chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Afib; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant) and FATIGUE (Tired). At the time of the report, ATRIAL FIBRILLATION (Afib) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (abnormal) Abnormal.         Concomitant product details were not provided by the reporter.  Treatment details were not provided by the reporter.  action taken was not applicable.  Company comment: This case concerns an 81-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date after an unknown dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns an 81-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date after an unknown dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Very sore shoulder at site of injection.  I could not raise my arm without sever muscle pain.
Child profile and EHR vaccine records did not match. I was using the child profile for looking up the immunization needed for the pt. I later figured out that I had given extra vaccination that she already took (MMR & Hep B).
Extremely dizzy; very tired; a little nauseous; Left Arm Pain/ in pain closer to the vaccine; This is a spontaneous report received from a contactable consumer. A consumer (patient) reported a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) via unspecified route on left arm single dose for COVID-19 immunization on 03Apr2021 10:01, at 27-year-old. Medical history and concomitant medication were not reported. The patient had Left arm pain hurt so bad on Saturday (03Apr2021), 13:00, that she cried; took some ibuprofen (ADVIL) Saturday and Sunday to relieve her arm pain. The patient was nauseous on 04Apr2021 and very tired on 05Apr2021, reported extremely dizzy and difficult to wake up on 08Apr2021. The patient reported that she woke up this morning (08Apr2021) feeling really, really, really dizzy. She was a little nauseous and in pain closer to the vaccine. No emergency room or physician office visited. Outcome of the events left arm pain/ in pain closer to the vaccine, nauseous and very tired was resolving; outcome of the other event was not resolved.  No follow-up attempts are needed. No further information is expected.
Developed case of Rubella after receiving MMR on 2/2/01, due to negative titer.
Loss of Taste; Loss of Smell; Fatigue; Positive COVID-19 Test; Body Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test), AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell), FATIGUE (Fatigue) and MYALGIA (Body Aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 06-Jan-2021, the patient experienced MYALGIA (Body Aches) and HEADACHE (Headache). On 16-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test). On 18-Jan-2021, the patient experienced AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and FATIGUE (Fatigue). On 09-Jan-2021, MYALGIA (Body Aches) and HEADACHE (Headache) had resolved. On 16-Jan-2021, SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test) had resolved. At the time of the report, AGEUSIA (Loss of Taste), ANOSMIA (Loss of Smell) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test positive: Positive.     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 concomitant medications provided. No treatment information provided.
Sore arm & 10 x 5 cm erythematous area in lt arm @ inject site;
No reactions seen in clinic. Pt was given KINRIX which is for ages 4-6, Pt is only 5 months.
Pain and swelling in the right foot, making it difficult bear weight and walk. Improved on Ibuprofen 800 mg. Tenderness in the dorsum of the same foot. Also improved after ibuprofen.
beginning the day after the vaccine Patient experienced dairrhea, extreme nausea, cramps, coughing and weakness. This persisted for 3 days.  Patient suffered a stroke or multiple strokes either 5 or 6 days after administration of the vaccine.  She has since died as a result of the strokes.
soreness on the entire body; tired more than usual, sleeps a lot; R arm sore at the injection site; injection site pink; injection site on R arm swollen; R arm injection site itchy; tired more than usual, sleeps a lot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (soreness on the entire body), SOMNOLENCE (tired more than usual, sleeps a lot), INJECTION SITE PAIN (R arm sore at the injection site), VACCINATION SITE ERYTHEMA (injection site pink) and VACCINATION SITE SWELLING (injection site on R arm swollen) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included EZETIMIBE, ROSUVASTATIN, MEMANTINE, PANTOPRAZOLE, CHLORAMPHENICOL (CHLOROTIN) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (soreness on the entire body), SOMNOLENCE (tired more than usual, sleeps a lot), INJECTION SITE PAIN (R arm sore at the injection site), VACCINATION SITE ERYTHEMA (injection site pink), VACCINATION SITE SWELLING (injection site on R arm swollen), VACCINATION SITE PRURITUS (R arm injection site itchy) and FATIGUE (tired more than usual, sleeps a lot). At the time of the report, PAIN (soreness on the entire body), SOMNOLENCE (tired more than usual, sleeps a lot), INJECTION SITE PAIN (R arm sore at the injection site), VACCINATION SITE ERYTHEMA (injection site pink), VACCINATION SITE SWELLING (injection site on R arm swollen), VACCINATION SITE PRURITUS (R arm injection site itchy) and FATIGUE (tired more than usual, sleeps a lot) outcome was unknown.            treatment med:  tylenol or Ibuprofen  and a topic cream. conmed: cranberry tablet
After 5 days of nothing but a slightly sore arm near injection site my right upper arm began to itch.  Nothing too major but odd. On eve of 1/25 I looked at arm and it seemed normal. Next morning, January 26 i looked at arm and red vertical rash and quite itchy. Emailed Dr he said if it became larger or more itchy we might need to treat with steroid cream.  Since I had some hydrocortisone cream i put some on at bedtime and again morning of 1/17.  Took pictures morning of 1/27 also.
Diaphoretic, weakness. Seen by EMS. Discharged home at 12:35. Recorded by employee.
Severe swelling and splitting of lips two weeks after vaccination.  Lips were very inflamed and burned.   I have never had any lip or facial fillers or procedures done.  I initially used ice compresses and Vaseline to treat my lips and after one week began using hydrocortisone lip balm to help with healing.
Patient received the Pfizer vaccine on Sunday (06/13/21) and had mild upset stomach, headache and felt achey for approximately 24 hours post vaccine that then fully resolved. At approximately 4am on 06/16/21 he developed sharp substernal chest pain that was located centrally and a bit to the left with pain worse on inspiration and with movement. No other symptoms at that time. Went to the Emergency Department where he was transferred to Hospital as his troponin was elevated at 4.02 ng/ml. His chest pain resolved with 1 dose of Ibuprofen 400 mg.
This case was reported by a physician and described the occurrence of injection site redness in a 4 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. Medical history included allergies to penicillin and cefaclor (Ceclor). There were no concurrent medications. On 5/3/2006 at 4:00pm, the subject received 5th dose of Infanrix in the left arm (lot AC14B018AA). On 5/3/2006, the subject also received the 4th dose of inactivated poliomyelitis virus vaccine (Ipol, lot Y0241) at an unspecified site of administration. On 5/5/2006,  2 days after vaccination with Infanrix, the subject experienced injection site redness, hardening injection site and heat at injection site at the site of the Infanrix administration. The subject was treated with ibuprofen (Advil) and compresses. The physician considered the events to be disabling. The outcome of the events was not reported.
Patient tested positive for COVID-19 after vaccination. She reported to the ED "not feeling well" with worsening cough and congestion and diarrhea. Once she spiked a fever, she presented to the ED per the recommendation of her PMD and oncologist. She was started on 2 L of oxygen by nasal cannula which she is still continued on.
Symptoms started January 21,3021 with Fever, Chills, Bodyaches, Weakness and Exhaustion.  Symptoms continued January 22 and I was unable to go to work.  Bodyaches , Weakness and Stomach Pain an Nausea occurred for another week .  Shoulder and Back Pain with intermittent Headaches and Neck Pain continues currently as of today?s date 2/14/2021
Information has been received from a physician concerning a 16 week old patient who was vaccinated with the first oral Rotateq. There was no concomitant medication. Subsequently, the patient experienced diarrhea and vomiting for twenty four hours after the vaccination. The outcome was reported as unknown. The patient sought unspecified medical attention. Additional information has been requested.
a patient only received the DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV (DTAP-IPV) portion and not the HIB portion of Pentacel vaccine, due to the two components not being mixed, No AE; Initial information received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a two months old female patient who received the Diphtheria, Tetanus, AC Pertussis, IPV (DTAP-IPV) portion and not the HIB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], due to the two components not being mixed (lot number: UJ496ABA, expiry date: 29-MAY-2022), dose: 0.5 ml, frequency: once, strength: standard via intramuscular route in left thigh for prophylactic vaccination on 21-Jun-2021 (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  List concomitant: No other vaccines.   It was an actual medication error due to inappropriate reconstitution technique (latency: same day).  Potential Product Technique Complain: No, Treatment: The clinic calling the manufacturer and  Product used.  At the time of reporting on adverse event was reported.  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.
Patient admitted for altered mental status on 8/22. She underwent total knee procedure on 8/18 and was COVID negative on 8/17. She is currently undergoing inpatient treatment for COVID-19.
Rapid heart rate, tachycardia and possible Atrial fibrillation detected (on a single lead EKG), dizziness and lightheaded.  Heart rate went from the high 70s to the 140s.  It has since slowed down to the low 100s, but it's still very high.
Patient states Moderna booster shot on 7/25/22 caused reaction within hours of pain starting in right arm and shoulder which then radiated to left shoulder and arm and down both arms to hands right greater than left.  She felt like her "bones were one fire" and couldn't touch her skin was very sensitive, noted swelling.  Also reported fever.  States the pain lasted for months and then resolved however it occasionally returns as similar pain at random times and then will go away. Can no longer tolerate allergy shots.
The client called to report adverse events 24 hours post administration of vaccine on 4/24/01. The pt complained of malaise, weakness in hands and fever. The pt had not taken temp so was unsure what it was.
Erythema & warmth onset 6/13/12. Injection site pain 6/12/12. No c.p. SOB, fever, chills, rigors.
This spontaneous report was received from a pharmacist via a company representative referring to a 73 year old female patient. The patient's medical history and concurrent conditions were not reported. On 09-JUN-2016, the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not provided). No other suspect or concomitants therapies were reported. On the same date, the patient experienced soreness in arm and upset stomach. It was also reported that the patient sought medical attention in doctor's office at the time. Additionally, it was reported that no intervention to prevent a serious criteria was necessary, that pain in extremity and abdominal discomfort was no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. The outcome of soreness in arm and upset stomach were not provided. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
increased new palpitations/an increase in the amount of chest palpitations; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EH9899), intramuscular on the left deltoid on 29Dec2020 at SINGLE DOSE as COVID prevention at the hospital.  Medical history included ongoing hypothyroidism for about 3 or 4 years, sinus headache, and ear pressure. It was reported that the patient had palpitations in the past but has not had any recently. Concomitant medications included ongoing liothyronine sodium (CYTOMEL) for hypothyroidism and phenylephrine (PHENYLEPHRINE) from unknown date until 31Dec2020 for ear pressure and sinus headache. The patient had her first dose of the COVID vaccine on 29Dec2020 and she had no problems at first, but she stated that she was seeing an increase in the amount of chest palpitations that she was having since 31Dec2020. She knew it was cold and fly season (uncommon for her to have ear pressure and headaches with weather changes) and she had to take some sinus medicines, so she just blew the palpitations off as having come from those sinus medicines but she was no longer taking those medicines and the palpitations were still persisting. The patient also mentioned that she was watching her caffeine intake, and she even was not having any more caffeine than she normally does. She really noticed the palpitations over the holiday weekend, and it felt like it was getting worse, and then she started feeling like she needed to reset herself. Outcome of the event was not recovered. As per causality, the patient also mentioned that it was unknown if the palpitations were caused by the vaccine, but she feared that they were. She also mentioned that she had no other vaccines on the same day as the COVID Vaccine so she was not sure.
muscle soreness at injection site: 4 days muscle soreness, whole body: 4 days extreme fatigue, tiredness: 4 days
Notes swelling, redness, tenderness of upper right arm where vaccine was delivered.  Noticed this when he woke up on Thursday morning.
vaccine removed from freezer and only thawed for 20 minutes before being administered to patient; A spontaneous report was received from a healthcare professional concerning a patient, of unknown age/gender, who received Moderna's COVID-19 vaccine that was removed from the freezer and then allowed to only thaw for 20 minutes before being administered to the patient.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient received Moderna's COVID-19 vaccine that was removed from the freezer and then allowed to only thaw for 20 minutes before being administered. Treatment information was not provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the event, vaccine removed from freezer and only thawed for 20 minutes before being administered to patient, was resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender, who received their first of two planned doses of mRNA-1273 (Lot: 027L20A), reporting Product preparation error.
red blister on cheek; diarrhea; blisters in nose; Fatigue; Shivering; cold; headache; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lung disorder, dry mouth, eye dryness and gluten sensitivity (Gluten hypersensitivity). Concomitant products included iron (Iron Infusion).   On 2nd February 2023, the patient received the 2nd dose of Shingrix. On 2nd February 2023, less than a day after receiving Shingrix, the patient experienced shivering and cold. On 3rd February 2023, the patient experienced fatigue. On 5th February 2023, the patient experienced blister. On 6th February 2023, the patient experienced diarrhea. On 8th February 2023, the patient experienced blistery rash. In February 2023, the patient experienced headache. On an unknown date, the outcome of the shivering, cold, fatigue, diarrhea, blister, blistery rash and headache were unknown.   It was unknown if the reporter considered the shivering, cold, fatigue, diarrhea, blister, blistery rash and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-FEB-2023  Reporter's Comments: The case was self reported by the patient. The patient received second dose of Shingrix into left arm and experienced shivering, cold, fatigue, diarrhea, headache, red blisters in nose and on cheek. The reporter consented to follow up.
Pfizer Adult 12+yo vaccine administered instead of Pfizer 5-11yo vaccine. No adverse reaction reported
Fever (not taken), vomiting 48 hrs p/below immun; Febrile seizure approx 72 hrs p/immun; Seen @ Hosp 25JUN & treated w/Amoxicillin for dx of OM;
Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R023736 with expiration date on 20-AUG-2020 (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -6 degrees Fahrenheit (°F) to 14°F for the time frame of 30 minutes, and another temperature range of 15°F to 46°F for the time frame of 1 hour. There was no previous temperature excursion and the call was because of a data logger.
This spontaneous prospective pregnancy report was received from a consumer's husband refers to his 32 year old wife. On 18-DEC-2013 the patient was vaccinated with MMR II (therapy route reported as injections, dose and frequency unspecified) and was 4 weeks pregnant. Estimated Last Menstrual Period date was 05-NOV-2013. Estimated date of delivery would be 12-AUG-2014. The patient was 7 weeks pregnant at the time of report. The reporter also stated that the patient was nauseated after receiving MMR II. On an unknown date, the patient underwent unspecified blood work test. The patient sought medical attention by visiting doctor. Outcome of the event and causality were not reported. Additional information has been requested.
First night: Heart beating fast, shortness of breath Second night: Heart beating fast, shortness of breath, fever Third night: Heart beating fast, shortness of breath
Initial report was received from a healthcare professional on 29 October 2012. A patient (age, date of birth and gender not reported) had received an injection of FLUZONE (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced a reaction involving swelling of the eyes, slight throat swelling along with typical symptoms of slight sore throat and generalized malaise. The reaction was short-lived. The patient received an influenza vaccine last year without reaction. The patient's outcome was recovered. Documents held by sender: None.