chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Monday morning 01/11/2021 I had a headache, fever, chills, and nausea. I did not go to the hospital/doctors office for treatment. The symptoms lasted 24 hours. I have not had any other symptoms since then.
30 yo M w/Rx HIV, seasonal allergies and flow murmur, was seen in clinic 3/24 for appointment, and received vaccination with PNEUMOVAX 23 as per the CDC recommendations. Patient called on 3/25 reporting left arm redness and pain originating from the site of the injection and extending to his elbow. Photo of the reaction was sent to the provider. Provider prescribed cephalexin to treat presumed cellulitis, and the patient was advised to go to the nearest ED if the redness increases, or if he develops a fever, chills, rigors or the erythema starts to spread. No further follow up noted at this time to be seen in outpatient clinic 4/17/17.
I experienced flu like symptoms of fever, body aches, fatigue, weakness which began 4/6/21 at 9pm and lasted around 24 hours.
This spontaneous report as received from a dentist refers to himself who was a male patient of unknown age. Patient developed an unknown reaction to a Streptomycin injection when he was a child. On an unknown date the patient was vaccinated with MUMPSVAX (injection, strength, lot#, dose, route and duration were unspecified) and developed thyroid inflammation (date unspecified). The action taken and outcome was unknown. Additional information has been requested.
The patient came in to get a flu shot. The flu shot was administered and by Thursday of the same week the patient developed pneumonia. The patient complained of fever and had to be seen in urgent care where she received an antibiotic.
Arm was sore for a prolonged period following administration.  On 3/1, she noticed a red, round area about the size of a dime at the injection site.  This area grew in size.  On 3/4. she contacted us and explained that the area was now the size a 50 cent piece.  Patient was advised to contact her physician or go to a walk-in clinic to have it checked out.
Eight hours after receiving vaccination patient developed explosive diarrhea.  This lasted for weeks.  She ended up being hospitalized twice and was eventually diagnosed with lymphocytic colitis. She has never had this before. In consult with gastroenterology it is believed that because she received immunotherapy 2 months prior to vaccination that her immune system was primed.
I am a healthy, fit, 37 year old male, previously infected with COVID in 2020 and mandated to receive the COVID vaccine by my employers.  I received my first dose of Pfizer COVID19 vaccine (LOT 30135BA) on October 26th, 2021. Hours after receiving the vaccine I developed facial numbness. It started in my neck, beneath my chin and all around my chin. Later it would move into my cheeks, around my jaw, and near my eyes. It would only go away for short periods of time and remained pretty constant. This lasted until about November 9th (15 days).   Two days after the numbness subsided, I began to have sharp abdominal pains and felt very bloated. The pain and discomfort was constant and would not go away, even days after it began.   I received my second dose on November 19th (LOT FE3590). The day after the second dose I began having joint inflammation in my knees and ankles.    By November 22rd my stomach pain had become more concerning. I could no longer button my pants due to abdominal swelling. I went to the ER locally where I was given CT scans and was diagnosed with acute appendicitis. The surgeons wanted to perform surgery immediately, but I was hesitant and declined.  On November 23rd, after doing research and making an informed decision, I proceeded to the ER of a second hospital. I was again given a CT scan and diagnosed with acute appendicitis. I stayed overnight in the ER and on November 24th I had an appendectomy performed.
Patient is a 77 y.o. male who presented from home on 9/17/2023 with falls and weakness ,found to be COVID positive.  Patient was not hypoxic, no need for steroid, antiviral therapies, continue supportive care, PT/OT for weakness and falls recommended skilled nursing therapy and sent to SNF.  Patient had acute kidney injury on CKD stage IV that resolved with IV hydration and temporarily hold lisinopril and restarted on 9/24.    COVID 19 Infection Generalized Weakness - Presented with: Weakness, fall - Symptom onset: Day of admission - Positive COVID-19: 9/17 at facility - Vaccination status: Vaccinated with Pfizer and boosted with Pfizer with booster dose on 11/2022 - CXR on admission showed borderline cardiomegaly, nonacute - Oxygen status: Room air - Decadron: Does not qualify due to SpO2>94% on RA. - Remdesivir: Does not qualify due to SpO2>94% on RA.  - DVT prophylaxis: Subcutaneous heparin - Serial COVID labs ordered: No, given no hypoxia - Case Management/Social Services consulted: Yes -Supportive care and physical therapy and Occupational Therapy.   AKI on CKD 4-resolved -Baseline creatinine of 1.9-2.5 -Cr worsened to 3.06 on 9/21 -He noted vomiting, and pre-syncope with hypotension yesterday -Appreciate nephrology Cr improving, no signed off -Resolved AKI with IVF and holding antiHTN meds -Resume lisinopril 9/24   Ischemic colitis Noted colitis on CT abd/pelvis from 9/20 -Suspect that this is ischemic over infectious or inflammatory.  Patient has had some hypotensive episodes and noted some bleeding.  -We will support blood pressure, check lactic acid and monitor abdominal pain -Less concerned for infection, blood cx ngtd, gi path panel cancelled per protocol  Frequent Falls Patient does need a walker at home at baseline.  Does not have any home health care services in place. Presented with falls at home.  -Likely with exacerbation of weakness due to COVID, with baseline gait impairment 2/2 MS and deconditioning -CT cervical spine, head, and maxillofacial scan showing no acute injury. -PT and OT evaluation -Orthostatic positive on 9/20, likely also with slowed baroreceptors -TSH and b12 not deficient   Essential HTN, uncontrolled  RAS - pt with uncontrolled HTN secondary to bilateral RAS. S/p stent to L renal artery on 5/18/22, right renal artery stent placed on 6/17/2022 -Has had hypotensive episodes: hold parameters on his Norvasc and Coreg -Resume lisinopril 9/24, continue to hold hydralazine  -Patient on aspirin Plavix, post stenting  -Continue to monitor   Diabetes mellitus type 2 with hyperglycemia  -Continue home Januvia 25 mg QD   MS - follows with Dr., OP follow up as scheduled  -Not on any biologic therapy or DMARDs. - uses 4 wheeled walker at baseline -Neurology consulted for concern for possible worsening MS with LUE weakness: recommended supportive care of MS.   Pulmonary HTN - mild, RVSP 40 mmHg
A non-serious spontaneous report of "felt like his eyes were swollen" and headache has been received from a registered nurse concerning a 16-year-old male, subsequent to FLUMIST. The patient denies any medical history of egg allergy. Concomitant medications were not reported. The patient received FLUMIST on 15-Oct-2009 in a school immunization program. After receiving FLUMIST, the patient complained of headache and "felt like his eye were swollen". As of 16-Oct-2009, no symptoms were reported. The outcome of the events was resolved.
Brief (5-10 seconds) tonic - clonic movements of the arm followed by vaso-vagal reaction including drop in blood pressure to 73/43 and HR 53 with steady increase to normal.  Pt also had emesis.  She left clinic when stable, but then about 2 hrs later her mother returned for copies of note prior to taking pt to ER with repeated emesis and dizziness.
On approximately 09/15/2000, the patient experienced 2 lesions. The patient sought unspecified medical attention. No further information is available.
I received both vaccines simultaneously on 11/19/2021 shortly after 11 AM. 12 hours later around 11 PM the following symptoms occurred - extensive body aches, fever, headache, fatigue, inability to sleep, sore arms. These  symptoms continued for the next two days. Also very noticeable are swollen lymph nodes under both arms. Fatigue continues as of today, 11/23/2021.
people that have gotten some of their shots have died of COVID; people that have gotten some of their shots have died of COVID; This is a spontaneous report from a contactable Other HCP and a consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  In a qualitative interview, when asked 'Are you aware of any COVID related activity from this manufacturer (Pfizer)'? the respondent said 'I know that people that have gotten some of their shots have died of COVID'. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: People that have gotten some of their shots have died of COVID; People that have gotten some of their shots have died of COVID
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Mar-2021 at 4:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 4:35 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient age was reported as 60.89. No concomitant medications were reported. The vial was initially moved to the fridge on 09-Mar-2021 and proposed beyond use date was 08-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree F. On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree and at 10:00 A.M., the temperature recorded was 30 degree that has been reached by the vial. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. No treatment information was provided. This case was linked to MOD-2022-566976 (Patient Link).
Janssen COVID-19 Vaccine EUA  3/15 12:30pm -Rash developed on injection arm and down right side of upper body.
Information has been received from a nurse concerning a 12 year old female who in 1996 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included Zovirax and Healtheries Arthrex. In 1999 the patient experienced "mild breakthrough." In 2007 the patient experienced "severe breakthrough." The patient had a significant fever for one day but did not require hospitalization. Follow-up information from the nurse indicated that she did not have any further information. No additional information is expected.
This was my second dose. Shots don't bother me. I can remember the first dose stinging as it went in; the second dose seemed to be worse. My left arm (same both times) was quite sore for multiple days after the first shot; the soreness seemed to ramp up faster with the second dose. Pain level isn't debilitating (and I'm not tempted to take anything to relieve it), but it is curtailing my activities. Moving the arm often produces sharp jabs of pain at the injection site. The injection site is noticeably swollen although not, at least several hours ago, discolored. The symptom that prompts me to file this report is that about 12 hours after receiving the second dose, I suffered a bout of extreme shivering; my whole torso was shaking. (I'm 6'1", 260 lbs.) That lasted about 15 minutes, but it took at least four hours for me to warm up -- even though I was in bed with multiple blankets. (I should have been sweating bullets.) Given the downsides of shingles, I don't think these symptoms are severe enough to keep people away -- only that recipients should be aware that "shivers" and "moderate pain" reported in the list of known side effects might be more severe. It's now 21 hours post injection. The arm is still sore as all get out, but no more shivering or feeling like my feet are going to freeze off.
It was a booster shot.  First two shots were Pfizer.  Two week since the shot, my left scalp started feel tingly and tender to touch.  Pulsating headache started that evening; feels like electric shock sporadically.  Next day, the headache became more of a throbbing pain and started making its way down to the left ear area and down my neck (on the left side).  Spoke to the naturopath, wondering if it may be the supplements (all of the supplements I have been on for more than 3 months+, and nothing new was added).  Measured blood pressure and it was 119/75 normal.  Took 2 Advil to manage the pain.  Couldn't sleep that night.  Next day, noticed rash/hive near the forehead/hair line (close proximity to the tender spots).  Headache remains to be rhythmic throbbing.  It goes away if I close my eyes and sleep face down on my pillow.  Today is day 4 and hive is worse and skins in the area is starting to flake.
missed 2nd Shingrix dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had missed 2nd of Shingrix dose and till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
6 hours after injection patient experienced  inflammation in the upper arm near the injection site which became hot to the touch. The area of inflammation spread from below the acromion process almost to her elbow. It caused significant discomfort and pain. Patient self treated with an ice pack and acetaminophen every 6-7 hours. She called her doctor's office and let a nurse know what happened and then reported it to the pharmacy where she received the injection. By morning of 2/20/21, the area of swelling had gone down significantly and patient was feeling better.
Swelling left arm felt hot to touch, redness 2 inch red below injection, itching severe site hard to touch with 3 red spots. Low grade temp.
Chest Pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN (INSULIN HUMULIN-N) and GLIPIZIDE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest Pain) and HEADACHE (Headache). At the time of the report, CHEST PAIN (Chest Pain) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Action taken with mRNA-1273 in response to events were not applicable.   This case was linked to MOD-2021-079160 (E2B Linked Report).; Sender's Comments:  MOD-2021-079160:Second dose case
Extreme swelling at injection site, and slight problem swallowing --> patient started recovering on 11/21/13 after being seen at Urgent Care on 11/20/13. She was given Prednisone one tablet every day x 5 days.
Patient developed welt- erythema and edema of right leg after immun w/ MMR and Varicella.
Redness on upper left arm near the injection site. It's 9 days out from the day of vaccination. It's the first time I'm noticing the redness. It does not itch and is not tender to the touch. (The site was tender for 3-4 days after the injection.) It's not a complete circle. Only a section of what would be the bottom of a circle is red.
On XXXXXXXX X, 2009 a 68 year old female received a TDAP vaccine not a TD.  The client was informed, there was no adverse reaction.  Similar names: verbal and written.  Generic names look alike.  Generic names sound alike.  Error reached patient; no patient harm.
Swollen axillary lymph node in left arm (injection arm) about the size of a ping pong ball, additionally swelling in upper arm near injection site since Saturday April 3.
Severe nausea with no vomiting occurring 12 hours later, also accompanied by injection site soreness.
Severe headache - attempted to treat at home with OTC Tylenol Extra Strength x 2 and Maxalt 10 mg x 2. I took the Maxalt?s 2 hours apart. After no relief and sweating and committing due to severe headache called primary care office. The got me in and gave me a shot of Toradol. A couple  hours later my headache pain/symptoms improved.
Clarified question with caller and she states the expiration date printed on the vial is 11/2021; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Lot number: FE3592, Expiration Date: Nov2021) as dose number unkown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Clarified question with caller and she states the expiration date printed on the vial is 11/2021".  Additional information-The caller was calling about the purple cap formulation of the vaccine and wanted to confirm the expiration date for her vaccine specific lot number. She was looking online and information she read was the expiration date was 6 months from initial expiration date, and all vaccines in that time frame so far; Lot withheld. Clarified question with caller and she stated the expiration date printed on the vial was Nov2021. She states. she wants to know does that vial with this expiration date had 6 month expiration date or was it extended. She also asked if it was given to patients after expiration what do we do. She stated doses were given after the extended expiration date of 28Feb2022.  No follow-up attempts are possible. No further information is expected.
light headed, tightness in chest, pale, flushed about 5 minutes after TdaP administration
This spontaneous report has been received from a Nurse Practitioner concerning an adult patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 13-OCT-2015, the patient was inadvertently administered a pediatric dose of RECOMBIVAX HB 5/0.5 mcrg/ml (lot # J007943, exp. date on 05-FEB-2016), (route of administration was not provided), 0.5 ml. There was no concomitant medication reported. No adverse effects reported. A product quality complaint was not involved. Additional information has been requested.
Patient developed fever of 103.0 per mom. Next day went to local ER and fever was 101.9. Raised Erythematous area on right thigh with pustule lesion.
This case was reported by a consumer via call center representative and described the occurrence of flu in a 68-year-old male patient who received Flu vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for COPD, emphysema and asthma. Concurrent medical conditions included hypercholesterolemia, chronic obstructive pulmonary disease, emphysema and asthma. Concomitant products included SPIRIVA, Albuterol Inhaler, cortisone cream and simvastatin. On an unknown date, the patient received Flu vaccine (unknown) and ADVAIR Diskus (inhaled) 1 puff(s) twice daily (2 puff(s) daily). In February 2015, an unknown time after receiving Flu vaccine and ADVAIR Diskus, the patient experienced Flu (serious criteria hospitalization), bronchitis (serious criteria hospitalization), coughing and breathing difficult. In February 2015, the outcome of the Flu, bronchitis, coughing and breathing difficult were recovered/resolved. The reporter considered the Flu, bronchitis, coughing and breathing difficult to be unrelated to Flu vaccine and ADVAIR Diskus. Additional details were provided as follows: The patient used ADVAIR for 5-6 years but recently had to switch to SYMBICORT because his insurance will no longer cover ADVAIR. On an unspecified date, the patient had high cholesterol. This patient was hospitalized for 8 days and released on 25 February 2015. During this hospitalization, he was diagnosed with Flu and bronchitis. He said that he was having difficulty breathing and uncontrollable coughing. No information will be available because the patient had denied permission to contact his physician or to provide any contact information. He did not provide the completed details for this report.
This spontaneous report as received from a physician via a company representative refers to a 25 year old patient of unknown gender. No medical history provided. On an unknown date the patient was inadvertently vaccinated with ZOSTAVAX, (dose unknown, subcutaneous, Lot# unknown, indication: prophylaxis ("immunization")) instead of VARIVAX. There was no concomitant medication. No adverse effects noted. No treatment was given. The patient sought medical attention. No further information reported. Additional information has been requested.