chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient reported that left leg was numb for a while immediately after receiving injection. Pharmacist called patient again on Thursday, July 29 at which time reported no more problems that was experienced on 7/28/2021
Local reaction to Left arm. Severe redness. Cellulitis. Treated with Bactrim, hydrocortisone cream and ice.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored RECOMBIVAX HB lot# L038018; expiration date 13-AUG-2017, dose and route of administration were unspecified. The vaccines had been exposed to 32 degrees Fahrenheit for 11 hours. There was no previous temperature excursion. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Case previously recorded as MA2009-3709. A health care professional reported the following information via MedCom, on 5 NOV 2009: A 29-year-old breast-feeding female patient with a seven week-old baby was vaccinated i.m. with one dose of S-OIV FLUVIRIN (batch no. unknown) on an unknown date in 2009. No adverse event was reported. MedCom Ref. no.: NA09-007632.
Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: FK5618) as dose 2 (tris), single and administration date 20Nov2021 (Lot number: FK5618) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 31Jan2022, outcome "unknown" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive.
Within two hours. My left face went numb likened to having a dental anaesthetic.   Within six hours I was in the hospital with loss of sensation on the left side of my body loss of strength.  Paralised left side of my face. Loss of vision and severe pain in my left eye and  greatly demonised cognitive ability.   I was In hospital   for one week and am still not much better.  Still weak and numb on my left side though some of my cognitive abilities has returned and improved.   I w have needed help to fill out this form.
Within 2 hours I could not keep my eyes open and had to go to sleep. I woke up the next morning and my head was killing me. My glands in my neck were swollen, my ears hurt, my tongue was swollen and had sores on the sides of it. I was severely fatigued, running a low grade fever and could barely move my left arm. These symptoms lasted for a couple of days and then dropped off. Then, exactly one week later I woke up and could barely move my left arm. My lymph node under my armpit was swollen to the size of a baseball and was in excruciating pain. The injection site was also red and swollen and had a rash going down my arm as well. This lasted for about a week before going away.  After the second dose, about 2 hours after receiving the shot, I had to lay down and take a nap. I got up about 2 hours later and was already feeling ill and running a low grade fever. I went to bed and woke up at 3:00 am in a ridiculous amount of pain. My whole entire body was cramping  like I had not had water to drink in a week, then I was having sharp shooting stabbing pains throughout my whole body. My whole body felt like I had been run over by a bus. Every muscle hurt, I was sweating, freezing, running a temp, my head felt like it was about to explode. The lymph node in my left arm swelled up instantly and my arm hurt so bad I could not move it.  I was in and out of sleep and when I would wake up I would have to change my clothes because they were drenched in sweat and having to lay a towel down on the bed because it was wet but I didn't have the energy to change the sheets. This went on for FOUR days. I was on the verge of going to the ER on day three but after being helped out of bed and into a hot bath, the pain in my body started easing up. I had COVID in March of 2020 and this second shot was ALMOST as bad as when I had COVID. The only difference is I was sick for about 4 weeks and my lungs were really bad when I had COVID. The shot did not affect my breathing.
09/06/2021 I was sneezing and felt like I had a headache. Over the next 2-3 days I lost my taste and smell. I had a telehealth call with my MD, on 09/08/2021. 09/09/2021 I had the infusion (4 injections) monoclonal. I did develop ringing in my ears 09/21/20021 and still have that.
Urticaria immediately following injection of varicella vaccine Treatment: Benadryl 25g by mouth every hours.
a lot of pain in the muscle where he got the injection left deltoid; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a lot of pain in the muscle where he got the injection left deltoid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE PAIN (a lot of pain in the muscle where he got the injection left deltoid). At the time of the report, VACCINATION SITE PAIN (a lot of pain in the muscle where he got the injection left deltoid) outcome was unknown.            Concomitant product use was not provided by the reporter.    No treatment information was provided.   This case was linked to MOD-2021-404841 (Patient Link).
Projectile vomiting & severe diarrhea causing incontinence & dehydration. Oral rehydration successful & patient recovered
Patient passed away; Heavy breathing; Shortness of breath; Low temperature; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Patient passed away) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired). On 20-Mar-2021, the patient experienced DEATH (Patient passed away) (seriousness criterion death), DYSPNOEA (heavy breathing) and DYSPNOEA (shortness of breath). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (heavy breathing), DYSPNOEA (shortness of breath), BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired) outcome was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient has a history of fainting upon receiving vaccinations.
10-15 min after Zoster vaccine administered in (R) deltoid area SQ, patient reported weakness in (R) arm down to hand. Denied itching or diff. breathing. Was asked to stay for monitoring and further assessment, but unable to locate her 5 min later.
Patient passed away on 9/2/17. Cause was apparent SIDS but autopsy results are still pending.
AS SOON AS SHE HAD THE SHOT ARM STARTED TO HURT. SAYS IT IS STILL PAINFUL ESPECIALLY WHEN SHE LIFTS HER ARM OVER HER HEAD. SHE FEELS IT IS GOING NUMB WHEN SHE TRYS TO BUTTON HER BRA. PATIENT FEELS LIKE A NEVER WAS DAMAGED. HER DOCTOR TOLD HER TO GIVE IT SOME TIME AND DO SOME PHYSICAL THERAPY
Patient presented to the ED and subsequently hospitalized for CVA within 6 weeks of receiving COVID vaccination.
Patient presented to clinic for COVID19 booster followed by receipt of J&J for primary series. Full-dose Moderna was administered by mistake. RN attempted to reach patient via phone to notify of dosing error without success, left voicemail.
Rather large rash extended down arm from injection site in the deltoid.  Warm and irritated for a few days then resolved.
Nausea; Vomiting; Chills; Red in her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red in her arm at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red in her arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Mar-2021, NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red in her arm at the injection site) had not resolved. Not Provided          Concomitant medications included blood pressure pills and cholesterol pills.  Action taken with mRNA-1273 in response to the events was not applicable.
Tinnitus continues 8 to 10 level from when received Dose 2.  developed nausea
family reports sz occured on 5APR97;no prev sz hx;pt recv vax 21MAR97;
Nurse who administered vaccine injected high in the deltoid, possibly irritating the joint. Pain in the left shoulder  x 2 weeks. Pain with ROM.
Throat & eyelid swelling & tongue swelling, nausea, black out, headache, severe sinus, shortness of breath (hyperventilating), congestion. Lasted 45 minutes.
PATIENT WAS EXTREMELY TIRED AND "OUT OF IT" AND SAID SHE HAD SUCH CONFUSION AND COULDNT EVEN HEAR WHAT HER HUSBAND WAS SAYING. HUSBAND TOOK HER TO THE HOSPITAL AND THEY RAN A BUNCH OF TESTS AND EVERYTHING CAME BACK OK. THIS HAPPENED WITH HER FIRST DOSE AS WELL, MODERNA 03/03/21 LOT 013A21A, BUT ALSO HAPPENED A YEAR AGO AROUND THE SAME TIME OF YEAR.
Severe pain in arm where shot was given: Immediate - Point of injection: severe pain, soreness and burning. Immediate pain in shoulder joint  I could not lift my left arm or use it to lift due to severe pain. Pain radiates across to right shoulder; neck to base of skull resulting in headache. Pain radiates to left shoulder blade. Pain radiates from left shoulder joint down left arm to the middle, ring and pinky fingers. Restless sleep; throughout the weekend. Mild fever Friday evening. Sporatic through the weekend  would occur in waves. Weakness, throughout the weekend. Joint pain; throughout the weekend. Fuzzy vision; some feeling of vertigo; (avoid driving unless necessary) throughout the weekend. Mild swelling of  hands, body, legs throughout weekend (subsiding on Tuesday, August 11). Mild swelling in back of throat  began Sunday; continues Tuesday. Used ProAir inhaler for relief on Sunday night. Local pain; radiating pain down arm to fingers; still evident on Tuesday, August 11, 2015. August 11, 2015  late evening around 10 PM, swollen gland left side of throat. August 12, 2015  morning; swelling in left throat gland decreased; just uncomfortable feeling. Have a follow up at Dr's office at 1PM today.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 10-DEC-2018, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 milliliter injection, intramuscularly lot # R011632, expiration date 02-FEB-2020 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA008566: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA014100:
Noted mild edema marked redness & marked tenderness at R ant thigh where PENTACEL had been given ~ 4 hrs previously. Exam at office showed resolved erythema, no in duration, sl edema, mod tenderness. Sl fussy next day.
2 days after the vaccine tip of her right thumb was purple; look like finger got slammed by door; This spontaneous case was reported by a health care professional and describes the occurrence of CYANOSIS (2 days after the vaccine tip of her right thumb was purple; look like finger got slammed by door) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced CYANOSIS (2 days after the vaccine tip of her right thumb was purple; look like finger got slammed by door). At the time of the report, CYANOSIS (2 days after the vaccine tip of her right thumb was purple; look like finger got slammed by door) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information included Tylenol.
8.5 CM IN DIAMETER RED, RAISED ERYTHEMATOUS AREA ON PTS LEFT DELTIOD. LOCATION IS ITCHY AND TENDER TO THE TOUCH.
SORE HAND; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced sore hand. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore hand was not reported. This report was non-serious.
3/25 temp 99.1, change in condition form sent to dr.  3/26   Res continues to be lethargic this AM shift. Res does nothing to participate with cares, transfers or eating. Denies any pain or SOB when asked. Difficult to have res to keep eyes open. Appetite very poor, even with full assist provided- sent to ER- admitted to hospital dx of UTI/hypernatremia 3/29 retn to nursing home and3/30 admit to hospice
Patient has developed gradual subacromial bursitis following the injection over the last two months.  She is currently prescribed physical therapy and is still symptomatic.
No actual adverse event known at this time but patient was pregnant at the time that this vaccine was administered. Patients EDC is 8/28/19. This vaccine was not administered by our office but our provider (Dr.) requested that this form be completed. The vaccine was administered by Agency to the patient as one of their employees. Dr. is the medical director for that center.
18 days after administration of Varicella Vaccine in right SubQ area, she had generalized-scattered vesicles of varicella on trunk, arms, face, and few on lower extremities.  Antipuritic provided, and vacation from hospital work environment till all lesions crusted and dried.
Within hours of injection on 01/11/2021, patient stated she experienced severe diarrhea followed with facial and arm swelling and chest tightness the next morning 01/12/2021. Pt sought treatment in the Urgent Care on 01/13/2021. Pt prescribed methylprednisone (Medrol dosepack) by physician.
Hx of diabetes, hypertension, and chronic renal failure with baseline cr of 1.7-2.1 that because quadriplegic secondary to acute demyelinating encephalomyelitis with onset of H1N1 vaccine in November of 2009. He was initially admitted to hospital on November 6th 2009 with flulike syndrome. Discharged and currently residing in a long term care facility.
Swollen arm; Extremely dizzy when standing; Patches on face at night; Rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), DIZZINESS POSTURAL (Extremely dizzy when standing), RASH (Patches on face at night) and VACCINATION SITE RASH (Rash around injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm), DIZZINESS POSTURAL (Extremely dizzy when standing), RASH (Patches on face at night) and VACCINATION SITE RASH (Rash around injection site). At the time of the report, PERIPHERAL SWELLING (Swollen arm), DIZZINESS POSTURAL (Extremely dizzy when standing), RASH (Patches on face at night) and VACCINATION SITE RASH (Rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
COVID arm, redness, itching swelling and pain.  Started menstrual cycle June 14 and it was severely heavy and painful which is not a normal cycle for me.  I don?t have heavy cycles. Treatment for covid arm was benedryl for 3 days until the rash disappeared.
pt recv vax 17OCT96 & 25OCT96 had grand mal sz assoc w/fever 5 days p/vax;MD & neurologist felt not r/t vax;
Client experienced adverse effects with her primary series of Moderna vaccines. First dose, Lot# 042L20A on 02/02/21 she had an instant headache, numbness around her right eye and lips, and had leg weakness 30 minutes after (could not stand), her husband rushed her to the hospital and while she sat in a wheelchair they asked her questions that she could understand, but stated she could not respond verbally. This lasted for 5 hours and then symptoms subsided on their own without any interventions from the DR. With her second dose of Moderna, Lot# 001B21A  on 03/11/21, she only had flu like symptoms for three days after. She wanted a Pfizer booster vaccine today and after a medical consult with our medical doctor was okayed, she received Pfizer, Lot# FK9895 at 2:45 PM in her left arm. SHe was advised to wait in observation for 30 minutes. About 15 minutes into it, she developed numbness on her nose and was having neck pain. She developed a headache as well. Her vital were taken at 3:05 PM and were 127/87, HR: 67 bpm, 100% O2. She stated she had a headache 5 out of 10 pain level and felt dizzy. We placed her in the gravity chair to lay down. She also drank a bottle of water. Dispensed liquid benadryl 50 mg to client at 3:09 PM. Took vitals 3 more times and were all within normal limits. At 3:30 PM client was educated on vaccine safety, signs and symptoms of allergic reactions,  recommended following up with her PCP. Client stated she felt better and left the facility with a steady gait and unlabored breathing.
Breakthrough COVID-19 case with unknown symptom onset date: Aches, Runny Nose/Congestion, Sore Throat, Nausea/Vomiting, Fatigue or tiredness, Cough. Patient reports that she went to the doctor a total of 3 times. She was tested for COVID-19 on the third doctor's visit. Patient had a fever, but cannot recall her temperature. She was on home O2 and has home health services. Patient has completed self isolation period. Her strength is diminished and she does not have energy. She said she gets tired easily. Tested at hospital but not admitted.
This spontaneous report was received from a pharmacy student refers to a 4 months old patient. On 03-OCT-2012 (also reported as on 04-OCT-2012), the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # reported as 1420Y, expiry: 03-AUG-2012, route not reported). No adverse effect were reported. It was not specified if the patient sought medical attention. Additional information has been requested.
On week after receiving the first dose my arm started itching and I have a big red patch. I looked it up and the article encouraged me to report it.
pneumonia (felt cold, fever, difficulty breathing, body aches); A spontaneous report was received from a healthcare professional concerning an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia.  Medical history included atrial fibrillation. No relevant concomitant medication was reported.  On an unspecified date, the patient received a dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced being cold at night, felt fever in the morning, had difficulty breathing, body aches, and was diagnosed with pneumonia at the hospital. The patient was treated while in the hospital (treatment was unknown).  Action taken with the mRNA-1273 in response to the event was not reported.  The event, pneumonia, was considered resolved.
Information has been received from an advanced practice nurse via company representative referring to an adult male patient who was a relative of the nurse's. On an unknown date the patient was vaccinated with a dose of MMR II injection (lot # not reported), 1 dose once subcutaneously. On an unknown date the patient experienced measles. The reporter reported that there was some uncertainly whether this was actually a diagnosed case of measles or not. There was also some uncertainly as to whether the patient had actually received MMR II as a child. At the time of this report, the event outcome was unknown. The causality between the event and the vaccination was not reported. Additional information has been requested.
I have no reason to think this was caused by the vaccine but a lady from the CDC that called me asked me to file a report. I found out less than a week after my second vaccine dose that I was pregnant. At the time of the vaccine I was probably 3.5 weeks pregnant, but I didn't know yet. At my first pre-natal appointment, on 6/17/2021 I found out that I was having a miscarriage. The fetus had stopped growing about a week earlier at 7.5 weeks (around 6/10/2021) and had no heartbeat. There's no known cause for the miscarriage and I have not yet actually passed the fetus, so I'm still in the process of miscarrying. It was a missed miscarriage.
pt recvd vax 18NOV93 & devel severe generalized rash next day which lasted a wk or so but still c/o itching;