chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body was really heavy to maneuver.; Tiny headache.; Rash on lower legs and feet.; I felt like my body was really heavy to maneuver; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's and diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Patient had no allergies to medications, food, or other products. The patient received other vaccines within four weeks prior to the vaccination which included adalimumab (HUMIRA) via an unspecified route of administration in the right thigh on 14Apr2021 for an unknown indication. On 16Apr2021 at 15:30 the patient felt that body was really heavy to maneuver, tiny headache and rash on lower legs and feet. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body was really heavy to maneuver, tiny headache and rash on lower legs and feet was recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm got really swollen, and red; he's been fussy, decrease in appetite. Have give Motrin. 07/22/2002 arm cont. swollen hard, but child better now.
Information has been received from two nurses referring to a 61 year old female patient. The patient was allergic to sulfa, developed an unspecified rash to unspecified sulfa products on an unknown date, and received PREVNAR 13 on 26-SEP-2014. On 25-MAR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K020214, expiry date: 25-MAR-2016, 0.5 ml, intramuscularly. On the same day, the patient developed severe pain and swelling from her "shoulder to her elbow" of an unspecified arm, and had a fever of 100.5F. On 26-MAR-2015, the patient had a fever of 101.8F. On 27-MAR-2015, the fever was tested as 99.9F and at later of that afternoon, the patient had a fever of 100.2F. And on the same day, the patient developed a dark pink area at the injection site that was 2-3 inches wide. The patient sought medical attention by calling the physician's office to report her reaction on 27-MAR-2015. There was no treatment given to the events and no lab diagnostics studies were performed. The pain and swelling from the patient's shoulder to her elbow was "reduced" on 27-MAR-2015. The outcome of other events was unknown. Additional information has been requested.
Entire arm sore, shoulder and elbow throbbing with pain. Underarm pit area swollen and sore. Severe headache interrupting and preventing sleep. Extreme malaise.
IM given in left arm 3rd dose, (Booster). Moderna Covid-19 Vaccine Lot 045C21A given was removed from freezer on 10/6/21 @ 11:45 am. Given on 11/5/21, out of time range. Patient contacted that evening. Moderan manufacturer called. Patients called the following Monday letting them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them. Called patient today 11/17/21 and let him know that Moderan let us know the vaccine was vlable, no additional booster vaccine is required.
This spontaneous report as received from a Nurse Practitioner (Prescriber) referring to a 14-months-old patient. The patient's historical conditions, concurrent conditions, historical drugs or allergies were not reported. The patient's concomitant therapies included sterile diluent. On 07-SEP-2018, the patient was vaccinated with M-M-R II (strength, dose, frequency, lot # and expiration date were not provided) dose 1 for prophylaxis, and on 03-OCT-2018, the patient was vaccinated with M-M-R II dose (Inappropriate schedule of drug administration). No adverse effects were reported.
No additional AE information provided.; HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline administering it to patients/accidentally; the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering it to patients; This spontaneous report was received from a registered nurse and referred to a 15-month-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-SEP-2022, the patient was going to receive the 15-month booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #W002453, expiration date: 24-JUN-2024, strength, dose, frequency and route were unknown) for prophylaxis. During the preparation, the vaccine was diluted with sodium chloride (NORMAL SALINE) 0.5 milliliter (ml) (strength, lot #, expiry date, route of administration, and indication were not provided) and then drawn up 0.5 ml of the mixed solution and administered it to this patient (vaccine preparation error, accidental underdose). No additional adverse events were reported.
cold symptoms, throat, horrible headaches, low temps, body aches, extreme tiredness( hard to keep eyes open)
SBO (small bowel obstruction) - She was admitted to the hospital and was initially managed with conservative management with NGT decompression, serial exams and symptom management. She had a gastrografin small bowel follow through (SBFT) on 12/23, contrast did not move through to the colon, hence she was taken to the OR on 12/24 by Dr. for a diagnostic laparotomy, lysis of adhesions and small bowel resection. She tolerated the procedure, she receive IV abx for four days given risk of abscess s/p succus spillage intraperitoneally. An abdominal CT was obtained on 12/30/2021, which revealed a large abscess adjacent to the anastomosis, and a drain was placed under ultrasound guidance later that day. She was restarted on IV antibiotics. Throughout her hospital stay she received TPN for severe malnutrition and eventually transition to adequate PO prior to discharge. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Onset of feeling tired; Irritable; Headache; Fever (not documented with a thermometer); Achy arm; This is a spontaneous report from a contactable physician. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 16Apr2021 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included iodine contrast allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if the patient received any medication within two weeks of vaccination. On 16Apr2021, starting 3 hours after the second dose of the Pfizer COVID vaccine, the patient experienced the onset of feeling tired, irritable, headache, fever (not documented with a thermometer) and achy arm. All the events resolved within about 3 to 4 hours except for local arm ache which the patient felt was not unusual for a vaccine. The patient was the reporter's friend and she had called on 18Apr2021 and related the above, "so that you can report it". The reporting physician was not the patient's physician. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events feeling tired, irritable, headache, fever and achy arm were resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
On April 6, the day after the vaccine, she started to experience a slight discomfort in her left eye (tear duct area).   On Wed,. April 7, extreme pain was experienced in the same area and she went to the emergency room.   They could not diagnose the problem.  Nothing in her eye.  Pain has been on-going ever since.  Neurologist thought it could be trigeminal neurology, so Gamma Knife Surgery was performed.  No help.   Now on pain medication.   She was in a car accident in her teens and her left eye socket and cheek bone were damaged.   I believe some nerve damage was also  a result of the accident.   I now believe that the vaccine may have triggered an autoimmune response which attacks the nerve in her eye  (small fiber neurothphy).    This has been terrible for her and has changed our lives.
It stated with a mild headache and neck pain but after a week it saw sever and my jaw starting hurting. Though I had toothache, went to doctor, was told everything was fine and wasn't sure what was leading to pain. Made an appointment with my physician. My appointment was in 2 weeks, through this two weeks I was told by family and friends that my voice has changed, and I was loosing lots of hair, sweating very easily (especially night sweat. It was now March and I had lost 11 pounds, I was fatigue and didn't have energy to do any activities. During my visit, told my doctor all my symptoms, did my vitals, all was within the normal range and she ordered for me to get blood works done. Which I did, which I was waiting for my blood works and to hear back from my doctor. The next day I couldn't move with ease, if I moved fast, or run up/down the stairs, I run out of breath and felt nauseas and dizzy. I felt my heart racing really fast, that I could hear it. I checked my BP and HR, my HR was in 140s. I immediately emailed my Dr. and after looking through my lab results she referred me to an endocrinologist. We found that my thyroid was over acting. I was given Propranolol to control my symptoms. But as I waited for my next appointment with the Endocrinologist, my symptoms resolved, was asked to do another thyroid labs and CT scan. CT scan was normal, my thyroid was now almost in normal range (without even starting any medications).
Patient had severe urticaria, skin rash/irritation over a large area of her body (back, chest, sides) . She went to the doctor and they prescribed a oral steroid.
her blood pressure was 235/145; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (her blood pressure was 235/145) in a 68-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (her blood pressure was 235/145). At the time of the report, HYPERTENSION (her blood pressure was 235/145) outcome was unknown.            On an unspecified date, the patient's CT scan showed negative fluid. Concomitant medications were not provided. Treatment information was not reported.
Burning sensation from the injection site down to her elbow; Not feeling well in general; Soreness; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation from the injection site down to her elbow), MALAISE (Not feeling well in general), PAIN (Soreness), FATIGUE (Fatigue) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Hypertension and Cholesterol.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation from the injection site down to her elbow), MALAISE (Not feeling well in general), PAIN (Soreness), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Arthritis, at a dose of UNK dosage form and DIURETICS for Hypertension, at an unspecified dose and frequency. On 10-Feb-2021, MALAISE (Not feeling well in general), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. At the time of the report, BURNING SENSATION (Burning sensation from the injection site down to her elbow) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-099179 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient Email address was not provided.
pain in the arm pit; This case was reported by a nurse via call center representative and described the occurrence of axillary pain in a 9-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number HY2XM, expiry date 30th June 2020) for prophylaxis.   On 29th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, unknown after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced axillary pain. On an unknown date, the outcome of the axillary pain was unknown.   It was unknown if the reporter considered the axillary pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were received as follows: The patient complained of pain in the arm pit area on the side of injection after receiving Fluarix. The reporter consented to follow up.
Within 24 hours of getting vaccine severe fatigue and drowsiness developed which lasted for 10 days.  At the same time tickle in the throat without sore throat and lingering cough developed.   Cough is still lingering but severity has gone down somewhat after Prednisone pack
Pt vaccinated with Meruvax II developed swollen joints, headache & paresthesia in feet & intermittent rash. Platelet count 106000. ANA neg, Rheumatoid factor negative & sed rat - normal. Arthralgia persisted.
HAd trembling, heart racing, chest tingling some difficulty swallowing and swelling of the tongue.  She premedicated with benadryl.
Aching. Starting to develop low grade fever. Itching that resolved itself w/in 24 hours. Pain in left arm.
This is in follow-up to report(s) previously submitted on 8/14/2007. Additional and follow up information has been received from a medical assistant concerning a 15 year old female who on 11-JUN-2007 was vaccinated intramuscularly with the first dose of Gardasil (Lot#656371/0181U). On 11-JUN-2007, post vaccination while still in the physician's office the patient experienced "numbing of her entire arm and she couldn't move it". The medical assistant reported that after the patient waited approximately 15 minutes in the office she was fine". Follow-up information received stated that the patient found the injection site very painful. The patient was considered to have recovered from the event. Additional information has been requested.
Hospitalized 01/14/2022-still currently admitted; COVID-19 positive 01/02/2022 (per notes) COVID-19 positive (hospital records) 01/14/2022; fully vaccinated  ASSESSMENT / PLAN:   Acute toxic metabolic encephalopathy, improving - currently A&O x1, baseline A&Ox3-4 - CT head negative for acute process - ammonia WNL, check TSH - EEG, MRI brain - check UA - neuro checks   Transient hypotensive/hypoxic episode - monitor labs/VS - interrogate PPM, cardiac monitoring, check ECHO - check AM cortisol   Mild lactic acidosis - Lactic 2.2, continue IVF and recheck AM - 0/4 SIRS criteria met, likely related to hypovolemia, doubt infectious process   COVID-19 Infection - pt daughter, pt tested positive around 1/2-1/3 and has been relatively asymptomatic - CXR: probable vascular congestion vs viral process - no indication for steroids d/t no hypoxia, out of window and no indication for remdesivir - monitor VS - supportive care  01/18/2022 notes: COVID-19 Infection - Patient tested positive around 1/2-1/3 and has been relatively asymptomatic, mild cough - CXR shows probable vascular congestion vs viral process - Decadron not indicated as he is not hyopxic - Out of time frame for Remdesivir 01/25/2022 notes: Acute toxic metabolic encephalopathy, improving New right facial droop New right upper extremity weakness - CT head negative for acute process - EEG without evidence of seizure activity - Ammonia and TSH WNL - Stroke RRT called 1/16. NIHSS was 9, but 4 when corrected for baseline deficits. Decision was made to hold off on tPA.  - CT head and CT perfusion without any acute process that would correlate with patients symptoms. Incidental finding of small area in right cerebellum noted that may have hypoperfusion.  - CTA head/neck with areas of moderate stenosis, but no large vessel occlusion - Neurology consulted - MRI without acute abnormalities decrease ASA 325 to 81 daily - Lipid panel WNL. Continue statin for CVA prevention.  - A1c 7.2 - MRI brain w/o acute abnormalities  SLP recommending NPO. Oral medications discontinued. Initiate comfort measures.  Appreciate palliative care input.  Dispo:  Palliative care team met with patient regarding goals of care discussion.  Comfort measures initiated.  DPOA activated.
fell down the stairs; unable to speak; unable to  move her left side; Patient received COVID 19 and was not feeling well afterwards.; This is a spontaneous report from a non-contactable nurse.  A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), intramuscular on 13Jan2021 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.   On 13Jan2021, after the vaccine, the patient was not felling well and the patient called out of work on 14Jan2021.  On 16Jan2021 at 03:00, the patient fell down the stairs and was unable to speak or move her left side. She was taken by ambulance to the emergency room and admitted to neuro intensive care unit. She was treated with unspecified medications. She was in the hospital for 12 days from 16Jan2021 to 28Jan2021. From 28Jan2021, she was in rehabilitation. The clinical outcomes of the feeling unwell, fall, unable to speak, and unable to mover her left side was not recovered. The events were reported as serious for hospitalization and being life-threatening.     No follow-up attempts are possible; information about lot number cannot be obtained.; Sender's Comments: On 13Jan2021, after the vaccine, the patient was not felling well.  On 16Jan2021 at 03:00, the patient fell down the stairs and was unable to speak or move her left side.  A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) to the onset of events feeling unwell, fall, unable to speak, and unable to mover left side cannot be excluded.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Red, swollen, warm to touch, no drainage, painful to touch, site was double size of none effected leg.
On 12/11 at 1434 at the local vaccination site, I (patient) was informed by the EMT in observation that a patient was having an adverse reaction. Upon further inspection a 7-year-old female patient was breaking out in hives on her cheeks. After getting a medical history from the parents, it was determined that the patient had no known allergies and that a similar reaction had happened with her first vaccine after she had left the clinic. The patient was given a 12.5 mg benadryl chewable tablet and kept for further observation. After ten minutes, the patient had the hives spread to her nose but the parents insisted that she was okay. The patient had no swelling or tingling. The patient was given another chewable benadryl tablet (per instructions) and the family left the site.
had a stroke that left him paralyzed; had a stroke that left him paralyzed; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 at 09:45 (lot number: EW0158) as SINGLE DOSE for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 27Apr2021 at 11:15, the patient had a stroke that left him paralyzed. The events  resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. The events were considered serious (hospitalization, disability, life threatening). Therapeutic measures were taken as a result of the events which included full stroke treatment (as reported). The patient had Covid-19 nasal swab test with unknown results on 27Apr2021. The outcome of the events was recovered with sequel.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician refers to a 35-month-old patient. There was no information about the patient's pertinent medical history or drug reactions and allergies provided. On an unknown date in 2000 (reported as at age of 15 months), the patient was vaccinated with the first dose of M-M-R II injection for prophylaxis (exact dose, vaccination site, rout of administration, lot and expiration date were not provided). On an unknown date in 2002 (reported as at age of 2 years 11 months), the patient was vaccinated with the second dose of M-M-R II injection for prophylaxis (exact dose, vaccination site, rout of administration, lot and expiration date were not provided). Concomitant therapies included STERILE DILUENT. No adverse effects were reported.
Fever; Chills; Body Aches; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-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 PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body Aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  No side effects were reported with the first dose of the vaccine.
Soreness around injection site, body aches, low-grade fever (100-101°F).
After my 12/1 booster shot ( pharmacy), I had a miscarriage on 12/2.
Hives, tightness in throat. ER IV fluids, IV Solu-medrol, IV Benadryl, Benadryl, IV Pepcid PO, Prednisone, PO x SD, P O Zyrtec, Zantac, Nexium