chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little soreness at the site; sore arm; Caller stated a COVID 19 bivalent booster shot was mixed in the same syringe with a flu vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from medical information team.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Little soreness at the site"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PRODUCT PREPARATION ERROR (non-serious), outcome "unknown", described as "Caller stated a COVID 19 bivalent booster shot was mixed in the same syringe with a flu vaccine".  Additional information: Caller stated a COVID-19 bivalent booster shot was mixed in the same syringe with a flu vaccine and administered to one family member. She stated her family member was "not concerned, guessing it would work, but she became aware today and she just wanted to make sure this was okay. They were not having adverse reactions, just a little soreness at the site, which was expected but she concerned about the efficacy, and side effects. Dose/dosage form: Gray cap, original/Omicron BA.4/BA.5 (bivalent), greater than or equal to 12 years - 15/15 mcg per dos. She was a nurse, and she knew that they were not doing this when they were administering the vaccines. She wanted to know if that was an acceptable practice, and if not, what concerns they should have as far as efficacy and monitoring for adverse reactions. Her family member was having no adverse reactions, just a sore arm, nothing else or anything that would be unexpected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and swelling to left posterior upper arm onset Friday morning. Was seen at Hospital Emergency Room, given KEFLEX to take 4 times a day for 7 days.
This spontaneous report as received from a licensed practiced nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-NOV-2015, the patient was vaccinated with improperly stored doses of GARDASIL 9 was vaccinated with improperly stored GARDASIL 9 (lot# was reported as L014239, expiration date 21-JUL-2017, dose and route were unknown). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
The night of my second dose I went to sleep and my arm was sore (to be expected; I wasn't concerned). I woke up at 3:15am because I couldn't feel my feet and hands.  It spread so that I could not feel my shins or my arms. And then I couldn't open my eyes. I told my husband to call 911. When they arrived my HR and respirations were 100-120. My BP was elevated. I couldn't move my limbs and the paramedics said they were contracted. They were unable to get oxygen saturation from my finger, but stuck something in my ear and my saturations were 100% They walked me through breathing exercises for hyperventilation. HR, respirations, and BP all started to come down. I've never had anything like this happen before and, like I said, I was completely asleep prior to this event. But, of note, one of the paramedics said this happened to him after his second dose of the vaccine.
headache, nausea, chills, severe muscle aches and joint aches (ankles, knees, wrists shoulders), fatigue, anorexia Nausea and headache were gone in 24 hours Appetite improved in 36 hours Joint and muscle aches have decreased in severity but were a 9.5 out of 10 for 48 hours after receiving vaccinations. Very painful and difficult to move. Covered with three blankets. Able to drink flds but only ate soda crackers for over 60 hours. Used Icey Hot, Naproxen and Cyclobenzaprine with little relief
that day she began feeling dizzy. She stated the dizziness got worse and she felt like she was going to pass out so she stayed home. Patient stated by Monday she was feeling fine, but read over the paper she received when she got her flu shot and it said to call and report if adverse reactions were experienced.
C/o severe muscle cramping and pain. Did not report to ER stated it subsided within 24 hours and reported  it to us on his FU 12-5-08
I have a major blood clot in my left leg. I had two ultrasounds and now starting blood thinners.
03/21/2019 Given ROTATEQ vaccine. 03/23/2019 mom spoke with dr on call pt fussy, gassy. Cried for 1 hr. no stool for 3 days. Given glycerine supp. Discussed signs of intussusception to watch out for. 03/24/2019 mom called Dr on call again. Now pt had flecks of blood in the stool. Pt sent to ER. Ultrasound normal. Stool guaiac positive. Discharged home. 03/26/2019 pt seen by pcp Dr. Pt continues to have loose mucoid stool, guaiac positive. Sent a Diarrheal PCR Panel to Lab and came back positive for Rotavirus. Pt is taking probiotics once a day per mom.
High Fever (103); chills; body aches; headache; nausea; fatigue; pain at injection site; injection site swelling and redness; lymphadenopathy; injection site swelling and redness; This is a spontaneous report from a contactable consumer(patient). A 54-year-old female (non-pregnant) patient received second dose of BNT162B2 (Solution for injection, Lot number: EL9269, Expiration date: unknown), in left arm on 11Feb2021 at 03:30 PM, at single dose for COVID-19 immunization. The patient historical vaccine included first dose BNT162B2 (lot number: EL8982) left arm on 21Jan2021, at single Covid-19 immunization. Patient medical history and concomitant medications were not reported. After second shot Patient experienced High Fever (103), chills, body aches, headache, nausea, fatigue, pain at injection site, injection site swelling and redness, lymphadenopathy on 12Feb2021 at 09:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovered.
On 08/24/2021 I started having symptoms like cough and congestion. I happened to have an appointment with my PCP that week so I got tested on 08/26/2021. My symptoms did get worse I had fatigue, fever, increased cough, extreme diarrhea, and lost taste /smell.  On 8/29/2021 I have Monoclonal Infusion and had worse diarrhea after and projectile vomiting, and severe fatigue. I felt like I got significantly worse after the infusion. On 08/31/2021 I called my PCP and he prescribe an anti-nausea medication. All I did was sleep and on 5/3/2021 I called my doctor and they asked me for my O2.  My husband got a Pulse ox reader and my O2 was 74. My PCP called back and told me to get to the ER right away. I was admitted to the Hospital for six days were chest x-ray confirmed COVID-19 Pneumonia and lab results were my potassium was very low so I was given two potassium infusions and also oral potassium. I also received another infusion for COVID-19 but I am not sure what it was. I was on oxygen for the entire length of stay at hospital and sent home with oxygen for a few weeks. The main things that have been lingering that cause me difficulties is brain fog, I still do not have full sense of taste or smell, and I still have fatigue issues.
No Wheal and observed leakage on first Intradermal administration attempt. Successful 2nd administration intradermally
Palpitations, anxious, no temperature but my body feels really hot in the inside, very bad pain under the arm pit close to my breast on the arm of vaccine,  weak ,lightheaded, sweating, headache,
She claims that she felt a swelling in her throat approximately 10 minutes after receiving her COVI-19 vaccine.
I have developed bell's palsy.   I am not sure if that is due to the Pfizer vaccine.   Otherwise, I am in excellent health.
one week after injection, patient started experiencing leg numbness/tingling, headache, left sided face tingling, burning in chest. Tingling/numbness progressing to full body.
Myalgia, Fever, CoughWheeze, Also having sob off and on Narrative:
TC from pt 29OCT91 reporting ached all over, had temp from 103-105; was in bed most of week; no pvt MD; also called ER was told poss sinus infection;
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 19-MAY-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Tachycardia for approximately 8 hours, from 8:00 AM (may have started earlier while asleep - don't know) until about 4:00 PM. Normal resting heart rate is 68-72. Heart rate was 105 for about four hours, dropped to 100 for an hour, then to 90 for another two hours, before dropping back to normal 71 late afternoon.
LD IM injection pneumovax.  Pt RTC for BP check 11/30/05.  L upper arm/bicep -Erythema, swelling, TTP, good ROM strength with it, radial pulse. RTC 12/1/05 decrease erythema, swelling.  RTC 12/6/05 symptoms mostly resolved.
Arm was sore; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Tired) 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 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (Tired) was resolving.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
1/23/21 Initial 'stinging' on injection (not bothersome).  Other course of several hours the (L) deltoid muscle was sore (deep muscle ache and superficial 'burning sensation').  Other reactions included chills and myalgias in both shins (these resolved within 12 hours).    Over night, the left deltoid became painful to even light touch (almost like a severe sunburn). The area was not erythematous and there was full ROM.  Over ensuing 3 days the pain gradually resolved.    On 1/31/21 the (L) deltoid became very 'itchy'...deep within the muscle.  The sensation was alleviated by deep massage and superficial scratching of the area.  No nodules were appreciated on deep palpation.  On 2/1/21, the left deltoid region was markedly erythematous and pruritis persists.  Reporting event due to new vaccine.
CHILLS, FEVER STARTING WITHIN FEW HOURS, SORE RED, WARM INJECTION SITE LASTED 2-3 DAYS. NEXT DAY MALAISE, FATIGUE, LOSS OF APPETITE. SPENT 2 DAYS ON COUCH, WRAPPED IN BLANKET.
dizziness while preparing her meal; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness while preparing her meal) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (dizziness while preparing her meal). On 04-Feb-2021, DIZZINESS (dizziness while preparing her meal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-209805 (Patient Link).
To ED with c/o persistent dyspnea on exertion. Acute on chronic respiratory failure with hypoxia and hypercapnia. Atrial Fibrillation with RVR HR 116 History of Atrial Fibrillation with RVR. C Diff diarrhea, Cardiomyopathy, Diabetes, CHF
Woke up with several stomach pain, diarrhea, headache, muscle aches and tiredness.
Caller reports that her mom also has laryngitis, but no fever; This is a spontaneous report from a contactable consumer (daughter).  A 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced caller reports that her mom also has laryngitis, but no fever on an unspecified date. The  outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained
severe fatigue started the day after the vaccine, on day 5 generalized joint pain started,  loss of strength, nausea, loss of appetite,  mental and physical fatigue, some shortness of breath this continued with possibly some mild improvement till the second vaccine was given on 2/26/2021. Same symptoms  plus also following this second covid vaccine tendon inflammation started with clear swelling redness, pain, on random places over tendons left wrist, right ankle, back of left hand, top of right foot, right jaw, right shoulder, random shooting pains over nerves and joint pain, my body seems to have aged 20 year, I wake up stiff in the morning and after an episode of sitting I feel stiff and it takes time to get going. This has been going on for the past 10 months with no improvement. Fatigue continues, loss of appetite continues, loss of strength continues, mental tiredness, exhaustion, sense of shortness of breath and palpitations .  Inflammation occurs after a minimal level of activity. My physical capacity has been reduced by 60 % . Prior to this I was a healthy person with no physical symptoms, young for my age. So it is very clear to observe the changes that have happened. I also am a physician and so am able to identify and interpret the changes in my body well.
Information has been received from a pharmacy technician referring to unspecified patients of unknown age and gender. Information about the patients' concurrent condition, medical history, drug reactions/allergies and concomitant medication was unknown. Since 21-DEC-2016, the patients were each vaccinated with a dose of improperly stored VARIVAX (dose and route were unknown, lot # M034583 with expiration date 27-JUL-2018, lot # M031970 with expiration date 30-JUN-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 41 Fahrenheit for 9 hours and 15 minutes and there was no previous excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments:  US-009507513-1612USA012899:
Patient stated that she had pain, numbness and tingling of right arm, due to flu shot. Possibly given too high in the deltoid. Denies any redness, fever, or chills.
It was reported that a patient (4 of 4) received a Fluzone '00-'01 vaccination, given IM on 19 Oct 2000. Reportedly the patient developed numbness and tingling in the arm and hand after the injection. No specifics were provided. Further information is being requested. For additional correspondence received on 16 March 2001, it was reported, "mild relieved with ice packs." The pt reportedly recovered from this experience. Additional responsible facility, vaccine, and pt information was provided.
DEATH Narrative: Patient was a 73 year old gentleman presented to the ED with Worsening SOB, abdominal distention, leg swellings and generalized weakness. On physical exam he had abdomen tenderness, distension and BLE 4+ pitting edema. CT abdomen showed liver malignancy which on CT was found to be 6.4x 4 cm mass in caudate and R hepatic lobe obstructing R portal vein, main portal vein/splenic vein and IVC (likely tumor thrombus or blood clot). Labs suggested liver failure and renal failure was deteriorated 2/2 outflow obstruction. Providers discussed with vascular surgery and gastroenterology, they did not have any treatment options to offer. Palliative care was involved in his cares. After detailed discussions with family amd palliative care regarding guarded prognosis, his code status was switched DNR/DNI. we were looking into palliation options. Oncology was consulted, given that the imaging findings were not definitive for a diagnosis of hepatocellular carcinoma, they recommended biopsy of the caudate lobe mass to establish a tissue diagnosis to see if the tumor is radiation or chemosensitive. Vit K was being given to lower INR <1.3 to do a biopsy. However, patient decompensated rapidly in 1-2 days developing altered mental status from acute liver and renal failure. Providers discussed with radiation oncology to see if they would consider emergent radiation mainly for local tumor shrinkage/relief of IVC obstruction to relieve hepatic/ renal congestion: suggested they would not offer radiation in the setting of acute liver failure + acute renal failure; and radiation typically does not work/ not used for acute settings. Providers also discussed with interventional radiology, surgical oncology: they said has nothing to offer at this time given his large tumor burden and significant vascular involvement. Patient became unresponsive overnight, we offered and provided comfort/care to patient after discussion with daughters. Time of death 03:50AM on 02/23/2021.
Pt recvd 2 doses of Engerix-B vax 30JUL91 & 3SEP91 & 3-4 days p/2nd inject pt exp a large red raised area @ the inject site; Reporter indicated further skin testing is being done;
Within one hour after shot was given, I was tired, achy body, chills, crabby, had shortness of breath, the next morning, I felt dizzy, sick to my stomach, head ache, body ached all over, and my head felt funny. This was after I received  hte Tetanus & Diphtheria Vaccine shot.  The lot number will be provided to you when I hear back from the Dr's office. including the Mfg. name.
Developed shingles on right side of upper back shoulder area; This is a spontaneous report from a contactable consumer (patient).A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in Arm Right on 14May2021 at 16:00 (age at vaccination 26-year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no known allergies. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm right on 23Apr2021 at 16:00 as a dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27May2021, the patient developed shingles on right side of upper back shoulder area. Therapeutic measures were not taken as a result of the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had not yet recovered from the event.  Follow-up attempts completed. No further information expected.
The night of getting the first dose of Moderna, I woke up to my stomach having a burning and tingling sensation, severe nausea, fast heart rate, feeling like I was going to stop breathing and faint, my lips were numb. These symptoms lasted for about 20 minutes and then they resolved. I did not have any of these symptoms since it initially happened on 1.8.21 at 230am. I did not seek medical care at the time since my symptoms resolved. I did contact my doctor on 2.1.2021 about this and he stated the symptoms I described aligned with symptoms of a panic attack, but if I felt it was related to the vaccine that I can report it.
This subject is a 69 year old male who died of natural causes while enrolled in RSV S & I study. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/9/02. The subject died 255 days post immunization on 6/21/03. The death was reported by the investigator as not related to the study vaccine. Cause of death was not reported. Additional info is requested. Subject developed a cough, chest congestion and SOB 30 days post immunization and was admitted to the hospital on 11/8/02. A chest x-ray showed patchy bibasilar infiltrates superimposed upon fibrotic changes. Treatment included IV Solumedrol, antibiotics, Levaquin, Lanoxin, Surfak, and oxygen. The subject recovered and was discharged from the hospital six days later on 11/14/02. The event of an acute exacerbation of COPD was reported by the investigator as unrelated to the study vaccine. A 15-day follow up report received 11/13/2003 adds: Additional info received 10/21/2003: Copy of Death Certificate dated 06/25/2003. Cause of Death: Emphysema, due to tobacco abuse, coronary artery disease, insulin dependent diabetes mellitus. No autopsy was performed.
Pateint developed rash approximately 24 hours after vaccine on back and side (bra strap area). No reaction at injection site or area. This was reported to pharmacy several days later in search of remedy to help rash.