chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of two reports. A 70-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, he had his first shot on 03Feb2021 and scheduled for the second one on 25Feb2021. After a day, he kind of got sick for a whole week. He run a test, and came out to be positive, that was after one week of the shot. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021211673 same reporter, product and AE, different patient
This spontaneous report was received from a nurse concerning an unknown number of patients of unknown age and gender. There was no information about the patients concurrent conditions, medical history or concomitant medication. On an unknown date the patients received PROQUAD and VARIVAX following a temperature excursion (indication and doses were not reported). Temperature variables reported: 6F to 14F(-14C to -10C) (6F) for 96 hours. Previous temperature excursion 6F to 14F (-14C to-10C) (6F) for another 96 hours. No adverse effects were reported in any patients. No other information is available. This case was considered to be non-valid due to the lack of patients identifiers.
Several hrs after Tdap booster pt developed aching, pain & tingling in vaccinated arm.
bones hurt, chills, migraine and throwing up for 2 days. Then only mild Headache for 2 more days. 1 week out still don't feel as good as before the shot.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. The medical assistant reported that an unspecified number of doses of ROTATEQ (lot # L027070, expiration date: 30-APR-2017, dose was not reported, orally) were administered to the patients on unknown dates following a temperature excursion of 32.9F for 22 hours and 17 minutes. No adverse effects were reported for any patients receiving doses. This is one of three reports received from the same source. Additional information has been requested.
Fever started on 5/24/16 and has continued to date.  She got a mild rash on her face and neck that started on 5/25/16.  The rash has spread to her entire body today, and appears to be itchy.  The doctor's office advised us to give her Benadryl, which we just started, and that we'll need to bring her in for a check up if any of the symptoms last more than 72 hours.
March 1 the day of vaccine my arm had pain and itchy at injection site. March 2 my arm red and itchy site of injection. March 3 my arm a little more red and itchy at site of injection. March 4 the red area a little bigger and itchy.  This is my second shot. the first shot this did not happen till a week after shot. I had the same symptoms after first shot but they were delayed a week and this time it stated within hours.
Pt. stated his arm started hurting really bad a couple of days after vax.  He said pain moved into all of his joints and had 101 temp. He said he is aching, burning and hurting really bad.  Pt went to the Hospital ER on 1/26/21 and again on 1/27/21 with these symptoms.  He was given a drip w/ medication and released.  Pt will FU w/ his PCP.  Pt says he is still having severe right arm pain.
Large reddened area around injection site of left thigh. Dx: early cellulitis.
BODY ACHES; LOSS OF APPETITE; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a 52 year old female. The patient's weight was 54.5 kilograms, and height was not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no illicit usage of drugs. The patient experienced drug allergy when treated with diazepam.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 11:30 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced loss of appetite. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, body aches, fever and loss of appetite was not reported. This report was non-serious.
sick; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a social media via consumer or non-health care professional.  This case involves patient with unknown demographics who experienced sick (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  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 vaccine.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for illness.  There will be no information available on the batch number for this case.
Blood pressure kind of high; Severe headache; very nauseated; light headed; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), HYPERTENSION (Blood pressure kind of high), DIZZINESS (light headed), HEADACHE (Severe headache) and NAUSEA (very nauseated) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included Ozempic, Lisinopril and ATORVASTATIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 28-Feb-2021, the patient experienced DIZZINESS (light headed) and NAUSEA (very nauseated). On 01-Mar-2021, the patient experienced HYPERTENSION (Blood pressure kind of high) and HEADACHE (Severe headache). At the time of the report, PAIN IN EXTREMITY (arm was sore), HYPERTENSION (Blood pressure kind of high), DIZZINESS (light headed), HEADACHE (Severe headache) and NAUSEA (very nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt recv vax on 10/28/98; on 10/30/98 pt exp red/ heat/ pain of vax site-LA, watery eyes, rhinitis, myalgias, arthralgias; tx=Motrin, Claritin PO; dx=local allergic rxn to vax/ viral syndrome
Info has been received from a physician concerning a 35 month old male who was vaccinated, SC, with a 0.5ml dose of varicella virus vaccine live. Subsequently, the pt  experienced shingles. Unspecified medical attention was sought. The pt's shingles persisted. A product quality complaint was not involved. Additional info has been requested.
c/o itching -rash on both arms.  Pt had premedicated with Benadryl.  RR called.  Benadryl IM administered.  Itching resolved, rash decreasing.  ER precautions given 911 precautions given.  Pt dispo home -boyfriend picked up.
ED to Hosp-Admission Discharged   10/30/2021 - 11/3/2021 (4 days) Weakness  Presenting Problem/History of Present Illness/Reason for Admission Weakness  Diarrhea, unspecified type  COVID-19   Hospital Course   86 yo female admitted with generalized weakness, shortness of breath, leg discomfort, diarrhea. Was found to have both rhinovirus/enterovirus, and COVID-19 positive on viral PCR. She was started on appropriate medications, and did show improvement in terms of viral infection. She was however found to have a lower extremity DVT in spite of being on Eliquis for stroke prevention and A. fib. Due to this we considered her to be a treatment failure, and she was transitioned to Coumadin. She was bridged with heparin, and became therapeutic today at 2.6. She received 5 mg x 3 days, I will transition her to 1 mg daily with INR check in 3 days. Attempted to obtain stool cultures to rule out infectious etiology for diarrhea however patient having minimal stool output therefore cultures could not be obtained. If she continues to have symptoms this could be addressed as an outpatient.  She will discharge to skilled nursing facility for post hospital reconditioning and then return home. The remainder of her stay was otherwise unremarkable.
severe right-sided headache, right side of scalp/head tender to touch, occasional feeling of thunderbolt clash from right temporal area to right ear
Syncope about 5 minutes after shot. Fell out of chair, immediately awake. Sweating, no trouble breathing. Paramedics checked her out, said she was ok. Mom picked her up.
On 3/19/2021, I drank 4 cups of coffee and 2 Monster energy drinks. I also received a prescription of Provigil in the mail, and I took one pill. In about 30 minutes, I didn't feel well. I checked my blood pressure, which was about 166/95. I called the Medical Center advice nurse, and she told me to call 911. I was taken by ambulance to the ER at the Hospital. Three EKGs were done (one at home, one in the ambulance, one at the ER), as were also a chest X-ray and a CAT scan of the head. However, I got no report of any diagnoses or other findings. I stayed overnight in the hospital and was transferred by ambulance to Hospital Center on 3/20/2021. I stayed there until the afternoon of 3/21/2021 and I then went home. On the evening of 3/21/2021, I checked my pulse, which was 37. I again called the Medical Center advice nurse, and an ambulance was sent. This time, I was taken to another Hospital Center. Once again, 3 EKGs, a chest X-ray, and a CAT scan of the brain were done. I was also hooked to a heart monitor and an oximeter. Early in the morning on 3/22/2021, a doctor came and told me that no abnormalities were found and that I could go home.   On several subsequent occasions, I had a really low pulse rate, and I was again advised by the advice nurse to go to the ER. I was tired, though, and didn't feel like going to the hospital. I just stayed home instead.  I'm still having a lot of dizziness. I discontinued artificial sweeteners, and my low pulse doesn't seem to have been a problem since.
Throat tender hard to swallow, sour taste crying. Occured 45 minutes to 1 hour after receiving pediatric Hep A vaccine. Duration of event 90 minutes.
p/inject almost immediately, area of inject was sore exp tenderness & reddness for 2 wks post inject had a reddened area which appeared like a bug bite @ inject site; p/reddness disappeared lt arm still is very sore; difficulty raising arm;
After receiving shots, pt turned pale, fell backwards and started seizing for 15-30 seconds. Resolved.
On Sat morning I woke up tired.  After getting Covid test done, I immediately felt flu-like symptons.  Then at 10am I went back to bed and slept another hour.  I got up thinking I was just tired from lack of sleep then started to feel extreme fatigue, lethargic, chills, sweats, loss of appetite, muscle pain, dizziness.  I went back to bed around 1pm and slept most of the day Saturday.  Sunday I slept till 4pm after which I made myself get up to shower and eat.  Then nausea set in with more chills.  Right now it is 9:08 pm, Sun, May 23, and I still feel woozy.  I have not taken any OTC meds because I am having surgery for carpal tunnel on Wed, May 26.
Pt recvd Td vax & devel erythema which improved then worsened (55 x 40 mm) by 12MAY92; lesion improved gradually & resolved w/in 1 wk; poss hypersensitivity reaction, & poss cellulitis;
No adverse event.  Vaccine used was indicated for 18 years and above.  This patient was 16 years old at the time.
Had a fever of 101.2 for 24 hours.  Difficulty getting fever down with  both Tylenol and Ibuprofen.  After 24 hours, fever was gone and no other symptoms.
heaviness in her chest; "I'm a walker, but I couldn't do that effectively"; whenever she walked, she got very tired and had to stop; thought it looked like asthma but it didn't clear up with medication; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (heaviness in her chest), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I'm a walker, but I couldn't do that effectively"), FATIGUE (whenever she walked, she got very tired and had to stop) and ASTHMA (thought it looked like asthma but it didn't clear up with medication) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Elevated liver enzymes. Concurrent medical conditions included Arthritis, Hypothyroidism and Asthma. Concomitant products included GINGER [ZINGIBER OFFICINALE RHIZOME] and CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +) for Arthritis, OMALIZUMAB (XOLAIR) for Asthma, RAMIPRIL for Hypertension, THYROID (ARMOUR THYROID) for Hypothyroidism, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHEST DISCOMFORT (heaviness in her chest), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I'm a walker, but I couldn't do that effectively"), FATIGUE (whenever she walked, she got very tired and had to stop) and ASTHMA (thought it looked like asthma but it didn't clear up with medication). On 05-Mar-2021, CHEST DISCOMFORT (heaviness in her chest) and ASTHMA (thought it looked like asthma but it didn't clear up with medication) had resolved. On 12-Mar-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I'm a walker, but I couldn't do that effectively") and FATIGUE (whenever she walked, she got very tired and had to stop) had resolved.        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.   treatment reported was Inhaler   This case was linked to MOD-2021-365222 (Patient Link).
This spontaneous report was received from the patient's mother refers to his son a 2 year old male patient. Patient with no pertinent medical history, drug reactions or allergies. On 27-DEC-2013 (three weeks ago) the patient was vaccinated with MMR II (dose, route, lot number and expiration date no reported) in the upper left arm for route vaccination. There was no concomitant medication reported. It was reported that the patient initally had fever and soreness at the injection site, but on 15-JAN-2014, the patient had developed and was diagnosed with regional adenopathy. The patient sought for medical attention and was seen in office visit. Lab diagnostic studies performed: bloodwork, chest x-ray and Purified Protein Derivate (PPD) test (results not provided). The outcome of the event was reported as not recovered. Additional information has been requested.
Woke with a temperature of 99.10 (I take my temperature each morning for fertility reasons.) Painful arm, unable to move full range of motion. Fever, chills, and skin sensitivity starting at 11am. Highest temp was 102?F. Temperature stayed from 100.5-102? for the remainder of the day. Some nausea and a mild to severe headache as the day progressed. Slept through the night and woke up with a normal temperature (97.3?)
stroke/ Istemic Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunization, reaction(s): "stroke/ Istemic Stroke"; Bnt162b2 (DOSE 2), for Covid-19 immunization, reaction(s): "had a vaccine and booster". The following information was reported: ISCHAEMIC STROKE (medically significant) with onset Apr2022, outcome "unknown", described as "stroke/ Istemic Stroke".  Clinical course: Recently the patient learned that Pfizer vaccine was link to cause Istemice stroke, the patient had a vaccine and booster. The patient had to have it as well as the booster as the patient was in healthcare. The patient either had the pfizer vaccine or stop working. Last Apr2022, the patient had a Istemic Stroke, the patient contributed to the stroke to the vaccine the patient had. This was even before the patient knew that this vaccine was linked to this type of stroke. This stroke forever changed patient's life. The patient was still dealing with the aftereffects. The patient was not sure what to do.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300026585 Same patient/vaccine/event, different vaccine dose;US-PFIZER INC-202300062472 Same patient/vaccine, different vaccine dose/event;
I26.99 ACUTE PULMONARY EMBOLISM 8/26/2021 HIATAL HERNIA
eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1685) intramuscular at arm left, on 19Dec2020 06:45 at single dose for covid-19 immunisation. Medical history included ongoing acne. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included isotretinoin (ACCUTANE). On 19Dec2020 11:30, approximate 5 hours after vaccine, the patient experienced pain, joint pain and tenderness at injection site, progressively loss of strength and eventually inability to move arm. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was recovered.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Inconsolable crying, left leg red (at home). *Patient was seen back at clinic the same day. No knot, no swelling, no redness noticed at injection site. Per FNP
Itching and hives at the injection site 24 hours post injection.  Have not had treatment--was instructed to fill out this form to report.  I'm going to assume that I will recover :)
Pain at the injected site; Pain at the injected site / makes it difficult for her to lift her left arm; Buzzing in her head; Cannot sleep; Earache in both the ears; Tip of her tongue is tingling; Feels heat in the inside of both her arms from the elbow to the palms/hands; Joint pain all over her body; Having difficulty focusing; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a history of shingles on gabapentin for neuralgia states). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in right arm on 29th July 2020). Concomitant products included gabapentin.   On 17th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased, noises in head, sleeplessness, ear pain, tingling tongue, feeling hot, generalized joint pain and mental concentration difficult. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased, noises in head, sleeplessness, ear pain, tingling tongue, feeling hot, generalized joint pain and mental concentration difficult were unknown.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, noises in head, sleeplessness, ear pain, tingling tongue, feeling hot, generalized joint pain and mental concentration difficult to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in left arm. The reporter stated that, after vaccination the patient had pain at the injected site which makes it difficult for her to lift her left arm, buzzing in head, because of which cannot sleep, earache in both the ears, tongue was tingling, felts heat in the inside of both her arms from the elbow to the palms or hands and had joint pain all over body and difficulty focusing. The reporter consented to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020231823:Same reporter. 1st dose
This spontaneous report as received from a nurse refers to a 10 months 15 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Received Pfizer vaccines on 3/11, 4/6/21 COVID-19 positive by PCR on  1/17/22 hospitalized 1/17/22 in ICU for severe hyperglycemia, acidosis and hypoxemia associated to COVID-19 acute infection. major comorbidities including uncontrolled type II DM, CKD, HLD, HTN, morbid obesity BMI 47, previous STEMI and prior PEA arrest in 12/2020 with HFrEF (EF 35-40%) and ischemic cardiomyopathy
This spontaneous report was received from a registered nurse via a company representative and refers to a 35 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 02-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (exact dose, lot # and expiry date were not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information is not expected as no consent to contact the patient's physician was given.