chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 77-year-old male who has history of lung cancer on chemotherapy, colon cancer status post colectomy, prostate cancer who came to the hospital because of difficulty urinating. It started this morning when he woke up. He went to the bathroom and was having difficulty moving his bowels and urinating. After an hour, he was able to defecate but still could not urinate. Complaining of lower abdominal pain. Denied any hematuria. So he decided to come to the ER to get checked.  He denied fever, chills, chest pain, shortness of breath. At the ER, he was noted to be hemodynamically stable. He is on 3 L of oxygen which is his baseline. CT scan of the abdomen and showed markedly distended urinary bladder.  There was also a large amount retained fecal matter consistent with constipation. He was placed with a Foley catheter and he felt better. Urinalysis was negative for UTI.
administered dose past the manufacture expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.
From 10/30/2008 to 11/18/2008- severe joint pain- head to toe.  No fever- painful to even walk.  Resolved on own 11/18/2008 AM.  No missed work.
Pt had some swelling and redness from injection site to left elbow and said she had discomfort(pain) up thru left shoulder
Feels like throat is closing, dry throat (not mouth), feels like swollen throat, dizziness for 10 minutes, nausea
I had strong reactions to both my vaccines and was in bed for two days following the first vaccination and three days following the second vaccination. Shortly after recovering from the second vaccination I started to have wandering pains that went up and down my legs and sometimes elsewhere, in my arms and shoulders. These pains would wake me up a night. I also lost strength in my right leg and had trouble lifting it to go up stairs.
ON 2/17/22 patient was administered vaccine that expired on 2/12/22.
Pt. was administered 1 pediatric dose of Hep. B vaccine 10 mcg/0.5 ml Engerix B on 6/18/07 instead of an adult dose. No adverse event noted.
broke his ankle; due to get second vaccine; A spontaneous report was received from a 70 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced broke his ankle and due to get second vaccine.  The patient's medical history not reported. No concomitant product use was reported.  On 16-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 042(6)?20A) intramuscularly for prophylaxis of COVID-19 infection. The patient stated that, the patient was due to receive second vaccine on 20-FEB-2021 and he broke his ankle on the same day and went into the hospital for surgery. While the patient was in hospital, he received a flu shot and pneumonia shot, and hospital recommended him to wait 2 more weeks for his second COVID shot. Since that time patient had been at home on clutches and was waiting on someone to help him get to clinic and receive second shot vaccine which was scheduled for Monday 22-MAR-2021. The patient was to know if he need a third dose.  The seriousness of the event broke his ankle was medically significant.  Action taken with mRNA-1273 in response to events was unknown.  The outcome of the event(s) broke his ankle was unknown and the outcome for event due to get second vaccine was recovered/ resolved.; Reporter's Comments: This report refers to a case of a 70-year old male patient who received the first dose of Moderna's COVID-19  vaccine (Lot # 0426?20A)and experienced ankle fracture, and received the second dose later than scheduled. The causality of the event ankle fracture is assessed as unlikely related to mRNA-1273.
ACUTE NON ST ELEVATION MI 12/21/2021 &  12/23/2021  -- RECURRENCE OF SAME SYMPTOMS
Child presented to ER 12-9-02 with left sided facial swelling and ear pain due to parotitis  - possibly secondary to MMR. Child was better the next day when she saw ENT for follow-up check. Treatment was pain medication and warm compresses.
redness swelling around inject site lt deltoid; fever no thermometer; ice pack to arm;
My husband had got covid. Then I started to feel like I had a cold. I went to get tested witha a rapid and PCR covid test which both came out negative.  I was sick all night. The next morning I took another covid test, and I was positive. I was sick all of that day. I only had a fever for 3 days and a lot of coughing and sneezing. It took a while to test negative. A week later I was still positive. About a week and a half later I was finally testing negative. I took some Ibuprofen, Sudafed, cough medicine, inhaler, and Benadryl. This was the most I have sneezed ever in my life. It wasn't as bad as pneumonia or the flu. It just felt like a bad cold.
Tinnitus in left ear, no signs of hearing loss, increased ringing and clicking noises that are audible to others
I woke up with a fever and extreme thirst. I had a hard time sleeping, but at some point during the night my fever broke. When I woke up (~5 hours later) I felt significantly better, though I was experiencing a headache, eye pain, and fatigue. I got up and then went back to sleep after eating something, and when I woke up I felt completely fine.
Woke up with moderate pain in coccyx lower back area. Applied heat, essential oil applied. Pain is intermittent still, today took Tylenol.
pt reported feeling nausea and tachycardia after shot. pt states she gets pain after  hr =82
other zoster-related conditions; shingles; Information has been received regarding a case in litigation from a lawyer and referred to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On or about 03-APR-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot number and expiration date were unknown), as prescribed and/or administered by a healthcare provider at local clinic for the long-term prevention of shingles and zoster-related conditions. At the time of the pt's vaccination, the pt relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the pt's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced the pt to be vaccinated. Alternatively, on or about April 3, 2013, the pt's healthcare providers at local clinic, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine and believed that it was effective in preventing shingles on a long-term or permanent basis, and that it did not carry any significant risks of adverse effects. Subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers at local clinic for shingles, and other zoster-related conditions (Ill-defined disorder). As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered as not recovered. The causality was related.
I was breastfeeding and my milk supply dropped to almost nothing a week after getting the vaccine. I am so upset about it. I also got my menstrual cycle back. I can no longer breastfeed my baby.
The patient presented on the 9th day post-vaccine administration with a significant 7 cm x 5 cm firm urticarial lesion at the site of her vaccination with pruritus and surrounding erythema.  Prior to this point, she was asymptomatic other than a small amount of soreness at the vaccination site with no reaction, lesions or pruritus.
the room is spinning; if I stand up, I feel like I'm going to faint/ dizzy; felt it in my throat/ taste it in my throat; diarrhea; slept all day; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (felt it in my throat/ taste it in my throat), DIARRHOEA (diarrhea), SOMNOLENCE (slept all day), ASTHENIA (felt weak) and VERTIGO (the room is spinning) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Thyroid disorder and Prediabetes.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (felt it in my throat/ taste it in my throat), DIARRHOEA (diarrhea), SOMNOLENCE (slept all day) and ASTHENIA (felt weak). On 24-Mar-2021, the patient experienced VERTIGO (the room is spinning) and DIZZINESS (if I stand up, I feel like I'm going to faint/ dizzy). On 24-Mar-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (felt it in my throat/ taste it in my throat), SOMNOLENCE (slept all day), ASTHENIA (felt weak), VERTIGO (the room is spinning) and DIZZINESS (if I stand up, I feel like I'm going to faint/ dizzy) outcome was unknown.        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.   Relevant concomitant medications included, thyroid and hypertension medications were reported.   Treatment information was not provided.
This case was reported by a physician via sales rep and described the occurrence of hives in a 5-year-old male patient who received KINRIX. Concomitant products included MMR (MMR vaccine) and Varicella (Varicella vaccine). On an unknown date, the patient received KINRIX. On an unknown date, less than a day after receiving KINRIX, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl), epinephrine (Epi Pen) and steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the hives was recovering/resolving. It was unknown if the reporter considered the hives to be related to KINRIX. Additional details were provided as follows: The patient just moved from other country and was behind on his shots. The patient was given three at the time of his visit. The physician reported that the patient experienced hives in the night after receiving the vaccines. The patient was given Benadryl but it did not help. The patient was taken to urgent care and given an Epi pen and steroid. The next day the hives were worse and he was treated at the emergency room with a steroid. The patient was seen by the physician the following day and the hives were resolving. The patient had not returned to the office since. There were no dates provided. Follow up information received from the physician on 1st June 2018: The reporter details were updated. The patient demographic details were updated. On 6th April 2018, the patient received 0.5 ml dose of KINRIX intramuscularly as a 5th dose of DTaP and 4th dose of IPV (batch number and expiry date was updated). On 6th April 2018, the patient experienced hives. The VAERS details were updated.; Sender's Comments: US2018068884: Previous VAERS submission in paper format
IW states she rcvd flu shot at 2300ish.  She developed a hard knot at injection site.   At 0100 she states she had pain that went into her shoulder and neck.   At 0300 she began itcing around shoulder, neck and injection site.   At 0330 she noticed hives.  She had an ER doc she was working with look at it and he suggested Benadryl.   At 0430 she took some Benadryl (25 mg).  The hives went away but the itching continued.   At 0900 itching and hives were gone but knot was still there. At 2049 the next night she still had a small knot, but itching, redness, heat, and hives were gone.  No medical treatment required.
hoarse voice; felt like she had a big lump in her throat; difficulty swallowing; Allergic reaction; This is a spontaneous report from a contactable consumer (patient's daughter) received via Medical Information Team.  An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 04Feb2021 (at the age of 85 years) at single dose for COVID-19 immunisation.  The patient medical history included allergic to different medications.  The patient's concomitant medications were not reported.  It was reported that on 04Feb2021, the patient an hour after the vaccine developed a hoarse voice and two hours later felt like she had a big lump in her throat and had difficulty swallowing, their healthcare provider said he didn't believe it was an allergic reaction and was leaving it up to her if she wants to get it or not. The reporter stated her mother is allergic to different medications and those allergic reactions started the same way this did. The patient outcome of the events was unknown.
Within hours of receiving 1st dose, I suddenly felt a very itchy, tingly, burning sensation throughout my entire body, including my fingertips and scalp. I also felt lightheaded, hot and my chest felt very tight, making it difficult to take breathe. I looked down and noticed a hive forming on my right lower arm. I then noticed a hive on my abdomen and another hive on my left shoulder. I took an antihistamine immediately. A residual painful lump is still present that is red and elevated on my right forearm and left shoulder. These lumps seem to be getting bigger. I am monitoring. I plan to continue taking antihistamine every day until resolved and will seek emergent care if other symptoms recur despite antihistamine.
Extreme chills with severe uncontrolled teeth chattering  and uncontrolled hand and arm swaying. I took a Tylenol tablet and symptoms subsided within 15 minutes. I have never experienced this reaction before or since this episode.
Lower extremity weakness and paresthesias beginning mid-September 2021. The lower extremity weakness and paresthesias progressed and on October 31, the patient was hospitalized for weakness. The patient was officially diagnosed with Guillian-Barre Syndrome on November 10, 2021 via LP and EMG.
Patient got pale and started closing his eyes right after vaccines were finished being administered.  Patient seemed to be holding his breath during vaccine administration.  This RN encouraged patient to take some deep breaths while vaccines were being administered.  When patient got pale and started closing his eyes, patient's head was placed between knees.  Vitals were taken and were BP: 90/64; Resp:24; Pulse 74, Temp 98.6.  Pt  c/o of headache so 911 was called.  Paramedics arrived within 5 minutes.  EMS stated it was most likely a vaso-vagal response.  EMS gave the parent the option to go to ER to be evaluated.  Parent chose to have child transported to ER for further evaluation.
redness around the inj site, swelling  and pain. The Patient came in and got checked out by another NP for the adverse effect and she said he should be okay no cellulitis.
Patient reported going to the ER 24-48 hours after vaccination. Severe chest pains, severe abdominal pain, 104 fever and other flu-like symptoms
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 50-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 at 15:00 as dose 3 (booster), single (Lot number: 30155BA) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol (treated); "Cancer" (unspecified if ongoing), notes: Cancer, (surgery and radiation treatments from, Jan2022-May2022). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2022, stop date: 26May2022. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood cholesterol: high; SARS-CoV-2 test unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received vaccine was yes. Antiviral details-Product- COVID 19 Treatment, Brand- Paxlovid, Treatment start date- 27May2022, Treatment stop date- 31May2022, Indication-Treatment of COVID-19. Adverse event- Rebound COVID-19 infection, with symptoms starting to become apparent during the late evening (after 10 PM) on 3Jun2022. The symptoms include fatigue, a mild headache, runny nose, sore throat, and feeling of constriction in the airway plus cough. If patient recovered was recovering, The patient did not receive treatment for AE.  No follow-up attempts are needed. No further information is expected.
Tachycardia, palpitations, lightheadedness, fatigue, pain at infection site, lethargy, shortness of breath
KNOT IN RIGHT ARMPIT, BODY ACHES, CHEST PAIN, SHORTNESS OF BREATH, PALPITATIONS
(R) axillary adenopathy 2 days after ADACEL vaccination given in (R) deltoid.
This spontaneous report as received from a licensed practical nurse refers to a 11 year old male patient. Medical history and concurrent conditions were not reported. On 13-AUG-2015, the patient accidentally received a dose of LIQUID PEDVAXHIB lot number reported as L006545, expiry date 16-NOV-2017 (dose and route were not reported). There was no concomitant medication provided. The patient has not experienced any adverse effects at that time. Additional information has been requested.
Lost motor function and fever over 102F, hospital admission next day after injection, currently still hospitalized.
Information has been received via company representative, from a health professional (HCP) concerning her 16 year old daughter, with restless legs syndrome, who on 20-JUN-2007 was vaccinated IM with the first dose of Gardasil (Lot # invalid). Concomitant therapy included Menactra and tuberculin purified protein derivative (manufacturer unspecified). On 20-JUN-2007, "within 5 minutes of being vaccinated," the patient experienced weakness, elevated temperature, difficulty walking and she felt like she was going to faint. The HCP confirmed that her daughter had recovered (date unspecified), and "is fine now." The HCP stated she had concerns about continuing with the Gardasil series.  The patient sought unspecified medical attention. Additional information has been requested.
Patient had radiating pain in shoulder and down arm. He though he was having a heart attack. Went to the emergency room on the morning of 3/7/18. MD gave him a injection of anti inflammatory and said that the injection was put into the shoulder joint instead of the deltoid.
administering an expired ACTHib to a patient/no AE; Initial information received on 11-Mar-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 months old patient who was administered an expired ACTHIB to a patient (expired product administered), while he/she received vaccine HIB (PRP/T) VACCINE [ActHIB].  Medical history, medical treatment, vaccination and family history were not provided.    On 25-Feb-2020, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI916AA expiry date 19-Nov-2019 via intramuscular route in unknown administration site for prophylactic vaccination.  This is a case of actual medication error due to expired product administered.  At the time of this report, no adverse event was reported.   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 Directive and Module VI of the Practices. 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.
08/27/22 presents to EC ED for "shortness of breath". PMHx of "alcohol abuse"
Patient exhibited mild signs of nausea, cool, clammy skin, anxiety approximately two minutes after immunization. PT was examined immediately by a nurse with no signs of adverse reaction, anaphylaxis, or any allergic reaction. It was noted that the PT was nervous/agitated during the administration of the vaccine and was demonstrating signs of anxiety. PT was further monitored for approximately 45 minutes successfully tolerating the immunization.
Patient received moderna vaccine on 2/11/21, 3/11/21 and 11/26/21. Presented to ER on 6/30/22, COVID positive prior on 6/14/22. FOund to be COVID positive on 6/30/22 as well. She states it was like a bad cold, maybe a little worse.  She had some coughing and she states some myalgias and felt very fatigued.  She was seen in the office today complaining of continued shortness of breath and easy fatigability than usual.  When questioned it sounds like this was happening prior to the diagnosis of COVID, by maybe a week or so.  Had a chest x-ray yesterday that showed pulmonary edema versus inflammatory changes.  She denies chest pain.  She denies syncope.  She denies any fever or chills or other sequela from the COVID but has continued to be increasingly short of breath with minimal activity that she found tolerable a month ago.  In the office she had evidence of fluid overload with 10 lb weight gain from prior appointment about a month prior and also pedal edema and rales.  She had an irregular rhythm and EKG confirmed atrial fibrillation with RVR.  No known history of atrial fibrillation in the past.  She has been admitted to the hospital for further workup and treatment. Discharged on 7/5/22