chrisvoncsefalvay/vaers-outcomes huggingface dataset:
non responder, recvd 1 dose of Engerix B (deltoid area) as a second F/U booster /p a needle stick injury. Titers checked and none detected.
Slept poorly that night and felt like heart rate may have been slightly elevated.; Anxiety; soreness in arm greater than normal flu shot, but it is subsiding; Slept poorly that night; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 24Feb2021 at 09:00 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included heart diease, raynauds and allergy to pre-surgical wipes which caused significant rash. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), amlodipine (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN) taken for unspecified indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Feb2021 at 22:00, the patient slept poorly that night and felt like heart rate may had been slightly elevated. The patient was not a great sleeper and had heart disease so considered it possibly related to anxiety. On same day, patient experienced soreness in arm greater than normal when had flu shot, but it was subsiding. The patient was feeling better currently and heart rate seemed normal. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slept poorly that night and felt like heart rate may have been slightly elevated, possibly related to anxiety and soreness in arm greater than normal was recovered on an unknown date in Feb2021.   No follow-up attempts are possible. No further information is expected.
Redness, warmth & induration to injection site in (L) thigh. Treated with Cephalexin to cover for cellulitis.
Left elbow redness, swelling, warmth that began on 10/04/2016. Septic bursitis of elbow. Treated with BACTRIM DS x10 days.
Progressively getting dizzier and out of sorts every day since the vaccine. Getting worse every day. No brain function. Cant drive. Cant work. Feeling weak, shakey and like shit. Blood oxygen levels dropped to 93. Deep breathing brings it up to 98 but drops again as soon as deep breathing stops. All other vitals normal.
I started noticing some brain fog, but I was not really sure. I discussed it with my doctor. My hair changed texture, it went from being thick and straight to being curly and frizzy and thin. It literally was falling out by the handful. I cannot say for sure it was the vaccine, but it started a month after. I went to the doctor in April, and we started discussing it. He referred me to a dermatologist and unfortunately it took months to be seen. I was not seeing until 08/12/2021. They did not do any medical tests or prescribed any medications. They said they do not know what the cause was. They said they noticed that my hair is growing back. They suggested to use Rogaine to help with the growth. I was Covid positive the Monday after thanksgiving of 2020. I do not know if this is related. I know when I went for my first dose it was 01/25/2021 and they said it was within the 90 day timeframe of active disease but they said they will still give me the vaccine because I work in healthcare. I am still in the process of recovering.
This is a spontaneous report from a contactable nurse. A 4-month-old female patient received on 18Jan2017 first dose of PREVNAR 13, lot number N44209, expiry date 31Oct2017, NDC number 00005-1971-02) at 0.5 ml single dose intramuscular for immunization.  Medical history included ongoing milk allergy since birth. Concomitant medications were none. On 18Jan2017, the patient had bloody diarrhea and was taken to the emergency room on the same date. The reporter did not think that the patient was admitted into the hospital. Outcome was unknown. Sender's Comments: Based on the information currently available, a causal relationship between the administration of PREVNAR 13 and the occurrence of the reported event cannot be completely excluded based on the temporal relationship.
This is a spontaneous report from a contactable consumer. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: el3247 and Batch no/Expiration date: not provided) via an unspecified route of administration in Arm Left on 18Feb2021 09:00 AM (age at vaccination 40-years-old) as dose 2, single for COVID-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. Patient had past drug codeine and experienced allergies. Historical vaccine included previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL3247 and Batch no/Expiration date: not provided) via an unspecified route of administration in Arm Left on 28Jan2021 09:00 AM (age at vaccination 40-years-old) as dose 1, single for COVID-19 immunization. Patient did not receive other vaccines within four weeks and did not receive other medications within two weeks. Patient had no covid prior to vaccination and not tested post vaccination.Two days later on 20Feb2021, the patient experienced Sore arm, felt tired and headache most of the day. The patient received treatment for the reported events which included Tylenol. Outcome of all the events was recovering. Follow-up attempts completed. No further information expected.
PATIENT IS A 69 AND 6 MONTHS OLD FEMALE WHO GOT HER FIRST COVID-19 VACCINE ON 01/19/21 AND EXPERIENCED OF WHAT SHE THINKS AN UNUSUAL EVENT/ FEELING AFTER VACCINATION. PATIENT REPORTED THAT 3 MINUTES AFTER VACCINATION, SHE FELT A STRANGE SENSATION AT THE BACK OF HER TONGUE, SHE THEN FELT FLUSHING SURGE FROM FEET TO NECK AREA, FOLLOWED BY STRANGE TASTE AND TINGLING SENSATION AT THE BACK OF HER TONGUE. SHE THEN REPORTED THAT OTHER SYMPTOMS LASTED FOR ABOUT A MINUTE BUT THETINGLING AND STRANGE TASTE DIDN'T WENT AWAY UNTIL AFTER THE BENADRYL WAS ADMINISTERED. SHE ALSO REPORTED THAT HER HANDS WERE SWEATING AND IT FELT COLD AND CLAMMY. SHE FELT HER HEART RATE WAS INCREASING. SHE SAID THAT AS SHE WAS WALKINGFROM HER CAR TOWARDS THE EMS VEHICLE, SHE FELT WEAKER AND WEAKER AND THIS WEAKNESS LASTED FOR ABOUT 2 HOURS. SHE ALSO FELT HER LEGS WERE HEAVY.  EMS PERSONNEL TOOK V/S: BP WAS 161/97 MMHG; HR 89 BPM. SHE ALSO REPORTED THAT THE EKG THAT WAS TAKEN BY EMS PERSONNEL WERE NORMAL. SHE DENIED ANY DIFFICULTY BREATHING, NO SWELLING OF TONGUE OR FACE, NO ITCHING, NO HIVES.  SHE REPORTED THAT EMS ADMINISTERED IV BENADRYL 25 MG AND SHE WAS GIVEN FAMOTIDINE(PEPCID) 10MG ORAL DOSE. AT THIS POINT, PATIENT DENIED ANY DIFFICULTY SWALLOWING.  SHE THEN TRANSPORTED TO ER AND WAS OBSERVED FOR 2HRS AND WAS SENT HOME. PATIENT REPORTED THAT NO LABS DONE AT ER, THEY ONLY DID V/S MONITORING. UPON DISCHARGE, PATIENT REPORTED THAT HER BP WAS 142/76; HR-84 AND O2 SATURATION OF 96-100.  PATIENT VERBALIZED THAT ALL SYMPTOMS WERE GONE BY THE TIME SHE WAS DISCHARGED. PATIENT REPORTED THAT ER DOCTOR MENTIONED THAT BASED ON HER S/S, IT SOUND LIKE ITS A MILD SIDE EFFECT OF VACCINATION. PATIENT REPORTED THAT SHE CALLED HER PCP AND REPORTED THIS INCIDENT TO HIM, HER PCP THEN RECOMMENDED TO NOT GET THE SECOND DOSE OF MODERNA VACCINE AND WAIT FOR THE JOHNSON'S AND JOHNSON'S COVID-19 VACCINE INSTEAD.  PATIENT SAID THAT HER PCP REFERRED HER TO AN ALLERGY DOCTOR AND WAS SCHEDULED TO SEE HIM ON 01/26/21.  WILL CONTINUE TO FOLLOW-UP ON PATIENTS REPORT.
Breakthrough case admission after 3 vaccines  Moderna 3/15/21 lot# 031L20A;  Moderna 4/19/21 lot# 040B21A;  Moderna 11/15/21 lot# 039F21A
Beginning 8  days after painless injection my right arm, posterior aspect from deltoid to elbow became swollen, hard, livid red and intensely itchy.  No systemic symptoms.  The reaction finally faded away 10 days later, leaving some desquamation of the epithelium.
A report has been received from a Health Authority, concerning a patient of unknown gender. The patient's concurrent disease included known egg allergy. No relevant medical history or concurrent disease has been reported. The patient had been receiving nasal FLUMIST started on an unknown date. The patient experienced anaphylactic allergic reaction. The outcome of the event of anaphylactic allergic reaction was unknown. The report was considered to be serious due to important medical event by the reporter. Follow up of information received by AstraZeneca/MedImmune on 22-Jun-2012 upgraded this case to serious expeditable: the event of anaphylactic allergic reaction was upgraded to be serious due to important medical event.
Patient visibly upset before receiving vaccine but did go ahead and receive She then went to waiting area where she felt faint and other RPh said she had what looked to be a small seizure for a very brief moment but then she came to and was feeling ok--EMS came and checked her out and she left with her family without any assistance
02/03/22 presents to ED for "CVA-Weakness". PMHx of "hyperlipidemia, depression, and GERD"
Patient received dose one of the Pfizer vaccine at 1150am and around 1230 begun to feel tingling in the right of her face/cheek. She then noticed significant swelling of the left cheek and bottom lip. She was taken to the emergency department and received steroids, benadryl, and fluids. She was observed for a few hours and then discharged. She was feeling well the same day.
This spontaneous report as received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unspecified dates, the patients were inadvertently vaccinated with improperly stored PROQUAD lot # M015698 and expiration date: 26-SEP-2017 (dose and route were not provided). No adverse event was reported. There was not product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
Chills difficulty breathing loss of consciousness  altered mental status fainting fever fatigue gastrointestinal pain
At the time of being inoculated, the patient refers to feeling weak, pale and cold. Her vital signs 70 pulse, 70/40 B/P, 12 Respiration Sat 98% Dextrose 174.
This is a 72y.o. female with PMHx significant for CAD prior PCI, HTN, sarcoidosis, CHF diastolic dysfunction who presented for shortness of breath progressively worsening over the last few weeks. She endorses mild SOB at baseline and does not use supplemental O2 or CPAP at home. Endorses a dry cough. She is vaccinated against COVID and did not test positive in the past until 9/26. Recently hospitalized for HTN. States she has a hx Pulmonary embolism from early 2000s. Denies chest pain, abdominal pain, nausea, vomiting, paresthesia, fever, chills. During ED eval, chest CT showed no PE, but a bulky calcified lymphadenopathy in the hila and upper abd. Trop negative, COVID positive. procalcitonin 7.32. Admit for further eval and management. covid precautions removed 10/6 and sats stable on RA now. She completed IV decadron and Remdesivir 10/1. ID was following and completed ceftin . She has hx of Dysphagia S/p dilation on 7/21 via EGD. Esophagram showing no evidence of obstruction and Esophageal dysmotility and she is tolerating reg diet. Per cardio, CP likely due to MS in nature. ECHO with EF 55% and stress test neg with EF 70%. Psych was following and trazadone increased, continue xanax.  PT/OT recommending SAR and pt agreeable. She is stable for d/c with close Op follow up
Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was provided. Action taken with mRNA-123 is not applicable.
This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, GARDASIL 9 was inferred to have experienced the following temperature excursions: 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours; 38.6 F for 20 minutes on 27-DEC-2016, at 07:51 hours; and 44.9 F for 20 minutes on 31-DEC-2016 at 03:41 hours. They were called out because of a digital data logger. On 31-DEC-2016, at 11:41 hours, the patient was vaccinated with the first, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M021407 with an expiration date of 30-APR-2018), intramuscularly, in the left arm, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA011160: US-009507513-1703USA011162: US-009507513-1703USA011159: US-009507513-1703USA011158: US-009507513-1703USA011161.
25 y/o male, is exposed to recent vaccines of Smallpox vaccine by wrestling contact on 24 Jun 10 and develops right arm contact transmission with vaccinial lesions and eye itching. Left eye symptoms progress to swelling, leakage and lid lesions and eventually diagnosed as Ocular Vaccinia. Patient is currently on treatment with Ophthalmology.
Pfizer vaccine was administered outside of the clinic - reported by patient   HYPOXIA 7/4/2021 RENAL FAILURE
General malaise starting 7/28/21. 8/7/21 hot flashes, nausea, headache, fatigue. All previous symptoms vanished 8/8/21 and all over body rash takes over. As of 8/18/21 feet and hands are now shedding skin. Patient consulted and the provider asked that the patient have us submit a VAER's. Patient to provider in 2 weeks and will do blood work at this time.
don't think it HELPED AT ALL; still got the flu symptoms; Initial information received on 19-Dec-2022 regarding an unsolicited valid serious case received from a Consumer/Non-HCP (non-healthcare professional) via social media.  This case involves a patient of an unknown age and gender who reported still got the flu symptoms and don't think it helped at all after receiving Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown lot number, expiry date, formulation, route, strength) in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed events of still got the flu symptoms (influenza) and don't think it helped at all (vaccination failure) (latency: unknown) 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: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Unknown  Seriousness Criteria: Medically significant for don't think it helped at all (vaccination failure).
My right arm was sore almost immediately after being vaccinated, but it wasn?t bad. Then later at night when I was trying to get to sleep I was horribly restless, shaking, and feverish. I had to bundle up in blankets because I was so cold. My whole body ached terribly, and I had a headache. It lasted a few hours and I couldn?t get to sleep. At one point I felt extremely nauseous and ran to the bathroom, barely holding back vomit, but then it went away and never came back. The day after that (April 15th) I was extremely fatigued and still had body aches and a headache. I took my temperature at 5 am on April 15th and it was 99.4°. I mostly just slept a lot and didn?t have much of an appetite. My arm was still a little sore during this whole time. As I?m writing this at 5 am on April 16th, I still have a headache.
Fatigue, headache, chills, muscle aches, runny nose, cough--first experienced about 36 hours after 2nd vaccination. Feeling okay mornings--symptoms begin early afternoon, some days earlier--will crawl into bed with covers overhead for ~ 12 hours--cycle recurs.  Initially attributed this to "building immunity", but cycle has persisted, even worsened , with passage of time.
After injection next day arm was purple,  Red and Hot to touch. Pt. was scheduled  Doctor prescribed Augmentin.
Patient felt faint and passed out 5 minutes after receiving the vaccine.  After he came too he did not feel well.  911 was called and EMT's check him out.  They released him to go home after checking vitals.
Mild edema with redness over anterior thigh inside and slightly inferior to injection site. No fever or increased warmth at site of redness. Non-tender.
20DEC temp 101; rash, sz, to ER; 3JAN91 4 szs 24 hr temp 106 admitted, rash developed dx Roseola;
Allergic reaction: tongue swelling, difficulty breathing, wheezing.  Adminstered 2 erpipen doses and called 911. EMS showed up and took over. Pt seemed slightly better when she left with EMS.
Increase LFT's required daily visit to outpatient clinic to received Solumedrol 150 mg x 3 days.
Pt reported that pt started having ADEs on 4/16/2021 ~2pm with a headache and body ache. Today (4/17/2021) the headache and body is a little more intense than the day before, along with sore left arm (cannot lift arm) and chills.  Pt (pt's sister-in-law, per pt does not speak English) reported that the pt to 1 tablet of Advil this morning. **NOTE** Recommend that pt can take either Ibuprofen or Tylenol PRN, consume adequate meals, stay hydrated and rest. Advised ADEs usually occurs within 1-3 days post vaccination but should subside in a couple of days after. Recommend if symptoms does not get better to contact MD.  4/19-Placed follow up call on 4/19/2021 at 16:58: Pt reported that pt felt much better on 4/18/2021. Pt switched from taking Tylenol to Ibuprofen, and followed recommendations from the inital call and that helped. As of today, all ADEs went away and pt is back to her normal self.   **NOTE** Advised Pt if pt experience any ADEs from 2nd dose to please call back to report.
This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In November 2021, the patient received the 2nd dose of Shingles vaccine. In November 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown. It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got second shot last week and it kicked his/her ass but better than getting shingles.
Began to experience pain in shoulders, then in knees, then in hands over several weeks which increased rapidly, until 2+ months later, I could barely sleep or move for pain. My RH levels skyrocketed. Eventually I was diagnosed with "sudden onset severe RA" never having had any indication of that condition, nor any in my family. No doubt it was underlying, but I couldnt believe how fast it happened, relatively speaking. Now I am not sure whether I should get any more boosters.
had metallic taste in mouth; where they gave the vaccine was really painful; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (had metallic taste in mouth) and VACCINATION SITE PAIN (where they gave the vaccine was really painful) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Gastroenteritis.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DYSGEUSIA (had metallic taste in mouth) and VACCINATION SITE PAIN (where they gave the vaccine was really painful). On 20-Jan-2021, DYSGEUSIA (had metallic taste in mouth) had resolved. On 22-Jan-2021, VACCINATION SITE PAIN (where they gave the vaccine was really painful) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included an unspecified medication used for gastroenteritis.   The patient used ice for treatment of the vaccination site pain.; 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.
Information has been received from a physician concerning a 12-month-old female who in September 2008, was vaccinated with MMR II, Hep A (manufacturer unknown), and VARIVAX (Merck) (MSD). "About 3-4 days after receiving shot" the patient developed a severe rash and went to the hospital, but was not admitted. The patient was prescribed BENADRYL. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
On March 23, 2021, I began having an extremely heavy menstrual flow, passing clots and requiring protection to be changed at least hourly which lasted approximately three weeks.  There has been no period since that time.  Previous periods were irregular presumably related to peri-menopause, but were never heavy enough to change protection more often than every 4-5 hours and never lasted longer that 4-5 days.
RACING HEART FEELING FOR 4 TO 5 TIMES; RASH AT SITE OF INJECTION LIKE RED DOTS ALONG ALL THE ARM; This spontaneous report received from a consumer concerned a 53 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the patient experienced racing heart feeling for 4 to 5 times, and rash at site of injection like red dots along all the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the racing heart feeling for 4 to 5 times and rash at site of injection like red dots along all the arm was not reported. This report was non-serious.