chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the 7th, I woke up with flu-like symptoms. Arm was sore. I was fuzzy headed/loopy and general flu-like symptoms. Lasted one day and it was gone. 2nd event, I felt fine until two weeks or so later. I started having severe abdominal pain - it felt like diverticulitis. I went to my doctor and she ordered a CT scan to be done. I have had diverticulitis in the past. They treated my  newly diagnosed (Dx'd on 3/19/2021)  diverticulitis with antibiotics and diet. That helped with my symptoms.
101+ fever for 2 days, dizziness, sleepiness, disoriented, delirious at times, speech impairment.
Severe body pain, muscle aches, joint pain, feverish without fever, chills, exhaustion, starting 3 hours after shot, worsening for 24 hours, gradually improving until 4 days, nausea, diarrhea, starting 72 hours post shot and continuing for 36 hours, considerable muscle twitching (mostly legs, arms, and hands) starting 36 hours after shot and continuing for 10 days, at which time it became less severe but has continued for an additional 5 days so far.
Suspected Vaccination failure; had a case of them; This case was reported by a consumer via media and described the occurrence of suspected 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 details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient was told that, there was a new vaccine out there at the time of reporting, so he/she would try that one too. 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 confirmation of shingles were not provided.
Narrative:  Patient called seeking evaluation of a rash/red spots that began approx 7-10 days ago, states he had the 2nd covid-19 vaccine approx 2 weeks ago. Patient stated "I think the rash is a side effect of the vaccine." Patient states the rash is on bil arms, upper back/shoulders with redness and itching. Patient has been applying anti-itch cream with relief. Denies worsening rash, SOB, wheezing, facial/throat swelling. Team please advise.
Pt. received ZOSTAVAX (shingles) vaccine 07/07/2014 Rt upper arm 0.65 ml SQ. Returned 7/9/14 with approx. 5 inches in diameter of erythema and 3 inches induration area of medial aspect proximal to elbow. Pt. returned 7/10 showing approx. 25% improvement.
local pain & induration around vax 2inches diameter lasted 3 days;went to nurse @ work place
Headache - AM 3/9/21 - took Tylenol, which helped to reduce it. Headache went away completely later in the day Fatigue - not severe but I wasn't as energetic as usual. Lasted until next morning (3/10/21)
This spontaneous report was received from a licensed practical nurse referring to an Infant female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies included ranitidine, TOPAMAX and phenobarbital. On 28-MAR-2018, the patient was vaccinated with first dose of ROTATEQ (strength, dose, lot # and expiry date were not reported) orally for routine vaccination. On 02-MAY-2018, the patient was vaccinated with second dose of ROTATEQ. After receiving the second dose, on an unknown date in 2018, the patient could not swallow and had to use Gastrostomy tube. It was unknown, if treatment was given for the event or if lab diagnostics or studies were performed. The patient sought medical attention and saw physicians. The outcome of dysphagia was unknown. The causality assessment between the event dysphagia and ROTATEQ was not reported. There was no product quality complaint (PQC) reported. The reporting nurse considered the event dysphagia to be serious due to significant disability or incapacity.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: en6202), in left arm, on 20Mar2021 as dose 2, single (Lot number: en6202), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: en01179), in left arm and on 17May2022 as dose 4 (booster), single (Lot number: FX9894) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Tested positive for Covid after taking. The patient received COVID 19 Treatment Paxlovid from 28Oct2022 to 02Nov2022.  No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after two vaccines  Moderna 10/2/21 Lot# 046C21A;  Moderna 11/5/21 Lot# 051F21A
PATIENT DEVELOPED A RASH OVER BODY ON 01/09/2022, TWO DAYS AFTER INJECTION. PATIENT WAS ADVISED TO TAKE BENADRYL, AND TO GO TO EMERGENCY ROOM IF ANY WORSE REACTIONS WERE TO OCCUR.
day after receiving 2nd moderna vaccine, patient start breaking out in welts on arms and back. Told patient's wife he needs to contact his doctor.  He can try antihistamine (Benadryl otc) but needs to contact his doctor.
2in x2in red raised rash at site of injection. Ice 2-3 days as needed per Dr. Area of rash was Lt arm at varicella vac site.
This spontaneous report as received from a Licensed Vocational Nurse regarding unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 28-JUL-2015, the patients were vaccinated with 4 doses of improperly stored doses of (Merck) PROQUAD lot# L003221 and expiry date: 30-JUL-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
9/6/21 - Patient is a 15 year old male with no significant PMHx. presenting with chest pain, fever x 1 day, emesis, and diarrhea. Patient received the 2nd dose of Pfizer vaccination on 9/3, and symptoms began on 9/4. Mother also reports some fatigue and tiredness in this period. He denies any palpitations, shortness of breath, exertional dyspnea, orthopnea or peripheral edema. No dizziness, syncopal episodes or seizures. No recent travel, sick contacts or Covid exposures.  Due to persistence of the chest pain, he initially went to a local Hospital where CBC was done and unremarkable; BMP revealed hypokalemia (3).  EKG done with some non specific ST changes. Troponin was elevated to 44,585 ng/L (44.5 ng/mL). Chest x-ray was unremarkable.  SARS-CoV-2 PCR was negative.  He was given ibuprofen x1, potassium chloride x1, and referred to ER for further management.  At ED, he was vitally stable and without reported chest pain. Repeat EKG was done. Troponin at 40 ng/mL. Patient was then admitted to CICU.   9/7/21 - Patient examined with mother at bedside. He reports chest pain recurred last night around 7 pm. It had the same characteristics as described initially on presentation, lower intensity (6/10) and resolved 40 min after ibuprofen was administered.   9/8/21 - Pt seen with mother at bedside. Mother denies adverse events overnight. No further chest pain and patient was able to tolerate well his walk around the floor last afternoon. VS wnl on room air and only synus arrhythmia seen on telemetry overnight.  Patient is improved, stable and medically cleared to continue treatment at home with prescribed medications (lisinopril qDay and Motrin PRN) and follow up apointments as detailed below (Cardiology, ID, Rheum and PCP).
Patient had dose #1 of Varivax on 9/13/19. She returned for dose #2 of varivax but when questioned before administration she told RN she took a pregnancy test that morning and it was positive. Confirmed (+) urine HCG while in office on 10/11/2019. Varivax #2 was not given. Told to followup with OB. Denied pregnancy before #1 on 9/13/19
5/08/2021- I woke up that morning with chill, severe muscle pain, arthritis pain was worsen, flu like symptoms, elevated temperature 6/4/2021 - Colonoscopy and Endoscopy done
Pain in left arm  site of injection that moved across upper ribs and moved to shoulder blades and upper chest. Pain is burning numbness above and below heart and into lungs.   Neck pain and numbness on left side of head and chest region.  Chills , nausea and diarrhea. Cough.
Woke up next day with swollen, red and aching eyelids. Eyes were burning and painful.
Bruise; Pain; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise) and PAIN (Pain) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced CONTUSION (Bruise) and PAIN (Pain). At the time of the report, CONTUSION (Bruise) and PAIN (Pain) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Pt recvd 2nd dose of Hep B vax & 45 min p/inject pt exp nausea, dizziness, flu-like sx & malaise; 2 hrs post vax nausea subsided; 5 hrs post vax dizziness subsided; 24 hrs p/vax flu-like sx persisted w/tingling sensations in face;
Initially, itching at injection site.   Five hours later, swelling at injection site with itching spreading down arm to above elbow.   Difficulty sleeping.  Next day, lethargic with other symptoms continuing.   Next day, swelling decreasing but itching continuing.  Noticed a small cyst in upper arm the size of a small pea.   Energy has returned.
Patient was given the dose for 5-11 year olds, which was the incorrect dose for age  range. Patient should have received the dose for 6 months through 4 years of age.
reportedly became ill after she received her COVID-19 vaccine 4 days ago. She developed myalgia and other flu-like symptoms and was followed by SOB in the last 24 hours. She also developed some headache and palpitations with heart rate in the 130s so she went to our ER yesterday and was sent home after she was stabilized. Patient however continued feeling poorly and claims pleurisy and pleurisy further worsened associated with dry cough hence the decision to come back to our ER where she presented febrile, tachypneic and tachycardic. Workups done showed mild hypokalemia, hypoalbuminemia and hypocalcemia. respiratory symptoms found to be related to lung nodule. Pt. also noted to have redness, erythema and itching on Right arm, site of vaccination.
I scratched my arm and it was inflamed; I felt I had been beaten by a bee; I scratched my arm and it was hot; itching went away; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (I scratched my arm and it was inflamed ), PAIN (I felt I had been beaten by a bee), VACCINATION SITE WARMTH (I scratched my arm and it was hot), VACCINATION SITE PRURITUS (itching went away) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (I scratched my arm and it was inflamed ), PAIN (I felt I had been beaten by a bee), VACCINATION SITE WARMTH (I scratched my arm and it was hot), VACCINATION SITE PRURITUS (itching went away) and VACCINATION SITE ERYTHEMA (Redness at the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 28-Jan-2021, VACCINATION SITE PRURITUS (itching went away) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (I scratched my arm and it was inflamed ), PAIN (I felt I had been beaten by a bee) and VACCINATION SITE WARMTH (I scratched my arm and it was hot) was resolving and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Advill, ice and then cortisone cream.
PT CAME IN FOR 2ND MODERNA VACCINE AND STATED SHE HAD A RASH APPEAR 7 DAYS AFTER  1ST INJECTION EXACTLY.  SHE STATED THE RASH WAS IN A CIRCLE AROUND THE INJECTION SITE AND ONLY LASTED 2 DAYS.  IT ITCHED SOMEWHAT BUT NO OTHER ISSUES EXCEPT HEADACHE.
Since I have neurofibromatosis type I and unlimited number  tumors, the tumors have started to bleed, along the peripheral nerve routes spontaneously , on the back of my cranium just above the shoulder blades, on my back, various locations. I have and my spouse have observed numerous locations,  on legs, feet and groin, most recently on my neck and face, these spontaneous bleeding sites are problematic and the bleeding is quickly brought under control, the locations on my back have bled through the tee shirt but have not bled through my normal dress shirt, this has also caused excessive itching which is controlled with Benadryl and Ibruprophen and Acetaminophen for somatic pain
Fever (99F 1hr after dose of Extra Strength Tylenol), chills, muscle aches, headache, congestion, nausea, fatigue, elevated heart rate. Typical resting heart rate 50-55 bpm, resting heart rate during event 100-120 bpm.  Most symptoms lasted ~2 days. Headache and fatigue lasted 3 days.
1. Cold sore outbreak on nose the very next morning, treatment was acyclovir cream 5% (have not had an outbreak since 2018) 2. Burning sensation from chin to chest started the next night after the vaccine, treatment was lotion and prayer 3. Headache on and off for 3 days started about 5 hrs after vaccine, treatment tylenol as needed
Employee developed heart palpitations shortly after receiving the COVID-19 vaccine. Heart palpitations lasted approximately 1 hour. No medical intervention needed. Pulse remained within normal limits (60-100).
development of acute liver injury and troponin leak with hepatic encephalopathy.  patient ultimately transferred from local facility to Hospital for liver transplant evaluation.  received steroids and Acetadote
This spontaneous case, was initially received from other health professional (nurse) on 06-Oct-2017, concerning a 41-year-old adult male patient. The patient's current condition included pre-hypertension. The patient did not receive any concomitant medications. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128 (reported as 195198), expiry date: 30-Apr-2018, route of administration: intramuscular, anatomical location: deltoid). The patient received the vaccine after multiple temperature excursions over a week. It was reported that, the storage temperature of the vaccine fluctuated between 36-degree F and 48.18-degree F, which reached to maximum of 49-degree F over a week period of time instead of storing between 36-degree F to 46-degree F and no adverse event was reported. The reporter assessed the report as non-serious. Non-significant case correction received 06-Oct-2017: Batch number (195128) was captured in the case form and narrative was amended accordingly.
14 hours after the shot, localized arm injection site pain, chills/body tingling/muscle fatigue lasting eight hours so far.
Chief Complaint Patient presents with ? Sinus Problem     x week  ? Fever     on satuday  ? Immunizations     1ts covid vaccine was 01/29/2021     Patient is a 87 y.o. female    HPI   Patient is an 87-year-old female who presents with URI symptoms with her daughter.  Patient does have dementia so history is coming from her daughter.  Daughter is having similar symptoms for the similar length of time.  Over-the-counter Tylenol for her mom on Saturday otherwise no other over-the-counter medications used. Symptoms started suddenly and have been persistent.  Patient appeared feverish to her daughter on Saturday (flush in cheeks) but daughter denies any other known fevers and did not check her temperature. Admits to nasal congestion, nonproductive cough Denies rhinorrhea, ear pain, sinus pressure, sore throat Denies chest pain, trouble breathing, abdominal pain, n/v/d.
Vaccine administration error occurred when it was discovered after the client received the vaccination, that the vial used had been previously labelled as opened and accessed 8/20/21 at 3:15 PM and was beyond use according to manufacturer's instructions not to use > 6 hrs after first being punctured. Vaccine had been continually stored at 2-8 degrees Celsius in the refrigerator since it was initially opened with no temperature excursions, but had been moved from expired bucket to current vaccine bucket in the fridge in error and was inadvertently given because the label with opening time had become smudged and was very faint. Vaccine was not discolored when administered. Patient was notified by phone when the error was discovered 30 min after administration and agreed to return to the clinic the following day for potential re-vaccination in the other arm. However, after calling Janssen for guidance as per CDC instructions for this type of administration error on the following morning when they opened on Eastern time, they were unable to provide any information about whether vaccine was invalid or could be repeated. Called CDC-INFO and awaiting a call back from clinical team for further information. When completing documentation in chart and VAERS, it was then noted in Vaccine Registry information that patient had previously received a dose of Janssen COVID-19 vaccine on 5/29/21 that he did not disclose at the time of his vaccination on 9/2/21. Client will be notified that he does not need to repeat another dose at this time and that second dose which may be invalid is unlikely to cause harm but to notify vaccine provider if any symptoms develop.
left clinic; napped; wakened about 530PM w/high pitch screaming; blood red swollen leg; t101.0; MD contacted said cont APAP, put ice pack on leg, elevate leg;
Fainted at 9am with little warning, fainted again at 2:30pm with little warning.
8:40am received vaccine. 8:50 stated tongue thick, "burning" around eyelids, itchy face that went to arms, upper thighs. At 10:25 am patient took 25mg Diphenhydramine. 10:35am eyelids better, tongue better. 11am felt nausea, gave crackers; 11:10am better; 11:15am itchy resolved, nausea gone.
sores itch; sores look like bubbles; sores on left side of body-lower back and around; achy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (sores itch), BLISTER (sores look like bubbles), PAIN (achy) and PAIN (sores on left side of body-lower back and around) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 041120A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (achy). On 14-Mar-2021, the patient experienced PRURITUS (sores itch) and PAIN (sores on left side of body-lower back and around). 14-Mar-2021, the patient experienced BLISTER (sores look like bubbles). At the time of the report, PRURITUS (sores itch), BLISTER (sores look like bubbles), PAIN (achy) and PAIN (sores on left side of body-lower back and around) had not resolved.            No concomitant medication use was provided by the reporter. No Treatment information reported.
9cm x 9cm tender, edematous, and erythematous swelling at site of Dtap.
Patient received vaccine at age 17 of age even though EUA is for 18 years of age and older.   No adverse effects noted.
This is a spontaneous report from a contactable physician received via Pfizer sales representative.  A 16-year-old male patient received TRUMENBA (lot S26986) in right deltoid, at single dose and MENACTRA in left deltoid, both on an unspecified date, for immunization. Medical history and concomitant medications were not reported. On an unspecified date, a couple of hours after vaccinations, the patient experienced pain at the injection site, fatigue, malaise, chills and myalgia. These events lasted approximately 24 hours and resolved on an unspecified date.
Administered expired doses to patients past the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Number of doses/vials 1 vial, 1 dose involved. The Lot 018B21A  vial was initially stored in the refrigerator on 13Oct2021. The vial did not undergone any temperature excursions.   This case was linked to MOD-2021-365264 (Patient Link).