chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reactions or allergies, concurrent conditions and concomitant therapies were not reported. On 29-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. Lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 88 hours with a lowest recorded temperature of 33 Fahrenheit (F) (0.555555556 Celsius (C)) and other one of 84 hours with a lowest recorded temperature of 34 F (1.111111111 C) and 16 hours at temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L016428, expiry date 30-JUL-2017; dose and route of administration were not reported). The doses were stored under the temperature of 50F for 35 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tested positive for the COVID-19 virus; Tested positive for the COVID-19 virus; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable male consumer (patient) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, NDC#, UPC#, LOT# and expiration date: unknown) via an unspecified route of administration on 21Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Apr2021, the patient tested positive for the covid-19 virus. The patient underwent lab tests and procedures which included covid-19 virus: positive on 03Apr2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Pt received 4 mo immunization on 12/11/19, less than 12 hours later began having bloody diarrhea. Had 2 bloody stools total. No vomit. No fever. Not ill otherwise. Then stools returned to normal.
Gastrointestinal distress, upset stomach, acid reflux, heartburn, diarrhea
Initial unsolicited report received from pharmacist on 22 Nov 2017. This case involves a female patient who is in her early 60s and was vaccinated with 0.5 ml dose of FLUZONE QIV (Frequency: once, batch number, expiry date and site of administration were not reported) intramuscularly on an unspecified date. The patient was undergoing chemotherapy. Concomitant medication was not reported. On an unspecified date, post vaccination, within 3 weeks she was admitted to the hospital with an active case of Influenza. Patient had to be hospitalized due to the severity of her symptoms. Other hospitalization details were not provided. Laboratory investigation and corrective treatment were not reported. Patient was recovering from event. List of documents held by sender: none. Sender's Comments: The patient experienced influenza post vaccination with FLUZONE QIV. Time to onset was compatible i.e. within three weeks but exact latency was not known. Patient was undergoing chemotherapy for an undisclosed condition. there was no information reported regarding the strain of influenza There could be an alternate etiology responsible for the event. Additional information regarding lap tests including PCR/serology should be obtained along with patients medical history, ongoing medical condition and status of immunity. Based upon reported information the role fo the vaccine can not be assessed.
I started to get chest pains 4 days after receiving my 2nd dose of the vaccine.  I went to immediate care and they thought I had Pleurisy.  The pains did not improve and kept getting worse.  I went to my regular doctor and then had a stress test done.  My heart was fine but I had imflamation in my chest walls.  The doctor said it was either pericarditis or costochondritis.  She put me on Naproxen for 5 days.  This seemed to help some but had to come off of it due to it causing issues with my Kidneys as I am stage 3 kidney disease.  I am still having chest pains but they are getting better daily.
tested positive yesterday; This is a spontaneous report. A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got symptoms last Monday, 05Apr2021, and tested positive yesterday, 07Apr2021 for Covid-19. She would like to know whether she should proceed with her second dose appointment which was why she was calling. Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
cellulitis tx w/ATB; pt exp stiff lt arm;pain in area, flu type sx;flushing, itching, urticaria, local gen, dyspnea, n/v, nasal ocular sx, dizziness;
Rash on upper left arm in AM on 10/28/13, rash also on R thigh and R arm on Nov. 1 in Am. Rash and swelling moving to entire left arm and hand on Nov. 4th advised by nurse to take Allegra and use calamine lotion. Developed fever on Nov. 13. Nurse advised to go to ER. Blood drawn and WBC was elevated. I was given Benadryl and corticosteroid. Also give 1 liter NaCl via IV, for elevated HR.
stroke; blood clots on her legs, lungs and head; blood clots on her legs, lungs and head; blood clots on her legs, lungs and head; This is a spontaneous report from a contactable consumer (patient son). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history was none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as 1st dose on 10Mar2021 for Covid-19 immunization. After having the first dose she told him that she could not make a whole 20 minute walk as she used to, she could for 10 minutes as she felt tired. She presented a consistent cough, that was not "bad". The patient's concomitant medications were not reported. Caller stated that he would like to consult about side effects of the Pfizer Covid-19 vaccine that may have caused his mother to be passing away right now. Stated that they both received the first dose on 10Mar2021 and the second dose on 31Mar2021. A month and a week later she went to her sister's house and this Tuesday he received a phone call where they stated that she had a stroke due to blood clots on her legs, lungs and head. They just left the hospital and the nurse stated that she could have hours or a couple of days left. He would like to consult if there are any reports of these side effects. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021568883 same patient, different dose/events
Right side of neck-back painful bump, two days later second painful bump appeared bethind left ear plus low-grade fever, Saturday 10/05 upper chest and back rash appeared, fever continued.  Went to clinic Saturday, started on medication - Allegra. Sunday rash was all over face and body.
patient tested + for covid on  2-12-22 and was asx on the date of testing and was resident of Geriatric Center. He presented to ER with acute MI on 2-17-22 and was unresponsive and had a cardiac arrest.  initially started on levophed for hypotension , made comfort care and DNR by POA.  He deceased on 2-17-22
Patient  under the age 18 when received her 1st and 2nd doses of Moderna COVID vaccine.  No reported reactions reported to this agency.
hives-started from the neck and ear before spreading to the upper body, followed by the rest of the body.; rash-started from the neck and ear before spreading to the upper body, followed by the rest of the body.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) and RASH (rash-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 007M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced URTICARIA (hives-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) and RASH (rash-started from the neck and ear before spreading to the upper body, followed by the rest of the body.). The patient was treated with PREDNISONE in 2021 for Adverse event, at an unspecified dose and frequency; FAMOTIDINE in 2021 for Adverse event, at an unspecified dose and frequency; HYDROXYZINE in 2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) in 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) and RASH (rash-started from the neck and ear before spreading to the upper body, followed by the rest of the body.) had not resolved.            Prior to the vaccination, patient  was not on any routine medication  Treatment medication provides 3 to 4 hours of relief  Treatment medication Benadryl interchanged with hydroxyzine  Patient went to urgent care twice(25/26 NOV 2021)  and to primary physician once(29 NOV 2021)  Patient  is planning to see an allergist.
I was working outdoors and was stung  by a bee.  Normally,  the site of the sting will swell up a little and be itchy.  This time, within 15 minutes I was breaking out in hives and feeling woozy as well as having my ears, throat and tongue swell up.  My heart beat was very rapid and I managed to lie down on the ground in the shade and not pass out.   Luckily my breathing was okay  and once I felt less woozy,  I went to my truck and took and Advil ( the only medication I had with me) and poured my iced drinking water on a bandana which I applied the back of my neck . Then I simply sat down on some steps in the shade with my head down for about an hour.  When I felt well enough to drive, I bought Benedryl and went home for a nap . I had another Benedryl, some food and went to bed.   I feel very lucky that this reaction was not worse.  I was just very surprised at having such a reaction to a bee sting and felt very tired and muzzy for several hours. I should be clear and state that this is the 5th bee sting that I have received in the last 12 yrs.  I work as a gardener and I realize that as I am older, my immune system may have developed a much stronger allergic reaction to bee stings.   But I do not have any other health issues and I exercise and am in fairly good shape.    I am just wondering if  it  just a coincidence that I recently had my first Covid shot.? Or not?
Warmth, redness, swelling, discomfort. Treatment at this time Ibuprofen, ice, call tomorrow if larger.
Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Client given vaccination of NS instead of Covid 19 vaccination. Client notified of error. Encouraged to return to clinic for re vaccination. Which she did on April 24, 2021. E 8736  exp date 7/31/2021
Itchy; Severe rash, arms and back; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 13:15 (Lot number: FF8839) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: kiwi" (unspecified if ongoing), notes: known allergies: kiwi. There were no concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Itchy"; RASH (non-serious) with onset 01Dec2021, outcome "not recovered", described as "Severe rash, arms and back". Therapeutic measures were not taken as a result of pruritus, rash.   Additional information included: After getting the Covid 19 vaccine, the patient started to develop a severe rash and her arms and back. On 08Dec, the patient had still itchy every and the rash had not gone away. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Joint pain in arm; Swelling near the injection site on her upper arm; Pain near the injection site on her upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling near the injection site on her upper arm), VACCINATION SITE PAIN (Pain near the injection site on her upper arm) and ARTHRALGIA (Joint pain in arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02FL20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling near the injection site on her upper arm) and VACCINATION SITE PAIN (Pain near the injection site on her upper arm). On 07-Jan-2021, the patient experienced ARTHRALGIA (Joint pain in arm). At the time of the report, VACCINATION SITE SWELLING (Swelling near the injection site on her upper arm) was resolving and VACCINATION SITE PAIN (Pain near the injection site on her upper arm) and ARTHRALGIA (Joint pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Red, Itchy, Sore arm at  vaccine site  Headache Fever Chills Nausea Joint pain
tested positive after receiving the Covid-19 vaccine; tested positive after receiving the Covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. This case refers to the first of three employees tested positive for Covid-19 after receiving the vaccine.  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL0140, expiry date Mar2021), via an unspecified route of administration, on 05Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 51-years-old. Medical history and concomitant medications were unknown. The patient was tested on 08Jan2021. She received the results on 12Jan2021 and tested positive after receiving the Covid-19 vaccine. She is asymptomatic. It hasn't affected her but she has not been able to work. The event was reported serious as medically significant. Outcome was unknown. She states she was asking about getting 2nd vaccine.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported tested positive based on the known safety profile. However the short duration of 3 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Chest Pain, Myopericarditis; From EPIC: From cardiologist healthy man who comes to the ER with left anterior chest discomfort for the last 36 hours or so.  Symptoms are made worse by deep inspiration.  Were improved following self administration of 600 mg of ibuprofen earlier today.  2 days ago he received his second COVID-19 vaccine (Pfizer).  Following day he experienced arm pain muscular aches and pains severe discomfort of the right arm (injection site) later in the day there was nausea and vomiting on one occasion (nonheme).  By last night he was able to eat dinner but subsequently felt short of breath with worsening chest discomfort morning the left arm continued to ache with musculoskeletal pains.  Developed more discomfort in the left anterior chest radiating to the throat made worse by deep inspiration. Does not describe typical sharp catching pain of pericarditis.  No cough sputum bruising bleeding abdominal pain change in color or character of bowels.  Sign in the emergency room he was hemodynamically stable, in sinus rhythm with a normal EKG.Torrey work-up notable for an initial troponin of 1.28 and a follow-up troponin of 2.14. Chest x-ray perfectly normal. Elevated d-dimer. CT angiography negative for pulmonary embolism vascular injury, cardiomegaly, pericardial effusion but the radiologist did note thickening of several right posterior and lateral axillary lymph nodes raising a question of recent right-sided vaccination or injury/infection to the right arm. Presently he is perfectly comfortable able to take a deep inspiration with mild chest discomfort, breathing easily.  I met him in July 2018He came to the emergency room with a 3-day viral syndrome manifested as headache nausea vomiting diarrhea and abdominal discomfort and then developed chest discomfort.  He was found with diffuse mild J-point elevation on EKG consistent with a viral type pericarditis with troponins which rose to a maximum of 10.4.  Work-up for myocarditis was negative.  Echocardiogram perfectly normal.  Symptoms responded to a course of nonsteroidal anti-inflammatory agents and colchicine.  Seen in follow-up of repeat echocardiogram was perfectly healthy.  Our diagnosis was myopericarditis. There is no history of shortness of breath dyspnea on exertion decrement of exercise capacity peripheral edema orthopnea PND palpitations lightheadedness syncope or collapse.  No ill contacts.  He works in a high security position and therefore qualified for early administration of the Pfizer COVID-19 vaccine.  Graph past medical history notable only for the episode of myopericarditis and a remote tonsillectomy. There is no significant family history of sudden cardiac death or unusual heart disease. He takes no medications. Patient was recommended to take 4 weeks of ibuprofen and colchicine if needed for worsening chest pain.  Patient was recommended to follow-up closely with his primary care doctor and check ESR, C-reactive protein as well as renal function.  Needs close follow-up with cardiology as an outpatient.
Started with a high fever of 102.9, body aches, chills, fatigue. I had a severe headache that lasted for about 2 weeks.  On 9/3/21 I started with severe stomach pains that lasted for about 12 hours, I went to the ER and had a CT scan and ultrasound done, both came back normal. I had stomach pains on and off for the following week and a half to two weeks after.  I found out after the fact that the vaccine came cause stomach pains for up to 3 weeks after the fact. Starting 9/5/2021 I had a rash that appeared, it was a full body rash and was very itchy and uncomfortable. I was told it was unsure if related to the vaccine or not. Rash went away by 9/9/2021.
Patient stated: "her left armpit area hurts & it hurts to bring the arm up, she has a rash of 1.5 to 2 inches in circumference and another circle circling that , the rash are is red and warm, and she feels really sleepy"  -- I counseled to take pain reliever, anti-itch medication & perhaps a applying cold compress over clothing covered rash area. I also urged if still not better by mon 2/24/14 to give her PCP a call for a consult.
drowsy; sharp pain for 2 seconds; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (drowsy), PAIN (sharp pain for 2 seconds), PYREXIA (fever) and HEADACHE (headache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21 and 088D214) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced SOMNOLENCE (drowsy), PAIN (sharp pain for 2 seconds), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (drowsy), PAIN (sharp pain for 2 seconds), PYREXIA (fever) and HEADACHE (headache) was resolving.            No relevant concomitant medications were reported.
Day of injection: sore arm (to be expected), nausea,.  Next day, Saturday, left arm very red, itchy, swollen, warm to touch.  Headaches, loss of appetite.  Day 3: Sunday: left arm very swollen, very red, very warm to touch, left arm hurts.  Feel like fluids have built up on arm.  Headache.  Fatigued a bit.