chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received Hib (Hiberix) (batch number ZE47D, expiry date 23-MAR-2023) for prophylaxis.   On 12-APR-2023, the patient received Hiberix. On 12-APR-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Patient received an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-April-2023 The nurse reported that the patient received an expired dose of Hiberix. The reporter consented to follow up. The patient was administered an expired dose of Hiberix, which led to expired vaccine used.
Dark stools and facial swelling the day after vaccination - unknown if resultant from vaccination, but no other identifiable cause (no exposures to any ill people, no symptoms of illness, no new foods or other exposures, etc). No treatment required yet - monitoring and seems to be slowly improving.
1 day after vaccinations, pt. developed fever to 38.4 degrees C, incapability and passed large amount of fecal after her meal. Barium enema performed, (-) for intussusception; septic work up performed with all cultures being negative.
Local redness and swelling at the site of injection and temperature 100.1 next day.
Patient came back after 1 hour of receiving his vaccines. He said that the left side of his face were "tingling" or feeling a little numb. Patient asked if he should go to the hospital. I advised the patient it would be a good idea to be checked out. Patient was well enough to drive and leave.
This spontaneous report as received from a health professional refers to a 53 year old female patient. The patient's medical history included sicca syndrome, rheumatology issues and myalgias. The patient also experienced hives following the administration of ibuprofen, swelling following the administration of "sulfa" and vomiting following administration of LORTAB on an unspecified dates. Concomitant therapies included hydroxychloroquine sulfate, pilocarpine hydrochloride (manufacturer unknown), naproxen, LIPITOR, magnesium oxide, phentermine, loratadine (manufacturer unknown), CYMBALTA, pantoprazole, B12 injections, FLONASE, LAMICTAL, ESTRACE vaginal cream, baby aspirin, vitamin B complex, vitamin D (unspecified) and "FLINTSTONES GUMMY with OMEGA 3". On 11-MAY-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K020215, expiration date 15-MAY-2016; dose and route of administration were not reported). On 12-MAY-2015 in the evening, the patient began to experience pain at the injection site and immobility of the injected arm. It was reported that on 13-MAY-2015, the patient sought medical attention via the doctor's office visit due to the symptoms. The patient was given a steroid injection. The patient returned to the office on 15-MAY-2015 and she was still experiencing the pain and was therefore given MEDROL dose pack for treatment. No lab diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between the adverse events and the vaccination with PNEUMOVAX 23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Rash all over shoulders and down back resembling shingles and low grade fever. Started the day after vaccine and the rash is still present almost 2 weeks later
Mom states pt had immun approx 330PM 14OCT91; went home & went to sleep; woke w/inc temp & was given APAP; Pt was quiet & wouldn't let anyone touch; pt hasn't voided in approx 24 hrs; emesis & diarrhea; Advised to take to MD or ER;
Heated arm; A little red spot, quarter-spot; Arm hurt; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Heated arm), ERYTHEMA (A little red spot, quarter-spot), PAIN IN EXTREMITY (Arm hurt) and HEADACHE (Slight headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Heated arm), ERYTHEMA (A little red spot, quarter-spot), PAIN IN EXTREMITY (Arm hurt) and HEADACHE (Slight headache). At the time of the report, FEELING HOT (Heated arm), ERYTHEMA (A little red spot, quarter-spot) and PAIN IN EXTREMITY (Arm hurt) outcome was unknown and HEADACHE (Slight headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-047157 (E2B Linked Report). This case was linked to MOD-2021-047157 (Patient Link).; Sender's Comments:  MOD-2021-047157:
Tested positive with covid 19 with symptoms; Tested positive with covid 19 with symptoms; This is a spontaneous report from a contactable healthcare professional.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "I received the covid 19 vaccine on 22Dec; was supposed to have 2nd dose on 12Jan2021. Tested positive with covid 19 on 01Jan2021 with symptoms. I want to know how long I need to wait to get the second dose".The outcome of the events was unknown.   Information on the lot number has been requested.; Sender's Comments: Although, BNT162B2 vaccine immunogenicity is not in full effect after short time (10 days in this case) of first dose administration, a causal relationship between event "Tested positive with covid 19 with symptoms" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.
For the next 36 hours, my urine turned a dark amber to brown color. It was darkest in the 12 hours following the injection, and gradually returned to normal color within 48 hours. It was deeply dark, with what I would describe as a alkaline or sharp scent to it. Again, it returned to normal within 48 hours of receiving the vaccine.
C/o tingling of right arm and palm. . Hx of being in car accident and right side effected.  EMS evaluated.  Given stretching exercises and felt better.
5 mm purple flat macule on left lower lip edge (non-tender, no symptoms).  mild palpitations, upper back pain, and sore throat for a day after vaccination.
Left arm soreness since 4/08/2021. Rash on left elbow (appeared on 4/15/2021) and right forearm (4/14/2021). Red, swollen, hot, burning, itchy and painful to the touch. Itchiness on my back and both legs began yesterday, 4/15/2021.   Previously had two rashes on my head and on on my head two days after receiving vaccine.   Also, decreased appetite started on 4/12/2021.
Pain in arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination, PREDNISONE.    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 PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   Reporter did not allow further contact
I had pericarditis 2 years ago and 4 days after my 2nd dose of Moderna I felt similar symptoms to when I?d had it. They subsided after a day but came back 3 weeks later. Because of my history of having had Pericarditis I had ultrasound and CT Scan and they showed some inflammation. Blood tests showed  C-reactive Protein levels high (70). On my own I googled if pericarditis was a side effect from vaccine as it was odd to me that my symptoms started so soon after. I read that there have been rare cases reported recently  but mostly in young people and they?ve subsided. Perhaps  because I had it two years ago it triggered a recurrent effect. I was prescribed 600 mg ibuprofen as before by Cardiologist and colchicine as before. My PCP suggested I might want to notify you.  I thought I should report this given what I read and that I'm 55, so it?s different than other reports you?ve received.  I do not know if I have pericarditis again but the symptoms have been identical to when I did and the CRP level increase would suggest so. I had Echo and EKG and heart alright so it's not Myocarditis. Symptoms included: pain in abdomen chest area, pronounced in URQ this time but it migrated, increased when walking or lying down, difficulty sleeping in side, slightly elevated fever 98.9-95 when I?m usually in  96-98 range, breath hiccups, some nausea. Since taking colchicine and ibuprofen have been feeling better, just concerned that this seemed to have recurred, and started exactly 4 day after my 2nd shot.
This spontaneous report as received from a nurse refers to a 63 year old patient. On 18-JUN-2014, the patient was vaccinated with first dose of VAQTA (dose, route, and lot # unknown), concomitantly with hepatitis B vaccine (manufacturer unspecified). On 18-JUL-2014 the patient was inadvertently vaccinated with second dose of VAQTA 1 ml, (lot #J010653 expiry date 02-AUG-2015), intramuscularly. No adverse effects reported. Additional information has been requested.
When I was at home a few hours after getting the shot I started having nerve pain in my fingers and my toes. This pain did not go away and I also started having pain in my hands and feet. It affected my daily activities. Over time the pain would come and go. I am now still having pain in my hands and sometimes my feet. Some weeks the pain is there and some weeks the pain is not noticeable.
really sick; deathly suck vomit; Diarrhea sick for 2 days in bed; 2 days in bed; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 63-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (The patient saw her parent go through pain at home for shingles in 2021 age 88 years old).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, vomiting, diarrhea and mobility decreased. On an unknown date, the outcome of the sickness, vomiting and diarrhea were unknown and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the sickness, vomiting, diarrhea and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's parent. The patient got the shingle shot at age 63 years this year. She got really sick from the shot. She had side effects including deathly suck vomiting.  The patient also had diarrhea and was sick for 2 days in bed.
Pt developed fever 101 degrees, which continued 9/2/04 - 9/6/04. Presents 9/7/004 with generalized red, macular/ papular rash face/ trunk and extremities, no fever. Treatment was Tylenol prn for fever, no other medication.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 06-Dec-2021,Lot 012H21B vials were placed in refrigerator.  Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-448109 (Patient Link).
33yo F having intermittent palpitations causing near syncope, dizziness causing gait instability, and nausea/vomiting and headache. This is day 3 of these symptoms and she states they have not improved at all.
had some confusion, and was speaking  (which she normally spoke to me in); frequent urination 2-3 weeks; Did not feel well for a few days; Did not want to get out of bed for a few days; Was speaking a different language; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An elderly female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "had some confusion, and was speaking English to me instead of French (which she normally spoke to me in)"; POLLAKIURIA (non-serious), outcome "unknown", described as "frequent urination 2-3 weeks"; MALAISE (non-serious), outcome "unknown", described as "Did not feel well for a few days"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Did not want to get out of bed for a few days"; LANGUAGE DISORDER (non-serious), outcome "unknown", described as "Was speaking a different language".  Additional Information: The reporter (daughter of the patient) stated that her mother also had severe pain in her back and leg after second vaccine dose. Reporter wanted to know if this is a neuro response to Pfizer vaccine. Reporter called the pharmacist to review the Pfizer vaccine ingredients and she was looking specifically for beef and anything that comes from a cow. Reporter get anaphylactic reactions to anything that has beef. Reporter declined to complete report. Reporter stated that her mother is living in a retirement facility.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shivers/ teeth chattering; feeling miserable; This case was reported by a medical representative via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivers and feeling miserable. On an unknown date, the outcome of the shivers and feeling miserable were unknown.   It was unknown if the reporter considered the shivers and feeling miserable to be related to Shingrix.  Additional details were provided as follows: Adverse event receipt was given to the sales representative during the call. The adverse event which was made known to medical representative by a physician via email sent in March 2019. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The physician's email reportedly quoted an email sent to him by a patient, which stated that the patient felt miserable and experienced shivering and teeth chattering after receiving Shingrix. The reporter did not consent to follow-up. The sales representative was reportedly on medical leave at the time and did not notice the email until recently. The sales representative stated that she wanted to call the adverse event into Medical Information instead to report the adverse event due to the adverse event being reported late. No other information was available, besides the healthcare provider's details. This case has been linked with US2019AMR141887, US2019AMR141888 and US2019AMR141889, reported by the same reporter.
This case was reported by a other health professional via sales rep and described the occurrence of chills in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills and fever. On an unknown date, the outcome of the chills and fever were unknown. It was unknown if the reporter considered the chills and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced not just an injection site. This was 1 of 3 cases reported by the same reporter.
Moderate Fatigue, Fever 99.7-100.2, Elevated heart rate, Diarrhea, Cough, lost 6 pounds from diarrhea. Duration of entire event 36 hours.
A pharmacist reported that a pt had an unknown reaction to a previous dose of tetanus toxoid which contained thimerosal.  No further information was available at the date of this report. On 5/10/99, the reporter stated that no adverse event had occurred and that he only called for drug information.
Severe headache chills fever 103 photophobia inabililty to walk for 8 hours due to severe weakness in legs. No ability to eat of drink x 12 hours . Unable to move out of fetal position x 8 hours . Severe numbness and tingling x 4 hours. Severe headache and photophobia contd x 72 hours . Cognition was limited x 72 hours. Unable to work x 5 days. Severe headache and brain fog contd x 2 weeks . Intermittent headaches still continued at this time.Ny head feels at times still like it is being hit with  a ping pong paddle across the room .
Dizziness, BP: 122/78 - Pulse: 76 - Patient starts feeling dizziness after she completed her observation period. - Patient instructed to lie down on gurney and vitals checked. - Adviced her not to drive on way back to home. - Patients daughter came to accompany her. - Patient stayed in observation area longer than 15mins.  - Patient is adviced to go to ER, rejected by patient left with her daughter.
suspected vaccination failure/get the shot, came down with a bad case of shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The patient decided to get the shot and came down with a bad case of shingles. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and  laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
ADMITTED: 11182021: History of Present Illness: patient is an 86 yr old male with medical history significant for CAD, diastolic CHF, COPD, afib, history of TIA and SDH, orthostatic hypotension, and bladder cancer. He is the grandfather of  APRN. Today, his son noticed that speech was slurred all day, but could not say for sure when symptoms started. L facial droop was also noted. He reports a history of TIAs with similar symptoms. Pt backed up to sit in his recliner, but missed the chair and landed on his buttocks on the floor. He also believes he may have hit his shoulder when he fell. He denies any pain in hips or shoulders. He c/o weakness and also has had a cough for 3 days productive of yellow sputum. He denies fevers/chills and is afebrile in ER this evening. He also reports heartburn yesterday but none today. He had 2 episodes of diarrhea on 11/16 but none since. Due to stroke-like symptoms, he was brought to the ER for further evaluation In the ER, MRI brain is without acute process. CTA head/neck shows no large vessel occlusion or flow-limiting stenosis. Slurred speech has resolved. Pt still appears to have L mouth droop but when he smiles, droop disappears. He is moving all extremities well. Labs in ER significant for WBC 15.9 with left shift, procalcitonin 0.15, sed rate 47, crp 4.6, BUN 28 with Cr 1.5 (appears consistent with recent baseline).  EKG shows NSR with rate 70, trop 5Gen is 13.4. COVID/flu ordered and results pending. Addendum: COVID results returned positive, pt is fully vaccinated, received last injection in March/April. Pt is a candidate for monoclonal antibody treatment, as he is hospitalized for reasons other than COVID and is not requiring oxygen therapy. This treatment has been ordered. PT REMAINS INPATIENT - NO DISCHARGE DATE AT THIS TIME.
Chest Pain and shortness of breath. Stabbing sensation in upper quadrants of lungs.  Started in neck and moved to right side then moved to the left side also.
Dizziness, Headache, Myalgia, Arthralgia, Fever,  NauseaVomiting,   INJECTION SITE PAIN, SWOLLEN GLANDS,  MALAISE   Narrative:    Other Relevant History: