chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Shortness of breath; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, expiration date unknown, 1st dose via an unspecified route of administration on 18Dec2020 14:00 at a single dose at right arm for COVID-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient experienced fever, shortness of breath, headache and muscle ache on 19Dec2020 01:00 am. There was no treatment received for the events. The patient underwent lab tests and procedures on 19Dec2020 which included COVID test post vaccination (Nasal Swab): unknown result (pending). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. The action taken in response to the events was not applicable. The outcome of the events was recovering.
Approx 15 minutes after receiving the vaccine she started c/o lip abd facial itching. She was given Benadryl 50mg Im to L Deltoid. She said within 5 minutes she was feeling better already. She called a friend that is a nurse practicioner to come and pick her up. no other problems noted
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Within minutes, hives, local redness noticed on left upper arm. Hive faded. Later evening arm redded 6 cm x 6 cm in office on 08/02/02 hard, tender, red.
Approximately 2 minutes after vaccine was administered patient very suddenly became drenched in sweat, appeared very pale, experienced loss of vision, and lost consciousness briefly. Before losing consciousness patient was able to sit down before slumping to the side. Patient's mother and father were able to ensure patient did not fall and alerted pharmacist that administered vaccine. The pharmacist checked patient's vitals at which time consciousness returned and instructed patient to bend down to put her head between her knees. Also provided patient with sips of a cool drink during recovery period. Patient remained seated in pharmacy for 20 minutes after episode resolved before leaving for home with her parents after this information was collected and recorded.
29 minutes after receiving COVID VX, started to develop left itchy ear & itchy throat with mucus production & cough.  O2 given. Benadryl 50mg, Solumedrl 40mg, Pepcid 40mg, Epi-Pen Q3mg IM x2 q5min. Within 1 hr, pt's throat itch was much improved. Pt. talking smiling throughot. Pt discharged once recovered, vital signs stable. ER precautions given
Severe muscle pain; Severe joint pain; rib pain; pain at injection site(entire arm); severe fatigue(both shots); This is a spontaneous report from contactable consumer (patient). A 56-Year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Lot number: Ew0151) via an unspecified route of administration in right arm on 07Apr2021 at 15:00 (at the age of 56 years old) as dose 1, single for COVID-19 immunization. The patient medical history included high bp, generalized anxiety disorder, autoimmune history and allergic to sulfur. Concomitant medication included bisoprolol, lisinopril, alprazolam (XANAX), paracetamol (TYLENOL) all for an unknown indication from an unknown start date. Patient did not receive other vaccine in four weeks. On 07Apr2021 at 18:00 the patient had severe muscle and joint/rib pain, pain at injection site (entire arm) and severe fatigue (both shots). Patient did not have covid prior vaccination and not tested for covid post vaccination. Patient did not receive treatment for the events. The outcome of the events were not recovered. No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of ear pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 5th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced ear pain and headache. In January 2019, the outcome of the ear pain and headache were recovered/resolved. It was unknown if the reporter considered the ear pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX in the left arm. In January 2019, the patient experienced an earache in her left ear and a headache after the SHINGRIX injection and that both issues had resolved. The patient did not consent to follow-up.
01/15/2022 I woke up and felt like I had not slept, I had extreme fatigue, body aches, headache, feverish, alternating hot flashes and cold sweats. Mainly the fatigue and body aches were the main symptoms. I took a home COVID test which was positive. This lasted for a week to 10 days. I then took a couple of more home COVID tests that were negative. I had trouble concentrating for a while after the other symptoms subsided. I started feeling fatigued again last month and felt similar as I did before with COVID. I had body aches and fatigue which lasted a few days. I also have congestion which could be allergies. I am waiting for the results of a COVID PCR test. I now feel 100% again.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On 29th July 2016, the patient received BEXSERO./5 ml. On 30th July 2016, 1 days after receiving BEXSERO, the patient experienced injection site pain and vomiting. On an unknown date, the outcome of the injection site pain and vomiting were unknown. The reporter considered the injection site pain and vomiting to be probably related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination was not reported. The field representative reported that doctor's unknown patient experienced pain at injection site and vomiting after receiving BEXSERO vaccine. The patients details were unknown and limited event details were available. The doctor requested safety report to be mailed to office manager.
feeling flushed; feeling uplifted; face was red; Expired vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (feeling flushed), FEELING ABNORMAL (feeling uplifted), ERYTHEMA (face was red) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced HOT FLUSH (feeling flushed), FEELING ABNORMAL (feeling uplifted), ERYTHEMA (face was red) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved. At the time of the report, HOT FLUSH (feeling flushed), FEELING ABNORMAL (feeling uplifted) and ERYTHEMA (face was red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-362005 (Patient Link).
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/10/2023 Discharge Date: 2/27/2023  PRESENTING PROBLEM: NSTEMI (non-ST elevated myocardial infarction) CAD in native artery   HOSPITAL COURSE: Patient is a 78 y.o. who on 2/9 presented to outside hospital with complaints of cough and worsening dyspnea. She had elevated troponins, nT proBNP, and +covid. She was transferred. 2nd degree AVB was present. Cardiac cath demonstrated severe multivessel CAD. Her echo demonstrates LVEF 55%, with basal inferior and basal inferolateral wall segments appearing severely hypokinetic. Previous medical history includes HTN, DM2, HLD, CVA in 2018, brain surgery for meningioma in 2005 and 2015, seizure disorder. CABG scheduled pending Plavix washout.   2/20 CABG 2/21: Holding betablocker for bradycardia, transfer to 7H 2/22: Start low dose beta blocker, increase activities. Remove cordis and left mediastinal chest tube this PM. 2/23; Remove pacer wire and all chest tubes. CXR in AM. Increase activities. Anticipate discharge in 1-2 days.  2/24: All surgical tubes removed. Increase activities. Trending hypertensive, adjust blood pressure medications. 2/25: Hemoglobin 7.9 today, recheck H&H 2/26: NSR/SB overnight, HR in the 40s. Stop beta blocker and monitor HR overnight. Anticipate home tomorrow if no significant bradycardia
pt recvd vax 7SEP93 & 8SEp93 devel redness & swelling @ the inject site which measured 3" in diameter & was warm to touch, as well as pain from elbow to shoulder;
Flu-like symptoms; chills; nausea; patient was "sick"; gave third dose, August of 2022 / third dose of Shingrix on 5-Aug-2022; sore arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2021) and Shingrix (2nd dose received in December 2021). Concurrent medical conditions included hypertrophic cardiomyopathy.   On 5th August 2022, the patient received the 3rd dose of Shingrix. On 5th August 2022, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, nausea, sickness and extra dose administered. In August 2022, the patient experienced pain in arm. On 7th August 2022, the outcome of the influenza-like symptoms, chills, nausea and sickness were recovered/resolved. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, nausea, sickness and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-AUG-2022 and 12-AUG-2022 Reporter's Comments: The patient called and only gave limited demographic information.  Her pharmacy gave her a third dose two weeks ago of reporting date in August of 2022.  The patient then experienced chills, nausea, and a sore arm.  The nurse reported that the patient (reporter´s sister) who had a clinical history of hypertrophic cardiomyopathy received a third dose of Shingrix in error on Friday.  The patient was sick from Friday to Sunday and described it as flu-like symptoms. Adverse event filed. Gave medical disclaimer.  Referred to Health care professional.  Spoke per package insert and content.  Provided medical incharge phone number for health care professional reference.  Offered after call survey. Additional Supportive Information: The patient received 3rd dose of Shingrix which led to extra dose administered. The reporter consented to follow up. The case US2022118022 was identified as duplicate of US2022118577. The case US2022118577 would be voided, and all the future correspondence would be added in this case US2022118022 which stands as a case of record for this patient.
arm sore, achy, shoulder and neck pain, nausea and diarrhea, acid reflex, gassy
Fever (100.8) after about a day, took tylenol and slept and fever did not return.  Pain, red warm patch at the site of injection, appeared after a day and is still (48 hours) present. Some pain and discomfort in the armpit on the side of infection. No self or medical treatment for these.
Worsened peripheral neuropathy; Nerve Pain; Tingling; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Worsened peripheral neuropathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Peripheral neuropathy.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Worsened peripheral neuropathy) (seriousness criterion medically significant), NEURALGIA (Nerve Pain), PARAESTHESIA (Tingling) and MYALGIA (Myalgia). At the time of the report, NEUROPATHY PERIPHERAL (Worsened peripheral neuropathy), NEURALGIA (Nerve Pain), PARAESTHESIA (Tingling) and MYALGIA (Myalgia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Itchy small bumps developed first on chest then back and now legs. Bumps on chest dissipating, but still appearing on legs
This spontaneous report was received from a 64 year old female patient reporting on herself. The patient's concurrent conditions, medical history or allergy/drug reactions were reported as none. In approximately July 2015, reported as 8 months ago, the patient was vaccinated with ZOSTAVAX (dose, route, frequency, lot # and expiration date were not provided). No concomitant medications were reported. Since vaccination, the patient has been experienced fever blisters in her nose and mouth "every 6 weeks". No treatment was given to the patient. No laboratory tests were performed. At the reporting time, the outcome of fever blisters in nose and mouth was unknown. Additional information is not expected as no contact information was provided.
After I Received the second dose of the vaccine on 02/23/21, 3 days later 02/27/2021 at 10:00 AM I started having flu-like symptoms (very mild), 2 days after the flu symptoms on 02/29/2021 went away the  muscle pain in my left arm started and lasted 11 days, it was extremely painful picking up anything. By 02/06/2021 all symptoms went away. I Took Tylenol for this and Did not receive any medical treatment.
Vial contains .5ml and is labeled as "single dose", staff in clinic erroneously gave full contents in vial as opposed to recommended dose of .25ml. Adverse reactions not yet reported.
Vaccine was administered and two minutes later patient reported to feel "weird." She kneeled over and started to breathe heavy. Pharmacist was asking if the patient is okay and the patient stopped responding so the pharmacist kneeled over to pick up the patients head and she looked flushed, her eyes were bulging and she began to sweat. The pharmacist asked the technician to call 911, asked the patient if she could breathe and the patient said yes but said she is not feeling well. She kneeled back over and the pharmacist was holding her hand telling her to continue breathing. The patient was very sweaty continued to breathe heavily. About two minutes passed and the patient was expressing she was feeling better and better as the pharmacist was speaking to her. The EMTs arrived 7 minutes after the call the patient had sat up already and was speaking and feeling alert.  She expressed that she felt like she was underwater and the pharmacists voice was fading during the minutes after the shot and she felt like her heart was racing. She explained that she suffers from anxiety.  The EMTs took her blood pressure when the patient was sitting and standing up, blood pressure was in normal range and also checked her blood glucose with a finger stick which was also in normal range. The patient had mentioned previously that she biked to the pharmacy. Later on the pharmacist called to check on the patient she said that she is feeling well and biked back home.
Left deltoid has a 50mm round, pink, warm, raised area that is itchy over 7 days. Medical staff states to use warm compresses several times per day & return to clinic if not getting better.
rapid heartbeats; blood pressure droped; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (rapid heartbeats) and HYPOTENSION (blood pressure droped) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PALPITATIONS (rapid heartbeats) and HYPOTENSION (blood pressure droped). At the time of the report, PALPITATIONS (rapid heartbeats) and HYPOTENSION (blood pressure droped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment drugs included aloquit and tropomin
Approx 1wk post 2nd Twinrix vaccination client began to experience arthralgia in the opposite shoulder which eventually radiated to L knee. Client is currently in physical therapy. Client also relates increase hair loss since starting series.
Post vax, the patient had brief apnea, trouble breathing and a temperature of 103-104F.
Side effects began 10 hours after vaccine and lasted approximately 36 hours. Fever (101), extreme chills, joint pain, muscle aches, headache, upset stomach. I did NOT experience any pain, soreness, or swelling at injection site.
Patient received Td vaccine on 08/12/09. In January 2010, the patient reported left deltoid and should pain since receiving the Td vaccine (onset date unknown). The patient was referred to an orthopedic doctor for further treatment. Follow-up obtained 12/14/12: Patient is currently being treated for a rotator cuff tear, believed to be unrelated to the vaccination with Td. Patient is not disabled by the arm pain.
I am very nervous and hyper / I  am getting really nervous now; I am very nervous and hyper; Insomnia; Headache; I have chills and chills are really bad; Feeling unwell / Just don't feel good; This is a spontaneous report from a contactable consumer, the patient.  A 82-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 04Mar2021 (at the age of 82-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing (Blood pressure about 30 years ago). Concomitant medication included valsartan (DIOVAN) for blood pressure abnormal, start and stop date were not reported; amlodipine besilate (NORVAS) for an unspecified indication, start and stop date were not reported. The patient experienced very nervous and hyper, insomnia, headache, chills are really bad, feeling unwell / just don't feel good. The patient stated, "Well I have the first vaccine on the 4th of March and sometimes I have had quite outcome probably many-many side effects but the side effect I am concerned about is, the first week I had insomnia for one week I do take sleepy meds the sleep developer and then I am very nervous and I couldn't relax that just appeared after week so that's not too bad still get a headache. I have chills and chills are really bad, I kept two sweater on and I just still cold all the time and then I feeling unwell. Just don't feel good you know I am very nervous and hyper I took "Quinidine" (drug name not clarified using as a treatment) I am wondering I am due for second shot on Thursday, will the side effects intensify or will get better? Will it get worst or some people I talk to say that the second shot is better, clear all the side effects I really don't know I am just concerned. I am getting really nervous now. Should I take the second vaccine or not?" Outcome of the events, very nervous and hyper, insomnia, headache, chills are really bad, feeling unwell / just don't feel good was unknown.   No follow-up attempts are needed. No further information is expected.
Patient reports redened area, warm to the touch surrounding area of vaccination to left upper arm. Patient reports pain and discomfort at injection site. Denies fever started 9/6/19, the day after vaccination.
AT APPROXIMATELY 1000, PATIENT BEGAN COMPLAINING OF FEELING "VERY NAUSEOUS" AND NEEDED A BIN.  PATIENT WAS BROUGHT BACK INTO THE IMMUNIZATIONS CLINIC FROM THE WAITING ROOM.  ONCE SEATED, PATIENT THEN BEGAN FEELING "HOARSE AND TROUBLE BREATHING", WHICH THEN EPI-PEN WAS GIVEN AT 1004.  VITALS AFTER EPI PEN BP 133/77 O2 99% HEARTRATE 103.  CODE WAS CALLED SIMULTANEOUSLY.  PATIENT WAS THEN BROUGHT TO EMERGENCY DEPARTMENT VIA WHEELCHAIR WITHIN THE HOSPITAL BY CODE TEAM.