chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  72 yo male with PMH CAD, fatigue, sleep apnea, AFib, HLP, HTN, COPD, gout, and DDD was admitted 8/22/2021 following a positive COVID19 infection for acute hypoxic respiratory failure secondary to COVID19 pneumonia, HFpEF, and GERD. Pt was intubated on 8/23/2021, completed extended course of dexamethasone, remdesivir, and barcitinib. His P/F ratio continued to decline even with vent setting adjustments and lasix. Pt developed AKI 9/5, anemia (no active source of bleeding were found on his CT scan), sepsis, and multiple organ failure secondary to COVID pna. Pt's family was called on 9/6 and opted for comfort care. Extubation occurred on 9/7, pt passed away on 9/7/2021.
Systemic itchiness - no rash, but I was very itchy all over my body for 2 days following the injection Left eye burning sensation intermittently for 2 days following the injection
From telephone contact with the reporter it was stated that an adult patient (2 of 2) received a Tetanus Toxoid Adult vaccination. The patient developed a local reaction, and fever. No specifics were provided. Further information is requested. Correspondence received on 6/4/01 stated the 62-year-old female patient received Tetanus Toxoid vaccination on 4/16/01. Two weeks later she complained of arm pain, redness, swelling and fever. Patient was not seen in physician's office. Did not notify physician's office until 5/29/01. The patient recovered from this experience. No further information is anticipated for this report. This case is closed.
RN calls to report VAXELIS and ROTATEQ given during a TE. No further AE. No PQC; This spontaneous safety report, , was received by the partner on 18-SEP-2023 and forwarded to agency on 18-SEP-2023, from a health professional.  Due to the nature of the event, the causality between the event "RN calls to report VAXELIS and ROTATEQ given during a TE. No further AE. No PQC" and Vaxelis was not applicable.  Further information is expected.
One day post vaccination the pt developed an area of induration and erythema which measured approximately 8 X6 cm. There was some slight overlying warmness and no associated adenopathy. The pt sought medical attention. The reporting physician noted that he thought this represents a lical reaction. I do not thing there is anything here at this point to suggest cellulitis. i recommend some cool packs for 15-20 minutes at a time, for 2 or 3 times a day. On an unspecified date, the pt recovered. No further information is available.
Patient received Moderna Covid Vaccine 2/26/2021 and 4/5/2021.  Tested positive for Covid 7/30/2021
Given Tdap 5-1-07 at approx. 0830. On 5/2/07, at OC, felt aching in joints, flu-like symptoms, and generalized weakness (no strength). Progressively getting worse.
Red patches on left arm, sore muscle. No treatment needed. Naproxen 1 tab BID as needed.
No problems for the first 24 hours, then development of coughing, hives, and shortness of breath.
Patient with 2 COVID vaccines who admitted with mild COVID symptoms with concerns for bacteremia.  Provider d/c note:  "Well preserved vaccinated 103 year old residing with her daughter who recently was infected with COVID presents with episode of encephalopathy and apparent syncope.  Testing revealed COVID detected but patient appeared well.  Patient released home but then monitoring blood cultures reported positive for Gram positive rods.  Patient admitted for IV antibiotics but patients culture then interpreted as pseudobacteremia due to Bacillus species.  Patient continued to appear well and without complaints, fever, hypoxemia or pain and was slated to be discharged home but the positive blood culture was then reported to have Bacteroides in it in addition to the Bacillus species.  Patient was observed another day without fever, leukocytosis, or symptoms.  Three other companion blood cultures remained sterile.  She was found to have a mild strep UTI, and received several days of oral Keflex and IV Rocephin.  Physical exam, CXR and CT AP did not note a likely source of Bacteroides.  Given that the bottle from which Bacteroides grew was clearly contaminated as evidenced by the Bacillus species and that three other culture bottles were negative, it was decided not to treat the first culture bottle results.  At the patient and her families request she was discharged home.  She did not have any symptoms of COVID warranting treatment."
Severe depression and anxiety started about 1 hour post injection and lasted for about 36 hours.; Severe depression and anxiety started about 1 hour post injection and lasted for about 36 hours.; This is a spontaneous report from a contactable Consumer (patient, self-reported). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, in Arm right, on 05Feb2021 at 10:15 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included anxiety disorder. The patient had known allergies with metformin and fluoxetine. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) (300 mg) and sertraline hydrochloride (ZOLOFT) (50 mg). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 05Feb2021 at 11:00 AM, she had severe depression and anxiety started about 1 hour post injection and lasted for about 36 hours. The patient did not receive any treatment for the events. Outcome of the events was recovering.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 13-MAY-2010, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 01-NOV-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
pt recv vax 23OCT97 & 2hr post vax pt became dizzy & sick to stomach;pt returned to medical clinic;area assessed & no red-swell-warm to touch noted;exp inc in heart race & BP;pt observed & disch stable;
NSTEMI went to cardiac cath and received stent in LAD. Started on prasugrel 10 mg daily, lisinopril 2.5 mg daily, and aspirin 81 mg daily discharged home
Called around 9:40am. The patient reported that she has started to get itchy on her arms. Denies rash. Denies shortness of breath and swelling of her lips, tongue and face. She reports that she had a previous anaphylactic reaction to a meningitis vaccine. She does not have an epi pen. She started to feel like her throat was getting hoarse, so she used her albuterol inhaler. It seemed to help after a few minutes. She was also given benadryl 25mg capsule and famotidine 20mg tablet to help with itching. Physical exam was WNL, no swelling of lips, tongue or face noted. No urticaria. Lungs CTA bilaterally. Heart RRR. She was monitored until a little after 10:00am and reported that she felt like her symptoms were not worsening. Denied shortness of breath. She was heading to the school to study, so she was advised to study in a public area and to let doctor or someone else at the school know what happened so someone could check on her.
Chest pain; This literature-non-study case was reported in a literature article and describes the occurrence of CHEST PAIN (Chest pain) in a 20-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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization). At the time of the report, CHEST PAIN (Chest pain) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: 88 mg/l (High) CRP elevation and 2.5 mg/l (normal) 2.5mg/L. On an unknown date, Echocardiogram: unknown (Inconclusive) Revealed a Left Ventricular Ejection Fraction (LVEF) 45% with  moderate hypokinesis of the apex and apical septum. On an unknown date, Electrocardiogram: abnormal (abnormal) Down-sloping PR depressions, diffuse ST elevations. On an unknown date, Serology test: negative (Negative) Negative. On an unknown date, Troponin I: >27,000 pg/ml (High) More than (>) 27,000 pg/mL Troponin elevation and 0.03 ng/dl (normal) 0.03 ng/dL.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHEST PAIN (Chest pain) to be possibly related.    No concomitant medication was provided by the reporter.  Patient was presented with a 2 day history of progressive chest pain, 2 days after receiving his second dose of the Moderna vaccine. His symptoms started with a viral prodrome approximately 10 days prior to the onset of his chest pain. Viral serologies for HIV, hepatitis B and C viruses, coxsackie virus  type b, and EBV were all undetectable. Outpatient cardiac  magnetic resonance imaging (CMR) remains pending. His chest pain resolved the following day. On  day 3 he was discharged from hospital. He presented to clinic 11 days after discharged for lab tests.  No treatment medication information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-293677, MOD-2021-293733 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recvd vax;exp flu like sxs & achy joints for approx 2 mo p/ inject;previously recvd 1st dose & exp similar sxs but not the severity as exp p/ 2nd dose;
approx 23 days p/ vax pt exp cervical & axillary node swelling.
Patient complained of feeling dizzy after receiving vaccine. Patient stated he needs to lie down. Patient diaphoretic placed on stretcher. BP 105/65, HR 64, RR 14, SP02 95% RA. Patient felt better in stretcher. Talking
Information has been received from a physician concerning a female who on June 2007, was vaccinated with a 0.5 ml first dose of GARDASIL. Subsequently the patient developed headaches, dizziness, and unusual olfactory response where she was smelling feces and other abnormal smells. The physisican referred the patient to a neurologist. Magnetic resonance imaging results were normal. The patient contacted the office by telephone. At the the time of the report the patient had not recovered. Additional information has been requested.
Systemic: Abdominal Pain-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe
Fever, body aches, headaches, nausea, vomiting, diarrhea. Headaches and body aches continue at 29 days after second Moderna vaccine. Reports as severe on right side of body only. Also reports after resting right sclera is red.
I got my shot at 11am on the 18th. There were no immediate symptoms so I went home and went about my day. Around an hour after my arm started to get sore and I felt tired. I started to get some small hives on my legs and I was itchy all over. By the next morning my whole left arm, left armpit, and back was really sore and I was itchy mainly on my neck. I started to notice bumps on my neck that have slowly grown. The whole second day I was very itchy allover and was very tired. By the third day (the day I am reporting this) my left shoulder and armpit still hurt and the bumps on my neck are still there. By the evening when I went to take a shower I noticed my whole entire legs were red and inflamed and I was severely itchy from head to toe. The shower did not help with the itchiness and the severity of the itchiness has only gotten worse and the hive breakouts have gotten worse as well.
About 5-10 minutes after administration, began to have tingling sensation on tongue/mouth, sharp chest pain and difficulty breathing. BP and HR remained stable, no wheezing, pulse ox upper 90s throughout. Received BENADRYL 25mg PO as well as Sprite. Symptoms resolved but developed some swelling of bottom lip on (R) side.
This spontaneous report as received from a pharmacist refers to a 64 years old male patient. The pharmacist reported that on an unspecified date the patient developed redness and swelling at the injection site after ZOSTAVAX (lot # J002865, expiry date: 07-JUN-2014), at unspecified location intramuscularly was administered on 30-SEP-2013. No concomitant medication, drug reactions/allergies were provided. The patient had no pertinent medical history. No treatment was given for the events. No lab diagnostic studies were performed. The patient had sought medical attention via went to pharmacist. At the time of report, the outcome of the events was not recovered. Additional information has been requested.
Swelling/redness in circular area around site of shot in right thigh. First noted on 6/4/02; shots administered on 6/3/02. No fever. Placed on Benadryl/steroid cream to site on 6/4/02.
Skin itching all over. Started after applying hair permanent on 4/2/13 in afternoon and showered to remove hair permanent. Itching continued daily. On 4/11/13, client called clinic to report symptoms. Client was sent to seek medical advice at his primary doctor. Was prescribed Benadryl 25mg by mouth twice a day for 10 days. On 4/12/13, client reported itching continued and he had to call his doctor's office again on 4/12/13.
Total 6-days reaction, Muscle Pain body, Redness upper left arm; Swelling upper left arm; Headache, Shivering, Fever for 6 days 99.8 - 100.9, Tired, Weak, Loose stools.
Client mother reports a seizure that was differnt and longer than any other seizures ever noted in client.  Seizure lasted approximately 15 minutes. 11/5/2009 note from Public Health nurse stated patient had seizure activity that was of more intensity and lasted a longer duration than her "normal seizure activity". Patient did not see PCP or seek any tx for this event.
Vaccine:  Pneumovax, given intramuscularly in right deltoid, on 02/28/2006 at 14:40.  Patient reports feeling bad starting 16:00-17:00, by 20:00 fever 101.7 degrees, chills, achy all over, then injection site very sore.  Next day arm red, swollen, warm.
Pfizer on 4/15 and 5/12. Positive on 8/30 admitted on 8/30 to current
underarm swelling; pain in the arm; blue marks on the swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (underarm swelling), PAIN IN EXTREMITY (pain in the arm) and SKIN DISCOLOURATION (blue marks on the swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (underarm swelling), PAIN IN EXTREMITY (pain in the arm) and SKIN DISCOLOURATION (blue marks on the swelling). At the time of the report, PERIPHERAL SWELLING (underarm swelling), PAIN IN EXTREMITY (pain in the arm) and SKIN DISCOLOURATION (blue marks on the swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Received 1st Pfizer dose 3 weeks ago, today took covid test and is positive; Received 1st Pfizer dose 3 weeks ago, today took covid test and is positive; This is a spontaneous report received via Pfizer sponsored program COVAX US Support from a contactable consumer (patient). A male patient of an unknown age received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown) via an unspecified route of administration on Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received 1st Pfizer dose 3 weeks ago, and on 06Apr2021 took COVID test and was positive. These events were considered serious (medically significant). The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Extremely sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Flu vaccine.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient reported that she took flu vaccine and always got extremely sick after taking it. The patient was no longer taking Flu vaccine. The follow up would not possible as contact information was not available. For tolerance of Shingles vaccine refer case US2021AMR205442.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205851:tag at post US-GLAXOSMITHKLINE-US2021AMR205442:same reporter
The pt experienced an onset of infantile spasms and an abnormal EEG. Follow up information received 10/18/02, stated, " Infantile spasms controlled by meds, long-term developmental outcome - too soon to tell."
skin discoloration/has "circular skin color changes."; This is a spontaneous report from a contactable pharmacist (parent) reported for patient (daughter). A 12-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8736), via an unspecified route of administration, administered in left arm on 16May2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. The concomitant medications of the patient were not reported. The additional vaccines administered on same date of the Pfizer Suspect and Prior Vaccinations within 4 weeks list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were reported as none. The AE(s) following prior vaccinations and family medical history relevant to AE(s) were reported as none. On 20May2021, the patient experienced skin discoloration/has circular skin color changes. Parent of patient, also pharmacist, called to see if Pfizer had any information regarding the Pfizer COVID-19 Vaccine and any association with skin discoloration. She stated that she already filed a report reference. Mother and father have tried to search on their end as HCP however had not been successful in finding anything similar to their case. They however found information more so releated to COVID arm skin erruptions which did not met the same clinical presentation. She stated her daughter has circular skin color changes. One on the right hand, which was her 1st reaction after the 1st injection. The second notable skin color changed was located on her left pointer finger, more so on top of the finger between main knuckle and joint down. She noted it to be elongated and uniform in pattern. Not irregular. No jagged borders, it was an oval. These reactions occurred 4 days after the 1st dose, noticed a skin discoloration spot on her right hand. It was slightly red, grown darker over time more like a brownish color. There were no changes to the skin, just pure discoloration. Did had to go to a dermatologist. Was not sure. Was advised by Dermatologist and pediatrician to just watch and wait. Could it be related, pediatrician and dermatologist had not seen anything related. They were just watching it. It was a discolored spot. was not anywhere else. Nothing else was abnormal or associated with those two marks. Dermatologist initially said it was a bug bite. The event led to the physician office video visits since they were away on vacation. The event was reported as non-serious. The outcome of the events was reported as resolving.
Child complained that tongue hurt, and shortly after, parents noticed hives on hand and ankle.  Tongue pain went away, and hydrocortisone applied to the hives helped.  Next day, more hives on hands and tops of both feet up to ankles, gave Benadryl, called pediatrician who advised 1 tsp. Benadryl 3x/day for 5 days, and would like to see patient.  Patient still under supervision.
I developed headaches after the vaccine. I never had headaches before in my life and every now and then I would get these sharp pains in different spots in my head. I could feel where the headache was. These would come and go. Sometimes I would get them daily for a few days and then they would disappear for a few weeks and then return.
Patient admitted as observation on 12/15 and upgraded to inpatient on 12/16 due to AKI.