chrisvoncsefalvay/vaers-outcomes huggingface dataset:
skin its burning like there was fire in her leg; Right leg was so swollen; can't walk; pain was excruciating; Knee problem; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm right on 01Mar2021 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The first dose was received on 08Feb2021 at age 65 years old. Medical history included diabetes and heart condition; both from unknown date and unknown if ongoing. The patient's concomitant medications were not reported. After the vaccination, patient was in the hospital. They can't find nothing wrong with her, patient's right leg was so swollen and the skin its burning like there was fire in her leg and she believe that this was.. (statement incomplete). Patient had been in bed can't walk, her skin burns and the pain was excruciating. It was reported that three weeks ago, like 01April, she started getting the symptoms. Patient started having knee problem like a week, it got out worse and worse and then on 01Apr2021, it started really highly worse that she had to go back to the doctor and then can do X-ray. The things were worse and worse that she ended up in the hospital (reason not clarified) that she couldn't work,  couldn't walk and it was burning achy and unbearable. Patient was still on bed, still can't work and was still have the burning feeling in her leg. She was hospitalized on 01Apr2021 but had problems prior to it but got worse on 01Apr2021. Date of discharge was reported was 18Apr2021. Outcome of the events was unknown.
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 12-FEB-2014, the patient was vaccinated with dose 3 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Follow up information provided patient's recovery status and number of days hospitalized. Information regarding Prevnar was received from a medical assistant regarding a 15 month old male patient who received a first dose on 12/03/04 and developed pneumococcal meningitis. On the same day, the patient also received a second dose of Act-HIB and a first dose of Varivax. The patient had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 12/3/04. Dose regimen was 0.5ml 1 time per day (IM). Concomitant vaccines included Act-HIB and Varivax administered on 12/3/04. The patient was not taking any concomitant medications. On 12/5/04, the patient experienced an episode of vomiting, lethargy, and developed a temperature of 103 degrees F. On 12/6/04, the patient was evaluated at the doctor's office; his temperature at that time was 103.6 degrees F. On the same day, he was admitted to the hospital and later that night was diagnosed with pneumococcal meningitis. The patient remained in the hospital 14 days. On 1/10/05, the reporter indicated that the patient recovered.
January 21, 2021 at 2am severe right arm pain going down arm into fingers and up into shoulder blade. Painful to touch vaccine site.  No problem with first dose.  5am severe chills and body aches more so on right side of body than left.    lasted throughout day becoming worse again at 6PM until 1:30am January 22, 2021.   No further chills or body aches since then. Did take 2 doses of Extra Strength Tylenol
According to patient his R arm was sore the day after receiving H1N1 vaccine in R deltoid on 2/25/2010. Soreness was apparent upon elevation of arm above shoulder and when reaching down. A few days later he notice a bump in axillary area. On 3/2/2010 he took some Ibuprofen and said the swelling seemed to move distally down R arm. On 3/3/2010 Pt indicates some tingling down R arm towards hand. MD interviewed pt, suggested ice pack on and off, continue Ibuprofen if it helps and avoid movements causing pain.
I started out with congestive and a running nose. Then I had a cough. It has just been mainly a running nose. These symptoms are still ongoing since Jan 6th and I got tested for Covid-19, negative results. On Jan 9th, I got retested for Covid-19 test, positive result. Yesterday I had mild fever.
Myalgia, Fever, injection site pain, chills , fatigue Narrative: Employee reported injection site pain/discomfort and swelling, as well as "feeling hot," chills, body aches "especially back/neck", fatigue, and "sharp shooting pain to left eye." Reports "pain immediate, then symptoms regressed at approximately 10am." Also noted "shortness of breath" with mask on.
Body pains (particularly muscular pain upon pressure), marked fatigue, headache. Resolved after 1.5 days without treatment.
The morning after I received the vaccine, I started feeling tired and my arm was quite sore. The following day, I had a fever of probably 100. I had chills and my heart rate and blood pressure went up. Since I have A-Fib, it was irregular. After several hours, my HR went back to normal and that is when I called my Cardiologist NP. She said that she thinks it's related to the fever I had. The next day, I felt a tad better, but fatigue and generally not feeling well lasted a few days. I feel that it took about a week before I felt normal again. About two months later, I was making plans to go out of town and I became very ill. I started having chills, fever, nausea and extreme fatigue. I may have taken some Tylenol. I was drinking a lot of water because I did not have an appetite. A couple days later I felt a little better so I did not contact my doctor, but I did go to an urgent care (05/22/2021) and had a COVID test. The test came back negative and I felt better two days later. On Monday, I started feeling bad again and I contacted my PCP, and I went to see him on Tuesday. He ran some blood tests and another COVID test, which came back negative. The fatigue just stayed around for quite some time. He monitored my sodium and chloride and they were both low so the doctor wanted them monitored. I was admitted into the hospital for two days. I was on liquid restriction. I had a bunch of tests ran that came back negative. I did have an AMA test which did come back positive. I am still on water restriction, but I am feeling much better. I'm a bit leery about receiving a booster shot.
Diarrhea x 1 week/ loose stools after Prevnar 13, 1st flu dose injection and subcutaneous polio vaccine administration in one visit.
allergic reaction to shingles vaccine; allergic reaction to shingles vaccine/a major reaction in the area/there was itching and redness/it was over 2 inches in diameter, the redness; allergic reaction to shingles vaccine/a major reaction in the area/It made her arm swell and was extremely hot; allergic reaction to shingles vaccine/a major reaction in the area/It made her arm swell and was extremely hot; allergic reaction to shingles vaccine/a major reaction in the area/there was itching and redness; This spontaneous report was received from a 68-year-old White female patient via Pfizer. The patient was referring to herself. No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided. The patient had a history of allergy to lisinopril (manufacturer unknown) (case # 2108USA005499).  On an unknown date in 2013 (reported as 8 years ago), the patient was vaccinated with zoster vaccine live (manufacturer unknown) (reported as shingles vaccine) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in 2013 (reported as 8 years ago), the patient had a major allergic reaction to zoster vaccine live (manufacturer unknown) in the area of the vaccination. It was further described that the patient's arm was swollen and was extremely hot. There was also itching and redness around the vaccination site. The redness was inch and a half to 2 inches in diameter. The patient put ice on vaccination site as a treatment for the events, but she stated that it "never took the heat away". The redness was over after about 6 weeks to 2 months (date not specified). The outcome of the rest of the events was unknown (it was reported that the swelling did not go away for 6 weeks).  The events were considered to be related to the suspect vaccine, as the patient reported that the events were an allergic reaction to zoster vaccine live (manufacturer unknown).  This is one of two cases received from the same reporter and referring to the same patient.; Sender's Comments:  US-009507513-2108USA005499:
Client went to laboratory in the clinic after receiving vaccines for blood drawn and fainted and during blood drawn. Client awake after a few minutes and taken to a room for observation.
Initial report received from a nurse on 29 Sep 2010: On 31 Aug 2010, this patient was inadvertently vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number not reported), (dose 0.5 ml, intramuscularly) without being reconstituted with the MenA lyophilized conjugate component. On an unspecified date, the patient was revaccinated with the full dose of MENVEO. The outcome of the event was not reported.
Nausea, vomiting 3 times, chills, sweats, nystagmus on exam.
28-year-old male states that after receiving his 4th Anthrax Vaccine on 10/5/03 he started experiencing bone and muscle pain in his left shoulder, rib and arm.   States that one week after receiving the anthrax vaccine in the left deltoid he started experiencing a warm, burning sensation in his left shoulder, halfway down his left humerus and under left axilla halfway down ribcage.  Denies any numbness or tingling, headache, swelling of lymph nodes or fever.  Reports no other associated symptoms.  States that he went to an urgent care where x-rays were taken of his ribcage, which were negative.  Took over the counter Advil that helped with the bone and muscle pain.  States that the pain was constant for approximately one month.                                                      After receiving his 5th Anthrax Vaccine on 4/10/04, he states that the pain started again but this time it was bilateral including both shoulders, upper half of both upper arms and under both axilla down to the middle of the ribcage.  Pain was a little more intense on left side where he received his vaccine in the left deltoid again.  When the pain first started, he rated the rib pain as an 8 on pain scale 0-10 and shoulder pain as 4-5 on pain scale 0-10.  States that the pain is not as intense and constant as previously and rates it now as a 3 on pain scale 0-10.  Currently taking over the counter Advil for pain.
A report has been received from a Health Professional concerning a 7 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL) started on 08-Apr-2014. The patient received expired FLUMIST on 08-Apr-2014. The reporter stated that several FLUMIST doses were entered into their system as expiring on 7/4 (04-Jul-2014) instead of 4/7 (07-Apr-2014). There was an error in entering the expiration dates into their system. That's why there was an administration error. No adverse reaction reported. The patient experienced EXPIRED FLUMIST QUADRIVALENT ADMINISTERED. The outcome of the event of EXPIRED FLUMIST QUADRIVALENT ADMINISTERED is unknown. The report was considered to be non-serious by reporter.
HSV outbreak; hasn't been able to remember/issues remembering stuff; had problems with speech/Issues talking and stuff; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (hasn't been able to remember/issues remembering stuff), SPEECH DISORDER (had problems with speech/Issues talking and stuff) and HERPES SIMPLEX (HSV outbreak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included HSV infection (Patient has not had an outbreak in a really long time). Concurrent medical conditions included Memory impairment and Speech disorder.   On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced MEMORY IMPAIRMENT (hasn't been able to remember/issues remembering stuff) and SPEECH DISORDER (had problems with speech/Issues talking and stuff). On 17-Dec-2021, the patient experienced HERPES SIMPLEX (HSV outbreak). At the time of the report, MEMORY IMPAIRMENT (hasn't been able to remember/issues remembering stuff) and SPEECH DISORDER (had problems with speech/Issues talking and stuff) had not resolved and HERPES SIMPLEX (HSV outbreak) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided. Patient got the shot on the 16 December 2021, she has not been able to remember and has had problems with speech. She has a HSV outbreak the day after. She has not had an outbreak in a really long time. Long term she has had issues with memory and talking. It was like a relapse.   Reporter did not allow further contact
appeared on my back / small itchy sp[ots on the left side of my back; This case was reported by a consumer and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2020, the patient received the 1st dose of Shingrix. On 17th September 2020, less than a day after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. Within the day or two, very itchy was appeared on back, directly across on the left side from where the shot was given. The patient still getting small itchy spots on the left side of my back. The patient asked should get the 2nd shot.
fatigue, fever/chills, axillary and cervical lymphadenopathy, enlarged tonsils
Large local reaction around injection site with redness, pain, and warmth. Fever (Tmax 102F) for 36 hours, fatigue.
pt came in @ walk-in clinic for a pneumonia shot & wanted it in rt deltoid;had a cast on this arm; about 3 hrs later arm started to swell & pt needed to go to MD & have cast cut off;swelling lasted 2-3 days & is presently okay
Pt had soreness of injection site which has persisted x 2.5 months and pain is now extending up to her shoulder.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 1st October 2018, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced headache, fever and abnormal physical sensation. On an unknown date, the outcome of the headache, fever and abnormal physical sensation were recovered/resolved. It was unknown if the reporter considered the headache, fever and abnormal physical sensation to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The patient received SHINGRIX vaccine on an unknown deltoid. In October 2018, The patient received a flu shot at the same time as her dose of SHINGRIX and experienced headache, fever and a mild mouth sensation that lasted for 12 hours. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK045374. The patient had an appointment with a throat specialist on the day of reporting. The reporter consented to follow up.
reaction to vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (reaction to vaccine) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to vaccine). At the time of the report, VACCINATION COMPLICATION (reaction to vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Patient reported tongue swelling after 35 minutes of receiving vaccine. She was given liquid benadryl 50mg. After 25 minutes of benadryl, she reported tongue swelling has improved. Patient felt safe going home and was counseled to continue benadryl at home until symptoms subside and to go to the ER if symptoms worsen.
LTCF staff received her first dose on 1/21. Inadvertently, patient attended a vaccine clinic and got the second dose on 2/2. Patient has no adverse reactions yet.
Information has been received from a registered nurse concerning a female (age not reported) who on an unspecified date was vaccinated with dose (lot number not reported). The nurse reported that the patient, after receiving the Gardasil, did not received her next expected period. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Approximately 1.5-2 months after second patient noticed shingles on center portion of back. Has gotten shingles in the past, but now is recurring every 3-4 weeks in a larger patch. Goes away after approximately a week. Patient takes Shingle Soothe when notices rash.
Urticaria, dermatografia, ear and hand warmth and erythema starting 10 days after 3rd dose and still continuing
excursion lasted for about 6 hours, in middle of night and the lowest temperature reached is 0C with no reported adverse event; 2 of the FLUBLOK vaccines have been administered since the excursion with no reported adverse event; Initial information received on 14-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 53-year-old male patient who experienced excursion lasted for about 6 hours, in middle of night and the lowest temperature reached is 0c and 2 of the flublok vaccines have been administered since the excursion with no reported adverse event while receiving vaccine Influenza Quadrivalent Recombinant Vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date the excursion lasted for about 6 hours, in middle of night and the lowest temperature reached is 0c with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient received a dose of suspect Influenza Quadrivalent Recombinant Vaccine post excursion (lot: U8058AA, Expiry date: 31-May-2024) with unknown strength, formulation via unknown route in unknown administration site for Immunization with no reported adverse event (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.
PT RECEIVED FLU MIST ON THURSDAY, HAD 3 RED ROUND AREAS TO LEG ON FRIDAY THAT RESOLVED. SUNDAY AM WOKE UP WITH GENERALIZED RED ROUND, FLAT  RASH . PT CAME TO ER ON SUNDAY AND WAS TREATED AND DISCHARGED TO FOLLOW UP WITH HER PRIMARY CARE MD.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. Then the patient was administered a second dose of GARDASIL 9 "12 months and one day later" on an unknown date. No adverse effect reported.