chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 71 y.o. male patient of with history of diabetes, hypertension, hyperlipidemia, asthma, neuropathy presented to Hospital with encephalopathy on 9/4/2023.  Hospitalization has been prolonged and complicated by COVID-19 pneumonia and subsequently aspiration pneumonia with MRSA.  Patient status post PEG tube this hospitalization.   The following describes as Hospital course in further detail by problem:     Hospital-acquired aspiration pneumonia Elevated risk for aspiration Failed swallow eval Initially finished cefepime per ID ID following - now back on vanco after sputum culture from 9/30 growing mrsa That is post 10-day course of vancomycin for MRSA pneumonia.  Antibiotics completed at time of discharge Status post NGT feeds, now s/p PEG tube 10/2 Started on tube feeds, now at goal, tolerating well Continue aspiration precaution   Acute hypoxic respiratory failure Infectious disease following throughout admission and treated for both COVID-19 pneumonia with steroids and remdesivir and subsequently aspiration pneumonia as above. Oxygen patient stable at time of discharge on nasal cannula Discharge to skilled nursing facility PEG tube placed as above.  Remains n.p.o. at time of discharge.  Continue speech and language pathology services on discharge   Metabolic encephalopathy Delirium with agitation Continue Seroquel at night, increased dose to 50 mg 9/29 Neurology was consulted-EEG negative.  Rec to continue Wellbutrin, Zoloft, Seroquel, PT OT   Hypertension Better controlled Currently on Coreg, losartan, amlodipine   Recurrent major depression Seen by psychiatry  Currently on Wellbutrin, sertraline, Seroquel Acute kidney injury-improved  Hyperkalemia, improved obstructive uropathy, POA Nonobstructing right renal calculi Mild bilateral hydronephrosis Prostatomegaly Hematuria Initially, mostly due to obstructive uropathy CT C/A/P on admission showed moderate to severe bilateral hydronephrosis Urology  recommended continuing Foley on discharge Continue Flomax.  Had to be switched to doxazosin due to NG tube use. Nephrology signed off S/p ivf Discharge with foley and follow-up with urology   Acute hypoxic respiratory failure due to COVID 19 Covid-19 Virus Infection Date of onset of symptoms: Unknown yes Symptoms present on admission: yes Date of covid positive test: 9/4/2023 Vaccination status: pt says he Is vaccinated but isn't sure how many he got s/p dexamethasone for 10 days No remdesivir due to AKI. Status post IV Lasix.    New onset A-fib Rate controlled.  EKG reviewed from 2 days ago. Eliquis on hold for possible surgery next week.  Was changed to heparin dip Continue apixaban and Coreg on discharge   Hyperlipidemia Continue statin   Type 2 diabetes  currently controlled Continue aspirin statin Last A1c 7 in 8/28/2023 Continue to hold metformin. SSI   Hypothyroidism, primary Continue levothyroxine 25 TSH within normal limits 2.3 in 9//2023 Right middle lobe lung nodule 12 mm identical finding CT in 3 to 6 months as outpatient   Neck lipomas Ultrasound soft tissue of the neck showed lipomas
pt states became so totally weak and fatigued he was not able to get out of bed.  This lasted 3 days. He also states it seemed as if he had a urinary infection without having a urinary infection. pt states he is puzzled about the symptoms as he is in good shape but having extreme weakness and fatigue that is not normal for him. He has had some pain in his right side in his back which he thinks it maybe his kidney. He feels like he has Rhabdomyolysis so may see his physician for treatment.
Was supposed to receive TDAP vaccine for pregnant women.  Instead received Gardasil vaccine for HPV prevention due to nurse error.  Waiting to determine any birth defects/adverse/congenital defects on baby.
Approx 15 hrs after receiving injections patient began to break out in hives all over.  She was fussy, decreased appetite and decreased sleeping.
patient after getting the pfizer vaccine , she felt nauseous and vomited , kept watchin her she was hydrating, then shortly she said she feels fine and much better
bad sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (bad sweating) in a 41-year-old male patient 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 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. On an unknown date, the patient experienced HYPERHIDROSIS (bad sweating). At the time of the report, HYPERHIDROSIS (bad sweating) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Redness at injection site; Swelling at injection site; Warmth at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number PP9L5, expiry date 16th October 2021) for prophylaxis.   On 29th May 2020, the patient received Kinrix (intramuscular) .5 ml. On 30th May 2020, 1 days after receiving Kinrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Kinrix.  Additional details were provided as follows: Later on the day of vaccination patient experienced redness, swelling and warmth to touch at the site of injection. It was no longer warm to touch. The swelling and redness had improved, but it was still present. No other details were provided. This case was 1 of 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091774:Same reporter US-GLAXOSMITHKLINE-US2020091771:Same reporter US-GLAXOSMITHKLINE-US2020091771:Same reporter
Patient was due for her Influenza vaccine at the appointment. Vaxelis was mistakenly administered instead at 11:45AM.  Mother was made aware of error at 11:48. Patient currently not experiencing any adverse reaction, and will return at a later date for her Influenza vaccine. Mother aware of potential reaction types and voiced understanding.
Numbness in left side of face approx 30 mins after shot which lasted 30 hours. Signs of Bells Palsy approx 2.5 days after shot. Doctor treating for Bells Palsy with steriods and anti-viral drugs.
PT RTO 8/14/19 after shots done 8/13/19. Pt had large area of swelling on RT measuring 19cm x 10cm.
Lymph node under r axilla enlarged (ipsalateral side)  Narrative: 2/2/22 nearly 1 year after covid vaccine series completed, reports lymph node swelling to r axilla. COVID vaccine #1 and #2 dose were administered in l deltoid
Fever, itchy red swelling and rash, after work. I took BENADRYL Allergy, an TYLENOL Plus.
Fever 102.2 oral for 24 hours, malaise, muscle aches, congestion, sneezing, headache - symptoms lasted for 5 days. Treated with Tylenol and decongestant.
Approximately 1 week post dose, I woke up with significant skin redness around the injection site about 1 inch wide by 3 inches long. I did not experience any injection site skin reactions prior to this, just muscle pain in that shoulder for a couple days after the dose. The redness faded away within 24 hours.
DISCOVERED 2 LARGE AREAS AT THE BACK OF MY HEAD WHERE HAIR WAS MISSING- ALOPECIA, WHICH HAS SLOWLY INCREASED IN SIZE SINCE THEN.  HAD SECOND DOSE VACCINE ON 03/19/2021  (WILL CONTINUE TO MONITOR  FOR ADDITIONAL HAIR LOSS)
The patient was "fine" / No additional AE reported; the patient received four total doses of GARDASIL 9; the patient received 1st dose on 27-JUN-2016, 2nd dose on 07-SEP-2017, 3rd dose on 15-OCT-2019; This spontaneous report was received from a certified medical assistant and refers to a 15-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-JUN-2016, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # L016428, expiration date was not reported but upon internal validation was established as 30-JUL-2017 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. On 07-SEP-2019, the second dose of the vaccine was administered (lot # N004798, expiration date was not reported but upon internal validation was established as 31-OCT-2019; exact dose, route of administration and anatomical location were not provided) (inappropriate schedule of vaccine administered). On 15-OCT-2019, the patient received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1614898, expiration date was not reported but upon internal validation was established as 15-NOV-2021 (exact dose, route of administration and anatomical location were not provided) and on 22-MAR-2021, the fourth dose was administered (lot # 1687292, expiration date was not reported but upon internal validation was established as 25-AUG-2022; exact dose, route of administration and anatomical location were not provided) (extra dose administered). The reporter stated that her office had been unaware that the patient had received the first two doses at other clinics, so they had restarted the series for him. At the time of report, he was fine (no adverse event (AE) was reported), but the medical assistant was wondering what to tell him to expect. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Approximately 1-2 months after I received my last COVID-19 vaccine dose in February 2021, I started developing unexplained, spontaneous skin rashes (itchy eczema/blistering with continuous oozing primarily on the back of my hands, but also on face/forearms/ears/neck/legs) that I eventually found to be an allergic reaction to multiple lotions, soaps, rubber/latex, and various fabrics (namely polyester). I had previously never had allergic reactions to any of these items before and had in fact had been using/wearing these items for years prior to the development of the rashes. I first reported these symptoms to OHS (at Hospital) around ~April 2021 when the rashes persisted despite multiple home remedies (mainly application of different lotions, which only made things more inflamed and worsened the oozing). The rashes continued to persist despite using some of the creams they recommended too. The rashes even persisted despite antibiotics. Over the past few months, fortunately, the rashes everywhere except for the back of my hands/forearms have healed mainly as a result of my avoiding the main triggers listed above. I have found it difficult to healmy hands though (although they are healing very very slowly) because I have to wear rubber gloves constantly for my job as a pathology resident. When my hands sweat underneath the gloves, it intensely irritates my skin and the rash/wounds unfortunately open again. Over the past severalmonths, I have adapted to this by constantly wearing cotton gloves (which is the only fabric I'm now not allergic to) and this helps to relieve the irritation a bit. In addition to these skin rashes, I also noticed that I have become intensely allergic to bug bites, which I have never been allergic to before. For example, this past August 2021, when I was bitten by a bug (presumed mosquito) on my mouth, my lips swelled to 4X its size. Fortunately, the swelling eventually resolved on its own (however I did take photos and showed them to my PCP). I also recently had episodes of persistent brown right breast discharge in ~April 2021. After a lengthy workup/imaging and eventually surgery, it is still not clear what the source of the discharge was. When my R breast /nipple ducts were finally removed surgically and examined pathologically (leading to resolution of the breast discharge), there was only chronic inflammation present. I have been recently tested by my PCP for possible autoimmune diseases however allmy labs and blood tests have thus far been negative/unremarkable. I was previously healthy prior to these events and had no significant medical issues/allergies (except to cats, which caused itchy eyes/runny nose). I also rarely got sick (I would get flu-like symptoms once every ~ 3 years) I am deeply concerned that these allergic reactions are related to the COVID-19 vaccine. Nothing about my life changed last year before and after the onset of these events, EXCEPT that Icompleted my COVID-19 vaccination.
This case was reported in a literature article and described the occurrence of uveitis in a 35-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received 1st dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A). It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes, which initiated the ocular response of uveitis.
6 hours after receiving the shot, I had the worse body aches (every nerve and muscle hurt in my body), and chills.  I never ran a fever that I'm aware of, and never developed any respiratory issues.  But my body was in so much pain, I could barely get out of bed to use the restroom.  This lasted almost 3 days straight.  I missed Thursday and Friday of work.  By Monday, I was still feeling achy, but I went to work as I had just started this job beginning of May, and I was the Financial Controller.  I got through Monday, and Tuesday morning, I felt good.  No body aches and my head felt fine. By Tuesday mid-afternoon, I started developing a migraine. By end of day Tuesday, it was the worse migraine I've ever had.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On an unknown date the patient received a 4th dose of GARDASIL (lot #, dose, route not reported). Concomitant medications were not provided. No adverse symptoms were reported. This is one of several report received from the same reporter (other MARRS#1408USA007680). Additional information has been requested.
restless; uncomfortable; Shortness of breath; tired; feeling different; This is a spontaneous report from a contactable consumer (patient). A 70-year-old  male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm on 03Mar2021 (age at vaccination was 69-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included heart condition and kidney condition; both started a couple years ago. There were no concomitant medications. The patient experienced being restless, uncomfortable, and shortness of breath on 11Mar2021 while tired and feeling different on Mar2021. It was further reported that on 11Mar2021, patient was feeling restless, uncomfortable, shortness of breath and stuff so he went to the ER. The patient told them that he got a shot of BNT162B2, but they gave him another unknown shot. It was reported that he was kind of feeling uncomfortable and tired so he doesn't know if he needs to take another BNT162B2 shot or not. The patient declined the second dose last 24Mar2021 since he doesn't know if they gave him the second shot at the ER or not. The patient reported that he has been feeling different since then and he doesn't know whether he should have taken it or not. It was also reported that for his shortness of breath he felt better, but he was feeling uncomfortable this day. He stated that he just went to the hospital but was not admitted. The outcome of the event uncomfortable was not recovered, shortness of breath was recovering while other reported events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt cried, turned blue, developed cyanotic colored rash on thighs and then turned limp. Afterwards, had vesicular papular rash and was very dazed and sleepy. Symptoms resolved in 24-36 hours.
5/15/2021 1120: EW0182 1st dose QMC -BVC Pt c/o itching to throat, chest tightness immediately.  Mother gave benadryl at 1207. Epi pen at 1235. Pt taken to ED by mother.  Pt rec'd prednisone, famotidine after observation and dx of anaphylaxis to Pfizer Covid 19 vaccine.
Admitted with c/o generalized weakness and significant pain to BLE s/p J and J vaccination.  Neurology diagnosed pt with Guillain-Barre syndrome and is s/p IVIG and steroids'.  Pt improved with IVIG and steroids'.  Of note pt. states he has been to the hospital multiple times with these symptoms and told he had rhabdomyolysis 2/2 statin use therefore it was d/c on prior evaluations and he was d/c home. Further evaluation showed pt has Guillain-Barre syndrome.
bursitus like pain in lt shoulder & progressing mid-way dow medial aspect of arm to index finger & thumb into anterior wall;also has tingling & numbness sensation w/buring type pain;has presisted now for 3 1/2wk;tx meds;
Patient complains of vomiting day of vaccine. Patient did receive follow up call on 08/20/14 AM, but patient did not return phone call.
started w/rash on neck & then vomited & diarrhea w/some resp problem; seen in ER given DPH; 29OCT92 still feeling nauseated; prescribed Medrol dose pak;
A few hours after flu vaccine, patient began to feel very weak, dizzy, fever and myalgias throughout the body. He call again the next morning with continued sickness, flu like symptoms.
For 2 days following the vaccine, I missed work, experiencing sever body aches and nausea
Had covid after the first 2 doses of moderna vaccine; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Had covid after the first 2 doses of moderna vaccine) and DRUG INEFFECTIVE (Lack of drug effect) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 046E21A) for COVID-19 vaccination.     It was reported that the patient has no allergies.  Concomitant products included SERTRALINE for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (Had covid after the first 2 doses of moderna vaccine) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Had covid after the first 2 doses of moderna vaccine) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 antibody test: positive (Positive) Positive.         Birth control was also reported as concomitant medication. No treatment medication was reported. Company comment:This spontaneous case concerns a 28 year old female with no reported medical history, who experienced the unexpected, non-serious ADR of COVID-19. The event occurred approximately 7 months after receiving a dose of mRNA1273 as second dose of COVID-19 vaccine. This was supported by the positive SARS-COV-2 Antibody test. The patient received both the doses of primary vaccination series from Moderna within 28 days from each other. The clinical course and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 28 year old female with no reported medical history, who experienced the unexpected, non-serious ADR of COVID-19. The event occurred approximately 7 months after receiving a dose of mRNA1273 as second dose of COVID-19 vaccine. This was supported by the positive SARS-COV-2 Antibody test. The patient received both the doses of primary vaccination series from Moderna within 28 days from each other. The clinical course and treatment details were not reported in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 67-year-old female patient 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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact
Vaccine administered to a 16 year old; A spontaneous report was received from a nurse concerning a 16-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine administered to a 16-year-old.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. The patient was 16-year-old. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine administered to a 16-year-old, was considered resolved.; Reporter's Comments: This case concerns a 16-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age.
Bottom lip extreme swelling . It happened on the first dose of Pfizer but It was a week later so I thought it was unrelated. 2 days after the second dose of Pfizer, my inner bottom lip started to feel coarse and I knew it was coming back. On 3rd day, my bottom lip swelled so bad it cracked and ripped on the inside and top of the lip is dry. My inner check on right side also swollen and broken skin
11-15-06 noticed numbness, swelling, pain, and blisters roof of mouth behind two front teeth. Stomach ache evening of 11-13-06. Will go to see a doctor if symptoms do not resolve.