chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight dizziness; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 25th June 2021, 2 days after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   The reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows:  The reporter was patient itself. The patient received Shingrix vaccine in right arm and experienced dizziness. Caller will call HCP if symptoms of dizziness gets worse. Caller does not give permission to contact health care professional. The reporter did not consent to follow up.
I lost my smell and taste while I had covid. I regained both after about 5 weeks. Just recently, I have no been able to stand the smell of body odor, my breath, taco meat, pickles, they all smell the same to me, kind of like a rotting onion/sour type smell.
Information has been received from a physician concerning a 23 year old female who on an unspecified date was vaccinated with the first dose of GARDASIL.  The patient fainted in the office after receiving the vaccine.   The outcome was unspecified.  This is one of several reports from the same source.  Additional information has been requested.
Patient alert and orinted reporting "out of body experience, something strange going on inside body". Reporting increase of fatigue after second Hepatitis B vaccination.
High level or pain began in right groin and eventually moved to outside of right upper leg.  Pain lasted for 12 day and only subsided after taking perception strength inflammatory after receiving MRI.
Breakthrough case admission after 3 vaccines Moderna 1/19/21 lot# 011L20A;  Moderna 2/16/21 lot# 004M20A;  Moderna 3/26/22 lot# 027L21A
Symptoms of myocarditis which started July 1 2021 a couple weeks after receiving 2nd shot of vaccine. Currently been to the emergency room twice and have another follow-up with Dr. on Sept 2. Was placed on buspirone due to fact doctors thought it was anxiety or panic attacks.
10 seconds of tonic clonic seizure like activity 6 minutes after administration of the Moderna COVID-19 vaccine with associated hypotension, bradycardia, diaphoresis, and visual disturbance (spots in his vision) that self-resolved after being shaken.
01/18/2005 - Extreme dizziness onset and upper respiratory congestion. 01/19/2005 - Upon awakening myalgia neck, shoulders, continued respiratory congestion, temperature 100.4 - symptoms continued all day. 01/20/2005 - Increase in myalgia to lower body, headache, continued respiratory congestion - saw physician received Tamiflu.
Information has been received from a mother of a patient concerning a 11 year old daughter with headache and seasonal allergy who on 02-MAY-2008 was vaccinated with a first dose of GARDASIL vaccine and on unspecified date was vaccinated with a second dose of GARDASIL vaccine. After each dose of vaccine the patient's headache became more severe. The patient sought unspecified medical attention. On unspecified date the patient recovered. Additional information has been requested.
Moderna  bivalent dose(09/16/2022) given only 1 month after the last moderna booster dose (08/11/2022) patinet was notified 1 hour after the shot and was  not experiencing any side effects except sore arm.
Client states that after his first vaccine he developed some numbness in his lower legs at night. Does have a family history of DM. He has not had his HgbA1C checked in a while and does not check his blood sugars.
Day 1, extreme fatigue, Day 2 extreme fatigue, sore arm on arm injected, low grade fever, Day 3 less arm pain, loose stool, low grade fever, less fatigue but still tired
Nothing bad happened related to the vaccine! They told me to fill this out because I got a breakthrough case of COVID in January 2022, several months after my third dose of Moderna. But it was very mild, and I was very glad to be vaccinated and boosted!
fever 100;rash, red, fine over entire body-no blisters;T102.8 highest level reached;nose bleeds 9 days since 91.8 does have freq nose bleeds;to ER saw PMD did not think rash was from MMr thought rash was from inc temp;
This spontaneous report was received from a medical assistant also a office manager regarding a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-NOV-2016 or 17-NOV-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M032650, expiration date: 31-MAR-2019) (dose, frequency and anatomical location not reported) intramuscular. The administered dose experienced a temperature excursion of 26 F for 18 hours, 52 F for 3 hours on 16-NOV-2016 and 22F for undetermined amount of time on 17-NOV-2016. Previous temperature excursion includes 49 F doe 70 hours on 14-NOV-2016. The call was not because of data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Condition most likely being pericarditis. Matching symptoms include: Chest pain Back pain shortness of breath symptoms worsen when lying down symptoms worsen when taking deep breaths  No treatment as of yet
I had very extreme side effects, which lasted for several days. They included pain in the injection site, chills, headache, dehydration, fatigue, nausua, it was debilitating for the first several days. After about 3 days, the more intense symptoms subsided, but I am now experiencing life altering neurological complications. I am very fatigued, both physically and mentally. I have trouble concentrating, remembers words, or I stumble on my words. I will forget what I am saying mid conversation. I find it very difficult to focus and am experiencing memory loss. I feel my cognitive abilities have become impared. A week after the vaccine, I caused a major car accident. I believe the side effects of the vaccine to my brain were a major contributing factor to the crash. The side effects have been impacting me at work and in my personal life in many ways. I am worried I have suffered some sort of brain damage as a result of the vaccine.
About 30 minutes after receiving vaccine, she began to have a coughing fit and could not catch her breath or stop coughing. She used her rescue Albuterol inhaler and the coughing started to slow down. When she got to the clinic around 45 minutes after the injection she was still coughing slightly but breath sounds were clear bilaterally and had no difficulty breathing. She chose to go back to her unit, use her inhaler again and if things progressed would go to the ER.
had no problem getting out of bed at 3:00 a.m. but I could not stand up when attempted to get out of bed twice at 7:30 a.m. -- felt like going to pass out; shortly afterwards was able to stand up and walk to other room; could not go any further and vision became very blurry; husband got chair and assisted me in sitting; husband took my vitals which were 58/43 bp with heart rate 72 bpm; (my typical bp is about 130/80); husband gave me 3 dark chocolate covered espresso beans as a stimulant; husband retook my vitals about 5 minutes later (75/53 bp with heart rate 78 bpm); vision began to improve; vitals signs retaken another 6 minutes later (70/51 bp with heart rate 78 bpm); vision continued to improve; about another 10 minutes later 99/52 bp with heart rate 71 bpm, at this point my strength and vision returned to normal and I got out of the chair unassisted; another 33 minutes later 108/56 bp with heart rate 72 In addition to the above reported incident I have experienced (and continue to experience) the non-severe side effect of muscle pain at injection site and severe nausea.  However, I also experienced these same symptoms up to 5 days with some of my prior doses of the COVID-19 vaccine.
This spontaneous report as received from a pharmacist refers to a 67 year old male patient with allergy to penicillin. On 17-SEP-2013 the patient was vaccinated with PNEUMOVAX23 (lot # J004332, exp date 26-SEP-2014), (0.5 ml dose, intramuscular). Also the patient reported getting an unspecified pneumonia vaccine seven years ago also. Concomitant therapy was not reported. On 17-SEP-2013 the patient experienced pain in arm that went over his shoulder and down his back. The patient had not seen physician or taken any treatment for the pain. Laboratory diagnostic studies were not performed. At the time of the report the patient's outcome was not recovered. Additional information has been requested.
Patient lost consciousness.  He began struggling to breathe and turned very red.  He was audibly gasping for air.  An epi-pen 0.3 mg was administered to the right leg.  He resumed breathing and laid down on the ground.
Tiredness, sneezing, stuffy nose, cough, sweating, itchy and watery eyes, headache, sensitivity to light, loss of appetite and sore throat for seven days.
c/o arm hurting that evening , had a headache on 1-26 and 1-27  but on 1-27 she also c/o stomach ache and some diarrhea. On 1-30-21 her arm "swelled a little and I had some tenderness."  1-31 deltoid area was bright red and slightly warm to the touch ,not only at the site but  all around the site., she c/o it itching.  Came into the health department on 2-2-21 arm is better but still remains red and has some itching and warmth to the touch. Has full range of motion. Called her on 2-4-21 stated she is better, no itching, not sore, and no swelling now.
J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/22/2021 GI HEMORRHAGE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 9/6/2021 COLON CANCER, UNSPECIFIED SITE I82.409 ACUTE DVT, UNSPECIFIED VEIN 7/13/2021 COLON CANCER, UNSPECIFIED SITE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/22/2021 COLON CANCER, UNSPECIFIED SITE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 9/6/2021 ACUTE RESPIRATORY FAILURE I82.409 ACUTE DVT, UNSPECIFIED VEIN 7/13/2021 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/22/2021 ACUTE RESPIRATORY FAILURE
This is a spontaneous report from a contactable nurse received via a sales representative. A 18-years-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient received other two unspecified vaccines. The patient medical history and concomitant medications were not reported. The patient experienced seizure on an unspecified date with outcome of unknown. The reporter does not think it was a real seizure because the patient did not have the symptoms that would have went along with a seizure. No follow-up attempts possible. No further information expected.
Pt had inadvertently received their first dose of the COVID-19 vaccine on 1/17 while admitted to a long-term care facility. I had asked the caregiver and patient to confirm if they were receiving their first dose when I visited the nursing home on 1/27/2021, and they had confirmed it was their first dose. I did not learn that they had already received one dose 10 days prior until after the fact and verifying it.
COLD AND FLU-LIKE SYMPTOMS  RECOVERED FULLY WITHIN A WEEK OR SO
Massive migraine traveling from my right temple to around my right eye, down my right nose and back to my temple
Red rash at injection site, roughly 2 inches in diameter. Started the same night as getting injected, and is still there unchanged a week later
This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of RASH (Rash) and PARAESTHESIA ORAL (Tingling on the lip) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced RASH (Rash) and PARAESTHESIA ORAL (Tingling on the lip). At the time of the report, RASH (Rash) and PARAESTHESIA ORAL (Tingling on the lip) 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.   No relevant concomitant medications were provided.     No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
On October 25, 2007, I received the Zostavax shingles vaccine.  This shot was given in my right deltoid.  The vaccine was Merck lot #1081U, expiration January 12, 2009.  At the same time, I was given a flu vaccine in my left deltoid.  This vaccine was Novartis lot #80074, expiration June 30, 2008.  My wife received the same vaccines.  My wife's only reaction was a very sore arm with a slight red swelling.  This decreased and the arm returned to normal in about four days.  However, my reaction was quite severe.  Over the next several days I began to develop a red rash.  I have enclosed five photos of myself taken in a relaxed posture.  The date and file number are on the back of the photos.  Photo JWG-11062007-0022 is a photo of my back made twelve days after receiving the vaccine.  This photo was made just before going to be treated by my dermatologist on November 6, 2007.  On this day she took a biopsy of the large red spot near my left shoulder blade.  The next four photos JWG-11162007-13, 14, 16, and 22 show my front, sides, and back, ten days later.  This is when the rash peaked.  From this time the rash continued to improve until my skin was back to near normal by January 1, 2008.  The rash also covered my hips and legs down to my ankles, even though that does not show well in the photos.  However, you can see a red spot on the front of my left ankle in photo -13 and on the rear of my right ankle in photo -22.  I am still being treated for the after effects of this vaccine.  Other visit dates included November 19, 27, and December 20, 2007.  A second biopsy was made on the bright red spot near my right shoulder blade on December 20.  Both Dermatopathology Reports came back with the same diagnosis: "Nummular/contact dermatitis.  The epidermis shows parakeratosis, serum exudates, spongiosis, and superficial chronic inflammatory infiltrate."  My treatment of this rash since November 6 included covering the rash area with Cetaphil cream and/or lotion and Triamcinolone Acetonide Cream USP, 0.1%.  The very red spots were treated with Clobetasol Propionate Cream USP, 0.05%.  This procedure was repeated morning and evening.  There was no pain associated with this rash, but it was quite itchy without the above treatment twice a day.  However my skin was extremely dry, scaly, and chapped.  The dry skin peeled easily.  I did not have my normal great feeling and I was somewhat mentally depressed over my skin condition, especially since I could not go to the gym to work out and swim as I frequently did.  As of this writing on January 22, 2008, my skin is well on its way to normal.
Felt sluggish; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 08Mar2021 15:00 (Lot number: EN6199) as dose 2, single for covid-19 immunisation. Relevant medical history included: "HTN" (ongoing); "hypothyroid" (ongoing); "hypokalemia" (unspecified if ongoing). Concomitant medication(s) included: HCTZ taken for hypertension (ongoing); LISINOPRIL taken for hypertension (ongoing); LEVOTHYROXINE taken for hypothyroidism (ongoing); METOPROLOL taken for hypertension (ongoing); KCL taken for hypokalaemia (ongoing). Vaccination history included: Bnt162b2 (Dose: 01, Time: 02:30 PM, Anatomical location: Right Deltoid, Route of administration: Intramuscular, Lot Number; EN6201), administration date: 15Feb2021, for COVID-19 immunization. The following information was reported: SLUGGISHNESS (non-serious) with onset 09Mar2021, outcome "unknown", described as "Felt sluggish".  No follow-up attempts are possible. No further information is expected.
patient reports short of breath and chest pressure, started about 5 mins after vaccine.  Patient took Advair Inhaler at that time.
Vaccine within 3 weeks of receiving the first one; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine within 3 weeks of receiving the first one) 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.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine within 3 weeks of receiving the first one). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine within 3 weeks of receiving the first one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     The patient was administered with the second dose of vaccine within 3 weeks of receiving the first one.  No concomitant medication was reported.  Treatment information was not provided.
Received shot at a Pharmacy.  Had some headaches the first week, soreness in injection site accompanied by finger and toe joint pain.  Felt fatigued.  After one week, slight tingling in hands and feet started to appear in the evening.  Continued to have tingling, numbness now spreading to the legs and arms.  Went to see primary care doctor at to diagnose.  First suspected vitamin B12 deficiency.  Lab test performed and B12 levels were within normal range.  At the same time a SPEP test was ordered (protein panel looking for other causes of tingling).   This also came back negative (8/27/2021).  No clear diagnosis.  The tingling and numbness continued to worsen and on evening of 8/31/2021.
It was May 16 in the afternoon. I was feeling just very unenergetic. Temperature was hardly up at all. I'm normally low, my temperature is usually 97.7. it went up to 98 around there. It wasn't bad temperature wise. I noticed I was getting a lot of nasal congestion and just no energy. With the nasal congestion, I was thinking of the smoke from the wild fires. That's why I didn't do testing right away. As the afternoon went on, I started feeling no energy at all and started developing a cough. I had the nasal congestion and cough that were my first indicators. I had no temp change. I took the at home test and it was positive and isolated to the guest bedroom. Wore a mask around the house. It went on like that, felt like I got hit by a truck with no energy. That continued and I was basically in bed because I was tired and couldn't do much. Kept eating normally but wasn't too hungry. I noticed that all of a sudden, when I ate, I couldn't tell what I was eating. Lost my taste and smell, and that's slowly coming back. On May 18, I called Dr. and we set up an appointment online in the afternoon. He listened to my symptoms and he wasn't too worried about me. We went over the check sheet for qualification for medication. He said I was doing fine and I wouldn't be eligible for the antiviral pill. I waited it out and said I'd get back with him Friday. Friday the 20th, my wife went in to a HCF and came back negative. They called me and said to come in to take a test in the afternoon. It was a rapid test and it came back positive. I got an interview with a doctor and she recommended the Paxlovid. She sent a prescription in and I picked that up later that day. Started taking it immediately that evening. 3 in the evening and in the morning for 5 days. I started that the evening of the 20th and finished the morning of the 25th. It wasn't miraculous. It didn't cure me over a day or two, but things started to get better. On the 25th, I finished that up. And I was up a lot more, wasn't in bed as much like the previous week. I was able to venture out with my mask on. I tried to get another test on the 5/27 but they were booked and said they could take me in on the 28th. I went in, got retested and this came back negative. Happy with that. 4PM on 5/28 was the negative test. Just been careful and wearing a mask since. At the moment, I'm doing better. I'm not real active right now, but will try to get myself going again next week. Congestion has moved from nasal passages to chest during the COVID time period, a little bit of congestion left in chest. Currently in recovery.
Adverse Event:  12 hrs after receiving the shot I had severe side affects that came on quick .   Chills, fatigue, muscle and body aches through out which made me very unstable, massive headache, constant running nose, nausea and diarrhea.    I also had a low grade fever as well as my  heart bpm were erratic.  The chills were so bad that 3 comforters and a heating blanket would not help.  During the time I was so cold I also had numbness in my finger tips and toes.   Treatment :   solid bed rest, electrolyte fluids, Tylenol and Advil, several boxes of tissues  Outcome:  Day three of reporting this information.  I still have all the systems above except I no longer have the chills or fevers.
patient was administered Adacel was exposed to temperature excursions and not acceptable for use, no AE; vaccines were not good/they had already given out 5 of the Adacel vaccines before receiving email; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157616, 2019SA157599, 2019SA157614 and 2019SA157615 (same reporter).  This case involves a 20 years (also reported as 28 years) old female patient who received a second 0.5 ml dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5585AA and Exp. Date 06-Mar-2021 via intramuscular route in the left deltoid on 29-May-2019, which was exposed to temperature excursions and not acceptable for use.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage and Poor quality vaccine administered  It was reported that Adacel was ordered on 22-May-2019 and did not arrive until 28-May-2019. Patient was administered Adacel that were exposed to temperature excursions and not acceptable for use.  No reactions reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
8 hours after shot: muscle and joint pain, chills, tiredness and sweating. Lasted 24 hours,  Fine the next day.