chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost my taste; lost my smell; This spontaneous case was reported by an other health care professional and describes the occurrence of AGEUSIA (lost my taste) and ANOSMIA (lost my smell) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (lost my taste) and ANOSMIA (lost my smell). At the time of the report, AGEUSIA (lost my taste) and ANOSMIA (lost my smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: This spontaneous case concerns a patient with no relevant medical history who experienced non-serious unexpected AESI of ageusia and anosmia, that occurred after the dose of the mRNA-1273.  The exact time to onset and dose number were not provided. The rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient with no relevant medical history who experienced non-serious unexpected AESI of ageusia and anosmia, that occurred after the dose of the mRNA-1273.  The exact time to onset and dose number were not provided. The rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Janssen COVID-19 Vaccine  13 days after receiving her Covid vaccine, the patient stated ?I have been experiencing bad headaches that makes the right side of my face numb and/or painful to the touch. Although I have had headaches in the past, these feel different.? Patient stated that she started noticing these headaches late in the week that followed that administration of the vaccine (beginning on or around 6/4/21) Patient also stated that she began developing stomach aches approximately one week following the vaccine administration (beginning on or around 6/6/21)
pt recv vax; had 5 wk of myalgia p/ vax; flu like sx dyspnea, tightness, denied inject pain;
3/13 vaccination. 3-4 hours later, I started having symptoms to include tickle in throat, post nasal drip. By 11:40 I had a HA, I was very tired, quite a bit of secretion. I continued taking Benadryl every 3 hours. At 2 :30 PM, heart palpitations and angina. My BP was 98/69. I took more Benadryl, drank some fluids. By 4:15, I was getting drowsy and tired, having pain in multiple joints through my body; 8/10 scale, especially in my hands in feet. I took something for pain. My arm was very sore. I had mild to moderate slight cough. By 7:40 PM I took my regular medication.  I was having a sudden intense HA and pain in joints was 9/10. I was having stiffness, chest congestion, feeling 'flu like' symptoms, brain fog, and weird pains / electro shock pains on extremities. By 830, my symptoms increased to almost a really bad allergic reaction. I couldn't think well, dizzy, cough, chest congestion and my lungs started to hurt. By 10:30pm, I started to have a low grade fever, pain 9/10, I took Ibuprofen and Benadryl every 3 hours.  3/14 Ibuprofen, slight fever, slight HA, joints were swollen and stiff; 8/10 on pain and stiffness. I had muscle pain and brain fog, could not say words. Dull pain back of head. My kidney area, I felt like it hurt, severe anaphylactic reaction it felt like. I still had photophobia. It continued into the evening. I continued taking the Benadryl and ibuprofen. Around 6pm, I had 101.5 temperature, nauseated, crying, chest congestion. By 10:45, my temp was going up again.  Monday I had low grade fever, continued medication. Symptoms continued for a few more days with palpitations, brain fog, pain in lungs and kidneys. I couldn't do anything. By the end of the week, I started to recover.  *My PCM knew before I got the vaccine they were on board and knew what was going to happen in regards to my reaction, EKG, I had epi pen, didn't pass out, I decided I was going to stay home.  *It took me a good couple weeks to recover to my baseline. But it was pretty tough.
This spontaneous report as received from a pharmacist via sales representatives refers to a 20 year old male patient. No information about medical history, concurrent conditions and concomitant medications were reported. Approximately on an unknown date in December 2013 (reported as 7 months ago) the patient was vaccinated with ZOSTAVAX (route and dose not reported). The reported stated that the patient was 20 year old patient and was administered ZOSTAVAX. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Patient's daughter came in and informed us that her Mother had her flu shot on 10/20/18 and has since developed a hard lump that is below and off to the side of the injection site. It is not painful to patient. It is warm and red in appearance. Told pt daughter to apply compresses to area and see how it does in the next few days. If it doesn't get better or worse told them to contact their PCP.
This case was received from a health care professional on 09 March 2009. A 29-year-old patient received a subcutaneous left arm injection of YF-Vax (lot number UF430AA) ON 06 March 2009. Within 24 hours of vaccination, she developed an elevated temperature, muscle aches, anorexia, fatigue, and a two-inch area of redness and swelling on the left deltoid. She was seen in the emergency room relevant testing and treatment were not reported.
Student felt dizzy three minutes after receiving vaccines. He looks pale and clammy. Denied any shortness of breath. Awake, alert, oriented, responds to verbal stimuli. Student is assisted to lay down on the cot with feet elevated. VS taken. O2 given.  V/S 3:08PM BP 82/48 HR 64 O2 sat 94% Laying down       3:13pm BP 117/67 HR 80 O2 sat 97% Laying down. Normal color       3:16pm BP 119/64 HR 77 O2 sat 97% Sitting        3:30pm BP  114/70 HR 82 )2 sat 97% Sitting Student went home with his mother in no acute distress. Normal color. Denied any dizziness.
The vaccine was diluted properly but the entire vial was administered to the patient; She did not use a flashpoint needle, but a regular needle and syringe.  She diluted the purple cap Pfizer BioNTech Covid-19 vaccine vial with 1.8 mL of diluent, then drew up the entire vial; The overdose only happened yesterday, and the patient has only reported a sore arm so far; This is a spontaneous report from a contactable Registered Nurse via Medical Information Team. This Nurse reported for a 65-years-old male patient who received bnt162b2 (Pfizer COVID 19 Vaccine, Solution for injection, Batch/Lot Number: EW0217, NDC number, Expiry Date: Unknown) via an unspecified route of administration in right arm on 10Nov2021 (age at vaccination: 65-years-old) as dose 3 (booster), 1.8 ml single for COVID-19 immunisation. No medical history (The patient denied medical conditions) and no other products were reported. Historical vaccine included bnt162b2 (Pfizer COVID 19 Vaccine) on 11Feb2021 as dose 1, single and dose 2 taken on 11Mar2021; both doses taken for COVID-19 immunisation. Reporter did not have any information about the patient's other two doses of the vaccines except for the dates. Reporter stated that she had never drawn up the vaccine before and did not read the instructions carefully. She did not use a flashpoint needle, but a regular needle and syringe. She diluted the purple cap Pfizer BioNTech Covid-19 vaccine vial with 1.8 mL of diluent, then drew up the entire vial and administered it as the booster dose to the patient. Stated that the patient was a 65-year-old male, and it was his booster dose of the vaccine. Reporter further stated that they had never drawn up a vaccine on their own and did not use a flash point needle to do so. The vaccine was diluted properly but the entire vial was administered to the patient. The overdose only happened yesterday (10Nov2021), and the patient has only reported a sore arm (on an unspecified date in 2021) so far. She was asking for information on that administration error. Reporter declined to provide patient's initials, name, date of birth, height, weight, or ethnicity, she was not comfortable providing any patient information. Reporter also declined to provide her mailing address, alternative phone number, or fax number. When probed for specific seriousness criteria for the patient receiving the entire vial of the vaccine the reporter replied only with no. The reporter was not comfortable providing more specific patient details or practice address, and provided her manager contact information to speak to for future follow up. Reporter denied labs, testing, No Investigation Assessment was there, and she denied treatments taken by the patient for these events. The outcome of the event "The overdose only happened yesterday, and the patient has only reported a sore arm so far" was unknown.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2014US021798 is an initial spontaneous report received from a pharmacist on 27 Oct 2014. This case refers to a 46 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with an expired dose of MENVEO (batch number: A12119 and expiry date: not reported), intramuscularly on 24 Oct 2014. No adverse event was reported following this administration error (expired vaccine used).
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route were unknown). No concomitant therapy was reported. On an unknown date (reported as "several months ago") the patient experienced rash. Then on an unknown date the patient had to go to an unspecified physician because of the development of cellulitis. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Onset memory loss issues, headaches, and difficulty concentrating that begin 4 days after booster vaccine.  I?m not 100% sure it is from the booster vaccine and have not reached out to my PCP at this time. My husband, close coworkers, and myself will be monitoring my memory and concentration over the next week and I will schedule a doctors appointment for further evaluation if things do not get better or worsen.
Felt faint; Throat itchiness; A report was received from a non-health care professional and experienced throat itchiness and felt faint.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020. On 22 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the patient felt faint and had throat itchiness. Treatment for the events included diphenhydramine hydrochloride and the events went away.   Action taken with mRNA-1273 in response to the events was not reported.   The events, felt faint and throat itchiness, were considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the events, felt faint and throat itchiness.; Reporter's Comments: This case concerns a subject, who experienced the unlisted events of dizziness and throat irritation. The events occurred on the same day after first dose of IP on 22 DEC 2020. The event was considered resolved on 22 DEC 2020. The events were considered related to IP due to temporal association. However, further details are requested to better assess the case.
No additional AEs reported; Expired MMR II vaccine administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 13-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, Live recombinant human albumin (rHA) (M-M-R II) (lot # T001214 and expiration date 12-JAN-2022), 0.5 milligram, subcutaneous for prophylaxis (expired product administered).
After the vaccines were administered, lesions appeared on the skin.  The lesions were raised and oozing.  One was behind the ear. Over the next 4 months, more presented on the arm, and torso.  The pediatrician and dermatologist presumed it was eczema, especially when a biopsy of the non-lesion area confirmed that the child also had eczema.  However, a lesion area on the child's thigh was finally biopsied on 2/23/08 and it was found to be psoriasis, an autoimmune disease. The child's psoriasis lesions did not respond to treatments with topical steriods or Protopic.  The lesions disappeared when child was treated with an oral nystatin suspension, only to return at the end of nystatin treatment.  Again, a second, third and fourth treatment with nystatin, cleared the psoriasis lesions. Between each nystatin treatment,successively smaller lesions reappeared.  Currently, the child does not have any lesions. On a Lymph culture stimulation test, the child makes a very limited response to candida.
swelling, pain and reduced ROM of the R shoulder, redness, warmth and axillary Lymphadenopathy
Woke up the following morning after shots- vomited twice and then got a fever of 103. Reduced fever with TYLENOL. Completely fine by 3 pm.
Dizziness, high blood pressure, stomach ache, headache, noise in my ears, pain all over. I lost 6 1/2 lbs. Almost fell down many times. Constipation, nausea on 11/2/14 I almost passed out. Could not move my bowels for many days. I was never so sick in my life. MIRALAX and other laxatives were given by my 2nd doctor.
No adverse events were reported in the patient; the patient received a dose of PEDVAX HIB at age 1 month 26 days; This spontaneous report was received from a medical assistant and refers to a 1 month and 26 day old patient of unspecified gender. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided.  On 26-JUL-2019, the patient received a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # R036177, expiration date 08-OCT-2021 (exact dose, dose number, route and site of administration were not provided) for prophylaxis. No adverse events were reported.
Initial symptoms on 7/21/2021 Fatigue, malaise,  dizziness, chills later on at night  Symptoms day after 7/22/2021 extreme fatigue, extreme malaise, leg pains, left arm was sore to the point of not being able to move it, left side of my upper chest to my neck
Perfect heart  on arm after 1st dose; Black and blue on arm after 1st dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Perfect heart  on arm after 1st dose) and CONTUSION (Black and blue on arm after 1st dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) 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 PAIN IN EXTREMITY (Perfect heart  on arm after 1st dose) and CONTUSION (Black and blue on arm after 1st dose). At the time of the report, PAIN IN EXTREMITY (Perfect heart  on arm after 1st dose) and CONTUSION (Black and blue on arm after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication  and treatment information were reported.
headache, fatigue, joint pain, injection site pain, slept for 10 hours which is extremely unusual
slightly sore arm: Initial information was received on 05-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Regulatory Authority.  This case involves an elderly patient (exact age and gender not reported) who had slightly sore arm (pain in extremity) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Details for the concomitant medications was not reported.  On an unknown date in 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date in 2021, the patient developed a non-serious slightly sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got my 65 and over flu shot this week....almost no side effects except a slightly sore arm."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There would be no information available on batch number for this case.
patient c/o itching arms, back and upper chest. Administered 20 mg of cetirizine po x 1. R=Itchiness resolved after 30 minutes
"Moderna COVID-19 vaccine EUA" Patient received 0.5ml instead of 0.25ml COVID booster dose.
Pt. has onset of rash 5 days ago with small vesicles on an erythematous base on legs, trunk, and face, no other symptoms. She had been vaccinated w/ VZ on 6/8/12.
pt recv vax 11AM @ 230PM vomited/diarrhea went to ER on 16APR97 because pt was lethargic-given APAP & pedialyte;temp next morning 102.6 R;16APR 103 R;330PM still has vomiting;
Information has been received from a registered nurse concerning her 26 year old daughter who on 13-JAN-2000 was vaccinated with a second dose of GARDASIL 0.5 ml. There was no concomitant medication. After a couple of hours the patient experienced dizziness, horrible headache and blurry vision. At the night of 13-JAN-2009 ("last night") the patient recovered. The patient sought medical attention of the nurse is also her mother. Additional information has been requested.
Hx of anaphylaxis to bee stings. Rash and hives over upper chest began immediately following vaccine. Taken to ED and given IV Benadryl, Famotidine and Solu-medrol. Discharged home from ED. Recommended to not receive second dose of covid vaccine.
Rebound of symptoms.; This spontaneous case was reported by a consumer and describes the occurrence of REBOUND EFFECT (Rebound of symptoms.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    Concurrent medical conditions included Drug allergy (Allergy).   On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced REBOUND EFFECT (Rebound of symptoms.). At the time of the report, REBOUND EFFECT (Rebound of symptoms.) was resolving.            No concomitant medication was provided.  Reported event was rebound of symptoms, device date - 12 MAY 2022.  No treatment received.
Patient noted with increase lethargy, fever of 102.5,RR=20, and a pulse of 115.
Menstrual bleeding occurred 1 day after each of my COVID vaccines.  Light spotting and only lasted 1 day.  But occurred after each of the covid vaccine and was approximately 8 days after my menstrual cycle had ended.
Blurred vision; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 10:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to any medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks of taking the COVID-19 vaccine. Concomitant medications included unspecified blood pressure medication. On 10Mar2021, the patient experienced blurred vision, dizziness and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. 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 blurred vision, dizziness and nausea was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Reported tingling at injection site after vaccination administered. Resolved within 20 minutes, no other findings.
10/24/2020 - the day after vaccination 6:00 AM - Woke with pain and redness in right eye 2:00 PM  - Tried to spit into sink and realized a problem with her mouth.  Realized stroke type facial symptom and went to ER.  The diagnosis was Bell's Palsy.  I was given Prednisone and Valtrax. 10/25/2020 - Continue with lost of motor funcion on right side of face. Right eye does not close during blinking and cannot close completely without taping down the eyelid.  Using a patch and gel drops.
ADMINISTRATION ERROR:  Pt.'s daughter called stating Pt. received Moderna 06/10/2021 and then again received the Phizer 06/28/2021. Low blood pressure since 2nd vaccine, 100/39 decreased HBP meds, doctor recommended No vaccine because of the Antibiotics due to pneumonia. No consent given by family. More pronounced swelling in the legs, a little more difficulty finding words to community. Pt. states soreness throughout the whole body.
Developed vomitting, diarrhea, and low grade temp withiin 12 hours of vaccine
Systemic: Fainting / Unresponsive-Medium, Systemic: Vomiting-Severe
Only mild injection site discomfort following first dose. Fatigue and left arm pain within 6 hours of second dose; dizziness, body aches, moderate muscle pain, joint pain, chills, swollen lymph nodes starting  8 hours after second dose. Pain lasted 24 hours. Fatigue lasted 72 hours. Muscle pain, joint pain and body aches were managed with 800 mg  Ibuprofen prn.