSHL with possible cause of vaccination.  Prescribed 60mg prednisone and 1gm Valacyclovir daily.  Hyperbaric treatment indicated.
13JUN94 grandma stated pt c/o sorenesss @ inject site & exhibited red rash around same; APAP was given; 14JUN94 pt c/o sore throat & trouble swollowing; By late evening t101 & raised rash down over elbow could not raisearm over head; to ER
soreness in her arm/arm is hurting; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in her arm/arm is hurting on an unspecified date. Caller response her last name was confirmed with caller and documented. Therapeutic measures were taken as a result of soreness in her arm/arm is hurting was Tylenol. The outcome of the event pain in extremity was recovering.  No follow-up attempts are possible; information about batch number cannot be obtained.
BlurredVision, Headache & Diarrhea Narrative:  Other Relevant History:
Blistery-painful rash; Blistery-painful rash; Extremely painful arm at injection site; Armpit is swollen on injection site arm; Armpit is tender on injection site arm; Inappropriate age at vaccination; This case was reported by a consumer and described the occurrence of blistery rash in a 45-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 5th September 2019, less than a day after receiving Shingrix, the patient experienced blistery rash, painful rash, injection site pain, local swelling, axillary pain and inappropriate age at vaccine administration. On an unknown date, the outcome of the blistery rash, painful rash, injection site pain, local swelling, axillary pain and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the blistery rash, painful rash, injection site pain, local swelling and axillary pain to be related to Shingrix.  Additional information received were as follows: A day before the reporting date, at 10:30 am, the patient received Shingrix. In the evening of the day before the reporting date, the patient experienced blistery-painful rash on side. The patient called the pharmacy who gave the vaccine to ask about side effects and they told the patient to call patient's MD. The patient was seeing MD in the afternoon but wonder if this was an expected reaction. The event was not listed in the common reactions. The patient also experienced extremely painful arm at injection site and my armpit was swollen and tender on injection site arm. The reporter thought that the longer needle was used thus she thought it was intramuscular. The NDC number was reported as 58160-0823-11.
approximately  2 hours after my vaccination, I started with a very severe headache and felt extremely tired. I had difficulty staying awake. I slept about 2 hours. When I woke up my headache was gone and I was no longer tired. I went to bed and slept well until a headache woke me up the next morning however it was not as severe as the previous night. I was a bit lethargic but not too bad.   My headache continued until the evening of 1.11.21 however I was not lethargic and was able to work. Today is 11.12.21 and I feel fine.  I had no injection site discomfort to speak of.
Information has been received from a physician concerning a 9 year old male with rhinitis allergic who on 08-OCT-1999 was vaccinated with a first dose of VARIVAX (Oka/Merck). On 30-JUN-2008 the patient was vaccinated with a second dose of VARIVAX (Oka/Merck) (The lot # is reported as 659948/1851U). Concomitant therapy included CLARITIN. Two days later on 02-JUL-2008, the patient experienced an injection site reaction of not a very large raised area as the physician believes this is because the patient was also taking  loratadine for allergic rhinitis. No reaction was reported after the first dose of VARIVAX. The patient had contacted the physician. Subsequently, the patient recovered on unspecified date. This is one of several reports from the same source. Additional information has been requested. Follow up information has been received from a health professional concerning a 9 year old male patient with rhinitis allergic and cough who on 30-JUN-2008 at 09:45 was vaccinated with second dose of VARIVAX (Oka/Merck) (Lot  # 659948/1851U) in the arm. Concomitant therapy included CLARITIN. On 01-JUL-2008 the patient experienced redness and swelling at the injection site. Size was about half dollar size. The patient use cool compress and BENADRYL. for swelling/itch. On 04-JUL-2008 the patient was recovered. Additional information has been requested.
Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received: Event outcome updated.
Swelling in arm starting the following day, continued for approx a week then on the 4th week after the dose the arm began swelling and pink again just like after the injection