chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis of skin at injection site treated with Keflex and Benadryl, Pain, redness, swelling.
15jan90 pt vax hepta B. 17jan90 pt devel. pain in the elbow and a soreness at the inject site.
hospital call center received call from pt's relative on 5/26/21 reporting  pt has decrease oral intake and lip swelling started 5/22/2021. HX of history of cerebral palsy with mental retardation. Patient received covid vaccine 2nd dose Pfizer at  on 5/21/21. Pt advised to go to nearest ED for evaluation.
Janssen Covid-19 Vaccine EUA.  Left arm muscle continues to be sore- not able to use arm for functionality-  It has continued to be very sore- when I use the arm - it gets worse. I rely on ibuprofen but still pain is there.
L sided focal seizure (1st time) in same side as vaccine given 3 1/2 hrs post vaccine.
Thurs PM T104.6 started; HR 145; Pt listless, not wanting to eat or play; mom called @ 150PM 6SEP91 & wanted MD to see PT; mom called @ 415 & said PT was still sick & mom would take to ER; 10SEP91 aunt said MDs at ER found nothing wrong;
We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date; The vaccine was not expired, but was given after it was at refrigeration for more than 30 days; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date), PRODUCT STORAGE ERROR (The vaccine was not expired, but was given after it was at refrigeration for more than 30 days) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date), PRODUCT STORAGE ERROR (The vaccine was not expired, but was given after it was at refrigeration for more than 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date), PRODUCT STORAGE ERROR (The vaccine was not expired, but was given after it was at refrigeration for more than 30 days) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We have had limited cases of the monovalent Moderna vaccine being administered past the beyond use date) and PRODUCT STORAGE ERROR (The vaccine was not expired, but was given after it was at refrigeration for more than 30 days).    No concomitant medication information was provided.  The vaccine was not expired, but was given after it was at kept at refrigeration for more than 30 days.  No treatment information was provided.
I got bruised, because shot hit a vein. Bruise is still there aftern11 days. But pain in shoulder started back up. First weekend I could not lift my arm. Now it is back to being painful when using my shoulder.
Severe pain, swelling and redness in joints. Numbness and tingling in hands and feet.  Issues continued  for past 4 weeks. Had one round of steriods. Starting another dose of steriods to try to relieve pain.
Patient came to the clinic today, with his father, to get a Td.  His father wanted him to get a Td because he poked himself with a tack. Patient was administered the Td vaccination in the left deltoid muscle, he reported he was feeling fine after vaccine and was talkative. Father and son then left clinic room. Approximately 10-15 minutes later the father came to desk and reported that his son just had a seizure.  RN was at the desk when father reported incident and went into the Immunization room and told RN, emergency supplies and oxygen canister were gathered by both RNs and returned to waiting room.  By that time father had brought son (patient) back into the waiting room from parking lot and patient was sitting in a chair.  RN asked how he was feeling and he stated ?fine? there was no visible signs of injury.  RN suggested he lay down in the clinic room and he verbalized okay and that he also could walk there on his own.  Patient was steady when he walked to the clinic and lay down on the exam table, RN elevated his legs.  A third RN was in the clinic room with oxygen canister and gave him 8L oxygen via mask.  Throughout patient was alert and talking to RNs.  BP was 102/62, pulse 60.  Father explained to RNs that they walked to the car and as son was getting into the car he had a ?seizure.?  911 was called and arrived within approximately 10 minutes, patient talked with EMS crewmember for approximately 10 minutes and then walked to gurney and got on.  Patient then was transported to the hospital for further evaluation.
severe headache, trunkal rash front and back. Took Benadryl and Tylenol. symptoms lasted 2 days
It was 12/26/2022 after lunch I started to feel hot and so I laid sown and took a nap, I still felt flush so I took my temperature which was 101.5 I took aspirin/TYLENOL the next morning still feeling flush, had a hacking cough with aches and pain, the cough lingered for a week and a half. I took a COVID-19 test which was positive. My temperature was 99.1 on 12/27/2022.
This spontaneous report was received from a pharmacist and refers to a 70 year old male patient. The patient's medical history included an occasional infection (unspecified) once or twice every year and his historical drug included unspecified antibiotics on an unspecified date in October 2016. His concurrent conditions were not reported. Approximately on 18-MAY-2017 (reported as "2 days ago,") the patient was vaccinated with a dose of ZOSTAVAX lot # M037015, expiry date 22-NOV-2017 (dose and route were not reported) for prophylaxis, along with a sterile diluent, lot #M024782, expiry date 29-FEB-2019 (dose, route and indication were not reported.) Concomitant therapies included uspecified "statins." Approximately in May 2017, the patient experienced an unspecified adverse event, that required a prescription for methylprednisolone (MEDROL DOSEPACK) (dose, route and frequency were not reported.) On 20-MAY-2017, the pharmacist reported that the patient presented himself to the pharmacy with the prescription for methylprednisolone (MEDROL DOSEPACK). However, the reason of the prescription was not reported. Information regarding laboratory tests was not provided. At the reporting time, the outcome of the unspecified adverse event was unknown. The reporter did not provide a causality assessment between the event and the ZOSTAVAX or the sterile diluent. Additional information has been requested.
Resident received Pfizer vaccine on 1/19/21 in rehab center and returned back to Assisted living.   Physician told resident since she was out of her 42 day window that it was ok to start series over.  Registration form said 1st dose.  Moderna was given and it wasn't discovered until logging information into website that there was another person with same name but different address that had Pfizer vaccine.  Facility returned email on 3/28 where I discovered resident had received 2 different vaccines
Left arm started with tender knot on the left deltoid for one week.  After one week the rash started which spread to the upper torso over a 3 week period, causing red, painful ulcers.
Welts and rashes from head, eyes, torso, groin area, back, legs, hands wrists, arms - ongoing now for 4 days.  Prescribed Prednisone 10mg tablets on a 12 day regiment.  Symptoms are better but still not good. Background: after first vaccination, My eye swelled shut and it took prednisone to clear that up.  The second vaccination I had welts on legs and groin area for a couple of weeks.  It seems I may be allergic to the vaccine at some level and now believe I should not take another for fear of really bad adverse events that are not curable.
Persistent headache; joint pain; body aches; pain at site of injection; swelling; base of neck and shoulder pain; neck cracking; nausea; blood pressure spike; tightness on right side of chest; dizziness/lightheadedness; feeling of fullness in stomach; chills; difficulty sleeping and staying asleep;  and itchiness. Initially it was also painful to lift either arm; however, that pain is gone.
numbness at the injection site on the left arm; some tingling at the injection site on the left arm; swelling at the injection site on the left arm that has gone down a lot, but there is still a little hardness; experienced heat, some warmth or heat at the injection site; Initial information received on 23-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 57 years old female patient who had numbness, some tingling and experienced heat, some warmth or heat at the injection site and swelling at the injection site on the left arm that has gone down a lot, but there is still a little hardness after receiving diphtheria-2/ tetanus/ 5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Cancer (Neoplasm malignant).  Concomitant medications included Hepatitis B Vaccine; and Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination.  On 15-Aug-2023, the patient received 0.5 mL dose of suspect diphtheria-2/ tetanus/ 5 AC pertussis vaccine, suspension for injection (batch number: 2CA61C1; expiry date: 06-Jun-2025) via intramuscular route in the left arm for Immunization.  On an unknown date in Aug-2023 the patient had numbness at the injection site on the left arm (vaccination site hypoaesthesia), some tingling at the injection site on the left arm (vaccination site paraesthesia), swelling at the injection site on the left arm that has gone down a lot, but there is still a little hardness (vaccination site swelling) and experienced heat, some warmth or heat at the injection site (vaccination site warmth) (unknown latency) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Reportedly, The patient experienced swelling, heat, numbness, and some tingling at the injection site on the left arm. As of today (23 Aug 2023), the numbness and tingling have resolved, and the swelling has gone down a lot, but there is still a little hardness and some warmth or heat at the injection site. Caller stated that the patient came back in this morning, and it still feels hot.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (swelling at the injection site on the left arm that has gone down a lot, but there is still a little hardness, numbness at the injection site on the left arm, some tingling at the injection site on the left arm, experienced heat, some warmth or heat at the injection site).  At time of reporting, the outcome was Recovering / Resolving for the event swelling at the injection site on the left arm that has gone down a lot, but there is still a little hardness, was Recovered / Resolved on 23-Aug-2023 for the events numbness at the injection site on the left arm and some tingling at the injection site on the left arm and was Not Recovered / Not Resolved for the event experienced heat, some warmth or heat at the injection site.
Conjunctivitis in both eyes. Began in left eye two days after receiving the vaccine shot and spread to right eye on the third day. Doctor advised it was viral or allergies and did not prescribe antibiotics.
fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302, expiry date: not reported), intramuscularly, on 14Jan2021 11:15, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered a clinic, not a facility vaccination. There were no additional vaccines administered on same date of the bnt162b2. The patient did not receive other vaccinations within 4 weeks prior to receiving bnt162b2. Medical history included high blood pressure, obesity (has obesity but does not have diabetes), and menopause (10 years). Family history was none. Concomitant medications included metoprolol succinate (METOPROLOL SUCCINATE) for high blood pressure (been taking for 10 years). The patient experienced fatigue on 17Jan2021 10:00 after receiving the first dose of the covid vaccine on Thursday 14Jan2021 11:15. She received her first shot on Thursday (14Jan2021) and everything was fine. She was just experiencing a little bit of fatigue. She would like to know if you would get side effects immediately or after a few days. She wants to know when the side effects typically start after receiving the vaccine.  Outcome of the event was recovering.
Baseball sized red inflammation surrounding injection site for last 2 1/2 days-pain, does not itch. Recommended use of hydrocortisone 1%-seek medical attn., if not improved in 2 days (allergic to BENADRYL).
On 8/16/00, had hives/urticaria on face, arms, legs, trunk and was treated with Benadryl no respiratory distress. On 8/17/00 had hives/urticaria over entire body. Treated with Benadryl and Prelone as directed. Not yet recovered.
This spontaneous report as received from a Licensed Practical Nurse refers to a 20 year old female patient. On 10-JUL-2017, the patient was vaccinated with RECOMBIVAX HB lot number reported as N009802, expiration date 19-DEC-2019; for prophylaxis. On 10-JUL-2017, a pediatric dose of RECOMBIVAX HB was administered to the patient (drug administered to patient of inappropriate age and under dose). No adverse events were reported.
Pt got faint et no warning fell et hit head on window sill near (temporal area). Pt assessed after no cuts/lacerations, small nickel size swelling over (R) ear. Pt c/o h/a at "hurts a little". Denies SOB, vision disturbances, N and V. Denies neck pain. Advised mother on s and s to ER. Alert et oriented x 3 able to state name, age, where he was. Reviewed with pt as well after head injury. HD will f/u with parent et call today et tomorrow to ensure he remains stable. 15 min later BP 98/50 P 89 R 12.
This case was reported by a nurse via call center representative and described the occurrence of passed out in a 16-year-old female patient who received BEXSERO (batch number ABX711AA, expiry date 31st December 2019) for prophylaxis. Co-suspect products included MENACTRA for prophylaxis.  On 10th September 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml and the 2nd dose of MENACTRA. On 11th September 2018, 1 days after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant) and fever. In September 2018, the patient experienced injection site swelling and malaise. On an unknown date, the outcome of the passed out was resolved with sequelae and the outcome of the injection site swelling, malaise and fever were not recovered/not resolved. It was unknown if the reporter considered the passed out, injection site swelling, malaise and fever to be related to BEXSERO. Additional details were provided as follows: The patient received the BEXSERO in right deltoid and MENACTRA in left deltoid via intramuscular route. Less than a week after receiving BEXSERO,  the patient experienced swelling at the injection site. Less than a week after receiving BEXSERO and MENACTRA, the patient experienced general malaise. On the morning of reporting date, the patient's body temperature was 104 degree F and in afternoon, it was 102 degree F. The patient passed out at school and at the reporting time he was at home from school. This case has been linked with case US2018GSK165853, reported by same reporter.
On 6/6/00, the vaccinee received his 1st adult dose of Havrix. This was described as a mal-administration (wrong dose). The most recent information, received on 6/29/00, reports the outcome of the event as unknown.
EE developed cellulitis (L) upper arm after flu vaccination. Was treated with antibiotics x 8 days. Sx resolved.
A few hours after the injection I started to get hot sweats that lasted about 15 mins per session 4 times the first day only then i got diarrhea that was  nearly completely watery and lasted roughly 3 days in length giving way to extreme stomach pains every hour until bathroom occurred also gave me a cough that has lasted from the injection date to current date with cough episodes lasting 15 mins per time and often nothing comes up  and nearly leaves me breathless difficulty falling asleep lasted one the first night.
fever to 101.6 ax 2 days p/vax; eruption of maculopapular rash on face & trunk 6 dasy p/vax given;
This morning, the day after the vaccine: chills, nausea, fever of 100.5. Still ongoing ? it's been less than 24 hours since the injection.
Saw Dr and was given a brief Neurological Reflex test with Normal results; Dr thinks my nerve problems could have exacerbated the injury I had in 2009.
Ringing in my ears started same evening. It's never stopped and is slowly worsening. Had to purchase a white noise machine to be able to sleep.
Patient walked in to clinic 3/4 to discuss reaction to a vaccine.  Patient received PPSV23 and Shingrix, both in left arm.  Left arm is red, hard, hot, and some swelling present.  Can feel the heat radiating through patient's shirt.  Patient also reported that she had a fever, vomiting, and some shakes.   Home care given of Tylenol, ibuprofen, and cool compresses.
full body rash, fever, itching lasted 72hr;tx w/atarax & APAP for fever;required visit to ER;swollen glands;
02/20/23 presents to ED for "fever, fatigue". PMHx of ". fib on Eliquis, CAD status post CABG ×2, diastolic heart failure with EF of 55%, hypertension, sick sinus syndrome status post pacemaker placement, hemorrhoids, and PUD"
No adverse reaction noted. Patient was given MMR-V Proquad outside of licensed age group.
pain and burning on urination (dysuria), urinary urgency within 18 hours of receiving vaccination
Two doses administered at the same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 18th January 2023, the patient received FluLaval Quadrivalent 2022-2023 season .5 ml. On 18th January 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.   Additional Information: GSK receipt date; 18-Jan-2023 Reporter's comment: The nurse called to asked for information about the administration of two 0.5 ml doses of Flulaval quadrivalent to a patient at the same day.  The reporter asked if there was any harm expected. The reporter declined sharing patient and vaccine information since she said that they were not sure about the extra dose administration. Did not consent to follow-up. Additional supportive information: The patient received two doses of Flulaval quadrivalent on the same day, which led to overdose.
The next morning after the flu shot, I had SEVERE diarrea and 102 deg. fever. Stayed in bed most of the day. Never had such a reaction before.
Fever; Chills; Body aches; Pain at injection site; Headache; Nausea; Dizziness.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247), via an unspecified route of administration in the left arm on 03Mar2021 at 11:30 (at the age of 42-years-old), as a single dose for COVID-19 immunisation and nitrofurantoin (MACROBID) on unknown date for unspecified indication and experienced drug allergy. 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 25Mar2021 at 01:30, the patient experienced fever, chills, body aches and pain at injection site with headache, nausea and dizziness. On 25Mar2021 at 01:30, the body temperature was reported as 101.3 (units unspecified). The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, general body pain, vaccination site pain, nausea, headache and dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), in May2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID Long Haul symptoms" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant) with onset 2021, 10 days after the suspect product(s) administration, outcome "not recovered", described as "Bells Palsy". The event "bells palsy" required emergency room visit. Therapeutic measures were taken as a result of bell's palsy. Clinical course: In May2021, Patient took our COVID Vaccine, assured by doctors it was safe and would help with patient's COVID Long Haul symptoms. 10 days later patient came down with Bells Palsy. Happening so suddenly he/she feared it was a stroke. After being rushed to the E.R. (Emergency Room) examined by physicians, the diagnosis was made. The Bells Palsy was only supposed to last 2 weeks to 6 months. It was been over 2 years now and it was permanent. Physical therapy, muscle therapy, medications and a surgery. Thousands of dollars and pain caused.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Dizziness After 5 minutes after being vaccinated, pt began to feel lightheaded and dizzy and slightly short of breath, heart rate was 160 and BP was 128/90 with 100% O2 sats on 6L. After that her heart rate started to come down two minutes later to 129
Recipient reported chest tightness on one side then the other. Blood pressure was checked- 162/103. The recipient was escorted to our facility's outpatient clinic. He reports receiving medication for the blood pressure and being monitor for a few hours but his blood pressure did not decrease. He was encouraged to visit his PCP.