chrisvoncsefalvay/vaers-outcomes huggingface dataset:
02/04/2022 - test result +. Patient was already aware.  30 yo no pmhx presents from quarantine site for cough, chest pain, body aches. Pt  symptoms started 4 days ago, worsening. Tested positive for flu and coronavirus  yesterday, started on tamiflu. HOwever overnight symptoms worsened and pt now  with chest pain, 7/10, center of chest, non radiating, worsened by coughing. Seen  by PHN who noted that her heart rate was grossly elevated. Took tylenol 30 min  PTA, allergic to ibuprofen.  02/04/2022 - This patient meets inpatient  level of care because of: Covid, Flu A  02/05/2022 - 30 year old FEMALE currently on (Privacy) was admitted on FEB 4,2022 17:24.The patient is being discharged 05-Feb-202
Developed an infection at the injection site; 5 days after shot I developed a cold. I never get a cold. It's basically in my chest; 2 weeks after shot my arm is still red an inch or two below where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (5 days after shot I developed a cold. I never get a cold. It's basically in my chest), VACCINATION SITE INFECTION (Developed an infection at the injection site) and VACCINATION SITE ERYTHEMA (2 weeks after shot my arm is still red an inch or two below where I got the shot) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and #040A214) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (2 weeks after shot my arm is still red an inch or two below where I got the shot). On 14-Mar-2021, the patient experienced NASOPHARYNGITIS (5 days after shot I developed a cold. I never get a cold. It's basically in my chest). On an unknown date, the patient experienced VACCINATION SITE INFECTION (Developed an infection at the injection site). At the time of the report, NASOPHARYNGITIS (5 days after shot I developed a cold. I never get a cold. It's basically in my chest), VACCINATION SITE INFECTION (Developed an infection at the injection site) and VACCINATION SITE ERYTHEMA (2 weeks after shot my arm is still red an inch or two below where I got the shot) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medicines includes antibiotic for 3 weeks.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-272299, MOD-2021-272299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Added New event and  Event Outcome. Second dose information were added. On 30-Jul-2021: Follow-up contains no significant information.
Patient had swelling at the injection 2 days post injection. Patient went to local walk-in clinic and was determined to have cellulitis at the injection site.
Upper airway narrowing resulting in stridor; drove to HCF and received IM steroids and started a steroid dose pack to alleviate upper airway swelling. Of note when sick with the virus in 2020, this was a complication for me of the virus.
The patient's father reports that in 2019, the physician office did not have records of administration, and a fourth dose was administered; This spontaneous report was received from a consumer referring to his daughter as a 17 years old female patient. The patient had none pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant.  On unknown date in 2016, when the patient was 15 years old, the patient completed the 3 dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number and expiration dates were unknown).  On unknown date in July 2019, the physician office didn't have the records of administration, and a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Extra dose administered) as recommended by pediatrician for prophylaxis (route of administration, lot number and expiration date were unknown by the reporter). The consumer reports that the physician office did located her records of prior vaccination. The consumer was considering speaking with Legal Counsel regarding the mishandling of his daughter's medical records and possible side effects of extra dose administration. It was also reported that the patient didn't sought medical attention and none laboratory diagnostics or studies were performed.   The outcome of extra dose administered was unknown.
Before Oct 6, 2011, I was an active person. I took care of 160 acres of land, 50 head of cattle and 20 goats. My husband worked for 14 days and then home 14 days. On Oct. 6 I had the shot and felt the first effects on Oct. 15. Was sitting on a bale of hay and could not get up. My husband had to help. Later that evening my legs started to ache. I had started taking a cholesterol pill in Sept and I figured from what I had heard and read that this was causing it. This continued through November when I fell and the numbness & tingling started. Even into December, this kept up, but by January 2012 my balance went. This is when I went to dr, my family doctor. He did blood work and sent me to another dr who ordered MRI's and did part of an EMG on my right side. The MRI showed a mass in my stomach, so I was sent to a dr & had surgery on Feb. 14, 2012, no cancer was found. She referred me to dr (neurologist) who saw me in the hospital the next day Feb. 15. He examined me and told me I had GBS. No one ever mentioned flu shot until April 4 when I had CTS surgery with dr. The nurse with me and some of her friend had gotten it about 10 years before right after flu shots. That is when my time line all fell into place. No one would comment on it, so we started checking on our own. Dr had told me after the EMG that what I had was permanent. There was nothing that could be done for me. I now am walking with a cane or walker, can't step up without help, and live with the numbness, tingling and pain. I can no longer take care of the land and cattle and we had to sell my goats. The worst part is telling my little 2 1/2 year old grandson I can't sit on the floor and play, run or walk with him. I now sit back and watch others have fun. So much for the golden years.
Patient arrived for flu shot. Last year she received Afluria flu vaccine and had blisters on the posterior palms bilateral to fingertips. Notified and stated okay to give vaccine. Plan discussed with the patient if reaction occurs to take Benadryl ASAP and call the clinic At, 3:30pm the patient presented to clinic. She has started developing hives that were on the bilateral palms to fingertips, left more than right. She denied any chest pain. Shortness of breath, angioedema itching. She had taken a Benadryl immediately after receiving vaccine. Dr. evaluated the patient, he stated that she should continue taking Benadryl until the hives resolves, Take as directed on the packaging. She was advised to never received the vaccine again in her lifetime.
3rd dose of Shingrix; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ) and Shingrix (2nd dose received on an unknown date ).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced Extra dose administered . On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to Extra dose administered.
Majority of the vaccine" was not administered to the patient; During the administration the vaccine squirted into the patient's eye instead; The needle connecting to the syringe was detached and the vaccine squirted from the connector joint; The needle connecting to the syringe was detached and the vaccine squirted from the connector joint; This spontaneous case was received on 07-Jan-2022 from other healthcare professional (nurse) via regulatory agency (reference number: SEQW22-00095) with additional information (being processed together) received on 11-Jan-2022 and 18-Jan-2022, and concerned a 64-year-old, female patient.  The patient's medical history and concomitant medications were not reported.   On 07-Jan-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml; route of administration, anatomical location: not reported) for seasonal influenza prevention. The batch number was reported 308467 and expiry date 30-Jun-2022. It was reported the Luer Lok Syringe component of the combination product Flucelvax Quadrivalent  has been identified with a malfunction (leak).  The nurse stated that while administering the Flucelvax Quadrivalent vaccine, the needle connecting to syringe was detached and the vaccine squirted from the connector joint (explicitly coded as 'Device disconnection issue' and 'Syringe leak'). Furthermore, it was reported that the vaccine only 'flushed into the patient's eye' and not into administrator (explicitly coded as 'Accidental exposure to product'). The nurse also reported that 'most of the vaccine' was not administered to the patient (explicitly coded as 'Incomplete dose administered').  At the time of initial reporting on 07-Jan-2022, no adverse events were reported after Flucelvax Quadrivalent administration.  This case has been entered onto manufacturing quality assurance tracking database and allocated.  The case was assessed as non-serious.  Company comment: A 64-year-old female patient was vaccinated with Flucelvax Quadrivalent (explicitly coded as 'Device disconnection issue', 'incomplete dose administered' and 'Syringe leak'). Besides, it was reported that the vaccine only 'flushed into the patient's eye' and not into administrator (explicitly coded as 'Accidental exposure to product'). Causality for the reported events is assessed as not related to the vaccine and related to the luer lock syringe.; Sender's Comments: A 64-year-old female patient was vaccinated with Flucelvax Quadrivalent (explicitly coded as 'Device disconnection issue', 'incomplete dose administered' and 'Syringe leak'). Besides, it was reported that the vaccine only 'flushed into the patient's eye' and not into administrator (explicitly coded as 'Accidental exposure to product'). Causality for the reported events is assessed as not related to the vaccine and related to the luer lock syringe.
Patient received vaccine beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided. no treatment information was provided. The vials were in refrigerator for over 30 days.   This case was linked to MOD-2021-338604 (Patient Link).
very negative reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (very negative reaction) in a female patient of an unknown age 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 VACCINATION SITE REACTION (very negative reaction). At the time of the report, VACCINATION SITE REACTION (very negative reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
I didn't have any symptoms that night but when I woke up I had all over body aches especially on my left side, back, and arm where shot was and then I was tired throughout the day and I took 1/2 day off work to get some sleep later on in the afternoon and the other symptoms went away but my arm pain got worse and then I had a lot of pain in armpit area and lymph nodes were swollen so I called my Dr and I was having trouble sleeping because of the pain and the Dr responded in the middle of the night and they said it was normal to have the immune response to swollen lymph nodes and to use a warm compress and Tylenol.
Developed hives (urticaria) 1 hr after immunizations. Also had ingested chocolate prior to vaccine administration which causes rashes.
Pt experience dizziness and fainting beginning 9/6/17 and a low grade fever, dizziness, although improved, still exists.
mom states w/in 1 hrs p/vax inject site became red & swollen; area is bigger than fifty cents piece & warm; reddness noted, temp 100.8 last PM;
After administration, spoke with parent for approximately 10 minutes in the administration(counseling) room. While speaking with parent, my back was turned to the patient. Patient fainted, hit the wall then started to slide down the wall of the counseling room.I was able to guide her to the ground without injury. She awakened almost immediately and stated "did I go to sleep?" Patient did not appear upset.  Remained in the floor for approximately 5 minutes. Provided a cold Sprite beverage. Patient drank and was soon able to arise with assistance. Observed for approximately 10 more minutes. Parent and child left soon afterwards with no ill effect observed.
extreme tiredness, low garde(100) fever, muscle aches, headache has lasted, but with diminished severity for two days.
Herpes Zoster Shingles on right side front to back. Went to MD. prescribed Valtrex. Blisters and pain for several weeks.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. On 19-MAY-2015, the patient was vaccinated with improperly stored M-M-R-II (route of administration and dose were not reported) (lot number reported as: K016152, expiry date: 24-SEP-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Loss of Efficacy- The patient contracted Covid-19.; Loss of Efficacy- The patient contracted Covid-19.; administration date: Sep2021, dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Sep2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy (post Graves disease)" (unspecified if ongoing), notes: Other medical history: Thyroidectomy (post Graves disease). Concomitant medication(s) included: SYNTHROID; CYTOMEL.  The following information was reported: IMMUNISATION (medically significant) with onset Sep2021, outcome "unknown", described as "administration date: Sep2021, dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovering" and all described as "Loss of Efficacy- The patient contracted Covid-19.". The event "loss of efficacy- the patient contracted covid-19." and "loss of efficacy- the patient contracted covid-19." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with monulpiravir.  Clinical course: No other vaccination was reported in 4 weeks. No known allergies were reported. Covid prior to vaccination was reported as no.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Medical assistant mixed Shingrix with  the wrong diluent. She mixed the powder  form w/ sterile diluent, instead of  Lyophilized gE antigen, No adverse  reaction occurred.
Patient admitted to hospital after 2-3 days of shortness of breath and calf pain, swelling in foot distal to calf with pain.  Admission date 4/23, vaccinated with second moderna dose on 4/12 Two clots identified: right lower extremity DVT "Positive study for acute DVT in the right lower extremity, extending from  the calf veins up through the right external iliac vein.   Positive study for acute superficial thrombophlebitis involving the  imaged lesser saphenous vein."  and PE: "Acute pulmonary embolism involving the main pulmonary arteries (saddle  pulmonary embolism) and extending to the lobar, segmental branches  bilaterally with some extension of the subsegmental branches in the right  lower lobe, overall worse in the right lower lobe with occlusive  segmental branches. "  Was initially started on lovenox when admitted, switched to Eliquis, no IVC filter was placed discharged in stable condition on 4/26,   Of note: Patient had bone marrow biopsy of right iliac crest of April 15th 2021 - carries diagnosis of chronic lymphocytic leukemia but is currently in remission
12/4 after shots patient reported red streaks and swelling in right armpit and around upper arm. Arm tender to touch painful with movement, bearing weight. 12/6 was seen by provider, arm still red/tender. Was treated for cellulitis with Clindamycin and Zyrtec.
severe headache at back of head behind earon side of injection.; feeling a strong tingling in my neck, jaw and inner ear on side of injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8733) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 63-years-old) at 11:00 as a single dose for COVID-19 immunisation. Medical history included high cholesterol. No known allergies were reported for the patient. Concomitant medications included atorvastatin 10 mg (MANUFACTURER UNKNOWN) for unknown indication received within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19, since the vaccination. On 25Mar2021 at 12:30, about 1.5 hours after the vaccination, the patient started feeling a strong tingling in her neck, jaw and inner ear on side of injection site which stayed all day but lessened after about 6 hours. In the next day morning after 22 hours, on 26Mar2021, the patient had severe headache at back of head behind ear on side of injection. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events feeling a strong tingling in my neck, jaw and inner ear on side of injection site and severe headache at back of head behind ear on side of injection was resolving at the time of this report. Information about lot/batch number cannot be obtained. No further information is expected.
General weakness, nausea, vomiting, slept for more than 24 hours after sleeping the day of the shot (work nights). Effects lasted for 72 hours.
mom reported rash from hip to ankle on back of legs only (left);rash noted 6AUG98, seen by MD 10AUG98;tx w/DPH & westcort cream;mom stated rash still visible but fading on 19AUG98;
Per email sent by patient.. "I received my first COVID vaccine, Wednesday, January 13th, at vaccine clinic. Other than a minor soreness in the arm, I had no adverse effects. On Friday, January 22nd, however, the area around the injection site became red and warm. At this time, two days later, the inflammation continues and the reddish "patch" is beginning to itch. Just thought that you would want a report of this delayed reaction." Per conversation with patient, on this date 1/25/21, pt reports that she is still experiencing small amount of itching as well as redness and slight sensitivity to the injection site.  Pt denies need for further medical care, and that she is fine but thought we should know.
Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of   in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 12M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided by the reporter.  It was reported that the patient did not take any treatment medications for the events.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR Attached, event outcome updated.
Red rash; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 53 years old female patient who experienced red rash, while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Oct-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed a non-serious red rash (rash erythematous) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No laboratory data was provided.  Final diagnosis was red rash.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for red rash.  Information on the batch number was requested.