chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; ANXIETY ATTACK; VOMITING; CHILLS; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included radioactive iodine, and concurrent conditions included penicillin allergy, graves disease, and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced anxiety attack. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety attack on 12-APR-2021, vomiting, chills, and nausea on 10-APR-2021, and fatigue on 11-APR-2021, and had not recovered from headache. This report was non-serious.; Sender's Comments: MAC; V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Began with an itchy nose, which is typical of my reactions.  Progressed to a tightness in my chest and difficulty getting air in, starting coughing and wheezing.  Nurse on site gave me two oral Benadryl and also administered an epi pen.  Paramedics were called, additional epi given. In ambulance started a nebulizer, enroute chest began to tighten so they gave more epi and an additional nebulizer.  At hospital had Pepcid, steroids, fluids, Benadryl and more nebulizer treatments. Released home on steroids, Pepcid, albuterol.  Last night at home had headache and a mild fever of 99.7 took ibuprofen for those issues.  Today no headache or fever.  Coughing continues and some issues getting air in but wheezing is gone. This is a very typical course for my reactions.  I have had flu shots and most recently had both doses of the shingles vaccine last one was January of 2021 with no reactions like this.
PAIN AND SWELLING IN LEFT ARM FOR 3 DAYS. VACCINE GIVEN SQ AND NOT IM. NO OTHER ADVERSE SIDE EFFECTS NOTED.
Mother states his eyes rolled back in his head and he had a grand mal seizure that lasted several months with a postictal phase. Taken to ER per 911.
I don't think it is the medication but how it was administered. My shoulder upper arm has hurt since I received dose 1. I told the person administering the second dose that my arm still hurt and she said that was normal. I advised  her to administer the second shot to the same arm because I did not want both arms hurting.  My arm urts to lift it and reach behind my body or place my arm up next to my back. I have lost mobility in this arm such that it is difficult to put on a bra normally. I called in regarding the pain and stated there was no rash or swelling but that it continued to be problematic. Around six weeks post second dose I had telemedicine with the NP for asthma and pain in my chest which has subside now. At that visit, I told him that my arm continued to hurt but this was not my reason for the visit.  It has now bee almost 4 months since the pain began after the vaccination and it continues to hurt. I still have limited mobility in that arm. It only hurts when I move it. My right arm is my dominate arm. There is still no swelling or rash.
Patient received her first dose on 10/5 and came to our clinic on 10/24 and received another seasonal flu shot.
June 19, 2021 8:30 PM extremely tired. Went to bed.  June 20  woke up at 1 am with a fever (101.4 F). When I got up at  7am (6/20) I noticed my arms and chest were red as if I were sunburned. Felt tired and feverish. Went to emergency room after speaking to hospital over the phone. The ER Doctor discussed my situation with hospital doctors and Tests were run to determine if there was and infection, blood problem or metabolic problems.  No significant problems were immediately detected. Put on a prophylactic antibiotic.  June 21, 2021 felt worse. Fever and widespread rash. Admitted to the hospital. Continued blood tests.  June 24 determined the problem was GVHD. (After eliminating infection) Graft vs Host Disease (GVHD) was likely triggered by the immune response from the Shingrix vaccine. I had not experienced GVHD in the 5-1/2 years post transplant.  Currently being treated with prednisone.  2nd COVID vaccine dose was administered 6 weeks prior to the Shingrix vaccine
PT STATED THAT HER ARM IS IN SEVERE PAIN. " AS THOUGH SOMEONE WITH A KNIFE IS STABBING HER" AND THAT THIS PAIN HAS BEEN OCCURING FO RTHE LAST 2-3 WEEKS NOW. AFTER SHE HAD RECEIVED THE VACCINE SHE SAT FOR 5 MINTUES BECUASE THE INJECTION SITE HURT HER SO MUCH SHE WANTED TO CRY. SHE HAD A SORE ARM FOR A DAY OR TWO BUT AND WAS FINE AFTER THAT BUT A WEEK LATER THE PAIN CAME BACK AND HAS BEEN THERE SINCE. SHE HAS NOT TAKEN ANY MEDICATIONS OR SEEK MEDICAL ATTENTION FOR THIS.
Went to bed and woke up after midnight with terrible joint pain.  Shoulder joints hurt, knee joints hurt (I could barely walk), and the most serious issue was with my left wrist.  I could barely move my fingers and when I was able to move my fingers, it felt like something in my wrist kept popping.  I had to use my other hand to rotate my wrist around until it made a loud pop noise and then I was able to move my hand without it continuously popping and hurting.  I went back to bed and woke up about 2 hours later with the same issue.  The rest of my joints are better now, but I'm still having issues with my left wrist/hand.  I can't always fully stretch my thumb, my wrist continues to pop randomly throughout the day and it's painful, sometimes my hand seizes up and I can't move it, and I have to wear a wrist brace during work because I work on a computer all day and it will randomly seize up without a brace on.  I never had an issue with my wrist before until that night.
pt rt arm is red & swollen from above elbow to deltoid region;clinic made arrangements for pt to see pvt MD;
Feels unsteady on her feet; Feels nauseas; Body got really hot; Very weak; Felt sick; Short of breath; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Body got really hot), ASTHENIA (Very weak), MALAISE (Felt sick), DYSPNOEA (Short of breath) and BALANCE DISORDER (Feels unsteady on her feet) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Blood pressure high, Asthma and High cholesterol. Concomitant products included LISINOPRIL, MONTELUKAST, PANTOPRAZOLE and RIVAROXABAN (XARELTO) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced HOT FLUSH (Body got really hot), ASTHENIA (Very weak), MALAISE (Felt sick) and DYSPNOEA (Short of breath). On 18-Feb-2021, the patient experienced BALANCE DISORDER (Feels unsteady on her feet) and NAUSEA (Feels nauseas). At the time of the report, HOT FLUSH (Body got really hot), ASTHENIA (Very weak), MALAISE (Felt sick), DYSPNOEA (Short of breath), BALANCE DISORDER (Feels unsteady on her feet) and NAUSEA (Feels nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea is consistent with the product safety profile.
I received my booster shot on 11/11/2021 and adverse event on 11/28/2021 2-3 weeks after. I noticed in the morning while I was taking shower I felt that something wrong with my toe. I felt some kind of lump on my toes. I felt like it was coming out of my toes. The toe became swollen, very painful, the lumps of my toe would move and change and then my toe became blue. Then I noticed a large lumps on my toe. It was blood in the lump. The doctors told me that a blood clot  got into my toe. My cap or capillary vain that flow blood to my lungs could have caused it but he wasn't sure. He send me to a podiatrist and send me to get x-ray. My doc had no idea how to treat it. The x-ray came back and there is  nothing was there. Except for arthritis was in my joint. The podiatrist had no idea what to do. He gave me some pain medication for my toe. He send me to the hospital for vascular test for my extremities ( chest). No negative results were shown. There is no reason found behind it. I went back to my PCP, I showed him my test result I told him about the podiatrist. My PCP gave me different pain medication. ( hydrocodone pain killers which didn't work. Then he referred me to a cardio vascular specialist. I told him that the medication my PCP gave me wasn't working. I have difficult with everything I do. My toe hurt when I walk, my toe hurt when I sit. My toe change colors and move. Swollen eventually  went away, the lump became a dot. I had sore on my right side of the toe then I went to my PCP. He gave me more medication it went away. Then another one came after about 4 months, my toe shattered to change again it looked like diabetic toe. My toe was healing. I woke up one morning the dot bottom of my foot went way it healed. The skin top of my toe came off. The new skin was tender. My toe is almost normal. This entire process took 4 and half month to 5 months.
Moderna COVID-19 Vaccine EUA I developed a red rash at the injection site. I noticed it a few days after the injection. It's about 1" by 1.5" and feels firmer than the area around it. It itches but not terribly and it's not really tender to the touch.  It does not bother me but I thought I should report it.
Patient received a letter in the mail from the doctors office stating that the vaccine he received "may have been past the expiration date" and that the doctor recommends receiving a booster.  The day after the vaccine patient's arm was red around the injection site according to the patient's wife.  When they received the letter, patient's wife called the doctors office to inquire what the expiration date on the vaccine was and the office informed her that the vaccine expired in Nov 2021. The patient received the vaccine well past the expiration date on 3/29/2022.  Patient would like guidance on if and when he should receive another vaccine since the one he received was expired.
This spontaneous report as received from a nurse refers to a 6 months 5 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Swelled softball sized lump, hot to touch red hot lasting 2 weeks, I had multiple vaccines. pnue. similar reaction tetanus no reaction
Patient received her vaccination then started to feel palpitations as she was waiting for 15 minutes. Then the patient felt dizzy and her BP was elevated (SBP ~135 mmHg) than her normal which is around 90/60 mmHg.
I had an increase pain in right knee, muscle ache and tightness. Also, had a crick in my elbow all of the sudden. On 3/8 my doctor did a blood test and found it to be rheumatoid arthritis. 3/22 The results were given and will start on 4/1 a weekly methotrexate injections and prednisone. 4/1 Visit doc for informational instruction and 05/19 Scheduled follow up for continued review.
09:07 10 minute after receiving the 2nd Pfizer vaccine, pt.c/o being hot and clammy. Pt. states she had the same reaction after the 1st Pfizer vaccine. There was no syncope event, hr 71, O2 98%, and AAO. Cold pack applied to her head and water given. Pt. monitored for 30 min, feelings resolved. Pt. discharged from clinic and accompanied by her husband.
Patient went into staring seizure, and her parents could not get her out of it. She started to convulse, and an ambulance was called. Patient came out of it on her own when paramedics arrived and was very sleepy. She may have had a mild fever around a 99.
This spontaneous report as received from a 79 year old male consumer reporting on himself. On an unknown date, "a few years", the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Concomitant therapies included gabapentin. The consumer reported that on 01-SEP-2014 "3 weeks ago", he had a case of the shingles after receiving the vaccine. The consumer mentioned that before the tingling sensation he was experiencing memory loss for about 3 hours. Around the same time he got the tingling sensation and got a case of the shingles. The patient received treatment for the adverse events. At the time of the report, the patient's outcome was unknown. Additional information is not expected. There is no contact information.
Narrative:  Pt was a 58 YO male with PMH of gout, EtOH abuse, enteritis, GERD, HTN, and sleep apnea presented to hospital due to MVA with multiple injuries (multiple vertebral fractures). He was hypotensive on arrival and required intubation d/t AMS and respiratory distress. Pt's condition continued to worsen. He was changed to comfort care and terminally extubated. Death does not appear related to COVID-19 vaccine.
Fever 99.9 degrees, throwing up, nausea, disorientation, loss of appetite, body aches, headache, loss of speech, loss of writing, loss of understanding. admitted to ER hospital the Wednesday 2/17 @ 3:30pm.  Sodium level dropped to 123 and dehydrated.  Given IV and stayed overnight
Exremely sore arm. All-day fever, 100.8 f. Weakness. Lethargy.
PATIENT RECEIVED MODERNA VACCINE 04/22/21.  PATIENT REPORTED MINIMAL REDNESS AND SWELLING  24HRS POST INJECTION.  PATIENT THEN REPORTING ITCHING OF ARM AT INJECTION SITE AND ON 05/01/21 LEFT ARM AT INJECTION SITE WAS RED, WARM TO TOUCH, AND SWOLLEN.  PATIENT REPORTED SWELLING THE SIZE OF A BASEBALL.  IN CLINIC TODAY ON 05/04/21 AND SWELLING HAS SUBSIDED, BUT REDNESS REMAINS.
swelling of tongue and turned purple/tongue started to swell and turn purple; swelling of tongue and turned purple/tongue started to swell and turn purple; This is a spontaneous case received from a contactable consumer (patient) reported for herself that: A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ER8730) as DOSE 1 SINGLE for covid-19 immunization. The patient past medical history included hypertension from an unknown date and unknown if ongoing. Caller states she has recent HX of reaction to medications. Concomitant medication(s) included atenolol (TENORMIN) taken for hypertension, start and stop date were not reported. On 23Mar2021 after the first vaccination between 2-3 hours later her tongue started to swell and turn purple. Patient states over the past few years at different times her tongue has swelled and turned purple.  States she went to the doctor on Tuesday about it doing it again but by the time she saw the doctor the swelling was gone. Patient says today at 0500 her tongue was pink and normal also but by 0700 it was purple, says this has happened over the years to her. The patient Sick for a few months after flu vaccines, lost 7 pounds one time and 13 pounds another; states she doesn't know if it was from the vaccine or not. If patient receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, he should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.1Side effects that have been reported with the Pfizer BioNTech COVID-19 Vaccine include: These may not be all the possible side effects of the Pfizer BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer BioNTech COVID-19 Vaccine is still being studied in clinical trials.1. Patient states she is trying to get more information to decide if she should take the second vaccine she is scheduled for on 13 Apr 2021. Patient mentions at the end of the call that she was outside to help read the Lot number.  States she hasn't gotten new glasses since Covid shut everything down.  Mentions she is going tomorrow to get her eyes checked.  States hopefully soon life can start again in 2021.The event outcome was unknown.  Follow-up attempts are completed. No further information is expected.
Medical assistant administered expired dose to 1 patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant administered expired dose to 1 patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant administered expired dose to 1 patient). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Medical assistant administered expired dose to 1 patient) had resolved.        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.  No treatment medications were reported.
I received my vaccine one 04/23/2021, left arm. About in May 2021, I experienced itchiness all over my body. I developed redness and my skin was marked red all over my body, torso, face and my body. I went to the dermatologist and expressed what was happening to me. The dermatologist told me she could not say that it was directly related to the vaccine. She said I had "urticaria" and that the reasons could be of many of unknown origin. This redness lasted few weeks. I can say today the redness has gone down. Complete lab work was performed as well. I also developed nodules in my neck after my vaccine. After an ultrasound of the neck performed in mid October it showed they are benign. I am following up with my doctor in regards to the nodules of my neck.
Patient received his first dose of the vaccine and went to the restroom while waiting for the 15 minutes to elapse. Patient returned to waiting area stating that he fell  Unconscious and woke up finding himself on the ground. Upon further assessment it was discovered that the patient also bumped his head during his moment of unconsciousness. Patient was further assessed and questioned where it was revealed that he Had not eaten any food all day. He was given something to drink and a blood pressure check was also conducted. patient was in normal range .  after another 15 minutes patient relayed that he feels fine. Patient was escorted by a coworker from the facility.
Initial unsolicited report received from social media on 22 August 2016. This case video captures discussions. This case is linked with case 2016SA157332, 2016SA157340, 2016SA158486 and 2016SA157319 (same social media report). This case involves 4 year old patient (gender not reported) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)) (dose, batch number, expiration date, frequency, site and route of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced whooping cough. Laboratory data and corrective treatment were not reported. Patient's outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: whooping cough. List of documents held by sender: none. Sender's Comments: A 4-year-old child developed Whooping Cough after vaccination with DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) of unknown manufacturer. This case is poorly documented, Hence Details regarding date of vaccination, onset of event, relevant medical history, prior history of vaccination and its tolerance are needed to further assess the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
Rash on left arm about the size of 3 x 5 at injection site; redness; Itchiness; soreness; feels warmer than other body areas; hardness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness), PRURITUS (Itchiness), PAIN (soreness), VACCINATION SITE WARMTH (feels warmer than other body areas) and VACCINATION SITE INDURATION (hardness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ERYTHEMA (redness), PRURITUS (Itchiness), PAIN (soreness), VACCINATION SITE WARMTH (feels warmer than other body areas) and VACCINATION SITE INDURATION (hardness). On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on left arm about the size of 3 x 5 at injection site). The patient was treated with BENADRYL COMPLEX ongoing since an unknown date at an unspecified dose and frequency and TRIAMCINOLONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), PRURITUS (Itchiness), PAIN (soreness), VACCINATION SITE WARMTH (feels warmer than other body areas), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE RASH (Rash on left arm about the size of 3 x 5 at injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment included Benadryl triamcinolone cream topically.
This spontaneous report was received from the patient's brother refers to a 13 months old female patient with no pertinent Medical History or Drug reactions/allergies who on unspecified date in approximately November 1994 (when the patient was 13 months of age) was vaccinated with MMR II (dose, lot number and route no reported). No other co-suspects were reported. No concomitant medications were reported. The night the patient received the vaccine, the patient developed a high fever (107-108 F) and was sent to an unspecified hospital where she was admitted and treated for an unspecified period of time. On unknown date, the patient had multiple unspecified surgeries, became blind and her "immune system failed." The patient was two years of age when she died (approximately in 1995). The outcome of the events patient developed a high fever (107-108 F), became blind and her "immune system failed" was unknown. The relatedness for the event and MMR II was unknown. Additional information is not expected.
Moderate rash around the neck and the lower right side of the face. Soreness and redness around the injection site. Fatigue.