chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Attack of Gout 20 yrs ago, but had an acute extreme attack within 24 hrs of my 2nd vaccine; This is a spontaneous report from a contactable other healthcare professional. A 69-year-old female patient (who was not pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number en6203) via an unspecified route of administration, administered in arm left on 06Mar2021 at 14:00, as second dose, single dose for COVID-19 immunization at other facility. Medical history included hypertension, melanoma, diverticulum and reported that she had a one and only single attack of gout 20 years ago. The patient had unspecified known allergies (hypersensitivity). The patient received unspecified medications in two weeks of vaccination. Historical vaccine given to patient previously was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number en9269), via an unspecified route of administration, administered in arm left on an unspecified date at 02:00, as a single dose for COVID-19 immunization. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19, prior vaccination. The patient has not been tested for COVID-19, post vaccination. It was reported that the patient had a one and only single attack of gout which was 20 years ago. On 07Mar2021, at 13:00 she had an acute extreme attack within 24 hours of her 2nd vaccine dose. Adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated by her MD with Steroids Medrol dose pack. The patient felt it could have been brought on by the vaccine. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Swelling, mild pain and sensitivity to touch.  Has yet to stop 5 days later.
Patient presented at field site for Moderna Dose #2.  Registrar handed off patient to injector for Dose #2.  Injector mistook requested dose type and injected patient with a Moderna booster syringe (0.25mL).  Error was discovered since our SOP is not to pre-draw primary-dose syringes until needed.  So, Lead RN walked over to LVN with a primary-dose syringe.  LVN realized error and reported error to Lead RN.  Per our SOP & CDC "COVID-19 Vaccine Administration Errors Revaccination Guidance" (12-01-2021), Lead RN instructed LVN to inject patient with another booster syringe (0.25mL) to make for a primary dose (0.5mL).  LVN had primary-dose syringe in her hand.  Lead RN instructed her to grab a booster syringe instead.  At this point, narratives differed between RN & LVN, but a miscommunication/confusion occurred.  LVN additionally injected patient with a primary-dose syringe.  So, patient received a total of 0.75mL.  Lead RN discovered this error when doing vax count reconciliation.  She was missing a primary-dose syringe.  Inducing the error, she reviewed the patient with LVN who confirmed additionally injecting a primary-dose syringe.  Lead RN telephoned me to report error.  Lead RN telephoned patient to disclose the higher-than-normal dosage and to counsel that no harm is expected but patient should watch out for vigorous side effects and manage with OTC analgesics.  Duty Officer telephoned patient on 2/3/22 for F/U.  Patient reported feeling OK as of the day with only residual pain at injection site.  However, patient reported a very unpleasant experience the day after injection.  Severe feeling of nausea.  No actual vomiting.  General lethargy.  No visit to ED/UC.  Only had to take Tylenol for 2 days after.  Our duty line was left with patient for further questions or concerns.  A 2nd F/U call will be done on MON 2/7/22.
Got poison ivy on 10/17.  Received oral steroids 10/21.  Was better 10/23.  Got really bad 10/24 and hives started.  Received steroid injection on 10/24.  8 hours later was much worse.  Went to ER and received another steroid injection and benadryl injection 10/25.  Hives and poison ivy continued to get worse.  Went back to ER on 10/28 with Edema as well.  Received multiple doses of iv steriods, benadryl and pepcid.  Continued oral steroids for two weeks after.  Thought is immune system went into overdrive with poison ivy after having both vaccines at the same time.
Mild urticarial eruption mid thighs to upper chest; DPH given; Has recvd flu shot every yr for past 10 yrs;
Systemic: Lymph Node Swelling-Medium, Additional Details: swelling and pain under armpit
16 hours after vaccine, stuffy nose and lethargy.  24 hours after vaccine, headache, fever 101-102, slight sore throat lasting 18 hours so far.  Also lack of appetite, one episode of vomiting.  Children's Motrin given 2x for fever.
I noticed my heart was beating faster a few days to a week after receiving shot, and my heart rate at night sleeping was higher, this is not something i was freaking out about but it has gotten worse, i am more tired during the day, headaches that are..different than i would get before. Increased fatigue after only a few hours after waking up, but when i go lay down my heart is beating so hard.  Im "winded" usually i could and was walking minimum 2 miles a day...always busy, now i get winded after 1/2 mile. Over the last 12 days my chest is heavy off and on, as is between shoulder blades, a dull ache, mild dizziness off and on which usually coorosponds with heart beating fast  My period was later, i could be menopausal but i dont think so. Chills and nausea is off and on, the nausea, i have always had an iron stomach,
Expired doses administered to 8 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 16-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to 8 patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
loss of appetite; achy; lower back pain; cold sweats; Chills; tired; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), PAIN (achy), BACK PAIN (lower back pain), HYPERHIDROSIS (cold sweats) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthritis and Hip replacement (two hip replacement.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), PAIN (achy), BACK PAIN (lower back pain), HYPERHIDROSIS (cold sweats), CHILLS (Chills), FATIGUE (tired) and PYREXIA (fever of 102). On 01-Mar-2021, DECREASED APPETITE (loss of appetite), PAIN (achy), BACK PAIN (lower back pain), HYPERHIDROSIS (cold sweats), CHILLS (Chills), FATIGUE (tired) and PYREXIA (fever of 102) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No concomitant information was provided.
As I began to administer the medication, the patient pulled away and the needle came out of his arm and some medication was administered into the body and some leaked out on his arm.  I did not know how much he actually received.  I contacted the Medical Director, and was advised to administer another dose of the medication in the opposite arm.
Fluctuating Fever with 100.8 at top range. Fever lasted 14 hours. Accompanied by by chills shakes joint pain
This spontaneous report as received from a nurse refers to a 65 year old patient of unknown gender. On 13-FEB-2013 the patient was vaccinated with ZOSTAVAX lot # H020000, subcutaneous. On 13-FEB-2013, 5 minutes after onset of therapy the patient experienced severe back pain. The nurse applied heat to the patient's back and the pain resolved within 30 minutes. The back pain recurred a few minutes later and the patient was sent for a lumbar spine x-ray, which revealed "mild arthritis". No further information provided. The outcome of severe back pain was not provided. This case was cross referenced with case 1302USA009575. Additional information has been requested.
Pt had 3 febrile seizures, one with cyanosis requiring oxygen. Pt was transported by ambulance to the hospital and admitted.
Later in the afternoon on the day I received my second dose, I noticed that I felt really congested in my chest.  It is Tuesday now, and I'm just starting to feel less congested.  I have had no fever, nor loss of taste or smell, just the congestion.  Coughs are infrequent and dry.
Patient received vaccine that afternoon and went to be that evening without issue. The next morning woke up with localized swelling and had decreased weight bearing on left leg. Was fatigued and napping alot throughout the day. Taken to the ER for low grade fever, given Tylenol and Benadryl and discharged home. Represented to ER later for temp of 103, stabilized with motrin and discharged home. The following morning was admitted to hospital for vomiting, fever of 10, and rash over the neck and chest. ID work-up with viral PCR, urine culture, chest xray was negative. Patient discharged from hospital after 72 hrs stay.
About 10 hours after receiving the vaccine, I had a fever. The fever only lasted about 4 hours after I took some Motrin.
Pt went to the Emergency Dept. at 0600 on 5/1/21 due to swelling and arm pain 5 says post vaccination. Pt states her arm continues to swell and extends from shoulder past her elbow.  Pt states swelling at injection site and 4 inches in diameter around site, bruised, hot to touch swelling and redness. She has been treating with Ibuprofen and Tylenol. She states no improvement at this time.
On 9/11/2012, pt received a tetanus shot Left Deltoid at 4pm and by 7pm had pain. By 3:45 on 09/12/12 has muscle weakness and SOB.
Fever over 100 degrees, body aches, headache, tiredness, injection site pain
Joint pain 1-2 weeks after 2nd injection.   Pain is in the ankles, knees, hips, neck
Patient stated after 2nd dose of COVID-19 Moderna vaccine he experienced vomiting and weight loss.
Bilateral hand tremors. Experienced tenderness surrounding vaccination site, lasting approx. 2 weeks, nickel to quarter sized knot noted at vaccination site lasting approx. 3 weeks. Experienced significant redness, swelling, pruritis, and warmth surrounding vaccination site (about the size of baseball) with onset within 3 days of vaccine and resolution by 2 weeks post vaccination. Experienced flu-like symptoms (rhinorrhea, cough, sinus pressure, generalized myalgias and possibly a fever) approx. 1 weeks following vaccine administration and lasting x 1 week.
Breakthrough case admission after 3 vaccines 2/15/21 Moderna lot# 015M20A;  Moderna 3/15/21 lot# 002B21A;  Moderna 11/18/21 lot# 065F21A
Swollen lymph nodes on right side of neck, top of ear, down side of face, down to collar bone, some soreness in armpit
Immediately upon vaccination in the central area of deltoid muscle, the patient reports significant pain at the area of injection. Upon questioning of where she remembers getting the shot, she specified it was neither too high or low on the deltoid. Three days after the vaccine the patient noted flu-like symptoms (myalgia/fatigue, no fever) that lasted several days. She presents at our pharmacy today (11/06/17) questioning why her shoulder still hurts. She has restricted strength and flexion in her left shoulder that has been continuing ever since the vaccine, and is quite painful. I suggested that she see her physician regarding this, due to the long duration of pain (16 days). She did note upon visual inspection of the injection site, no bruising or swelling was noted.
The injection site is red and warm to the touch. The size of a silver dollar.  Started sometime today.
Pt stated that post vaccination she developed a large rash, described as "blotches", to her entire face, that were quarter size. The rash began the same night post vaccination and lasted the entire night and into the next morning. Pt did not take any medication and the rash went away on it's own. Patient did not report this until presenting for her second dose.
patient stated she was lighted headed after vaccines. Patient was placed in supine position with legs elevated. patient waited 30mins for post vaccination.
Pt. presented > 24 hours post vaccine with an acute episode of angioedema with lip/tongue/throat swelling that required Benadryl, Prednisone, and Epinephrine x 2 shots. He was transferred from Urgent Care to ER where he continued to improve and was discharged from ER several hours later with Rx for Benadryl and Prednisone.
DATE OF ADMISSION:  10/19/2022   DATE OF EXPIRATION:  11/04/2022     EXPIRATION DIAGNOSIS:   DATE OF EXPIRY:  11/04/2022 at 1:20 p.m.   PRIMARY DISCHARGE DIAGNOSIS:  Respiratory failure secondary to metastatic colon gallbladder cancer and pulmonary embolus.    SECONDARY DIAGNOSES:  COVID-19 positive, hypotension, hyponatremia, hypokalemia, hypomagnesemia, anxiety, thoracentesis and hemoptysis, anemia, and remote minor tobacco history.
10 PM after 2:30 injection of vaccine booster (Pfizer) started having symptoms--fever 102, chills, very upset stomach, wanted to vomit, diarrhea, muscle pain, charlie horse, unable to sleep, frequent trips to bathroom with urination every hour, for most of the night , charlie horses in both legs at same time.  Next AM, still fever 101, very tired., chills.  Severe for 1 1/2 days.
Initial reaction to vaccine in following days were weakness in legs with high fever.  On 4/18/2021, she experienced pain in chest, shortness of breath and high blood pressure.  Called 911 and ambulance arrived to transport her to Medical Center.  She was diagnosed with congestive heart failure.  No other symptons or ailments that could have led to this event.  Doctor couldn't find any blockages or any other indicators.  Upon discussion with doctor we decided to report as a potential adverse event since no other factors present leading to congestive heart failure.  She was treated with lasix and released on 4/21/2021.
Patient (student) received a dose of Tdap even though he already received a dose @ 0840.  Both times he came with a consent which was signed by the mother. He had removed the bandaid of the earlier dose & did not question the nurse when he received the additional dose. No adverse side effects noted.  Mother notified by telephone call @ 1110 on 6/6/12.
second shot until February of 2021 / first shot in October of 2019 / a year and 4 months between the first and second shot; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on October 2019.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follow: This case was reported by consumer herself. The age at the vaccination was not applicable for this report. The patient was late for 2nd dose,  which lead to lengthing of vaccination schedule. The patient did not consent to follow-up. No further information was provided
We discovered that a specific pharmacist had been getting seventh doses consistently during his shifts by adding 2.0 mL of diluent instead of 1.8 mL. From his comments and his record of consistently getting 7th doses, it seemed, though we could not confirm, that he was obtaining 7th doses for weeks using this method. We cannot be sure which specific patients were affected.   However, we approached Pfizer for internal data regarding what volume of diluent is allowable. They provided documentation that 1.5 mL to 2.0 mL of diluent was acceptable.
pt died suddenly @ 5PM @ sitters shortly p/being layed down for a nap; presumed SIDS;
feel hot , red at injection side, itch near the injection side, pain at the injection side: patient  use cold/hot pad and aleve to release pain for 5mins then pain came back feel heavy on the left arm, hardly move left arm no fever
Excessive bleeding from 3-5mm cut/scratch on scrotum during the night. Site was still bleeding upon awakening--taking @10 minutes of  direct pressure. Time that bleeding started is unknown. Patient woke in small pool of blood that saturated bottom sheet, mattress cover and top sheet (area of 6x3 inches)
Assumed it was a cold initially, due to sore throat. Sore throat came without other side effects of cold.  Used a flashlight to look at throat. I appear to have developed a canker sore on my tonsil. Because of the location of it, the tonsil is also agitated and has been bleeding leading me to have black stool as well as cough up blood and an upset stomach. This is something I have never experienced before.  It may be unrelated to the vaccine, I am not sure, but I figured it is something worth reporting.
Patient experienced a hypotonic hyporesponsive episode immediately following vaccine administration. He stopped crying after just a second or two and had a blank stare on his face. He felt limp in my arms when I picked him up. He maintained the blank stare while being dressed and placed into his carseat, until he fell asleep in the car ride home about 10-15 minutes following administration. About 3-4 hours later he awoke and his thigh was swollen, red and warm to the touch. He started intensely crying. He cried persistently and inconsolably for about 2 hours. Patient given age/weight dose appropriate Tylenol and put in warm bath per nurses instruction with no change in behavior. Patient finally fell asleep after over an hour of skin to skin time.
Information has been received from a registered nurse concerning a female patient who in approximately 2006, one and a half years ago was vaccinated with the first dose of GARDASIL.  On an unspecified date was vaccinated with the second dose of GARDASIL.  On an unspecified date was vaccinated with the third dose of GARDASIL.  After the three doses the patient experienced pancreatitis and was hospitalized for 8 weeks but has been discharged from the hospital on 18-AUG-2008.  On an unspecified date, the patient recovered from pancreatitis.  Additional information is not expected.
t102, responded to APAP, fever climbed to 106 p/2 days, rash devel on face, abdo, back, mouth, no sz; was seen in ER & told was virus; In ER > 8 hrs was released when t103;
Fever 103 9 days after administration accompanied by head jerking/twitching. These tics have persisted occurring several times a day since 3/22/03. Currently, patient seen in our office 4/10/03.
Early AM 09/11 at about 04:00: red, itchy, rash appeared.  No fever, eating fine.  Child moderatly cranky-consoled easily.  Exam: skin: red, blotchy, raised papules with urticaria.  Lungs: clearn, wheezing.
Patient presented to clinic to receive booster dose of vaccine.  Her second dose of vaccine was in October 2021, so had only been 2 months since her last dose.  She did not report any medical conditions that would warrant a third dose of the primary series.   In effect, she came in very early for her booster vaccine, and it was not noted at the time.  We now need to know what the patient should be advised in regards to receiving any additional booster doses, or does this dose suffice as her booster dose?
could not sleep and could not get up from bed because of body aches; could not sleep and could not get up from bed because of body aches; A lot of body aches; A lot of headache; The night patient started feeling a little fever; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (could not sleep and could not get up from bed because of body aches), BEDRIDDEN (could not sleep and could not get up from bed because of body aches), MYALGIA (A lot of body aches), HEADACHE (A lot of headache) and PYREXIA (The night patient started feeling a little fever) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 620M72A) for COVID-19 vaccination.     The patient's past medical history included HbA1C increased (because of inactive insulin she was taking). Previously administered products included for Product used for unknown indication: flu vaccine (3 weeks ago). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Type 1 diabetes mellitus (8 or 9 years ago), Hypothyroidism (8 or 9 years ago) and Allergic reaction to analgesics. Concomitant products included LEVOTHYROXINE for Hypothyroidism, INSULIN DEGLUDEC (TRESIBA) and INSULIN GLULISINE (APIDRA SOLOSTAR) for Type 1 diabetes mellitus, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and IRON for an unknown indication.    On 20-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Nov-2022, the patient experienced INSOMNIA (could not sleep and could not get up from bed because of body aches), BEDRIDDEN (could not sleep and could not get up from bed because of body aches), MYALGIA (A lot of body aches), HEADACHE (A lot of headache) and PYREXIA (The night patient started feeling a little fever). At the time of the report, INSOMNIA (could not sleep and could not get up from bed because of body aches), BEDRIDDEN (could not sleep and could not get up from bed because of body aches) and HEADACHE (A lot of headache) had not resolved and MYALGIA (A lot of body aches) and PYREXIA (The night patient started feeling a little fever) was resolving.             Patient did not receive any treatment.   This case was linked to MOD-2022-675472, MOD-2022-679416 (Patient Link).   Reporter did not allow further contact
brain mass; twitch; sore arm (sensitive to touch); headaches; blurred vision; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTRACRANIAL MASS (medically significant), outcome "unknown", described as "brain mass"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitch"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm (sensitive to touch)"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision"; NAUSEA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Computerised tomogram: Unknown results; Electrocardiogram: Unknown results; Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: My 18-year-old granddaughter has had many Covid tests -all of which were negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.