chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1/30 08:00 Severe chills, weakness, fever. Slept for approx. 10 hrs. Symptoms began to ease in the evening with full recovery to baseline 1/31.  2/1  05:00 Upon waking, I noticed I could feel cold sores beginning on my lips. I occasionally experience A SINGLE cold sore after extreme exposure to elements, but not usually after illness. This morning I could feel MANY cold sore forming on my lips (top and bottom) as well as insides of my cheeks and gums. I can count at least 15 different sores that all came on simultaneously.  Treating sores as usual with frankincense and balm to reduce cracking and bleeding. Sores taking usual clinical course, not healed yet.
1315: Pt c/o itching in throat, ears, and eyes ~ 45 minutes post Pfizer COVID 19 vaccination. VSS: BP: 156/90 P: 81 RR: 18 non labored, SaO2: 97% on RA, lungs CTA all fields, no stridor or wheezing noted. 1320: Pt medicated with Benadryl 25 mg po. 13,50: P
Above patient was treated and diagnosed with Herpes (shingles) outbreak on 10/04/07 at hospital urgent care facility. She received Rx's for 1) Acyclovir 800 mg five times daily for 5 days 2) Prednisone 20 mg 2 daily for 7 days 3) Vicodin for pain
Injection site swelling; This is a spontaneous report from a non-contactable consumer. A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 03Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 04Mar2021, the patient had injection site swelling. The patient did not receive any treatment for the event. The outcome of the event was recovered on an unspecified date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I contracted COVID-19 01/07/2023. I had cough, stuffy nose, loss of my taste and smell and some headache. I took an at home COVID-19 test and it was positive. I called my doctor, and he prescribed a prescription for PAXLOVID. I am feeling good now no symptoms.
suspected vaccination failure; Got the shingles shot and had shingles anyway. It was a very mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at the vaccination was not reported, however age group was captured as an adult as per vaccine indication. The patient received the shingles shot and had shingles anyway. It was a very mild case and it surprised the patient's physician. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Mild vaccine altered varicella. Tx'd w/Benadryl. 4-6 papular, vesicular lesions on abdomen last 24 hrs, itchy.
Swelling/Redness pronounced at injection site. Recipient believed it severe enough to be reported.
It started with light-headedness; basically my vision would go dark around the edges. Mostly around standing or moving. Orthostatic hypotension - similar to. Lasted 10-15 seconds each time. I have experienced them daily for the last three months now since they have started. I experience it about three to five times a day. I also have tightness of the chest. It doesn't come at the same time necessarily - it comes and goes as well - sometimes at the same time and sometimes not. It is almost like a pressure on my upper chest - underneath my breast but not underneath my rib cage. Where my breasts connect to my chest. I sought medical attention. My first appt was 8/13. I went to my NP. September I had follow up with Doctor. - I was still having some of the chest tenderness and pressure - we think it might have been muscular in nature and brought on by exercise - Naproxen - 500 mg twice a day for two weeks. And after a week, I was to let her know. After a week, I didn't see a change so she ordered a chest x-ray. And so I had that on October 4th. That came back normal.  I have continued to take the Naproxen for the full two weeks - it seems like most of the chest discomfort has been elevated but I do still have light-headedness. The chest discomfort currently is very limited - I don't think I have noticed it in the last three days - I am trying to take it really easy with exercise currently, too and that I think has helped. I still do experience the light-headedness. Yesterday, I had a migraine for the first time with no obvious triggering events. This was something brand new - have never had a migraine before. My doctor wants me to call back in another week to see how I'm doing with the chest pain symptoms and with the lightheadedness she said there wasn't as much as she could do about that.
Patient reports that she felt numbness and tingling in her left arm as soon as she got the injection. She said she flinched during the injection, something she normally doesn't do. She felt the tingling go all the way to her pinky finger and also down to her toes. In a follow up phone call today (4/3/2021) she reports that this tingling is not unusual for her, due to her fibromyalgia. She states she has a sore arm at the injection site, but other than the tingling, she is fine.
Three days after the first vaccination I went into AFIB,  I waited 13 hrs at home until my heart reset itself. Three days after the second vaccination, I went into  AFIB once again and went to emergency with heart racing at 176. Approximately 8 hrs later my heart reset with the aid of medication. I stayed in the hospital over night for observation then released @ 2 PM. I am now under the care of a cardiologist monitoring and now taking other medications for my heart
headache; low fever; muscle aches; fatigue; Not able to function as normal for 1 day; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EL1283 and expiry date was not reported), via intramuscular route of administration in right upper arm, on 04Feb2021, approximately 09:30 am (age at vaccination: 79 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes angioedema (date: Started many years ago- ongoing), hypothyroidism (date: many years ago, 1985- ongoing), macular degeneration (date: Many years- ongoing). Reportedly in the past the patient tested positive for COVID-19 (21Dec2020 to Mid Jan2021). The patient concomitant medications include levothyroxine for thyroid (start date unspecified to ongoing), ascorbic acid, fish oil, vitamin e nos, xantofyl, zeaxanthin, zinc (Ocuvite) for macular degeneration, VITAMIN C [ASCORBIC ACID] and Vitamin D3 (Vitamin C+D3), Probiotic, Stamets 7 for immune booster. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EK5730 and expiry date was not reported), via intramuscular route of administration in left upper arm, on 14Jan2021, approximately 10:30 am, as a dose 1, single for COVID-19 immunization and experienced headache, low fever, muscle aches, fatigue, GI tract Symptoms, not able to function as normal for 1 day. On 04Feb2021, within 08-10 hours of vaccine shots the patient experienced all the same symptoms she had during 3 weeks of COVID symptoms. The patient COVID had from late Dec2020 to Mid Jan2021 the exception of GI tract symptoms. Reportedly for the 24 hours the patient had headache, low fever, muscle aches, fatigue. It was reported that the patient was not able to function as normal for 1 day. The events assessed as non-serious. After second vaccine patient took Narco 5-325 mg few hours after the shot because the patient was miserable for 24 hours after first vaccine. The patient did not received treatment for the events. On 05Feb2021, after 24 hours outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Patient's mother called to report diarrhea 24 hours post vaccination.  Patient has taken pepto-bismol and imodium, but the diarrhea persists.  She called the doctor and was told to call the pharmacist.  Patient reported no fever  nor changes in routines or diets.
Information has been received from a Nurse Practitioner (N.P.) concerning a female who on 22-SEP-2010 was vaccinated with a dose of PNEUMOVAX 23. On 23-SEP-2010 (also reported as 22-SEP-2010), the patient could not move her arm (side not specified). At the time of the report, the outcome was unknown. The patient sought an unknown medical attention. Additional information has been requested.
Began the morning with a sore throat, and increased asthma symptoms (Asthma symptoms usually present ONLY following exercise). Use of albuterol inhaler relieved asthma symptoms. Developed diffuse myalgia around 3pm. Mild headache developed around 8pm.
I experienced a little soreness in the arm at the injection site. On 07/09/2022, I started feeling different. I had a scratchy and sore throat. From 7/10-7/13,2022 , I tested negative for COVID-19. I started having achy joints at this point. On 07/14/2022, I tested positive with a home test for COVID-19.  The worst part was the flu like symptoms. This wreck havoc with my diabetes. My endocrinologist adjusted my insulin and it has helped me. As of today, I still have a cough.
Woke up with headache and generalized body aches.  Got progressively worse throughout the day.  Headache and muscle aches were severe.   Ibuprofen provided no relief.  Symptoms  began to resolve at around 10 am on April 10.
5/31 to 6/9 or 10th on cruise ship.   6/11/2022 Developed a cough and fatigue struck late in the evening accompanied by a headache that got progressively worse.  Fever in the night of 101.  At home test for Covid tested positive.  6/12 Cough became wetter and phlegmier.  Fever shifted between 99 and 101 for about 15 hours.   On call doctor advised to go to ER.  ER doctors provided Monoclonal antibodies and saline.  Symptoms improved after time in ER and I was released.    Symptoms have been steadily improving, but not fully recovered.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 12-AUG-2014, an unknown number of patients were vaccinated with improperly stored single dose of PNEUMOVAX 23 (lot#, dose number and route were unspecified). No adverse effect was noted. This is one of several reports received from the same reporter. Follow up information has been received from the office manager regarding the patients. The office manager was able to share the lot# J008799 (expiration date 16-APR-2015) for PNEUMOVAX 23 that experienced a temperature excursion. The office manager had no patients' information or dates of vaccination available to share at this time. This is one of several reports received from the same office manager. Additional information has been requested.
patient become diaphoretic and felt like she was going to pass out. pt wheelchaired to bed bp 100/64. pt never lost consciousness. bp came up to 126/74. pt called husband to come in and drank 2 apple juices. EMS requested at 1615. patient then stated she felt woozy and became diaphoretic again. repeat bp 85/56. it later increased to 109/68, sat 97, hr 82. pt also incontinent
A friend got a shingles shot a year ago, she just got a second shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first shot a year ago on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: A friend got a shingles shot a year ago, she just got a second shot). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter stated that, the friend (patient) of him/her got a Shingles shot a year ago and she just got a second shot, which led to lengthening of the vaccination scheduled. The reporter wanted to know, did patient need an additional shot since she waited so long. The consent to follow up requested.
Patient fell on the way out of the store, hit both arms and her head. Bleeding from arms was cleaned with antiseptic and covered with bandages. Emergency services (911) was called to check blood pressure and cognitive functions.
Patient experienced tinnitus or ringing of the ears for a few minutes and began to go slight pale but the symptoms stopped and then she felt fine after.
Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     It was reported that patient did not have any allergies and never had COVID positive test or diagnosis. Patient did not had history relating to mentioned AE . No acute and chronic illnesses at the time of vaccination.     On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided.  Patient received first booster dose of vaccine.  No treatment drug information was reported.
Reddened area appeared just below injection site approximately 2" long x 1/2" wide.  No itching, pain, or swelling.
Pt states that yesterday she was in a conference and she started feeling lightheaded and having tingling in the arms. She states that she was driving home with a coworker and she was having trouble breathing and passed out momentarily. Her arms felt numb and she was having chest pain as well. She states that she went to the ER and they did a work-up. They did a EKG, CXR and BW which included a D-dimer. She was told it all was normal and they sent her home.   Pt states that she is not feeling any better. She currently has chest pain and she feels swollen around the neck and her arms felt tingly.   Pt denies any heartburn, wheezing, trouble breathing or swallowing.  Pt denies this being anxiety- she states feels nothing like it.  Pt states that she did get the J and J vaccine on Monday and unsure if any of this is related.
approx 16 hours after dose, developed fever of 103, aches, joint pain, general malaise, extreme nausea/vomiting requiring rx for ondansetron. symptoms resolved 24-48 hours later.
Patient received vaccine at 10AM and waited 15 min then exited the site without any complaints or stated rxn.   Per the patient, after she had left the site, she began to feel short of breath and instructed her husband to drive her back for evaluation.  Patient complained of intermittent tightness in her upper chest and brief periods of difficult breathing.  Report below per physician on-site.   4/19/2020 11:48am  This morning, I attended a 43 year old accompanied by her significant other. They returned to the Center after she received her 1st Moderna Covid-19 vaccination here about 40 mins prior. She complained of an intermittent tightness in her upper chest and felt she was having brief periods of trouble breathing. She denied tongue swelling, wheezing, pruritis, or rash. She did not take any medications after her vaccination. She noted a distant (20+ years ago) of a food allergy to ?seeds? that required transport to a hospital and what sounds to me that she had epinephrine administered at that time. She has not had another severe allergic reaction since but notes seasonal allergies and takes Allegra and uses an inhaler PRN. She does not have these medicines with her. On exam, she is sitting on the cot in the EMS tent. She is in no acute distress and is speaking in full sentences. There is no urticaria, no tongue swelling, no stridor, and no voice changes. She is not tripoding and there is no increased work of breathing. Her left radial pulse is strong, steady, and not tachycardic nor bradycardic. Her pulse oximetry was 95-98%. I informed her that at the time, I feel that close observation in warranted and she and her significant other agreed to stay to be observed. Shortly after this, she was observed to sit up, hold her upper chest and cough with slight stridor. This only lasted a few seconds and then resolved. Several minutes later, this happened again. I informed her that I felt that caution was advised with her history of a severe allergic reaction and intermittent upper airway signs. I recommended that she be observed in a hospital setting for her safety. She agreed and the Fire Department was contacted through 911.  When the paramedics arrived, she stated she was feeling much better. There were no longer any upper airway signs/symptoms. She declined transportation by ambulance to the hospital. I observed her for an additional ~10 mins and she continued to be asymptomatic. She was again offered transport to the hospital by ambulance and again declined. She sated she would like to go home with her significant other who would be with her to watch for any worsening signs//symptoms. I strongly recommended that if developed any upper airway signs such as feeling her throat is closing, tongue swelling, difficulty breathing, or any other concerning symptoms she should immediately call 911 as these may indicate a life-threatening emergency. She and her significant other indicated that they understood my instructions and agreed to abide by these recommendations.  I asked her to discuss her reaction with her primary provider before receiving another dose of a Covid-19 vaccine. Medical Director
1st dose 2018, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the first dose was received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's comments: The caller was the patient. She reported that patient had not yet received the second dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of vaccine, which had led to incomplete course of vaccination. Since it was a medication error case without any other AE and therefore outcome was not captured as not recovered based on the structured field value and kept as unknown only.
His arm really hurt; Really bad headache; He was super tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His arm really hurt), HEADACHE (Really bad headache) and FATIGUE (He was super tired/fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (His arm really hurt), HEADACHE (Really bad headache) and FATIGUE (He was super tired/fatigue). On 11-Mar-2021, PAIN IN EXTREMITY (His arm really hurt), HEADACHE (Really bad headache) and FATIGUE (He was super tired/fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-463046 (Patient Link).
This spontaneous report as received from a pharmacist refers to an approximately 22 years old female patient reporting on herself. Patient with no drug reactions or allergies. Patient non pregnant. The patient's medical history included at age 2-3 years old had measles. On an unknown date the patient was vaccinated with MMR II (route, lot number and expiration date not reported) for vaccination schedule and due to school requirements, patient received the two doses as a child. There was no concomitant medication reported. On an unknown date in 1996 the patient showed no immunity to measles during pharmacy rotations and received another series of MMR II (subcutaneous, lot number and expiration date not reported) and then titers during graduate school on an unknown date in 2006 showed no immunity to measles and the pharmacist was given another series of MMR II (subcutaneous, lot number and expiration date not reported). Pharmacist reported that the series given during pharmacy rotation and graduate school were the standard dose given subcutaneous. Pharmacist was unsure the dose and route of the 2 doses given as a child. Pharmacist stated that a hospital job requirement recently was to do titers and the pharmacist showed no immunity to measles. On an unknown date the patient sought for medical attention and was seen in office by an unspecified physician. No additional doses of MMR II had been given at the time of this report. The patient currently status was reported as patient showed no immunity to measles. Additional information has been requested.
Chills, shaking, heart palpitations, delusions - lasted all night long. Actually felt as it were dying. Dry cough, shortness of breath.
I started feeling tired and achy around 6pm. My left arm is really sore. I have a temperature or 99.6 and a Headache
Approximately 15 min after receiving Menactra and meningococcal B (Trumemba), pt was leaving the clinic area when he fell to the floor and had a brief episode of body jerking. He regained consciousness about 3 min later and was able to state his location and date of birth. EMS arrived and took patient to the Hospital for further evaluation.
Approx 112 hours after receiving vaccination patient started feeling feverish.  Awoke with large tennis ball signs lump in R axillary.
No adverse event.  Vaccine administration of a Pfizer Booster dose to a patient under 18 (17 1/2).  Final approval has not been granted for Pfizer Booster in patient age 16 and 17
Achy, slight fever, chills, and nauseous. Peaked about 20 hours after shot, back to normal approximately 36 hours after shot.