chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No addittional adverse effects reported; MMR II that underwent temperature excursions was administered; This spontaneous report was received from an unspecified reporter referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 18-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, (valid lot #T033814, expiration date: 05-OCT-2022), administered for prophylaxis (strength, vaccination scheme frequency, anatomical location, and route of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 12.4 degrees Celsius for 53 minutes; 9.6 degrees Celsius for 34 minutes; 9.5 degrees Celsius for 23 minutes; and 8.5 degrees Celsius for 9 minutes. There was no adverse effect reported.; Sender's Comments:  US-009507513-2112USA007443: US-009507513-2112USA006870: US-009507513-2112USA007442:
Pfizer COVID Booster was administered, the expiration "time" on the vial was 2400 02/01/2022 the dose administered at 0900 on 02/02/2022. Phoned Pfizer manufacturer, if stored properly the vial is actually good for 24 hours after puncture. This vial was stored properly and the dose given within 254 hours. Revaccination was not advised. The patient was notified reports filed
POSSIBLE DELAYED REACTION-FEW DAYS AFTER VACCINE IN THE EVENING  (4/29) EXPIERIENCED HIVES ON TORSO (NOT AT INJECTION SITE)LASTING FEW DAYS 5/2 PURCHASED BENADRYL AND HYDROCORTISONE CREAM. . HE SPOKE TO A NURSE  ,DONT BELIEVE ACTUAL OFFICE VISIT., WHO BELIEVED REACTION WAS DUE TO SOMETHING HE ATE. HE DID HAVE EGGS AND UNWASHED STRAWBERRIES THAT DAY BUT ISNT ALLERGIC. AS OF 5/11 FOLLOW UP CONVERSATION HAS FULLY RESOLVED. MODERNA CASE NUMBER MOD21-085398 VI PHONE CALL.
Vaccinated 5/17/01 with TD adult in right deltoid. Developed increased redness and swelling and was placed on Medrol dose pack on 5/24/01.
Beginning Wednesday, Feb 3, 2021 I had two bouts of diarrhea during the day. Thursday I had 4. Friday 4. Saturday 7, Sunday 6. Any time I eat something within 30 minutes to 1.5 hours I have cramping and diarrhea.  Starting Saturday I modified my diet to bland foods and have drank plenty of fluids for hydration. As I share the same diet with my husband and he has no symptoms, I do not believe this is food borne. I have had no other lifestyle or dietary changes within the last week.
Patient felt flu like symptoms. Patient c/o stiff arm, neck. Lasted 3 days but symptoms are getting better.
rash at injection site; tenderness; itchiness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (rash at injection site), TENDERNESS (tenderness) and VACCINATION SITE PRURITUS (itchiness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at injection site), TENDERNESS (tenderness) and VACCINATION SITE PRURITUS (itchiness). At the time of the report, VACCINATION SITE RASH (rash at injection site), TENDERNESS (tenderness) and VACCINATION SITE PRURITUS (itchiness) 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.
Received vaccine (L) arm had numbness and sore tingling in arm that resolved it self. Bump on same arm that left and feels fine now.
Pt received PEDIARIX, rotavirus PCV next am mom c/o red rash head to toe & fever.
Day of vaccine fever to 104.6, brief 30 sec seizure. No treatment for this. DX febrile seizure.
28MAY97 pt recv vax & 2JUN97 swollen arm & hand (softball size);smaller 2" area red w/bumps in middle of swollen area;pus in area of inj;denies pain;denies fever;referred to MD;
4 year old with L arm swelling and erythema developed approx 24 hours post immunizations. No systemic symptoms worsened over 24 hours then began to resolve. Treated with Motrin and Benadryl.
Body rash on foot 4/3/2021 Edema/fluid in lungs 5/7/2021 Kidney Failure w dialysis 5/16/2021 CRRT & ECMO  5/28/2021
Right Deltoid area at injection site - red and swollen post 2 weeks after injection. No pain or tenderness at site after 24 hours post vaccination
At 1335 in the observation unit, client stated he felt itchy and warm to the touch. Vital signs BP 116/58, Pulse 70, Respirations 20, SaO2 95%, Temp 96 F. No pain. No complaints of shortness of breath. Benadryl 25 mg PO given immediately. Client tolerated passing the medication and water without difficultly. At 1345 itching reduced according to patient. No other signs of rash, hives, present. Patient denies dizziness. Steady gait. Alert and Oriented. 1400 Vitals BO 120/90, Pulse 78, Respirations 16, SaO2, 95%, Temp 97.9. Patient stated that he wanted to leave the premises. Patient educated on S/S of a severe allergic reaction and too seek medical attention if reaction occurs. Patient left site without incident.
pain & swelling in injection site, pain & lymph edema behind right ear & right neck and tenderness at left underarm on 1/6/21  Narrative:
New onset autoimmune disorder, symptoms began following vaccination and progressive. Diagnosed with Raynauds and Sjogrens disease
Received injection  2/11/21.  2/12/21 in the evening began to experience mild tremors throughout my body.  2/13/21 tremors became more intense primarily in me chest.  As the tremors increased,  it affected my speech and I began to stutter when trying to speak.  This continued until the morning of 2/14/21.  The tremors started to reduce intensity, but while teaching my chest began to tremble and I felt  my stutter returning.  That has since subsided
Rash/welps on both of her arms and face. No fever. Fussy.
Deathly sick; Thought she was going to die/ Amost died; Could barely walk; Could barely see; Could not breath; Had a great deal of pain; Urinary infection; This spontaneous case was reported by a patient and describes the occurrence of URINARY TRACT INFECTION (Urinary infection), ILLNESS (Deathly sick), FEELING ABNORMAL (Thought she was going to die/ Amost died), GAIT DISTURBANCE (Could barely walk) and VISUAL IMPAIRMENT (Could barely see) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (3 months ago). Concurrent medical conditions included Pollen allergy, Drug allergy (Codeine), Penicillin allergy, Drug allergy (Tramadol) and Thyroid disorder NOS.    On 20-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced URINARY TRACT INFECTION (Urinary infection). On 20-Oct-2022, the patient experienced ILLNESS (Deathly sick), FEELING ABNORMAL (Thought she was going to die/ Amost died), GAIT DISTURBANCE (Could barely walk), VISUAL IMPAIRMENT (Could barely see), DYSPNOEA (Could not breath) and PAIN (Had a great deal of pain). At the time of the report, URINARY TRACT INFECTION (Urinary infection) outcome was unknown and ILLNESS (Deathly sick), FEELING ABNORMAL (Thought she was going to die/ Amost died), GAIT DISTURBANCE (Could barely walk), VISUAL IMPAIRMENT (Could barely see), DYSPNOEA (Could not breath) and PAIN (Had a great deal of pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant medications included Thyroid medication and pain killers. Patient received first dose of Moderna COVID-19 vaccine on 10-Feb-2021 (Lot Number: 031L2BA), second dose on 09-Mar-2021 (Lot Number: 010A21A), 1st Booster Dose on 27-Oct-2022 (Lot Number: 939905). Patient received the Moderna COVID-19 bivalent vaccine on 20-Oct-2022 and patient almost died after this. Patient was so deathly sick. Patient stated that some hours after patient received the vaccine, patient could barely walk and see. Patient could not breath. Patient had a great deal of pain. Patient called her vaccination provider, and they said it would wear off. Patient thought she was going to die. After 4 days the symptoms subside. Patient also has a urinary infection last week. No treatment medications were reported.   This case was linked to MOD-2022-667037 (Patient Link).
Fever, nausea, headache, pain/swelling/warmth at injection site.
OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 13 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced off label use. On 20-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211217956, 20211218548 and 20211218731.
Extreme and severe liver pain followed by loss of consciousness at home 14 hours after 2nd Moderna COVID-19 vaccine.  Rushed to local ER, life flighted out of State by helicopter in acute liver failure, hospitalized for 4 days.
booster dose; slight fever; body aches; chills; Tenderness; very little swelling around the mouth where she received dermal fillers; she gets reactions after every vaccine given to her; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: EW0175) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "received dermal fillers", start date: May2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733), administration date: 30Mar2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "she gets reactions after every vaccine given to her"; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735), administration date: 24Apr2021, when the patient was 47 years old, for COVID-19 immunization, reaction(s): "she gets reactions after every vaccine given to her". The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "booster dose"; PYREXIA (non-serious) with onset 20Nov2021, outcome "recovered", described as "slight fever"; PAIN (non-serious) with onset 20Nov2021, outcome "recovered", described as "body aches"; CHILLS (non-serious) with onset 20Nov2021, outcome "recovered", described as "chills"; TENDERNESS (non-serious) with onset 20Nov2021, outcome "recovered", described as "Tenderness"; MOUTH SWELLING (non-serious) with onset 20Nov2021, outcome "recovered", described as "very little swelling around the mouth where she received dermal fillers"; VACCINATION COMPLICATION (non-serious) with onset 20Nov2021, outcome "recovered", described as "she gets reactions after every vaccine given to her". Therapeutic measures were taken as a result of pyrexia, pain. Therapeutic measures were not taken as a result of chills, tenderness, vaccination complication.  Additional information: patient reported tenderness and very little swelling around the mouth where she received dermal fillers on May2021. the swelling and tenderness resolved in less than 24 hours. she mentioned that she gets reactions after every vaccine given to her. No treatment received. Facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. She mentioned that she gets reactions after every vaccine given to her. she ran a slight fever and had body aches and chills. motrin helped with the pain and fever. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.
On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; On the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing, dizziness, and headaches; HCP states that expired PNEUMOVAX-23 was administered on 14-SEP-2023; HCP also reports that patient was anxious and upset on the phone and was also upset about the physician who treated her; This spontaneous report has been received from a nurse, regarding a 66-years-old female patient. The patient's pertinent medical history included depression and anxiety, previous drug reactions or allergies were not reported. Concomitant medications included clonazepam (KLONOPIN) and salbutamol (ALBUTEROL).  On 14-SEP-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: W007356, which was determined to be valid as vial formulation, with an expiration date on 10-AUG-2023) (strength, scheme, route and anatomical location of administration were not reported) (Expired dose administered).  In addition to administration of expired vaccine, patient also reports symptomatic adverse events after receiving Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). HCP states that patient reported that on the same day of administration that she was starting to experience heart palpitations, blurred vision, difficulty breathing (dyspnea), dizziness, and headaches. HCP also reports that patient was anxious (anxiety) and upset on the phone and was also upset about the physician who treated her. Patient was advised to go back to the clinic, an urgent care, or an emergency room for further treatment, but patient declined all options.   Nurse reporter states that patient has not called them back yet and they are unable to collect any additional information, they would receive a notice if patient went to the hospital or emergency room and states patient has not received any kind of treatment yet.  It was confirmed that vaccine did not experience any temperature excursions in its lifetime.  The outcome of the events was not provided.   The causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned events was not provided.
Varivax given 7/18/02 associated varicella type rash stated 8/2/02.
cold; sick; cough; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route on 14Mar2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The second dose was scheduled on 03Apr2021.  The patient had cold on 29Mar2021, sick and cough on an unspecified date in Mar2021. The clinical course includes when she went to have her first covid vaccine there was a paper that asked if you are allergic to anything. Her sister said it said or are you sick. Caller states she has been sick for about 3 days and asks if it is safe to get the vaccine with a cold. She was going for her second vaccine on Saturday. Caller states the paper said have you done steroids in the last week or something like that but that can't remember what it said. Clarified with caller details and states that both her and her sister saw the paper and she thought she signed it. Caller states it was just a cold, she gets a cold about once a year. The patient took cough medicine and Alka-Seltzer Plus once. Caller also asked if it's okay to proceed with her 2nd dose of the vaccine even if she has colds. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
approx 2 hrs p/receiving 3rd dose of Engerix-B pt exp onset of bell's palsy, flushing & ptosis; all sx resolved w/steroid inject;
Information has been received from a registered nurse concerning a female with no pertinent medical history who on 01-JUN-2007 was vaccinated intramuscularly in the right deltoid with a second dose of Gardasil (Lot #0210U). There was no illness at the time of vaccination. The patient's mother reported the patient's arm had been sore since injection 01-JUN-2007 and the pain extended to the elbow. A small induration could be felt at the site. The patient was treated with ADVIL, gabapentin, LIDODERM patches, prednisone, and ice. On 06-JUL-2007 and 16-JUL-2007 the patient was seen in the physician's office. On 05-AUG-2007 an magnetic resonance imaging (MRI) was performed on the right humerus findings of the proximal humerus are nonspecific and can be related to trauma, infection or neoplasm and should be correlated with clinical findings. There is synovitis of the Glenohumeral joint, which again could be reactive, post-traumatic, or infectious in etiology. On 30-AUG-2007, it was noted that the patient was doing "much better." It was reported that the patient had no problems with the first injection of Gardasil. It was reported that the patient's sister had the Gardasil injections with no problems. The nurse considered the painful arm and injection site induration to be persistent and significant disabling events. Additional information has been requested.
Tightness and pain in calves; Pain in calves; Calves very swollen and painful to touch; Facial swelling; Painful to touch, painful to walk and painful to rest legs on pillows.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 23Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to soy, lactose, beans, pork and corn. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine Concomitant medications included paracetamol (TYLENOL), tilactase (LACTAID) and loratadine (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 24Apr2021, the patient experienced tightness and pain in calves. The patient's calves were very swollen and painful to touch, painful to walk and painful to rest her legs on pillows. The patient had some facial swelling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events tightness and pain in calves, calves were very swollen, painful to touch, painful to walk and painful to rest her legs on pillows and some facial swelling were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
weak; feel very tired; sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 07Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Nov2022, outcome "unknown", described as "feel very tired"; PAIN IN EXTREMITY (non-serious) with onset Nov2022, outcome "unknown", described as "sore"; ASTHENIA (non-serious) with onset Nov2022, outcome "unknown", described as "weak".  Additional information: It was also reported that patient got the vaccine shot day before reporting day and felt very tired and sore. Patient had been so good and have to go in 3 weeks to get another shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd flu vax & devel severe nausea, vomiting, diarrhea, h/a & mylagia; pt was treated w/Compaxine;
Pt complained bilateral upper extremity weakness and dizziness post vaccination during her initial 15 minute observation. She was taken into the tent and observed for another 30 minutes with RN present. 2:19 BP 140/85 HR 85 R 18, T 97.5. 2:24 BP 180/92. Pt denies acute distress, admitted she ?ate pizza and soda before getting into the clinic which could have increased my pressure. But I feel fine?. Pt left the clinic alert and oriented x 4, ambulatory self on a steady gait,. Writer walked pt to her car.
Vaccine lot number 022J21A for Moderna was expired on 04/24/2022. The vaccine was injected to the patient on 05/13/2022. We were notified on 07/03/2023.
Pt seen 8/19/07 for herpes zoster with several cluster of vesicles on erythematous bases in dermatome pattern on back. Mother of patient is convinced shingles case was directly caused by vaccine received 8/8/07, due to patients dx of Aspergers
Fever, muscle aches, sore arm by the evening on the 18th with the first two over on the 20th.  Noticed ?covid arm? on the 21st (half of the upper arm was red, warm to the touch, itchy and still sore).  Treated with antihistamine and Advil.  Only some redness as as of the 23rd.
Headache, body aches, chills - general not feeling well.  As long as I take ibuprofen I'm fine.  Symptoms continued this morning (day after vaccination) so I'm continuing to take a low dose of ibuprofen.
Pt. states "after getting my covid 19 booster on nov 9 2021 approx. 1 week alter I noticed a rash was developing on both of my thighs. The rash was getting bigger so in December 2021 I went to see a dermatologist at center for dermatology. The dr. had to treat the rash and a bacterial infection. it was determined that it was the result of the covid-19 booster vaccine. After 8 months of treatment and 3 biopsy's it was finally under control. I had a follow up exam on  10/27/2022 and everything looks good.