chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I shortly after the shot I having had random pains in arm, including joints [like when the pressure changes ... don't think I have arthritis]) but they only lasted a few minutes and then would go away.  About 10 hours later I started feeling sick.  One of the first things I noticed besides a headache was my heart rate jumped up to over 100 beats per minute (it is normally below 84).  I started getting chills and fever.  It was worse than any flu fever I ever had and I could not sleep.  Worst part was my heart rate would not go down, remaining above 100 but below 110-115 beats per minute.  I considered calling 911 but after looking online decided not to as long as it remained below 120 bpm.  I don't know my maximum temperature - I did not think to take it until after the peak had passed by 20 minutes or so (was 99.4 at that point - normal temperature runs 97.2 (low 96.8, high 98.2)).  Heart rate finally started to drop around 3:30 am.
Injection site soreness/muscle pain - ongoing soreness Tiredness - general tiredness/fatigue Headache - started morning after vaccination Chills - lasted a couple hours before fever started Fever - started after chills subsided Chest pain - lasted a couple hours simultaneously with chills
Approx 12 hours after 2nd covid vaccine, patient developed myalgias in arm, armpit, neck, progressing to 'large' - 2cm? tender lymph node in left anterior cervical chain with pain radiating to axilla. T max 100.1 on day 2. Pain/chills resolved with NSAIDs. Over the next 14 days, lymphadenopathy slowly decreased in size. On day 14, she presented to clinic with persistent non tender lymph node, 1cm in size, mobile without c/f infection.  Expectant management advised.  Reaction reported due to duration of LAD; appears to be on average 10 days.
Thrush; Mouth was tingly; A Spontaneous report was received from a consumer concerning herself a 66 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mouth was tingly/paraesthesia oral and thrush/ candidia infection.  The patient's medical history was not provided. Concomitant medications included diclofenac, pravastatin,flaxseed oil, fish oil, ubidecarenone, Vitamin D3, Curcumin, Magnesium, vitamin B12 and oxymetazoline hydrochloride.  On 04 Jan 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: unknown)intramuscularly in the left arm for prophylaxis of covid 19 infection.  On 07 Jan 2021 the patient started exhibiting symptoms of thrush, her mouth was tingly initially. On Sunday, 10 JAN 2021, she realized it was thrush. On 11 JAN 2021 she feels a little uncomfortable. Her 2nd dose of the COVID-19 vaccine is scheduled for 1 FEB 2021.  On 18 Jan 2021 update received, She had to take another 150mg Fluconazole. Her doctor prescribed an oral nystatin to be taken for the next 7 days.  Treatment information included fluconazole and oral nystatin   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of events, mouth was tingly and thrush were not resolved.  A follow up received on 18 Jan 2021 which included the treatment details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Pt exp sz about 3 days post vax; Has had 2 EEG's & CT brain scan is on Depakote;
Pt noted intense tinnitus in the right ear 12 hours after the vaccine that has not subsided
Severe right knee pain- bed  for 4 days- chills, sweats, dry heaves, fatigue, unwell, increased blood pressure. Used Ibuprofen, Tylenol, naproxen, no appetite , lasted 2 weeks. Rash on right arm and scalp,
It started around 2 today. I'd never heard anything about that reaction so I looked it out. The rash wasn't noticeable just itchy at first.  But the rash is showing up now.
flu; Initial information received on 24-Jan-2023 regarding an unsolicited valid Social Media non-serious case received via consumer.  This case involves an unknown age and unknown gender patient who had flu after receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported: I got my vaccine too and I'm on day 13 of the flu. The worst case I've ever had in 59 years. They missed it this time I'm afraid. So many flu cases here after the vaccine  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Began to have pain around ear and behind right eye. Headaches moved to upper back of head. Felt weird on right eye. headache got worse, took ibuprofen. Next morning right side of face couldn't move or blink, then entire right side of face unable to move. Diagnosed at Urgent Care with Bell's Palsy. Started on prednisone and gabapentin. Following day, seen in the ER, had normal MRI. Started on antiviral acyclovir. Pain was still intense, given Norco. 12 days since vaccine.
was tested positive for COVID-19; was tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2021, outcome "unknown" and all described as "was tested positive for COVID-19". A female individual who received 2 doses of the Pfizer-BioNTech COVID-19 vaccine was tested positive for COVID-19. This was 6 month after Dose 2. Her symptoms included fever (99 F), sore throat, and tiredness. She still had her taste and smell.  The patient underwent the following laboratory tests and procedures: body temperature: (Nov2021) 99 Fahrenheit; sars-cov-2 test: (Nov2021) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sensation in left ear which includes a fluttering thumping noise which is not going away--was not present prior to Vaccine and is still present.  Includes a numb and tingling sensation around ear and head.  Have not yet sought medical treatment for this.  Is present only in the left ear.
Patient came in with an appointment for a rash on 8/3/11. Was diagnosed with varicella. Is taking TYLENOL/MOTRIN prn for temperature. Gave varicella handout. Advised to return to clinic for worsening cough/difficulty breathing. Recommended immunization of other children at home (mom declined).
NO ADVERSE EVENT; dose of PEDV AX HIB was administered following temperature excursions; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, an dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T020615, expiration date 13-MAR-2023,0.5 milliliter (route and anatomical site of vaccination were not provided), for prophylaxis that was improper stored on 14-APR-2021.   Temperature 3/8: 49.29F FOR 15 MINUTES 3/17: 46.75FFOR 15 MINUTES 3/30: 46.71F FOR 15 MINUTES 4/2: 46.75F FOR 15 MINUTES Time frame: CUMULATIVE TIME: 1 HOUR Previous temperature excursion? YES Was call because of a "data logger"? (YIN) Y
With each Moderna vaccine or booster I've received I have had vaginal bleeding about 5 days after even though it is in the middle of my cycle and I'm not due for a period.
Headache, Myalgia, Fever, chills, malaise Narrative:  Other Relevant History:
Moderna COVID-19 Vaccine   Major dizziness started day after vaccine and is continuing for 2 days so far
sz-generalized convulsion;Annual follow-up dated 01/24/01 provided no additional data. 60 day follow-up dated 09/27/00 provided no additional data.
Pt has cellulitis rxn, F, 12 hours after immunization on L deltoid.
Pt. had large reported by pt., 12 inches of red, swollen, itchy and hot area. Pt. is a nurse and was treating herself.
Anaphylaxis approximately 18 min after vaccine injection. Received epinephrin through epi pen.  Transported to hospital via ambulance. Received IV steroids at hospital and monitored for 4 hours.
shortness of breath, walking up a small flight of stairs was exhausting. I cried one day because it was so bad and I could not breath after picking up my two year old and walking her to my car just a very short distance.
temperature excursion involving a punctured IPOL with no reported adverse event; administration of punctured IPOL after excursion with no reported adverse event; Initial information received on 13-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA119119, 2023SA119943, 2023SA119961 and 2023SA120330.  This case involves 17 years old male patient who had administration of punctured IPOL after excursion with no reported adverse event and reporter reported temperature excursion involving a punctured IPOL with no reported adverse event for vaccine poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine for Immunisation.  On 03-Mar-2023, the patient received a standard dose of 0.5 ml total of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection (lot V1B901M, expiry date- 02-JUN-2024) via intramuscular route in the left arm for Immunization.  Caller reported temperature excursion involving a punctured IPOL with no reported adverse event (product storage error) (unknown latency) and on 03-MAR-2023, (latency- same day), the patient had administration of punctured poliomyelitis vaccine (inactivated) IPV (VERO) after excursion with no reported adverse event (poor quality product administered). Caller was asking if the dose is considered a valid one. She stated that the health department wanted them to inquire if dose needs to be repeated  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the 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.
This spontaneous report as received from a healthcare worker refers to an unspecified number of unspecified patients of unknown ages and genders. On unknown dates the patients were vaccinated with doses of RECOMBIVAX HB (reported as RECOMBIVAX) (lot #, expiry date, dose, route and indication unknown) that were exposed to supported temperature excursions. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a physician refers to a 33 year old female patient. The physician stated that the patient received VARIVAX (Merck) (lot#, dose, route not reported) on 03-JUN-2014. The patient was determined to be pregnant, with conception 1 week before the administration of the VARIVAX (Merck) on an unspecified time. An ultrasound was performed on 13-AUG-2014 which confirmed conception the week prior to 03-JUN-2014. The Date of Conception was on 27-MAY-2014. The Last Menstrual Period (LMP) was on 13-MAY-2014. The Estimated date of delivery (EDD) was estimated on 17-FEB-2015. No treatment was given. The patient had sought medical attention via an unspecified way. The outcome of the pregnancy was unknown. Additional information has been requested.
12 hours after vaccine was administered vomiting began. Lasted for 10 hours until he was given a double dose of anti vomiting medicine. Vomited every 30-40 minutes for the 10 hours. Confusion, weakness and extreme fatigue.  Follow up appointment with pediatrician the next day.
I broke a pimple and came liquid after taking the pimple out, it came a little thing like clear and then it came like blood; it was like a clot; broke a pimple; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "I am kind of concerned because I was showering myself like 30 minutes ago, well I was cleaning my face and well you like night routine and I broke a pimple that I didn't have and came liquid after taking the pimple out, it came a little thing like clear and then it came like blood not too much for sure, then I realized that the blood that came out wasn't liquid, it was like a clot. I cleaned it with a t-shirt and I was able like to move it. So I am kind of concerned because I got my first dosage of the Pfizer vaccine on March the 6th, I am about to get my second dosage this Saturday and as you know and everyone should know right now what's going on with this (name) and (name) vaccine and then what everyone is talking about, it's impossible to not be concerned about the side effects." The event clot blood was assessed as serious (medically significant). The outcome of the events was unknown.    Information on lot/batch number has been requested.
torn retina; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around In or around 21-JUL-2017, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2017 [reported as shortly after receiving zoster vaccine live (ZOSTAVAX)], the patient suffered from a torn retina. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the retinal tear was considered to be not recovered.  Retinal tear was considered to be disabling.  Upon internal review retinal tear was considered to be a medically significant event.   Additional information has been requested.
A nurse reported that a 2 month old male received his 1st injection of Prevnar, Infanrix, PedvaxHib and IPV and a 2nd injection of Engerix-B on 2/16/01. The following day, the child developed congestion, a slight fever, vomited 1 time and was sleeping more frequently. The child was seen by a local pediatrician and noted to have clear lungs, soft abdomen, a soft stool with some mucous and blood. The child's mother was advised to stop drinking milk (child is breast fed). On 2/18/01, the child was noted to have a yellow stool, additional physical examination findings were normal. On 2/22/01, the child's pediatrician noted "mucoid stools, intermittent and blood noted. Child acts fine, 6 to 7 stools/day with blood, appear not as green." The child's mother received "Keflex 2 weeks ago for mastitis." This is 1 of 2 cases received from this reporter concerning adverse events following Prevnar lot 473331. Follow up information was received on 05/01/2001 from the patient's pediatrician. The patient continues to have diarrhea stools with mucous and further blood. Further evaluation is pending with a pediatric gastrointestinal physician. Follow up info has been received on 06/11/2001 from the 2 month old pt's pediatrician. The child has recovered.
PATIENT C/O LIGHTHEADEDNESS, PALPITATIONS, AND "A LUMP IN HER THROAT" 10 MINUTES AFTER VACCINATION.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning an elderly pt who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Subsequently, the pt experienced a local reaction including arm redness, heat and soreness over the whole arm. The pt also had a fever and felt ill. Treatment included acetaminophen (Tylenol) and warm moist compresses. It was reported that the pt recovered. No product quality complaint was involved. Additional information has been requested.
HYPOXIA 12/18/2022 HYPOGAMMAGLOBULINEMIA HYPOXIA 12/18/2022 DM 2 W EYE MANIFESTATION
Both arms started swelling due to the different vaccines given.  The area was 3-4 cm and red and warm to the touch.
My arm is swollen. Very red ,and very hot, soar and it itches, and burns badly. It started turning red and irritated late that evening. It kept getting worse as time went on. I went to the dr. and she said I had an elegiac reaction. She gave me Benadryl and storied cream. I am to use an ice pack for 15 min. of each hour.
pt recvd Engerix-B 3 doses Hep B & did not seroconvert; booster doses were administered;
Excruciating neck pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Excruciating neck pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, TOPIRAMATE (TOPAMAX) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced NECK PAIN (Excruciating neck pain). At the time of the report, NECK PAIN (Excruciating neck pain) outcome was unknown. Not Provided          Treatment information included steroid injection.   This case was linked to US-MODERNATX, INC.-MOD-2021-102933, US-MODERNATX, INC.-MOD-2021-103601 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-102933:2 dose case US-MODERNATX, INC.-MOD-2021-103601:Same reporter
First dose was administered on 1/22/21 (lot#EL3302) after which I began with hormonal fluctuations consistent with pre-menstrual symptoms (would be normal for someone 2 Yrs POST-menopausal) On 2/15/21, following my second dose on 2/12/21, I experienced the onset of what could only be described as menses, which, although extremely light, continued for 3 days.  Coincidentally, on 2/19/21, I had an annual exam scheduled at which I mentioned this odd occurrence.  I was advised that post menopausal bleeding is not normal and I needed follow up tests.  I am relatively informed and explained that my experience was not random bleeding, it was truly a menstrual period with all symptoms relating to such, but decided to follow through with testing to be sure.  I had an ultrasound performed on 2/25/21 which noted an endometrial stripe of 5mm (1mm wider than ?normal?) and a hysteroscopy was scheduled and performed on 4/9/21.  Biopsies taken and visual inspection showed NO abnormalities whatsoever and my bleeding occurrence was considered idiopathic.  In speaking with the physician, she refused to acknowledge that the Covid vaccine could have had anything to do with the event, but several others I know in healthcare have stated that there is a possible link and there is documentation to support.
itching all over   difficulity  in breathing wheezing tightness in chest   had to take benadryl for 4 days due to itching
On day 8, woke up with an itch at injection site. As the went on, it became larger, redder and hot to the touch. Accompanied by headache, congestion, sneezing and fatigue and fever. On day 9 & 10 the site grew larger and was swollen, with slight fever. I am now on day 14 and the area is still present but getting less red, less swollen and no fever
17 y/o F erroneously received first dose Moderna 3/1/2021. Returned for second dose when error was identified. RN notified site lead for additional review.  Consent obtained from pt and pts father to proceed with dose 2 of Moderna vaccine. Pt waited for 15 minutes without adverse reactions observed.
Fever 100, chills, hot flashes, nausea, splitting headache, low ringing in ears, upset stomach
I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R29.810 - Facial weakness
Red, itchy warm area the size of a silver dollar, immediately (within 15 minutes)- became larger , harder and quite painful over the next few hours. Pain woke me five or six times overnight. Day two is the same - applying Cortaid cream eases itch a bit.
Patient arm became swollen, red and painful.  Patient was given a course of Moxifloxacin
site hard and cold cold sensation near needle site and lower down, went away after about 1 week
Patient presented to vaccine site stating he was due for second dose of Moderna despite being informed throughout the week prior to the scheduled vaccine day that he was not due for another 2 weeks.  His appointment was removed, but he ended up rescheduling the day of and showing up.  Made it through the check-in process and received his 2nd vaccine, with the issue in timing being identified once it was logged into his vaccine history.  He had received his first dose on 9 Apr, so just 2 weeks earlier.  He developed some fevers and chills, with arm soreness.  Has since recovered.  No treatment required.
Myalgia, Arthralgia & Fever Narrative: WOULD HAVE MISSED WORK WITH THESE SYMPTOMS, WAS OFF WEEKEND