chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Present to ER with SOB and coughing. Second COVID-19 vaccine was given at 10:30 am and she started feeling chills and cough about 2 hours later. Also, pt reported body aches and neck spasm. Patient given EpiPen as reports feels hard to breath, Solumedrol, Pepcid and Benadryl and reports sob resolved.  Ptient watched for 2 hours, no return of symptoms, SOB resolved, and patient start eating and drinking and feeling well. discussed with patient use of Tylenol and Motrin for post vaccine aches and fever and follow up with employee health tomorrow. Patient discharge to home.  Note: 1) patient doing well and get back to working the next morning  (2/10/21)           2) Past medical history: Asthma and diabetes
103+ fever. Blood work 2 days later the dropped wbc significantly.  3 days later the blood work came back to normal levels
pt had numbness of upper lip and lower nose within a few minutes of receiving vaccine. She was given benadryl and observed for 45 min. Symptoms subsided. No other issues. Pt reports similar issues with prior to 2 shots, but not as bad
NO ADVERSE EVENT; improperly stored vaccine administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent.       On 13-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Lot # S005078, Expiry date : 19-FEB-2021 or lot # R019237, Expiry date : 04-JUL-2020, the reporting nurse was unable to confirm which lot was administered to the patient) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-9.74 Celsius) for an unknown time frame (product storage error). There was no previous temperature excursion. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
Pt received vaccine on 6/21/17. Awoke 6/22/2017 AM with all over body aches, stomach achy and headache. Took TYLENOL, hydrated, rest. Next day 6/23/17 Pt felt better with exception of still sore at injection site.
afib; lungs plugged up can hardly breathe; prostrate plugged up can barely walk; pain in my back; sinus leaks all day; they had to cut off some of my toes; Initial information was received on 18-Nov-2021 regarding an unsolicited valid Social Media serious case from a consumer/non-healthcare professional.  This case involves Adult (unknown gender) patient who experienced Afib (atrial fibrillation), lungs plugged up can hardly breathe (dyspnoea), prostrate plugged up can barely walk (gait disturbance), pain in back (back pain), sinus leaks all day (paranasal sinus hypersecretion) and they had to cut off some of toes (toe amputation) after receiving INFLUENZA VACCINE.  The patient's medical treatments, vaccinations, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious Afib (atrial fibrillation), lungs plugged up can hardly breathe (dyspnoea), prostrate plugged up can barely walk (gait disturbance), pain in back (back pain), sinus leaks all day (paranasal sinus hypersecretion) and they had to cut off some of toes (toe amputation) (unknown latency) following the administration of INFLUENZA VACCINE.  Atrial fibrillation event was assessed as medically significant.  It was also reported that patient did not get covid (coronavirus disease).  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for the events.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns an Adult (unknown gender) patient who experienced atrial fibrillation, dyspnoea, gait disturbance, back pain, paranasal sinus hypersecretion and toe amputation (unknown latency) after vaccination with INFLUENZA VACCINE. The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
diarrhea; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and CHILLS (chills) 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.No relevant concomitant medications were reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and CHILLS (chills). At the time of the report, DIARRHOEA (diarrhea) and CHILLS (chills) outcome was unknown.       No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via other company (Pfizer Inc.) concerned a patient of unspecified age, sex, race, ethnicity. The patient's weight, height, and medical history were not reported. The patient received first dose with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAR-2022 for covid-19 prophylaxis. No concomitant medications were reported.  The patient additionally received 2 doses with Non-company suspect vaccine Moderna covid-19 vaccine, (elasomeran), (Dose number in series 2), (batch number: 035C21A, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 27-AUG-2022, and (batch number: AS7163B, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 22-SEP-2022 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The patient also received Non-company suspect vaccine Moderna covid-19 vaccine, (elasomeran), (Dose number in series 3), (batch number: 041C21A, expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 08-OCT-2022 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3).   On an unspecified date, the patient experienced confirmed covid-19 infection (Dose number in series 3) and had confirmed clinical vaccination failure (Dose number in series 1).  The patient started taking treatment with Non-company suspect drug Paxlovid, (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 04-JUL-2023 to 08-JUL-2023 for treatment of covid-19.  The patient experienced Rebound covid-19. No additional symptoms yet but tested positive after testing negative 48 hours prior. Laboratory data (dates unspecified) included: COVID-19 virus test Positive, COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20230733563- confirmed clinical vaccination failure. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Event occurred after 2nd dose. Patient was diagnosed with Covid Remdesivir Discharged home
Patient Developed a fever to 101.2 F, with redness, swelling, tenderness of the left arm.   Mom called from Grandmothers house.  He was given 2 Aleve tablets and a cold compress. Later on that evening he was given two 200 mg Ibuprofen.  On the following day,  Mom repotted that he still had pain and fever.  He was referred to the  emergency department for evaluation and treatment
Injection site bump; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (Injection site bump) and INJECTION SITE PAIN (Soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No medical history was provided by reporter.  No concomitant medication reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced INJECTION SITE NODULE (Injection site bump) and INJECTION SITE PAIN (Soreness). At the time of the report, INJECTION SITE NODULE (Injection site bump) and INJECTION SITE PAIN (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medication not provided. Treatment medication not provided.    Reporter did not allow further contact
Injection site redness,erythema,and pruritus, induration of the area, about  one inch on the upper part of the lesion. Treatment: Cephalexin 500mg course given for 7 days.
Pt recv vax on 12/29/98; on same day pt exp aching joints, felt feverish (98.4F); tx=Aspirin
9/10/2013 Phone message on Immunization phone from mom after hours last night. Returned call and she asked to call me back when she was not at work. Information was supplied by mother patient is in school. 9/12/13 Mom called back to file the report and told us the following information: 8/21/13 Patient came into clinic for meningococcal vaccine prior go going to college. MENVEO was given on that day and client went home with no problem for 18 days. 9/8/2013 Patient got ready for church that morning feeling dizzy and complained of her eyes spinning around in her head. After arriving at church she was lurching to the left, left eye was twitching and pupil was small with the right pupil large. She was taken to the Emergency Department. There they evaluated her eyes. It ws hard for her to open her eyes because it felt like things were moving. An MRI was done and did not show anything. The discharge diagnosis was Right Ocular Motor Nerve Palsy. She was sent on prednisone 80 mg and after taking the prednisone the first day all signs had gone away by evening but returned again the next day. She was evaluated by an Ophthalmologist and a Neurologist after which she was to see a Neurologist after which she was to see a Neuro-ophthalmologist. While still on the prednisone, she saw the ophthalmologist and both eyes were tracking. When they saw the Neurologist and right eye wouldn't move past midline. She has set up an appointment with the Neuro-ophthalmologist  on Wednesday 9/18/13. Talked with mom about this not being a usual reaction to the meningococcal vaccine but mom had read on the internet that this could be caused by vaccine. I talked with immunization department and they talked with CDC and to their knowledge nothing like this had occurred after meningococcal vaccine. Mom requested the VAERS report be filed. 10/15/13 Phone call to mom re: the outcome of the Neuro-ophthalmologist and she reported that they had not kept that appointment because the symptoms had gone away. Patient was seeing fine and has no further symptoms. Mom asked again that the report be filed with VAERS and I assured her that I would file it for her.
Patient develop paresthesia in hands within 5 minutes of administration, which then led to widespread itching about 10 minutes post administration. Patient also develop intermittent and widespread erythema. Patient took diphenhydramine 50mg at 8:09pm, was administered epinephrine at 8:47pm, EMS arrived at 8:55pm. Patient was advised to go to the hospital, patient declined. Advised to take diphenhydramine at scheduled intervals to continue treating itching and erythema.
This spontaneous prospective pregnancy report was received from a Registered Nurse (RN) referring to an 18 year old female patient with no concurrent conditions. The patient's medical history included leukaemia. On 05-JUL-2017 and 05-SEP-2017, the patient was vaccinated with the first and second doses, respectively, of GARDASIL 9 lot number M035486 (expiration date of 05-JUN-2019) for prophylaxis (strength, dose, and route of administration were not provided). There was no information on concomitant medications. On an unspecified day in 2017, the patient became pregnant (confirmed by a positive ultrasound test performed on 21-SEP-2017). The patient's last menstrual period (LMP) was reported as on 25-SEP-2017. The patient's estimated delivery date (EDD) was on 04-JUL-2018. Neither the pregnancy outcome nor the fetal outcome were known at the time of the report. The therapy was taken before the patient became pregnant.
rash is noted on the face ( forehead , periorbital region , cheeks , perioral region , and chin ) , on the chest , and across the abdomen ; ; the color is mainly pink ; ; it is best characterized as papular and urticarial ; ;
Initial report received on 31 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 16-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3613AA received on 19 May 2011, C3686AA received on 14 July 2011 and C3913AB received on 06 September 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 20 July 2012, approximately 10 months after the last dose. On 23 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 23 July 2012. Chest x-ray findings were unknown. Corrective treatment consisted of azithromycin starting on 24 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
-> Injection site did not  bleed initially. Approx 1-2 min after administration the site began to bleed. -> The site began to swell. -> Pt asked to stay a little longer for observation - refused. -> Pt asked if she wanted some BENADRYL - refused. -> When I called her a few days later to f/u pt complained of lot of bruising. -> Pt stopped in about 7-10d later & showed me injection site. Bruise was v. yellow & diffuse told pt. it appeared to be in late stages of healing. Told her it probably would be resolved in a few days. No swelling or anything else observed.
A report has been received from a Health Professional concerning a 49 year old, female patient, who had been receiving FLUMIST QUADRIVALENT.  FLUMIST QUADRIVALENT started on an unknown  date. It was reported that inadvertently administered FLUMIST QUADRIVALENT to 2 patients over the age of 49 which started on 01-OCT-2014. The outcome of the event  of inadvertent administration of FLUMIST QUADRIVALENT to patient over 49 years of age is unknown. The report was considered to be non-serious.
seen in ER 6JUL for inc swelling, redness, difficulty moving arm; red line from lt deltoid to above lt calvicle; given 2 doses of Keflex in ER
Patient received Pfizer COVID vaccine on 3/26/21 (lot # EP6955), 4/16/21 (lot # ER8731), and 9/30/21 (lot # FF8839). On 1/12/22, patient tested positive for COVID. On 1/25/22, patient admitted to our inpatient facility with AKI on CKD (s/p renal transplant x2) and COVID pneumonia. As of today (1/27/22), patient is still admitted in the med/surg unit.
vaccine administered 15 days after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 15 days after first puncture) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 15 days after first puncture). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 15 days after first puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
inappropriate schedule of vaccine administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved.            No concomitant information was provided by the reporter.  No treatment information was provided.
First dose in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   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. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021218228, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218228:same reporter
Received flu shot (dose 2; 1st dose 10/13/2004: no problems) in AM 11/11/04. Fine all day until 6pm. Became quieter than usual. Temp 102 degrees R. No appetite. Injection site slightly swollen. No redness, no warmth. Not hard. Tylenol given 9:00p T 103 R. Mom called doctor. Additional Tylenol and Children's Advil given. No runny nose and cough. Not pulling at . No vomiting or diarrhea. 103 degree temp  99R. 11/12/2004 early am. T101 degrees R by that pm, acting fine, fever gone. 11/15/04 fine. No fever.
Good Afternoon:  Per the instructions on the back of my Covid Vaccination Record I am advising you of a severe reaction I had to a recent vaccination. On Sunday, February 7, I had my second shot at the clinic. It was a Moderna vaccine. I was injected at 11:00am. I immediately had a very sore arm but no further symptoms until later Sunday evening. I began to feel nauseous and a headache. By early morning I had a severe headache, fever of 103.0 degrees, severe nausea and had a very severe rash that broke out from the injection site down my arm. All this was accompanied by extreme fatigue. the only medication I took was Tylenol during the day. The symptoms lasted all of Monday. Monday night the symptoms began to diminish and by Tuesday morning all but gone other than fatigue. Today, Wednesday I am feeling fine other than slight fatigue.
Rash 20-30 mild papules arms legs, face, trunk. Low grade fever, 2 wks after vaccine given.
Fatigue night of, chills/feverish through the night & through late afternoon the next day, fatigue through 2nd day after
Burning at injection site near bone.  No loss of mobility, denies numbness or tingling.
Information has been received from a pharmacist concerning an adult patient who on approximately 11/07/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649111/0287P or 649076/0213P).  Subsequently the patient experienced local reaction at injection site, soreness, warmth, erythema, swelling, induration, cellulitis-like reaction.  Unspecified medical attention was sought.  At the time of the report it was noted that the patient was recovering.  Additional information has been requested.
Severe flu symptoms, including high fever, vomiting, nausea, chills, aches, etc.
One week after I received the shot, 2 round spots, approximately 1/4" round, showed up below the injection site.   As each day went by, the redness came together to form a larger area.    Exactly 2 weeks after the shot, I had a 6" x 5" bright red area just above my elbow, and it was very itchy.   I started to ice it for relief and used Benadryl cream for the itch, to no avail.   Went back to the pharmacy & saw the head pharmacist.   I showed the rash to him.  He suggested I use hydrocortisone cream.  I used that for a couple of days, but it didn't stop the itch.   On 2/26 I called my doctor's office & spoke to a doctor there.   I described what I had.   We both determined that it was most likely a side effect from the Covid vaccine shot.   I was concerned because I'm due for the 2nd shot on March 12, and I want my arm healed.   The doctor prescribed an oral antihistamine for 10 days, if needed.    I started on that 2/26,  once a day and continue to ice the area.   The rash has just about stopped itching.   The area is still the same size as of today.   I'm hoping to see that start to lessen.
Coughing up phlegm with blood present.  Started on Antibiotic on March 31.  Culture taken on March 31.  Antibiotic changed on April 5 or 6 due to culture results.  did not feel well and began having breathing problems the evening on April 7.  Went to the emergency department on the morning of April 8 and admitted to hospital.  Diagnosed with pneumonia.  Leased from hospital on April 13