chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He tried to get out of bed and put his feet down. He was unable to walk; Dizzy; Unbalanced; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (He tried to get out of bed and put his feet down. He was unable to walk), DIZZINESS (Dizzy) and BALANCE DISORDER (Unbalanced) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (He tried to get out of bed and put his feet down. He was unable to walk) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization) and BALANCE DISORDER (Unbalanced) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to BALANCE DISORDER, DIZZINESS and GAIT INABILITY. At the time of the report, GAIT INABILITY (He tried to get out of bed and put his feet down. He was unable to walk), DIZZINESS (Dizzy) and BALANCE DISORDER (Unbalanced) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. About 3 weeks ago on a Thursday, patient took the Moderna vaccine. 10 days after, on a Monday, he tried to get out of bed and put his feet down, but he was unable to walk, felt dizzy, and unbalanced. He then went by ambulance to the hospital. Spent 5 days in the hospital. He was working with a physical therapist but did not take any medications or treatments. He then started to walk 2 days after being admitted and was discharged 2 days after that. Treatment information was not reported.  Company comment: This spontaneous case concerns an elderly male patient, with no medical history reported, who experienced the unexpected, serious (hospitalization) events of gait inability, dizziness, and balance disorder. The events occurred approximately 10 days after a dose of Spikevax 2023-2024 vaccine (Andusomeran); no information about previous immunisation schedule was provided. The report stated that when the patient tried to get out of bed and put his feet down, but he was unable to walk, dizzy, and unbalanced. He was hospitalized for 5 days and had a physical therapist, but he did not require any medications or treatments. He was able to walk after 2 days after being admitted. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax 2023-2024 vaccine (Andusomeran) is not affected by this report.   This case was linked to MOD-2023-748396 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received and added references.
Began feeling right eye twitching and same facial tingling / pain h??? prior to receiving smallpox vax. Did not alert anyone to condition prior to receiving vax. Sx's worsened throughout the day which were dry/watery eyes and eventually facial disep??? Denies prior he of flu like symptoms. Assessment: CN VII paralysis. Right side only.
first vaccine on 8-27-2022, second on 10-10-2022; pain at injection site; redness at injection site; skin around injection site darkened; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 27th August 20222, refer link case US2022149849).   On 10th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 10th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In October 2022, the patient experienced injection site pain, injection site erythema and injection site discoloration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site discoloration to be related to Shingrix.     Linked case(s) involving the same patient:  US2022149849   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient reported that, she received her second Shingrix vaccine, in the left arm. (Inappropriate schedule of vaccine). After second Shingrix vaccine again had pain and redness at the injections site that has resolved, but this time the skin right around the injection site was darkened. The reporter reached out to her health care professional if it did not resolve.  The reporter did not consent to follow-up Additional Supportive Information: The patient received 1st dose on 27th August 2022 and received 2nd dose of Shingrix on 10th October 2022, which led to shortening of the recommended interval between vaccine doses.; Sender's Comments:  US-GSK-US2022149849:Same reporter
sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-098088 (Patient Link).
Injection site raised bump, red circle around  site. Fever of 101, alternating chills and hot Headache, body aches Nausea
Patient started to experience redness and itching near the injection site. Around the injection site, she started to feel a hard bump and warmness.
I did not have an adverse reaction to the vaccine but I tested positive for COVID on 04/2/2022.
Diarrhea/when he blows wind it is watery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Mar2021 12:30 (Lot number: EN7534) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 17Mar2021 05:30, outcome "not recovered", described as "Diarrhea/when he blows wind it is watery". Additional information: Patient had no Family Medical History Relevant to the adverse events. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations within 4 weeks and no adverse events following prior vaccinations. The patient was querying if the event has anything to do with the vaccine. The patient had will have have his second dose on 06Apr2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a certified medical assistant (CMA) concerning a 10 week old male twin who on 16-JAN-2008 was vaccinated po with the first 2.0 ml dose of ROTATEQ (lot#657988/1193U).  Concomitant vaccines included PEDIARIX, PREVNAR and ACTHIB.  It was reported that on 29-JAN-2008 the patient was seen in the office when he became very fussy, spitting up, screaming if not being held, irritable and increased drooling.  Nothing was found on physical exam and the patient was treated with ZANTAC and formula change, blood tests (unspecified) were normal.  The patient was seen again on 31-JAN-2008 with no improvement, the parents had not been giving the ZANTAC.  The patient was seen again on 05-FEB-2008 with limited improvement and on 06-FEB-2008, the patient had an X-ray of the kidney, ureters and bladder, results were normal.  On 08-FEB-2008 the parents stated the patient was doing better.  On 18-FEB-2008, the patient had bronchiolitis, wet cough and wheezing.  A few days later, approximately 20-FEB-2008, patient was started on steroids and ROTATEQ was discontinued.  On 25-FEB-2008, the patient was hospitalized with bronchitis and was discharged on 01-MAR-2008.  The outcome is reported as recovered.  Additional information has been received from a physician reporting that when the patient was seen in the office on 29-JAN-2008 the biggest thing was his "extreme crankiness", a sepsis work-up was performed: blood cultures were negative, Sed rate was a little high at 27, C-reactive protein was less than 1, CBC was normal and an allergy test showed a class II allergy to milk, (reported as not that significant) and was placed on ALIMENTUM formula.  On 30-JAN-2008 and 31-JAN-2008 the patient was seen in the office and remained very cranky, a stool culture on 31-JAN-2008, negative for blood.  Intussusception was ruled out.  On 01-FEB-2008 it was reported that the patient was doing a little better.  On 05-FEB-2008, seen in the office with fussiness but "definitely improved".  On 06-FEB-2008, an abdominal x-ray was performed which was normal.  On 18-FEB-2008 the patient's "GI stuff" improved and the patient was seen for a cold.  On 20-FEB-2008 patient had a lot of congestion and wheezing.  On 25-FEB-2008, the patient was admitted to the hospital with bronchiolitis, official diagnosis was intermittent wheezing.  On 01-MAR-2008, the patient was discharged from the hospital to home of FLOVENT and albuterol PRN.  On 03-MAR-2008 patient was seen in the office, was doing well but still had wheezing.  On 10-MAR-2008 patient was seen in the office and was "doing great".  The physicians opted not to give the second dose of ROTATEQ.  A product quality complaint was not involved.  This is one of several reports from the same source.  No additional information is expected.
Currently pregnant due April 4.   I had increase in heart rate at 120 bpm, slowly decreased over the day to around 75 bpm. I also had heart palpitations and it seemed like I felt short of breath after light walking during work.
DEATH; SLIPPED AWAY; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age and race. 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 (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient slipped away (accident) and died after 2 month (death). As per reporter "My bro in law got the Jab, 2 months later he died sitting on his sofa, he was cooking, just slipped away 1 week later." It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slipped away was not reported. This report was serious (Death). This case, from the same reporter was linked to 20211254110, 20211254092, 20211247927 and 20211254072.; Sender's Comments: V0: 20211253879-covid-19 vaccine ad26.cov2.s - Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
small bruise; This case was reported by a other health professional via sales rep and described the occurrence of contusion in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of contusion (1st dose received on an unknown date and experienced small bruise).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced contusion. On an unknown date, the outcome of the contusion was unknown.   It was unknown if the reporter considered the contusion to be related to Bexsero.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced small bruise.
Myalgia Difficulty moving arm, fingertips were numb/decreased sensation, extreme fatigue-falling asleep while sitting at the  desk Narrative:
Information has been received from two nurses at a physician's office concerning a female (age not reported) who in October 2006 was vaccinated with the first dose of Gardasil (yeast). In October 2006, the patient developed excessive vaginal bleeding (during her period). The patient sought unspecified medical attention. At the time of this report, the patient had recovered from the event (date unknown). Additional information has been requested.
achiness through out her body; Fatigue; achiness through her joints; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achiness through out her body), FATIGUE (Fatigue) and ARTHRALGIA (achiness through her joints) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 025J20-2A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced MYALGIA (achiness through out her body), FATIGUE (Fatigue) and ARTHRALGIA (achiness through her joints). In December 2021, MYALGIA (achiness through out her body), FATIGUE (Fatigue) and ARTHRALGIA (achiness through her joints) had resolved.            No concomitant product was reported.  No treatment medication was reported.  It was reported that symptoms lasted for 2 hours.   This case was linked to MOD-2022-459082, MOD-2022-459041 (Patient Link).
Sore arm Tenderness to arm Vomit Sweats Diarrhea  Headache Lethargic  Tiredness
Immediately had blurry vision, neck stiffness, systolic blood pressure up to 150s.  Patient reports that she has been unwell since her second vaccine.  Having myalgias and fevers up to 102. She was diagnosed with lingular pneumonia at urgent care on 5/10/2021.  She believes that this is related to the vaccine.  After treatment with doxycycline, she is starting to improve.
Pt received pfizer booster on 11/3/21 in L deltoid, received seasonal flu vaccine on 11/4/21 in R deltoid with HCP consent. No reactions identified at the time of either administration. Pt current status at time of vaccination was non verbal with late stage dementia, which is his baseline. Initiation of hospice services had been discussed with HCP prior to both vaccines. Pt expired on 11/6/21.
15cm reddened area to arm, red and warm to touch, pain in arm when moving or touching
Patient was admitted to Hospital on 12/11/2021 for COVID related symptoms. This is considered a breakthrough case.
Anxious child prior to injection H1N1 received injection, appeared fine, waited in waiting room after 5 min came into office - Mother says he feels funny "syncope event" MD in attendance. Prior flu vaccine Another year "he vomited" afterwards.
initial possible immediate allergic reaction resolving mostly in a day, then very serious trouble with vaccine the following day, that progressed to agony, near inability to even stand or function, bizarre symptoms, very severe pain, including lymph glands, headache, dizziness, and brain disfunction.  After 3 weeks brain disfunction still very serious, headache, red and painful eyes (that had whole time), inability to think, problems with memory and focusing attention.
Within week of vaccination, red bumps appeared - *Note: sores on all parts of body except face.  Various sizes - sore - itched - pus - crusted - some sores faded - others repeat cycle and are still present today - still sore and painful.  Took SINEQUAN - prednisone still using BETHAMETHASONE.
Patient received Anthrax vaccine at 4:00pm on 3/6/2019. Patient experienced involuntary tremor or shakiness in right arm at 4:10pm. Employee notified asap. Employee gave BENADRYL and involuntary tremor or shakiness in right arm resolved. Unknown if patient sent to healthcare facility afterwards.
This spontaneous report was received from a physician via a company representative and refers to the physician's 4 month-old grandchild of unknown gender. The patient's concurrent condition included unspecified malabsorption issues. The physician reported that on an unknown date her 4 month-old grandchild was vaccinated with a second dose of ROTATEQ orally (dose unspecified) and became very ill (date unspecified). Within 10 days, the infant experienced diarrhoea and dehydration and as, a result, the infant was hospitalized for an unspecified period of time on unspecified dates. It was reported that since the infant was hospitalized and received unspecified treatments for the dehydration, the infant may have had a life-threatening condition. It was not reported which of the laboratory tests or diagnostic studies were performed. The physician informed that the infant would not receive the third dose of ROTATEQ due to these adverse experiences. The outcomes of the events were reported as recovered/resolved (date unspecified). The relatedness between the events and ROTATEQ was not reported. Additional information has been requested.
A 60 y.o. female who presented on 9/28/2021 from outside hospital for management of likely COVID-19 pneumonia.   The patient had her first vaccine shot approximately 10 days prior to admission.  She developed fever and chills on 10/27/2021 and went to the outside ER for evaluation where she is found to have PNA and a positive covid-19 test.   She was admitted with hypoxia and required oxygen and steroids.  She was discharged to home on room air and prednisone taper.
Began with pea sized swelling of left parotid gland 09/28/2001 which way by 10/01/2001 had progressed to gross swelling of left side of face, low grade temp, headache and neck pain. As of 10/04/2001 swelling and temp have almost resolved HIA "better". Treated with Arigment arophylactically by ENT who saw pt.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 20-MAY-2015 the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (strength, lot#, dosage, frequency and route unspecified). The temperature excursion for RECOMBIVAX HB was unsupported with in-house stability data and the initial temperature excursion was on 15-OCT-2014. No adverse event was reported. This is one of several reports from the same reporter. Additional information has been requested.
I had already had a J&J vaccine where I live on 4/5/21 (Lot EN1808978). I was getting extremely anxious about the Delta variant and reports of the declining efficacy of the Janssen vaccine so when visiting family, I went to pharmacy to get a booster of the Moderna vaccine. I had to claim I had not been vaccinated before to be eligible to get the shot, which was uncomfortable and why I hesitated to report my reaction initially. I had the usual chills after the vaccine which were fine. But about 36-48 hours after receiving the shot, my shoulder (neck, upper left back, left shoulder) began to completely freeze up. Since I have been doing PT for rotator cuff surgery for months, I know what frozen shoulder feels like. The only pain I had was along the line of my bicep tendon from the humeral head to my elbow. It was a burning pain. But my whole shoulder was completely stiff. This was very different than the shoulder soreness at the injection site and stiffness that I felt after my shingles vaccine. In the hours after my shot, I was still doing my PT exercises which included range of motion (ROM) and strength exercises for my left shoulder. However, once this reaction started, I could barely move it in any direction even with the assistance of a pulley or my other arm. This persisted for about 5 more days before it started to subside. I was about to report it to my orthopedic surgeon when it started to subside. It still is not completely back to normal ROM. None of the information I read anywhere suggested that this might be a possible reaction. I took my sister-in-law's Nabumetone (she has lupus) for about a week because Ibuprophen was doing nothing, and it seemed to be a severe inflammatory reaction. The only list of symptoms which accorded with mine were ones I read online related to SIRVA, but I assume that that was not the cause here because my shoulder has begun to unfreeze. (I sure hope I don't have any permanent RTC damage.) I want to report this because it is a serious side affect in case others experience this. I don't recall if my J&J shot was in my left arm as well and if this might have made a difference. Please feel free to call me if you have any questions.
Newborn has continuous, high-pitched, inconsolable screaming/crying, not feeding, lethargic, very ruddy and plethoric, tremors.
Chills, Fever, muscle pain, spasm, headache, stuffiness, dizziness, weakness, nausea, cramps, fatigue, heaviness in legs, needle sticking sensation on hands and feet, sore left arm (limited mobility)
Patient came in  for the first Pfizer COVID vaccine. Patient received her injection at 9:56am and started feeling " funny in the entire front chest wall" at 10:01am. no chest pain. " the same feeling when she received CT contrast or when she was diagnosed with seizure".  Bp elevated. 170/76 initially at 10:05am, then repeat 164/74 at 10:15am. 152/74 at 10:50am. EKG-NSR> Her sx lasted from 10:01am to 10:25am. then restarted at 10:31am. EMS was called and she was transported to the hospital by EMS for further evaluation.
4 days after receiving shingles vaccine, shingles rash appeared - confirmed on ER visit 10/18/15. Treated with valacyclovir.
This case was reported by a consumer via call center representative and described the occurrence of itchy legs in a 77-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension and diabetes.  On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 6th March 2019, 281 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced itchy legs. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the itchy legs was not recovered/not resolved and the outcome of the product supply issue was unknown.  It was unknown if the reporter considered the itchy legs to be related to SHINGRIX. Additional case details were reported as follows: The patient experienced itching on both legs. The patient reported that she had been unable to get her second dose since 29th November 2018.