chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had a hard knot with erythema from day 2 after receiving MMR on back of RA. Treated with cold compresses and took Advil for pain. AT 3 1/2 weeks was encouraged to seek medical help due to no resolution. Pt had 50mm indurated area with surrounding erythema. Was seen and prescribed Cefprozil 500 mg and Lortab for pain.
Patient started having a headache and felt a little nauseous. "throat feels tight?" but no SOB, or palpitations.  VS at 9:25am 114/78 P70 o2sat 98.  Only had coffee this morning.  VS repeated at 9:35am 106/66 P66 o2sat 99. Patient felt no different, but feels safe to leave and drive to work.  Still no trouble breathing no rash. VS and gave her water and juice and f/up with PCP or if any adverse effects call 911
1st dose administered to patient from expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1st dose administered to patient from expired vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, a nurse had given 10 doses between 8AM - 12 PM on 01/Sep/2021 from a Moderna vial that expired she stated that it was a new vial that had never been opened. It had been moved into the refrigerator on 25/Aug/2021 (8 days prior).    Concomitant product use was not provided.  Treatment product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: The significant followup was received on 7-SEP-2021 and contains Patient details, Vaccine facility information and Vaccine information.
Numbness and paresthesia around the lips and chin area. Metallic taste in mouth. Tip of Tongue feels as though I had something that was scolding hot, a mild sensation. It First happened a half hour after having the Moderna Vaccine Starting at 12:00 pm today 1/8/2021. Subsided approximately about a hour or so lat. Returning  back around 6:30 pm this evening  with mild numbness to my lips only and the same sensation to the tip of my tongue. No swelling and still have taste.
When I returned home from the urgent care my right arm was exceptionally painful. When I woke up two hours later I couldn't lift my arm and had to brace my wrist to keep from having tremendous pain. I called the urgent care facility and reported my trouble and was told to ice my arm and that it was a typical reaction. I have had four children without even tylenol- at all during or after my deliveries. The tremendous pain was constant and sharp and I assured the nurse that it was unlike any of the other (probably 7 or 8) other DTaP vaccines that I have had in the past. She said that I should return to the facility to be checked out. Since I was leaving the beach to return home I was never examined. My husband is a physical therapist and he spent the next day trying to keep some passive movement going to keep my shoulder from becoming stiff. I was completely unable to use my arm, lift, rotate, etc. in any capacity for three days. On the morning of the fourth day (today) I was finally able to begin moving my arm on my own, yet I still have pain.
Covid-19 breakthrough. 1st vaccine received on 04/07/2021. 58 y/o with PMHx of Kidney transplant, ESRD, HTN, HLD presents to ED with c/o neck pain since was hit with chair 9 days ago. Patient states was treated with steroids by PCP but swelling and pain has progressed. Room air sat 100%, afebrile, CXR normal. Patient on IV Abx and steroids.
Was sick less then two weeks after my vaccine; Runny nose; Congested; Bone ache; Tired; Cough; Difficult breathing not severe; Sore throat; Pain in front of the chest; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DYSPNOEA (Difficult breathing not severe), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Pain in front of the chest) and RHINORRHOEA (Runny nose) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (Advil) and Drug allergy (ibuprofen). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) and OXYMETAZOLINE HYDROCHLORIDE (ZICAM [OXYMETAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced CHEST PAIN (Pain in front of the chest). On 24-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 25-Apr-2021, the patient experienced COUGH (Cough), DYSPNOEA (Difficult breathing not severe), BONE PAIN (Bone ache) and FATIGUE (Tired). On 26-Apr-2021, the patient experienced RHINORRHOEA (Runny nose) and NASAL CONGESTION (Congested). On an unknown date, the patient experienced ILLNESS (Was sick less then two weeks after my vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and EMERGEN C at an unspecified dose and frequency. At the time of the report, COUGH (Cough), DYSPNOEA (Difficult breathing not severe), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Pain in front of the chest), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congested), BONE PAIN (Bone ache), ILLNESS (Was sick less then two weeks after my vaccine) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-090661 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Newevent were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090661:Case of son
TINNITUS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus. This report was non-serious.
Lower extremity myalgia; Right hip pain; Fever; This is a spontaneous report from a non-contactable physician. A 26-year-old male patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, lot number: EL324), intramuscular on 01Feb2021 07:00 at single dose for covid-19 immunisation. No other medical history, allergies to medications, food, or other products and concomitant medications were reported. Prior to vaccination the patient diagnosed with COVID-19 was unknown. The past medication included first dose of BNT162B2 (COVID 19, Pfizer, lot number: EK4176), intramuscular on 11Jan2021 07:00 at single dose for covid-19 immunisation. The patient experienced lower extremity myalgia, right hip pain and fever on 02Feb2021 07:00. The patient received acetaminophen as therapeutic measures of events. The outcome was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients (unknown age and gender). On an unknown date in 2013 (reported as past year), the patients were vaccinated with ZOSTAVAX (dose, lot number and route of administration were not reported). On an unknown date in 2013 (reported as past year), the patients experienced injection site reactions. The outcome of injection site reactions was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a LPN regarding a patient who on 08/15/1995 and 09/26/1995 was vaccinated with the first and second doses of varicella virus vaccine live. On 08/09/2000 laboratory evaluation revealed a lack of response. Medical attention was sought. No further information is available.
5cm x 6cm induration/wheal; red, itchy, achy, firm, warm and tender to touch. Patient presented to pharmacy, had tried cold compress with no benefit, advised to see physician.
Swollen gland in neck on same side as vaccination site. About 1 inch in diameter. Sore to touch. Does not hinder ability to breathe or swallow. Still swollen 9 days after receiving vaccine.
Discharge Provider: MD  Primary Care Provider :  MD    Admission Date: 7/12/2022 Discharge Date: 07/14/2022  Hospital Course: Patient is a 75 y/o female with PMH of  HFpEF, CKD3, s/p right nephrectomy, SS/RA/SLE, T2DM, CAD, and COPD (baseline 2L O2) admitted for respiratory failure.   She presented to the ED via EMS for altered mental status and SOB after taking both her daytime and nighttime medications (which are heavily sedating) in the morning. In the ED she was in respiratory distress and placed on 55L O2. Covid + and leukocytosis. CXR showed mild vascular congestion. In the hospital she was treated with prednisone and albuterol. Condition improved rapidly and she was weaned to her 2L baseline O2. CRP and WBC trended down. Discharged 7/14.
Soreness; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The age group of patient was not provided but captured as adult as per vaccine indication. The patient was vaccinated with 1st dose of Shingrix on past Monday afternoon of reporting day. After vaccination patient had soreness.
Severe right leg pain (patient required the use of an assistive device), headache. Evaluation is ongoing.
Received first dose Dec 20 with no symptoms.  Second dose received Jan 9 and ~12hours afterwards felt full body muscle aches and fatigue at which point I took Tylenol 500mg 4hrs apart twice with no relief. Went to sleep Jan 10 7AM until 4PM and woke up symptom free.
Acute onset anemia, depleted B12.  Symptoms were dizziness, fatigue, weakness and headache.  Symptoms started on 5/12/21.  Resulted in hospitalization, 2 blood transfusions and multiple tests (colonoscopy, EDG) to determine cause.  No cause ever determined.
Redness at vaccine site, headache, arm pain - all starting 36 hours after shot.
This spontaneous report was received from a pharmacist refers to patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent. On 17-AUG-2017, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017) for prophylaxis. Reporter informed that, there was temperature excursions for the ZOSTAVAX (Lot # M040146 and expiration date 26-DEC-2017) at a temperature of 15°F to 46°F and time frame 14 hours 30 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported.
Subject in pneumococcal vaccine trial, with severe COPD, died on 10/31/2008 of multiple drug intoxication. Vaccination took place on 3/13/2008. According to the physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request   3/12/09 Death certificate states COD as multiple drug intoxication.  SAE & ER medical records from study center reveal patient found asystolic w/o signs of trauma.  Patient was not on any know medications.
For no apparent reason other than the vaccine, my blood sugar increased from 122 before breakfast to 497 after lunch (and the appropriate basal for the food I ate). It remained high for approximately 12 hours despite numerous correction bonuses via my insulin pump. There were no ketones present. I think I've been using a blood glucose meter for 30 plus years and have NEVER tested this high.
AKI; IgA vasculitis; dleukocytoclastic vasculitis; Petechial rash; Hematuria; This is a spontaneous report from a contactable physician.   A 77-years-old male patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE);  intramuscular, administered in Arm Left on 23Feb2021 at 15:30 as SINGLE DOSE for covid-19 immunization.  Medical history included type 2 diabetes mellitus,  hypertension,  benign prostatic hyperplasia.  Past Drug Event included a 'Dulaglutide-Rash'. Concomitant medication(s) included metoprolol tartrate (METOPROLOL TARTRATE),  gabapentin (GABAPENTIN, ; insulin (INSULIN), metformin (METFORMIN), amlodipine (AMLODIPINE),  atorvastatin (ATORVASTATIN),  hctz (HCTZ),  alfuzosin (ALFUZOSIN),  triamcinolone (TRIAMCINOLONE), hydroxyzine (HYDROXYZINE),  sertraline (SERTRALINE). Historical vaccine includesBNT162B2, Dose 1, on 02-FEB-2021 at 15:30 intramuscular, administered in Arm Left.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 25Feb2021 the patient experienced petechial rash, hematuria and Acute kidney injury,  IgA vasculitis and dleukocytoclastic vasculitis. The clinical course is as follows patient presented to the Emergency Room with complaint  of acute onset of petechial rash, hematuria, Acute Kidney Injury 48 hours after the second dose of Pfizer vaccine. Urine microscopy showed rare dysmorphic RBC's and hence IgA vasculitis was suspected. Skin biopsy was done that showed dleukocytoclastic vasculitis thus confirming the diagnosis. The patient was hospitalized for four days for the events Treatment was given. The clinical outcome of the events was recovering. The patient underwent lab tests and procedures which included biopsy skin: dleukocytoclastic vasculitis on an unspecified date, sars-cov-2 test: sars-cov-2 test on an unspecified date, sars-cov-2 test: (PCR) TEST obtained via a nasal swab negative  on 01Mar2021,  urine analysis: showed rare dysmorphic red blood cells on an unspecified date. The clinical outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
COVID-19 breakthrough. The first time was mild, runny nose, sore throat, headache. I took Tylenol and was normal around day five I felt normal. The second time I got it was 4/8/2022. I felt like I had a cold with post nasal drip. I was feeling yucky. By Saturday night I was down. I came home from church and I only had energy to get to bed. The next day I had a fever that kept increasing. Saturday night the nurse at my doctors office called me back to instruct me to take a COVID-19 test. I told her I could barely move. She told me to take Tylenol. My temperature was 102.7 degrees. I was going between hot and cold for the next three days. I did a telehealth appointment with my doctor and he prescribed me Paxlovid but no pharmacy within 300 miles had it in stock. I had the fever, body aches and no taste or smell. I still have no taste or smell a month later. My sugar was also extremely high during all of this. Its usually between 110-115 but it was 166. By Friday my doctor prescribed me an antibiotic thinking I had a secondary sinus infection. By Sunday I felt somewhat normal and by Monday I felt better. My head is still blocked.
Headache, Myalgia, NauseaVomiting, FATIGUE, CHILLS Narrative:
I had upper respiratory congestion, runny nose and fatigue. This began on June 11th and symptoms stayed around for an entire week. After my sickness I had severe pain that developed on left side of my neck and left side of my tongue. This began on June 27th. On June 29th I went to an immediate care facility and they couldn't determine what was wrong. They suggested I see my ENT. On July 2nd I went to ER for severe pain in those areas and had scan and blood work, which was all normal. Neuralgia is everyone's best guess. I will have to wait until I see my ear nose and throat doctor.
large raised warm swollen area on L upper arm, with considerable pain immediately after injection. Next day fever of 101, fatigue, slept for 11 hours straight, nausea, slight cough, red area on Left arm continued to enlarge and  increase in pain.  both wrist and thumbs started to become painful. All symptoms lasted 4 days but L arm continued to be painful. Now 3 weeks post injection still have discomfort in L arm  some limited range of motion in L shoulder.
Red, swelling with warm touch- Radius 4 inches started on 9/5 and still have reaction until 9/15/17 with redness, swelling went down to 3 inches radius. Recommend to put ice on injection site and take Tylenol.
Fever 104 x 2 days, vomiting x 2 days, diarrhea x 5 days. Also began day care day after shots given. Went to ER 7 days after shots, diagnosed with gastroenteritis. Told was not dehydrated. Told to use Motrin and place child on cl leg. Unsure if any reaction to shots.
Most were normal reaction reactions per documentation - pain, redness at the injection site  Additional:  Severe deep shoulder pain (right). Unable to raise right arm. This started during sleep the night of receiving the shot and continued for 3 days, subsiding on day 4. Upper body rash, Chest, arms, and back. Started day 3 and continued through Day 4. The rash appeared to only be in the area where exposed to sunlight. Rash appeared as raised irregular shaped red blotches with severe itching, No fluid.  On day 5, at the time of this report. Symptoms have subsided slightly and appears to getting better but no completely gone. able to raise arm level with shoulder but painful any further. Raise appears to be lessening with Benadryl and topical creams.
This spontaneous report as received from a consumer via HRA as part of market research program (1110-X686) refers to an unspecified number of immunocompromised patients of unknown age and gender. Concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23 (lot number, expiration date, strength, dose and route were not reported). Concomitant medications were not reported. The reporter stated that, on an unknown date, the patients may had had a decreased response to PNEUMOVAX 23. The outcome of therapeutic response decreased was unknown at the time of the report. The reporter did not assess the relatedness of PNEUMOVAX 23 to therapeutic response decreased. Additional information has been requested.
WEAKNESS AND TREMORS OF BILATERAL UPPER AND LOWER EXTREMETIES, CHRONIC COUGH, HEADACHES, SLURRED SPEECH, CONFUSION AND DIZZINESS,LOW BLOOD PRESSURE, ASPIRATION
A report was received from a health care professional on 31Oct02 concerning a male vaccinee of unk demography who received 0.5ml Fluvirin SC on 31October02. There was insufficient information to determine the reporter's causality assessment. Update 1, 03Dec02: A report was from a health care professional indicating that the vaccinee was 72 years old. No adverse reaction was reported.
Patient fainted after injection was given. Came to after 4 minutes of Dr. trying to have her come out of the spell. After patient woke up, she stayed in the office for 20 minutes so that the Dr. could monitor her post fainting health. She left 20 minutes later and suffer no other effect from the injection.
Developed flu symptoms that lasted 6 days, but then by day 10 headache grew worse and worse- lasted 35 days, couldn?t sleep and or focus, brain fog type symptoms along with head and scalp pain
Approximately two hours after vaccination, the patient started getting severe chills, he got into the shower, then started having wide swings in blood pressure (172/103->91/70). He then started having shortness of breath. He was taken to the emergency room by family members where his EKG and other tests came back negative for a cardiac event. He has had flu shots in the past with no reaction. He has since recovered completely
Developed a severe migraine and tinnitus two days (May 13) after second shot.  The tinnitus continued for several months but has become much less severe and currently is rarely noticeable.  The migraine has lasted for months (it is now October 1 and this began on May 13) and causes sharp head pain when sneezing, coughing, and bending over.  I have also experienced pressure sensation on the top of my head associated with the sharp pains.  I do not have the sharp pain/migraine all the time it can come and go throughout the day or it can last the entire day.  There seems to be no reason for why it begins.  It does grow worse if I become hot during exercise.
Extreme sweating, dizziness, temperature, left side arm, neck and fingers were numb, headache, and fast heart beat.
RPh was unable to located current vials being used and took new vial out of the freezer. The vial was only thawed at room temperature for 45 mins vs the hour that is procedure. The vaccine however was completely thawed before administration. Once it was discovered that time allot time was not fulfilled. RPh called manufacturing company, in which it was stated not to revaccinate patients but to proceed as normal with schedule for second dose. Then RPh made market director aware of the incident.
Information has been received from a nurse concerning a male with no known allergies and reported no pertinent medical history who was vaccinated with two doses of MMR II as a child (dates, dose, route and lot numbers are not known). Concomitant therapy included cholesterol medication (unspecified). The nurse reported that the patient had a negative measles titer (less than 0.91U). The patient sought medical attention at an office visit. The outcome was not reported. A product quality complaint was not involved. Additional information has been requested.
numbness and tingling in stocking and glove pattern, both lower extremities to mid calf and both arms to mid forearm. symptoms started the evening of the vaccination, and were maximal at 48-hours after vaccination. At 96 hours after vaccination, the symptoms were less, only in ulnar aspects of both hands (not in forearm) and feet, not above ankles. No treatment was instituted. CBC, CMP and UA were normal at 48 after vaccination.