chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in her arm; Redness popped up around the site; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 75 year-old female patient received BNT162B2 (BNT162B2), administered in arm, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Soreness in her arm"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2021, outcome "recovering", described as "Redness popped up around the site".  Additional Information: The patient received the Pfizer COVID-19 vaccine three weeks ago. The patient still has soreness in her arm. Redness popped up around the site a week after the vaccine. Redness is almost gone and looks better today but her arm is still sore. The patient wanted to know if she should get the second dose and should she get it in the other arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 60 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, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body aches. On 24-MAR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 25-MAR-2021. This report was non-serious.
Pt received dose one hour after the punctured vial should have been discarded. No ADRs so far
3rd dose of bexsero was administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB05BA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose on an unknown date) and Bexsero (received 2nd dose on an unknown date).   On 14th June 2021, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 14th June 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, 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 details were provided as follows: Age at vaccination was not reported. The patient received 3rd dose of bexsero on 14th June 2021, which led to extra dose administered. The reporter would like to know any possible effect and any info on 3 doses. The reporter consented to follow up.
Patient complained of non visible arm shaking. Shortly thereafter complained of feeling warm and was becoming flushed. Nurse checked NP with reading of 212/104. Patient complained of headache and was taken to emergency department where BP was 240/112.
Patient describes developing sensation of shortness of breath the night prior to adverse event. On the next morning he woke, again with sensation of shortness of breath. At 11:30 AM he developed a seizure. He was taken to the hospital where he had another seizure while in ER. He was hospitalized and had multiple tests including MRI, EEG, Lumbar puncture, and lab test that failed to reveal any abnormality. As of today, patient has recovered, still in the hospital and will be discharged soon. Information provided by patient through a telephone call.
I had itching on my ears and neck area. I took Benadryl.  I took Benadryl before I got my vaccine and continues  every four hours for seven days then took twice a day. I continue some itching but not as severe .
Patient passed out briefly, fell to floor. Was awake thereafter. Supportive support and epinephrine. Was transported to ER via ambulance.
Pain at injection site with movement. Constant severe dizziness, lightheadedness, and fatigue.
With the second dose my symptoms started late evening on 01/13/2021. I started feeling bad, but finished my shift. Felt drained, headache to start. By next morning (01/14) I had fever (101.5F) and the whose body aches, nausea, diarrhea, horrible horrible headache, like a migraine, severe congestion, runny nose and some days later I started having an earache on my right ear. I would like to mention I also had a vaginal discharge with an unpleasant odor that started with the first dose and had not resolved by the time I received the second dose and this time the odor is much stronger, it is awful, I already made an appt with my GYN. The odor got much stronger about a week after the second dose. I kept self medicating at home with Tylenol, Ibuprofen, but the fever would return as soon as the dose was weaning off. The 101.5F fever lasted for about 9 days.  I also experienced shortness of breath from 01/14 until the 22nd and I never had to use my rescue inhaler before. I had to use it and had to even call for a second one. I am very athletic and active and never need it even after my runs and workout activities. I consulted with my PCP on the 19th and again she gave me a covid test. Negative. She diagnosed me with inner ear infection (right ear). Prescribed me Levaquin and in 2 days I was much better. On the 22nd I finally started seeing the symptoms subside and started feeling better.  Also, I wanted to tell that I had a gas pain episode that almost sent me to the ER. My chest, my left shoulder hurt really really bad. I called a friend who is a physician and he told me to take some gasex first and if that did not work to go to the ER. Fortunately it worked. But the pain was excruciating.
Redness & tender to touch at injection site. Fatigue & nausea for 48 hours status post injection.
Body aches, chills, fever, nausea, cough and fatigue after COVID vaccine
Uncontrolled vomiting, for 12 hours, couldn't even make it to the bathroom which was the next room over,   very weak, diarrehea, headache for 3 days still going on, fever 101.5, chills , no appetite. chills for 2 days tiredness
This spontaneous prospective pregnancy report as received from a female patient of unknown age, refers to herself. On 16-AUG-2013 (reported as "had just gotten) the patient was vaccinated with the third dose of GARDASIL (dose, not number and route of administration were not provided). The patient stated that she had just gotten the 3rd shot in the GARDASIL series and now she realized that she was 1.5 months pregnant. The patient did not seek medical attention. The patient became pregnant with last menstrual period (LMP) of approximately 05-JUL-2013 and estimated delivery date (EDD) of 11-APR-2014. Initial exposure to GARDASIL was at approximately 6 weeks (1.5 month). The pregnancy outcome was pending. Additional information has been requested.
Onset of swelling, erythema <48 hours after vaccine administration. Seen in ER for I & D, cultures obtained and (-). Placed on P(o) ABTx x2 for 7 days. Packing remains in wound X10 days.
got strong chills and sweats, alternating about every 20 minutes, for the next 14 hours, along with a headache
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 84.86. Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 06 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021. 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.
Vertigo, exhaustion, legs and arms numb, sharp stabbing pains in legs, fingers, toes and face, headaches, unable to sleep, swollen glands
A heavy head; Feverish; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (A heavy head), PYREXIA (Feverish) and HEADACHE (Headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (light heart attack  years ago) and Stent placement (a heart stent). Previously administered products included for Product used for unknown indication: AstraZeneca Covisheild on 20-Mar-2021 and AstraZeneca Covisheild on 04-May-2021. Past adverse reactions to the above products included No adverse event with AstraZeneca Covisheild and AstraZeneca Covisheild. Concurrent medical conditions included Type II diabetes mellitus.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (A heavy head), PYREXIA (Feverish) and HEADACHE (Headache). At the time of the report, HEAD DISCOMFORT (A heavy head), PYREXIA (Feverish) and HEADACHE (Headache) had not resolved.      It was reported that  patient  has been getting feverish with a heavy head and headache those go away after about 5 hours then come back after another 3 hours. No relevant concomitant medications was reported. Treatment information was not provided.
injected expired booster vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (injected expired booster vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (injected expired booster vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (injected expired booster vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided.Treatment information was not provided.Patient was administered with booster vaccine.
patient was given a COVID Monovalent vaccine instead of a COVID Bivalent vaccine. No adverse reaction to the vaccine.
Initial unsolicited case received from a physician on 08 January 2015. A 2-month-old female patient received DTP (manufacturer and lot number not reported) approximately 25 years ago. Medical history and illness at time of vaccination was unknown. An unspecified amount of time following vaccination, the patient developed fever and nuchal rigidity. She subsequently recovered. No additional information was reported. Documents held by sender: None.
her heart is racing and feels like it is going to beat out of her chest. Her nerves are so bad right now she is about to have a heart attack; weird bumps, explained as one red spot in right upper arm; weird bumps, explained as one red spot in right upper arm; Her nerves are so bad; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA6780) via an unspecified route of administration in right upper arm on 15Jul2021 at around 09:00 (at the age of 26-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient had no medical history (none) and no relevant family medical history. Concomitant medications were not reported. Patient had no vaccines within four weeks of COVID-19 vaccine. Patient had no history of adverse event following vaccination. On 15Jul2021, after receiving first dose of vaccination, patient was breaking out in weird bumps and had one red spot in her right upper arm. She reported that about an hour after the shot she took a magnet and put it to her arm at the place she got the shot and it stuck, the magnet did not move. On 15Jul2021, patient experienced her heart was racing and felt like it was going to beat out of her chest. Her nerves were so bad, she was about to have a heart attack. Patient asked what she should do, should she go to the doctor or the emergency room. Patient did not receive any treatment in response to the event. Outcome of the events were unknown.  Follow-up attempts are completed. No further information was expected.
Itchiness, redness, a little swelling; looked like hives - took BENADRYL -had vaccine last year w/no rxn.
This spontaneous report received from a health care professional 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 not reported, batch number: 213021 expiry: UNKNOWN) dose was not reported, administered on 01-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On 01-FEB-2022, the patient experienced administration of vaccine from a vial that was opened on 28-Jan-2022. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine from a vial that was opened on 28-Jan-2022 was not reported. This report was non-serious.
Patient received 2nd dose Pfizer COVID 19 vaccine today.  The patient was observed for 15 minutes without incident.  After he left the facility,  it was discovered that the patient received undiluted 0.3ml Pfizer COVID 19 Vaccine.  Physician contacted tried to contact patient immediately after discovery of the incident X 2.  Voice mail was left.  At 6:15, physician was able to reach patient who reported that he felt fine.  He was advised to contact physician or his primary care physician for any minor symptoms.  For significant symptoms he is to contact 911 for immediate assistance.   Doctor reached out to him again today, 2/17.  Per patient, he feels fine.
"Covid arm."  Red rash at the site of injection.  Itchy.  Hot.
No additional AE,; Medical assistant calling to report pediatric dose of V AQT A that was administered to an adult patient; This spontaneous report was received from a medical assistant and refers to an adult patient of unspecified age and gender. The patient's pertinent medical history, concomitant medications, past drug reaction or allergies were not provided.  On 08-DEC-2021, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (dose and vaccination scheme frequency were unknown by the reporter, route of administration and anatomical site of vaccination were not reported; lot number T037788 that was verified to be a valid lot number for syringe formulation with and expiration date reported and established as 30-APR-2022) (product administered to patient of inappropriate age) for prophylaxis.  No additional adverse event was reported (AE) (no adverse event).
First week after vaccination-flulike symptoms. Second week and to present  nerve pain around heart, waist, to left shoulder, now moving to right shoulder.  Three visits to the ER, three days in hospital.  First course of Valacyclovir resulted in improvement in left side symptoms, second course in progress to treat right side symptoms.  Patient has been diagnosed with internal shingles.
Within 12 hours developed T101.7, local shot site pain, achiness, fatigue and headache. Seen the next day in the office Exam: Local shot site pain hurt greatest discomfort is over distal Tricuspid. Fatigue w/ diffuse abdominal pain but no other localized findings.
coarseness, SOB, Itchy throat, swelling to the tongue, normal Vital signs and alert and oriented, hx of anaphylactic reactions given epi, Benadryl and famotidine
Patient started having stroke like symptoms at approximately 1145am on May 30th.   Pt was having difficulty dressing and generalized feeling of being paralyzed for a brief moment or two.   Pt was also having trouble getting out her words/thoughts.  Pt never had loss of function of her limbs, No weakness, No facial droop, No loss of bowel or bladder control.   Once in ER at Hospital,  pt was found to have irregular heart rhythm e on EKG (Sinus Tachycardia with possible AFib with rate in the 100's up to 130's) - CT Scan of Head was negative for bleed or acute ischemia.  By 8pm the same day the pt had improvement of speech and getting out words/thoughts better and by the next day at 10am sounded back to normal self and still with no other neurological deficits.   During that next day we learned that the patient had been to her Primary Care Dr on 5/24/2021 for routine visit when they did an EKG in the office and pt was thought to have an "irregular Heart rhythm" and referred to see a cardiologist.  During course of hospital stay the patient was treated with heart rhythm medications and Eliquis for Diagnosis of Afib/TIA.
His leg was severely swollen, red and hot to the touch. He couldn't walk or move it without screaming in pain. He threw up at midnight and had a low grade fever. It would have been high if I didn't have him on Motrin for pain relief. It took him 3 days to finally start trying to put pressure on it.
Information has been received from a physician concerning an approximately 13 year old female who "a few years ago" in approximately 2004 was vaccinated with a dose of RECOMBIVAX HB.  Subsequently the patient fainted after vaccination.  No further information was provided.  The patient's outcome was not reported.  Additional information is not expected.  The patient had a similar experience after vaccination with GARDASIL (MSD) (WAES # 0706USA05225).
Patient developed a fine pink rash on arms, cheeks and abdomen one day after influenza vaccine. Using Loratadine for symptom relief.
Rec'd vaccination on 11/15/01 (Prevnar, Trihibit, and MMR - on 11/16/2001 penny size area of redness at injection site. Today golf ball size area and warm to touch. Seen in office 11/17/01 placed on Augmentin.
At 17:35, 8mins post vaccination, pt c/o throat tightening, nausea, feeling shaky. Vitals: @17:37 HR 83; @17:42 BP 181/91, HR 84, RR 19, Sat 96-97% on RA; @17:50 BP 171/90, RR 24; @17:54 HR 76, Sat 96% on RA. At 17:37 pt was administered Epi 0.3mg IM and 911 was called.  A second dose of Epi 0.3mg IM was administered @17:44. EMS arrived @17:50 and the patient was taken to the ER @18:00. ER course and outcome unavailable to this writer.
1. Arm is hurt 2. The whole body is pain 3. The throat is itchy
I felt extremely achy all over (including inside my body/torso); also felt very sensitive to hot and cold surfaces and touching or making contact with things in general.; also felt very sensitive to hot and cold surfaces and touching or making contact with things in general.; chills; arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 09:00 (Lot number: ER8736) at the age of 24 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CONCERTA; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose 1, Single; at 09:00; Batch/Lot No.EW0162; Administration site: Left arm), administration date: 20Apr2021, when the patient was 24 years old, for COVID-19 immunization, reaction(s): "sore ram". The following information was reported: PAIN (non-serious) with onset 11May2021 20:45, outcome "recovered" (2021), described as "I felt extremely achy all over (including inside my body/torso)"; TEMPERATURE INTOLERANCE (non-serious), HYPERAESTHESIA (non-serious) all with onset 11May2021 20:45, outcome "recovered" (2021) and all described as "also felt very sensitive to hot and cold surfaces and touching or making contact with things in general."; CHILLS (non-serious) with onset 11May2021 20:45, outcome "recovered" (2021), described as "chills"; PAIN IN EXTREMITY (non-serious) with onset 11May2021 20:45, outcome "recovered" (2021), described as "arm sore". Therapeutic measures were not taken as a result of pain, temperature intolerance, hyperaesthesia, chills, pain in extremity.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 20:45, the patient experienced "Side effects weren't unexpected, but wanted to report that I felt extremely achy all over (including inside my body/torso) and also felt very sensitive to hot and cold surfaces and touching or making contact with things in general. Symptoms on-set about 11-12 hours after second shot and eased off by another 16-ish hours after they began. No coughing or anything, just chills and very strong aches. Also, my arm was less sore after I received the 2nd shot than it was for my first shot.". The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of all events was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.