chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had her Pneumovax and Tdap shot on Friday.  Later on that day she developed hives and itching.  The next day she had near syncope, EMS was called and she was taken to hospital.  Work-up in the ER was negative.  She was given Benadryl and prednisone and sent home.  Today's last day of prednisone.  She is taking 25 mg of Benadryl 3 times daily.  Currently she still has hives and itching throughout.  Feels her face is swollen but no swelling of lips, throat, tongue.  No sensation of throat closing. Otherwise well.
Developed bilateral swelling of neck 3 weeks post MMR vaccine. Absess was drained and tested at hospital.  Diagnosis: bacterial adenitis. Keflex:150mg PO x3 daily for 10 days.
Information has been received from a county health registered nurse concerning a 6 year old female who on 21-JUN-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 07-MAR-2007, the patient developed varicella, <50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007 and this student was identified during the county health investigation. An immunization clinic was conducted in the school were students received a second dose of varicella virus vaccine live (Oka/Merck). This is on of 28 reports received from the same source. No further information is available.
2 DAYS AFTER RECEIVING THE BOOSTER I HAD A HORRIBLE HEADACHE, SWOLLEN LYMPH GLAND IN RIGHT ARMPIT AND PAIN ALONG ARM (CONSTANT PAIN IN THIS RIGHT ARM SINCE 2ND DOSE ON 4/02/2021 - XRAYS DONE) EVENING OF TUESDAY 11/30 DEVELOPED RIGHT BREAST PAIN AND ON EXAMINATION MY BREAST WAS SWOLLEN ALMOST TWICE THE SIZE OF MY LEFT BREAST. I CALLED THE MODERNA HOTLINE AND WAS ADVISED TO CONTACT MY PCP. I HAVE LEFT A MESSAGE. AS I AM WRITING, MY BREAST FEELS SORE AND PAINFUL, AND IS STILL SWOLLEN, PAIN ALONG MY RIGHT ARM. I HAVE TAKEN A MOTRIN 600MG WHICH PROVIDES AT LEAST 30 MINS OF RELIEF. MY MAMMOGRAM WAS DONE ON 8/19/2021 AND IS NORMAL.
A spontaneous non-serious report of administration of half dose has been received from a medical assistant in a doctor's office concerning a 36-month-old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. There was no adverse event associated with this event; therefore, treatment and reporter/sponsorcausality assessments are not applicable, and the event is considered resolved. This case is admitted in accordance with edImmune's post-marketing commitment on accelarated reporting for the newly indicated population of 2 years to 55 months of age for FLUMIST.
WOKE UP WITH RIGHT ARM PAIN, NUMBNESS IN RIGHT HAND AND PAIN IN ELBOW AND WRIST JOINTS.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No treatment was provided by the reporter.
9/9/21: Patient came to the ED today due to SOB. Patient initially on 2 L in the ED due to conversational dyspnea, currently maintaining saturations on room air. 6 min walk test showed patient desatting to 90 after taking approximately 20 steps but then needed to stop due to him feeling weak. Patient initially tested negative on rapid Covid test but subsequently tested positive on PCR. Patient admitted to floor on isolation precautions.  Discharged 9/11/21  Readmitted 9/18/21 with pleural effusion and pneumonia.
my arm is in so much pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (my arm is in so much pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C211A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced VACCINATION SITE PAIN (my arm is in so much pain). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (my arm is in so much pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not reported.
First symptom was sore throat and headaches, than joint point. All over Joint pain has persisted and gotten much worse. Now having trouble walking raising arms going to see Pediatric Rheumatology. Still sore throat having trouble concentrating and very fatigued.
My adverse event started on 12/10/2022. In the evening I starting having violent shaking chills, headaches body aches,  dry cough, vomiting and fever of 104.00. I thought this was normal after vaccinations but at night I was feeling so bad that my husband had to take me to the restroom. I had a seizure which made me very weak. I tested negative for COVID-19 infection. I called my doctor's office for medication/advise but it didn't help because the RN didn't mention anything. I took TYLENOL. Since I live on a mountain I have to wait till April 4th to see my doctor. The dry cough occurs at night most of the time still as of today 01/04/2023.
1)Intense blood swelling  2) Dryness  3) Itchiness that is causing big dark red spots all over the body 4) Exactly looks like fungal infection
on March 20 I initially woke up with vertigo which I later found out was an adverse reaction to the first shot of the vaccine. Approximately three weeks after the second shot of the vaccine I endured a chest pain and had to call 911, where I later woke up after having open heart surgery, Due to the fact that I had an aortic tear I needed Emergency open heart surgery. In the midst of that I had a mild stroke, two seizures and blockage in my carotid artery, Which I will need additional surgery to fix and put a stent in my neck.
Information has been received from a physician concerning his 22 year old daughter with an allergy to "Kombuka" who on approximately 28-DEC-2006 was vaccinated with a first dose of Gardasil.  There were no concomitant medications.  On approximately 04-JAN-2007 within a week of vaccination the patient developed an oral food reaction while eating mussels.  Symptoms were described as discomfort at the back of the throat, itchiness, feeling as if the tongue was swelling, and difficulty swallowing.  It was noted that the tongue did not actually swell.  The patient was treated with BENADRYL.  Subsequently the patient recovered.  On 17-AUG-2007 the patient was vaccinated with a third dose of Gardasil.  Subsequently, the patient developed similar symptoms of tightening of the upper throat, discomfort, and flu-like symptoms.  The patient was treated with BENADRYL.  Subsequently, the patient recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007.  Initial and follow-up information has been received from a physician concerning his 22 year old daughter with an allergy ot "Kombuka", unspecified food and pollen who on approximately 28-DEC-2006 was vaccinated with a first dose of GARDASIL.  There were no concomitant medication.  On approximately 04-JAN-2007 within a week of vaccination the patient developed an oral food reaction while eating mussels.  Symptoms were described as discomfort at the back of the throat, itchiness, feeling as if the tongue was swelling, and difficulty swalling.  It was noted that the tongue did not actually swell.  The patient was treated with BENADRYL. Subsequently the patient recovered.  On an unspecified date the patient was vaccinated with a second dose of GARDASIL.  Subsequently, the patient had a milder similar reaction and recovered.  On 17-AUG-2007 the patient was vaccinated with a third dose of GARDASIL.  Subsequenlty, the patient developed similar symptoms of difficulty swallowing, flushing and dizziness.  The episodes were self limited lasting 30-60 minutes occuring approximately 4-5 times over two weeks.  It was unrelated to other counts.  The patient was treated with oral BENADRYL and may have had a positive or negative response.  It was reported that the reactions were milder and similar to the reactions after the first and second doses.  It was thought to be a food allergy but probably wasn't.  The patient had 5 physicians visits:  2 primary care physician (PCP) visits, 2 allergist visits and and 1 ears nose and thoat (ENT) visit.  At the time fo the report the patient's outcome was unknown.  Additional information is not expected.
pt exp fever (?) not taken & splotchy rash that devel into swelling over entire body; swelling in face until eyes almost swollen shut; c/o itching all over; sx started 3-4 hrs p/inject & lasted 4-5 days; rash;
1-my body felt cold and I felt tightness in my chest 2-not easy to take my breath 3-left and right foot started to get swollen. Gotten worse over night but i was able to sleep. 4-both left and right foot got more swollen(mostly the left one) and chest tightness got worse.  5-I'm having pulsing pain on mainly the left foot. Right foot also have pulsing pain but not as much as left foot 6-it's 3:20 am now and im Having very hard time to sleep with. Both feet specially the left one have pulsing pain and my chest feels tight.   This is my 2nd vaccine shot. I have already made a report to VAERS please refer to : Temporary VAERS E-Report No: 601059 Date Form Completed: 08/01/2021
Patient recieved Covid vaccination from our intern and 10 seconds later reported feeling dizzy and unwell. Pt sat down immediately in consult room but then fainted and fell out of the chair and landed face first on the floor and experienced seizing motions. Patient was out for 30 seconds to a 1 minute. The patient came to and reported feeling better, wanted to sit up and wanted water. A water bottle was provided for the patient. 911/paramedics were called and 3-5 minutes later the patient fainted with seizing motions again but was supported and did not fall out of chair again. shortly after the second fall, paramedics arrived and took over. patient ate 4.5 hours prior to vaccination and also reported never fainting before after or while getting a vaccine.
Patient seen by provider. No indication to with hold routine vaccines. Patient is up to date with age appropriate vaccine recommendations in series. Due to her being 4 years of age the vaccines administered above given. Patient started to report difficult breathing and assessment conquered. Itching and more distress with breathing. Epi 0.15mg administered. EMS transported to ER. Benadryl administered. Patient was discharged with no further intervention after being observed.
Pt took the second dose of oral typhoid vaccine and 5 hours later she had severe stomach cramps. An hour or so later she became diaphoretic and she went to ER. Her blood pressure in the ER was 75/49. She was given IV fluids, observed for 3 hours and released after her vital signs were normal.
Patient had 4cm induration with redness and pain. Patient treated with Tomadol IM and Keflex PO and discharged with keflex. Vaccine administered 10/22/02. Symptoms started same day.
Sore arm; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Joint pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Solution for injection in pre-filled pen. In October 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Joint pain). In October 2021, PAIN IN EXTREMITY (Sore arm) and ARTHRALGIA (Joint pain) had resolved.            The concomitant medication was not reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Left leg with 10.5 cm x 17 cm area of erythema and edema - suggested they could try Benadryl. Started 1 day after vaccination.
About a week after receiving the vaccine I developed some pretty large panic attacks and anxiety. I had not experienced anxiety or panic that bad in a while. Now I am 17 days since vaccine and it's still not better. I get bad panic attacks daily and don't feel quite right anymore. All since the Pfizer shot. Also might have had psychotic break a week after the vaccine.
Breakthrough case admission after 2 vaccines Moderna 4/13/21 Lot# 037B21A;  Moderna 5/11/21 Lot# 043B21A
First afternoon:  weird taste in mouth, tingling hand, pain in arm (hurts to lift and heavy feeling), dizzy, fever of 99 F (norm is 97.7).  Day 2:  Difficulty sleeping night before, arm hurt to even touch from shoulder to elbow, headache which turned into a migraine by the end of the day, pulse ranged from 85 to 104 bpm while sitting (normal pulse mid-60s to mid-70s resting) , skin pink and flushed (legs, arms, stomach, chest, face, etc.), loss of appetite and nausea.  Tremors in hands. Pain in neck.  Day 3: Difficulty sleeping continued, arm starting to feel better, head still hurt, still no appetite (down 2.4 lbs), still fever of 99.1.  High pulse and tremors in hands and arms.   Day 4:  Difficulty sleeping still.  Temperature was normal that morning.  Arm hurt way worse all the way from my deltoid to my shoulder.  I could barely use my arm.  Pulse still will not go down below 85 bpm.  Tremors in hands especially bad when I woke up and my heart felt like it was racing.  Still flush.  Decided to take blood pressure, it came up as 189/111 on my wrist blood pressure monitor, double checked it using a arm blood pressure reader about a half hour later it came up as 129/86. Which is still a lot higher than my normal but closer.  Ate some lunch which caused diarrhea within the hour.  Day 5:  Still difficulty sleeping, pulse still high, arm hurts up in the shoulder and between where my shoulder meets my body.  Called Teledoc who told me to go to Urgent Care. My temperature there was 99.1.  They ran several tests such as bloodwork, covid test, urinalysis, and EKG.  The PA said test were normal all but the EKG stating I have PVCs and she referred me to a cardiologist.  Day 6:  Still difficult sleeping, arm finally feeling almost back to normal, weighed in at 130 lbs (3.8 lbs less than normal), temperature of 99.3, pulse still really high.  Day 7:  Slep even less, heart was pounding, decided to go to the hospital.  When I arrived heart rate was at 145 bpm and a blood pressure of 132/99.  I was admitted.  They ran a bunch of tests and put me on an IV.  The IV seemed to be helping.  Apparently I was very dehydrated.  They said I had Sinus Tachycardia.  I was feeling better and blood pressure and pulse were back to acceptable levels so they discharged me.  Still tired but feeling better afterwards.  Day 8:  Still exhausted.  Pulse getting down into the 70s if  I stay still, but if I do anything like wash dishes it's back up to around 130 bpm.  Eating more normal now.
Had rash on neck after 1st shot (4-5 days later) thought it was from something else, itching also. After 2nd shot rash widespread on trunk, neck, arms and itching. A lot worse. Took a couple of weeks to go away. (Also 4-5 days later). Instructed to tell physician.
Facial flushing, itching, redness, rash, warmth. Worse after coming out of shower. PREDNISONE 10 mg. as ordered.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient Received vaccine beyond 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient received booster dose vaccination time was given as 11:50:54. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. We no longer possess this lot number. Treatment medications were not reported.
Swelling to upper arm (L), noticed by patient around 24 hr. To office at 48hr - first time mother has seen. Pt did not know site is red. (L) upper arm with 2 puncture sites of vaccines in deltoid, irregular splotchy, red, firm rash inferior to sites and posteriority with finger of red nearly to elbow. Margins marked KEFLEX only if worse. BENADRYL 50 mg, cool compresses.
lip tissue & under tongue-had swelling;itching in back of throat;excess amount of drainage;
swelling, hives, itching an and off for the past 3 weeks.  Face, Lips, groin area, hands arms, legs   on and off different places different times
Information has been received from a pharmacist who reported that 2 unknown patients (demographics unknown), received improperly stored ZOSTAVAX 19400 PFU, (lot #M038864, expiration date 12-DEC-2017) (dosage and route of administration not provided). No adverse effects reported. Temperature: Total time in the range 6°F to 14°F Time frame: 2 hours Previous temperature excursion: No "Data logger" involved: Yes No additional information was provided. Additional information has been requested.
Baby was immunized 4/6/11. Baby was born prematurely. Hep B refused.
weakness; muscle aches/arm soreness; nausea; nose running; pain in the arm where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MYALGIA (muscle aches/arm soreness), NAUSEA (nausea), RHINORRHOEA (nose running) and VACCINATION SITE PAIN (pain in the arm where I got the shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 006M20A and 042120A) for COVID-19 vaccination.     Concomitant products included VALSARTAN for Blood pressure, CLONIDINE for Digestion impaired, DILTIAZEM for Gut pain, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Reflux esophagitis, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), POTASSIUM CHLORIDE, COLECALCIFEROL (D3) and CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), MYALGIA (muscle aches/arm soreness), NAUSEA (nausea), RHINORRHOEA (nose running) and VACCINATION SITE PAIN (pain in the arm where I got the shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), MYALGIA (muscle aches/arm soreness), NAUSEA (nausea), RHINORRHOEA (nose running) and VACCINATION SITE PAIN (pain in the arm where I got the shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-311614 (Patient Link).
Dizziness, headache, Myalgia, NauseaVomiting, Tachycardia,  TINGLING IN BACK OF THROAT  Narrative:  Within 10 min of the vaccine I became light headed, racing pulse along with a tingle in the back of my throat. I would have rated this 3/10. If symptoms would have worsened I would have notified the nurse. It took my approximately an hour to feel somewhat normal again. 1530-Left flank pain 4/10 Later in the evening became fatigued 0438-Woke up with horrible chills, body aches, headache, fatigue, slight nausea and loss of appetite. I had episodes of this throughout Saturday and Sunday. I alternated Tylenol and Ibuprofen to help managed symptoms. I remained a febrile. Last episode was Sunday 23:20. Monday I only experienced some minor headache and nausea.
ARM IS STILL REALLY SORE FROM THE INJECTION.; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced arm is still really sore from the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm is still really sore from the injection. This report was non-serious.
Got sick as heck; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient stated that he/she would never take another dose, did one time got sick as heck. Also stated that they could take all of their vaccines and stick it where the sun did not shine.