chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a health professional and described the occurrence of grand mal seizures in a 7 month old male who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. On 5/14/03, the patient received the 3rd dose of Infanrix. On the same date, the patient also received an injection of inactivated poliomyelitis virus vaccine. On 5/16/03 the patient experienced a grand mal seizure and was hospitalized. The event improved. The patient experienced subsequent seizures and, as of 10/3/03, was receiving an unknown medication for control of seizures. Information from Annual Follow-up report states no further information available. Reporter no longer with clinic.
Patient administered Janssen , unable to take pfizer #2 due to allergic reaction. Evaluated by Allergist and cleared to receive Janssen vaccine. 10 mins following injection, reported throat tightness, headache, tingling sensation mouth and tongue, lips felt puffy, denied sob.  Given benadryl 50 mg IM x1, reports in 10 minutes symptoms improving ., however persisted x 1 hour, milder, still reported lip tingling and mild throat tightness, headache improving.  EMS activated and patient transported to Emergency Room for further monitroing.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient complained of feeling light headed and then passed out. He was laid on the floor until he regained consciousness. We called EMS and kept an eye on the patient. EMS arrived and checked him out and he was responsive and was sent home.
Nursing facility called us and request to provide vaccine to their residents , and I was inform only one person was getting the second dose but everyone else was  getting  the first dose and it Moderna. When entering the vaccine into the MCIR,  I noticed the patient received Janssen and Janssen vaccine on May 17 2021. I spoke with employee and he informed Dr.and Nurse.  I was told by employee the patients  doing fine  they will monitor him for any adverse reaction.
Localized swelling of left arm at site of DTAP injection.  Bruising 11/22/2003.
Got really sick; Bad headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick), HEADACHE (Bad headache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got really sick), HEADACHE (Bad headache) and NAUSEA (Nausea). At the time of the report, ILLNESS (Got really sick), HEADACHE (Bad headache) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided. Treatment medications were not provided.   This case was linked to MOD-2021-370042, MOD-2021-370043 (Patient Link).
3/13/12 Pt received appropriately Rotavirus, PENTACEL, PCV13. Mother return to clinic 3/22/12 but reported 3/13/12 baby had a rash at the injection site. Progress all over body up to today 3/22/12.
This spontaneous report was received from a Registered nurse regarding a 15 year old patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Patient was in to get Covid-19 vaccine for the first time for work. Nurse, LPN accidentally gave Moderna Bivalent ( instead of Moderna Monovalent). She did not realize until after the patient had already left. When she realized she had given the wrong vaccine. She immediately came to me to let me know what was going on. So I emailed State & also called our Health Officer. I called patient to let her know what had happened. I explained to her the next course of action per Dr. Patient voiced understanding.
After patient received third vaccine, patient fainted. RN was able to keep patient on exam table during fainting episode. After 15 seconds, patient became A&O x5. Patient was given juice and sugary snack. Patient's blood pressure at 11:14am, 2 minutes after fainting episode was 114/69. Patient remained in office for 15 minutes for observation post-fainting episode. Patient's blood pressure at 11:30am, prior to patient leaving, was 124/67. Pt stated she felt well and stated that she was able to stand. Pt walked out of clinic with sister without difficulty.
Felt tired slightly achy around 8:00PM. When to bed and woke up with symptoms. Fever 101, chills, body aches. Symptoms did not self resolve. Took 800mg Ibuprofen and symptoms slowly resolved by 8 AM the next morning.
Treatment of COVID 19; Treatment of COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 at 12:00 as dose 1, single (Lot number: er8735), in left arm, on 14May2021 at 15:30 as dose 2, single (Lot number: 208730), in left arm, on 24Nov2021 at 14:30 as dose 3 (booster), single (Lot number: 320208D), in left arm and on 31May2022 as dose 4 (booster), single (Lot number: em9803) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "spinal tendinosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Opioids morphine, reaction(s): "Allergy"; Hydrocodone, reaction(s): "Allergy"; Oxycodone, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment with Paxlovid from 14Mar2023 for COVID-19; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300118741 same reporter, same patient, different product, different event;US-PFIZER INC-202300119914 same reporter, same patient, same product, different dose, different event;
Coughing SOB tightness in throat increased heart rate palpitation started not feeling well 30 min after vaccine given, within 3 hours SOB - throat tightness increased heart rate.
This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a child patient who received KINRIX (batch number 74G79, expiry date 16th August 2019). On an unknown date, the patient received KINRIX. On a unknown date, unknown after receiving KINRIX, the patient experienced injection site reaction and pharmaceutical product complaint. On an unknown date, the outcome of the injection site reaction and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter believed that there was a quality issue with the lot because she had three patients that were administered the KINRIX vaccine and all three patients experienced a severe local injection site reaction. A related product quality complaint was being registered. The physician would retain the product for return to GlaxoSmithKline for investigation. The reporter was requesting GlaxoSmithKline to put a hold on this lot until investigation was completed and requested investigation results. No credit was arranged. The physician refused to provide details and would fax the adverse event information to the Safety Department and also email photos to the Quality Department. The physician already reported the adverse event details to VAERS. This was 1 of 3 cases, reported by same reporter for same events.
Face had become numb; This spontaneous case was received on 18-Aug-2021 from a pharmacist via Med Communications (reference number: SEQW21-01639) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Afluria Quadrivalent 2019-2020 formulation (influenza vaccine; anatomical location, route of administration and dose: not reported) for influenza prophylaxis. The batch number was not reported.   On an unknown date, an unknown amount of time after receiving Afluria Quadrivalent, patient's face had become numb for eight weeks. It was unknown if the patient received any corrective treatment.  On an unknown date, the patient recovered from the event 'numbness facial'.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A female patient developed facial numbness after vaccination with the suspect product Afluria Quadrivalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information causality is unassessable.; Sender's Comments: A female patient developed facial numbness after vaccination with the suspect product Afluria Quadrivalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to limited information causality is unassessable.
Patient of 4 weeks old received Flulaval; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-week-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 5N7J, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th January 2022, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 12th January 2022, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: The office manager reported that, patient received Flulaval at the age of 4 weeks old, which led to inappropriate age at vaccine administration. The reporter wanted to know if there was any further information regarding the safety of the patient or any side effects due to this matter. The reporter consented to follow up.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 9/6/2022  --  RECURRENCE OF SAME SYMPTOMS
Narrative:  COVID infection following COVID vaccine series 03/09, Pfizer,  dose #1 03/30, Pfizer, dose #2 12/22, Pfizer, dose #3 12/28 COVID swab, result:  detected 12/23 pt cc: exposure: unknown 12/28 pt admit to ED cc: request swab  dx:COVID EXPOSURE LOS: 1 day
Nurse reported to Nurse Manager on 7/1/21 she diluted the vaccine with 0.8 ml. diluent with Pfizer vaccine and administered 0.3ml to patient in right deltoid on 6/30/21.   Once she recognized her error she immediately notified provider and pharmacist.  She was advised by medical director to contact patient for the next couple of days to ensure that no adverse reactions had occurred.  She continues to follow patient daily telephonically and patient is doing well and has not reported any adverse reactions or side effects.
20 minutes after injection patient complained of itching to her face. blood pressure 144/81 pulse 66 O2 100% patient given Benadryl 25mg @0823 Vital signs repeated 127/78 pulse 62 O2 100% per patient she feels better released home
Problems with menstruation. Heavy flow.  Heavy spotting. Every 7-9 days. It is continuing.
Information has been received from a nurse practitioner, for VARIVAX (Merck), a Pregnancy Registry Product, concerning a 15 year old female with no pertinent medical history and no drug reactions/allergies who on 23-DEC-2009 and 06-JUL-2010 was vaccinated subcutaneously with the first and second 0.5 mL dose of VARIVAX (Merck) (second dose LOT# 665880/1299Y). There was no concomitant medication. Subsequently the patient was determined to be pregnant. On 31-JUL-2010 the patient was evaluated in a local emergency room due to experience vaginal spotting. The patient was seen in the office on 06-AUG-2010. A urine pregnancy test was positive and prenatal ultrasound was normal on that date. The LMP is 11-JUN-2010; the EDD is 18-MAR-2011. The nurse practitioner didn't report the outcome of vaginal spotting at this time. Follow-up information has been received from the nurse practitioner who reported that the patient was in clinic to her pediatrician on 06-JUL-2010. She received intramuscularly (formerly reported as subcutaneously) with the second dose of VARIVAX (Merck). She received her first prenatal care appointed on 06-AUG-2010. Review indicated presently 33.1 weeks gestation. She received vaccine when pregnancy. She was being monitored regularly. No obvious problems encountered to date. The patient "now" had different insurance. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (reported as "hypodermic needle"), administered in arm left on 25Mar2021 (Batch/Lot Number: EN6206) at age of 62-years-old as single dose for covid-19 immunization. Medical history included atrial fibrillation from Sep2016 (Diagnosis date: Sep2016). Concomitant medications included diltiazem taken for an unspecified indication, start and stop date were not reported; metoprolol taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for blood thinner, start and stop date were not reported; pravastatin taken for blood cholesterol, start and stop date were not reported.  The patient received first shot on 25Mar2021. On 02Apr2021, the patient got shingles and his foot swelled up, his left side throat swelled up, the patient had shingles in his left arm pit and his left shoulder blade and now the patient do not get shingles. On his left armpit, the patient got a patch of shingles or hurting "roster" (not clarified) and also his left shoulder blade the patient got a patch and the same thing. His left foot swallowed up, it may or may not be related but it had appeared, had all appearances of very bad gout flare up, the patient couldn't walk in his whole foot and lower part was completely swollen, the patient didn't know this was related or not but the time being, the patient can't. The patient would like to report it and want to know. The rash on his body is still has but was subsided now, it was tolerable now. The patient was putting a topical cream on his armpit and shoulder. It was a burn cream, twice a day, it calls for at least twice a day. Outcome of the events was recovering. The patient got his bnt162b2 second shot (LOT#ER8729) on 15Apr2021.  No follow-up attempts are needed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received BOOSTRIX. On 6th June 2016, the patient received BOOSTRIX .5 ml. On 8th June 2016, 2 days after receiving BOOSTRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BOOSTRIX. Additional details were provided as follows: This case was not previously reported to anyone. The reporter stated that, the patient experienced pain in arm, in arm opposite of vaccinated arm. Date of birth of the patient was unknown.
Pt had on left upper arm a small bruise then the entire bicep was red, hard and hot to the touch.
Eryethema at injection site 4 inches by 3 inches that was raised and extremely itchy and hot
I had severe aches and pains with headache for about a day and a half. These aches and pains were equal to or worse than any flu related aches and pains that I have had. The pain was such that I did not sleep at all first night and I could not get out of bed during that day and a half. I did not seek medical attention. My reaction was not an allergic reaction.
Fatigue; minor soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 10Mar2021 at 18:00 (at the age of 63-year-old) as dose 1, single for covid-19 immunization. Patient's medical history was not reported. Concomitant medication included ONE A DAY (reported as 1 a day vitamin) from an unspecified date and unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient experienced 3 days of minor soreness at injection site, peaked on day after injection. On 11Mar2021, the patient experienced fatigue. The patient did not take any treatment for the adverse events. The clinical outcome of the events minor soreness at injection site and fatigue was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter (patient) information, suspect information, concomitant information, event information and narrative were amended.  No follow-up attempts are needed. No further information is expected.
Moderna booster was given on 1/2/22.  Patient noticed swollen lymph nodes in her neck on 1/7/22 on left side then the next day 1/8/22 on the right side.  Patient did not go to hospital.
hx OF ANAPHYLAXIS TO MMR; PATIENT EXPERIENCING TONGUETHICKNESS AND ITCHING5-7 MIN POST INJECTION. VITAL SIGN   130/78-78-100%.NO TONGUE SWELLING VISIBLEPATIENT TALKININ FULL SENTENCES. USED INHALER. PLACED ON STRETCHER   0915 EPIPEN ADMIN TO LEFT QUAD.; MD IN TO EVALPATIENT TRANSFERRED TO ER FOR EVAL AT 0935.
pt came to ED with c/o SOB, cough for past 9 days at home; found to be positive for COVID; COVID pneumonia; O2 supplementation; treated with steroids and inhalers, remdesivir and baricitinib; pt's condition worsened; admitted to ICU where he required intubation; condition deteriorated quickly; acute renal failure; transitioned to comfort care; pt expired in the hospital
11:15am: Hep B given; 11:30am: Pt complained of itchy throat and dizziness; 11:30am: Benadryl 25mg given; 12:00pm: Pt stated she feels better. No distress noted.
Vaccine given in L deltoid. Pt c/o L arm pain and chest pain that is rather strong and continuous. The sx started at midnight after a  2 pm vaccination 1/6/06. She continues with chest pain today 1/12/06 arm pain, left 1/9. Pt states she had #1 and #2 Hepatitis B injections without adverse reaction.
Received the Influenza Vaccine in the left Deltoid on 10/22/06.  On 10/24/06  the injection site has a 10cm oval erythema area and the entire arm is edematous and tender to touch.
On Sunday 10/3/21 got Pfizer booster at 1:00pm in left deltoid administered at a vaccination clinic.  Came home and arm hurt a little bit and was tired.  10/4/21 her joints were hurting and felt very tired.  Left side of chest also painful.  Today 10/5 noticed swollen painful lymph nodes in left axilla.
On 5/22/21 he was taken emergently to the operating room and underwent repair of Type A aortic dissection with replacement of ascending aorta with re-suspension of his aortic valve.  Post op he developed new onset right arm and right sided facial twitching along with right arm weakness.  Neurology was consulted for focal motor status epilepticus and he was loaded on Keppra and started on Vimpat.  EEG and MRI brain ordered.  MRI revealed small foci of acute infarcts in the left occipital and right  temporal lobes which may be embolic in etiology.  He was initially very slow to wake up and follow commands appropriately.  This improved over a number of weeks.  By day of discharge on 6/21 to acute rehab, his right arm and facial twitching had completely resolved.  He was alert, oriented X 3.  His right arm continued to have slow return of function with fine motor skills. 6/22, patient reportedly had a 1 hour episode of AMS, witnessed by wife and daughter, in which his eyes rolled back into his head. He was arousable and answered simple questions. He had no associated tremors, shaking, rigidity. This resolved with an episode of emesis and patient was back to baseline within minutes of vomiting. 6/23, patient had another episode described as  "generalized seizure" involving upper and lower extremities last several seconds followed by multiple focal seizures including only UEs. Was readmitted on 6/24 and was discharged on 7/16/21. He subsequently passed away on 7/19/21
Heated rash with itching developed on arm around the injection site about 2 inches in diameter and had a fever of about 101. Patient took ibuprofen for the fever and temperature returned to normal the next day. Patient also used cortizone cream for the itch.
Pt reported sleeping four hours after receiving vaccine. Upon awaking, dizzy and shakey and headache until late that night.
The infant was examined on 12/5. The examination was normal and was given vaccination. The parents report that she appeared normal the evening of 12/5 and the day of 12/6. She awakened at 11 PM on 12/6 crying and was given a dose of Motrin for teething. When parents went to waken her on 12/7 AM she was found blue and unresponsive. She was pronounced dead at the scene by the paramedics. Autopsy states cause of death sudden death associated with history of febrile seizure disorder.
pt called and reported pain in the arm where she recieved the injection on 12/12/20. The pain has caused her to not be able to fully use her arm.
Developed fever, nausea, upset stomach, swollen arm ( from the shoulder to the elbow), painful arm, and arm was red and hot to the touch The fever and nausea lasted 32 hours following the vaccination.  The arm was red, swollen, and hot for 3 months. The pain in the shoulder is still present (11/28/2021).