chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Uncontrollable Shaking) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced TREMOR (Uncontrollable Shaking) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 pill. At the time of the report, TREMOR (Uncontrollable Shaking) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 100.9 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.
Arm soreness began immediately after injection.  Started chilling in middle of night.  By morning, still chilling, very weak and nauseous. Headache started very early morning and wouldn't go away, despite Tylenol  (8am), Ibuprofen (noon) or aspirin (3pm).  Temp in early morning was 100.   Chills lessened during day, but every time I tried to sit up, headache and nausea worsened.  Threw up fluids in early morning and at noon.  By 5pm, was able to get a little fluid and plain bread to stay down.  Headaches and fatigue on Sunday and , although lessened, that continues today (Monday).  For whatever it's worth, I reacted to first vaccine 3 months ago, with chills, aches and fatigue, but not all the rest.  Also, got bette
Pain; Swelling, and tingling in bilateral hands and half way up forearms.; Tingling in bilateralhands and half way up forearms.; This is a spontaneous report received from a contactable nurse (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 25-year-old) as a single dose for COVID-19 immunization. Medical history included asthma, opioid type dependence and anxiety from an unspecified date. The patient did not have allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), naloxone hydrochloride, buprenorphine hydrochloride (SUBOXONE) and vitamin nos (DAILY WOMENS VITAMIN) from unknown dates taken for unknown indications. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Apr2021 at 09:00, the patient experienced pain, swelling, and tingling in bilateral hands and half way up forearms. Therapeutic measures were taken as a result of pain, swelling, and tingling in bilateral hands and half way up forearms and included treatment with rest, ice, compress and elevate. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events pain, swelling, and tingling in bilateral hands and half way up forearms were recovered with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
None at the time of vaccine administration or immediately thereafter. Saw Afib / flutter in ECG as part of annual physical about 12 days after 3rd COVID vaccine administration in Dec 2021. Not seen AFib or Flutter in ECGs during previous annual check ups
Patient's mom stated her arm was really sore where injection given when did follow-up call on 11/3/09. Also, mom said patient ran fever and threw up on 11/2/09, but no fever 11/3/09.
Headache, Myalgia, Arthralgia & Fever Narrative:  Received #1 dose covid vaccine on 2/26/21. Over weekend had T 102.4, myalgia headache joint pain injection site pain. T 98.4 today and rtw. No ed or hosp. Had covid infection requiring hospitalization 11/21/20.  Other Relevant History:
Pt left room after vaccinating and passed out in store. Seized, Brought patient around, eyes rolled back. Seized, called 911. Ambulance took  to regional medical center per mom. Mom reported back thought may have been vasovagal syndrome associated with needle phobia.
pt got 2 different vaccines administered. pt did not express and current side effects  incident report was created and supervisor and medical director was notified
bilateral Tinnitus more severe in right ear. Relatively constant and loud for first few months after vaccination. Slowly reduced in intensity. Now only present in quiet settings and occasionally in the middle of the night leading to awakening. Symptoms started day 1 post vaccine and I have never experienced this in the past.
lot of fatigue; Woke up with her left eye swollen; Woke up with her left eye red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Woke up with her left eye swollen), OCULAR HYPERAEMIA (Woke up with her left eye red) and FATIGUE (lot of fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EYE SWELLING (Woke up with her left eye swollen) and OCULAR HYPERAEMIA (Woke up with her left eye red). On an unknown date, the patient experienced FATIGUE (lot of fatigue). At the time of the report, EYE SWELLING (Woke up with her left eye swollen), OCULAR HYPERAEMIA (Woke up with her left eye red) and FATIGUE (lot of fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided
Rash with discrete papules with red have scabbing. Diagnosed with clinical Varicella.
After receiving the shot on 10/6/21; on 10/7/21 at approximately 0800, I developed severe midgastric abdominal pain with diarrhea, nausea, perfuse sweating, and dizziness.  This is similar to my experience with the Covid-19 vaccine which resulted in ER hospitalization.  Diarrhea lasted for approximately 45 minutes with the sweating.  Dizziness and fatigue is current.
11/16/2021 received vaccine and reaction started on 11/27/2021. on the 27th I developed a rash all over body.
A report has been received from a Health professional concerning a child, subject of unknown gender. Patient's medical history and concomitant diseases were not reported. The patient's had been receiving FLUMIST quadrivalent (intranasal). It was reported to health professional that out of 75 influenza vaccinations, 65 tested positive later for the flu. Action taken with FLUMIST quadrivalent was not applicable. The outcome of the event of multiple patients tested positive for the flu is unknown. Reporter considered event of multiple patients tested positive for the flu to be non-serious.
I was extremely fatigued, then catatonic. My husband brought me to the emergency room, where I was admitted to the ICU. I do not remember when the spinal tap I had done but it did reveal that I had encephalitis. I was in the hospital for eight weeks while the treated me to get rid of the infection. I was released for the hospital fifty-six days later. I am currently in speech therapy but am getting better every day.
Pt fainted and became very diaphoretic but came to a minute later alert and orientated.
Information has been received from a physician concerning an 18-year-old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient experienced a "large injection site reaction". The physician reported that the patient was in the office for a follow up visit and appears to be doing better. A product quality complaint was not involved. Additional information has been requested.
11 y.o. female client post vaccination found on floor crying, conscious at 20 min. post vaccination.  Rescue was called, vital signs were taken.  Ct kept immobile until paramedics arrived.  BP 100/60, Pulse 72, Resp. 22, PERLA, MAE.  Paramedics left clinic at 3:15 pm. with client. 7/23/08-records received for DOS 7/15/08-Impression: convulsive syncope. Episode of syncope versus seizure with documented loss of consciousness followed by convulsive activity noted shortly after receiving vaccination. Collapsed and had generalized shaking with some mental status changes.
Hives of face and neck. Began 30 minutes after injection. Given 50 mg diphenhydramine, 20 mg famotidine and 125 mg methylprednisolone. Began to improve after another 30 minutes and almost fully improved after 2 hrs.
very intense headache; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number unknown) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced very intense headache on an unspecified date. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from the patient's husband, referring to a 76 year old female patient. The patient did not have any historical drugs, medical history, drug reactions/allergies or concurrent conditions. The patient's concomitant therapies included statins. On an unknown date in August 2006, the patient was vaccinated with PNEUMOVAX 23 dose reported as multiple revaccinations, injection in the right arm, for avoid pneumococcal disease (strength, frequency, lot # and expiration date were not reported). On August 2011, the patient was revaccinated with PNEUMOVAX 23 dose reported as multiple revaccinations, injection in the right arm, for avoid pneumococcal disease (strength, frequency, lot# and expiration date were not reported). On an unknown date in 2015, the patient was vaccinated with PREVENAR 13 (strength, dose, route, frequency, lot# and expiration date were not reported). On 28-AUG-2018 (reported as "yesterday"), the patient was revaccinated with PNEUMOVAX 23 dose reported as multiple revaccinations, injection in the right arm, for avoid pneumococcal disease (strength, frequency, lot# and expiration date were not reported) and on the same date, the patient experienced injection-site pain that grew worse during the day in her right arm where she received PNEUMOVAX 23 revaccination. The patient sought medical attention with the nurse and received TYLENOL as treatment for the pain. The patient continued with pain in the injection-site arm but the pain was fading. The reporter said the patient did not have pain this bad after receiving the prior PNEUMOVAX 23 vaccinations. The reporter confirmed that the patient never had pneumonia since received the vaccinations and had not been hospitalized. At the time of reporting, the outcome of injection site pain was reported as recovering. Additionally, the causality assessment between injection site pain with PNEUMOVAX 23 and PREVENAR 13 was not provided.
Fever, chills night after shot was received. Also next day and into second night.  Fever broke during second night.  Injection site red and sore third day after shot.
On the 8th I was feeling congested and had a scratchy throat. On the 9th I woke up with a sore throat and more congestion. I did two at home tests on the 8th and the 9th and they were both negative. I was developing a fever and felt worse and worse and on the tenth I tested positive. I ended up doing a virtual appointment with my doctor after that test.
multiple patients were vaccinated with improperly stored VARIVAX; No adverse effect; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 21-NOV-2018, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R017642 and expiry date 20-JUN-2019) for prophylaxis and no adverse effects were reported (product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
2 days after vaccination; onset of numbness, diminished fine motor control in (L) hand, and weakness. All symptoms in (L) arm & hand. Beginning to resolve as of 11/12/10.
C/O REDNESS AND TENDERNESS TO R ARM BUT HAD BODY ACHES WITH FEVER >100 X 24 HOURS -
10/6 COVID Diagnosis 10/9 CT: Small left pleural effusion with adjacent airspace disease/atelectasis. Perihilar airspace opacities. 10/11 COVID-19 pneumonia: on Remdesivir and steroids, O2 therapy
Approximately 3:15 pt returned back to office with c/o lips/mouth swelling and SOB and chest pain. Noted to have hives, O2 Sat 98%, EKG nl - BENADRYL 50mg IM given at 3:42 pm. TX to ER - given prednisone and albuterol neb. Contacted pt 2/17/2015 and she was much improved.
2:30pm mother called and stated that their child's throat was swelling and she is making a funny noise. She was in the car almost to the ER. I advised her to go to the ER and call us back later.
Severe right scapular pain and spasm (?supraspinous) 2 hours after vax, in right deltoid. Pain has persisted for 5 days without abating.
On 3/23/07, had "bump" with 2 smaller bumps" on labia. 3-24-07 another appeared, but  'first was almost gone" Referred to private physician.
Double vision, tingling in feet, abnormal walking, fell into wood chair at home, weak and tired. Patient call us and md today, Dr.'s office told her to go to the Emergency Room.
unconsolable crying from early evening to the next morning to about 8AM; Temp not taken by mom, but pt felt warm; Contacted MD during the noc, gave tepid bath, APAP, consoling measures;
Started with aches during the night of 3-10-21. progressed to having to use inhaler , with resolution of those symptoms. progressing aches and headache in the morning of 3-11-2021. 10:30 am of 3-11-2021 started with shaking chills, exhaustion, headache, and overall malaise. Had 2 more chill/exhaustion/ aching spells with ongoing headache in the afternoon and evening . Nighttime of 3-11-21, continued exhaustion, headache, chills, aches with highest fever recorded around 101 at 2 am 3-12-21.  Better the morning of 3-12-21, still slight headache, temp. elevation, aching resolved.
Rash started on the inside of left elbow about the size of a coffee cup.  Started to get bigger, hotter, and more red on 03/28/21.  Today ( 03/01/21), client reports rash is getting better.  Less red and less hot to the touch.
about 1 1/2-2hrs p/vax pt began crying unconsolable for 6 hrs;pt was examined again as the crying ceased;PE was significant for OM tx Augmentin
Every time I got a flu gab I actually got worse so no thanks; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient stated that every time get flu vaccine actually got worse. The patient stated that the covid-19 killing thousands of dear dear loved ones.
Seriousness criteria, other medically significant. Initial report received on 01 February 2007 from a consumer. A female patient (demographics not reported) reported that she had received a Tetanus Toxoid injection (date not provided), and since that time has had problems that include loss of feeling in her right hand, that it is gradually coming back. The patient went to the emergency room where she was evaluated by a neurologist who did nerve conduction tests. The trade name, manufacturer name, route and site of administration of the Tetanus Toxoid vaccination was not provided.
rectal bleeding; lower abdominal cramps; This is a spontaneous report from a contactable consumer or other non hcp (reported herself).    A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 03Jun2021 at single dose for COVID-19 immunisation. The patient took 1st dose of BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE solution for injection) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Jun2021, the patient experienced rectal bleeding (medically significant and lower abdominal cramps (abdominal pain) (non-serious). At the time of reporting, the outcome of the events were unknown.  Information about the Lot/batch number has been requested
pt stated around midnight after getting the vax  he had some GI issues, fever of 101, body aches, fatigue, felt like he had the flu.  Said it hurt to touch the hair on his body.  The left arm was sore around the injection site. After about 30 hours after his vax his symptoms subsided.
This spontaneous report received from a pharmacist via Pfizer referred to a 70 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, lot number and expiry date not reported) for protection against pneumococcal pneumonia (prophylaxis). On an unspecified date, the patient had trouble in arm because it was severely swollen. Outcome and causality of the event were not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Approximately 40 minutes after receiving Yellow Fever vaccine and Hepatitis A vaccine, at 12:10 PM, client returned to clinic and complained of thickening tongue and excessively dry mouth.  Client refused Benadryl, stating, "It makes me too drowny.  I don't want that." BP 120/76, P88, R 20.  Physician notified at about 12:15.  After speaking with client, 911 was called, at about 12:18, and physician also alerted the ER doctor that client would be arriving via ambulance. No stridor, no shortness of breath and no gasping noted, though client became increasingly anxious and reported her throat felt a little tight.  O2 @ 2L via nasal cannula started. EMT's arrived at approximately 12:27 and took over care of the client at approximately 12:35.
Patient called back to the pharmacy about 5 hours after vaccine administration to report swelling and redness in most of upper right arm as well as itching. She also reported vomiting. Patient advised to seek medical attention. She went to the ER on 9/8/14 and was told that the needle possibly hit a vein. She stated she is feeling better and improving on follow-up 9/9/14.
Moderna COVID-19 Vaccine EUA  Received vaccine IM on Left arm on 1/16/21 at 6:30 pm. On 1/22/21, woke up with a swollen, tender and painful armpit that is hard to move.
Pt received flu vaccine 15 min later felt faint, had LOC for 2 min, pale, diaphoretic, cool for 2 sec. Became responsive. Pt voided with loss of bladder control. 50mg of BENADRYL given PO. EMS called. VSS now recovered. Walked back to dorm.
1-16-21 Sore arm and knot at injection site. 1-18-21 woke up with swollen lips, rash around mouth/face and my lips and tongue were numb
I woke up approximately Wednesday midnight with a tummy ache. I got out of bed a little woozy and proceeded to kitchen to have a bicarbonate of soda and blacked out and fell to the floor for a few seconds. I crawled to the bathroom for a bowel movement. I then went back to the kitchen for the bicarb walking at this time. Still a little woozy but okay. Went back to bed, realizing the area of the shoulder was very sore. Much more so than 1st shot. Very restless night. No treatment necessary.
Patient developed nausea/vomiting shortly after receiving vaccine.  He also spiked a temperature of 104.9.  He was given acetaminophen, which decreased his temp slightly, but it was still over 103 for a couple hours post developing the reaction.
About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.
Vomitting, cold chills, (per patient mother lasted 90 mins) rash on chest (very mild). Fever <101.5.
At location of injection, inflammation, raised skin temperature, discoloration, starting as redness, progressing to dark purple bruising, itching, symptoms lasting for several days, about the size of a softball.
Information has been received from a 22 year old female patient, for the pregnancy registry for GARDASIL, with no pertinent medical history and no known drug allergies/drug reactions, who on 26-OCT-2007 was vaccinated with the first dose of GARDASIL (Lot # not provided). It was noted that the patient did not receive her second or third doses. Concomitant therapy included ORTHO TRI-CYCLEN. The patient became pregnant in February 2008 and gave birth on 13-NOV-2008. Her son was born with duodenal atresia and only one kidney. It was noted that the umbilical cord formed correctly but was not nourished "correctly" and therefore it looked "mutilated". There was also a tear in the umbilical cord near the belly button. The patient sought medical attention with the physician. Additional information has been requested.