chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red patches on injection site; Pain in body; Fever, side effects; Chills, it is horrible; Back pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2023, the patient received Shingles vaccine (unknown arm). On 05-MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: Red patches on injection site), general body pain (Verbatim: Pain in body), fever (Verbatim: Fever, side effects), chills (Verbatim: Chills, it is horrible) and back pain (Verbatim: Back pain).The outcome of the injection site erythema, general body pain, fever, chills and back pain were not recovered/not resolved.   The reporter considered the injection site erythema, general body pain, fever, chills and back pain to be related to Shingles vaccine.     The company considered the injection site erythema, general body pain, fever, chills and back pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 and 07-MAR-2023 This case was reported by a patient via interactive digital media. The patient was vaccinated with Shingles vaccine and experienced body pain, back pain, fever, chills and red patches on arm. The patient reported that he/she still had the side effects.  and stated that it was horrible and can imagine how painful the Shingles disease can be. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR023309:Same reporter
Moderna COVID?19 Vaccine EUA Pain, swelling, warmth to injection site.  Chills, body aches and headache onset the next morning.
Patient started to feel strange within 1 minute of receiving the vaccine.  Within 5 minutes of receiving the vaccine, patient felt very faint, dizzy, nauseous, tingly, lost feeling in lower body, blurry vision, and started shaking.  EMS was called at vaccination site.  EMS arrived about 5 minutes later and took patient's blood pressure.  First reading was 102/70, second reading a few minutes later was 108/76.  By that time, patient could sit up and was alert and oriented.  Patient never lost consciousness.  Patient was not taken to the ER.   Patient remained on-site for another 45 minutes until symptoms resolved enough that she felt it was safe to leave.  Patient has not had a reaction to vaccines or other medical treatment in the past.
Information has been received from a nurse referring to multiple unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose unknown, lot # L007560, expiration date 15-JUN-2017) by unspecified route. The vaccines had been exposed under temperature 1.05 degree Centigrade for 49 hours, but did not undergo previous excursion. Data logger was used. This is one of several reports received from the same reporter. Additional information has been requested.
very mild swelling of the area; sorest left arm where the injection was; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,Batch/Lot Number: EL1284) dose 1 via an unspecified route of administration, administered in Arm Left on 24Dec2020 09:30 as 1ST DOSE, SINGLE DOSE (at the age of 35-year-old) for covid-19 immunisation. Medical history was not reported and concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) ; colecalciferol (VITAMIN D [COLECALCIFEROL]). On 24Dec2020, the patient experienced very mild swelling of the area (vaccination site swelling), sorest left arm where the injection was (vaccination site pain). Clinical course of events includes; on 24Dec2020 upon 1st dose had the sorest left arm where the injection was out of all vaccinations for one day and there might have been very mild swelling of the area. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Jan2021, sars-cov-2 test: negative on 22Jan2021. The outcome for the events was recovered.
Pregnant patient was going to administer the IMOVAX rabies vaccine; tingling to her eye; irritation to her eye; product was squirted into her right eye; Initial information received on 15-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via Media Information (under the reference: 00899722).  This case involves a 30 years old female patient who had tingling to her eye (abnormal sensation in eye), irritation to her eye (eye irritation), product was squirted into her right eye (accidental exposure to product)and pregnant patient was going to administer the RABIES VACCINE [IMOVAX RABIES]( exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  Patient was exposed to the vaccine at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing medical history Pregnant.  On 15-Dec-2021, the patient received a dose of suspect RABIES VACCINE [frequency-once, lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On 15-Dec-2021, the patient developed a non-serious tingling to her eye (abnormal sensation in eye), irritation to her eye (eye irritation) same day following the administration of RABIES VACCINE. It was an actual medication error due to Accidental contact of product with eye and special situation due to exposure during pregnancy (latency same day).  It was reported "Medical assistant states they have a patient who works at a veterinary clinic; states the patient was going to administer the IMOVAX rabies vaccine, but the product was squirted into her right eye. Medical assistant also reports that the patient is pregnant. Medical assistant reports that the patient completed an eye wash; states the patient reports irritation and tingling to her eye, but denies any pain."  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the reported events.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Approximately after receiving vaccine, I started experiencing significant chills and body aches and also had a slight temperature (100.7). This continued through the following evening, in waves, with the evening of the vaccine and the following  evening being the worst. In the days (7) since, I have continued to experience waves of fatigue, headache, lightheadedness, feeling flushed, and low grade temps.  I also experienced pain at injection site and in lymph nodes in armpit on same side for several days. This has mostly resolved.
This case involves a patient (unknown age and gender) who administered an expired INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] with no adverse event (Expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot QFAA2026 and expiry date 30-Jun-2021] via unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error case due to Expired vaccine used (latency was on the same day). At the time of report, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Dizziness, Headache, Sedation, Myalgia, fatigue, chills, sweating Narrative:
landed me in hospital for a month and a half during school time; Initial information was received on 21-Sep-2021 regarding an unsolicited valid Social Media serious case received from a consumer/non-health care professional (under reference US-SA-SAC20210924000268).  This case is linked to cluster case 2021SA320957.  This case involves an adult with an unknown gender patient who was hospitalized for a month and a half during school time (hospitalisation) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not provided not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was hospitalized for a month and a half during school time (hospitalisation) (unknown latency) following the administration of INFLUENZA VACCINE.  The patient reported that he/she had not acquired the flu in 26 years. Last flu shot he/she had at 13 landed him/her in the hospital for a month and a half during school time. His/her dad said no flu shot next year and well no flu was taken that year also for next year and never again. So fast forward 26 years of no flu shots he/she had yet to catch the flu in all those years. The patient also reported that he/she too would take natural immunity over risking the higher chances of catching any disease or virus from  injections.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.; Sender's Comments: This case involves an adult with an unknown gender patient who received INFLUENZA VACCINE and was hospitalized for a month and a half. The time to onset is unknown with the event. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.
PT received her first dose of Pfizer covid 19 vaccine. While sitting in the lobby for her 15 minute observation period, she started to faint. Her mother was sitting next to her and immediately got our attention. We took her into the consultation room, put a fan on her and put cold compresses on her forehead and neck. She drank some orange juice and some water. She was feeling better after 10 minutes and was able to walk out on her own after 20 minutes. She had never fully lost consciousness. She had never fainted after receiving a vaccine in the past.
After my first vaccine I did start to have stomach issues come on drastically. 2 months to the day of the 2nd vaccine, I came down with diverticulitis and ended up in the emergency room. I had been out of work this week due to stomach pains. I had a lot of painful bowel movements and I started to pass very large amounts of blood during bowel movements and went straight to the emergency room. From the ER visit, they did not diagnose me with diverticulitis but did state I may have colitis. A week later I ended up back in the ER and was then diagnosed with Diverticulitis. I was then prescribed Flagel, Cipro, and Hydrocodone, and had me follow up with a GI who then performed a colonoscopy. Then removed a polyp that came back precancerous. After finishing my antibiotics, sometime in September I had another flare up and was given antibiotics again. Since September flare-up I have not had any more instances.
SOB, progressive cough with green production as well as diarrhea. Abdominal pain and hospitalization.
2 weeks later severe inflammation of right hip              ( trochanter bursitis) and Low back sacroilliac joints). Steroid shot in the hip, prescription anti-inflammatories. No help. In 2 days will get nerve blocks in lower back.
syncopal episode, shaky, diaphoretic, EMS evaluated, pt. refused transport.
15 days after varicella vaccine developed defused smaller varicella papule some with vesicles trunk + head shortly after fever to 103-104.
Headache from hell and throwing up lasted for about 3 days and still getting a slight headache.
Developed extensive erythematous maculopapular lesions to abdomen, thighs & legs 10 days after Smallpox, Tetanus, & Anthrax vaccination, 9 days afer oral surgery; 4 wisdom teeth extracted. Seen in ER & Dermatology. Next day developed faint erythematous lesions on neck, arms, & hands. Seen in clinic with c/o sore throat, light fever, feeling tired. Prescribed CLARITIN; ZYRTEC; ATARAX & BENADRYL.
Typical as listed until night time. I woke up five tomes to pee and poo. Then the nausea kept me up for several hours vomiting (dry heaves and bile.) Lost my appetite. Drumming headache. I almost forgot, I also took 12-hour guafenosin at 11:28 am on 12/09 as directed for the sinusitis. Today I have a headache but it isn?t a sinus type.
The patient experienced syncope and some twitching. The episode lasted about 10 seconds or less. The patient looked pale initially.
Patient just got the shot and immediately feel a weird sensation.  He sat on the chair to be observed and passed out almost immediately.  We rushed to him and called out for him.  He opened his eyes and slowly told us that he thinks he fainted.  I helped him elevated both legs on the chair and talked to him if he's hurt or any other weird feeling.  He told me he's feeling fine again.   I have him lay down with his legs elevated for another 5 minutes and helped him sit up.  He was able to get up by himself and sat back on the chair.  A couple minutes later, I took his blood pressure and it was 129/85 and pulse was 61.
Soreness in arm; Minor fever; Fatigue; Got pfizer vaccine 3rd dose after Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Minor fever), FATIGUE (Fatigue) and INTERCHANGE OF VACCINE PRODUCTS (Got pfizer vaccine 3rd dose after Moderna) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 041L20A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got pfizer vaccine 3rd dose after Moderna). On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Minor fever) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Soreness in arm), PYREXIA (Minor fever) and FATIGUE (Fatigue) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Got pfizer vaccine 3rd dose after Moderna) outcome was unknown.            Concomitant medications, Lab data details and Treatment information, if any,  were  not provided.   One day after the second dose patient had minor arm pain and a mild fever that lasted about two days and also have some fatigue for 2-3 days.   Patient received one dose of the Pfizer vaccine and did not have any symptoms after Pfizer vaccine. So roughly in 3 month time period patient had 3 separate COVID 19 vaccines with no major incidents and was planning on taking a 4th (booster) vaccine in the next few months.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Included additional event, facility Information updated. Lot No. of Pfizer vaccine dose updated, event outcome updated
approx 2 hrs p/vax were given pt began crying unconsolably; pt did not want to be touched; a dose of APAP was given 530PM; 1st dose had been given 130PM; pt did eat some food but would not drink fr bottle or cup; cried until 12MN;
No physical exam. Child received HIB and DTP on 7/15/08. Child was very limp, quiet the next day, and left leg where HIB was given was red and a small swelling.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 09-NOV-2015, the patient was either vaccinated with improperly stored MMR II (lot# L009214, expiry date 17-MAR-2017) or GARDASIL 9 (Lot no # L013429, expiry date: 21-JUL-2017). Concomitant medication of the patient was unknown. No other adverse effects were reported. The outcome of the incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
inaccuracy of dose given was given 0.5ml  had 3 days of fever and couldn't walk due to having both legs hurting
Patient stopped by the pharmacy to describe a reaction that appeared after leaving the pharmacy (given in past date of 10/28/21) just so we would have the information.  Patient experienced "pins and needles" feeling in hands and around eyes.  Patient is no longer feeling the effects.
Incessantly needing stimulation (desats/bradycardia) and apnea 10/10 evening - required PPV with facemask/bag a few hours after receiving PEDIARIX. * Blood Cx of 10/10/15 2150 (+). 10/9/15 increased spells receiving stimulation - vigorous and BBO2. 10/11/15 (R) thigh slightly swollen and firm after PEDIARIX vaccination.
pt recv vax & devel a scratchy throat, joint aches, rales mid rt chest, productive cough w/yellow sputum;placed on ATB, cult result pending;CXR revealed RLL pneumonia;
Summary: first symptom severe and involuntary chills with shivering and muscle tension/strain, second symptom fever of 101 degrees, third symptom muscle and bone aches, fourth symptom became light headed upon getting up at 8am. Details: couldn't do anything other than to get warmed up while enduring the shivering; once the shivering let up at around 3am, I got up and took my temperature, took two aspirin, drank two glasses of water (as the shivering/shaking/stomach clenching left me dehydrated) and went back to bed; slight shivering episode occurred after taking aspirin around 3am; fever ended around 5am; as of 10am 11/07/2013 the only symptom left were the muscle and bone aching.
Patient was anxious immediately after injection. She began sweating, feeling dizzy, anxious and lightheaded after about 10-15 minutes. About 15 min after inj. patient became SOB. Emergency personnel arrived and administered EPIPEN x 2.
Soft swollen, tender & itchy area at injection site appeared Monday 04/06/2021 or maybe Tuesday 04/07/2021 (12 to 13 days after injection date of 03/24/2021).  Slightly intensified still today, 04/08/2021. I expect a gradual reduction in irritation until gone.
fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 18Nov2021 (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False,, Prev dose lot unknown=True, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, Prev dose administration date=Mar/2021, Prev dose dose number=1), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False,, Prev dose lot unknown=True, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, Prev dose administration date=Mar/2021, Prev dose dose number=2), administration date: Mar2021, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 21Nov2021, outcome "recovered", described as "fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional information: It was unknown if patient had a covid prior vaccination. It was unknown if patient was covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be available despite the follow-up attempts made. No further information is expected.
Client reported event to nurse over the phone. Client described having to make a conscious effort to take deep breaths and to no get up and run around after receiving first Pfizer vaccine earlier in the day. Has taken vitals; BP; 137/98 and having an, "elevated heart rate". Client described it felt like her skin is crawling and not able to rest or sleep. Educated client to call provider that day or go to ER for a follow up. Called client today 10/19/21 for an update on health status. Client updated nurse by telling nurse vitals returned to "normal for her" and symptoms resolved after two and a half days and client was able to rest. Client received second Pfizer vaccine yesterday and client reported feeling dizzy, lightheaded, and feeling very tired. Client educated to call back with any changes or concerns.
Patient complains of left arm weakness since after receiving SHINGRIX first dose vaccine at Pharmacy 9/2018.
Sever itching rash and  whelps all over my body.  Started about 20 minutes after I got the vaccine.  My hands started to itch, then is moved up my arms.  By the next day my legs started itching  and the my stomach and back.   By Sunday my face started to itch and that when i went to the emergency room.
Redness and raised area to the right of the injection site on the left arm. Drew a border around the arm with a ball point pen as a point of reference. Followed up (08/27/2017) with the patient and she stated swelling and redness has gone down.