chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shaking uncontrollably bad headache, took Advil every 2 hrs. weak. couldn't walk very far. I felt like my heart was skipping a beat.  was dizzy but already having that before the shot.  Called the pharmacy and was told it was normal and to give it two weeks
Chills, Fever, Body Aches, Cough, Headache (for several months after injection)
Vomiting for 2 days (beginning 2 days after injection). Fever of 102ºF beginning about 72 hours after injection.
Patient had itchiness on non-vaccinated arm, rash on right arm and slight left arm elbow. Given Benadryl. Patient stable, released from vaccination site.
Large sore lump-upper (L) arm (lasted 2 wks) after flu vac. Severe and worsening joint and muscle pain in both shoulders/upper arms, also hips to knees (both) unable to sleep thru night, ALEVE gave some temp. relief. Saw PAC on 11/16/16. She ordered blood tests twice and prescribed 15mg/day prednisone.
extremly high blood pressure; severe headache; DVT to right leg starting at the groin and going down to the foot; worsen edema with 4+and 5+ pitting edema in right leg; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included DUPILUMAB (DUPIXENT) from 09-Mar-2021 to 06-Apr-2021 and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg). On an unknown date, the patient experienced HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache). At the time of the report, DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot), OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg), HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Ultrasound Doppler abnormal: abnormal (abnormal) Causative extensive occlusive thrombus", DVT in the right leg starting from the groin going down to the foot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had an ultrasound of the leg performed. The diagnosis showed "causative extensive occlusive thrombus". Patient reported taking heparin and acetaminophen(Tylenol) ad treatment for the symptoms.   This case was linked to (E2B Linked Report).; 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. MOD-2021-079102:1st dose
Patient got a swollen lymph node on her left side in the collar bone area on 12/18/2021 and the on 12-26-2021 she started having joint pain and a severe rash all over her body and a sore throat and dizziness, loss of hearing and sight for short periods of time and breathing issues. we saw her Doctor on the 27th and she prescribed Claritin and Hydroxyzine The night of the 27th she had her first dizzy, loss of hearing, and sight and breathing became troubled so we call 911 and they recommended going to the ER. At the ER they diagnosed her with Serum syndrome and put her on Prednisone and Pepcid and Zyrtec. Along with the joint pains she has swollen arm and the left foot is painful to walk on and feels stiff. The ER Doctor recommended patient seeing a  Allergist and a Immunologist.
No pain at injection site. 4 hours post injection pain in armpit and left breast severe. Pain lasted 2 weeks. The day after the injection extremely tired, body felt out of sorts.
Slow return of her memory; Fatigue for 7 days; Brain couldn't put into action what she needed to do.; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Brain couldn't put into action what she needed to do.), MEMORY IMPAIRMENT (Slow return of her memory) and FATIGUE (Fatigue for 7 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DISORIENTATION (Brain couldn't put into action what she needed to do.). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Slow return of her memory) and FATIGUE (Fatigue for 7 days). At the time of the report, DISORIENTATION (Brain couldn't put into action what she needed to do.), MEMORY IMPAIRMENT (Slow return of her memory) and FATIGUE (Fatigue for 7 days) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Magnetic resonance imaging: Inconclusive.         No concomitant medication and treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Non-significant Follow up received on 05-May-2021, The email id was added.
erythema, ecchymosis, pain & edema @ inject site arre reported in a tp receiving 1 dose of fluogen for influenza; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;
A report has been reported from a Health Professional concerning, male subject, who had been receiving FLUMIST (INTRANASAL), once for FLU VACCINE. FLUMIST (INTRANASAL) started on 23-Jan-2014 for FLU VACCINE. The nurse reported that she gave expired product which started on 23-Jan-2014. FLUMIST (INTRANASAL) was discontinued on 23-Jan-2014. The outcome of the event of GAVE EXPIRED PRODUCT is unknown. The report was considered to be non-serious.
13 days later patient is experiencing redness at the injection site as well as a feeling of a knot during palpation.  The site also feels warm to the touch and patient feels like it is warm also
fatigue, brain fog day starts normal, brain fog begins in morning and lasts the day, can't work with fatigue and brain fog
Information has been received from the mother of a 12 month old male child who in 2001 was vaccinated with a dose of MMR II. Concomitant therapy included a dose of varicella virus vaccine live. It was noted that "the family noticed he had delayed speech, balance issues and spatial issues that he may have had prior to receiving his vaccination and remain today." The mother noted that during a battery of tests to help determine the pt's condition it was discovered that some of his titers were "too high," with varicella IgG=126 (normal range reported as 0-100) and rubeola IgG=358 (normal range reported as 0-100). The mother also noted that "the doctors don't feel that he has autism or that his medical issues were caused by the high titers." Unspecified medical attention was sought. Follow up info was received from a physician who indicated that she did not  know what the pt's birth was like or if the pt was well at the time of vaccination, as she is an autism expert and not the pt's pediatrician. The physician reported that the pt did not have delayed speech, balance issues and spatial issues prior to vaccination with MMR II. It was also reported that the pt had not been diagnosed with autism but that "he had a lot of the medical markers." The physician reported that she believed that MMR II aggravated and brought out the pt's symptoms. Upon internal review, delayed speech, balance issues and spatial issues were determined to be other important medical events (OMIC). Additional info has been requested.
fast heart beat; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2 solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced fast heart beat on an unspecified date. The patient underwent lab tests and procedures which included heart rate: fast on unspecified date. The historical vaccine include BNT162B2 (DOSE:1) for COVID-19 Immunization. Reported as I had a fast heart beat on the first dose and I had that reaction for two days after I had the vaccine. Now the other person that I know that person said that he has the same reaction but it was on the second dose and I wanted to let you know that person I don't think is going to report it. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax & 1 day p/dose 1 exp noc sweats; exp noc sweats p/dose 2;
Information has been received from a pharmacist referring to multiple patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored VARIVAX (lot # L023589, expiration date 26-JUN-2017; dose and route were not reported). This is one of two reports received from the same reporter. Additional information has been requested.
Initial report received from healthcare professional via other company (Novartis Pharmaceutical Corporation) on 13 September 2013. A male patient whose date of birth, at the time of event, medical history and concomitant medications were not reported, had received a dose of Tdap-ADACEL vaccine (batch number, route and anatomical site of administration were not reported) on an unspecified date. It was reported that, a part of a dose of Tdap was lost during administration and a partial dose was administered to the patient; thus vaccine underdose. Documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Behcet's disease" (unspecified if ongoing); "Thrombocytopenia" (unspecified if ongoing); "Dyslipidemia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "History of thymoma (removed)" (unspecified if ongoing), notes: History of thymoma (removed). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jan2023) Negative; (05Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 24Dec2022 to 28Dec2022.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded
p/vax pt had nausea;chest tightness; & lightheadedness;pt took OTC benadryl;
Administration of an expired dose.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received Hib (Hiberix) (batch number CH392, expiry date 23-MAR-2023) for prophylaxis.   On 12-APR-2023, the patient received Hiberix. On 12-APR-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-APR-2023 The reporter reported that an expired Hiberix dose was administered to a 6 month old female patient. The reporter asked for recommendation about this situation. The patient received an expired dose of Hiberix, which led to expired vaccine used.
Swelling, hives, rash. Swelling started right after shot, rash began with 3 hours and hives 3-5hrs after.
Severe pain in injection site, chills, headache, fever and fatigue for 4 days.
3/17/23 I started feeling tired and had a scratchy sore throat. By 3/18/2023 I was sure I had something and tested positive for COVID with an at home test. I called Urgent Care and they said I was not a candidate of Paxlovid, but I was for Molnupiravir.  I began taking the medication that evening and went to bed. I was in bed for four days and slowly began to get better. I still have a residual cough. I tested negative with an at Home COVID test on 4/5/2023.
Patient returned to clinic 3 weeks after her first dose of the Pfizer COVID19 vaccine to complete the second dose in the series. When nurse asked regarding post vaccination response, patient reported expected muscle soreness at site (right deltoid) for 2 days, however expressed new localized symptoms at the site that began the evening of the second day. Symptoms included pain radiating down the length of right arm, tingling fingers, and weakness in right arm. Patient was able to manage pain with OTC analgesics, however expressed concern with length of the symptom's duration. After 21 days post vaccine administration, she expressed she continues to have pain in right arm when held in certain positions. Nurse took down information, notified supervisor and encouraged patient to follow up with her doctor. Nurse explained to the patient that a report would be completed and that further communication with her could be possible after reporting. Patient was in agreement with plan. Nurse completed assessment and education for second dose finding no contraindications. Patient consented to receiving her second Pfizer COVID19 vaccine in her left arm. Administration was completed in left deltoid with no immediate adverse effects.
Within 3 mins of receiving the Pfizer vaccine 0.3 ml IM RA, the patient became diaphoretic, experienced blurred vision, became cold, clammy, pale, nauseated, and stated "my throat feels like I cant talk, it feels weird and thingly". The patient denied difficulty breathing during the observation period.  Pulse rate became tachy at 110 BPM.  Extended the observation period to 40 mins.  At the end of 40 mins, the patient stated " I feel much better, my vision is not blurry now and my throat is feeling better".
Panic; Anxiety; Vertigo; Flushing feeling; Tachycardia; This is a spontaneous report from a contactable nurse (patient). A 45-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El01Y0, expiration date not reported), intramuscular on the left arm, on 08Jan2021 at 10:30, single dose for Covid-19 immunization.  The patient has no medical history and no concomitant medications. The patient previously took the first dose of bnt162b2 (Lot number: EJ1685), intramuscular on the right arm, on 18Dec2020 at 10:00 AM for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, at 10:35, the patient experienced flushing feeling with tachycardia 5 minutes post vaccine. On 15Jan2021, she is day 7 post vaccine and experiencing panic/anxiety, tachycardia, and vertigo type feelings. Since the vaccination, the patient has not been tested for COVID-19. The patient received treatment (prescription/monitoring) for the events. The outcome of the events was not recovered.  The reporter assessed the events as non-serious.  Information on the lot/batch number has been requested.
I had covid at the end of July, but I never actually took a test until I was feeling better a couple weeks later. I was unvaccinated at the time. At around 10:pm the day of the 2nd vaccine, I had slight runny nose and was tired, slight body aches. I woke up around 1am and literally started crying, I felt so sick, I couldn?t move, I had the chills so bad it felt like my blood was being mixed with dry ice and on fire, boiling. I was shaking profusely, and could not get warm. This was way worse than when I was unvaccinated and had covid, way worse. My body aches are double the intensity of when I had covid, I can barely move. There was some talk I got vaccinated too early after having covid. In fact, pharmacy down the street refused me, and said I had to wait longer. They asked me who told me to get vaccinated so early after having covid, and I told them the county health department, and he just shook his head and said I should wait at least 1 month from testing positive or for a negative test. Meanwhile I?m receiving emails and texts from the county to get vaccinated ASAP, if I need help scheduling appointment or need transpo, reach out to them.  The whole thing was confusing, do I wait, do I get vaccinated ? So I got vaccinated somewhere  that didn? t ask me if and when I?ve had covid. Now I?m thinking I?m feeling this sick because I?ve had covid too close to the vaccination and my body is way over reacting, and I feel miserable  and more sick than actually being unvaccinated and having covid.
EXTREME DIZZYNESS, AND BRAIN FOG, JITERY/SHAKEY, COULDNT LIFT UP HEAD FIRST DAY AFTER 6 HRS GETTING 2ND SHOT
A non-serious spontaneous report of "23 patients received expired FLUMIST" was received from a physician concerning a six-year-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST;  the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to included all their concomitant medications).  There were no adverse events associated with these medication errors;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.  Additional information was received on 31-Mar-2009 that included the results of a lot investigation:  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired.
Pain under the ribs; Pain around the back side; Pain around the C4 & C5 vertebrae; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain under the ribs), BACK PAIN (Pain around the back side) and SPINAL PAIN (Pain around the C4 & C5 vertebrae) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain under the ribs), BACK PAIN (Pain around the back side) and SPINAL PAIN (Pain around the C4 & C5 vertebrae). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Pain under the ribs), BACK PAIN (Pain around the back side) and SPINAL PAIN (Pain around the C4 & C5 vertebrae) had not resolved.            Concomitant medications were not provided It was unknown if the dose was given into the left or right deltoid. Patient visited doctor including a pain management physician and a neurologist. It was reported that she received unknown injections for treatment. The reporter stated that the patient has had ongoing pain since April 2021.
Patient described feeling weak, with muscle aches, and tiredness.  He also described significantly increased blood sugar.  He normally uses 0.8 unit/hr in his pump, but had to increase by 20-25 units over the course of the day to keep blood sugar controlled.
Initial unsolicited report received from nurse on 12-Oct-2015. This case was linked to 2015SA161942 (same reporter). This case involves a patient (age and gender was not reported) who was vaccinated with an intradermal dose of Fluzone QIV (batch number, expiry date and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, after vaccination, patient developed Weakness, numbness and pain in the arm that was injected. Lab test and corrective treatments were not reported. At the time of report, outcome of the events was not reported. Documents held by sender: none.
I was diagnosed with nodules in my lungs around 2017.  Approximately around May 1,2022 I noticed I was coughing more with a more productive cough. I also coughed up some blood for a few days.  I saw a new PCP and told her my history and she ordered a CT of my lungs.  This showed I had a mass in my lungs. I had a PET scan which showed that one of the metabolic activities had grown and metabolic activity in my lymph nodes in the center of my chest, the others were clear.  She referred me to the cancer center.  They are trying to set me up for a biopsy.