chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TROUBLE BREATHING; LIGHT HEADEDNESS/ DIZZINESS; HEADACHE; TIREDNESS/FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included asthma, allergies to pollen, allergy to penicillin, sulfur allergy, and she feels tired all the time. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for trouble breathing, and asthma. On 08-APR-2021, the subject experienced trouble breathing. On 08-APR-2021, the subject experienced light headedness/ dizziness. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tiredness/fatigue. On 08-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headedness/ dizziness, headache, trouble breathing, tiredness/fatigue, and nausea. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
I woke up with extreme gas pains. Dizziness, light headed, nauseous, diarrhea, passed out while sitting on toilet and was unconscious for at least 15 minutes. My hands were tingly, I was covered in sweat and I felt clammy. Temp was 99.1, heartbeat was normal
Prolonged high pitched crying w/clenched fists for 5 hrs then intermittently for the next 12 hrs;
She got her vaccine, everything was fine, and then hours later her arm started to hurt which she ignored.  As she was getting ready for bed she was getting cold, put on socks, a sweater, and another blanket, and started to freeze and shiver until 3:00 AM.  She had not been able to sleep and also had a headache which she never gets.  At 3:00 it changed to sweats, and still not able to sleep.  At 6:30 her dog got her up and she felt woozy and carefully she managed to go downstairs and was thirsty and drank some milk, which she immediately vomited, and had severe diarrhea.  She felt more woozier, made it to the couch and fainted.  When she came to she sat up slowly and the worst was over by then.  The entire day she was not able to each, and then ate a 1/2 can of Lentil soup which stayed down.  This was scary and felt she needed to report it.    Little by little her energy improved and today she is 95% improved.    She has had cancer in the past and said that the reaction from the booster was worse than her chemo.    She had similar reactions to previous vaccines, but not to the point of having diarrhea or throwing up or fainting.
(1) severe migraines, no treatment, eased after 36 hours (2) Rash on arm, followed by full-body hives, loratadine, still experiencing events
Fever at 102 at 2:30 am. Extreme pain in all of left arm. Fatigue, headache. Went away until 1pm following day where fever got up to 103.1. Extreme fatigue and soreness as well as headache. Went away overnight and now I?m feeling general soreness again in my back this morning at 8:30
Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history or concurrent condition were not provided. On 29-APR-2016 the pharmacist administered a dose of ZOSTAVAX (subdermal, lot#, dose, dose number were unspecified) to the patient. On the same date, the patient experienced bleeding at the injection site. The event was treated by covering the site with a band aid. The outcome of the event was reported as not recovered. Additional information has been requested.
12/09/08 - patient was administered Rotatec.  After immunization, patient had 10 days of watery diarrhea and vomiting.  02/11/09 - patient was administered Rotatec again - same thing happened - vomting with severe diarrhea.
I ran a temperature of 101-102 for three days then lower for a day or so.   About 2 days after my shot I had, I believe I had a neurological reaction. I was in bed and my arms and legs started flailing around uncontrollably. I was so sick, I'm not quite sure this lasted, but I don't believe it lasted very long, but I was in such a weakened state I can not be sure of the duration of the episode. I remember thinking, this must be the chills they have talked about. However, it was not like any chills I had ever experienced or heard of anyone else had. I wasn't sure how rare this was until I had my early checkup on November 4th. At that time I told my doctor how nervous I was to get  the booster.  She said that I shouldn't have the booster/. She had other patients that had neurological issues From the Covid 19 vaccination.
headache; high fever; chills, shivering; body ache; This is a spontaneous report from a non-contactable Other HCP reporting for herself. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number K9231), intramuscular, in left arm, on 06Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 52 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history and did not receive concomitant medications. She had no known allergies to medications, food, or other products. On the first and second day the patient experienced high fever, chills, shivering, body ache; headache the third day with chills. No treatment was given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The events were resolving.    No follow-up attempts are possible. No further information is expected.
Patient stated she was extremely thirsty and felt she had a really really dry mouth? Then stated the top of her head felt funny. At this point on site  ARNP was called over to Patient. and both myself and ARNP noticed flushing on face and neck and hives on neck area. On site EMS notified and came over. Patient then self medicated with 2-25 mg Benadryl. Patient exhibited mild cognitive slowing with some mild speech and thought degradation...felt funny....not sure what she felt.... Physical symptoms noted above showed some mild sign of improvement? Clinicians insisted that patient should be taken to hospital of choice via ambulance. Patient was taken to clinic where she was under observation, put on IV saline and administered IV steroid, dexamethasone. After approximately two hours patient was released and instructed to take over-the-counter Benadryl every six hours for six days and one Pepcid per day for six days.
Significant increase in blood pressure (over 50%) from  average 100-110/ 55-65 now up to 160-170/85-95 Also a major nosebleed that took over 1 hour to stop bleeding Result: Visit primary care physician for exam & get an EKG Started taking high blood pressure medication "Lisinopril" 5mg 1X daily
Temp 102. 300-500 widespread papules/macules. Vesicles DX Varicella, TX Acyclovir.
When I first got shot everything was good -  I just wanted to report 11 days in I got a red oval rash on the left arm around the injection site that was a  tender.  The rash has been there for only 3 days and the redness is starting to fade a bit. Just reporting that it took 11 days to show this reaction.
10/10/2022 I saw my PCP because I was having pain all over my body. She did a lot of tests which were normal and referred me to a Rheumatologist which I saw on 10/31/2022. All tests came back negative, except bloodwork which showed liver enzymes were elevated. On 11/30/22 I was sent to an outpatient facility to have an ultrasound done on my liver. The only thing they said was I had fatty liver. On 12/1/2022 I had a follow up visit with my PCP. During that time, I continue to have headaches from my previous vaccine which I reported. I saw a Chiropractor for this traveling pain. He was unable to find anything. I went back to my PCP who ordered physical therapy which made it worse. I then had an MRI; nothing was found that was an emergency. I did have arthritis and stenosis of the spine. Next week I will have a spinal epidural with an Orthopedist who specializes in spine. If needed, I will be referred to a spine surgeon. On top of all this, I had a dental appointment today because I have some soreness in my gums which I have never had before. Antibiotic powder was injected into my gums. The dentist is not sure if it will work. The only thing they found was inflamed gums. I have a follow up in two weeks.
Awoke this morning with hissing sound in both ears. Was not there 4 hours prior. Will not go away.
A review of patient provided responses to the vaccine screening form was not performed patient answered yes to question 10 which states "Do you have a child in the home less than one year of age".
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 11-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complainy (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Pneumonia after the 1st dose of Modernavaccine; A spontaneous report was received from a Pharmacist  concerning an 85-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pneumonia (Pneumonia).  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 10 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number-Unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unspecified date the patient developed pneumonia after the first dose of Moderna's COVID-19 vaccine (mRNA-1273). On an unknown date, the patient was hospitalized after developing pneumonia. On 11 Mar 2021 patient was discharged from the hospital.  No treatment information related event was provided. Patient currently on steroid treatment.  No relevant laboratory details were included.  Action taken with the drug in response to the events were not reported.  The outcome of the event, pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
immed felt vax moving up neck veins-lt sied of neck;stayed @ clinic 30" to assure no rxn;felt lt arm tingling all immed rxn 5 days later; felt pressure or as if someone was pushing on base of neck;19OCT95 saw MD
I received the second shot of the Pfizer vaccine on 1/12/21 around 11am. By 5pm I felt very tire and during the night on 1/13/21 I developed a low-grade fever. On 1/13/21 when I woke up my entire body ached, and it felt like a truck ran over me. However, by 1/14 I felt much better and it seemed that I had fully recover. On 1/15/21 I had nausea and stomach ache, which got worst over time. On 1/16/21 I also developed a diarrhea that was ongoing until 1/19/21. From 1/15 to present (1/19) I had a stomach ache and it seemed that my stomach was not able to tolerate any food. Any time that I eat, I went to the bathroom with diarrhea.
A report has been received from a Health Professional concerning a 6 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 08-Jan-2014. The patient was administered expired dose which started on 08-Jan-2014. The outcome of the event of administration of expired dose is unknown. The report was considered to be non-serious.
51 y/o female with syncopal episode following vaccination. Per witness pt suddenly fell out of the chair. Pt unresponsive about 15-20 secs. Per pt she started to have headache and suddenly fell to the floor. Pt has Hx of hypotension and depression. VS stable writer called emergency transport and husband. Pt requested to be sent to ER. Nurse attempted to get pt med list from husband and he was unable to locate it at the time but stated that he would bring list to ER. EMS present at the time of incident, monitored pt until Fire & Rescue arrived.
Patient experienced swelling in both of her legs and irritibility since the date the shots were admistered. Swelling at injection site, edema inject site, irratibility after immunizations, agitation. Autopsy Report received on 2/14/2005 states viral illness.
Pt called clinic on Thursday,06/13/19, stating that yesterday  her Lt arm was red and warm to touch, she had applied a warm compress to the area then the site started to itch.  Pt was informed to apply a cool wash cloth on the site, that the redness and swelling  was normal.
This spontaneous report was received from a medical assistant concerning a 24-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number reported as M003629, expiration date: 02-SEP-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursions of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:07 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.28. Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine date was 09-May-2021. On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively,9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Presented swelling, erythema and tenderness at right thigh, lasted for one week, required AUGMENTIN, did not improve with BENADRYL/TYLENOL.
Hard time walking; Fever (100.3 degrees fahrenheit); legs are sore (both left and right) / leg pain; leg pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (legs are sore (both left and right) / leg pain), GAIT DISTURBANCE (Hard time walking), PAIN IN EXTREMITY (leg pain) and PYREXIA (Fever (100.3 degrees fahrenheit)) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Pacemaker syndrome.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced PAIN IN EXTREMITY (legs are sore (both left and right) / leg pain) and PAIN IN EXTREMITY (leg pain). On 15-Aug-2021, the patient experienced GAIT DISTURBANCE (Hard time walking) and PYREXIA (Fever (100.3 degrees fahrenheit)). On 15-Aug-2021, PAIN IN EXTREMITY (leg pain) had resolved. At the time of the report, PAIN IN EXTREMITY (legs are sore (both left and right) / leg pain), GAIT DISTURBANCE (Hard time walking) and PYREXIA (Fever (100.3 degrees fahrenheit)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Admission  Discharged   10/6/2021 - 10/8/2021 (2 days)  Ephrata Community Hospital   Encounter for induction of labor Principal problem  DETAILS OF HOSPITAL STAY    Presenting Problem/History of Present Illness/Reason for Admission Encounter for induction of labor [Z34.90] at 39 weeks IOL for itching and GDM On Ursodiol after delivery   Hospital Course  postpartum Day #2 S/P SVD + Covid - but asymptomatic and had her vaccinations Breastfeeding well
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of PEDVAXHIB lot # L012837, expiration date 11-MAR-2018, which were exposed to temperatures outside of the recommended range. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID breakthrough case. I received my 1st booster shot on 11/30/2021 and my COVID symptoms started on 05/28/2022 in the morning I woke up with a cold. I had runny, congestions, headache, tired, fatigued, a little cough, body ache all over. Later on the day I tested around 06:00PM I was positive. I immediately took another one to make sure and it was positive again. On the same day around 8:00PM I went to urgent care and they tested me back again I was positive. They prescribed me PAXLOVID for 5 days. I am recovering slowly.
Information has been received from a pharmacist concerning a currently 5 year old female patient who about 3 1/2 years ago was vaccinated with a dose of MMR vaccine live (lot # not available). One day after vaccination the patient developed hives all over her body. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information is available.
Tested positive again for COVID on 05/11/2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive again for COVID on 05/11/2022.) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Autologous haematopoietic stem cell transplant. Concurrent medical conditions included Diabetes. Concomitant products included ACYCLOVIR [ACICLOVIR], ATORVASTATIN, METFORMIN and PIOGLITAZONE for an unknown indication.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 05-May-2022, the patient experienced COVID-19 (Tested positive again for COVID on 05/11/2022.). On 16-May-2022, COVID-19 (Tested positive again for COVID on 05/11/2022.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that concomitant drug METFORMIN included Active Drug substance JARDIANCE 25 MG.  Treatment medication included Bebtelovimab.  Device Date reported as 26May2022.  Company comment- This spontaneous case concerns a 54-year-old male patient with relevant medical history of autologous stem cell transplant and Diabetes, who experienced unexpected, non-serious adverse event of special interest Covid-19 3 months and 29 days after vaccination with a third dose of mRNA-1273. The patient tested positive again for Covid-19 6 days after his initial diagnosis. The outcome of the event was reported as resolved. The relevant medical history of autologous stem cell transplant and diabetes can be a contributory factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old male patient with relevant medical history of autologous stem cell transplant and Diabetes, who experienced unexpected, non-serious adverse event of special interest Covid-19 3 months and 29 days after vaccination with a third dose of mRNA-1273. The patient tested positive again for Covid-19 6 days after his initial diagnosis. The outcome of the event was reported as resolved. The relevant medical history of autologous stem cell transplant and diabetes can be a contributory factor for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
pt recvd vax on 20aug90; subsequently, it was learned that the lot of vax which was given had expired in april90;
I had 2 1/2 weeks of eye swelling, watering and swelling of my eyes.
rash at vaccine site 1 week post vaccine, itched if she touched it coaster size
tested positive for covid on binax rapid antigen test 6/10/2022- asymptomatic
Information has been received from a female concerning her 17 year old granddaughter who on unspecified dates was vaccinated with the complete series of GARDASIL. "Six months ago" (in approximately February 2008), the patient experienced severe pain on the lower part of her stomach. The patient was diagnosed of endometriosis and cyst that needed to be dissolved. The patient was not admitted to hospital but was brought to emergency room three times. The patient was still having big blood clots. This is one of three reports from the same source (WAES: 0807USA03323 and 0807USA3551). Additional information has been requested.
Rapid heart rate even when lying 100% still in bed. Lasted all night then it got a bit better but as of June 15 2021 I?m still having periodic racing heart, chest pain, tight, hard to breathe at least 1 time a day.