chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exposed eating out and then sx 5/8 head cold and covid positive AG; exposed eating out and then sx 5/8 head cold and covid positive AG; exposed eating out and then sx 5/8 head cold and covid positive AG; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), on 17Mar2021 as dose 2, single (Lot number: EL3247) and on 08Oct2021 as dose 3(booster) , single (Lot number: FF2589) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), NASOPHARYNGITIS (non-serious) all with onset 08May2022, outcome "unknown" and all described as "exposed eating out and then sx 5/8 head cold and covid positive AG". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: Covid test name post vaccination. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, exposure to sars-cov-2, nasopharyngitis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
The patient called pharmacy the next day asking if their symptoms of dizziness, lightheadedness and vomiting could have been due to the SHINGRIX or flu shot. The wife was asking on behalf of her husband saying they had to leave a restaurant because he was throwing up. They were planning on going to an immediate care clinic and will follow up with us on Monday.
Nausea, tiredness, fever, body aches day after Extremely sore arm one week later (2/22/2020)
No additional AE; Medical assistant reported that patient received an extra dose of GARDASIL 9. Patient started the GARDASIL 9 series at age 11 and was only suppose to receive two doses of GARDASIL 9 but was mistakenly administered a third dose of GARDASIL 9 on May 4,; Patient received first dose of GARDASIL 9 at age 11 on Jun 3, 2017. Patient received second dose of GARDASIL 9 at age 13 on Jun 14, 2019. Patient received third dose of GARDASIL 9 at age 17 on May 4, 2023.; This spontaneous report was received from a medical assistant and refers to a 17-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-JUN-2017, the patient was vaccinated with the first dose of human papillomavirus (HPV) rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, valid lot #M040412, expiration date: 30-JUN-2019, administered for prophylaxis (dose, frequency, strength, anatomical location, and route of administration were not provided) at age of 11. On 14-JUN-2019, he received the second dose HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, valid lot #R023607, expiration date: 06-MAY-2021, administered for prophylaxis (dose, frequency, strength, anatomical location, and route of administration were not provided) (Inappropriate schedule of product administration) at age of 13. Later, on 04-MAY-2023, the patient was vaccinated with an extra dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, valid lot #W002614, expiration date: 15-SEP-2024, administered for prophylaxis (dose, frequency, strength, anatomical location, and route of administration were not provided) (Extra dose administered). No additional information or adverse event was reported.
Patient fainted within 5 minutes of the shot and woke up within 45 seconds (fell to floor) was groggy for about 5 min afterwards. By 15 minutes he appeared fine.
I had typical arm soreness for about 2 days, slightly swollen. Nauseous off and on (not severe) for about 6 days, mostly in the middle of the night. About 9 days later, I noticed more swelling and tightness, along with a small pink patch. The patch grew much larger on day 10, 11, 12, 13 and became hot and slightly itchy. It is pink in color, with a white center (at injection sight- about 4 inches in diameter) and SLIGHTLY bruised-looking at the same time. The white area is very hard and hot to the touch. At the time of this report, the entire patch was measured at 9 inches x 6 inches. It looks worse than it feels. Not painful, but irritating.
Redness, swelling, hardness at injection site- approximately 3" in diameter.  Didn't occur until 1 week after inoculation.  I iced it; following morning it is the same.
I just started feeling very tired, like I would fall asleep while driving. After a few days of this I started with deep depression and anxiety. I couldn't breathe properly and started waking up in the middle of the night which  I don't normally do. Then I started having very intrusive thoughts that I don't feel like are mine. I have an active H-Pylori infection I'm working with an allergist to treat and just stared antibiotic. I am breast feeding also. I started having antihiatic reactions in August which I never had and then had a food allergy test.  I had COVI-19 in May and my heart rate was really high and it took 3 weeks for it to get back to normal. Then after COVID I had another virus and a zpack. The COVID-19 symptoms I had were a dry cough and a faucet of a runny nose. The cough lasted a few days and runny nose for a few weeks. For a few days I had a severe fever and body aches that I managed with Tylenol.
Developed a minor red itchy rash within inches of the injection site. After 2 days applied 1% hydrocortisone to the affected area 3 times a day. Today, 02/08 2021, the itching and redness have substantially declined to the point that I have discontinued the hydrocortisone treatment.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was unknown. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # M040624 (therapy type unknown) with expiry date 03-OCT-2018, lot # M027637 (therapy type unknown) with expiry date 02-JUN-2018, route unknown for prophylaxis. No adverse effects reported. The vaccines had been exposed under temperature 47 Fahrenheit (F) to 77 F for 4 hours and 18 minutes. Previous temperature excursion included 47 F to 77 F for 7 hours. A data logger was used.
Day after vaccine at 3 p.m.- chills; total body aches; headache; soreness on left side below breast bone.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 04Mar2021 16:00, as 1st dose, single for COVID-19 immunisation. Medical history included COVID-19. The patient's concomitant medication included Multivitamin (Other medications in two weeks). Other medical history was not provided. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 15:00, patient experienced day after vaccine at 3 p.m.- chills, total body aches, headache and soreness on left side below breastbone. Therapeutic measures were taken as a result of day after vaccine at 3 p.m.- chills, total body aches, headache, soreness on left side below breastbone. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
swelling; redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix. On 12th June 2019, 1 days after receiving Shingrix, the patient experienced swelling. In June 2019, the patient experienced erythema of extremities. On 14th June 2019, the outcome of the swelling was recovered/resolved. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the swelling and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received the Shingrix and developed swelling for 2 days and her arm was red from her shoulder to elbow. The swelling resolved after 2 days. The pharmacist last saw the patient on 14th June 2019.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 06-OCT-2011, the patient was administered with a dose of VARIVAX (Lot # 0345AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021 at 11:53 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
Information has been received from a Licensed Visiting Nurse concerning a female (age not reported) who in March 2005, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot number unknown). Subsequently, on an unspecified date, the patient became pregnant. A titer for rubella as drawn and it was negative for rubella. The patient's LMP and EDD were not reported. No product quality complaint was involved. Follow up information from a health professional indicated that patient did not become pregnant until 4 months following immunization with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Follow up information from a health professional indicated that the patient follow up with the reporter by telephone only. No other information was available at that time. Additional information is not expected.
immediately following the vaccine, the patient started feeling hot and became unresponsive. Patient was still breathing, but looked to be having a partial seizure or had fainted with her eyes partially opened. 911 was contacted and arrived on the scene within several minutes. Just prior to the medics arrival, the patient started to come back to consciousness and acted as if she was going to vomit, but only produced dry heaves. She was then transported to the hospital by the EMS.
PT hospitalized within 6 weeks of receiving COVID vaccine on 3-9 for 7 hours and on 3-23 for one day
Information has been received from a physician concerning her 56 year old mother with mild intermittent asthma as medical history and no illness at the time of vaccination, who was vaccinated with a dose of VARIVAX (Merck). On "the 14th day following vaccination" the patient developed a rash on both arms (2-3 vesicles on each arm) and face. She had 1 pox in the mouth and a fever of 100F, headache (early morning) and one sore in the oral cavity. No other details. Unspecified medical attention was sought. the outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
administered a vial that was punctured more than 12 hours ago; 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 EXPIRED PRODUCT ADMINISTERED (administered a vial that was punctured more than 12 hours ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a vial that was punctured more than 12 hours ago). On 29-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered a vial that was punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77° F) 27 and a half hours. Patients received the shot 27 and a half hours after the vial was punctured.  No treatment medications were reported.
Swelling and redness at injection site, about 2 inches in diameter, hard - observed day after injection - per pt events began day of injection. Advised pt. to use cold compress off and on, and to let us know if sym. worsened. Next day affected area approximately 6 inches in diameter, blistered, swollen, hot, painful.
had been involved in multiple low temperature excursion between dates of 11/3/2021 and 11/24/2021; no adverse event; This spontaneous report was received from a medical assistance and refers to a 13-month-old patient.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 03-NOV-2021, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # S036818 with the expiration date of 22-APR-2022, (exact dose number, route and site of administration were not reported) for prophylaxis. Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) had been involved in multiple low temperature excursion between 03-NOV-2021 and 24-NOV-2021 (storage product error).  The patient did not experience any adverse events (no adverse event). This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA003598: US-009507513-2112USA003534: US-009507513-2112USA003530: US-009507513-2112USA003546:
Hives; Rash across trunk and limbs; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Rash across trunk and limbs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa drugs), Hypertension since 2014 and Hypothyroidism since 2014. Concomitant products included LOSARTAN, HYDRALAZINE and DILTIAZEM for Hypertension, LEVOTHYROXINE for Hypothyroidism.    On 25-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jan-2021, the patient experienced URTICARIA (Hives) and RASH (Rash across trunk and limbs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg. On 30-Jan-2021, URTICARIA (Hives) and RASH (Rash across trunk and limbs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21JUN2021, added patient's demographics, medical history and concomitant medications.
Patient had 15 month shots on 1/22/15. Mom noted that child was limping a little today and he cried when she touched his right thigh; mom then saw the redness on his thigh. Pt has been afebrile. Follow-up appt 1/29/15.
Note 5/7/21:Patient is a 51-year-old woman who presents today for history of abdominal pain for the past 3 days.  Patient also reports that she has had some pain with urination.  Her bigger concern is that she had her second Covid 19 vaccine 3 weeks ago and became very sick.  She reports that she had COVID-19 March 2020 and her symptoms from the vaccine were much worse.  Her symptoms have included nausea, sore throat, body aches, ear pain, fatigue.  She reports she was very sick initially and the symptoms have just lingered.  Note 12/30/21:   Patient reports that she tested positive for COVID-19 in March 2020.  These records are not available.  She reports she went on to have positive antibody testing at an urgent care center. Test also not available.   Patient is requesting that I complete the vaccine adverse reaction form with the CDC.   Patient would like to report following symptoms after her second shot: Chronic nausea, chronic food sensitivities, persistent sore throat, persistent body aches, persistent headache, shooting pains down bilateral arms, dyspnea on exertion and severe exhaustion.   Patient reports that she has had several doctors and hospital visits not all of which are available to me now.  She reports that she has had brain imaging and abdominal imaging which were done at an outside hospital.    Patient reports that her most troublesome symptoms are her inability to eat food without intense nausea.  She is concerned about weight loss which per our records has been 20 pounds in the past year. She is also concerned that there is some sort of inflammatory process occurring.
Patient c/o of tingling on roof of mouth, and slight throat and tongue swelling approximately 12 minutes after IM injection.  Continued to monitor as patient stated symptoms were improving but then got worse so Benadryl was given at 12034. EMS was contacted concurrently. EMS transported to local ER at 12:30
tingling in hands and feet, anxiety Narrative:  Patient had a panic attack the day after receiving the vaccine after being anxious about getting the vaccine. She was having shortness of breath, brain fog, and tingling in her fingers and toes. This led her to go to the local ED and she was diagnosed with a panic attack, which hasn't happened for a few years.
Swollen/tender (left side - site of vaccine) lymph armpit area. Lasted approximately 20 days.
The only side effects I?ve had was soreness at the injection site and a gradual onset of heart palpitations. I have not sought medical treatment yet because I am waiting to see if they subside on their own. They are noticeable but not painful. I am also away from my home state for work at the moment so when I return home if they are still happening I will follow up with my doctor. I left the fields blank because I do not have a primary physician but I utilize health and see an NP within the practice.
(L) arm became red and very sore to touch - continued for 2-3 days. Erythema with some edema and pain lasted through Saturday - shot given on Thursday.
First night from 11 pm to 6 am, 102 degree fever. Fever broke at 6 am. So tired i could not keep my eyes open. Slept that whole next day. 3rd  day still extremly tired, pounding headache, stomach ache. By day 4 i felt better half way during the day. Pounding headache and extreme tiredness for 4 days.
pt recvd vax & had rash on face, shoulders & difficulty swallowing; told mom to bring pt to office immed; upon arrival pt face, arms, shoulders flushed-red rash; DPH 4MG stat; w/in 25 mins pt fine;
Within a few hours after - dizzy and feeling fuzzy, sore arm. 24 hours after - Sore arm, chills, fever (99.5), nausea, tiredness, soreness and a small red spot below the injection that has now turned into a very large, fist sized area of red blotches (48 hours after).
Starting in April, monthly periods have been super heavy. Had a chemical pregnancy May 2021, which lead to the discovery of high TSH levels. Previous blood test in December 2020 were normal. On medication to treat hypothyroidism. Also in May, started trying to conceive for a second child; besides the chemical pregnancy, it is going slower than the first time.
Information has been received from a physician concerning a 4 month old male who on 06-OCT-2007 was vaccinated p.o. with a dose ("1 tube") of Rotateq. On 07-OCT-2007 the patient experienced bloody stools and was hospitalized due to intussusception on the same day. The patient's diagnosis was considered to be immediately life threatening. The intussusception was corrected with surgery. No other information was available. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. The event was considered to be an other important medical event by the reporter. Additional information has been requested. 9/27/07- Seen on 10/5/07-visit after hospitalization for gastroenteritis. 1/29/08-records received for DOS 10/7-10/9/07-DC DX: Intussusception status post reduction with exploratory laparotomy, manual reduction and incidental appendectomy. C/O nausea, vomiting and bloody stools times 1 day.
The patient was seen 2 days after the immunization Daptacel Dtap R thigh.  His right thigh was swollen and tender and there was a rash noted around the injection site.  The pt. also had a fever of 103.1.  He was immediately referred to Emergency Dept.
Received 2nd Dose on 6/22.  On 6/23 & 6/24 she had "normal" reaction, for example- Headache, sore muscles, low grade fever, tired.  On Friday 6/25 she woke up with chest pain and the headache was still there.  She had a hard time taking in a deep breath and when she did it hurt really bad.  The chest pain hurt all the time, but worse when taking the deep breath. We call pediatrician and they told us to go to ER.
pt recvd vax;was fussy crying; would not take bottle for 3 hrs;T 99.2 A;red blotches all over body;taking bottle now;mom took pt to MD;probably  a viral infect;no meds x/ for apap;
Patient is 6 months under age of 18 and shouldn't have gotten the Janssen vaccine.