chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/4 morning, developed localized intense pruritis and hives to posterior scalp and posterior neck, with associated edema. About 6 hours later developed patches of hives to R hip, back, and legs. On 2/5, had purplish erythematous patches tender to touch, L wrist swelling and tenderness, bilateral knee pain, and worsening urticaria to buttocks, thighs, and legs.
Extreme pain radiating from injection site on upper arm up to neck my neck and down to my fingures.
light period roughly 3 weeks before I would have expected one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 12:00 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "PCOS" (unspecified if ongoing), notes: PCOS but consistently controlled for 10 years with weight loss and metformin; "weight loss" (unspecified if ongoing), notes: PCOS but consistently controlled for 10 years with weight loss and metformin. No COVID prior vaccination. No known allergies. Concomitant medication(s)/Other medications in two weeks included: LEVOTHYROXINE; METFORMIN; SPIRONOLACTONE. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (brand= Pfizer, Administration time= 04:00 pm, location= Left arm, Dose 1, had a heavier than usual period two weeks early), administration date: 29Mar2021, when the patient was 39 years old, for Covid-19 Immunization, reaction(s): "After dose 1, patient had a heavier than usual period two weeks early. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 20Apr2021, outcome "unknown", described as "light period roughly 3 weeks before I would have expected one". Therapeutic measures were not taken as a result of menstrual disorder. Additional information: Both doses affected her menstrual cycle. The day after dose 2, patient had a light period roughly 3 weeks before she would have expected one. Facility type vaccine: Hospital. COVID not tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pressure in Lungs; m I've been very ill; bad taste in mouth; loss of appetite; Phlegm; fell asleep for 5-6 hours; Sore Arm; Fever of 100.6; Severe headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Pressure in Lungs), MALAISE (m I've been very ill), DYSGEUSIA (bad taste in mouth), DECREASED APPETITE (loss of appetite) and PRODUCTIVE COUGH (Phlegm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Nerve damage. Concomitant products included GABAPENTIN and MORPHINE for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Pressure in Lungs), MALAISE (m I've been very ill), DYSGEUSIA (bad taste in mouth), DECREASED APPETITE (loss of appetite), PRODUCTIVE COUGH (Phlegm), SOMNOLENCE (fell asleep for 5-6 hours), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 100.6) and HEADACHE (Severe headache). At the time of the report, CHEST DISCOMFORT (Pressure in Lungs), MALAISE (m I've been very ill), DYSGEUSIA (bad taste in mouth), DECREASED APPETITE (loss of appetite), PRODUCTIVE COUGH (Phlegm), SOMNOLENCE (fell asleep for 5-6 hours), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 100.6) and HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2021: No specific follow-up information recorded.; Reporter'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.
Pt stated that 12 hrs after she received her first dose of Moderna vaccine, she experienced some side effects i.e., fever ,chills, nausea, dizzy. Seh said she passed out cold. The side effects lasted about 24-48hrs. She is feeling much better today.
pt recvd vax;red eyes,retrobulbar pressure in face & teeth,sore throat,HA & chills w/in 2hrs of inject;given epi & dph;watched for 2 hrs;was shaky w/ red sclera;took apap & covered w/ blanket which helped HA & fever;
09/03/21 The patient presents with 73 year old male with history of HTN and DM presents via EMS with malaise, fatigue, cough, occasional chest pain, and mild shortness of breath.Patient was diagnosed with COVID-19 x10 days ago. Patient informs he was seen by PCP earlier this week, he was prescribed ABX and steroids, he received Regeneron on 09/02. Sts he was seen by his PCP today and given a shot but unsure what it was. Wife informs the patient has a DNI and DNR but she does not have a hardcopy of the documents at this time, she sts the patient's PCP will call the ED with additional information. .  The onset was 10  days ago.
Fatigue; Arm pain; Fever - Temperature of 100.4F; Arm pain; A spontaneous report was received from a Consumer concerning her husband  67 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Fatigue,Injection site pain and Pyrexia.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 16-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 13-Feb-2021, the patient received second of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 17-Jan-2021, The patient experienced the event arm pain and on 14-Feb-2021 the patient experienced the events Fatigue,Injection site pain and Fever - Temperature of 100.4F.     Laboratory details was not  provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 17-JAN-2021, the outcome of the event Arm pain was recoverd/resolved and on 14-FEB-2021 the outcome of the events Fatigue was recoverd/resolved,Injection site pain was recoverd/resolved and Fever - Temperature of 100.4F was recoverd/resolved    The reporter assessed the events arm pain, Fatigue,Injection site pain and Fever - Temperature of 100.4F related to study drug is unknown.
Very sore/painful and hard at the arm. Very red. Felt like heat coming from the injection site.
pt states that the next day she had low grade fever, fatigue, nausea and malaise.   Pt had incontinence, diarrhea and fever never broke.  Pt contacted her PCP and he suggested she may have Covid so she got tested.  The results were negative.  Pt ended up getting worse so contacted her PCP and she was told to the ER hospital to get labs drawn, test for Covid again which was negative.  Fever was 102.3.  Chest XRAY showed she Pneumonia. Pt was admitted to hospital where she was given antibiotics and fluids.  She went into respiratory failure and her Pneumonia turned into bilateral infection.  She was unable eat and diarrhea.  After 5th day her fever broke and was released on the 6th day.  She was on O2 for two weeks after going home. On 3/8/2021 Pt is better now but still tired.
Caller got his 1st Covid dose and then got Covid right after; Caller got his 1st Covid dose and then got Covid right after; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient got his 1st Covid dose and then got Covid right after. They had to do an antibody infusion so he wants to know what effect that will have. The outcome of event was unknown.   Information on the lot/batch number has been requested.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On unknown dates, the patients might have received doses of improperly stored ZOSTAVAX injection, lot # M037014 with expiration date on 22-NOV-2018 and lot # M035149 with expiration date on 31-OCT-2017 (doses and route of administration were not reported). The administered doses of vaccines were reconstituted with sterile diluent (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 10 minutes and also an excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit, which lasted for 4 hours 40 minutes. Administered doses underwent previous temperature excursions: an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 2 hours and an excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit, which lasted for 1 hour 30 minutes. A digital data logger was involved in recording the excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA011480: US-009507513-1706USA008591.
Migraine, fever of 102, spreading rash and lump farther down on the arm from the injection site, chills, confusion/mental fog
hypokalemia; heart started pounding hard/diagnosed with heart palpitations and hypokalemia; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9262), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. Medical history included preexisting cardiac issues, she has heart arrhythmia, PAC's and PVC's (all ongoing). The patient's concomitant medications were not reported. On 01Feb2021, later that night (about 12 hours after vaccination), patient's heart started pounding hard. She stated that she has preexisting cardiac issues, she has heart arrhythmia and also has PAC's and PVC's. This is what she used to experience years ago before she was treated with medication. During event on 01Feb2021, EMT that came did EKG at the house, they were concerned about what was seen and patient was taken to Emergency Department and was given some medication to slow her heart rate down. Her EKG was "very erratic" and she was given Cardizem which resolved the issue quickly and was also given some Potassium chloride. Troponins and labs drawn on 01Feb2021. The patient was diagnosed with heart palpitations and hypokalemia. She received new cardiac home medications to take and referral to see Cardiologist next week. The patient was wondering if these were side effects from vaccine. Outcome of the events was unknown. The patient was hospitalized for the events.
pt had sz-entire body shaking-eyes closed-lasted 15-20 sec;felt hot @ time;mom did give motrin & wiped w/cool cloth p/episode;to ER T102.2;MD found lt ear & throat sl red;started ATB;had fever 100;
Tested positive on COVID after received two doses of Pfizer COVID vaccine; Tested positive on COVID after received two doses of Pfizer COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Sep2021 (Lot number: 301308A) at the age of 29 years as dose 2, single and intramuscular, administered in arm left, administration date 24Aug2021 (Lot number: FE3181) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant, life threatening), COVID-19 (medically significant, life threatening) all with onset 02Jan2022, outcome "not recovered" and all described as "Tested positive on COVID after received two doses of Pfizer COVID vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) positive; (03Aug2021) negative, notes: Nasal Swab; (30Aug2021) negative, notes: Nasal Swab; (29Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Dayquil, nyquil, tylenol, emergen-C, mucinex, sore throat menthol candies, traditional medicine for the events. The patient did not receive any other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The adverse events resulted in life threatening illness (immediate risk of death from the event).  No follow-up attempts are possible. No further information is expected.
Presented @ clinic 5 days p/vax w/swollen, tender-1.5 x 1.5cm mass deep @ site of inject (lt thigh); poss sterile abscess; rx meds;
2/23/21 1 week after my first dose, I started getting a pimply rash on my lower back.  Since then the rash has moved to my front torso, then my legs and arms.  Today it is pretty much all over.   I'm a little concerned because I've had the Zika virus and the shingles virus.  I've tried taking Benandryl which helps a little.
On 2/12/2021, had post-injection symptoms of joint pain, cold sweats and dizziness On 2/19/2021, she noticed injection site was red and raised then became "big, red and swollen" with 3 "bumps" noted. Was seen at Health Center on 2/20/21 and was diagnosed with cellulitis, prescribed Keflex and Claritin. Was seen by this provider on 2/24/21 for follow up and she states that initial red area surrounding the injection site is improved, however, a large red ring is present. Also C/O an additional irregularly shaped red area distal to initial red area surrounding injection site. No infection noted. Instructed to continue Claritin and add Pepcid 20mg daily to help alleviate the histamine reaction occuring. Denies shortness of breath, sore throat, facial/lip/tongue swelling.
On 02/15/2001 the patient developed and was diagnosed with chicken pox. The patient had 75 lesions located on her trunk and vaginal area. The patient complained of a sore throat. Additional information has been requested.
got sick; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient) via social media.  This case involves a 26-year-old patient of unknown gender, who got sick (illness), while being vaccinated with INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient got sick (illness). The patient would never take again and a also covid vaccination and already have a treatment that worked.   No laboratory data was reported.  It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Site: Pain at Injection Site-Medium, Additional Details: pt said had heavy feeling in arm after got it and it progessively hurt more- was concerned that vaccine was "stuck in there" said mobility was starting to be affected
On day 23 post vaccine I began with mild influenza like symptoms including aches, chills, sweats, general malaise and mild sore throat.  Within the next 24 hours a raging gingivitis and swollen submandibular lymph nodes followed.  No cough, chest congestion.   .         At this time my flu like symptoms remain at gradually reducing levels - mostly resolved.  My gingivitis symptoms also re reducing but it is still very painful to attempt brushing my teeth.
This spontaneous case was reported by a patient and describes the occurrence of NEAR DEATH EXPERIENCE (nearly died/nearly took my life) and AUTOIMMUNE DISORDER (several issues with my autoimmune system) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (nearly died/nearly took my life) (seriousness criteria hospitalization and medically significant) and AUTOIMMUNE DISORDER (several issues with my autoimmune system) (seriousness criteria hospitalization and medically significant). At the time of the report, NEAR DEATH EXPERIENCE (nearly died/nearly took my life) and AUTOIMMUNE DISORDER (several issues with my autoimmune system) outcome was unknown. Concomitant medication list was not provided. The patient had several hospitalizations. Patient was also seeking medical compensation. Patient only took two doses and refuses to take more. Patient had not been able to find work because they are requiring vaccinations, but patient was refusing to be re-vaccinated. Treatment information was not provided. Company comment: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant and hospitalization) events of Near death experience (reported as nearly died/nearly took my life) and Autoimmune disorder after receiving the mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset dates of events were not provided. It was reported that patient had received only two doses of vaccines. Patient reported that she nearly died and had several hospitalizations. Clinical course and treatment details were not reported. The outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement. Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant and hospitalization) events of Near death experience (reported as nearly died/nearly took my life) and Autoimmune disorder after receiving the mRNA-1273 vaccine. Onset latency could not be determined as date of vaccination and onset dates of events were not provided. It was reported that patient had received only two doses of vaccines. Patient reported that she nearly died and had several hospitalizations. Clinical course and treatment details were not reported. The outcome of events was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.
Patient is a 46 y.o. female that presented to the emergency department on 9/8/2021 for evaluation of continuous, severe dyspnea, cough, fever since first diagnosed with COVID 15 days ago. The patient noticed her oxygen saturation was in the low 80s for the past few days.  The patient was admitted with acute respiratory failure secondary to bilateral COVID pneumonia. Sepsis was present on the day after admission. She was started on Decadron, multivitamins and Pepcid. Pulmonary was consulted. She had rapid improvement of her hypoxia. She continued to have fevers while here and was monitored. Her procalcitonin was low at the time of discharge and she did not require oxygen. Pulmonary recommended continuing Decadron for total of 10 days given her immunosuppression from MS.
Abdominal aortic aneurysm - Endovascular abdominal aortic aneurysm repair via bilateral open femoral access. Discharged to home. Hospital admission was within 6 weeks of receiving the COVID vaccine.
State she had a fever that night 3/8/16 of 103. Site is hot, red, and swollen. States she is taking amoxicillin for another condition. Has been taking Ibuprofen and doing warm compresses. Declined to see MD at this time. Was given flu shot in (R) arm that day with no issues.
Patient felt light headed and needed to sit down, she said her tongue we itchy, paramedics were called, Breathing  was fine, Pulse was fine, blood pressure was fine, paramedics thing patient had anxiety
high fever @ noc, no sense of smell, nose stopped up, nose bleed-rash on rt side. Joints aching, primarily @ noc, joints sore in legs & back (legs cold circulation probs)
shingles; I got the shot years ago; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR139470   Additional Information: GSK receipt date :22-SEP-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient had shingles shot years ago and he/she currently had shingles. The patient stated get the shot immediately. He/she put it off to received the flu shot and it was bad choice. Additional Supportive information:Till the time of reporting, the patient did not receive 2nd dose of Shingle vaccine which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022AMR139470:Same Reporter
Fever and chills Fatigue Muscle and body aches Headache Diarrhea
Approx, 8 hrs after vaccine, c/o chills intil 0100 9-24-15; then 90 min, later c/o very hot and sweaty (profuse); no vomiting c/o bad tast in mouth the entire time; Headache-severe. Fever comes and goes (chill/fever).
Feeling tired; Feeling dizzy; Arm tingling moving towards patient's back. Patient feeling "shocks" in arms and legs.