chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rapid heart rate; rash on entire torso; Felt tired; Low grade temperature; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart rate), RASH (rash on entire torso), PYREXIA (Low grade temperature), CHILLS (Chills) and FATIGUE (Felt tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart beat abnormal neonatal.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Low grade temperature) and CHILLS (Chills). On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart rate) and FATIGUE (Felt tired). an unknown date, the patient experienced RASH (rash on entire torso). On 18-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, HEART RATE INCREASED (rapid heart rate), RASH (rash on entire torso) and FATIGUE (Felt tired) outcome was unknown and PYREXIA (Low grade temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38 (High) low grade temperature 100.4 F. On an unknown date, Heart rate: 112 (Inconclusive) 112.         No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: additional event reported (rash on entire torso).
Patient experienced vasovagal syncope approximately 2 minutes after receiving vaccination.  Patient's spouse was with him with the anticipation of him having an event.  He was pre-screened on our VAR. After it was determined that his experiences in the past were no longer an issue, we proceeded to administer the vaccine.  He rested with cool compress and fluids for 30 minutes before leaving on his own accord.
Extra dose administered; This non-serious case was reported by a physician via other manufacturer and described the occurrence of extra dose administered in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concomitant products included POLIO VACCINE (IPOL (POLIO VACCINE)).   On 28-SEP-2023, the patient received Pediarix. On 28-SEP-2023, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 3-NOV-2023  The reporter stated that the patient received a 2nd dose of IPOL, and they made a mistake of double dosing ipv to patient by administering a dose of Pediarix. The reporter consented to follow up. The patient received double dose of IPV which led to extra dose administered.
HYPOTENSION 12/27/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Fatiugue, pain in legs (calves/thighs), back pain, shoulder pain, fatigue, shaking, cold, warm, lethargic, overall feel worse than when I had Covid.
RADIATING PAIN DOWN ARM/PAINFUL THUMB; PAIN IN WRIST; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: not reported) dose was not reported, administered on 06-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the patient experienced radiating pain down arm/painful thumb and pain in wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from radiating pain down arm/painful thumb, and pain in wrist. This report was non-serious.
redness in the itchy areas; itching all over my body with a rash; itching all over my body with a rash; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8733, Expiration date: not reported), via an unspecified route of administration in arm right on 02Apr2021 at 14:15 (at the age of 51-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Allergies to medications, food, or other products was reported as no. The patient's concomitant medication received within 2 weeks of vaccination included amoxicillin 500 mg, taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6206, Expiration date: not reported), via an unspecified route of administration in arm right on 07Mar2021 at 14:15 (at the age of 51-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 06Apr2021, the patient experienced itching all over her body with a rash and redness in the itchy areas. Treatment was not received for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient received MMR #2, Varicella #2 and Havrix Hep A #2 in office at appt. Prior to departure patient began to quickly develop reaction including severe generalized swelling, redness and itching. Due to rapid response continuing to worsen, severity of reaction and extensive covearge of face and upper body concerns developed for possible affect to airway if not managed. Unable to use Benadryl due to inability to rule out its possible trigger of previous anaphylactic reaction patient was given epinephrine per peds pen and transported to ER for continuous monitoring and further treatment if indicated.
2 days after vaccination developed lip and throat swelling, hypoxia, required ER visit, epinephrine
Headache; Fatigue; Tested postive for COVID 19 after 1st Dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested postive for COVID 19 after 1st Dose), HEADACHE (Headache) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced COVID-19 (Tested postive for COVID 19 after 1st Dose). On an unknown date, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested postive for COVID 19 after 1st Dose), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator     Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Follow up received and events outcome updated as recovered
Patient had ED visit 38 days after receiving COVID vaccine dose #2 and was admitted to hospital 2 days following ED visit (patient was hospitalized 40 days after COVID vaccine dose #2.
3 days p/receiving the 2nd Engerix-B vax pt devel dizziness, loss of appetite, nausea, aching feeling, coughing & weakness;
rash which is slowly getting bigger and really itches; rash which is slowly getting bigger and really itches; feeling tired; sore arm; weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), RASH PRURITIC (rash which is slowly getting bigger and really itches), PAIN IN EXTREMITY (sore arm), RASH (rash which is slowly getting bigger and really itches) and FATIGUE (feeling tired) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ASTHENIA (weak), PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling tired). On an unknown date, the patient experienced RASH PRURITIC (rash which is slowly getting bigger and really itches) and RASH (rash which is slowly getting bigger and really itches). On 24-Jan-2021, ASTHENIA (weak), PAIN IN EXTREMITY (sore arm) and FATIGUE (feeling tired) had resolved. At the time of the report, RASH PRURITIC (rash which is slowly getting bigger and really itches) and RASH (rash which is slowly getting bigger and really itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Uncontrollable shivering (although I was not cold/did not have chills) for 45 min around between 12:00am-1:00am on the 16th. Had a fever at that time & woke up with a fever at 9:00am on 5/16.
5/12/21 annual  mammogram screening came back abnormal.  First time I had an abnormal mammogram
Dizziness, feeling hot, sweating, afebrile though. Starting about an hour or so after the dose was administered
Patient had lethargy and slightly elevated heart rate the evening of the second day after vaccination. The following morning the patient was still lethargic and had a heart rate over 200. Patient was taken to an urgent care, then to a local hospital. The local hospital noted SVT with a heart rate of 280. Three doses of adenosine were administered followed by an esmolol drip up to 40mcg/kg/min. Blood pressure was normal and the heart rate only came down to 250. Patient's potassium was slightly off, likely due to hemo lysis. Patient vomited once. Patient was then flown to a regional hospital. In-flight, two additional doses of adenosine were given with the final dose resulting in sustained conversion. Esmolol was continued at 30mcg/kg/min until the patient was transitioned to oral atenolol 1mg/kg twice daily. Approximately one month later patient was admitted again with SVT with heart rate of 160. Patient converted when the IV was being put in and was crying. Digoxin was added to his daily medication regimen.
employee stated that she began to feel dizzy after receiving  immunization   immediately after but continued to work instead of notifying msa. . After approximately 1/2 hour she notified msa that she was dizzy and everything was spinning.
Patient received Shingrix vaccine on a Thursday. On Saturday two days later, she noticed she had a rash on her arm (below the site of injection but not at or around the actual site). The rash persisted for a week after vaccination. It was not itchy or painful, but was warm to the touch. She ended up seeing her doctor on 4/28/22. The doctor noticed that she also had a rash on her other arm. She did not think it was an infection and concluded it may have been an allergy to a component of the vaccine but couldn't be sure. She was prescribed a course of Prednisone and the rash cleared up shortly after.
4 hrs post vax pt began persistent high pitch screaming; mom unable to stop pts crying; MD instructed to inc APAP & call if any other sx appeared;
This spontaneous report was received from a registered nurse and refers to a 12-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-NOV-2017, the patient was vaccinated with a dose of GARDASIL 9 intramuscular injection (dose, lot number and expiration date were not reported). On 17-NOV-2017, the patient experienced red splotches with itching above his eyebrow, along his cheek and on his neck. The patient was applied diphenhydramine hydrochloride (BENADRYL) cream to the affected area by his mother and was given diphenhydramine hydrochloride (BENADRYL) 50 mg orally once by the nurse as a treatment. The patient did not recover from the events at the time of the report. The relatedness between the events and GARDASIL 9 was not reported.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 28-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
Light headed, sweaty (beaded on face), tingly across chest, arms, felt swollen in face/cheeks. Ambulance called and tended to pt. Pt walked out on own power. AAA x 3. No visual changes in arm.
fatigue; weakness; grogginess; I feel drained and sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101212191.  A male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE-1), administration date: 2021, for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "fatigue"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness"; SOMNOLENCE (non-serious) with onset 2021, outcome "not recovered", described as "grogginess"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I feel drained and sick". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Caller, reporting on the Covid vaccine and who explains that he got both shots in either February and March or in March and April. Since then he has a lot of fatigue. Caller mentions he cant test for Covid because the symptoms are more than a few days old, this seems to have been going on was since the vaccine. He is wondering if the weakness and grogginess he is feeling could be long term side effects to the vaccine. Caller declines the report explaining that he cant be accurate on the events and when they started but it feels like this has been going on since getting the vaccine; he doesn't have exact dates and doesn't know when he was faced with this exactly. He feels like he has a virus without the respiratory symptoms but he is not sure he can make absolutely certain this is attributed to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9/19/23, 9:30am - woke shaking violently/uncontrollably, severely cold (unable to get warm), headache. Took 0.5 mg clonazepam to calm shaking, Tylenol for headache, piled multiple blankets and hunkered down in bed. Affects subsided after three hours, however, legs shaky and weak the remainder of the day
Pfizer-BioNTech COVID-19 Vaccine EUA: fifteen minutes after immunization patient reported scratchy throat. Diphenhydramine administered immediately and patient noted to have patient oral airway with small amount of swelling noted at left side of back of throat but no tongue or lip swelling. Eight minutes later patient reported difficulty swallowing, vital signs within normal ranges, patient placed on oxygen. Three minutes later wheezing noted and increased difficulty swallowing reported: epinephrine administered and patient transported to emergency department (ED). Patient arrived to ED hoarse with scratchy throat; vital signs within normal ranges. Patient monitored for several hours, symptoms improved, and patient discharged to home stable with prescription for prednisone and follow-up in place.
Patient came in for the update Moderna booster and was give 0.5 ml of the regular Moderna
Pt recv vax on 5/22/98; on 5/26/98 pt exp temple area headache, neck pain, nausea
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm after first shot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (Sore arm after first shot). At the time of the report, MYALGIA (Sore arm after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not  provided. Concomitant product use was not provided by the reporter. This case was linked to MOD-2021-163385 (Patient Link).   This case was linked to MOD-2021-163385 (Patient Link).
Patient received first dose of BEXSERO 8/23/16. Next day patient c/o mild headache, nausea. No fever or muscle weakness.
It's interesting as a non-medical person, the struggle I'm having, to get one person to just understand the period of time that I've seen different providers. Since my second injection I had suffered from ongoing problems, I have days where I can just hardly stay awake. I have never felt like there was a single medical professional who was trying to even find out what was going on with me. On May 28th I woke up in the morning at 2:30AM with an extreme case of dizziness and nausea. I got up and went to the bathroom and went back to the bed thinking I could go back to sleep. It was as if I had some type of horrible severe hangover or something, but I did not. About an hour later I got up, fell on the floor, then decided I had to go see somebody. I called the ambulance and was taken to the ER, where they ran lots of tests. The diagnosis was that I had severe peripheral vertigo. and prescribed medications for that. So in June 2021 I went to the DR for a stress test and echocardiogram and those came back fine. I get mild nausea and dizziness still but nothing like had happened originally. I had visited PCP, my DR, after my visit to the ER and she is the only one kind enough to me to care. I have had an ongoing effect on my ability to function so when I got the v-safe check in, of course I replied that I have had an event of course. Ondansetron 8MG as needed for nausea Meclizine 25MG as needed for dizziness, these are the medications they gave me at the ER by the way.
Had shot on Friday afternoon felt sore Friday night. Very sore over the weekend, and still today two weeks later.
Chills headaches,fever,muscle pain,swelling, redness, pain,itching,nausea shortness of breath, mild chest pain,fatigue rapid heart beats at times joint pain lightheaded.
Approximately 5 minutes post injection, patient reported feeling flush, overheated, and promptly vomited.  Patient was observed for s/sx of anaphylaxis. Patient was given 25mg diphenhydramine, temperature checked (temp had elevated ~2 degrees from time of injection), pulse and breathing function. Pt was visibly flushed in the face. Patient was given a cool rag as well. Patient was A&Ox3. Pt did not report any immediate issues of breathing issues, cardiac abnormalities, etc. Injection site was unremarkable.  Pt reported feeling a bit better after the medication.   About 7 minutes later, patient began to complain of scratchy throat and minor difficulty breathing. Patient does have a history of atopic reactions and has noted this sensation in the past when experiencing allergic reactions.  Observed patient tongue and mild signs of angioedema were noted. Patient given second dose of diphenhydramine and water. Epipen was on site. Patient was observed and monitored for 25 minutes further. After approx. 5 more minutes, patient reported feeling better and looked visibly less flushed and the swelling of the tongue had diminished. Approx 5-10 min later patient was walking around, talking normally, and showed no signs of distress or reaction.
pt recv vax 9JUL97 & JUL97 pt devel a vesicle @ the site of inj & other vesicles @ the tips of fingers;
Blood clots in both lungs; Swelling in left breast; The arm showed Small spots; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clots in both lungs) 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 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Blood clots in both lungs) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Blood clots in both lungs) outcome was unknown.            No concomitant medications were reported. Treatment of the events were not reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28APR2021 included a new event of "blood clots in both legs" - making this case serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
14FEB94 pt exp pain & tenderness @ inject site; 15FEB94 4PM chills, achiness, fatigue, nausea, h/a; APAP given;
Received vaccin on 3/24 3:00pm, started experiencing severe fever and chills on 3/24  from 10:00pm to 2:00am. Fever broke around 2:30am. Had fatigue, headache, and extreme body ache through 8:30 pm on 3/25. Residual full body muscle soreness and headache through 3/26 at 12pm.