chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 14 month old female who on Aug 2, 2002 was vaccinated in the right thigh with a first dose of MMR II (lot # 640140/1373L) and in the left thigh with a first dose of varicella virus vaccine live (lot # 640556/0258M). On Nov 01, 2002  the patient was seen in the physician's office for a rash on her back which had started the prior evening. The day of the office visit, the rash was in the patient's chest and torso, and it was not itchy. Examination revealed that the patient was pleasant with a " faint erythematous, mac-pap rash on torso-some on extremities-spares." It was noted that the patient was overall much better and had decreased upper respiratory tract infection and rhinosinusitis symptoms. The physician's assessment was "rashing illness," "rash-viral" questionably secondary to amoxicillin. The patient was to continue amoxicillin, take diphenhydramine hydrochloride (Benadryl) 1/2 tsp TID, and call if the rash spread or increased. On Nov 06, 2002, it was noted that the patient stayed on amoxicillin and the rash decreased. Vaccination records indicated that the patient had been vaccinated with hepatitis B vaccine recombinant (lot # not provided) on Aug 06, 2001: hepatitis B vaccine recombinant (lot # 638722/0325L) on Sep 06, 2001: and hepatitis B vaccine recombinant (lot # 641451/1499L) on May 10, 2002. The patient's mother had been exposed to varicella virus vaccine live during pregnancy. Additional information has been requested.  Follow up information from the physician indicated that the pt had no past medical history or allergies and that there was no illness at the time of vaccination. It was reported that the symptoms were related to vaccine and may have been related to food/viral. It was noted that the only report in the pt's chart that pertained  to a rash was recorded on 20Sep2002 and that there was no subsequent mention of a rash (conflicting information). Additional information has been requested.
pt screamed, held breath, won't lay down, cried was high pitched, startle movements, t101;
Severe chills, fevers up to 102.4, achiness, site tenderness, very fatigued and stomach pain (epigastric)
Pfizer-BioNTech COVID-19 Vaccine EUA Fever, throwing up, bad headaches and body aches
Mom states child had 'welts on entire body for 3 days beginning 18JAN91. Phone call to MD 18JAN91 ordered Benedryl, sx persisted & child was started on Atarax 19JAN91. MD stated child had experienced previous episodes of hives.
No adverse event; The patient recieved booster dose of expired Moderna Covid-19 vaccine/Patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient recieved booster dose of expired Moderna Covid-19 vaccine/Patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient recieved booster dose of expired Moderna Covid-19 vaccine/Patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient recieved booster dose of expired Moderna Covid-19 vaccine/Patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The patient recieved booster dose of expired Moderna Covid-19 vaccine/Patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers expiration date).    No concomitant medications was reported.  On 07-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.  The reporter thought that saw expiration date as 20-Jun-2022, but when looked this up before however had nothing in writing or printed to confirm the expiration date of 20-Jun-2022.  The patient had no known allergies. It was unknown, if the patient was ever tested or diagnosed with COVID and unknown if related to mentioned event and both Acute and Chronic illnesses at the time of vaccination, also unknown if, other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was also unknown, that if patient took any medical care.  No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Live follow-up received contains significant information as vaccination dates updated. On 02-Sep-2022: Follow-up received contains non-significant information appended as updated narrative.
At approx 1PM began to have fever and chills, nausea, took acetaminophen shortly after, fever decreased, started with joint pain, this continued until approximately 3PM 11/24/04.
Patient states arm is red, warm, swollen, and itchy at injection site for the last 2 days. He also says he doesn't quite feel right (feels like he is getting "sick"). No treatment has been done.
From telephone contact received 10/17/02, it was reported that a 52 year old (DOB 01/02/1950) female was administered Fluzone (lot # U0969AA) in the right deltoid on 10/14/02. She also received a Pneumococcal vaccine (unspecified) in the left deltoid. On 10/15/02, the patient experienced a rash from, the left shoulder to the elbow. She was seen by her doctor on 10/16/02 and was given an antibiotic (unspecified) and topical hydrocortisone cream for cellulitis. Per the reporter, these adverse events are resolving.
Notable change in feeding pattern and marked temporary loss/regression of social milestones approximately 1 week following routine 2 month immunizations. Stabilized and started to return to baseline within about 3 weeks. Did have neurology consult. No treatment indicated. Have modified immunization schedule since that time.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA227019 (same reporter). This case involves child male patient (age not reported) who was vaccinated with a 0.5 ml dose of QUADRACEL (Batch number: C5248AA and expiry date: 21-Aug-2019) via intramuscular route on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because stability on QUADRACEL, the excursion was actually for 9 days, starting in May, and ranged from 48-49 F. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
At lt upper arm marked pain, swelling red warmth, induration w/o sterile absces;s
Proquad given in the right upper lateral thigh on 2/24. Mom called on 2/25 stating that her right upper leg is red. Appears to have a "big hive" around insertion site.  Also had low-grade fever. Triage nurse gave directions to apply cool pack as needed, give Tylenol or Ibuprofen for discomfort as needed, Benadryl if it is itching her and to call back if it gets worse. Mom called on 2/26 and stated that it had doubled in size. She was seen that afternoon by Dr. Findings: Erythema and rash present. Comments: Right outer thigh inner erythematous area max 3.5x 3 cm then 1/2 to 1 cm pale circle and then another erythematous circle, 1-2 cm uneven borders and the whole thing is 9 cm by 8 cm at the greatest size. Warm and tender. No longer itchy. Plan: As she is no longer itching probably do not need to give her any Benadryl can give her some Tylenol if she continues to c/o pain due to the open scratched areas in the central portion of the rash and the warmth and increased erythema of the area we will treat as cellulitis secondary to broken skin on top of reaction to MMR. Started on cephalexin 250 mg/5mL suspension, take 3.5 mL by mouth 2 times daily for 7 days.
within 2 days developed ipsilateral upper arm numbness and pain and tingling into the L hand.  Within a few days, ipsilateral thigh had numbness and formication.  Shot was given into L deltoid.
The Pfizer vaccine was reconstituted with sterile water instead of normal saline and administered to the patient.  The patient did not report any adverse effects.
States two days prior to vaccine he first noticed a fever blister. Reports since receiving first vaccine dose last Friday (2/26/21) he has not been feeling well, notes swollen eyes (lid overlap eyelashes), eyes wet/watery constant, swollen throat, face swelling, and fatigue. Reports this has improved somewhat. Denies any pain/injection site reaction from vaccine.
This spontaneous case was reported by a health care professional and describes the occurrence of ARTHRALGIA (Joint Pain), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-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 03-Feb-2021, the patient experienced ARTHRALGIA (Joint Pain), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever). On 05-Feb-2021, ARTHRALGIA (Joint Pain), MYALGIA (Muscle Pain), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Patient  received vaccine at approximately 1230, started to feel lightheaded, dizziness, and nausea. Patient was pale, diaphoretic, and clammy at point of observation. Patient was brought to observation POD. Patient stated his blood pressure was abnormal. Initial blood pressure was 173/120 with HR of 72. Patient stated he was prescribed lisinopril and hydrochlorothiazide, however, has not taken medication in a month because he felt his "blood pressure was fine".  EMS was notified. Blood pressure on recheck was 168/110. Patient was evaluated by EMS, patient had been driven by escort. Patient declined visit to hospital transport with EMS. ER precautions were given and patient was notified to f/u with primary care provider in regards to incident.
Since receiving Vaccine, I am having daily left sided headaches with left neck pain, left arm pain with limited range of motion, left sided weakness and numbness as well as erratic menstrual cycles with heavy flow. After following up with my doctor on 08/13/2021 it was found I have no reflex response with deep tendon reflex test (patella) in comparison to the right side which is present. I have since been referred to neurology and an MRI has been ordered. These symptoms have been happening since May 2021 and worsening.
FLU HIT ME; LOW GRADE FEVER; NAUSEA; SORE ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 225 pounds, and height was 62 inches. The patient's concurrent conditions included diabetes, copd, emhysema, cardiovascular issue, peipheral artery disease, b/l lower extremities, rheumatoid artheritis, fibromylgia, chronic pain, asthma, smoker, shell fish allergy, sulfa allergy, iodine allergy, codein allergy, and pcn allergy. The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced low grade fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced flu hit me. On 10-MAR-2021, the subject experienced sore arm. Laboratory data included: Body temperature (NR: not provided) 98.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, nausea, and flu hit me on 10-MAR-2021, and the outcome of sore arm was not reported. This report was non-serious.
1st shot no issue 2nd shot - initial arm soreness, increasing in intensity in evening Morning after nausea, body aches, headache, fever peak at 101.5 -treated with anti-nausea Ondansetron ODT 8mg, Tylenol 500mg -
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with  improperly stored VARIVAX (which had a lot # of N021317 and an expiration date of 07-AUG-2019 also reported with this expiration date 07-FEB-2019; however, dosage number, route of administration, anatomical site were not reported), for prophylaxis. That was reconstituted with properly stored sterile diluent.  Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 15 F degrees to 46 F degrees (38.1 F degrees) for 59 minutes on unknown date. Reportedly, there had been no previous temperature excursions and no data logger. Furthermore, no product quality complaint was involved.
8/16/2006 Rt arm swollen, red "almost purple" within 28 hrs of administration of vaccines.By 31 hrs after administration, child was hospitalized for swelling in Rt arm, from elbow to shoulder. IV antibiotics, IV Solu-Medrol and oral Zyrtec were given. Diagnosis by ER doctor was an allergic reaction to the vaccines given. 10/13/06 Received D/C summary which revealed patient hospitalized from 8/16/-8/18 with D/C dx: allergic reaction due to TDaP & MMR vaccines.  Exam showed swelling shoulder to elbow of right arm, redness & pain over RUE after vaccination on 8/15 at Health Dept.   Seen in ER with marked swelling, redness & warmth.  Admitted for further eval & treatment.  Treated with IV antibiotics, steroids & antihistamine which were continued on d/c.  PMH: asthma.
7 days post vax the pt presented with hives and was diagnosed with an allergic rash. The rash was described as patchy, red and itchy. Pt was treated with Benadryl.  5 weeks post vax the pt developed a major outbreak of hives. Pt had been using Claritin for one week. Physician stated that the pt has mild, recurrent crops of hives described as erythematous, slightly raised , hive lesions.
Medical assistant calling to report administered vaccine temperature excursion on multiple patients. Per caller vaccines went out of range yesterday and it was not discovered until this morning when checking the data logger.; This spontaneous report was received from a medical asssistant (also reported as physician, conflicting information) referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 13-JUN-2022, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) (1 injection; lot #U031911; expiration date: 11-NOV-2022; strength, and route of administration were not provided), administered for prophylaxis (Product storage error).  Administered vaccine experienced the temperature excursion. It was reported that vaccines went out of range on 13-JUN-2022 (reported as yesterday) and it was not discovered until 14-JUN-2022 (reported as this morning) when checking the data logger.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2206USA004337: US-009507513-2206USA004154: US-009507513-2206USA004511: US-009507513-2206USA004187: US-009507513-2206USA004506:
Redness, swollen area on left thigh, tenderness. Motrin, Zyrtec, cool compress. All reactions occurred at DTaP injection site.
Fever of 103degF for 8 hours; migraine for 4 days; experiences chills; muscle ache; still have difficulty breathing for 8 days; extreme fatigue for 8 days; blurred vision; joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever of 103degF for 8 hours), MIGRAINE (migraine for 4 days), CHILLS (experiences chills), MYALGIA (muscle ache) and ARTHRALGIA (joint pain) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2011, the patient experienced ARTHRALGIA (joint pain). On 02-Jan-2021, the patient experienced VISION BLURRED (blurred vision) and FATIGUE (extreme fatigue for 8 days). On 02-Feb-2021, the patient experienced PYREXIA (Fever of 103degF for 8 hours), MIGRAINE (migraine for 4 days), CHILLS (experiences chills), MYALGIA (muscle ache) and DYSPNOEA (still have difficulty breathing for 8 days). At the time of the report, PYREXIA (Fever of 103degF for 8 hours), MIGRAINE (migraine for 4 days), CHILLS (experiences chills), MYALGIA (muscle ache), ARTHRALGIA (joint pain), VISION BLURRED (blurred vision), DYSPNOEA (still have difficulty breathing for 8 days) and FATIGUE (extreme fatigue for 8 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Chest X-ray:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was   liquid steroid Treatment medication was Tylenol, Benadryl, and albuterol inhaler  reported.   Reporter did not allow further contact
Approximately a few hours after my 2nd dose vaccination I felt the following symptoms: Pain in my left arm (vaccinated arm) was throbbing and still experiencing the pain up to this day 03/01/2022 - not a constant pain but when move movement is being initiated.
Puffiness at wrist of same arm of injection, 2 and 1/2" L x 1 and 1/2" W. Also reporting shooting pain alternating down left arm, right leg, and across chest and head
Patient woke up on 7/20/2014 with pain in right hip bone impairing mobility. It increased over the morning in severity until we had to go to emergency room. Dr said it was possible temporary arthritis in her hip joint a side effect from MMR vaccine. 2 days later she developed a rash looking like measles.
Patient received a dose of Pfizer COVID-19 Vaccine  Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Fatigue, internal noise when moving head/shoulders, inability to concentrate, irritability. Symptoms unusual in personal flu vaccine experience.
Your child received a vaccination at our clinic during the period between February 28 and April 16, 2020. During the period between February 28th, 2020 and March 2nd, 2020, our data logger had a technical malfunction that we were not aware of and it stopped sending its temperature recordings to the system.  During that period the fridge never stopped working. The temperature logs of the fridge before and after the incident were always within required range. Our fridge has been always in a perfect new condition and never had any temperature problems previously. There was no power outage in the area or inside the office during that period as well.       The CDC requires continuous temperature monitoring of all vaccines and due to lack of continuous temperature data documentation, the vaccine manufacturers have determined that the doses administered on these dates should be re-administered to ensure proper effectiveness.
3 hours later had tingling in the face that moved up from lip to cheek bone. Shooting nerve pain. Still to this day get this but was very prominent after both injections. Swollen lymph node in axillary region after each injection that lasted weeks. So severe it hurt to put arm down lymph node size of quarter. All covid like symptoms came back with both injections, worse after first injection.  Had to take 3 days off work with second one because did not with the first one and felt terrible. Fever, headache, severe body aches, shortness of breath, red rash and swelling of injection site, swollen lymph nodes, tiredness, tingling in face and nerve pain.
Headache, chills, fatigue, body aches Narrative: PT EXPERIENCED THE FOLLOWING ADR POST 2ND DOSE OF COVID VACCINE: headache, nausea, chills, fatigue, body aches
hypoxia,bradycardia,cyanosis,gen tonic clonic sz,petechiae over head & neck;transferred to hosp was intubated,end result of severe developmental delay,cortical blindness & cont sz activity
Felt some of the vaccine leak out of the injection site; A spontaneous report  was received from a pharmacist, concerning a male patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt some of the vaccine leaked out of the injection site.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On an unspecified date, after the administration of vaccine, when the syringe was pulled out of the injection site, the patient felt that some of the vaccine had leaked out from the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, some of the vaccine leak out of the injection site, was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of product leakage for mRNA-1273.  There were no reported adverse events associated with this case.