chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said the pain and discomfort in her left shoulder started on 1/27/18 in the evening. She had a drop in blood pressure and severe pain. She went to the ER and had x-rays taken to ensure the tip of the syringe had not broken off. It did not, and she was given pain medication, monitored, and then discharged. The pain has subsided (1/29/18) a bit but, she is having difficulty lifting her left arm higher than a few inches. She was referred back to her PCP for follow-up.
Parents brought child in for 6 months immunization stated that the day of last Rotateq vaccine the child had diarrhea. The next day she developed vomiting. It lasted one week. She also had a low grade fever for 2 days, the end" of the V & D. No treatment or tests were done.
no adverse event, I received an email that because the child was 14 days short of being 6, but was given the Moderna for ages 6-11, this was considered an adverse event.  The child is fine, no problems whatsoever.
fever; hip pain; 'pretty intense joint pain, felt like it was on fire; She feels ''like death today"/she did not feel good; Chills; This is a spontaneous report from a contactable nurse.  A 44-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248) intramuscular on 14Jan2021 single dose for COVID-19 immunisation. Vaccine location was deltoid left. No other vaccine was received in four weeks.  The patient medical history was not reported. Historical vaccine included first dose of BNT162B2 (Lot: EL1284) received on 28Dec2020 around 7pm, intramuscular injection right deltoid. There were no concomitant medications. The patient experienced fever (she woke up with a fever of 101.3 at 6am), pretty intense 'joint pain, felt like it was on fire' on 14Jan2021; with the first dose of the covid vaccine she had really bad hip pain about 24 hours after (as reported) and it lasted about 12 hours but she could still walk and move, it was just annoying. The patient was ''like death today"/ she did not feel good' on 14Jan2021, chills on 14Jan2021. Her temperature has improved and it is around 99. The outcome of fever and chills was recovering, of 'pretty intense joint pain, felt like it was on fire' was recovered on 15Jan2021, of she feels 'like death today'/ she did not feel good and hip pain was unknown.; Sender's Comments: A possible contributory effect of suspect BNT12B2 on reported fever cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
WHOLE BODY NUMBNESS; SLUGGISHNESS; MUSCLE SPASMS IN BACK AND NECK IN BOTH THE BACK AND FRONT AND UP AND DOWN ALSO; SEVERE CRAMPING TO BOTH UPPER  EXTREMITIES, ESPECIALLY HANDS, WRISTS, FINGERS; UNABLE TO MOVE WHOLE BODY; FEELING UNWELL; GENERALIZED WEAKNESS; BEAT UP, WASHED OUT FEELING; FEVER UPTO 100F-104.5F; THE PATIENT WAS IN TEARS; This spontaneous report received from a parent concerned a 22 year old male. The patient's weight was 160 pounds, and height was 69 inches. The patient's past medical history included covid-19, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced whole body numbness. On 22-JUN-2021, the subject experienced sluggishness. On 22-JUN-2021, the subject experienced muscle spasms in back and neck in both the back and front and up and down also. On 22-JUN-2021, the subject experienced severe cramping to both upper extremities, especially hands, wrists, fingers. On 22-JUN-2021, the subject experienced unable to move whole body. On 22-JUN-2021, the subject experienced feeling unwell. On 22-JUN-2021, the subject experienced generalized weakness. On 22-JUN-2021, the subject experienced beat up, washed out feeling. On 22-JUN-2021, the subject experienced fever upto 100f-104.5f. On 22-JUN-2021, the subject experienced the subject was in tears. Laboratory data included: Body temperature (NR: not provided) 104.5 F, 103 F, 102 F. On 23-JUN-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. Laboratory data (dates unspecified) included: COVID-19 (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body numbness, severe cramping to both upper extremities, especially hands, wrists, fingers, and unable to move whole body on 22-JUN-2021, was recovering from fever upto 100f-104.5f, muscle spasms in back and neck in both the back and front and up and down also, beat up, washed out feeling, feeling unwell, and the patient was in tears, and the outcome of sluggishness and generalized weakness was not reported. This report was non-serious.
Pfizer-BioNTech, Dose 2: 03/11/2021: EN6208. 4 months post vaccination, participant stated to feel symptoms related to Long Haul COVID. Undiagnosed never tested for COVID. No immediate symptoms until 08/01/2021 to current day. Experiencing symptoms of Long Haul COVID, extreme fatigue no heavy exertion, normal activity of walking the golf course of 6 miles. Post exertion and malaise and underlying sense of nausea, chest x-ray and echo scan, abdominal scan completed and nothing relevant showed up. Cyst and gallstone. Heart stress test on treadmill scheduled.
pt recvd vax & on 20NOV93 devel nausea, vomiting & body aches; pt was seen in ER & dx as having food poisoning; sx abated w/in 24 hrs;
Same day of shot: 1900: Muscle/Joint pain in whole body 2200: Fever and fatigue  2400: Fever of 104 Next day of shot: 0000-0430: Cycle of hot and chills every 15 min or so  0430-1700: Fatigue and fever still at 104. 1700-0000: Fever between 102-104, less fatigue. Still have hot/chill cycles Day 2 after shot:  0000-0800: Fever around 101-102. Less fatigue. No longer experiencing hot and chills. 0800-1400: Temperature between 98-102. No longer sleepy. Muscle ache and joint pain gone.  1400:Symptom free
Received Influenza vaccine (IM) 10/9/2008 at about 1530 hrs; was well day of and prior to vaccination. Within 40 minutes following immunization, felt extreme drowsiness while driving her car, fell asleep at the wheel, resulting in MVA. She was not injured in accident. Went home, took 4 hr nap and awoke about 2030 hrs feeling fine. No other associated systemic symptoms, no local injection site reactions; no prior vaccine-associated reactions; no meds; no significant past medical history reported. Was not seen by medical provider for evaluation. Symptoms: Lethargic.
No signs or symptoms reported; Excursions occured; This spontaneous report was received from an administrator referring to a patient (age and gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-APR-2021, the patient was vaccinated with an improperly stored dose of yeast)(GARDASIL 9) prefilled syringe, dose and frequency reported as 1 time dose with lot # T026168 (expiration date: 04-DEC-2022) or 1691180 (expiration date: 15-NOV-2022) for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of  49 and 48 degrees Fahrenheit on 09-APR-2021 and on 23-APR-2021 respectively  for 1 hours/ 15minutes. It was not recorded by a data logger and not previous temperature excursion was reported. No signs or symptoms reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Received phone call at 2:30pm. Patient stated she felt flushed. Had BP 140/90. Pulse 68. Respirations 14.  Lungs were CTA B, No wheezing, stridor, or respiratory distress , No Hives but did have erythema about bilateral cheeks. No murmurs noted and normal pulse rate on exam. Given 20mg pepcid and 25mg benadryl. Monitored for 30 minutes. Symptoms resolved. Repeat exam normal. Told to monitor symptoms for 24 hours and call 911 if any chest pain, SOB, or other signs of anaphylaxis discussed with patient.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Additional Details: Patient got his first Dose of Moderna COvid 19 vaccine. He was waiting in the waiting areas after the vaccine and had a seizure with profuse sweating. 911 was called but patient came back to senses and both caregiver and patient declined ambulatory service. Patient informed RPH that he had notting to eat since morning. The vaccine was provided around 5pm
Tinnitus has worsened to unbearable levels following the fever caused by second shot of vaccination
Fever for 5 days and rash of small red spots covering the body from the neck all the way down to the feet. Irritability and sleeplessness.
Felt fine going to bed around 9:30pm.  Woke up around 1:00am felling feverish, chills, soreness.  Restless sleep/non-sleep.  Took temp around 5am: 101.4.   Took 3 Tylenol and full glass of water (about 10-12 ozs).  Stayed in bed all day--fever and soreness worsened all day.  fever all day 1st day.  2nd night slept better.   2nd day, feeling better, but fever still around 100 at 7am.  mid-day, fever around 99.4.  still very sore.   3rd day, well.  arm still sore.
Client did not remember getting H1N1 on 12/17/2010.  Received H1N1 on 02/10/2010 also. No side effects from getting 2 H1N1 vaccines.
felt like a was marble was in throat; hurt to swallow; it felt swollen; fast heart beat 120 beats per minute; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (fast heart beat 120 beats per minute), OROPHARYNGEAL DISCOMFORT (felt like a was marble was in throat), DYSPHAGIA (hurt to swallow) and PHARYNGEAL SWELLING (it felt swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PALPITATIONS (fast heart beat 120 beats per minute). On 15-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (felt like a was marble was in throat), DYSPHAGIA (hurt to swallow) and PHARYNGEAL SWELLING (it felt swollen). At the time of the report, PALPITATIONS (fast heart beat 120 beats per minute), OROPHARYNGEAL DISCOMFORT (felt like a was marble was in throat), DYSPHAGIA (hurt to swallow) and PHARYNGEAL SWELLING (it felt swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       There were no Concomitant Medication used by the patient   Reporter did not allow further contact
No Adverse Event; They have given 13 patients an expired Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine).    This case was considered as 5th patient out 13 patients.  It was reported that age group of patients were mostly over 65.  No concomitant medication information provided. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 13 doses total given from 3 vials.  Vial size was multidose vials 5.5mL.  It was reported that vial was never put in the fridge. Vials went from freezer to room temperature on days of administration.   Dates vaccine was administered were reported as 14-Apr-2022, 21-Apr-2022 and 28-Apr-2022.  The vials did not undergo any temperature excursions.  No treatment information provided.    This case was linked to US-MODERNATX, INC.-MOD-2023-696547 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696547:master case
Administered Menactra U4001AA which expired on 04/28/2013. Re-Vaccinated with U4291AA EXP on 17 OCT 2013.
Patient had a panic attack after admin of shot. He lost consciousness and had sweating and a drop in BP. He also had rapid eye movements and was unresponsive. 911 was called and paramedics came top assist. He was given fluids and then returned to the pharmacy for observation as he denied a ride to the hospital.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "Patient is a 60 year old female with a past medical history of asthma/chronic obstructive pulmonary disease, type 2 diabetes mellitus who presents with shortness of breath.  Symptoms of COVID started 12/29 but she was not tested until 1/4.  Discontinue remdesivir due to bradycardia.  Patient's sent with prescription of Decadron to complete 10 day course.     Recheck BMP for hypercalcemia noted as outpatient.  Restart lisinopril as blood pressure improves, held for borderline blood pressures."
Vasovagal response - dizziness, vertigo. Improved with reclining and PO fluids.
Left arm swelling and redness, temperature 98.6 axillary advised TYLENOL and cold packs to area (left arm).  Report to physician if no improvement or increased symptoms.
sore arm; After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed.; After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), BEDRIDDEN (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed.) and FATIGUE (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Thyroid disorder, Bladder pain, Heart disorder, Lipid metabolism disorder, Type 2 diabetes mellitus, Asthma and Allergy (Patient has medical allergies.). Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB) for Asthma, AMITRIPTYLINE for Bladder pain, ATENOLOL and AMLODIPINE for Blood pressure fluctuation, LOSARTAN for Blood pressure measurement, CLOPIDOGREL BISULFATE (PLAVIX) for Coagulation disorder, ISOSORBIDE MONONITRATE for Heart disorder, FENOFIBRATE for Lipid metabolism disorder, LEVOTHYROXINE for Thyroid disorder, METFORMIN for Type 2 diabetes mellitus.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore arm), BEDRIDDEN (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed.) and FATIGUE (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed). On 11-Sep-2021, FATIGUE (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) had not resolved and BEDRIDDEN (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-351102 (Patient Link).
Patient passed out about 5 minutes after receiving vaccine. Hit his head on the floor requiring stitches. Paramedics arrived and the patient passed out again.
Client closed eyes, swayed to the right side while sitting and twitched for approximately 10 seconds. Then client was coherent and talking. Mom wanted 911 to come even though client was talking and coherent. 911 staff checked clients vitals and encouraged parent to take client to Emergency room if client had another episode like before. Nurse instructed parent and client to always tell staff when getting shots about passing out so precautions can be taken.
Patient received vaccine-KINRIX on 5.6.10 came in for an appointment 5.10.10. Left arm was swollen, red and tense (Angioedema). Patient was seen on 5.8.10 and followed up at the doctor's office today 5.10.10.
FEEL CRAPPY FOR A SHORT PERIOD OF TIME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced feel crappy for a short period of time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feel crappy for a short period of time. This report was non-serious.
Whole body soreness/fatigue, fever - severe for about 3 hours (6/4 11pm - 6/5 2am); overall about 36 hours
19jan90 pt vax hepta B. pt developed rash on chest w/ severe itching.  pt was treated w/ decadron phosphate iv and remained under treatment at time of report.
soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 002B21A and 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. It was stated that Concomitant medications were lots however denied to provide details of medications and No treatment information was provided by reporter.
My normal body temp is 97.5.  The first 2 days after the first shot I had a fever of  103.1 with entire body ache and extreme fatigue. The 3rd and 4th day still fever of 101 with continued fatigue and body ache which kept me bed ridden. The 5th day after 1st shot,  fever of 100.    For the 6th day and on temp was back to 97 but the continued fatigue lasted another week or so
Patient was given a covid vaccine on 3/4/21 at approximately 5:40pm.  The administration went well according to the patient.  After approximately 10 minutes, while the patient was sitting in the post vaccination area, he appeared to be pale looking to the imx RPh.  The pharmacist asked him how he was doing, he replied "I am doing so-so".  The RPh got up to check on him further when the patient fell to the floor.  The RPh rolled him on his back, got him in a comfortable position,  and elevated his legs.  RPh applied gauze to a cut in his lip, and with the immediate assistance of the health screener, applied cold compress to his neck and forehead.  Patient experienced faintness and sweaty skin only.  Patient did not show any other symptoms.  After about15 minutes, patient said he felt like himself again, and wanted to sit up in a chair.  The RPh assisted him into a chair, where he sat for 5 minutes.  At the request of the patient, he wanted to go home.  RPh escorted patient to his car and watched him get inside safely.  1 hour later, RPh followed up with a phone call to the patient and he was on his way to an urgent care clinic to get a possible stitch for his lip.
Severe pain/arm horribly sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Severe pain/arm horribly sore).  The outcome of the pain in arm was recovered/resolved (duration 3 weeks).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The reporter asked if everyone experienced severe pain after the first vaccination.  The patient's arm  was horribly sore for over 3 weeks.  The reporter was dreading the second  vaccine dose. The follow-up could not be possible as no contact details were available.
I had a sore arm for about 2 weeks. At about a month I started to experience issues with heart rate increase, high blood pressure. Started to have palpitations, and chest pain.