chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharged. Patient is a 78 y.o. male who presented with profound weakness, chills, cough.  He was found to be COVID-19 positive in the emergency department.  He was significantly weak in the emergency department but was not hypoxic at rest.  With minimal exertion he required maximum assistance during an ambulation trial and became mildly hypoxic at that time.  His initial lab work was relatively unremarkable with only mild anemia.  He had no imaging findings of COVID-19 pneumonia.  He was admitted for further evaluation and management.   He was started on remdesivir but not steroids given no hypoxia on onset of illness 2 days prior to presentation.  She received 5 days of remdesivir and worked with Physical therapy and Occupational therapy who recommended subacute rehab.  Patient's strength slowly improved throughout the course of his hospitalization.  He was intermittently hypokalemic and required potassium repletion multiple times.  He was started on daily supplementation the day before discharge and this was continued when he left the hospital.  He was ultimately discharged in stable and improved condition to subacute rehab.
Information has been received from a physician concerning a 26 year old female patient who on 25-NOV-2009 was vaccinated with the first dose of GARDASIL. On 25-NOV-2009 afternoon, the patient called the office and stated that she was having a vaginal discharge. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a physician concerning a 17 year old female patient with past episodes of fainting with vaccinations who on 18-APR-2007 was vaccinated IM in the left arm with her first dose of Gardasil, lot #657617/0384U. After receiving the injection the patient fainted, which lasted a few seconds. The patient was completely white in the face and she complained that entire body felt like she was burning up. She was not warm to touch and did not have a fever. The patient kept asking for water. She regained color to her face 15 minutes later. She felt tingling for one hour or so both legs and arms and was very dizzy. Her eyes were closed for approximately 1 hour and she felt exhausted. The patient was given smelling salts and when asked if she was aware of what was being done to her, she "smelled violets". She had a fan on her for 30 minutes and she started to feel better. Her blood pressure was taken 2 or 3 times for approximately one hour and her pulse was also monitored. "Blood pressure reading (90/60 normal for patient). Pulse (60 normal for patient) for first 15 to 30 minutes after reaction was very faint." She was very alert one hour later (eyes open and talking) but complained of her legs feeling heavy. The patient had to be wheeled out to her car. The physician did not believe the patient hyperventilated to bring these reactions on herself. The physician believed giving the patient smelling salts, monitoring the blood pressure, pulse and putting the patient in front of a fan to cool her down was another medical event and the patient's experience was disabling because she went to bed and not able to do anything for rest of the day. Additional information has been requested.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and indicated vaccine maintained activity necessary to protect against covid 19 on date of administration. Also patient did not call in to complain of adverse event. This is administrative error without adverse event.
Headache five minutes after getting vaccine. Woke up the next morning with full body aches. Tylenol helped relieve the symptoms. All symptoms abated after 24 hours. This was my first of the two-part vaccination.
There was not an adverse reaction but reporting that this dose was given after being stored beyond 31 days in the refrigerator.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The pharmacist reported that ZOSTAVAX 19,400 unit 1 standard package vial of 1 (dose, route, lot number and expiration date not reported) was reconstituted with an expired sterile diluent (lot number and expiration date not reported). There was no concomitant medication reported. Then on an unknown date the patient was vaccinated with this ZOSTAVAX. No adverse effects were noted. Additional information is not expected due to no permission to contact pharmacist was given.
Patient was fully vaccinated (dose 1: 1/19 dose 2: 2/16). Patient developed fatigue on 3/1 then tested positive for COVID the following day (3/2). Was self-isolating at home and did not receive any COVID therapies. He reports progressively worsening fatigue, productive cough (white sputum), loss of taste, disorientation, and poor PO intake. Patient arrived to the ED for COVID-19 symptoms (3/13), tested positive and was admitted for severe hypoxic respiratory failure due to COVID-19.  Patient with AKI (creatinine =2.48) Patient escalated to HFNC then down to 6L NC to 4L then slowly weaned to RA. Received dexamethasone 6 mg daily x 10 days. Patient was admitted from 3/13 to 3/18 for COVID-19.  Creatinine on discharge was 1.29
"Starting on 10/21/2021, around 17:00, mind and my body started feeling weird. My mind began to have racing thoughts. I felt like I was in a fog/haze. Then on 10/25/2021, I went into a state of psychosis. I went to the ER and had delusions. I was diagnosed Bipolar."
Woke up itching on legs, hives developed.  Patients father denied any difficult with breathing, patient acting well otherwise.  Hives improved with Benedryl.
soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in injection arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in injection arm). At the time of the report, VACCINATION SITE PAIN (soreness in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever; Small painful sore on the mid shaft of penis; Penile ulcer; This case was reported by a physician via sales rep and described the occurrence of fever in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, penile pain and penile ulcer. On an unknown date, the outcome of the fever was unknown and the outcome of the penile pain and penile ulcer were recovered/resolved.   It was unknown if the reporter considered the fever, penile pain and penile ulcer to be related to Shingrix.  Additional information received were as follows: The patient returned on the reporting date after receiving Shingrix vaccine 2 months ago. The patient experienced fever that night then recuperated. Three days later after receivng Shingrix, the patient experienced a small painful sore on the mid shaft of his penis. The patient was widowed and dating. The patient never had penile sores in past.  The patient did not seek medical care at the time.  It took 3 weeks for the painful sore to resolve. At the reporting date, the patient asked if this could be related to the Shingrix vaccine and should he receive a second dose. The reporter had advised that he seek medical care for viral cultures should a second sore develop and no intercourse if a sore develops.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative and from a contactable other HCP. This nurse reported similar event for two patients. This is the second of two reports. An adolescent (in the 16-18 year old age group) male patient received TRUMENBA (Lot # C13514) intramuscular in left arm at 0.5 ml single dose and the second dose of MENVEO (Lot # A15068) intramuscular in right arm as single dose, both on unknown date. Medical history and concomitant medications were not reported. The patient experienced arm pain at injection site, dizziness and flu symptoms. The arm pain lasted 1 week. Unknown how long dizziness or flu symptoms lasted. No specific tests and/or treatment were required. The outcome was unknown. Follow-up (27Jun2016): New information reported from a contactable other HCP includes: lot number, anatomical location, treatment details. Follow-up attempts completed. No further information expected.
I was exhausted the whole day and couldn't stay awake. Then I had a burning in the private part but I slept and the next day I had a burning sensation and couldn't pee and did virtual health. Never had UTI before. Still taking antibiotics. Still having symptoms yesterday like having to go to the bathroom.
Received MMR, HIB & Prevnar on 2/2/01 and at that visit pt had otitis, conjunctivitis and a low-grade temperature. Pt informed, but 6 days later, developed sudden onset of high fever and seizure. Seen in office and found to have exudative pharyngitis.
I woke up with a sore throat. I started feeling achy, and chilled. I took my temperature it was at 101. Throughout the day my temp had risen to 102. I took a COVID-19 test that came back positive. I had chills, achenes, and fatigue for the next 3-4 days. On the third day I had nasal congestion, and a slight cough. After 10 days I didn't have any symptoms at all. I had a telephone visit with my doctor the next day after taking the COVID-19 test. She advised me to get an oximeter and make sure that my oxygen levels weren't too low, and if that happened to go to the Emergency Room.
generalized rash, sharp chest pains, mild shortness of breath noted morning after receipt of vaccine.
Patient was to receive Hep B dose 2, however was given dose 1 rotate at age 20weeks. No signs of adverse reaction.
The injection site area immediately bruised & swelled up. The patient states that this happens when getting blood drawn & with previous vaccines.
This case was reported by a healthcare professional via a sales representative and described the occurrence of burning down arm in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced burning down arm. At the time of reporting th outcome of the event was unspecified. Follow-up information received on 08 July 2008 indicated that the subject was a 39 year old male. At the time of injection of the 1st dose of TWINRIX,  intramuscularly, the subject experienced burning down the arm and aching at the time of injection. The events resolved and were considered by the reporter to be related to treatment with TWINRIX. The reporter stated that she has had several clients in the past 2 to 3 months complain of these symptoms at the time of injection without ongoing effect.
Diffuse body aches/joint pain weakness, chest heaviness. Sx are on going & work up not completed to date.
Chills; Body aches; Diarrhea; Headache; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8735) via an unspecified route of administration in the left arm on 17Apr2021 at 12:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 16Mar2021 at 18:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. On 18Apr2021, the patient experienced chills, body aches, diarrhea, headache and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, body aches, diarrhea, headache and joint pain was not recovered at the time pf this report.  No follow-up attempts are needed. No further information is expected.
lymph nodes still swollen in left arm; low grade fever 100.1F; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lymph nodes still swollen in left arm), PYREXIA (low grade fever 100.1F), CHILLS (chills) and HEADACHE (headache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]), OMEPRAZOLE, ESCITALOPRAM OXALATE (LEXAPRO), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph nodes still swollen in left arm), PYREXIA (low grade fever 100.1F), CHILLS (chills) and HEADACHE (headache). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph nodes still swollen in left arm), PYREXIA (low grade fever 100.1F), CHILLS (chills) and HEADACHE (headache) had not resolved.            Treatment information was not provided.
pt recv vax & exp chills & fever the following noc;did not attend school for 2 days;the 2nd day was by MD who dx cellulitis;rx ATB PMD visit on day 6 problem resolving;
Within hours of my second Moderna vaccine, the area just below the shot site became swollen, firm, red, itchy, and painful.  It's about a 2 inch ovel shaped red area.  I have not treated it aside from taking some Tylenol for general shoulder soreness and the pain from the swollen area.  Area feels the same the day after the shot, day of this report.
underarm swelled; extreme fatigue; insomnia; body aches; joint pains; This is a spontaneous report from a contactable consumer or other non hcp (patient) reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 2 via an unspecified route of administration on 03Mar2021 as dose 2 single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunization on 09Feb2021. In Mar2021 the patient experienced underarm swelled, extreme fatigue, insomnia, body aches and joint pains. The patient stated that he already received both doses of the Pfizer Covid Vaccine and was experiencing long term side effects, he mentioned that his underarm swelled and that he's still experiencing extreme fatigue, insomnia, body aches and joint pains. He Wanted to know how long these will last and what was Pfizer doing about this. The patient stated that I can't believe that the FDA approved this. Also complained about Pfizer not saying that the side effects would last more than 24-48 hours. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Done at Pharmacy. NOT life threatening. Exacerbation of most current chronic problems.: Increase gut aches, muscle aches, joint aches. Dizzy, weak, nausea, chills, headache. If I were not recently retired, there would have been absolutely no way I could go to work.   Improved with acetaminophen 500 mg q6h , tea with cloves for nausea. I do not usually have this reaction to the flu vaccine that I have taken almost every year as repiratory therapy staff of Regional Medical Center
Patient received second dose on day 16, which is less than the required 17 day spacing between dose 1 and dose 2 of COVID vaccine.    Dose one was received on 12/23/2020 Dose two was received on 01/08/2021
pt suffered muscle aching stiffness swollen glands on 4/29. 5/1 went to ER. compared by pt to rigor mortis. Residual aching
fever; This spontaneous report was received from a consumer referring to 6 months old male patient. The patient's medical history included gastrooesophageal reflux disease. Concomitant therapies included ranitidine hydrochloride (ZANTAC) and vitamin d (unspecified). The patient had no drug reactions/allergies.  On 09-SEP-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (third dose, dose, unit, lot number and expiration date were not reported), orally for prophylaxis. On the same day, he also received pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), hepatitis b vaccine (recombinant) (manufacturer unknown), poliovirus vaccine inactivated (unspecified) (reported as POLIO), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as DTPA), and influenza virus vaccine (unspecified) for prophylaxis (all dose, unit, route, lot number and expiration date were not reported).  On the same night, the patient had a fever of 101.8 (unit not reported). He was treated with acetaminophen (TYLENOL) 2.5ml. No lab diagnostic/study was performed. The patient didn't seek medical attention. On 10-SEP-2019, the patient recovered from the event. The causality between the event and the therapies was not reported.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue, general body pain, chills, upset stomach, headache, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the fatigue, general body pain, chills, upset stomach, headache, inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the fatigue, general body pain, chills, upset stomach and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient moved her body while getting the injection and it caused some of the liquid to run down her arm, which led to inadvertent exposure to vaccine and exposure via skin contact. The side effects were experienced afterwards. The patient experienced body ache. The reporter did not give consent to follow up.
exactly 7 days after I got the 1st dose my arm started itching and felt hot night time the redness and hot had spread to my lower arm.  The area where I got the vaccine started to get hard.  I felt my breast tender especially my left one and I felt pain put my collard bone to by neck (left side).  Today (5 days later) my arm is not as swollen, or hot but still itches and is a bit red. I still have pain on my neck and left breast.
1st shot, no reaction.  2nd, fever, vomiting,  headache, site redness and swelling . Took Tylenol for 48hrs and ibuprofen,  alternating. Sips of water, but no food. By the 3rd day, she was if nothing happened.
Fatigue, sinus pain, nausea , vomiting  , Chills, Body Aches, Fever. Headache, Diarrhea, runny nose  Tenderness at the injection site.
Non tender right thigh, red. Erythema 6.5 x 4.5 cm. Induration 5 x 2.5 cm.
Urticarial rash on trunk, diarrhea X 2 days. Recovering from rash.
Fever; chills; achiness; arm hurts; didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills), PAIN (achiness), PAIN IN EXTREMITY (arm hurts) and MALAISE (didn't feel well) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INDOMETACIN SODIUM TRIHYDRATE (INDOMETHACIN AGILA), LISINOPRIL and METOPROLOL for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), PAIN (achiness), PAIN IN EXTREMITY (arm hurts) and MALAISE (didn't feel well). At the time of the report, PYREXIA (Fever), CHILLS (chills), PAIN (achiness), PAIN IN EXTREMITY (arm hurts) and MALAISE (didn't feel well) 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 provided.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Chills and fever are consistent with the product safety profile.
Patient feels "needles"; UTI symptoms; muscle pain; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Patient feels "needles"), URINARY TRACT INFECTION (UTI symptoms), MYALGIA (muscle pain), FATIGUE (fatigue) and PYREXIA (fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced MYALGIA (muscle pain), FATIGUE (fatigue) and PYREXIA (fever). On 10-Feb-2021, the patient experienced PARAESTHESIA (Patient feels "needles") and URINARY TRACT INFECTION (UTI symptoms). On 08-Feb-2021, MYALGIA (muscle pain) and FATIGUE (fatigue) had resolved. At the time of the report, PARAESTHESIA (Patient feels "needles"), URINARY TRACT INFECTION (UTI symptoms) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.