chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; soreness at the injection site on left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Lot number: FH8028, Expiration Date: 31May2022) at the age of 58 years, in left arm for covid-19 immunisation, prophylaxis. The patient's relevant medical history included: "High blood pressure" (ongoing), notes: About 20 years ago; "High Cholesterol" (ongoing), notes: About 20 years ago; "Sarcoidosis" (ongoing), notes: diagnosed maybe 12 years ago, Pertinent Details: He sees a respiratory therapist for this condition. There were no concomitant medications. Vaccination history included: BNT162b2 (First dose, Lot: E88732, Expiry: 31Jul2021, NDC: Unknown, not on the CDC vaccine record card., Dose: Unknown strength/volume/dose injection to he thinks left arm), administration date: 27Mar2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (Second dose, Lot: ER8731, Expiry: 31Jul2021, NDC: Unknown, not on the CDC vaccine record card., Dose: Unknown strength/volume/dose injection to he thinks left arm), administration date: 17Apr2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Oct2021, outcome "recovered" (Nov2021), described as "soreness at the injection site on left arm"; CHILLS (non-serious), outcome "recovered".   Additional information: He also mentioned having chills and soreness at the injection site on left arm after his first booster shot of Pfizer Covid-19. There was no prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). There was no AE(s) following prior vaccinations. Family Medical History Relevant to AE. Relevant Tests was none.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a licensed practical nurse (L.P.N.) and refers to multiple unspecified patient of unknown age and gender.  The patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot number: M024261, expiry date: 30-JUL-2018), route of administration was not reported. Temperature time excursion was 1 hour >46 degree of Fahrenheit but< 77 degree of Fahrenheit , and 3 hours between 32 degree of Fahrenheit  and 36 degree of Fahrenheit. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA006595: US-009507513-1702USA007042: US-009507513-1702USA007040:
Rapid heart beat, weakness, jaw clenched, throat felt tight within 5 minutes of receiving vaccine
1. Dizziness. 2. Nausea Vomiting. 3. Hypertension. 4. Eye itchiness/redness/weakness. Treatment Drugs Used: 1-Diphenhydramine 2-Clonidine
Patient recieved Menactra U6207AA Expiration 05/25/2020 during the visit.  Right after the patinet left from the clinic within few steps from the clinic door, the provider found mother calling for help holding the patient who was about to faint.  The provider assisted the mother and held the patient and placed the patient down to the floor in front of the side B clinic area.  Patient was conscious at that time but lathergic.  He was able to tell his name, place and date.  Vital signs were assessed several time over the 15 min of monitoring the patient by the provider about 5 mins intervals.  Those were 100/62, 110/62, 120/64.  HR were around 61-80.  O2 Sat was initially 94 % at the time of the occurence then up to 98 %.  The patient looked pale color but at the end of 15 min monitoring, pt. colored was back to pink.  The patient denied dizziness, HA, difficulty in breathing. The Patient was gradually encouraged to move the position from lying flat to sitting up, sitting up to sitting on the chair and finally standing up without help.  After confirming patient's last VS (noted previously) and the provider walked with the patient and his mother to the front door.  Gait was steady, the patient was AAO x4 and was able to communiate with the provider.  Mother left voice message twice between 6-6:37 PM.  Unable to reach to the patient or mother.
In the middle of September 2021, I broke out in hives around my entire body. It will get warm and itchy. Sometimes it was my back, sometimes legs, arms, neck, etc. I went to see a doctor with Medical Group who prescribed a generic Benadryl and prescription for steroids. It did not go away with the steroids but the Benadryl did take it away. I was prescribed a higher dose at my second follow-up but it did not work. The third time she wanted to increase the Steroids dosage but it declined. I started to self-treat with Zyrtec one daily and that helped but if I do not take it regularly it comes back. As soon as I stop, it comes right back. They said maybe I was allergic to milk or different things. I stopped those things but I am still having these hives. I tried to stop eating certain things but I continue having hives. It develops on different parts of my body but most of the time is on my legs. I saw a Dermatologist in January who stopped me from taking Zyrtec and he had me take Allegra. I feel it is less effective and I have to sometimes take twice a day. It doesn't eliminate the hives like the Zyrtec did. My doctors cannot determine why this is happening. It is not as severe in present time but they are still there especially places on warmer parts of my body. I do feel like it has subsided but my Dermatologist did not want me to take Zyrtec long-term to avoid liver damage but I feel I can treat it myself and use other OTL topicals. I do have a follow-up with my Dermatologist at the end of June.
she is 13 weeks pregnant after receipt ofGARDASIL 9 on 7/22/2019; no adverse reactions; This spontaneous prospective pregnancy report was received from a 23-year-old female patient who was referring to herself. She had no medical history, concomitant medication, drug reaction or allergies.   On 22-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) single dose, via route reported as normal (strength, frequency, anatomical location, lot # and expiration date were not reported) for indication reported as normal vaccination.    On 14-AUG-2019 (also reported as recently), the patient found out that she was 13 weeks pregnant. Her last menstruation period (LMP) was calculated as 15-MAY-2019 and estimated due date (EDD) was calculated as 19-FEB-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 9 weeks. The patient reported no adverse reactions. She did not seek medical attention and did not receive any treatment for the event.   The pregnancy outcome was outcome pending.
Patient vaccinated at 14 weeks pregnant; due 7/5/2021. Approximately one week following injection, patient developed an itchy, raised rash at the injection site. The rash persisted for 5 days, then resolved.
no adverse reaction or outcome. patient was given the moderna initial series (2 doses) while 17 years old when moderna is only authorized for 18 years and older.   Spoke with Mother 1/11/22.
Patient was expecting to receive the Pfizer Bivalent vaccine and instead received the Pfizer monovalent. There have been no ADRs as a result. The patient was consulted on the proper process for this error via recommendations ( fully vaccinated, may get bivalent in 2 months).
The pt experienced chronic extreme pain in ribs, joint and muscle pain, fatigue, nausea, treated with Prozac, Darvon, symptoms still persist.
Pain, swelling, heat and redness at injection site, body aches, fever(100.5), headache, extremely tired, nausea, chills, and sore joints. It is interfering with normal activities. I am attempting to get medical attention. The physician that administered the injection said there is nothing they can do. They just give the injection. I was advised to call urgent care but I have a call into my family physician.
had the flu shot and had a reaction,from her shoulder to her elbow were red; had the flu shot and had a reaction,from her shoulder to her elbow were red AND HOT; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves Adult female patient (64.41 kg) who had the flu shot and had a reaction, from her shoulder to her elbow were red and hot after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Cefdinir for Sinus infection.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient developed non-serious events of had the flu shot and had a reaction, from her shoulder to her elbow were red (erythema) and hot (feeling hot) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for both events.  At time of reporting, the outcome was Unknown for both events.
Fatigue - same evening, lasted for 4 days Fever - middle of the night Headache - all throughout the next day
2 inch area in diameter around the injection site of redness and swelling, lasting approximately 5 days.  Prescription with ice.  History: 1st flu vaccine: 4inch area of redness and swelling lasting several days, done in 2000.
1st 30 min: redness in face, pounding head went to CVS in Cohoes (where administered) to check on results. Heart Rate (HR) 125. Redness continued to worsen, they called 911. HR was 135 when EMS arrived. Took to ER. 30-60min (ambulance): HR about 140, was given Benadryl to ease symptoms. Almost vomited. given an IV. shaking started as soon as we arrived at the ER - compulsive, teeth shattering. 60-120min (ER): HR stayed at 140, was given prednisdone. redness had spread to my entire body, except hands/feet. 120-150min: completely red, but shaking stopped. 2 1/2 hrs-5hrs: HR dropped to about 115, redness was going down. discharged from hopsital approx 10:30 PM. Next day: face still red, HR back to normal. Followed up with doctors 11/5/2009 ED record for 10/8/2009, patient with c/o's rash, palpitations, swelling, difficulty breathing. TX: Benadryl and Zofran with sx resolution. DC DX: allergic reaction
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 57-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
Patient felt really hot. stood up and fainted. fell to the floor hitting her face. ended up with blood in the mouth and nose. Went with EMS
Fever of 100.4, chills, aches, malaise, lethargy, muscle weakness
I contracted COVID-19 on 06/27/2022 with symptoms of sore throat, cough, fatigue, fever of 102.3, chills, and body aches. I was prescribed Tussinex with Codeine, and Benzonatate on 06/28/2022. I was ill 10 days before my symptoms began to resolve. I am still experiencing a lingering cough intermittently.
Red, warm, and inflammation where shots were given. Patient will go to urgent card to be seen.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 05-JUL-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tub, which had the lot # K022995, with expiration date 22-JUL-2016, orally (dose and dosage number were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced temperature excursion of 24 hours. The highest recorded temperature was 47 F (8.333333333 Celsius degrees), the lowest temperature was not reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
first dose on 2019, second dose on 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 8th November 2019).   In September 2021, the patient received the 2nd dose of Shingrix. In September 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient did not return for 2nd dose in recommended time interval after 1st dose of Shingrix. The patient then went to a different pharmacy in September 2021 and was given another dose, which led to lengthening of vaccination schedule. No further details provided. The reporter did not consent to follow up. This case was linked with case US2021AMR258228, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR258228:same reporter
sore arm, with swelling and tenderness to axillae, sore throat, sore muscles in the right neck and shoulder,
VARIVAX given in RA while patient lying down, due to past issues with imms and fainting. As patient stood up he got dizzy and nauseated and vomited within 5 minutes of administration.
Pt given Tdap at 9:30, states feels ticklish, in Right deltoid; then HPV given and Hep A in Left deltoid. At 9:33 Pt states she feels dizzy and by 9:35 pt Is passing out, slumped to the Left side. Approximately 20 seconds later patient woke up and states what happened I fell asleep, skin was pale and she wasn't sure about where she was at that moment. 9:38 patient states she was going to be sick and proceeded to vomit. Asked patient if she ate today and she replied no not yet. After sitting and sipping water, color returned to face and states she felt much better. Pt left office after 10 minutes, to front lobby, walking on her own unassisted. Patient sat in lobby for another 10 minutes and states felt better. Grandmother and patient proceeded to leave building, without problem. Called grandmother at 11:00AM and spoke to patient who was eating lunch and looking forward to going skating.
Child complaining of left arm pain on 3/18/03 PM. Parents noted swelling, redness and firmness at site about 6cm X 6cm (very firm) and induration with surrounding redness and swelling involving much of left upper arm. Child was treated with an antibiotic starting 3/19/2003 - reactions resolved within 72 hours.
Allergic reaction to both doses. First dose happened the day after receiving vaccine and my whole left arm, across my chest and my upper back were itchy. Then within 1 hour after receiving the second dose, my entire body got itchy and my tongue started getting tingly. My body itched for a few days after the second dose.
pt recvd vax & went to ER w/ nausea & a fever of 104 & was incoherent; pt had dark urine & clay colored stools & was jaundiced; lab tests revealed pos hepatitis B surface antigen; SGOT 3110;LDH 495;& bilirubin 16.2;prothromin time was 3000;
Narrative:  Pt was an 80 y/o male with a PMH of St. Jude valve replacement in 1991, CVA 1998, atrial fibrillation, COPD with chronic hypoxic respiratory failure on 2L of oxygen, Hypothyroidism, dementia, BPH, right hemiparesis, major depressive disorder, PTSD, and seizure disorder who presented to hospital from 6/26/2022-7/7/2022 admitted for falls and weakness. CT head negative and UA on admission w/o signs of infection (6/26/22). Started on vancomycin, cefepime, and flagyl in the ED for possible pulmonary infection given elevated WBC. CXR negative, procalcitonin negative and WBC normalized so abx were stopped. Patient then presented to hospital on 7/13/2022 for neurology visit. Patient being evaluated for tremors, progressive memory problems, and balance issues. Per neurology, patient has mild neurocognitive impairment which is multifactorial in nature. polypharmacy has been described as a concern, but patient refused to make medication changes at visit. Of note, patient has 3 family members who died from covid recently. Patient received his COVID-19 vaccination on 7/13/2022. Patient was given vaccine information sheet listing the risks, benefits and side effects of vaccination. Patient reviewed the information and gave verbal consent to receive the vaccine. He received the Pfizer COVID-19 vaccine in the right deltoid. Vaccine was administered without complications and patient was observed for 15 minutes after vaccination. Patient was found on Thursday morning 7/14/2022 deceased in his sleep, appeared comfortable, some foaming at the mouth was noted.
Headache; Two hours after vaccine, pain from shoulder to hand; Couldnt move her arm due to pain, four hours after vaccine; Pain is moving to her armpit and her left side of back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Two hours after vaccine, pain from shoulder to hand), LIMB DISCOMFORT (Couldnt move her arm due to pain, four hours after vaccine), AXILLARY PAIN (Pain is moving to her armpit and her left side of back) and HEADACHE (Headache) 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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Two hours after vaccine, pain from shoulder to hand), LIMB DISCOMFORT (Couldnt move her arm due to pain, four hours after vaccine) and AXILLARY PAIN (Pain is moving to her armpit and her left side of back). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Two hours after vaccine, pain from shoulder to hand), LIMB DISCOMFORT (Couldnt move her arm due to pain, four hours after vaccine), AXILLARY PAIN (Pain is moving to her armpit and her left side of back) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment information was not provided.   Reporter did not allow further contact
ED visit for febrile illness; treated and released. 3 Days later admitted for AKI; suspected to be due to ATN vs immunotherapy mediated. Hyperkalemial. Was started on empiric Vanco and Zosyn > discontinued 2 days later after blood and urine cultures came back negative. Was seen by ID on 11/4 > recommendation was to stop antibiotics and monitor. Was also seen by oncology on 11/7 > fever thought to be either neoplastic fever versus Abraxane induced fever. Other hospital problems treated. ED visits and hospital admission within 6 weeks of receiving the COVID vaccine.
Started breaking out 9/15/11. Continues to breakout. Febrile rash itches. Pustule in scalp secondary scratch. 9/19/11 - seen in office - rash consistent with chickenpox - face, scalp, trunk / secondary infection. BENADRYL q 4-6h. TYLENOL q 4-6h. Calamine lotion. KEFLEX 500 one TID #21.
Migraines for 2 days, on the 3rd day finally better but still a mild pulsating headache, took Naprosyn to manage symptoms