chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-066334 (Patient Link).
pt noticed 3-4 Pox type blisters surrounding the injection site.  Usual site soreness
Developed right sided chest pain with sob approx 22 hrs after vaccine administration.  Felt lightheaded with increased heart rate. Fatigue, nausea, chills.  No fever.  Pt contacted office and pt was instructed to report to ED for evaluation.  Employee was evaluated at Medical Center.  Pt was released and is feeling better today (2/11/21).  No treatment per patient.  Pt stated ED felt symptoms were side effect of Covid vaccine.
Chills and sweating 8-12 hours after vaccine  Abnormally HEAVY menstrual bleeding July 20+ - never in 7 years has it been this heavy.  - normally, I only need to use light-normal pads ?? now I might need a diaper.
21 yr old female presents to clinic for immunizations.  Reviewed her imms record and she is due for Meningococcal and TDAP.  Pt is is college student. spoke to dr. and best to give her Meningococcal B.  Pt received these immunization at 1430.  At 1440 while pt was walking to exit she felt faint.  Her knees buckled and she kneeled on the floor in NP office.  Pt never loss conscience  Pt was placed in a chair.  She was responding appropriate to questions and was A/O x 3.  Pt was taken back to the treatment room and placed on a stretcher with HOB 40 degrees.  It was noted in her right hand her fingers were contracting.  Pt reports she did not eat or drink all day and the only water she had was with her Effexor.
Patient presented to ED and subsequently hospitalized on 3/15/2021, discharged and presented back to the ED on 3/19/21.
Client had injection site pain at first Client complained for post vaccination syndrome on Monday client complained of chest tightness and pain Clients BP was elevated at the time.  Client is now hospitalized
Near death; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provide as follows: The age at vaccination was not reported. The reporter said that, not everyone would be immune to vaccines that's why it so important for everyone to get vaccinated. Maybe you should research a ill more bout immunity. The reporter did not believe in three flu vaccine. For two reasons it almost killed reporter's mother and you could not make a vaccine for the flu because you did not know what strand would hit, but if future grandkids go to daycare or preschool it's a requirement they get the flu shot.
Rectal fever at 103.4 - shots received 5/11/10. Fever 5/12/10 at 3:00 AM.
Pt. received MCV-4 and HPV. Stood up after receiving vaccines and fell forward. Pt. hit mouth and last part of tooth. Pt. taken to E.R. and released.
constellation of symptoms which emerged about a week after Covid vaccination, whose association with one another is unclear, but which have all been reported in persons who have received Covid-19 vaccine. Those symptoms include: fatigue, malaise, lethargy, new or worsening lower GI pain, sebhorea (dermatitis of the scalp)  and pityriasis rosea.  Treatment: Triamcinolone cream Rash is still spreading I am to see the doctor in one month if condition worsens
My husband suffered a cardiac event at work on 03/08/2021 approximately two weeks after second dose of the vaccination. Although I am not certain this would be considered an adverse event I want to report its occurrence in case it is found to be a mitigating factor. He is currently hospitalized.
Patient and family had 2 days of explosive diarrhea and vomiting following ROTATEQ 6-17-08.
On 1-14-09 per mother at 10:30 pm she felt infant & he was hot.  She gave Tylenol and child had seizure.  Child taken to ER by ambulance with temp of 102.3 F, pulse 157, R 28, 99% O2 RA.  Tylenol given in ER.  Seizure lasted approximately 3 minutes.  Child delivered to home at 01:39 AM.  Temp 99.9 F.  Mom called me on 1-15-09.  This sibling's fraternal twin was vaccinated at same time with same vaccines and had no difficulties.  Mom said no redness at sites and no other s/s.
Developed shortness of breath, tachycardia, fever to 101 degrees, wheezing which progressed to some hypoxia & pneumonia (? viral). Hospitalized on 3/14 thru 3/20. Did have localized reaction to tetanus site.
Awoke feeling unsteady but not lightheaded, and very fatigued.  Took my blood pressure and it was 71 over 53.  My pulse was 110.  My normal blood pressure first thing in the morning is mid 90s over high 60s .  My normal pulse in the morning ranges between 58 and 70.  I also had a temperature of 101.  My normal body temp is just below 97.  The fever remained most of the day except for brief periods where ibuprofen seemed to control it.  My systolic blood pressure eventually climbed into the 90s and the diastolic moved into the 70s.  The rapid heart rate continued all day as did the extreme fatigue.  While I am 68 years old, I probably haven?t taken a nap in more than 20 years.  I took three naps that day.  I felt normal when I woke up the following morning.  I am reporting this due to the extremely low blood pressure and the rapid heart rate.  Material I was given warned of a possible rapid heart rate but made no mention of such a concerningly low bp.
Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the  coronavirus infection in March of 2020.  Patient continued  to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room.  On  1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday,  1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.
20-40 minutes after injection, pt experienced nausea & vomiting; dizziness, itching, pallor. No rash, no dyspnea. Rec'd in ED: Benedryl 50mg IV, Solu Medrol 125mg IV, Tagamet 300mg IVpb.  After-wards developed chest tightness.  Vital signs throughout within normal limits.  Sent home on Benedryl as needed orally.
Headache, body aches, chi.lls, fever, excessive tiredness, loss of appetite, injection site soreness
@ 4PM eyes, mouth, palms, bottoms of feet started itching;soon p/felt as if throat was starting to constrict;to MD office approx 5:30 MD prescirbed med sx sstopped;
16 years old was administered flublok quadrivalent/no AE; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 year-old-male who was vaccinated with 0.5 mL  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2006 and expiry date 22-May-2021) via unknown route at an unknown administration site on 04-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration.  At the time of report no 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 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.
Baby was given oral ROTATEQ on 1-4-11 and it was expired on 12-8-10. To be called back in for redose of this vaccine 4 weeks from invalid dose, per Dr.
Patient received Pfizer Bivalent 12+ Vaccine + Flucelvax Quad Vaccine at 5pm previous Friday 10/07/2022. Parent reported she felt fine over the weekend but started noticing symptoms of "fogged brain" at school and her hand-written notes in class looks "scribbled."
10 days post vax pt stopped walking, overnight; could not crawl, turn fr back to front or front to back, or hold up head; ESR ele @ 85, brain CT showed cortical atrophy & enlarged ventricles for age; Admitted to hosp; poss edema
About 8 p.m. the day of the vaccine  Monday, I felt chilled, achy, fever, heart palpitations, until about 4 a.m. when it subsided. still tired the next morning with my legs that ached. rested until 3 that afternoon. Ate light dinner. By Wednesday, I felt fine with no symptoms at all. Never needed to call a doctor.
This spontaneous report as received from nurse refers to a patient of unknown age. The patient's pertinent medical history was not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) as a child. Concomitant medications were not reported. On an unknown date (reported as now), the patient had negative anti-varicella antibody titers that were drawn on an unspecified date. No adverse effects were reported. No product quality complaint was reported for VARIVAX (Merck). Additional information has been requested.
Shot hurt more than usual when administered.  Experienced expected shoulder/arm pain, mild nausea and fatigue the day of and following day.  Shoulder pain of varying degrees has persisted to this day - seems rotator cuff related, not debilitating but very uncomfortable at times.
Shortness of breath/ breathing problem/ not being able to catch my breath; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath/ breathing problem/ not being able to catch my breath) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced DYSPNOEA (Shortness of breath/ breathing problem/ not being able to catch my breath). At the time of the report, DYSPNOEA (Shortness of breath/ breathing problem/ not being able to catch my breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: Nothing showed up. On an unknown date, Ventilation/perfusion scan: Nothing showed up.         No concomitant medications were reported.  Patient thought that, it was the fourth day before Thanksgiving, the patient developed a breathing problem. Later, the patient had a scan of heart and lungs, but nothing showed up. The patient still had the problem at the time of report. Patient further stated that, sometimes it was worse than others and was wondering if this was a result of having had the booster.  No treatment medications were reported.
Sorry, I couldn't read the pharmacist's handwriting for the lot number.  If not MWA, maybe 420?  Side effects were consistent with what I had read (slightly swollen arm & mild soreness around the site of insertion). This lasted 3-4 days & appeared to be lessening until day 7 (2/26), at which point, the site became extremely itchy with raised bumps. I accidently scratched it once without thinking about it.  After that point, the bumps flattened out & only a large, red rash appeared (5" long x 4" wide) around my arm. To alleviate the itching, I took Benedryl overnight & have been icing it in the evenings only. It itches when I first wake up, but less during the day (likely because I'm distracted with work). I just picked up generic topical analgesic itch stopping cream after speaking to the pharmacist. He told me that if the rash doesn't start healing in the next day, that I should get an Rx for steroids for which I will need a dr's appt.
3 moderna vacccines  Pharmacy 4-15-21; 5-13-21; 11-23-2021; bivalent pfizer 9-21-22 at local Health Services. Tested + for covid   10/19/2022   had a  fall and not eatig and not taking meds earlier in October.  Later had mucus plugging requiring mech ventilation 10-18-22.  extubated 10-21-22.  became obtunded and bradycardic.  and had shock.  reintubated til 10-31-22. blood cultures + for Klebsiella.  sputum cultures had pseudomonas.  given rocephin and merram,  Anemia requiring transfusion.  small Pulmonary embolus in left lower lobe.  distal bracial vein thrombosis.   Reintubated from 11-7-22 to 11-11-22.   It was decided no intubation, no debrillation or chest compressions .   She passed away 11-17-22 with acute on chronic resp failure hypercapnia and hypoxemia
This spontaneous report has been received from a medical assistant, referring to patient of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On an unknown date,  the patient was vaccinated with a dose of an improperly stored VARIVAX (route of administration, dose and frequency were not provided) for prophylaxis  lot # reported as L015460, expiration date 20-JUL-2017. The reporter stated that the current temperature range of the vaccine excursion was15 Fahrenheit (F) and the time frame was 8 hours. On 06-OCT-2016, the previous temperature excursion was 31 Fahrenheit (F) during 3 hours, this information was registered in a data logger. No adverse effect was reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA000942:
Shortly after receiving the vaccine (within 10 minutes) the patient's tongue swelled, facial redness, gasping for air.  This resident was marked for a 30 minute observation due to previous anaphylaxis type reaction.  Immediately administered 0.3mg epinephrine x 1 dose. Then administered 50mg IM Diphenhydramine. This treatment course resolved the adverse reaction. Patient was monitored onsite at facility. Her husband came to pick her up and take her home.  Tried to reach patient several hours after but was unable to at this time.
Local reaction; fatigue; weak; headache; fever and malaise per mom on 9/18/1998.
10 min after vaccine had numbness and tingling primarily on hands but also arms. This persisted for a couple of months including a buzzing sensation like after you've had an electric shot, it progressed to the legs with slight loss of sensation and altered sensation, when hands pointing down a feeling of having a rubber band around the wrist, as of two weeks ago it's on and off.
I woke up lightheaded the following morning which prompted me to take my BP. It was extremely low for me at 109/66. Three hours later it was 101/62 with temp of 99.2. By 2:30 on same day it was up to 127/72 which is still lower than my normal.
Approximately 2 months after my second dose I was diagnosed with shingles due to numerous sores being present on my back and chest.
Pt woke up with her arm painful, swollen and hot at injection site. On the third day, the pain went around her shoulder to the other arm, and her left arm from her elbow up was swollen. She felt feverish and nauseated, had cold chills, and a headache for 2-3 days after injection. She came into the health dept on 8/15/11. Her arm above her elbow was tight, hot, swollen, and red. She denied fever, headache and nausea at that time. She went home and used ice packs, and ibuprofen. After 1 week she was back to normal and she denies any problems now.
URI symptoms began on or about 11/6 progressing to asthmatic bronchitis on 11/13/02 with known history of asthma. Continue with asthma symptoms and swollen left thigh for ? exposure. Fever at times.
Initially had small reaction of itchiness (all over body) within 1 hour of vaccination; resolved with use of Benadryl  Friday, May 14th several hours after vaccination, a red, hot, itchy, painful spot appeared at injection site about the size of a quarter. Started taking Benadryl regularly at this point. By Saturday  afternoon, the spot had grown to the size of a whiffle ball in diameter and swollen to the point that it looked like there was an egg under the skin. It was extremely hot and painful to touch/movement. Continued Benadryl and added ibuprofen and ice pack. Size and pain unchanged with medication although itching decreased. Saturday night pain began radiating down arm into fingers and up into shoulder. Sunday spot continued to grow to size of softball with increasing levels of pain throughout arm. Continued Benadryl, ibuprofen and ice pack. Upon waking Monday, spot had continued to grow - no longer in a circle. Center of spot slightly discolored (darker almost like a light bruise). Pain stayed same as Sunday. At 11:30 am on Monday, had consult with Teledoc doctor who suggested immediately going to ER for suspected cellulitis. Spent 12:30 pm to 5 pm at ER where they did blood work and prescribed anti-biotics. Tuesday morning, spot has grown just a little, pain at touch still present, radiating pain not as intense.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 08-FEB-2019, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis (product storage error). No adverse effect was reported. The LIQUID PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
Headache and pain on left side of head and face.  Numbness on left side of mouth and lips.  Diagnosis: Bell's palsy.  This was confirmed by a CT Scan.   Doctor prescribed the following medications:  prednisone (10mg) Three tablets, two times a day for five days and Valacyclovir commonly known as Valtrex (1000mg) three times daily for seven days.   All returned to normal in about three (3) weeks
1/5/22 pt brought to ED with c/o vomiting, diarrhea and not eating; found to be anemic and positive for COVID; CT of abdomen showed bilateral mass-like lesion; admitted; received 3 units PRBCs; AKI on CKD; hemodialysis; pt's condition worsened; became unresponsive; PEA; ACLS initiated; ROSC achieved; pt intubated and on mechanical ventilation; transferred to ICU; pt's condition continued to decline; made DNR and comfort care; pt expired in the hospital
Pt reports extreme soreness and rash near injection site and edema. Soreness kept her awake X 2 nights.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.  The patient received booster dose of Moderna vaccine and Fluarix (379TF, intramuscular, at right deltoid) on the same day.   This case was linked to MOD-2021-370138 (Patient Link).
Employee received MMR 8/19/04 around 15:45 . She started to feel like her mouth and throat were swelling; her eyes were very puffy and watery. She had some dyspnea and a pruritic papular rash on her face. She went to the urgent care clinic and received Benadryl injeciton. Also complained of pain, swelling and redness around injection site and weak, heavy feeeling in that arm.