chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gastro-enteric problem; slight nausea upon waking up; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (gastro-enteric problem) and NAUSEA (slight nausea upon waking up) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced GASTROINTESTINAL DISORDER (gastro-enteric problem) and NAUSEA (slight nausea upon waking up). At the time of the report, GASTROINTESTINAL DISORDER (gastro-enteric problem) and NAUSEA (slight nausea upon waking up) outcome was unknown.            No concomitant information was reported.  No treatment information was reported.
Pt was sent to hospital on 12/28/21 due to fever. She was found to have infected permcath. While undergoing treatment, on 1/3/22, the patient became hypoxic. COVID-19 testing was performed, which was positive. Pt was symptomatic and required treatment.
BMI of 107 to 118; Fever of 101; Shortness of breath; This is a spontaneous report received from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration to left arm on 12Mar2021 (at the age of 39 years old) as a single dose for COVID-19 immunisation. The patient's medical history included asthma and penicillin allergy. Concomitant medications included Motrin 800, Allegra, and Clindamycin for an unknown indication and taken prior to the two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 13Mar2021, the patient experienced shortness of breath the next day of vaccination and still 4 days later, BMI (Body mass index) of 107 to 118 and fever of 101. No treatment was received for the events. The clinical outcome of the events shortness of breath, BMI of 107 to 118 and fever of 101 was not resolving. Information about lot/batch number cannot be obtained. No further information is expected.
woke up Sunday the day after felt ok, ate breakfast, then all of sudden was extremely tired, chills/fever, and body ached awfully, laid down woke up at 7pm felt worse took temp with forehead thermometer and it read 104, could not get fever under control for 24 hours. Now I am 3 days post vaccine and am extremely sore, no more fever, but highly dehydrated, have diarrhea as well, if I drink water I immediately pee it out.
2 hrs p/receiving vax pt screamed for approx 3 or more hrs unconsolably;
No immediate reaction noted by family - only 3 or 4 days ago did mom notice large pink, tender site Rt deltoid 5 x 4 cm. No pustule. No drainage. No axillary node. Father did have MRSA within past several months but now "ok".
At approximately noon on May 9, 2021, I observed that I was having some difficulty with hearing in my right ear consisting of a "blocked" feeling with some distortion  I have had occasional issues of this nature previously which have normally been rectified by "over the counter" products.On the afternoon of May 12, 2021, there had been no improvement, so I sought assistance at the facility located in town. Personnel there initially attempted to "flush" my ear without any improvement. I was then seen by a Dr. who was on duty at the facility  Dr. indicated that there appeared to be some sort of plastic "tube" in my ear. Dr. indicated that this was best handled by a specialist in the field, and provided me with the information on a local practice.  I was seen on May 18, 2021 at the offices of facility located near a Dr. I explained to Dr. what Dr. had seen  he located the item and removed it from my ear. This item has not, as yet, been identified  Dr. initially speculated that it may be part of a hearing aid, which I have NEVER had.  I subsequently saw Dr. again on June 1, 2021, as the issues were persisting. At that time, a "Hearing test" was administered by a ophthalmologist. Dr. prescribed a course of 50 Prednisone (10 MG tablets) to be taken as follows at breakfast time: Six tablets for the first six days Four tablets for the next two days Two tablets for the next two days One tablet for the next two days Dr. reasoning at that time was that he believed that the vaccine may have provoked some sort of "immune deficiency". He advised that I should see him again in two weeks for a further hearing test/consultation.  I completed the course of Prednisone on June 13, 2021. I underwent a further hearing test with ophthalmologist on the morning of June 15, 2021 as agreed  prior to the test, I indicated to ophthalmologist that I expected the results to be, to all intents and purposes, identical to the previous one: this proved to be the case. I subsequently indicated to Dr. that the Prednisone had been, from my perspective, totally ineffective. He is, at the time of writing, unable to offer any explanation for the issue or "path forward" from it: I am presently seeking a second opinion.
11 year old female patient came in with parents for school vaccines. She received 5 vaccines (tdap. flu, MCV4, varicella and polio). Immediately after being vaccinated patient became nervous, hot, paleness to skin, dizziness and some nausea. Vitals was taken and a wet cold cloth  was put behind her neck.  Pt. drank small sips of water and after a few minutes she started to get color back to her skin. She then open her eyes, raised her head. Recovered in 5 minutes.
About a half an hour after receiving the vaccine, the patient noticed hives forming all over her body.  There was no swelling or shortness of breath.  The area around the vaccination site was red and swollen.  The patient was given 50 mg of Benadryl to take and advised to continue that for several doses.  The patient was working in the pharmacy so she was available for observation for several hours following the vaccination.  No other adverse events were noted.
Pain in neck and shoulder, headache, shivering, nausea, stomach pain, injection site redness and hot, and no appetite. Arm was sore for a week and two days.
Injection site arm soreness started at 2 hours post-injection, fever, chills, myalgia, headache, swollen lymph nodes, joint aches, and nausea started 12 hours Post-injection
Missed appointment for second vaccine on 30Apr2021; Tested positive for Covid 19; Tested positive for Covid 19; Felt Sick; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153, Expire Date: Unknown), dose 1 via an unspecified route of administration, administered in left arm on 09Apr2021 as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient states that she had her first vaccine a couple of weeks ago. She was supposed to have her second one on Friday. States her kids were sick. She went and got tested for Covid 19 and it was positive. She has conflicting information on when she can have the second dose of her vaccine. Was calling to see when she could get it. States that it is hard to say. On 23Apr2021, patient experienced felt sick, Tested positive for Covid 19 after first dose of Covid 19 vaccine, she was supposed to get her second dose on 30Apr2021 but missed The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2) test: positive on 29Apr2021. Outcome of the events was unknown.  follow-up attempts are possible. further information is expected.
Erythema 8x9 cm, induration at site, minimal pain. No treatment needed.
reddness, itching, swelling, warmth, large red rash covering upper vaccinated arm--still present after 8 days
Today around 3pm I administered a first Moderna shot to a patient.  She had a long list of allergies to various medications and eggs.  I advised her that I would like her to sit for 30 minutes after her shot to be monitored due to this.  At about 3:27pm she informed me her upper lip felt tingly. I then offered her 25mg of Benadryl which she took.  She waited another 20 minutes and her symptoms felt about the same and she wanted to go home.  I offered her another dose of Benadryl or if she wanted me to call EMS.  She denied both and bought some Benadryl to take home.  I advised her to take another dose if symptoms did not improve or to call EMS if they worsen.  She left the pharmacy about 355pm.
This spontaneous report was received from a physician via a company representative referring to a 62 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, two years after the patient received ZOSTAVAX, the patient presented to the physician office with a significant case of shingles on one side of his torso. The reporter stated that the patient was treated for the significant case of shingles with an unspecified pain medication as well as unspecified anti-viral medications. It was unknown if the unspecified pain medication as well as unspecified anti-viral medications were effective. It was also unknown by the reporter if the patient was still currently taking the unspecified pain medication as well as unspecified anti-viral medications. The outcome of the event significant case of shingles was unknown was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with ZOSTAVAX.
It is interfering with her work; took too much ibuprofen and now she has a stomach upset; daily headache she cannot get rid off; This spontaneous case was reported by an other health care professional and describes the occurrence of IMPAIRED WORK ABILITY (It is interfering with her work), ABDOMINAL DISCOMFORT (took too much ibuprofen and now she has a stomach upset) and HEADACHE (daily headache she cannot get rid off) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 040A21A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 on 24-Nov-2020. Concurrent medical conditions included Bipolar disorder since 23-Oct-2015, Insomnia since 23-Oct-2015 and Restless leg syndrome since 23-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 23-Oct-2015 to an unknown date for Bipolar disorder, GABAPENTIN from 20-Jun-2021 to an unknown date for Insomnia and Restless leg syndrome, ESTRADIOL (ESTROGEN), ROSUVASTATIN CALCIUM (CRESTOR), Vitamin D and Vitamin B12 for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced IMPAIRED WORK ABILITY (It is interfering with her work), ABDOMINAL DISCOMFORT (took too much ibuprofen and now she has a stomach upset) and HEADACHE (daily headache she cannot get rid off). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 12-Oct-2021, HEADACHE (daily headache she cannot get rid off) had resolved. At the time of the report, IMPAIRED WORK ABILITY (It is interfering with her work) and ABDOMINAL DISCOMFORT (took too much ibuprofen and now she has a stomach upset) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient took too much ibuprofen and then she had a stomach upset.  Patient reported that the headache is right above the ears and on top of the head, it was not like a sinus headache, it was not like the headaches she had before, it was like up in her head.   Patient has been taking Lanietal 150 mg po for bipolar disorder from  23-OCT-2015 as concomitant medication.   This case was linked to MOD-2021-348352, MOD-2021-348417 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received on 13-OCT-2021. Patient demographic details and medical history added. New conmeds added. Event outcome updated.
This spontaneous report was received from a physician, concerning 12 year-old male patient. There were no concurrent conditions, medical history, drug reactions or allergies. His concomitant medications included CLARITIN. On 03-MAR-2017, the patient was intramuscularly vaccinated with the first dose of GARDASIL 9 (dose and frequency were not reported) lot # M031557 with expiration date of 07-APR-2019, for Human papillomavirus (HPV). On an unspecified date in 2017, after vaccination, he experienced high fever, was disoriented and hallucinating. It was not specified when symptoms resolved and no medical treatment was given per physician. On 05-MAY-2017, the patient was intramuscularly vaccinated with the second dose of GARDASIL 9 (dose and frequency were not reported) lot # M041990 with expiration date of 28-SEP-2019, for Human papillomavirus (HPV). On 08-MAY-2017, the patient went to the clinic and he was treated for an unspecified practitioner; the patient had a "rapid strep test" that was negative and also a throat culture was taken. The patient's mother gave him an unspecified dose of over the counter ADVIL which did not bring down a fever of 104°F. On the same date, he was taken to the hospital emergency room (ER) and treated by an unspecified physician. His laboratories (unspecified) were normal, a flu test was negative and a diagnosis of acute nasopharyngitis was given. Additionally, the patient also had a positive streptococcus culture come back from the clinic and Z-PACK was prescribed (unspecified dose). In summary, the patient was sick for 3-5 days after second dose of GARDASIL 9. At the time of the report, the patient was recovering from fever of 104°F, acute nasopharyngitis and positive streptococcus culture. The causality between the adverse events and GARDASIL 9 was unknown. Additional information has been requested.
(Lt) thigh with erythema on upper imm. site, app. 1.5x2"; warm to touch; afebrile; non-tender; moving well; non-ill appearing. Seen by PCP on 10-22-11. Tx with ice packs & ibuprofen-PRN.
Information has been received from a health professional concerning a 31 yr old female described as healthy with no known drug reactions or allergies who was vaccinated with a dose of varicella virus vaccine live (lot 649272/0653P). Concomitant vaccination included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot648671/1070P) and a dose of tetanus toxoid. On 06Jun05 the pt vomited and developed low blood pressure. Subsequently, on 06Jun05, the pt recovered from her adverse experiences. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 2nd September 2018, the patient received the 1st dose of SHINGRIX. On 2nd September 2018, less than a day after receiving SHINGRIX, the patient experienced fatigue, injection site erythema, walking difficulty, back pain and spasms. On an unknown date, the outcome of the fatigue, injection site erythema, walking difficulty, back pain and spasms were not recovered/not resolved. It was unknown if the reporter considered the fatigue, injection site erythema, walking difficulty, back pain and spasms to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of back pain. The patient received SHINGRIX on the left arm. The patient was upset because she had severe reactions to the SHINGRIX. On the same evening of vaccination, the patient started to develop the symptoms which included fatigue, back pain and spasms in the back. The patient clarified that, the back pain and spasms in the back are on the same side of the body where she received the SHINGRIX.  The patient said that she had difficulty walking due to SHINGRIX. The patient experienced a huge red circle at the injection site and still had it. The patient was upset because, she had been seeing an acupuncture specialist and physical therapist to handle the side effects with SHINGRIX. The patient mentioned a comment that she believed GlaxoSmithKline should pay for all her treatment expenses.  This is 1 of 4 cases, reported by the same reporter.
Sore arm first day, followed by headache. Within 24 hours, I was bedridden with severe headache, shaking chills, joint pain, myalgias - hurt to move, sweats and low-grade fever. Took ibuprofen to help.  By day 2-3 felt tired and weak but better.  Pain much improved but the joint pain never completely went away.  Then over the next 2 weeks I noticed pain and stiffness in my hands and feet like experiences during abut rheumatoid arthritis over 15 years ago.  Pain continued to worsen, and then developed in my shoulders and hips bilaterally.  Over the next 6 weeks it got more severe where it was hard to get up from sitting for a while, and very painful to move and get out of bed in the morning.  My past RA only effected hands and feet. The hips and shoulders were new.  I get a referral to rheumatology.     When I got diagnosed with RA in 2005,  I went gluten free (my children have celiac disease - I have always tested negative, but carry the HLA gene for gluten-sensitivity), and started taking omega 3.  My symptoms dramatically improved over a few months than completely resolved.  I reintroduced gluten without consequence after about a year and stopped taking the omega 3. No joint issues until the COVID-19 moderna vaccine #2.
This spontaneous case, initially received from Merck (reported to Merck by other health professional) on 08-Feb-2018, concerning a female patient of unspecified age. The patient current condition included allergy to egg (from an unspecified date). The patient had no concomitant medications. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date after vaccination, the patient had a red reaction at injection site and was treated with an unspecified medication. At the time of the report, the patient had recovered from event (injection site redness). The reporter assessed the event as non-serious.
After about15 minutes I proceeded to have heart palpitations and chest discomfort. It  made me feel very ill and I was unable to continue work for the day.  My doctor's office sent me home and I had heart palpitations ad chest discomfort for 4-6 more hours.  I continued to have heart palpitations on and off for for months after the vaccination.  I had a long term holter monitor in Dec of 2022 that showed I was still having symptomatic intermittent sinus tachycardia.
I received my shot at 11:47 and started to lose sensation in my hands in the waiting area. After about 25 minutes I felt dizzy and was about to stand up but my muscles started shaking. My heart rate was checked and found to be 140. This lasted for about another 30 minutes. My heart rate went down and I was taken to a private area and checked out by EMS they gave me water and concluded it was some sort of panic attack. However, these are the same symptoms I have whenever I am allergic to a medication, NSAIDS, dicyclomine, etc. It always starts with ascending numbness from my fingers to the rest of my body. Then I start to shake and my heart rate goes way up. Usually I start to cough then vomit and my airway closes. Thankfully this time we were able to slow the process and I never experienced some of the last symptoms.
I was having trouble sleeping. I woke up the next morning and took a COVID-19 test at home and it was positive. I called my doctor and since I had mild symptoms she did not recommend me taking PAXLOVID. I felt very tired for about 4-5 days. I did not have any other symptoms.
Chills, borderline rigors lasting 4 hours followed by temp of 102 (checked at 2am), took 1 GM of Tylenol, decreased to 101 after 2 hours of taking Tylenol.  Afeb at (6am 1/13/21) but increase temp again to 100.9 at 11am took 1GM of Tylenol, temp down after ~ 1 hour.  Nausea and severe headache evening of 1/12/21 starting around ~ 9 pm.  Nausea and severe headache lasted until 5m on 1/13/21,  nausea resolved, headache improved but continued until 11 am on 1/14/21.  Fatigue severe 1/13/21, improved but continued 1/14/2021, resolved by ~ 6pm on 1/14/201.  Pain in axilla and groin bilaterally evening of 1/12/2021, resolved by 5am on 1/13/2021, no adenopathy.  Muscle pains 1/12 until mid morning 1/13/021
I received the Pfizer COVID vaccine yesterday; I took a Covid test and it came positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Oct2023, 20 hrs after the suspect product(s) administration, outcome "unknown", described as "I received the Pfizer COVID vaccine yesterday; I took a Covid test and it came positive". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient received the Pfizer COVID vaccine yesterday; and took a Covid test and it came positive. Patient stated, "I received the Pfizer COVID vaccine yesterday at 11 o'clock in the morning and it is about 20 hours later,  took a Covid test and it came positive". It is the patient's question because patient got the vaccine yesterday. Further enquired, if it was showing positive because patient took the vaccine yesterday.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.