chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; chills; headaches; fever; cough; aches; This spontaneous case was reported by a physician and describes the occurrence of COUGH (cough), PAIN (aches), PAIN (Pain), PYREXIA (fever) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METFORMIN, METOPROLOL and ATORVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced COUGH (cough), PAIN (aches) and PYREXIA (fever). On 04-Mar-2021, the patient experienced PAIN (Pain), CHILLS (chills) and HEADACHE (headaches). At the time of the report, COUGH (cough), PAIN (aches), PAIN (Pain), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Signs: localized injection site hive in addition to smaller hives on both legs and a dime-sized hive to the face. Symptoms: 1:00 am shooting pain with complete numbness to the contralateral arm which lasted approx. 2 minutes and completely resolved. 4am sweats & chills, but afebrile. Itching to a very small area on the left pointer finger almost immediately after receiving the shot, but this resolved by around 10pm.
On 3/30/2021 Bronco spasm after 30 minutes of inoculation. He felt a tight chest, severe pain in the right lung, disorientation, headache, dizziness, and itchy throat. Quick use 2 inhalers: Albuterol Sulfate HFA and Symbicort. Also take 2 Benadryl 25mg. The next day 3/31/2021, use the inhalators preventively. Headache and muscle pain continued on 3/31/2021 and I took 2 Tylenol 600mg every 4 hours. On 4/1/2021, headache, muscle pain, and breathing problems decreased. At the moment there is mild pain in the head, arm and muscle.
Flu symptoms  Day 1-2: increasing flu-like symptoms--headache, aching joints, lethargy.  Day 3: flu-like symptoms gone  Site reaction  Day 2: vaccine site becomes red.  Day 3-8: site redness grows in size, extending down to lower bicep area and around tricep.  Site also very warm to touch (as recounted by examining physicians on Day 6 and Day 7)
About two weeks after vaccine she noticed itching. Over the next few days she had a rash on the right arm that was about 4-5 inches long and 3-4 inches wide. It was red, warm, and slightly swollen. It gradually went away over the next two weeks. She called the virtual clinic to be sure it wasn't an infection. Said it did not look infected but that she could use Benadryl cream on it.
tongue still feels strange; tingling and numbness in cheeks, lips and tongue; tingling and numbness in cheeks, lips and tongue; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA (tingling and numbness in cheeks, lips and tongue), PARAESTHESIA ORAL (tingling and numbness in cheeks, lips and tongue) and TONGUE DISORDER (tongue still feels strange) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PARAESTHESIA (tingling and numbness in cheeks, lips and tongue) and PARAESTHESIA ORAL (tingling and numbness in cheeks, lips and tongue). On 27-Feb-2021, the patient experienced TONGUE DISORDER (tongue still feels strange). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling and numbness in cheeks, lips and tongue), PARAESTHESIA ORAL (tingling and numbness in cheeks, lips and tongue) and TONGUE DISORDER (tongue still feels strange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Additional information received including reporter email, adverse event terms, event treatment, event outcome.
DID NOT SLEEP WELL; LITTLE TIRED; FELT HEAVY CHILLS/ FREEZING; BAD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 18-MAR-2021 09:45 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021 around 20:00, the subject experienced felt heavy chills/ freezing. On 18-MAR-2021 20:00, the subject experienced bad headache. On 19-MAR-2021, treatment medications included: paracetamol. On an unspecified date, the subject experienced did not sleep well, and little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt heavy chills/ freezing, bad headache, and little tired, and the outcome of did not sleep well was not reported. This report was non-serious.
Initial report received from a healthcare professional on 15 February 2013. A 66-years-old female patient who had no illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical condition and concomitant medication were not reported, had received a dose of FLUZONE HD vaccine (Lot number: U4497AA, dose number, route and site of vaccination not reported) on 17 January 2013. Within 24 hours of vaccination, the patient had presented a sudden onset of a severe sore throat, hoarseness and stuffy nose on 20 January 2013. Corrective medications were not reported and had no laboratory tests were performed. Symptoms were lasted for three days and on an unspecified date, the patient had recovered from adverse events. Documents held by sender: none.
Seen ER 9/13. (R) arm swelling s/p KINRIX vaccine on 9/11/15. Seen in our office 9/14 for follow up ER dx with cellulitis. Temp 100 on cephalexin. Area improved.
I experienced two days later bad earaches for some hours. I also had SOB.   Today, I am applying ear drops in my ear due to my ear aches.
Information has been received from a registered nurse concerning a 30 year old Caucasian female with a hx of hypersensitivity reaction after administration of a flu shot who on 6/22/99 was vaccinated with Hep B in the right deltoid. ON 6/30/99, the pt experienced a painful 1 1/2 - 2 1/2 cm area of induration at the injection site. she saw he MD again on 6/30/99. He found axillary node tenderness and enlargement. Her arm was edematous and warm to the touch from the injection site to the elbow. It was also reported that the pt had a moderately severe allergic reaction to substrate. No further information is available.
This spontaneous report was received from a consumer referring to his 78 year old female wife with congestive obstructive pulmonary disease (COPD), allergy to FLEXERIL, allergy to codeine, allergy to hydralazine, allergy to procardia, allergy to Darvocet, hypertension, spinal stenosis, allergy to iodine and allergy to quine sulfate. On 04-OCT-2014, the patient was vaccinated with a dose ZOSTAVAX (dose number, lot number and expiration date were not reported), 1 DF (reported as 1 vaccine), intramuscular route (reported as under the muscle) in the right arm. Concomitant included several different medications to treat blood pressure and other ailments. Husband reported that on 05-SEP-2014, his wife received the ZOSTAVAX vaccine and experienced rash and hives, swelling at the injection site. At the time of the report the outcome was unknown. Blood work were performed on an unknown date. Results were not reported. The husband reported his wife performed blood work every six months. Patient did not sought medical attention. Additional information has been requested.
Patient refers feeling dizzy. Mother indicates same thing happen during the week, and she took him to the doctor. Everything was ok.
This nurse contacted patient via phone about post-discharge care after released to home from nursing facility after covid pna dx. Member first stated he received covid 19 shot on 2/24/2021 during the day and then took his heart medication at 8 PM that evening.   He asked if his heart medication could have caused interaction with the covid shot. Stated was feeling funny last night after taking heart pill, arm was hurting and did not feel good, and at first stated he felt as he was going to die but then stated to this nurse later in the call that  he did not really feel like that but instead felt dizzy at at midnight or 1 AM and took heart medicine at 8 PM. THis nurse contacted the PCP and advised on symptoms and patient concern about heart medication interacting with covid 19 shot.
Employee complained of severe pain at the injection site.  She also noted pain radiated out from the injection site.  The next day her arm appeared bruised.
pt recvd vax @ 615PM 21FEB mom gave pt APAP q 4 hrs @ 230AM pt woke up vomiting & temp was 103 ax; pt was given cool baths & APAP; 130PM temp was 104.2 ax;
PT RECVD 1ST INJECT(LF,DELT) 4-2-90 ONSET OF LF NECK, SHOULDER AND LF JAW PAIN; EXP TINGLING IN LF HAND AND FINGERS AND RT SIDED HEADACHE WITH NAUSEA,SCOMATA.INTERMITTENT HYPERESTHESIA/HYPOESTHESIA OF THE LEFT CHEEK WHICH PERSISTS.
Feeling achy; Soreness at injection site; Feel ing very tired; Very bad headache/mild haedache right now; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feeling achy), VACCINATION SITE PAIN (Soreness at injection site), FATIGUE (Feel ing very tired), HEADACHE (Very bad headache/mild haedache right now) and NAUSEA (Nauseous) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PAIN (Feeling achy), VACCINATION SITE PAIN (Soreness at injection site), FATIGUE (Feel ing very tired), HEADACHE (Very bad headache/mild haedache right now) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Feeling achy), VACCINATION SITE PAIN (Soreness at injection site), FATIGUE (Feel ing very tired), HEADACHE (Very bad headache/mild haedache right now) and NAUSEA (Nauseous) had not resolved.            No concomitant medication was reported.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient was sweating and feeling dizzy after the administration of the vaccine. patient felt better after drinking water and resting for 15 minutes
I experienced amenorrhea for 9 months after receiving the vaccine with no other changes that would effect that
Right after receiving Hepatitis A, he felt dizzy and his body went limp (jelly) like. His eyes were open but had a blank stare, spacey looking. He doesn't remember passing out. He lost all color-very pale. It all lasted 1-2 minutes. After awake, BP 100/60 HR 60, Alert and oriented.
Approximately 15 mins following Hep B #2 and Hep A #1, driving home with father and had bried (15 sec) episode of stiffening and loss of consciousness. Apparent 1st seizure.
within 20 minutes of shot, became dizzy with nausea and headache.  left arm, hand and both feet went numb.  nausea and headache ended within few hours.  numbness in hand and both feet still exists 8 hours later.  this was 2nd of the 3 doses.  9/25/09 Neurology consult received DOS 9/17/09. Assessment: Focal neurological symptoms after second HPV vaccine. Patient reports numbess for several hours in injected arm. Developed headache, nausea, and dizziness. Subsequently tingling sensation in left hand. Tired. Numbness in both feet. Tripped. Neurological exam - normal.
Seemed sad/tired and no energy.  104+ fever. About 9PM had a partial seizure so we took him to the instacare.  Dr said white stuff on his throat and did a strep test. Came back negative.  She said it must be Adenovirus and sent us home and said to just keep the fever down. He woke at 12AM having another partial seizure, fever was 103. Developed a cough several days later. Took 4 days for the fevers to subside.  Returned to primary care physican on 03/14/14 because he still didn't seem like himself, but no fevers. Oxygen kept showing at 86.  They kept checking until it read 96 consistently on his foot.  Gave a prescription for Amoxicilin for ear infection and sent home.
This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune thyroid issue - hashimoto, and sulfa allergy. The patient experienced drug allergy when treated with doxycycline, and prednisolone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 18205018, and batch number: 18205018 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 10:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced tiredness. On 31-MAR-2021, the subject experienced pain to arm. On 31-MAR-2021, the subject experienced injection site stinging. Laboratory data included: Fever (NR: not provided) as high 101. On 31-MAR-2021 18:00, the subject experienced flu like. On 31-MAR-2021 18:00, the subject experienced shivering. On 31-MAR-2021 18:00, the subject experienced body aches. On 31-MAR-2021 18:00, the subject experienced fever. On 31-MAR-2021 18:00, the subject experienced headache. On 01-APR-2021, the subject experienced bump to site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like, shivering, and headache, and chills, and fever on 01-APR-2021, had not recovered from bump to site, body aches, tiredness, and pain to arm, and the outcome of injection site stinging was not reported. This report was non-serious.
The Pt reports central, dull and achey CP that began 5 minutes post 1st Pfizer vaccination to right deltoid. She rates the pain a 4/10 when it came on but a 2/10 upon evaluation. She denies radiation of the pain, nausea, SOB, lightheadedness, dizziness, or vision changes. Pt also denies swelling of the face, throat tightness, difficulty swallowing, or itching of the skin. The Pt has a Hx of CP in 2019 with resulting hypokalemia treated in the ER. She states that she was on a short course of K+ with frequent K+ monitoring but stopped being followed for this issue when her insurance changed. The Pt states that she has not had bloodwork or taken K+ supplements since late 2019. She does note a Hx of mild anxiety but denies taking any medications currently and states that her anxiety usually does not bring on CP. Pt reports food allergy to aspartame but no medication allergies.
Muscle soreness/cramping/pain ongoing with no improvement. Reported 10/30/07. No longer any redness or soreness directly at injection site. Pain radiates down arm. Began after shot. Treated with over the counter analgesics and now Tramadol 50mg. Also suggested ice/cold compresses.
This spontaneous prospective pregnancy report has been received from a medical assistant referring to a 37 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions was not reported. Concomitant therapies included anti-rh gamma globulin(RHOGAM (ANTI-RH GAMMA GLOBULIN)) and iron (unspecified), minerals (unspecified), vitamins (unspecified)(IRON (UNSPECIFIED) (+) MINERALS (UNSPECIFIED) (+) VITAMINS (UNSPECIFIE). On 21-JUN-2018, a pregnant patient was vaccinated with GARDASIL 9, intramuscularly (strength, dose, frequency, anatomical location, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
That evening I started a fever. My arm was very sore, but I didn't care about that. I was weak and feverish. I laid on my daughter's couch and I couldn't get up for two days. Fever and weakness. Forced myself to stay awake long enough to take my reg. pills and eat crackers.
Client presented with Mother to  received Pfizer Dose 1 Lot#FL8095. While in observation client reported having stomach pain 5/10, nausea, and feeling dizzy. Client was ?scared of the vaccine? Mother stated client gets anxious with vaccines but had never had a reaction to a vaccine. Client was AAOx4 and was mildly pale. Client was placed on zero gravity chair without assistance. Vitals taken by RN BP 99/60 HR 116 RR 16 02 100%. Mother stated that client had no medical conditions or allergies. At 1717 RN asked client how he was feeling, client responded, ?much better?. Client no longer felt dizzy. . At 1720 client stated his stomach pain was 1/10. Client denied itchiness or shortness of breath. . At 1725 client stated he felt ?good?. At 1728 client was able to drink water and a snack provided. Client had no trouble swallowing. Client?s face color was slightly pink, pallor subsided. At 1732 RN , asked client how he was feeling client, stated he ?still felt good?.  RN educated client on emergency room precautions for returning or worsening symptoms and recommended follow up with Primary care provider within 24 hrs
Positive COVID-19 NAAT on January 21, 2021 Treated with bamlanivimab 700 mg on 1/22/21; My blood sugar levels exceeded 600 and stayed above that range for approximately 12 hours. I increased my insulin pump accordinly. My asthma also became problematic and received no relief from the 3 inhalers for approximately 3 weeks.
Patient received flu shot on 10/1/19 w/out guardianship or parental consent Guardian/parent immediately warned staff to watch for reactions as patient had reacted to 15 month vaccines Ten (10) days later guardian/parent was advised that patient did have a seizure while at his adult day care Any other concerns are hard to track as can be hard to tell if symptoms  related to autism or vaccines
This spontaneous report was received from a Licensed Vocational Nurse (LVN), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength, dose number, dose and frequency were not reported) orally, lot number M041184, expiration date 31-MAY-2018, for prophylaxis. On an unspecified date, the vaccine was exposure to a temperature excursion; the data logger registered a temperature of 70.7° Fahrenheit (F) during a time frame of 2 hours and 36 minutes. There was not previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA000593: US-009507513-1710USA011267: US-009507513-1710USA011268: US-009507513-1710USA011270: US-009507513-1710USA011271: US-009507513-1710USA011272: US-009507513-1710USA011273: US-009507513-1710USA011274: US-009507513-1710USA011275.
Patient given MENVEO 8/16/16 and presented to after hours 8/18 for (R) deltoid swelling, warm to touch.
This spontaneous report was received from a pharmacist refers to a 66 year old male patient. The patient penicillin allergy. On 27-SEP-2016, the patient was vaccinated with first dose of PNEUMOVAX 23 lot # L019835, 23-MAR-2017 intramuscular in the left deltoid. On 27-SEP-2016, the patient experienced swelling, redness and pain at his injection site the same evening that he received the dose. The patient also reported of experiencing chills, sweating and feeling hot and cold. The patient consulted his primary care physician who prescribed doxycycline for treatment of the patient's adverse experience. The outcome of the events were reported as unknown. Additional information has been requested.
Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background. Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods. ESP-VAERS monitors patient's electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine system's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results. In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable pre-implementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. Keywords. Vaccine; immunization; adverse reaction; reporting; adverse event. This case involves a patient (age and gender not reported), who was vaccinated with a dose of INFLUENZA VACCINE (IIV) (Manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient experienced seizures. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Upon internal review case was confirmed as serious due to important medical event: seizure. Documents held by sender: none.
Cold sweats, migraine, nausea, stomach ache, body aches, and exhaustion.
Chills, soreness all over the body and very sleepy. Experienced this on the day of the injection. Went to the MD the MD on 06-27-18 and the MD gave him an injection which made him feel better but he does not know what it is. Then on 07-04-18 at 1:30 pm he felt the same way again.