chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath. This report was non-serious. This case, from the Others is linked to 20200953687.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Chills; Night Sweats; Body Aches; Dizziness; Headache; fatigue; weakness; joint pain; nausea; This is a spontaneous report from a contactable health care professional, the patient.  A 37-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number:  EK9231),  in the right arm on 30Dec2020 13:00  as a single dose,  for COVID-19 vaccination.  The vaccine was administered at a Pharmacy or Drug Store. Medical History include drug allergy to sulfa. Concomitant medication included Microgestin, Biotin and Prenatal Vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 31Dec2020 , the patient experienced Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea. No treatment was received given for the event. The clinical outcome of Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea was recovering.
knot on their collar bone on the left side,almost like a blood clot near their neck; vaginal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of MASS (knot on their collar bone on the left side,almost like a blood clot near their neck) and VAGINAL HAEMORRHAGE (vaginal bleeding) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding). On an unknown date, the patient experienced MASS (knot on their collar bone on the left side,almost like a blood clot near their neck). At the time of the report, MASS (knot on their collar bone on the left side,almost like a blood clot near their neck) outcome was unknown and VAGINAL HAEMORRHAGE (vaginal bleeding) had not resolved.            No concomitant medications was provided.  Treatment- Assured all day pain relieve
Red, swollen, hot, painful at site of injection on Rt hip. Started Keflex 500mg and Benadryl
COVID arm - itching for a few days and then red ring lesion appeared today (27 March)
This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received PREVNAR 13 via an unspecified route of administration on 26Sep2017 between 16:00 to 16:30 at a single dose in the left arm for preventative at the physician's office. Medical history included ongoing migraine from an unknown date since the patient was a teenager (about 30 to 40 years ago) and was taking timolol and flu vaccination from an unknown date (also reported as FLUZONE). Concomitant medication included ongoing timolol taken for migraine. On 27Sep2017, almost 24 hours after administration of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) the patient had a fever that maxed to 101. The patient took ibuprofen at 600mg every 6 hours and reported that he was taking it at 12-14 hours at the time of the report. The patient also took TYLENOL at 2 of 500 mg tablets every 4 hours in response to fever. On the same day of 27Sep2017, the patient also noticed a large welt across his left arm that is at least 5 inches across. The patient reported that he noticed it a little on 27Sep2017 and reported that it was getting worse at the time of the report and was not resolving yet. The patient has not recovered from large welt across his left arm while the patient was recovering from fever.
An 81-year-old  male with history of metastatic prostate cancer, HTN, HLD and a-fib (not on anticoagulation) presented with abdominal pain. He was found to have a bladder perforation and possible bowel obstruction on imaging.  He tested positive on 11/29/2021 while admitted. Daughter visited and later tested positive.
Approx. 15 min after vaccine administered, noticed a "flush" feeling of face and body. Three hrs. later, noticed muscle aches of arms and legs followed by hip, ankle and wrist pain bilaterally x 48 hrs. This day, states discomfort is subsiding.
Patient was given a dose of 0.2ml instead of the 0.3ml recommended. The vial did not contain 0.3ml doses.
I had muscle pain and joint pain that is ongoing.  It has gotten worst with my booster shot.  I went the doctor about this in April.  They did blood work, normal result.  She did not know what was causing these aches and pain.
Local reaction to immunization DTaP - ? cellulitis R leg 6x8cm 2+ red, warm, indurated. Treatment: Augmentin 400mg/5ml 3cc po bid x 10 days and benadryl 1 tsp q6hrs prn.
shoulder pain; lost mobility of my shoulder/diagnosed with Frozen Shoulder; Dose Number: 4, Moderna ; Dose Number: 5, Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 14:30 as dose 5 (booster), single (Lot number: GJ3277) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "covid-19" (unspecified if ongoing), notes: if covid prior vaccination Yes; "Penicillin" (unspecified if ongoing), notes: known allergies Penicillin; "known allergies Sulfa" (unspecified if ongoing), notes: known allergies Sulfa. Concomitant medication(s) included: WELLBUTRIN; GABAPENTIN; TRAZODONE. Past drug history included: E-myacin, reaction(s): "known allergies: E-myacin", notes: known allergies: E-myacin. Vaccination history included: moderna (Dose Number: 1, Batch/Lot No: 004m20a, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 24Feb2021, when the patient was 50-year-old, for Covid-19 immunization; moderna (Dose Number: 2, Batch/Lot No: 046a21a, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 25Mar2021, when the patient was 50-year-old, for Covid-19 immunization; moderna (Dose Number: 3, Batch/Lot No: 023C21A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 19Nov2021, when the patient was 50-year-old, for Covid-19 immunization; moderna (Dose Number: 4, Batch/Lot No: 004M21A, Location of injection: Arm Left, Vaccine Administration Time: 11:45 PM), administration date: 29Apr2022, when the patient was 51-year-old, for Covid-19 immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Sep2022 at 14:30, outcome "unknown", described as "Dose Number: 4, Moderna ; Dose Number: 5, Pfizer"; PERIARTHRITIS (non-serious) with onset 06Oct2022, outcome "not recovered", described as "lost mobility of my shoulder/diagnosed with Frozen Shoulder"; ARTHRALGIA (non-serious) with onset 06Oct2022, outcome "not recovered", described as "shoulder pain". The events "shoulder pain" and "lost mobility of my shoulder/diagnosed with frozen shoulder" required physician office visit. Therapeutic measures were taken as a result of arthralgia, periarthritis.  Additional information: The patient did not take other vaccines in four weeks. Patient took other medications in two weeks. Patient experienced covid prior to vaccination and was not covid tested post vaccination. Patient started having shoulder pain shortly after receiving the Pfizer vaccine. The shoulder started hurting more, and then lost mobility of shoulder. Patient have been diagnosed with Frozen Shoulder. This has affected patient's work and home life. Patient was treated for adverse event with Physical therapy, steroid injections, Celebrex.
Headache, deep sleep for 24 hours, nausea, diarrhea, fatigue and couldn't function as normal.
Stomach ache immediately after immunizations given. Developed SOB, mucosa edema, puffy eyelids, erythema and abdominal pain within 5-10 mins. 0.1ml epi given at 2:50PM 50mg Solucortif given at 3PM. 1 tsp Benadryl given at 3:10PM. Epi 0.1ml given at 3:30PM. No local reaction. Fully recovered and left office by 4:30PM. Tx: Orapred 2tsp q D.
Began with rash, severe body aches, loss of smell and taste, brain fog, unsteadiness, nausea, diarrhea that eventually led to dehydration and finally colitis that resulted in ER visit for fluids; sent home; next day, passed out at home, back to ER and was admitted for the colitis.
Light inflimation and itching sensation on and around small pox vaccination. three months for time of vacc. no treatment. not severe at this time.
Allergy: Pneumococcal Vaccine; Sertraline; Simvastatin; Prozac; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician report that a 58-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown), via an unspecified route of administration on an unspecified date at single dose for immunisation. Co-suspect drug inlcuded, sertraline (manufacture unknown, Tablet) at 100 mg, simvastatin (manufacture unknown, Tablet) at 10 mg, fluoxetine hydrochloride (PROZAC, tablet) at 10 mg, these drugs are all orally from an unspecified date for unspecified indications. The patient's medical history included active allergies to iodinated diagnostic agents on 23Dec2008 with reactions anaphylactic, active allergies to latex exam glove miscellaneous (Not Specified) on 14Jul2003, allergy to bee stings on 14Jul2003, allergy to dairy on 21Jun2016, allergy to fish (not sea food), shellfish, soy on 21Jun2018. The patient's concomitant medications were not reported. The patient experienced allergy to pneumococcal vaccine on 20Oct2015, allery to sertraline 21Sep2018, allergy to simvastatin on 28Jul2015, allergy to fluoxetine hydrochloride on 21Sep2018.  The action taken in response to the event for sertraline, simvastatin and fluoxetine hydrochloride was unknown. The outcome of the events was not resolved.   Pfizer is a marketing authorization holder of pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) and sertraline in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of  pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) and sertraline has submitted the same report to the regulatory authorities  Information on the batch number has been requested.
Administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Reporter reported that  expired (expiration date 13 Oct 2021) Moderna Covid-19 vaccine was given  to 4 patients on 15 Oct 2021 between 8:00-10:00am.  Reporter had no adverse drug reaction to report on four patients that received Moderna vaccine 36 hours post vial expiration.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Non Significant Follow Up received and updated contact information of reporter. On 19-Oct-2021: Non-Significant follow up  received. Email failure notification received. On 20-Oct-2021: Source Document contains no new information.
48 hours muscle aches, stiff neck.  84 hours and lasting two weeks large muscle group myalgia, joints (hips, knees, shoulders, metacarpals) pain,  Notified PCP on 11/22/21- labs ordered- negative. Preemptive treatment for Lyme disease, eventual Lyme ABY test negative.  Joint and muscle stiffness on 11/22/21 severe to prevent ambulation without significant alteration in gait. Slowly improved over the course of two weeks. Remained afebrile. Treated with ibuprofen and doxycycline .   Dec 23, 2021- return of muscle aches. Headaches and neck muscle pain 2-3 times per week. Migraine headache frequency notably increased since late November to present about 6-8  per month and ongoing.  From Dec 23  symptoms progressed as follows: Development of progressive chest discomfort in supine position and shortness of breath with exertion, intermittent lightheadedness.  ECG Jan 5, 2022: sinus rhythm with nonspecific T wave abnormality. Cardiologist examination revealed S4 abnormal heart sound and rapid pulse. Stat ordered echocardiogram completed , negative for effusion. EF normal. Labs completed-told were 'OK'.  Diagnosis- Pericarditis and tachycardia. Treated with high dose steroids and anti-inflammatory agents for two weeks. Symptoms returned late January with supine position chest heaviness, treated with another course of steroid and NSAIDS.  Headaches , joint pain are ongoing to date.
Case number PHEH2011US02198 is an initial spontaneous report received from a nurse on 05 Aug 2011 with follow-up received from a nurse on 06 Sep 2-11. This report refers to an 11-year-old female patient. She was given only the MENVEO (batch number: X10030 and expiry date: Sep 2012) intramuscularly on 01 Aug 2011. No adverse event reported following this administration error. The patient was revaccinated with MENVEO on 11 Aug 2011. No adverse event occurred after revaccination. Follow-up received on 06 Sep 2011: Patient demographics updated.
Headaches; This is a spontaneous report from a contactable Physician (Patient herself). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not reported, Expiration date: Not reported) via intramuscular route of administration in the left arm on 09Jan2021 at 08:30 as SIGLE DOSE for COVID-19 Immunization in the hospital. Medical history included asthma, dilantin allergy, singulair allergy and egg allergy from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular route in the left arm on 26Dec2020 at 08:15 as SIGLE DOSE for COVID-19 Immunization. The patient had not taken any other vaccine within four weeks and not taken any other medications within 2 weeks. The patient had not COVID-19 prior to vaccination and not post vaccination. The patient experienced headaches that are not like the chronic migraines that remitted after the first dose and restarted after the second dose and have not remitted. The patient not received treatment for the event. The outcome of the event was not recovered.  Information on the lot/batch number has been requested
Approximately two hours after recieving the Shingrix shot in my left arm, I felt mild pain in my left hip/upper outer thigh area.   The pain increased the following day and I managed the pain with ice and Ibuprofen.  The pain has decreased slightly but has been constant to this day and remains in the lower outer hip/ upper outer thigh area
Allergic reaction to my face, swollen, red, blotchy. My head became really hot as well
Fever of 100.3 degrees onset 24 hours after injection. Temperature returned to normal by 42 hours after injection. Soreness in arm where vaccine was administered.
Patient noted in to have already received 2 doses of Moderna COVID vaccine upon entering 3rd dose on 8/9/21.  First dose received at another facility per web on 4/16/2021, Second dose was given at Health Center on 7/12/2021, Third dose was given at Health Center on 8/9/2021 and that is when it was discovered this was his 3rd dose.  Patient brought vaccine card with him to visit that only reflected the 7/12/21 dose was given so far.  No adverse effects have been reported by the patient at this time. Attempted to call patient and was unreachable by phone at this time. Will continue to try to call patient.
Pt. states that after receiving the 2nd dose of Phizer 03/26/2021, started experiencing symptoms 03/27/2021 of swollen Lymphnoids under both arms lasting 72hrs. No other symptoms noted, No Primary visit noted.
Patient arrived to vaccination site with her COVID vaccination card. On her card the date of her last vaccine was 05/18/21 and she had received Moderna   it was explained to her that she was too early and would have to reschedule for when she was eligible. The patient was upset and asked what if she was immunocompromised, the Site manager who was in assisting to navigate the situation approved of her continuing through the process, Patient was escorted to registration, where the form was read verbatim to the client and it was confirmed that she had received Moderna. As the patient left registration, they went through the vaccine tracker to the vaccination nurse once again read through the form and confirmed it was Moderna and that the patient stated she was immunocompromised. Patient stated to vaccination nurse that she had spent a lot of time at registration going over this and that they had approved it.  The nurse administered the vaccine and the patient went to observation where she was observed for 15 minutes. The vaccination nurse came up approximately 18 minutes later and asked the Head Clinician to verify if a patient with Moderna who was immunocompromised was supposed to receive the same vaccination as the first two times or if they were allowed to get the other kind.  The nurse was re-educated as was the other staff members were all educated in the AM of the policies.
After I had my vaccine (on a Saturday) and that evening I was watching TV then I felt dizzy and felt really fatigued (about 10 pm at night) I can barely move, I crawl over to the couch and I told my husband that I will go to sleep. I couldn't go upstairs to my bed due to extreme fatigue. The next day I woke up and I still felt fatigued, I basically felt very tired and I got up- I didn't take any treatment/medications for it- I just took my normal listed medications and stayed home the whole day. I did start to have body ache around 1pm and still felt tired all the way through the night. Then by Monday morning still the same but by evening I started feeling better. Then when I woke up on Tuesday morning I was 100% feeling better and back to normal.
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Swelling of the injection site, jaw spasm, high blood pressure-Mild, Systemic: Hypertension-Mild, Additional Details: Patient started to have swelled injection site arm after about 30 minutes of vaccination but patient remained responsive. 11:40pm - BP 198/100, HR 72. 12pm- BP 198/100, HR 72 & complained of dystonia symptoms so we called 911 paramedics came within 5 minutes. 12:15pm- BP 240/110, HR 72. Called patient's daughter at 2:01pm (patient still in the ER), at 3:16pm (left message to voice mail). Patient did not mention she has history of dystonia after getting any vaccine when asked prior to vaccination
H/A with nausea and dizziness,  slight congestion.  lasted 1/2 day
Woke up at 6am feeling very tired, cold with chills , extreme body ache  and weak. Upon standing legs went weak and fell to the floor twice. Returned to bed for 2 hours. Attempted to get up again and was able to stand ok but felt very weak. All other symptoms remained . Called my doctors office , was referred to a triage nurse who contacted a clinical pharmacist. Was told my side effects would get better over the next 2 days and to take acetaminophen . I felt better the next day and still have some  body aches days later.
I fainted in my backyard on June 9th. I was brought to the hospital by ambulance and had elevated heart enzymes and a problem with my EKG. A subsequent CT scan was done and it was found that I had a massive saddle pulmonary embolism. I was air transferred to another hospital and given a TPA to break up the clot. I was in the ICU for 3 days and then the cardiac floor for 2 days. I also had a bleed where my central line was put in in my groin and a subsequent hematoma. The PE was most likely caused by a DVT in my right leg, believed to be caused because of a dislocated ankle and estrogen-based birth control.
I contracted COVID-19. My symptoms included a scratchy throat, headache, congestion, coughing, and achiness. I did not have a fever though. I started a course of PAXLOVID.
30 year old dead; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 30 years old and unknown gender patient who experienced 30 year old dead while receiving vaccine Influenza Vaccine.  The patient's past 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 lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious event 30 year old dead (death) (unknown latency) following the administration of Influenza Vaccine.   It was reported that  It goes on and on, and on. it's happening everywhere, and is not normal. 30 year old dead.  Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event 30 year old dead. It is unknown if an autopsy was done. The cause of death was reported as Death NOS.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) 30 year old  dead.; Sender's Comments: Sanofi company comment dated 03-Feb-2022. This case involves a 30 years old and unknown gender patient who experienced 30 year dead while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.; Reported Cause(s) of Death: dead
Received flu shot 9/10/09 @ mid morning (AM).  10:00 PM:  Itching of arms & legs -> hives, raised all over body shortly thereafter.  Heart racing.  Pulmonary doctor on call suggested 'BENADRYL'.  3 days now:  Rash almost gone.  Also seems to bother asthma.