chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was diagnosed with progressive Guillain-Barre. Symptoms started on 11/11 with sensation of numbness in the bottom of his feet. On 11/12, the patient reports progressing sensation of numbness to include his entire feet and legs below the level of the knee. He describes the numbness as similar to when "your feet fall asleep," though persisting in duration. On 11/13, the patient had an episode of emesis after experiencing difficulty swallowing. He reports sensation of food getting stuck in his throat when swallowing. He also reports sensation of tongue numbness that he describes as a "cold" sensation. The patient reports having fallen this morning in his bathroom after losing balance. He describes losing control over his lower extremities. Dad reports the patient not being able to stand from a laying position this afternoon, and had to be carried to the car in transporting to the ED. The patient denies recent illness, nasal congestion, cough or fever. He does endorse a headache that he describes as dull and aching sensation in the frontal region without radiation of pain elsewhere. He reports a vague aching sensation in his low back that is not made worse with positional changes. He also reports sensation of incomplete voiding with urination. He describes sensation of difficulty in taking a deep breath though denies shortness of breath. The patient has a history of stuttering and feels as though his stutter has gotten worse in the past few days. He denies recent rash or skin changes. He denies joint pain or aching sensation in his extremities. The patient had his influenza vaccination on 11/2. On 11/15 his symptoms worsened and had a harder time speaking with increasing lower extremity numbness. IVIG 1g/kg (80g) IV q24h was initiated on 11/15. He was intubated on the AM of 11/16 for respiratory failure.
H/O ALTE with apnea, both eyes rolled back & lip smacking (possible seizure). Required CPR x 2. Exam are benign. Admitted for investigation.
I was fine until Sunday. I started to feel like I had heartburn; chest pain in general. It isn't something that happens to me. I took some meds, but it gradually got worse. When I got home, my heart rate was all over the place. I went to the ER and they diagnosed me with general chest pain. I was given meds and discharged. After that, I was fine.
This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient did not have any relevant medical history or drug reactions/ allergies. The patient was not taking any concomitant medication at the time of this report. On 01-DEC-2016, the patient was vaccinated with ZOSTAVAX lot # M032638, expiration date: 30-JUN-2017, subcutaneous for prophylaxis (dose was not provided). On approximately 05-JAN-2017 reported as "about 5 weeks after vaccination",  the patient developed "itchy raised bumps at the nape of her neck", a "raised line" at the nape of her neck and "itchy bumps beneath her breast". It was reported that the patient used hydrocortisone cream (unspecified strength) on unknown dates. The patient changed her shampoo once during that time. It was also noted that the rash was "not symmetrical". At the time of this report, the outcome the events was reported as recovering. The reporter did not assess the relationship between ZOSTAVAX and the events. Additional information has been requested.
Hive like area above injection site, semi-circle over right shoulder from back to front toward arm pit.
No adverse events were noted. This report is being submitted due to the administration error of vaccinating a 12-year-old while the vaccine only goes as low as 16 years old right now.
Received vaccine on 5/29/01. On 6/1/01, developed urticarial reaction around injection site, 1cm diameter around injection site clear eryth raised area on rectangular pattern 4cm x 3cm on lateral aspect 3cm x 3cm medial.
PATENT STATES THAT SHE HAD CHILL, SWEAT, FEVER AND FLU LIKE SYMPTOMS FOR TWO DAYS.
Patient received immunization on 4/30/18 at approximately 4:30pm. On 5/1/18 she called the pharmacy at approximately 5:30pm to report her arm was red and swollen around the injection site and that it had spread down her arm toward her elbow. We discussed her putting ice on it which she was going to do. I suggested an otc antihistamine but she declined the use of that. I advised her to seek medical attention if the swelling/redness worsened or continued to spread.
This case was reported by a healthcare professional and described the occurrence of bicep tendonitis in a 50-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis.  On 26 October 2007 the subject received unspecified dose of Flulaval at 0.5 ml in the left arm.  At an unspecified time (shortly) after vaccination with Flulaval, the subject experienced bicep tendonitis.  At the time of reporting the event was unresolved.  Follow-up information received on 11 January 2008 indicated that bicep tendonitis began on the same day that Flulaval was administered to the subject, 26 October 2007.  At the time of follow-up, the outcome of the event was unknown, but had previously been unresolved.  In the reporter's opinion, the event was not related to treatment with Flulaval.
Pt. sat down at the nurses station, received the H1N1 injection and upon standing, immediately fainted, falling backwards onto a hardwood floor. He came to approx 20 seconds after fainting. He was pale and hands were clammy, BP taken. He was observed for 30 min. Mom present. No hematoma noted. Neuro checks is normal pupils reactive at approx 3.
Information has been received from a consumer concerning her approximately 9-year-old daughter with asthma and no allergies who in approximately 1997 or 1998 was vaccinated with a dose of Recombivax HB. There was no concomitant medication. Following vaccination, in 1997 or 1998, the patient developed hives and her asthma was activated. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved. No further information is available.
I had a heart attack on 04/25/21. I had open heart surgery on 04/26/21. I was hospitalized at local Hospital for ten days.
4NOV92 pt was vaxed w/pnu-imune; 2 days later pt exp edema & pain @ inject site, fever of 102, achiness; prior pneumococcal vax 4-5 yrs prior;
Right arm injection site painful and swollen, redness expanding 3+ inches in each direction from injection site.
itching/ feels like poison ivy; really bad headache/ still getting headaches; sore arm/ it is still sore to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm/ it is still sore to the touch), PRURITUS (itching/ feels like poison ivy) and HEADACHE (really bad headache/ still getting headaches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore arm/ it is still sore to the touch) and HEADACHE (really bad headache/ still getting headaches). On 27-Sep-2021, the patient experienced PRURITUS (itching/ feels like poison ivy). The patient was treated with ACETYLSALICYLIC ACID, BUTALBITAL, CAFFEINE (BUTALBITAL, ASPIRIN AND CAFFEINE) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm/ it is still sore to the touch), PRURITUS (itching/ feels like poison ivy) and HEADACHE (really bad headache/ still getting headaches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-337858 (Patient Link).
Received vaccinations at Health Department at 10:00 am on 10/23/03.  Began having left shoulder pain at 8:00 pm on 10/23/03, radiating down left arm.  Pain became worse during the night and the next day was unable to move arm. Noted swelling and redness of left shoulder.  went to doctor at 12:45 pm on 10/24/03.  Was sent to orthopedic surgeon and the MD drew fluid off left shoulder.  Was admitted to hospital on 10/24/03. Aspirated more fluid from left shoulder on 10/26/03.
At 8 weeks gestation baby had a heartbeat and was healthy. Got the vaccine two days later. Next sonogram visit at 9.5 weeks, no heartbeat detected.
Dizziness, Headache, Arthralgia, Fever,  Chills, Fatigue, Injection site pain  Narrative:
16DEC92 mom called stated pt would scream out now & then, then would start grunting; pt given APAP; pt suddendly became limp & started moaning; pt admitted to hosp 17DEC92 w/t105.3;
arm soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced MYALGIA (arm soreness). At the time of the report, MYALGIA (arm soreness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. No treatment details ere provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt slid down moms legs; nurse laid pt on floor eyes open responded to RN's question,pale scared look;
Left leg severely swelled up the day before I went to medical center to be admitted to ER, after bloodwork, ultrasound, CATscan and echo-cardiogram I was told that I had a DVT in left leg from knee to groin and 16 blood clots around lungs, was in hospital for 2 days while they thinned down blood with Heperin until they could figure out the oral dosage needed to stop anymore clotting and was told no strenuous or excessive straining until further notice. Went back for follow-up on 12/6/21 and was told it will take anywhere from 6-12 months for my condition to get better with blood thinner. Also was told I could return to work with light duty restrictions and when I told my employer they layed me off, filing for LTD that I had paid for thru employer.
heart has a lot of problems,; is like somebody is siting in his chest,; has troubling breathing.; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart has a lot of problems,), CHEST DISCOMFORT (is like somebody is siting in his chest,) and DYSPNOEA (has troubling breathing.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced CARDIAC DISORDER (heart has a lot of problems,), CHEST DISCOMFORT (is like somebody is siting in his chest,) and DYSPNOEA (has troubling breathing.). At the time of the report, CARDIAC DISORDER (heart has a lot of problems,), CHEST DISCOMFORT (is like somebody is siting in his chest,) and DYSPNOEA (has troubling breathing.) had not resolved.            No Concomitant product use was reported.  The patient received the Moderna booster and since the booster, the patient's heart had a lot of problems, and was like somebody was sitting in their chest, and had troubling breathing. Reportedly, it had been 10 days since the Booster.  No treatment information was provided.
This spontaneous report was received from the patient's wife concerning her 81 years old husband. The patient's concurrent conditions, medical history and concomitant medications were not provided. In approximately 2008 (reported as "about 6 years ago"), the patient was vaccinated with the first dose of ZOSTAVAX (lot #, dose and route were not provided). The reporter said that the patient then got a "booster" (second shot of the singles) few years later (on an unspecified date) (lot #, expiration date, dose and route were not provided). The reporter stated that her husband developed shingles a week ago (or approximately 12-AUG-2016), (unspecified location)l. The patient sought medical attention since he went to the doctor and was prescribed penicillin 3 times a day. It was also mentioned that "now" he had shingles in his head and nose. PQC was not involved. At the time of the reporting, the outcome of shingles was reported as not recovered. Additional information is not expected since the reporter did not give a permission to contact his physician.
patient received Moderna first dose and errantly received 2nd dose pfizer.  There were no adverse effects reported.  There was a documentation error made on the vaccine card at the first dose
Fever started same evening and continued into next day. Pt had viral URI symptoms prior to vaccination but no fever.
I was fine afterwards,  sore arm About  10 pm my Crohn's disease kicked in, stomach pain,  diarrhea,  nausea... Continued all day Saturday into Sunday
I experience breast tenderness and eventually soreness approximately 28 hours after my vaccination.  Rest, ice, and motrin helped with the symptoms.  Approximately 10 hours after the initial breast pain, the pain/tenderness went away.
No voice; Felt like I was catching a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt like I was catching a cold) and APHONIA (No voice) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced NASOPHARYNGITIS (Felt like I was catching a cold). On 07-Sep-2021, the patient experienced APHONIA (No voice). At the time of the report, NASOPHARYNGITIS (Felt like I was catching a cold) and APHONIA (No voice) outcome was unknown.            Concomitant medications were not provided.  Treatment medication was not provided.   Patient thought the third dose was booster and got vaccinated was told that third dose are for immunosuppressed.
One week after vaccine noticed fatigue, malaise, redness, swelling, itching and mild pain and injection site.
Swelling; Headache; Sore Injection Site; Vomiting; Body Aches; Joint pain; Fever 100.9F; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting) and MYALGIA (Body Aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was provided by the reporter.    On 10-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 10-Feb-2021, the patient experienced SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting), MYALGIA (Body Aches), ARTHRALGIA (Joint pain), PYREXIA (Fever 100.9F) and NAUSEA (Nausea). On 13-Feb-2021, SWELLING (Swelling), HEADACHE (Headache), VACCINATION SITE PAIN (Sore Injection Site), VOMITING (Vomiting), PYREXIA (Fever 100.9F) and NAUSEA (Nausea) had resolved. On 16-Feb-2021, MYALGIA (Body Aches) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100.9 (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-1273 with respect to events was not applicable.
2.5 cm diameter subcutaneous nodule lasting approximately 3 1/2 weeks; accompanying 9-10 cm diameter patch of swelling/redness lasting approximately 1 week on left arm at injection site.
Enhanced tinnitus in right ear, onset of positional vertigo that affects my work, and a chronic vertigo ailment since diagnosed as Meniere's Disease (incurable), and Bell's Palsy which manifested itself on October 5, 2021.
Fever of 101F after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever of 101F after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PYREXIA (Fever of 101F after first dose). In 2021, PYREXIA (Fever of 101F after first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (High) Fever of 101 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported  Treatment information was not reported   This case was linked to MOD-2021-319554, MOD-2021-319555 (Patient Link).
It was unknown by staff at the time of incident that patient is only 16, not the eligible age of 18.
8 hours after second dose pain started in right leg, pulling/tugging feeling. 24 hours after second dose did not have any pain and/or issues. 36 hours after second dose pain began in right leg and right arm. Opposite side from where first and second dose were administered. 7-10 days after second dose pain was in both legs and both arms.  No visual bruising or swelling.
This spontaneous report as received from a physician via a company representative refers to a 68 year old unpregnant female patient. Pertinent medical history and drug reactions/allergies were not reported. Approximately in 2012 when the patient was 65 years old (reported as approximately 3 to 4 years ago), the patient was vaccinated with 1 shot of ZOSTAVAX (dose, lot# and expiration date were not reported) subcutaneously. Concomitant drug was not reported. Around 31-MAY-2016 (reported as about 3 days ago), the patient visited the physician with shingles which had happened since an unknown date. It was a traditional case with blistering and redness on a unilateral dermatome. No lab diagnostics studies were performed. The patient was prescribed unspecified antivirals and painkillers and she was recovering. The causality was not reported. Additional information has been requested.
Developed acute respiratory failure; COVID like pneumonia/ tested negative 5 times for COVID; Right lower extremity DVT; she also developed small PE; This is a spontaneous report from a contactable physician. A 73-year-old male patient received bnt162b2 (unspecified trade name), dose 1 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included Chronic atrial fibrillation, chronic obstructive pulmonary disease, cerebrovascular accident with residual weakness. The patient's concomitant medications were not reported. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took erythromycin and experienced allergies. After patient initially had the COVID vaccine at the END of February she developed acute respiratory failure due to COVID like pneumonia, tested negative 5 times for COVID. She also developed small PE and right lower extremity DVT. Treatment of Enoxiparin received. The adverse event result in emergency room/department or urgent care visit, and Prolongation of existing hospitalization (vaccine received during existing hospitalization). Number of days in hospitalization was 4. The outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a causal association between the reported events and Bnt162b2 cannot be fully excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.,Linked Report(s) : 2021532932 same patient/drug, different dose/AE
itching all over; Mainly itching her upper body; Non stop itching the last four days; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over), PRURITUS (Mainly itching her upper body) and PRURITUS (Non stop itching the last four days) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (itching all over), PRURITUS (Mainly itching her upper body) and PRURITUS (Non stop itching the last four days). At the time of the report, PRURITUS (itching all over), PRURITUS (Mainly itching her upper body) and PRURITUS (Non stop itching the last four days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Different itching cream.
2 inches below inj site developed a demarcated area of erythema;pt was placed on pred & DPH & marked improvement noted 3rd day;
Pt went to urgent care yest. Her arm was red 5 inches x 4 inches warm to touch painful - like a burn with flu like symptoms. She was told to take BENADRYL and TYLENOL, ice to the area it is better now but not resolved.