chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a Physician  on 27 October 2015. This case involves a 30 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, route and site of administration not reported),on an unspecified date. The patient's illness at time of vaccination was none. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced pain in her joint, a heavy feeling in her chest and local allergic reaction at the site. Lab data was reported as none at that time. It was reported that the physician was planning to give some steroids and pain medication as corrective treatments. The patient required ER/doctor visit. The outcome of the events was not recovered. List of documents held by sender: none.
Eight days after the dose my arm swelled up so big and I ended up taking a ruler to measure it. It was 10cm x 7cm then it grew to 15cm by the 3/13/2021. It lasted for about a week.
pt recvd vax 11NOV93 & 13NOV93 devel swelling of the lips & face, raised, non pruritic rash, nausea, abdo pain, & severe h/a; seen in ER treated w/Toradol & Solu-Medrol; 16NOV92 devel swelling of the throat & tongue; dx of vasculitis;
I seem to be getting a new addition every day. Day 1 sore arm and chills Day2 neuralgia - on right headache, jaw pain, numbness in eye and ear and face. Heavy,wheezines in right lung. A total of 6 Tylenol eased pain. Day 3. Tremors. Body feels as if it's vibrating inside. Ongoing
Red rash on left leg at 5:15 pm day of vaccine. Daily since: vertigo, all over body itch and red bumps appear after itch begins. No precursor to itch qnd bumps go away shortly after the itch stops or moves to another site. Have tried benadryl liquid, pills a d lotion. Lotion offers around 10 minutes of relief. Other routes do not offer any relief. Worst areas of itch: behind and sides of knees, back of thighs, calves, shins, gluteus, lower rear neck, forearms, stomach, sternum, bilateral axillary qnd hands.
Child received IPV/DTaP/MMR in clinic. Developed "breathing problems" approximately 45 minutes after vaccines (while on bus). Taken to ER where oxygen was administered - no additional interventions reported - then discharged home. No repeat events.
This patient is a 12 yo male who was admitted to the Pediatrics Inpatient floor for abdominal pain and vomiting on 9/1. He presented abdominal pain around 9 pm last night (8/31), initially pain was described as sharp, located on both lower quadrants intensity 8/10, non radiating; and posterior pain localized on LRQ intensity 10/10 and accompanied with non-bilious non-bloody vomit in 1 occasion, as well as decreased appetite. He took pain medication without improvement, and as such presented to the ED at 3 am on 9/1. He denies diarrhea, sore throat, headache, chest pain, fever or any other symptoms.  At his arrival to the ED, he was febrile (T 100.5 F) and in distress due to pain. His abdomen was tender in the right lower quadrant, with guarding. Remainder of his examination was normal.   Tests performed at ED: CBC: WBC count 13.5, Hemoglobin 12.3, Hematocrit 37.6, Platelet count 276    BMP: Na+ 141, K+ 3.9, HCO3-, 24, Cl- 104, BUN/Creatinine 11/0.5, Anion Gap 13 Lipase: 15. Albumin 4.5. Bilirubin Total 0.2/Direct <0.2.  Alkaline phosphatase  299/AST 19/ALT 11 C-Reactive Protein 5.03 ABO: O Positive, Antibodies negative. RSV: Negative Influenza A/B: negative COVID: Pending  PT: 12.7. CT SCAN Abdomen: Appendicitis without perforation or abscess.   With these results, a consult was done to surgery and after evaluation they decided to perform a laparoscopic appendectomy. Patient was admitted to the Pediatric Inpatient Floor for pre-operative care.  NPO and IV fluids were started.   At his arrival to the floor (8:00 AM on 9/1), the patient was well appearing and was not in any acute distress. Abdomen was mildly distended, no palpable mass, tenderness at palpation on RLQ, normal appearance and normal bowel sounds. Remainder of his examination was normal. Patient was given IV fluids (Dextrose 5% + 0.9% Saline Infusion 1000 mL IV drip), Famotidine 20 mg q12h, and Cefoxitin IV 1500 mg q6 hours.   Vitals on admission: Temperature (degree F): 98.4 degrees F., Temperature (degree C): 36.8 degrees C, Pulse bpm: 95 bpm , Resp: 18 , BP Systolic: 112, BP Diastolic: 62,  SPO2: 100 % Patient was taken to the operating room at approximately 3:00 PM on 9/1. He underwent laparoscopic appendectomy. The procedure was uncomplicated and the patient remained on the pediatric floor for recovery. He was discharged home on 9/2 with ibuprofen 400 mg as needed for pain management and will be followed up by the pediatric surgery team to ensure adequate post-op recovery.
8 days p/vax pt had fever of 102.8 R, shaking & shivering, staring into space; lasted 2 1/2 days; no medical attention; mom gave APAP for fever only;
Had redness to face,  no itching or flushing. Redness is mild. Cleared by EMS.
6 x 8 cm erythematous, red, warm, pruritic, indurated area over entire left deltoid region.
2 weeks after second dose patient was freezing, tired, weak, racing heart, nauseated, dizzy, achy joints.  3 weeks after second dose, patient had swelling of hands and feet and had a severe full body rash that lasted about 10 days. She said her lips felt like cracked leather.
1/17/21: Woke up with red and raised rash all over back, chest, stomach, scalp, ears. No known fever, chills, nausea, vomiting. Extremely itchy. 1/17/21: Virtual visit with doctor. Prescribed 50mg prednisone and steroid cream. 1/18/21: Virtual visit with doctor. Minimal change in rash. Second opinion. 1/19/21: UC visit due to no relief from steroids or cream. 1/21/21: Finally felt improvement in itchiness and redness. 1/23/21: Noticed new appearance of rash on arms and legs. 1/24/21: Full rash on arms and legs. Again, no fever, chills, nausea, vomiting. Extreme itchiness and raised, red appearance. Still had continued itchiness around pelvis, lower back, armpit/side chest. ER visit since rash went onto palms and soles of feet. 1/25/21: Dermatology visit, biopsy taken. Was recommended by dermatologist and primary care doctor to report rash to VAERS due to proximity to first vaccination. 1/26/21: Slight relief of itchiness with use of Eucerin Skin Calming Cream and ice packs. Rash still present on arms/legs, lower back, pelvis, armpit/side of chest.
Shingrix + Late 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix + Late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 19 Jul 2023: The physician was  wondering if a patient had started the 1 shot series and forgot to get the second and it had been 5 years. The reporter asked if the patient had to restart the entire series? Till the time of reporting the patient did not receive 2nd dose of shingrix which led to incomplete course of vaccination.
Large lump on right delt- Elbow to shoulder Fever Bodyaches Rash on Face and Chest
got the shot and so far she has gotten the shingles two times since/ Suspected Vaccination failure; got the shot and so far she has gotten the shingles two times since; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's parent. The age at vaccination was not reported. The reporter commented not to bother to get the shot, as the patient got the shot and got shingles 2 times till the reporting date. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Patient was at his baseline health until after receiving his second SARS-CoV-2 vaccine (Pfizer) on Saturday, September 18th.  First developed symptoms of mild, diffuse headache, subjective fever and fatigue on Sunday, September 19th that progressed to some muscle aches into early last week.  However, on Wednesday, September 22nd, he developed substernal chest discomfort/pain associated with notably reduced functional capacity, SOB with activity, and worsening fatigue.  Pain was sudden described as sudden-onset while sitting in class, persisted for approximately 15 minutes and self-resolved.  Chest pain returned later that day and worsening by physical activity and coughing, being intermittently recurring until initial provider evaluation.  No associated rhinorrhea, congestion, conjunctivitis, recurrent fevers, rash, N/V, or changes in bowel/bladder habitus.   Evaluated by Peds on 9/24/21.  Vitals reassuring and physical examination unrevealing. Lab workup without evidence of WBC/CRP/ESR abnormalities and CMP unrevealing.  However, troponin elevated and EKG changes concerning initially for non-specific ST-T wave changes, but eventually referred to ED for further evaluation, where patient was noted to have significant ST-depression concerning for possible cardiac sequelae of underlying, unknown pathology. During admission, chest pain has improved and current being followed by Cardiology team.  Relevant labs: SARS-CoV-2 NP screen negative, troponin elevated (8,000+) but downtrending, normal pBNP, normal D-dimer, elevated LDH (250+), normal ferritin, negative respiratory pathogen panel, and only modest elevation of repeat CRP 0.55 mg/dL. CXR without acute abnormalities. Echocardiogram from 9/25/21 unrevealing .
By approximately 4pm the day I received the vaccine, I felt very tired. My arm the injection site was very sore, but there was no redness there. The next day, 9/2921, the fatigue was overwhelming-I felt like I had been hit by a bus. The pain in my arm was not just at the injection site, but went down my entire arm. I had chills (but no fever), no appetite, and palpitations off and on. I was not able to work on 9/29/21. On 9/30/21, I returned to work and all symptoms had resolved except for the soreness in my arm. By 10/2/21 the soreness in my arm resolved, however, I had developed an ulcer? in my mouth, inside of my upper lip. By 10/3/21, I had that ulcer as well as 3 places on the inside of my lower lip that weren't ulcerated, but had circular areas of skin peeling off -on the inside of my lower lip, not on the lip itself. As of 10/4/21, these areas are still present and are tender.
Proquad that underwent a temperature excursion was administered; Information has been received from the registered medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.   On 22-MAR-2021, the patient received a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 1 dosage form, lot # S030205, expiration date on 25-MAR-2021, that underwent a temperature excursion. The vaccine was stored on -15 degrees Celsius to -10 degrees Celsius (-11.53 degrees Celsius) for 10 hours. The call was because a data logger. According to the reporter, it was unable to clarify if symptoms were experienced by the patient.
Swollen, hot , red lump on arm. Ran to office and felt breathless. Was told to take Benadryl for 4-6 hrs and felt better in 24 hrs.
The next morning  after receiving my vaccine I woke up at 11:00am with a bad headache. It seemed to be over in about 24 hours. I took ibuprofen.
Itching at injection site, no redness or swelling; @ approx. 2 pm, developed warm red rash on right cheek, right side of neck and under chin; offered Benadryl IM (subject was given vaccine as part of employee vaccination program and is an LPN) but refused Benadryl IM and took her own Benadryl 25 mg tab po @ approx. 3:30 pm; at approx 5:30pm, noticed one hive on upper right chest; the following day, woke with red warm rash on both upper arms, upper chest, entire neck and face, and with orbital edema and called off work.
Syncope episode after receiving vaccinations, patient reports having dull hearing that eventually returned to normal after laying down with feet up.
Skipped menstrual cycle during the month of March; This is a spontaneous report from a contactable healthcare professional, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 12Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization. The patient later received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation  Medical history included allergy to dairy and the allergic reaction was worst with non-organic dairy products. Concomitant medications were unknown. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021 the patient skipped menstrual cycle during the month of March. Her expected due date for the month of March was the 25Mar2021, 2 weeks after her first vaccine date. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event patient skipped menstrual cycle during the month of March was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.   Follow-Up (04Aug2021) This follow-up report is being submitted to amend previously reported information: Dose 2 was removed from suspect dose regimen tab. Dose 2 start date updated in narrative. Reporter's first name added and last name leave blank.
Started with pain at injection site then headache in evening. The following morning, continued headaches, mild elevation in temp. (98.8) and tiredness. By the afternoon the day after the injection: fever 99.8F, headache, sore throat, continued tiredness, weepiness.
Pt did well with immunizations initially but as he stood with mom at scheduling desk he became light-headed and fainted. He sustained mild abrasion to the chin and both knees but mom was able to partially catch him as he went down. Legs were elevated and he was immediately aware of his surroundings. Felt faint and hot but resolved quickly. Looked pale, HR up to 100s but slowed to 80s within a couple of minutes as color also returned. He sat up on floor and had no pain to head, neck or elsewhere. He was able to get up into chair and sat for 5 minutes and drank some water. Denied any further dizziness.
Tiny Blisters on belly , breast and back; Felt itchy on all around her shoulders and neck; Fever; Chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (Tiny Blisters on belly , breast and back), PRURITUS (Felt itchy on all around her shoulders and neck), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032L20A) for COVID-19 vaccination.     Patient's medical history included No Adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (headache). On 05-Mar-2021, the patient experienced PRURITUS (Felt itchy on all around her shoulders and neck). On 08-Mar-2021, the patient experienced BLISTER (Tiny Blisters on belly , breast and back). The patient was treated with CORTISONE at an unspecified dose and frequency. On 04-Mar-2021, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (headache) had resolved. At the time of the report, BLISTER (Tiny Blisters on belly , breast and back) and PRURITUS (Felt itchy on all around her shoulders and neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
also had a very hoarse voice; throat starting feeling a little tight; This is a spontaneous report from a contactable Other HCP (patient). A 24-year-old female patient received first dose of BNT162B2 (Lot number: EK9231), intramuscular on 31Dec2020 15:45 at single dose in the left arm for COVID-19 immunization. Medical history included chronic sinusitis from an unknown date and seasonal allergies from an unknown date. Concomitant medication included azithromycin. The patient previously took penicillin and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that within 10 minutes of receiving the vaccine on 31Dec2020, the patient's throat started feeling a little tight. However, she did not have trouble breathing. The feeling continued for the next 3 hours. She also had a very hoarse voice. The ER suggested that she will be seen. They did an exam and gave her Benadryl which completely resolved her symptoms. The events resulted in emergency room/department or urgent care.
On 10/27/22 patient noticed that her right arm was swollen and she started have neck pain and stiffness. Her symptoms were associated with a sore throat and head pressure. The swelling in her right arm resolved when she presented to clinic on 10/31/22,. She continued to have neck pain that is almost unbearable. Neck pain was a 10/10 on a pain scale. She was started on a Robaxin 500 mg, TID and she stated that her neck pain has improved, however, as of 11/5/22, she continues to endorse neck and shoulder pain.
About 3 hours after the 1st dose of the vaccine, I was dizzy and lightheaded.  This continued for 24 hours. I then had a fever of 101.5 for about 30 hours. My arm is extremely sore.  I now have a splitting headache.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 23-JUN-2015, the patient was vaccinated with both VARIVAX (Merck) subcutaneously (lot #, expiration date, dose and anatomical location were not reported). No product confusion was specified. No known adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been information.
Lymph node disorder; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node disorder) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph node disorder). At the time of the report, LYMPHADENOPATHY (Lymph node disorder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication reported.   It was reported that Humira was not effective.  The reporter's causality for the event(s) of issue with lymph nodes by ear and Humira was not effective with Humira(adalimumab) was no reasonable possibility.  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.
Information has been received from a physician concerning a 51 year old female with depression, diabetes, neuropathy peripheral, an allergy to BEXTRA and hyperlipidemia and a history of urinary tract infection treated with MACROBID, who on 05-JUN-2008 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Oka/Merck) (Lot # 659760/0159X). Concomitant therapy included simvastatin, NASACORT, metformin, fexofenadine hydrochloride (+) ALLEGRA-D, LANTUS, aspirin, FLEXERIL, LYRICA, RHINOCORT, oxycodone, KLONOPIN, glipizide, NEURONTIN, CYMBALTA, VIAGRA and ZYRTEC. The physician reported that a patient who received ZOSTAVAX (Oka/Merck), experienced redness and swelling at the site of injection a few hours after being vaccinated on 05-JUN-2008. On 06-JUN-2008, patient developed severe migraines and took two IMITREX 100 mg tablets and the migraine went away. Patient also experienced a decreased in appetite. On 07-JUN-2008, the patient developed blisters with puss periorally. Patient visited the physician on 09-JUN-2008 and upon examination the physician stated the blisters looked yellow, were shrinking, and were slightly raised. Patient also experienced tongue swelling and developed a cold sore on her gum in the back. Patient was treated with prednisone and cetrizine HCl. Unspecified medial attention was sought. At the time of the report, the patient had not recovered from the AEs. There was no product quality complaint. Additional information has been requested.