chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a mild allergic reaction during the observation period including a red rash and itchiness to both arms. No other complications developed. Vitals were obtained as follows: BP 150/79, HR 86, SpO2 98%.  50 mg of Benadryl given PO. Patient was monitored for an additional 20 minutes and during that time the rash subsided. After receiving further education on which signs and symptoms would warrant seeking medical attention and reporting feeling much better the patient was released into self-care with her friend as the driver.
Got my vaccine on Monday in my right arm. On Thursday morning I had blurry spots in my eyes that lasted a couple of hours. It almost felt like i had something in my eyes. I kept rubbing and checking them. I called my primary care doctor and the office told me he would call me back. An hour later the blurs went away but the right side of my face down my neck had a numbing sensation. My right ear also felt like it need to be ?popped? like when on a plane that wouldn?t go away. Wasn?t completely numb but felt numb. When my doctor called me back i told him my symptoms and he told me to go to the emergency room. They ran blood work and did a CT and saw nothing abnormal beside my iron was a little low but I?m pregnant so that wasn?t surprising. I left not really knowing why I?m feeling this in my face. It still has that numbing feeling. And Friday i had a 10 minute nose bleed on my right side where I?m feeling the numbness.
Light headed; Shaking; Elevated HR beating so fast it would wake her up in the middle of the night; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program  support via  information team. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization at the age of 55-year-old. The patient medical history and concomitant medications were not reported. The patient experienced light headed, shaking, elevated heart rate (HR), beating so fast it would wake her up in the middle of the night on an unspecified date in Apr2021. The patient stated that the symptoms lasted close to two weeks. The outcome of events was recovered on an unspecified date in Apr2021. Her doctor recommended she wait to receive the second dose of the vaccine.  Information on the lot/batch number has been requested.
Patient received the flu shot (FluLaval, Lot # AFLLA053AA) at our health fair.  He developed swelling of the tongue with in six hours of taking the shot.  He had no previously known allergies to the vaccine components or contraindications to receiving the shot.  He called the employee health nurse(this writer) the next morning and reported the swollen tongue.  He was advised to see the doctor.  The doctor told him he had an allergic reaction to the flu vaccine.  She gave hime a steroid shot and advised him to get OTC Allegra as an antihistamine.  This morning (the 16th and two days after receiving the shot) he is back at work and reporting the the swelling has greatly decreased.  This writer does not know if the treating physician made a report of this episode.
Moderna booster (3rd shot) symptoms:  fever of 101.6; chills; weakness; shortness of breath; headache; fatigue; muscle aches; soreness at injection and in armpit of injection arm, still happening now (about 22 hours following vaccine).
Severe flu symptoms.  High fever up to 104° over the course of 3 days. Constant severe nausea. Heavy nasal congestion and cough. Muscle aches and chills. A bout of diarrhea. Lightheadedness. 3 sleepless nights. Last night, night five, a sudden attack of nausea accompanied by severe stomach pain caused me to almost lose consciousness. I thought I was dying. Thankfully, it subsided, and, this morning I feel like I am turning the corner. I still have heavy congestion and am very weak. I self-treated with OTC meds over the 5 days, thinking that it would end soon, as all the information told me the effects would be temporary. I also have been drinking a lot of water and Pedialyte.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 31 year-old female patient. On 09-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 ml via the intramuscular route. The AFLURIA vaccine was store at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
Patient reported redness and pain on 12/26/20. Redness and pain the size of a half dollar 12/27/20. Redness and itching the size of a lemon 12/28/20.
PT REMAINED IN STORE FOR REQUIRED 15 MINUTES.. SHORTLY AFTER ARRIVING HOME PATIENT BEGAN HEAVY VOMITING. PT WENT TO HER PRIMARY MD WHO SENT HER TO THE HOSPITAL. SHE REMAINED THERE 4/4/22-4/8/22 . IT WAS DETERMINED THAT SHE HAD LOW OXYGEN LEVELS AND DEHYDRATION///  PATIENT NOW AT HOME AND FEELING BETTER AS OF 4/13/22
Complained it felt as if someone was 'squeezing her chest'.   Gave two puffs of albuterol (did not help) and called off-hours RN who suggested we go to closest emergency room.  Performed EKG and lab work that were negative for myocarditis.  Provided her with 6 puffs of albuterol, after which point the squeezing feeling improved.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK-0.5 ml SD-PFS LLok wTip" (lot # M005286, expiration date: 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 120 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Complete lack of energy; slept for 24 hrs almost straight; incapacitated; This case was reported by a consumer via interactive digital media and described the occurrence of disability in a patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of disability (for tolerance of 1st dose, refer case US2019AMR142110).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant), feeling of total lack of energy and sleepiness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the disability and sleepiness were recovered/resolved and the outcome of the feeling of total lack of energy was unknown.   It was unknown if the reporter considered the disability, feeling of total lack of energy and sleepiness to be related to Shingrix.  Additional details were received as follows: The patient's age at vaccination was not reported. Previously, the patient had received vaccine but was not effective as Shingrix.  The patient was incapacitated for 3 days, had complete lack of energy and was slept for 24 hours almost straight. The patient had prescription of Shingrix but vaccine was received late because patient's physician warned that Shingrix could cause flu like symptoms for 4 days. The patient considered that, Shingles was way worse than a mild case of flu and received vaccines. The patient complained to GlaxoSmithKline that they were misleading the patient's as the side effects listed were massive and debilitating. It is one of two cases, reported by the same reporter.
The case report was received from a Health Professional and concerns a 58 year old male patient who had a pacemaker, high cholesterol, high blood pressure, overactive narcolepsy. Concomitant medications were unknown as the patient attended a different pharmacy. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): the patient received AFLURIA on 01-OCT-2015 - 01-OCT-2015 in the right arm, Batch no: T52508, Route of administration: Intramuscular, Dose: 0.5 ml, and on unknown dates, Batch no: not provided, Route of administration: not provided, Dose: Another dose was given in Oct, 2 weeks after first dose. AFLURIA was stored incorrectly. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-OCT-2015, the expired AFLURIA was administered in the patient's right arm (non serious, outcome: Recovered / Resolved). The patient was called and informed of mistake and he came in two weeks later to receive the correct AFLURIA vaccination serious, outcome: Recovered / Resolved), Medication error (non serious, outcome Recovered / Resolved). IT was reported that he was feeling normal and experienced no side effects. Outcome: Recovered. Action taken: not provided. Event treatment: not provided. Rechallenge/Dechallenge information: not provided. For relevant test results see appropriate report section. Reporter's assessment: The health Professional considered the event(s) Expired AFLURIA was administered in the patient's right arm, came in 2 weeks later to receive correct AFLURIA vaccine. Medication error as non-serious and causality of "Certain/Highly probable" in relation to AFLURIA. The reporter reported the term "Medication error".
patient complained of a metallic taste in his mouth, he said he felt slightly warm, and slightly nauseated, no redness at injection site.
Severe shoulder pain, inability to move shoulder within 2 hours after vaccine administration. The shot was given above where it should have been. Symptoms are ongoing -- still experiencing severe shoulder pain and cannot move my shoulder
expired vaccine is stored and then administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  HCP reported that there was a confusion between the expiration date printed in the carton and the expiration date when the quick response (QR) code scanned. On 29-OCT- 2021, vial was stored in the refrigerator. No temperature excursions was noted. No adverse events were noted.  No treatment medication was provided.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a consumer (the subject's mother) and described the occurrence of vaccine exposure during pregnancy in a 19-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy. A physician or other health care professional has not verified this report.  Concurrent medications included Prenatal vitamins.   On an unspecified date in April 2011 the subject received a dose of Boostrix (details unknown), and experienced vaccine exposure during pregnancy.  The subject was 27 weeks pregnant at the time of vaccination.  The consumer believed that the dtap vaccine administered was Boostrix, but was not sure.  The subject had had 3 ultrasounds since the vaccination and there were no abnormalities or issues identified.  The pregnancy had been without complications at the time of reporting.  Estimated delivery date was 13 September 2011.   Upon internal review done on 13th September 2019, the pregnancy outcome was updated to lost to follow-up.
Information has been received from a healthcare worker concerning a female patient, who on unspecified dates, was vaccinated with two doses of VARIVAX (Oka/Merck). The patient did not seroconvert after administrations of two doses of VARIVAX (Oka/Merck). The patient sought unspecified medical attention. Additional information has been requested.
18 hours after receiving shot, experienced extreme sweating, chills, diarrhea, dizziness, passed out in my husbands arms. Husband shook me awake, applied cold compresses, and took two Ibuprofen tablets. Chills and sweating continued for several hours. The following day I was very weak and had a head ache. Next day was better.
On the day I took the vaccine, my whole left side became sore and numb. The soreness and numbness continued on through the next day. Friday evening, I had the same symptoms coupled with nausea, headache, and chills. Saturday, I continued to have slight soreness and nausea. Today (Sunday), I'm still having a bit of soreness on my left shoulder where I took the vaccine.
Left Leg More Painful than the Right Leg; Left Leg is more swollen than the Right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Leg More Painful than the Right Leg) and PERIPHERAL SWELLING (Left Leg is more swollen than the Right leg) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: flu vaccine in 2014 and Prednisone (Patient stated that years ago she had leg swelling following the use of oral Prednisone); for Swelling face: Clindamycin (Oral Antibiotic treated for 7 days after receiving a high dose Flu Vaccine) in 2014. Past adverse reactions to the above products included Swelling face with flu vaccine; and Swelling of legs with Prednisone. Concurrent medical conditions included Drug allergy (Prednisone) and Allergy to vaccine (Flu high dose). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR), PARACETAMOL (TYLENOL), ESOMEPRAZOLE SODIUM (NEXIUM) and IBUPROFEN for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced PAIN IN EXTREMITY (Left Leg More Painful than the Right Leg) and PERIPHERAL SWELLING (Left Leg is more swollen than the Right leg). The patient was treated with POTASSIUM ongoing since an unknown date at a dose of 1 dosage form and FUROSEMIDE (LASIX) ongoing since an unknown date for  and COVID-19 vaccination, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Left Leg More Painful than the Right Leg) and PERIPHERAL SWELLING (Left Leg is more swollen than the Right leg) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Once patient stated that all tests were normal. Another time she stated that she did not do any tests after vaccination and those tests were from years ago and her kidney function tests were normal from years ago.  Concomitant medication also included High blood pressure medications.   This case was linked to MOD-2021-228465 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received and contains no new information. Corrections made from initial source document reporter address, relevant history, Updated initial event coding from Myalgia to Peripheral swelling.
1400 felt strange, 1410 notable wheezing audibly w/prolonged expiratory component able to converse & respond; 1425-1430 Methylprednisolone; 1435 Diphenhydramine, Albuterol; to hosp;
Several days after the Moderna Booster, my entire body started to itch - uncontrollably.  When I scratch and dried off with my towel after a shower, welts would appear.  I've been taking an antihistamine to control the itch, but the itching still occurs today - I was hoping it would go away after some time, but has not subsided yet.
BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative concerned multiple patients (family) of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-NOV-2021, one of the family member after business trip became infected and later others (the entire family). It was reported that, the breakthrough occurred in a manner of two weeks (suspected clinical vaccination failure). The patients had more mild symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209764. This case, from the same reporter is linked to 20220100988.; Sender's Comments: V0: 20220100666-covid-19 vaccine ad26.cov2.s- Break through infection.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20220100666-Covid-19 vaccine ad26.cov2.s-Suspected clinical Vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
pt recvd vax & 1 hr later pt was pale, fatigued, nauseated, & weak;
Severe migraine-type headache starting 1.5-2 days after injection, constant (without any moments of relief at all) until about 2/21/21. I discussed it with my primary healthcare provider on 2/3/21 and my topiramate was increased to 3 pills per day, and when that didn't help I saw another provider who does botox therapy for migraines on 2/12/21 and he said I didn't qualify for injections but he placed me on atenolol everyday, which did stop the headache. I am still taking both medications at the doses I was placed on as I still get a migraine if I miss a dose.  Prior to my covid shot I was already on a daily low dose of topiramate for migraines because I got on average 3-5 per month that lasted about 1 day each.
Bruising; 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 CONTUSION (Bruising) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Bruising). At the time of the report, CONTUSION (Bruising) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-097850 (Patient Link).
According to patient's mother on 4/8/15, patient developed a fever the evening of his vaccines. The fever which was as high as 104 degrees, lasted about 2 weeks. He also developed a facial rash and eye swelling the day after the vaccines. The rash lasted approximately 1 1/2 wks. He also had nasal congestion. He previously had a fever following vaccines on 9/2/14. Mother treated him naturally with sponge baths of water and vinegar. He did not see a doctor.
Information has been received from a pharmacist concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently, the pt experienced a local injection site reaction. Medical attention was sought. No further information is available.
pt recvd vax; T 105 p/ vax; fever cont 3 days p/ vax;
Tongue tingling followed by dry mouth Lasted about 4 to 6 hours from onset Note:  Dramamine also produces this symptom
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient stated that they started to feel dizzy when they got up from sitting down and may have gotten up to fast. She also said she came to get the vaccine right after leaving the gym so she thinks that may be a contributing factor too. She rested and was feeling better but said she  would rather go home. She said she was much better when I called to see how she was doing a few hours later.
A few weeks after vaccination with the above two vaccines and about 3 months after vaccination with influenza vaccine  and first dose of Shingrix (9/24/20), the patient experienced sudden acrocyanosis of the middle three fingers bilaterally, neuropathy and pain in the fingertips upon cold exposure, cyanosis of the earlobes upon cold exposure, shortness of breath, fatigue, and darkened urine.  Dermatologic evaluation led to diagnosis of cryoglobulinemia (type 1, IgM kappa).  Rheumatologic evaluation ruled out any rheumatological disorders.  Hematology/oncology evaluation led to diagnosis of cold agglutinin hemolytic anemia with possible warm hemolytic anemia component.  Bone marrow biopsy, CT scan of abdomen/pelvis, and ultrasound did not indicate any oncologic condition.  The patient?s anemia has not responded to prednisone 60 mg po daily x 5 weeks, so there is plan to taper off.  Treatment for cold induced symptoms has been non-pharmacologic with use of a space heater and cold avoidance.
Developed fever and chills 12 hours after receiving dose. Had extreme fatigue x 24hrs and significant Headache.
Ached all over, fever, shaking chills.  Physician Assistant diagnosed it as a urinary Trac infection. Antibiotics cured the issue. I also received Covid rapid and PCR tests and both were negative.
Patient was admitted to Hospital on 12/10/2021 for COVID related symptoms. This is considered a breakthrough case.
Child was sitting in chair, and after giving 1st Vaccine (Tdap) child fainted hitting Rt side of head on desk.  He quickly regained consciousness and was oriented.  Ice pack applied to Rt side of head. There was no bleeding and slight swelling noted.  Child stayed in clinic for 25-30 min. after.  He was able to walk to the car without problems and remained oriented, and mother stated he remained appropriate.  Mother was instructed to seek medical attention (urgent care).  This nurse spoke with mother later this day.  Per Mother child was doing fine.  The did go to a nearby Clinic and she stated they examined child and found no problems with exception of his BP being low.