chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to the ED from home for b/l lower extremity swelling x 2 weeks. She was reportedly in her recliner for approximately 12-18 hrs prior to being brought in via EMS. In the ED her b/l LE extremity was cold to touch and mottled. Her toes were white and nail beds blue. No pulses were found on Doppler on either extremity. She was also noted to be in a.fib with RVR. Doppler of LE showed extensive occlusive thrombus. Bedside echo showed the RV severely dilated with mobile thrombus and EF 20-25%. Given these findings there is a very high probability of massive PE, however given current situation of AKI and instability CT was unable to be performed. She was given TPA and admitted to ICU. Pt was started heparin gtt, as well as levophed and dobutamine for obstructive and cardiogenic shock as her troponin, kidney function, lactate and liver function all were elevated.  Of note pt lives in a hoarding situation and lives a sedentary lifestyle and reportedly only gets up from recliner to use the bathroom. Pt also has a 96 pack year history but was noted in her medical chart  to have quit smoking in 2017.
Feeling like she was going to faint; Hands were tingling; Sharp intermittent pain lower right back; Feeling woozy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Feeling like she was going to faint), PARAESTHESIA (Hands were tingling), BACK PAIN (Sharp intermittent pain lower right back) and DIZZINESS (Feeling woozy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced PRESYNCOPE (Feeling like she was going to faint), PARAESTHESIA (Hands were tingling) and DIZZINESS (Feeling woozy). 08-Jun-2021, the patient experienced BACK PAIN (Sharp intermittent pain lower right back). At the time of the report, PRESYNCOPE (Feeling like she was going to faint), PARAESTHESIA (Hands were tingling), BACK PAIN (Sharp intermittent pain lower right back) and DIZZINESS (Feeling woozy) outcome was unknown.         Concomitant medications were not reported.  Patient mentioned she received her 2nd dose and was feeling woozy and like she was going to faint. Her hands were tingling and she had a  sharp intermittent pain to lower right back.  Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-213261 (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 events, a causal relationship cannot be excluded.
Patient says that he still has pain in his arm at the site of injection.  There is no redness or swelling.  It is not hot to the touch.  Encouraged patient to put ice on his arm and see if that helps
The pt experienced fine pin-point sized rash and flattened lines over abdomen, buttocks and upper extremities approximately 24 hours post vax.
Fever; Muscle ache; Fatigue; Lymph node in left armpit swollen to the size of a small; laryngitus; lips are also now swollen; earache; lingering cold symptoms/feels like a head cold; sore throat; slight cough; tongue significantly swollen; Less than 19 days between dose 1 and dose 2; Less than 19 days between dose 1 and dose 2; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself.    A 52-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation  .  Medical history included psoriasis , blood cholesterol increased . Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took amoxicillin and experienced hypersensitivity and swollen tongue. The patient received the first dose of bnt162b2 vaccine on 04Feb2021. The patient experienced tongue significantly swollen  on 23Feb2021 07:00 with outcome of recovering ,  fever on 23Feb2021 07:00 with outcome of recovering , muscle ache on 23Feb2021 07:00 with outcome of recovering , fatigue  on 23Feb2021 07:00 with outcome of recovering , lymph node in left armpit swollen to the size of a small grapefruit on 23Feb2021 07:00 with outcome of recovering , laryngitus  on 23Feb2021 07:00 with outcome of recovering , lips are also now swollen  on 23Feb2021 07:00 with outcome of recovering , feels like a head cold  on 23Feb2021 07:00 with outcome of recovering , earache  on 23Feb2021 07:00 with outcome of recovering , lingering cold symptoms  on 23Feb2021 07:00 with outcome of recovering , sore throat  on 23Feb2021 07:00 with outcome of recovering , slight cough  on 23Feb2021 07:00 with outcome of recovering.  Swollen tongue was considered an Important Medical Event. The patient received the second dose 18 days after the first dose and this is considered an off label use.  Follow up information has been requested.
More than 36 days have passed since first dose; I developed COVID-19 after my 1st dose with no symptoms; rash in the hole body; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose), COVID-19 (I developed COVID-19 after my 1st dose with no symptoms) and RASH (rash in the hole body) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced RASH (rash in the hole body). On 28-Mar-2021, the patient experienced COVID-19 (I developed COVID-19 after my 1st dose with no symptoms). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose). On 04-Mar-2021, RASH (rash in the hole body) outcome was unknown. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose) and COVID-19 (I developed COVID-19 after my 1st dose with no symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included many steroids.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021, contains no newinformation.
Information has been received from an 18 year old female with no pertinent medical history and a penicillin allergy who on 17-JAN-2007 was vaccinated with a first dose of Gardasil (lot number unknown) injection who developed light headedness. On 19-MAR-2007 the patient was vaccinated with a second dose of Gardasil and experienced soreness in her arms. On 25-JUN-2007 the patient received a third dose of Gardasil and experienced soreness in her arms which was given 22 days earlier than scheduled. On 25-JUN-2007 concomitant suspect therapy included hepatitis A vaccine (unspecified) was given. Medical attention was sought. At the time of reporting it is unknown if the patient had recovered. No further information was provided. No further information is available.
swelling at the injection site; redness at the injection site; tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (tenderness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Blood cholesterol abnormal and AFib. Concomitant products included SIMVASTATIN for an unknown indication.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (tenderness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (tenderness at the injection site) had resolved.            The patient was also using steroid for asthma.   The patient was very active, did yoga and she used to stretching.   This case was linked to MOD-2021-361771, MOD-2021-362552 (Patient Link).
Fever - 102 degrees, headache, body aches chills. started 3-4-2021, took TylenoL, lots of fluids.  All that was gone by 3-6-2021 except for body aches.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Mar-2022; Patient received vaccine past its 30-days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30-days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Mar-2022) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Acute illness at the time of vaccination and up to one month before was reported as unknown.  Chronic or long-standing health conditions was reported as unknown.     On 26-Mar-2022 at 1:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Mar-2022 at 1:19 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30-days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30-days expiry date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.  On 26-Mar-2022 at 13:19:46, patient received an expired booster dose.  It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the MFG expiry date of 04-Apr-2022.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination or at the time of the adverse event were reported as unknown.  Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown.   This case was linked to MOD-2022-542869 (Patient Link).
This spontaneous report as received from a other health professional refers to a 5 year old patient. On 31-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
Muscle weakness; Unable to swallow; rapid heart beat; eyes red around rims of eyelids; Headache; flu like symptoms; body aches; sharp pains in quads; eyes red around rims of eyelids; stiffness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 08Oct2021 (Lot Number: FF2589) as DOSE 1, SINGLE for COVID-19 immunization at the age of 44 years old in the Pharmacy or Drug Store. Medical history included melanoma, cervical cancer carcinoma, current HSV1&2 and deathly allergic to escargot from an unknown date. The patient's concomitant medications were not reported. The patient previously took Keflex, clindamycin and tramadol and experienced anaphylactic response. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. The patient experienced unable to swallow, rapid heart beat, eyes red around rims of eyelids then followed by severe headache, flu like symptoms - body aches, sharp pains in quads, muscle weakness and stiffness on 08Oct2021 18:30. The outcome of the events was recovering. The patient did not received treatment for the events.  Follow-up attempts are completed. No further information is expected.
Had mild fever and body soreness starting day two which lasted for about 2 days. I had the vaccine shot on 04/29 (Thursday), I started attempting to work on computer from 05/02 (Sunday) and I have been feeling light headed and disoriented. Symptoms continue without changes today also (05/04)
headache chills weakness dizziness nausea no appetite body aches tingling in feet and hands pain in the arm that received shot sleepiness I kept hydrated took arnica and CBD cream on my arm  took a 2 hr nap which I never do felt better 14 hrs later with only headache and mild symptoms
COPD exacerbation secondary to COVID-19 infection, suspected bacterial Community-acquired pneumonia:  Chest x-ray with left basilar subsegmental atelectasis Currently afebrile, no leukocytosis, WBC WNL Completed course of Rocephin and azithromycin to cover possible superimposed bacterial infection
Information has been received from a physician concerning a 2 year old male patient who on 8/28/01 was vaccinated with a third dose of hepatitis B vaccine recombinant (yeast) (lot #640308/0815L) (Pl: 6/28/00 invalid lot # 2437K and 2431K reported: P:2 9/26/00 Lot # 636843/1029K). Additional vaccination included a dose of MMR vaccine (second generation) (invalid lot #2105K reported) administered on 1/29/01. At the time of vaccination with MMR (second generation), the patient was diagnosed with otitis media and was prescribed azithromycin. In approximately 2002 at the age of 2 years, the patient was diagnosed with autism. Unspecified medical attention was sought. As the time of the report, the patient was receiving therapy and was showing improvement. The child's mother felt that the autism was related to the hepatitis B vaccine recombinant (yeast). Otitis media was considered to be an incidental finding. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested. The follow up received on 5/14/03 states The physician stated, "there is no causal linkage which has been proven." The physician also noted that the doses of hep B vaccine recombinant that the pt received did not contain thimerosal. Additional info has been requested.
Pt received DTAP, PREVNAR, Polio, Hib (PENTACEL) & high-pitched scream - apneic/cyanotic/unresponsive - glassy-eyed, x 3-5 minutes, also red, blotchy rash over face, torso.
She became flushed with tachycardia, then nauseated.  Skin pale.  Face is itchy.  No shortness of breath.  Symptoms started 20 minutes following administration of vaccine and resolved about 30 minutes thereafter.  EMS came - thought it could be related to anxiety.
Got sick; Dizziness; Vomiting; Did not feel great; Kind of achy; On the arm it itches so bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel great), ILLNESS (Got sick), DIZZINESS (Dizziness), PRURITUS (On the arm it itches so bad) and MYALGIA (Kind of achy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epilepsy. Concomitant products included LAMOTRIGINE (LAMICTAL) and CLONAZEPAM for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PRURITUS (On the arm it itches so bad). On 27-Apr-2021, the patient experienced FEELING ABNORMAL (Did not feel great) and MYALGIA (Kind of achy). On 29-Apr-2021, the patient experienced ILLNESS (Got sick), DIZZINESS (Dizziness) and VOMITING (Vomiting). At the time of the report, FEELING ABNORMAL (Did not feel great), ILLNESS (Got sick), DIZZINESS (Dizziness), PRURITUS (On the arm it itches so bad), MYALGIA (Kind of achy) and VOMITING (Vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided.   This case was linked to MOD-2021-099223 (Patient Link).
Approximately 10 minutes after the vaccine, patient experienced: Total body itching, shortness of breath, red in color in her chest, tachypnea, wheezing. She has never experienced allergic type reactions to flu shots in the past.
Patient experienced moderate swelling and redness in the upper left arm at and around where the two vaccines were administered.  Scope of morbidity limited to area between elbo and shoulder.  No reported febrile response.  Patient visited primary care physician but no treatment was necessary, condition resolved on its own.
Sore Arm at site of injection onset couple of hours after shot Fever of 100.2  onset approximately 14 hours after the shot Chills and slight headache  onset 14 hours after shot Fainting  onset about 14 hours after the shot Aches and Pains onset about 14 hours post injection  Fatigue
This is a 17 y.o child care provider that received Moderna due to her employment for first dose. Because of receiving dose #1, allowed to give dose#2 by protocol for off-label use. Pt is aware and consents to proceed. Parental consent was also noted.
Vaccinated on 8/26/02. Swelling of right arm at site of injection of DTaP, painful. Next day pt seen 8/2/02 tense tender swelling of entire upper arm from shoulder to elbow. Arm erythematous very tender. Treated with Keflex 250mg bid x 10 days, Benadryl 25mg. Pt felt better 8/30/02 arm swelling decreased.
Very heavy period (began immediately- it is usually progressive for me throughout the days), extreme back pain (since Monday? soreness and constant throb), diarrhea
Uncontrollable shaking, chills, swollen lymph node within armpit of vaccinated arm, fatigue, aches throughout body, joint pain, fever, dehydration. Drank water consistently and switched between Tylenol and Ibuprofen every 6 hours to reduce fever and pain. Bed rest for entirety of symptoms.
Mother reported patient told her the am of 2/916 he had a rash around the vaccine site.  Mother contacted our office 8 days later and said patient still had red bumpy rash around vaccine sight and that it had spread to cheeks and forehead.  He was seen in office 2/18/16 with small bumps on his arm, forehead  and cheeks.  Mom had given Benadryl, nurse practitioner changed him to Zyrtec.
Right after patient received FLUZONE HD (1st) and PREVNAR 13 (2nd), she felt tightness in her throat. She immediately took 25mg of Benadryl of her own. She started having different sensation in her face and lips, she injected epinephrine 0.3mg pharmacy provided. Patient stated that she does not feel any difference, and 3 minutes later she received 2nd dose of epinephrine injection since the symptoms got worse. One of the technicians called 911. Patient said that the 2nd dose worked and she started feeling better in her throat. She was able to drink water and waited in her seat until paramedic came in. Paramedic took her and her husband to emergency room.
1st event started 03/13/2021, I could not see out of my left eye. I went to the emergency room. They referred me to retina specialist, who was on call that weekend.  There was so much blood, she was pretty sure I had a retina tear. I went to the retina surgeon the next day 03/14/2021. We did laser surgery and fixed it. On a follow up 04/03/2021, the retina specialist saw a small tear on my right eye. He did laser surgery and fix it. I still have some of the blood in my left eye. I still have a haze that moves around a little bit as I move my eye. The doctor said it might take 6 months to a year before it completely goes away. As far as my vision, it has not obstructed my vision.
Within 7 min. Of vaccine i began to feel like i was on a cold IV drip; the sensation started at vaccine site and traveled down my arm into my body.  I then went to pharmacy desk and said i thought i was having a reaction and went to the bathroom to see if i was red in the face.  Yes, my face and body were red splotchy which is my indicator of having an allergic reaction.   I also noticed that my chest was feeling tight like my bra was on too tight.  The pharmacist gave me a Benadryl and i waited 15 more minutes.    The Benadryl relieved most of the symptoms after an hour but my chest was tight the remainder of the day and fine the next day.
Pt admitted on 11/22 from nursing home with respiratory failure secondary to COVID19 infection. He was admitted to the ICU and placed on NIV.  Pt continued to require more oxygen and was unable to come off BIPAP. He did express that he did not want to be placed on ventilator and did not want any intervention in regards to his own blood clot. The patient was made a DNR/DNI. His family was contacted. Pt continued to decline over the next couple of days. Family was called in. Pt was transitioned to comfort measures. He did pass away on 11/29/2021 @ 1846.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administered improperly stored doses of RECOMBIVAX HB (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 270 hours at 9 C degrees. No adverse effects were reported. It was reported that all vaccines were back in range. The data logger was reported as yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 9/3/21 lot# FC3180;  Pfizer 10/14/21 lot# FC3180;  Moderna 6/22/22 lot# 049L21A