chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate vaccine site pain (~9 hrs after vaccine) + moderate/severe fatigue (started ~12 hrs after vaccine administered) + severe chills, low-grade fevers, moderate muscle aches, severe bone aches, moderate joint aches, and mild headaches (started ~18-24 hrs after vaccine administered). Ibuprofen (Motrin) 400 mg total and Acetaminophen 500 mg decreased/improved symptoms.
Dizziness, blurred vision, dropping things for 6 days.  Could not see up close and then away. motion sickness
VERY TIRED FOR THE NEXT 24 HOURS; FEVER; DISORIENTED FEELING; CHILLS; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 250 pounds, and height was 70 inches. The patient's concurrent conditions included: alcohol user, and cigarette smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol. On 31-AUG-2021, the patient experienced disoriented feeling. On 31-AUG-2021, the patient experienced chills. On 31-AUG-2021, the patient experienced fever. On 01-SEP-2021, the patient experienced very tired for the next 24 hours. The action taken with covid-19 vaccine was not applicable. The patient recovered from disoriented feeling, chills, and fever on 31-AUG-2021, and very tired for the next 24 hours on 01-SEP-2021. This report was non-serious.
Patient developed intussusception 3/15/07 sent to hospital - reduced with barium air enema. 03/28/07-DC summary received. DC DX: Intussusception. Confirmed by ultrasound and successfully reduced with air contrast barium enema.
During my regular health plan visit, I was inoculated with the new shingles vaccine ZOSTAVAX and the Tdap. Within 24 hours, swelling of hands and feet. Within 48 hours after injection and was given a steroid to alleviate swelling. Steroid injection did not alleviate swelling and rash intensified. Returned to physician 72 hours after first steroid injection and was given another steroid injection along with other medications to alleviate redness and itchy rash. As of 11/17/11 it does appear that the allergic reaction is subsiding. My physician indicated that the swelling and rash, most likely, resulted from the shingles vaccine - ZOSTAVAX.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 10:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:38 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient age was reported age 59.07. Batch number 0303B21A underwent temperature excursion on 03-APR-2021 with temperature 34 degrees Fahrenheit at 9:00 AM . This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-APR-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a brand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Pt vaccinated w/DTP experienced fever started 6-8hrs after DTP injection.
Diagnosed with Transverse Myelitis.  Experienced the following symptoms: Significant reduction in sensation from my lower chest all the way through my legs. Weakness in my legs to the point I can only walk short distances, in the past I have experienced times when I was unable to rise from a chair because my legs would not respond at all.? Loss of balance, I have fallen a number of times and now walk with a walker or forearm crutches. Continued disruption in both urination and bowel movements. Positional pain, when I am lying or setting in a reclined position there is little or no pain, when I stand or set up straight, the pain increases over time until I have to recline to avoid it.
Loss of muscle function. Joint pain. Chronic cough and flu like symptoms. Had to use cane and then walker. Cannot walk. Advised to report by doctor. Chills, fever, fatigue, cannot use muscles from hips down, they just give out. Shortness of breath.
Pain; Dizziness; Fever; Joint pains; Fatigue; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pains) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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 PAIN (Pain), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (Pain), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pains), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) 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.   No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Additional information received: Non-significant follow up information.
I received the second dose of the Moderna Covid 19 vaccine on Friday and on Sunday evening I had a rash under my left breast. Burning, not itchy, about the size of a baseball rash that is healing now after I applied calamine lotion.
has a problem with a single family member of 4 that received a dose of saline instead of the yellow fever vaccine with no reported adverse event; Initial information received on 10-Jul-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient, reportedly has a problem with a single family member of 4 that received a dose of sodium chloride (Saline) instead of the YELLOW FEVER VACCINE - [YF-VAX] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect YELLOW FEVER VACCINE (strength, formulation, route, frequency: unknown) (lot: UJ563AA and expiry date: 23-May-2023) in unknown administration site for Immunization.  On an unknown date, the patient started taking sodium chloride (strength, formulation, route, frequency, dose: unknown) (with an unknown batch number and expiry date).  On an unknown date the patient developed a non-serious event, has a problem with a single family member of 4 that received a dose of saline instead of the yellow fever vaccine with no reported adverse event (wrong product administered) (unknown latency).  It was reported, after hours call received at 12:10pm on 10jul2022. Doctor states that he has a problem with a single family member of 4 that received a dose of saline instead of the yellow fever vaccine. "Do I need to give a dose to every family member?" After hours call returned at 12:30pm on 10jul2022. Caller states that a family of 4 came in and introspect he counted the vials and determined that probably they gave one of the 4-member saline only and not the yellow fever vaccine. "Do I need to repeat the dose for all 4?" Do you know where they can receive a yellow fever titer?" What happens if they receive an extra dose?"   Action taken with YELLOW FEVER VACCINE (YF-VAX) and SODIUM CHLORIDE (SODIUM CHLORIDE) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
After my second shot on 09/29/2021 I experienced brain fog. The next day I woke up with a sore throat, headache, fatigue, nausea. I experienced these symptoms on 09/30/2021 - 10/01/2021. On 10/02/2021 I still experienced sore throat, headache, fatigue and now a cough. On 10/03/2021 - 10/04/2021 I am still experiencing fatigue, headache, sore throat, cough with green mucus, and throat swollen/ pain with deep breath. I am going to visit the hospital today. I?ve been taking DayQuil which has helped a little.
Patient fell back, lost color, eyes rolled back and he was shaky and unresponsive for about 1/2 a minute. He remained dizzy, but conscious for about 10 minutes after.
4 days after the first Moderna shot, I got several crazy migraines. 4 days after the second shot, I started spinning and woke up the following morning with extreme vertigo and vomiting. Went to Urgent Care. I am moving into week 7 and still unable to function due to dizziness. Also having lots of headaches/migraines. I am basically lying in bed most of the time (unable to drive, bothered by head movement, unable to spend to much time on screens, walking difficulty). This is debilitating and I am self employed (Losing thousands in pay). I am so frustrated and regret getting the vaccine. It feels like the vaccine caused an attack on my vestibular system.
Patient reports thickness on roof of mouth and back of throat. NP notified and 25mg Benadryl PO given with good effect
This initial spontaneous report was received from a pharmacist referring to a 77 year old male patient with high blood pressure, fingertip neuropathies and allergic to ciprofloxacin. On 05-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX subdermal injection (dose, frequency and lot number were not provided). There was no concomitant medication described. The reporter stated that the patient went to the pharmacy on 07-OCT-2015, complaining of pain and neuropathy in the arm of the injection. Lab diagnostics studies were not performed. Product quality complaint (PQC) was not involved. At the time of the report the outcome of pain in extremity and neuropathy peripheral was not recovered. Additional information has been requested.
Initial unsolicited report received from a non-healthcare professional (patient's relative) via social media on 01 August 2015. A 07-month-old female infant, whose medical history and concomitant medications were not reported, had received a dose of meningococcal vaccine (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. Reporter stated that her neighbour back in the eighties was not fortunate enough as on an unknown date her daughter contacted meningitis after receiving the vaccination (time from first dose to onset not specified) and she died within few hours of having fever which her mother thought to be a simple fever. Laboratory investigations and corrective treatments were not reported. It was unknown if autopsy was performed. Documents held by sender: none.
Has not received the 2nd dose yet passed 40 day period, Positive for covid after the 1st dose; I was a little sick but i m fine now; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the 2nd dose yet passed 40 day period, Positive for covid after the 1st dose) and MALAISE (I was a little sick but i m fine now) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the 2nd dose yet passed 40 day period, Positive for covid after the 1st dose) and MALAISE (I was a little sick but i m fine now). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the 2nd dose yet passed 40 day period, Positive for covid after the 1st dose) and MALAISE (I was a little sick but i m fine now) had resolved.            No concomitant medication reported. No treatment information was provided    This case was linked to MOD-2021-256441 (Patient Link).
Started @ 8:30 pm on 3-18-02 c/o Fever 102 degrees, chills, shaky, aches, pain joint pain, nausea and vomiting. Symptoms stopped 3-19-002 @ 5:00 pm
PC from Dad. Pt with vomit this pm 10x, NBNB, now dry heaving and diarrhea 3x, no bld/mucus, AF. Had H1N1 vaccine yesterday. Unknown sick contacts-goes to school. Ate nl today/nl uop today-no UOP tonight, went to school today. Called in ZOFRAN 4m TID PRN to pharmacy. Phone f/u with mom. Vomiting stopped after ZOFRAN, drank 2 cups fluids, resting comfortably. To call with worse/recurrent sxs. Rec OV tomorrow if not normal.
This spontaneous case reported by a consumer, describes the occurrence of tinnitus in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 27, 2021, patient experienced tinnitus. At the time of the report, tinnitus outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine): unknown. Concomitant medication and treatment information not provided.
Administered wrong dose of flu vaccine to patient. Administered 0.5cc IM of Flulaval-Influenza vaccine for Adults to a 6yr old child.  This patient did not have an adverse event the patient was given the wrong dose of medicine.
Had leg pain in the form of a knot in my left calf muscle. The muscle would tighten and feel like a Charlie horse. The issue lasted for about 3 weeks.  I tried cooling and then warming it since it felt like a pulled muscle at first. Then as the days went on there was more of a knot in the muscle and then tried warming, stretching, compression sleeve,  hot tub, and then tried a massage gun.  The issue finally went away but not sure if it was rest or a combination of the treatments.
Area directly over incision site 7 days after receiving vaccination felt like a sunburn. 2-3'' diameter in size and round shape. Red, swollen, itchy and sore.
Patient received Moderna COVID vaccine on 2/16/21 and 3/17/2. On 1/25/22, patient admitted to our inpatient facility (med/surg unit) for possible CVA and COVID19 infection. During hospitalization, she was placed in stroke care protocol and MRI of her brain did not reveal an acute infarct. Unclear if her symptoms may be manifested by her current COVID-19 infection. Patient was seen by neurology and was cleared for discharge. Patient was discharged back to adult family home on 1/26/22.
Patient was given second Hep A too soon. There was not 6 months between 1st & 2nd dose.
One week after receiving the second Pfizer vaccine, patient began having tachycardia, at one point measured at 160 bpm. Seen in ED. Other than sinus tachycardia, no other cause found. ECG showed sinus tach only, troponin neg, TSH normal. CBC showing mild thrombocytosis, Chem unremarkable other than mild d-dimer elevation (CT angio negative)
Pt had vaccine on 12/14 at 1600. Thirty minutes later, she had redness and swelling near left deltoid. Got worse over next few days (localized redness, swelling, warmth) but is some better now.
10 minutes after receiving her vaccination, she reported feeling left sided chest tightness. EKG showed normal sinus rhythm.
This spontaneous report was received from a nurse, who referred to a patient of unknown demographics. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB (lot# N004632 and expiration date 02-NOV-2019; dose and route of administration were not reported). The vaccine was stored at the temperature of 8.9 degrees Celsius (C) (between 9C and 25C) for 1 hour and 15 minutes. There were no previous temperature excursions. Digital data logger was involved. No side effects were reported. No product quality complaint was involved.
This spontaneous reprot as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 09-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number reported as J005672, Expiry date: 05-DEC-2015) (dose and route were not reported). No adverse experiences were reported. This is one of several reprots received from the same reporter. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA: One day after vaccination, patient presented to the emergency department with substernal chest pain and shortness of breath. History significant for COVID-19 "a few months ago".  Initialy patient felt fatigued with muscle aches and fevers that were "worse than COVID itself".  No cough, nausea, vomiting, abdominal pain, or rash reported. Initial vital signs: pulse 81 beats per minute, blood pressure 117/82 mmHg, temperature 36.7 degrees celsius, respiratory rate 18 breaths per minute, and oxygen saturation 97%.  Patient observed, administered potassium and ketorolac, and symptoms resolved. Vitals remained within normal ranges and patient discharged home ambulatory and stable.
This spontaneous report was received from a nurse practitioner refers to a 26 year old female patient with ZITHROMAX allergy and no pertinent medical history. On 04-SEP-2014 the patient was vaccinated with GARDASIL dose 3 (dose, lot # unknown). There were no concomitant medications. In the evening of 04-SEP-2014 the patient complained that she had pain in her left arm at injection site and that she felt her heart racing. When she woke up on 05-SEP-2014 she stated that she could not lift her left arm for three hours as if it was paralyzed. This symptom resolved itself throughout the day but came back every morning since the vaccine was administered. The patient stated that she still was not able to move her left arm every morning for approximately three hours and she slowly started to regain sensation in the arm and was able to go on with her daily activities. She did have another episode of her heart racing on an unspecified date and this resolved on an unspecified date in September 2014. The patient visited the nurse practitioner on 11-SEP-2014 and stated that she had been treating the arm with warm compresses and taking ibuprofen on unspecified dates. The nurse practitioner prescribed ADVIL as needed and cool compresses. The nurse practitioner also observed the injection site and stated that it was black and blue in appearance on 11-SEP-2014. The outcome of could not lift her left arm for three hours as if it was paralyzed, injection site was black and blue in appearance and pain in her left arm at injection site was reported as not recovered. Upon internal review, the event of could not lift her left arm for three hours as if it was paralyzed was considered to be medically significant. Additional information has been requested.
Right eyelid became swollen later in the day 11/6/21.  Next morning worse, watery, eye itchy and red.
This spontaneous case was reported by a physician and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA increased) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA increased). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Prostatic specific antigen: 299.99 (High) Prostate Specific Antigen (PSA) was very high. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 08-Feb-2021, the patient received their second dose of the Moderna vaccine. Few days later the patient reported that their prostate specific antigen (PSA) was done and it was very high. On 15-Feb-2021, the patient reported that PSA result from 12-Feb-2021 was 229.99 and the normal range was less than 4 as per the physician. No Concomitant product use was reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 13-Feb-2021: Follow-up was received on 16-Feb-2021. Added and updated the PSA value in lab data.