chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Pharmacist concerning an 11 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Pharmacist reported that the patient received only a half dose FLUMIST in one nostril which started on 11-Nov-2013 at one of the mobile clinics. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
From telephone contact with reporter stated that a 15-year-old female patient received a TD Adult vaccination on 6/18/01. The next day after vaccination the patient developed fever, muscle aches and nausea. Further information is requested.
Fatigue, chills, headache, heart palpitations, stomach pain, bruising, insomnia, change in mental status (depression), nerve pain in hands/feet
PATIENT PROVIDED VACCINE DURING VACCINE CLINIC AS SCHOOL SYSTEM EMPLOYEE.  NOTIFIED TODAY BY SCHOOL CLINIC NURSE THAT PATIENT COMPLAINT OF LYMPHNODE SWELLING AT RIGHT AXILLA WHICH STARTED 1 DAY POST VACCINATION.  PATIENT COMPLAINT THAT AREA IS TENDER TO TOUCH AND SWOLLEN.  REPORTED TAKING TYLENOL AND BENADRYL.  STATES THAT 2 DAYS POST VACCINE SHE "SLEPT MOST OF THE DAY".  TODAY, 03/29/21 SCHOOL CLINIC NURSE REPORTS THAT RIGHT AXILLA NODE REMAINS TENDER AND IS VISIBLY SWOLLEN.
Myalgia, Arthralgia, Severe arm pain right arm, swelling to right hand for a few weeks, difficulty swallowing saliva/food/liquids. Since November 2022 left foot pain.  Narrative: Employee did see a podiatrist for evaluation of foot pain, treatment included compression stocking, inserts, and recommended to file adverse vaccine event.
SOME SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced some side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210350170.  Version created to amend previously reported information on 25-MAR-2021. Upon review the following information was amended: Batch sentence in narrative corrected.
Malaise; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Nov-2021 and was forwarded to Moderna on 09-Nov-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021 at 8:00 AM, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MALAISE (Malaise) and HEADACHE (Headache) to be possibly related.    No concomitant products were reported.  No treatment drugs were reported.   This case was linked to MOD-2021-370370 (Patient Link).
pt recv vax JUL95 & was accidentally vaccinated w/a double dose of varicella vax;AUG95 pt threw up a blood clot;pt was fine for 4-6 wk afterwards;unspecified eval was neg;OCT95 pt devel a persistent cough;MAR96 pt threw up fecal;
Had a random cold, low grade fever , body aches, clogged/runny nose started 10 days after and lasted 4 days no treatment helped but Tylenol reduced fever
pt recv vax 18NOV98 & the nurse noted that the pt never had more than 1 hive @ a time & each hive was size of mom's fist;the hives lasted for hours;pt recovered;
4/28 vaccination 4/29 About lunchtime, I started having lower back pain, felt 'off'. Within 20 minutes on road, excruciating back pain. It was very bad pain;  8/10. I took Ibuprofen, called PCM (45 min wait for cb), icy hot cream on back. Four hours later went to a 4/10 pain level. By dinner time, I was uncomfortable but bearable. By the next day, the pain was gone.
Pt received Covid vaccine BUD. Vaccine expired on 10/13/22 and was given to pt on 11/10/22
Sore arm. Approximately 10 days later headache,  blood pressure elevated,  jittery,  dizziness and pressure in head. Dr changed current blood pressure medications. Blood pressure controlled but still experiencing jittery, dizziness and head pressure 2 weeks later
Tingly sensation in both arms and slow and heavy breathing.  Mask and morning exertion could have been a cause of the slow and heavy breathing.  Tingly sensation went away quickly.  The breathing issues resolved after inhaler was used and the patient drank some water.
Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 34 years old female patient who experienced redness, swelling and severe pain at the injection site and a little bit of dizziness, while she received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Mar-2019, the patient received a first 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6207AA and Exp. Date 25-May-2020) via unknown route in the right deltoid. On 17-Mar-2019, the patient developed a non-serious redness, swelling and severe pain at the injection site and a little bit of dizziness three days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 18-Mar-2019, the patient was admitted to the emergency room because the pain was so bad. Other relevant tests not reported. Final diagnosis was dizziness and vaccination site inflammation. The patient was treated with CLINDAMYCIN (x 3 days) and IBUPROFEN. The patient outcome was not reported for dizziness and vaccination site inflammation. List of documents held by sender: none.
Two patient / late for the second dose / first dose / on December 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose of Shingrix received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter mentioned that, patient did not received the 2nd dose. The patient's identifiers, LOT number and expiration date was not provided for the first dose. No exact vaccination date was provided. The reporter did not consented to follow up. This is 2 of the 2 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021129027:Same reporter. Patient #1 of 2.
Event: pneumococcal and influenza vaccine. Limping while taking walks, extreme muscle weakness, especially in right arm and right leg above knee. Walking and climbing stairs has become more difficult. Lab results show no arthritis. Have used Vioxx.
Severe sweating; Stomach cramps; Diarrhea; Severe chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Severe sweating), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), CHILLS (Severe chills) and VOMITING (Vomiting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced HYPERHIDROSIS (Severe sweating), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), CHILLS (Severe chills) and VOMITING (Vomiting). At the time of the report, HYPERHIDROSIS (Severe sweating), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), CHILLS (Severe chills) and VOMITING (Vomiting) had not resolved.            Concomitant medications were not provided. Treatment details were not provided.
warm arm at the injection site; very sleepy, could not stay awake; Very lethargic; Lump over area of vaccine; swollen arm; Red rash over the area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine) and PERIPHERAL SWELLING (swollen arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine), PERIPHERAL SWELLING (swollen arm) and RASH ERYTHEMATOUS (Red rash over the area). At the time of the report, VACCINATION SITE WARMTH (warm arm at the injection site), SOMNOLENCE (very sleepy, could not stay awake), LETHARGY (Very lethargic), VACCINATION SITE MASS (Lump over area of vaccine), PERIPHERAL SWELLING (swollen arm) and RASH ERYTHEMATOUS (Red rash over the area) outcome was unknown.            Concomitant medication were not provided by the reporter.  Treatment medication were not provided by the reporter.  Action taken with mRNA-1273 in response to the events was Not Applicable
Had stoke, Drs could not explain Couse, loss of use right side, will do 22 days in place therapy
Swelling right neck jaw area. Awoke with c/o right ear pain since 5:15 am. Pt took Ibuprofen at 5:20 am. States pains better. Parotid gland inflammation post MMR
Patient recieved first dose of covid 19 Pfizer. The dose given was 0.1ml vs 0.3mL IM. No adverse effect noted.
Rash on thighs 2 days following vaccines with left greater than R at the site of the vaccines. Rash was papular/red/similar reaction happened with first set of vaccines.
pt recv vax in 1995 & devel aching joints ("settled in bilat thumbs") & legs;sx have resolved;
Lymphedema in under arm area. Affected area is under the arm in which I received the vaccination.
Hospitalization: 10/21/2022 - 11/11/2022 (21 days) Presentation to the ED: shortness of breath. COVID + date: 10/21/2022. Treatment: Dexamethasone & Remdesivir.  Discharge to: hospice. Patient Deceased Date: 11/19/2022
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Relevant concomitant medications were not reported. Treatment information was not provided. This is a case of Expired Product Administered concerning a 43-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning a 43-year-old female patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
More than 36 days have passed since first dose; He went to see a doctor and an ultrasound was taken which showed a small hole in his heart.; felt tired; did not have energy; heart felt hot and cold; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (did not have energy), CARDIAC DISORDER (heart felt hot and cold), INTENTIONAL PRODUCT USE ISSUE (More than 36 days have passed since first dose), ATRIAL SEPTAL DEFECT (He went to see a doctor and an ultrasound was taken which showed a small hole in his heart.) and FATIGUE (felt tired) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ASTHENIA (did not have energy), CARDIAC DISORDER (heart felt hot and cold) and FATIGUE (felt tired). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (More than 36 days have passed since first dose) and ATRIAL SEPTAL DEFECT (He went to see a doctor and an ultrasound was taken which showed a small hole in his heart.). The patient was treated with VITAMIN D3 for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (did not have energy), CARDIAC DISORDER (heart felt hot and cold), INTENTIONAL PRODUCT USE ISSUE (More than 36 days have passed since first dose), ATRIAL SEPTAL DEFECT (He went to see a doctor and an ultrasound was taken which showed a small hole in his heart.) and FATIGUE (felt tired) 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.
One day post vax, the pt developed a high fever. The reporter indicated that 2 to 3 children experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sore arm, fever, chills, muscle weakness, leg cramps, fatigue, headache, body aches.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 4/13/21 (EW0153) Pfizer Dose 2 5/5/21 (ER8736) COVID Positive 1/3/22  1/3/22:  The patient presents with Patient has advanced COPD with chronic hypoxemic respiratory failure on home oxygen 24/7 at 2 liters/min. About 11 days ago she became ill with increasing SOB, cough productive of thick whitish sputum, malaise, fatigue, nausea, headache, and body aches. She was found to have Covid 19 pneumonia and is being admitted for IV remdesivir, steroids, fluids, nebs, and antibiotics PO2 on ABG in the ED was 60.  1/4/21: dmitted  01/03/2022, Discharged  01/04/2022, Patient was admitted yesterday due to COVID positive tests, hypoxia, shortness of breath and productive cough.  Patient states she has been sick about a week and has had 2 vaccines and came in yesterday because she felt that she could not breathe well.  Overnight the patient did well did not require any oxygen at all was able to eat and drink even go the bathroom and states she is feeling better. Patient received 1 dose of Levaquin room to severe and is medically stable.  Patient has home oxygen has chronic COPD and takes inhalers at home and sees a lung doctor.
Suffered ischemic stroke; This spontaneous case was reported by a patient and describes the occurrence of ISCHAEMIC STROKE (Suffered ischemic stroke) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 016M20A and 013L20A) for COVID-19 prophylaxis.     The patient's past medical history included Bypass surgery (Heart bypass) in November 2012. Concurrent medical conditions included Type 2 diabetes mellitus and Drug allergy (Had allergic reaction to unspecified drug).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2023 at 10:00 AM, the patient experienced ISCHAEMIC STROKE (Suffered ischemic stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 1 day due to ISCHAEMIC STROKE. At the time of the report, ISCHAEMIC STROKE (Suffered ischemic stroke) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 29-Dec-2022 at 09:30am, patient took co-suspect dose 5, Pfizer bivalent in left arm. Patient received co-suspect dose 4 from Pfizer tris-sucrose (12+) SARS-COV-2 (batch number: FP4554) in arm.  The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  The adverse event result in Emergency room/department or urgent care. Patient had CT scan, MRI, EKG, neurology visit, heart monitor.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not had been tested for COVID-19.  No treatment medication was reported.  Company comment-This spontaneous case concerns a male patient aged 74 years with relevant medical history of Type 2 Diabetes reported, who experienced the unexpected serious (Medically significant/Hospitalization) AESI event of Ischaemic stroke that occurred in the context of a dose of mRNA-1273 vaccination in covid -19 vaccination series. Latency cannot be assessed since date of vaccination was not disclosed. Patient had received initial 3 doses of mRNA-1273 and two doses Pfizer vaccines. It was reported that patient was hospitalized for one day, underwent CT, MRI, neurology review, EKG and heart monitor, details not reported. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment of the event was available in the report. Outcome of the event was resolving at the time of report. The relevant medical history remains as confounder and advancing age of the patient a risk factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient given Moderna Monovalent (o.5ml) versus Pfizer Bivalent (0.3ml) as a booster dose. Patient is 16 yo patient should have received Pfizer bivalent. Patient had no adverse reactions to medications. Patient was observed for 30minutes. Patient has n complaints. Aox4 response even and unlabored. skin warm and dry.  Parents and patient were both notified. Public health and Moderna were both contacted as well.
This child developed a mild chicken pox rash on 03/20/2001. No associated symptoms, no fever. the rash had increasing number of isolated, distinct erythematous macules or papules, some crusting vesicles, minimal.
He got his vaccines, and had someone with him, and he drove him home, and in the car around 2:00 he felt a little nausous.  Around 2:30 he felt like he was going to vomit or have diarrhea.  He then noticed he was perspiring diffusely, and lied on the bed and turned the ceiling fan on.  He then fell asleep and got up and it was 4:55 and those symptoms had subsided.  He noticed the other day that his arm is still red, and remains that way where the injection went in.  There is about a 6-8" circle in the upper arm.  The skin looks discolored and now is subsiding.  He did not take anything for his reaction.
Per mom: inflammation in armpit wrapped around to the front of his ribs. It looked like a flattened water balloon under his skin. No lymph node inflammation or pain. He could feel it when his arms were down near his body. He also had a fever, which resolved.
Days 3 and 4: Nausea, chills, fever of 100 1.5 hours after Excedrin and Ibuprofen Days 3-7: headache that is not relieved with acetaminophen or ibuprofen
12 minutes after injection, patient started experiencing jaw discomfort on the left side with sharp intermittent pain in the left ear
Chills, low fever, body aches, nausea, night sweating lasted 3 days. The first night I experienced my body shaking uncontrollably for about 45 minutes.
Pt had Flu and pneumonia inj. on 10/18/12. Came in on 10/19 and stated has hard and swollen arm and warm to touch on inj site. Pt had 2 OTC naproxen and didn't help. Went to EM and received Rx for KEFLEX and MD wanted to see pt if rash didn't decrease in size. Had 4 x 6 rash (inch) on arm. Cellulitis per MD.
Two days after I received the vaccine, starts of my body started twitching in my muscles in a way that I have never experienced before. It started in my thumb and my thumb would start twitching uncontrollably. Then, I felt it in my leg and spine. Then, it moved onto my face. I have videos of my lower lip and jaw twitching with muscles that I could not voluntarily move on my own even if I wanted to. It goes off and on, but certain muscles still sometime twitch during the day even though it has been almost a month since I became vaccinated against covid-19. I am seeing forums online of people having this same problem.