chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Terrible pain - redness, swollen, feverish, that was going down my arm. It reached below my elbow, when I went to the ER room. 10-8-12 Took flu-pneumonia shot at clinic 6:15 PM I only went for flu shot nurse suggested/recommended pneumonia also which I did both in same left arm. Before I went to bed I told my husband my arm was hurting - little red and hard. 10-9-12 4 hr. choir rehearsal at church. My arm was redder, larger area and had moved more redness toward my elbow. In PM took pain pill and put Epsom salts compress on it - then later because of pain soaked in a hot Epsom salts bath. Didn't sleep well - woke up about 1:00AM w/ pain. Decided to go to ER 5:00 AM. 10-8-12 Saw Dr. she said cellulitis got prescription for BACTRIM and NORCO. She drew sharpie lines on my arm top and bottom and said if redness got any more to come back to ER. Also for me to to go pharmacy and report it and also Dr. which I did. Called Health Dept they referred me to: 10-11 called Dr. the local Health officer - (Private Practice) I left message - (no call back). Fri 10-12 - got a call from VAERS and they are sending me paperwork to fill out to report it. 10-19 - Received paperwork from VAERS. 10-21 - Completed paperwork and included copies from clinic where I got the shots and also ER room - mailed back. I am still not up to par - my energy level is so low I have to push myself to do everything. Before shots I was very active.
Swelling, redness and pain of R thigh, at injection site.  Next day pt reported severe headaches & lymphadenopathy of head, neck, axilla, groin.
Arm sore and swollen, rash, till her elbow/Injection site rash; Injection Site Arm red/red mark; sore to the bone; Arm sore and swollen, rash, till her elbow/sore down to her elbow; Arm sore and swollen, rash, till her elbow/Injection Site arm sore; Arm sore and swollen, rash, till her elbow/Injection Site arm swollen; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; batch/lot number and expiration date were unknown), via an unspecified route of administration at the left upper arm on Oct2019 at a single dose for immunisation. The patient had no medical history and concomitant medications. The patient reported that she was vaccinated with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) 10 days ago (as reported) and since then she had reactions to it. She has experienced arm sore and swollen, rash, till her elbow. This last she applied cortisone cream on it and made her feel better. But she wonders if this is something that has been reported. It was reported that on an unspecified date in Oct2019, the patient experienced injection site arm sore, injection site arm swollen, and sore down to elbow. And on 10Oct2019, the patient experienced injection site arm red and injection site rash. The patient further reported that she had pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) about a week ago (as reported) after her normal physical. They said it might hurt a little but her arm was still sore to the bone and swollen now after 10 days. On 10Oct2019 (yesterday) during her shower she rubbed it a little to massage it with her wash cloth but it made a red mark and rash from the side of it. States her arm is still sore down to her elbow. Her husband said he would see why her arm was sore because it looked swollen. Reports she did call the doctor two days ago 08Oct2019 on Tuesday. They tried to call back but she did not get the call. 10Oct2019 yesterday she went to the doctor's office to try to see doctor and but no one was available to see her. 10Oct2019 she applied some cortisone cream to the site. It has helped a little and the rash has gone down. Asking if this was an expected side effect after 10 days. She has never had this vaccine before. The patient reported her brother and sister had pneumonia last year and she thought she should get the shot to prevent getting sick. The patient was encouraged to seek medical advice from her primary health care provider for further follow up. The patient underwent lab tests and procedures which included vitamin D: 27 on Oct2019. The outcome of the events was recovering.   Information on the batch/lot number has been requested.
Fever 100.2F , constant sneezing, coughing, fatiuge for 1 week. 11/14 1 neck gland swollen large. Returned to different doctor on 11/15 said he is OK for school.
Neck pain; Balance disorder; Asthenia; Fall; Arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), BALANCE DISORDER (Balance disorder), ASTHENIA (Asthenia), FALL (Fall) and ARTHRALGIA (Arthralgia) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported.  Concomitant products included TERAZOSIN, VITAMIN D2, FENOFIBRATE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.   On 19-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) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced NECK PAIN (Neck pain), BALANCE DISORDER (Balance disorder), ASTHENIA (Asthenia), FALL (Fall) and ARTHRALGIA (Arthralgia). At the time of the report, NECK PAIN (Neck pain), BALANCE DISORDER (Balance disorder), ASTHENIA (Asthenia), FALL (Fall) and ARTHRALGIA (Arthralgia) had resolved.            For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.          Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: updated events outcome
I had my cycle after the vaccine, 7 days later a full cycle started again and lasted 10 days. Less than 2 weeks later it started again. Less than 6 days later it started again. Constant spotting on and off. I have very bad cramps. I saw my doctor last Friday and she said we should wait to see if it would regulate and if not I should go back to see her.
I received a phone call from pt's mother stating pt is out of the country and thinks she is having reaction to JE vaccines. Having pain/headache back of head, fever, hives on chest, nausea, head spinning and feels like she is going to pass out. Sx x2 d at time of phone call. Per return phone call from mother family doctor recommended pt start BENADRYL 50 mg every 6 hr and continue for 2 days.
ACHY; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 13-JUN-2021, the subject experienced achy. On 13-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever and achy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210629335.
MAY 31,2021-FLUE LIKE SYMPTOMS-24 HOURS-WENT AWAY; JUNE 3, 2021-FLUE LIKE SYSMPTOMS-25 HOURS-WENT AWAY;  JUNE 7, 2021-BODY ACHE, FEVER, CHILLS, CHEST PAINS, LOSS OF BREATH, EXTREME FATIGUE DURING MODERATE PHYSICAL EXERTION, FELT LIGHT=HEADED, AS IS ABOUT TO PASS OUT, FEET AND FINGERS ARE SLIGHTLY SWOLEN,  0AUG 2, 2021-PEEING BLOOD AND UTI SYSMPTOMS-TREATED WITH ANTI BIOTICS. SEPT 17, 2021-CAME DOWN WITH KIDNEY STONES, LITHOTRIPSY RESULTING ON 10/11/, 2021 BLOOD PRESSURE IS STILL ELEVATED AS OF 12/17/2021 AFTER  SURGERY ON 10/11/2021.
patient was given an expired dose of Fluzone High Dose, no AE; a 64-years-old patient was given Fluzone High Dose, No AE; A 64-years-old patient was given Fluzone High Dose, no AE; Initial information received on 01-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case involves a 64-years-old female patient who received a 0.5 mL dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ288AA, expiry date not reported) via an intramuscular route in the right deltoid on 01-Sep-2020 that had already expired on 20-Jun-2020 (expired product administered  product administered to patient of inappropriate age and overdose).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Patient had no concomitant medications   It was an actual medication error case due to expired vaccine used, inappropriate age at vaccine administration and it was a case of overdose (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Just like the first shot I immediately got a headache. I also became light headed and dizzy. This lasted about 4 hours. I felt good that evening . The next morning I woke up and felt under the weather. As hours go by I feel worse and worse. I was nauseous, headache, fever of 102.3, exhausted, my chest hurt like a cold, chills, sweats, body aches, and my arm was sore. Today I woke up and still felt bad for about 2 hours but then began to feel better. I have ?Covid arm? as my injection site is red, hot, itchy and seriously swollen. I did not get tingly and numbness this time.
Local erythema of about 1.5cm diameter around injection site and significant edema from hip to knee, fever with Tmax 101.5, no induration or concern for cellulitis/myelitis/abscess.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 02/24/2021, 03/24/2021, and 12/06/2021. They tested positive for COVID-19 on 05/29/2022 and 05/30/2022 upon admission to hospital. Primary complaint was respiratory distress. The individual experienced complications of COVID-19 pneumonia and dehydration. They also had an aspiration episode which worsened their health condition. They remained hospitalized until their death on 06/19/2022.
Woke up feeling dizzy, sick to my stomach, severe headache, and very tired.  Stayed in bed all day on Saturday and slept.  Stayed home all day Sunday, 9/12/2010 and rested.  Still felt dizzy and had no energy.  Monday, 9/13/2010, felt much better.
Red, itchy sore swollen injection site bump; Red, itchy sore swollen injection site bump; Red, itchy sore swollen injection site bump; Red, itchy sore swollen injection site bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red, itchy sore swollen injection site bump), VACCINATION SITE PRURITUS (Red, itchy sore swollen injection site bump), VACCINATION SITE SWELLING (Red, itchy sore swollen injection site bump) and VACCINATION SITE PAIN (Red, itchy sore swollen injection site bump) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red, itchy sore swollen injection site bump), VACCINATION SITE PRURITUS (Red, itchy sore swollen injection site bump), VACCINATION SITE SWELLING (Red, itchy sore swollen injection site bump) and VACCINATION SITE PAIN (Red, itchy sore swollen injection site bump). At the time of the report, VACCINATION SITE ERYTHEMA (Red, itchy sore swollen injection site bump), VACCINATION SITE PRURITUS (Red, itchy sore swollen injection site bump), VACCINATION SITE SWELLING (Red, itchy sore swollen injection site bump) and VACCINATION SITE PAIN (Red, itchy sore swollen injection site bump) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment included over the counter topical antibiotic ointment.
Fever, peaking at 99.8 but averaging 99.5, for 36 hours. General malaise, fatigue, and soreness for 36 hours. Pain at injection site, moreso than 1st injection.
1ST DAY PATIENT HAD HIVES AND WAS TIRED TOOK BENADRYL 2ND DAY WENT TO WALK IN CLINIC AND GOT A CORTISONE SHOT 3RD DAY HIVES IN MOUTH AND DOWN THROAT TAKING PREDNISONE, A STEROID OINT, BENADRYL  EVERY 4 HOURS AND PEPCID AC
Patient said she began having symptoms 2 AM on December 1. She described the injection site as "on fire" red and swollen she said she was going to call her doctor. Pt. saw Dr. he didn't know if she was having a reaction or an infection, but prescribed cephalexin.
Information received on 10 November 2009 from another manufacturer (report number WAES 0910USA02799). "Information has been received from an office manager concerning a 57 day old male patient with no known drug reactions/allergies or pertinent medical history who on 07-OCT-2009 was orally vaccinated with his first dose of ROTATEQ (Lot # 663903/0088Y). There was no concomitant medication. The office manager mentioned that on 07-OCT-2009, the patient received ROTATEQ and developed diarrhea. On 14-OCT-2009 the patient sought medical attention by an office visit and the physician wrote in her office notes "patient had been stooling for 6-7 days, stools greenish at times, and a few drops of blood noted. Child has been acting well at home". No lab tests were performed. It was reported that when the child was seen the frequency of the stools had begun to resolve. The physician prescribed "baby acidophilus" and the mother was told to call if he did not improve. It was noted that the office had not received any additional calls from the mother. At the time of the report, the patient had recovered." "Follow-up information has been received from the office manager via telephone call regarding the patient who on 07-OCT-2009 was vaccinated with ROTATEQ also received PENTACEL (Lot # C3385AA), PREVNAR (Lot # D575886) and hepatitis B virus vaccine (unspecified) (Manufacturer Unknown) (Lot # 1102Y). The office manager reported that the patient did not experience hematochezia, rather there were a few drops of blood from an anal fissure noted at the 14-OCT-2009 office visit and Neosporin was ordered as treatment. Upon internal review, a few drops of blood in the stool was determined to be an other important medical event. Additional information is not expected."
Patient was hospitalized due to multiple blood clots, including jugular, brachial, and others. Patient was hospitalized for treatment on 4/10/21 and is still there.
3/11/2021 COVID-19 Positive Breakthrough Case>14- Days Post Vaccination Series Completion Narrative:
Got the vaccine still had a small patch of shingles/Suspected vaccination failure; Got the vaccine still had a small patch of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of Suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date,unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant)and shingles.On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.  It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and still had a small patch of shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Pt c/o tingling , swelling left side of mouth, sharp left arm pain, heart racing. RN could not visualize swelling of lips/tongue. Heart rate 70's and regular. 25 PO Benadryl given. EMS notified to eval pt. EMS directed pt needs ER eval. Pt declined.
Post vax, the pt developed a 46.5 cm area of induration and redness on left thigh at site of DTAP injection. A 2/5 cm area of redness on right thigh at site of HIB injection.
Information has been received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapy were unknown. On 03-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot# M024673, expiration date 17-NOV-2017, dose unknown) intramuscularly. On an unknown date in September 2016, after the administration, the patient experienced extreme pain at the injection site with inability to lift the affected arm, and also experienced fever of 102 Fahrenheit degree (F). No lab diagnosis was performed. The pain and fever resolved in 1 days without requiring treatment. The outcome of inability to lift the affected arm was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. The pharmacist was requesting a lot check of lot # M024673. This is one of several reports received from the same reporter. Additional information has been requested.
Hyper skin sensitivity approx 9 hours after injection. No bumps or rash present. Manageable pain all over the body caused by stimuli that do not normally cause pain (ie clothing)
Received his second dose Pfizer (LOT#: EW0172 EXP: 8/2021) at 0956 on 4/23/21. Patient alerted EMT. Patient stated that he was feeling nauseous. EMT provided patient with an emesis bag. EMT took patients vitals at 1000. BP: 160/110, pulse: 99, O2: 99%. EMT alerted PHN about patient. PHN asked patient if he had eaten anything that morning. Patient stated that he had not eaten anything. PHN gave patient a bag of pretzels and a bottle water. Patient was asked to stay an extra 30 minutes for observation. EMT retook vital signs at 1030. BP: 140/90, pulse: 84, O2: 99%. Patient stated that he was feeling much better. Patient had completed observation time. Patient walked out of vaccination site with a steady gait at 1032.
Extreme nausea and headache followed by migraine headache. The nausea subsided with treatment using Nauzene (OTC chewable tablet). The migraine lasted 24 hours and was treated with sumatriptan (a Rx pill). Left arm is BRUISED still, 3 days after the injection. The pharmacist who gave me my booster was AWFUL!
ROTARIX/oral vaccine was administered IM. Pt developed watery diarrhea for 12 days. Afebrile. Fussy.
On Feb 23, 1999 female was exposed to her significant other who developed chicken pox but was misdiagnosed. On Feb 26, 1999 her significant other was seen by a dermatologist and this time dx with chickenpox. On Mar. 10, 1999 vaccinated, subsequently she developed a fever of 102F and rash with 12 lesions. She stated that the varicella rash started on her chest then spread everywhere, including her throat. Several weeks later, she developed severe shingles, a strange tremor, left sided pain and abdominal distension. She sought medical attention and was treated with famciclovir. The women denied having a culture of lesions taken.
Slight feeling of light headedness. By 9:30 pm pounding heart beat, a few skipped beats with an irregular pattern. I could feel my heart beat at the tips of my fingers when I touched something. This lasted for slightly over two hours.
Approximately 2 weeks after I got my 4th dose vaccination I contracted COVID-19 and had the following symptoms: Fatigue, Sore Throat, Headache, Diarrhea, Cough, Fever. I took Ibuprofen for my headache but it did not do much. My headache, sore throat, diarrhea and fever went away on 05/13/2022, but the other symptoms did not go away (cough, fatigue). I went to an urgent care on 05/24/2022 because I couldn't sleep at night because of the cough. I was prescribed with my usual Albuterol Inhaler, Prednisone, did an X-Ray to verify if I had Pneumonia and it was negative and Tessalon and Mucinex D. On 05/26/2022 my cough has not improved even with the medications prescribed so I decided to go to my Doctor and he did a Spirometry Test  was prescribed with Singulair and Levaquin and Medrol. As of today 06/03/2022 I am feeling so much better but still experiencing some Asthma issues.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 29-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number T000886, which has been verified to be valid, the expiration date was reported and validated as 29-MAY-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
Approx. 4h after vaccine pt awoke from nap with " grunting/abnormal breathing" -> parents called 911, transported to hospital ER. CXR/KUB normal. U/S obtained secondary to concern for intussusception -> U/S could not r/o intussusception therefore air enema ordered but was normal. MD felt pt had intussusception that cleared prior to therapeutic air enema.
Patient was given Janssen vaccine #1, not approved for age under 18.  No adverse affects experienced by patient at time of vaccination, nor following the injection.
pt recvd vax 9JUN92 & on 29JUN92 devel a rash over the anterior chest wall & a sinus infect; 21AUG92 pt exp fatigue & was out of work several days; dx Epstein-Barr Synd;
1st dose (3/26/21) - strong spasms at injection site off and on for three weeks, sore arm four weeks  2nd dose (4/23/21) - fever and nausea started 10 hours after injection. Fever lasted about 22 hours. Vomiting, severe nausea, fever, headache, chills, tiredness, inability to keep down food or water lasted until about 7:00 PM 4/24/21. Mild nausea and tiredness continued until the morning of 4/26/21.
stability report was sent by pfizer for urgent removal of product but pt has received shot on 10/7/22. revaccination is not indicated and patient notification is not required.
Fever , Swollen Lymph Nodes , Lymphadenopathy, muscle aches, nerve pain, skin sensitivity,
101.6 fever, body aches, chills night 1; 99.6 fever, mild body aches night 2; arm redness, itchiness and tenderness continued as of day 5