chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He could not sleep/ his body was awake; When he gets up he gets dizzy; Strong headache; His body is very tired; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (He could not sleep/ his body was awake), DIZZINESS (When he gets up he gets dizzy), HEADACHE (Strong headache) and FATIGUE (His body is very tired) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced SLEEP DEFICIT (He could not sleep/ his body was awake), DIZZINESS (When he gets up he gets dizzy), HEADACHE (Strong headache) and FATIGUE (His body is very tired). At the time of the report, SLEEP DEFICIT (He could not sleep/ his body was awake), DIZZINESS (When he gets up he gets dizzy), HEADACHE (Strong headache) and FATIGUE (His body is very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
C/O hives 6 hours after H1N1 shot. Treated with BENADRYL, it was resolved.
Self reported: swelling of feet, chest tightness with inspiration, facial swelling, numb sensation on the inside of the mouth, feeling unwell, headache.
This case was reported by a physician via call center representative and described the occurrence of general body pain in a female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received SHINGRIX. On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced general body pain, fever and feeling cold. On an unknown date, the outcome of the general body pain, fever and feeling cold were not recovered/not resolved. It was unknown if the reporter considered the general body pain, fever and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the SHINGRIX shot day before reporting, and since morning the day of reporting she had body aches and pain, feeling cold and her body temperature was 100.2 F. The patient asked was that normal.
I got covid-19 vaccine 2nd dose ,in campus clinic 01/26 /2021around 3.30 pm . I felt sick around 4 AM(12 hours later , 01/27/2021). I felt dizziness , Chills , facial  and eyes swelling and body aches for 24 hours . I took Benadryl and Tylenol  1 hours before vaccine and  repeated every 8 hours  per MD.. Felt sick for 24 hours.
Cardiac Reaction- Cardiac Inflammation; Day 3 started chest pain, Pain radiating to L arm/back/neck, shortness of breath, elevated BP, fatigue, lightheadedness, mild EKG changes  Urgent care due to chest pains @ day 5  Follow up Cardiology and holistic MD December 18, 2021. Currently on Plaquenil and initially Prevastatin (Had to stop statin due to allergic reaction) and monitored biweekly
I had the first dose of Pfizer covid-19 vaccine on 02/23/2021. Six days later on3/1/2021  I developed abdominal discomfort over the entire abdomen. It progressed into strong abdominal pain. I didn't have any appetite and could not and did not eat for about 48 hours.  On 3/3/2021, the general pain subsided a bit, but the pain at lower right abdomen persisted and got stronger, and I still had no appetite. I called my doctor's office and was advised to go to a healthcare facility where I was diagnosed as having acute appendicitis. I was told to go straight to another healthcare facility where the surgeon performed appendectomy on me. I stayed at the hospital for two nights and was discharged on 3/5/2021.
100% healthy kid. Received FLUMIST 11.15.10 PM. 5:30 AM next morning he yelled out. There was something wrong with his lip. Not allergic to anything. 11.16.10 doctor did not rule out that it was an allergic reaction but said he doesn't know what's the cause?
Fever of 103.3 three days after receiving vaccines with taking Tylenol and Motrin. Rash on abdomen.
Pulsing and twitching in deltoid muscle daily post vaccine  continuing for over a month now
My last period was in Feb, 2019.  On Thursday, 04/29 a few hours after my 2nd vaccine shot I started spotting.  On Friday, I started menstruating
vagus nerve neuropathy - began one month after vaccine; dysphagia; vocal cord partial paralysis
pt recvd vax 14JUN95 & 14JUN95 pt devel 5 red dots on face;No further details were provided;
Patient Became hypotensive (supine BP 98/56, HR 70). Was asked to lay supine for few min. AFter 15min sx resolved. BP returned to normal (after 15 min sitting 116/63 HR 73, after 30min 117/68, HR 77). Able to drink water and no emesis. Monitored for >30min after before leaving.
A physician reported that a 2 month old male received his first doses of Prevnar, Acel-Imune, Hib-Titer, and IPVvaccines on 5/17/00. Following immunization, the infant developed a cold. On 5/19/00, he had a hypotonic-hyporesponsive episode with apnea. The infant required intubation and was hospitalized in the intensive care unit. An electroencephalogram was interpreted as normal. Diagnostic evaluations for sepsis and gastroesophageal reflux were negative. Complete blood count revealed a hemoglobin of 8; the infant received a blood transfusion. A copy of this report has been forwarded to the manufacturer of IPV.
Time: 1059AM:  Pt. calls to report that she is having side effects from the shingrix vaccine.  Of note, she did NOT react to the first vaccination.  Pt. reports that she felt okay last night.  She woke this AM with a pounding headache and stomach ache.  She has some nausea but has not vomited.  She has soreness in her arm but no redness, streaking, drainage at the IM injection site. Pt. does not have a thermometer at home.  She is calling pharmacy to see if she can purchase one.  She has had chills off and on and her whole body has felt warmer than normal.  Denies SOB, itching in throat, or swelling in face.  Advised for her to obtain thermometer and monitor her temp.  Advised she can alternate Tylenol/ibuprofen.  She asks about returning to work due to COVID-19 Pandemic.  Advised that per current CDC guidelines she should refrain from work until she has been fever and symptom free for, at minimum, 72 hours.  She is unsure if she will need a note or not.  Advised her to push fluids, rest, and touch base with me this afternoon.  Notify me promptly if s/s worsen.  She verbalizes understanding.  Time: 1452- Courtesy call to patient.  How is she doing?  She did get a thermometer and her temperature was 100.1.  She took a dose of Tylenol and the temp came down to 98.5 (checked while I was on the phone with her).  She feels better since taking the Tylenol.  Her stomach ache has resolved.  ER precautions reviewed at length.  If s/s worsen she is to notify me or go promptly to ER.  She verbalizes understanding.
Suspected vaccination failure/took the shot then got shingles; shingles//took the shot then got shingles; He said it hurts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 25-June-2022 Reporter's comment: The case was reported by the patient's friend via interactive digital media. The patient took the shot then got shingles, it never leave the body, shows up every once in a while and the patient said that it hurts. The reporter could not saw nothing on this video. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Left leg swelled up to the size of a golf ball 3 hours after vaccine admin. per report from mother. Also had a high pitched scream for 1 1/2 hours.  Ran a temp of 101.8. Was seen in ER and given Benadryl.
Pt witnessed sibling having adverse event to HPV vaccine in same appointment, and became faint. Pt has hx of low blood pressure, states he passes out when getting out of bed too quiclky. Pt was at facility for establishment of care, and did not indicate history on vaccine screening form. Pt was evaluated and released by medical staff. Pt experienced light headedness, over heating, lightness of skin color, and clammy skin.
Rash and raised bump at injection site about 2 inches. no fever. no other symptoms
Pt came into pharmacy about 30 hrs after vaccine administration with swollen arm, red. I advised ice pack and TYLENOL for discomfort. Not severe symptoms.
expired dose of Act-HIB given, stated that on the component or powder it say 29-May-2021 and the dilute stated 01-Mar-2021 with no reported adverse event; Initial information received on 04-Mar-2021 regarding an unsolicited valid non-serious case received from a physician and consumer/ non health care professional.  This case involves a 3 year-old female patient who was vaccinated with expired dose of HIB (PRP/T) VACCINE [ACT-HIB], stated that on the component or powder would expired on 29-may-2021 and the dilute expired on 01-Mar-2021 (Expired Product administered).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination.  On 03-Mar-2021, the patient received 0.5 mL (once) dose of suspect HIB (PRP/T) VACCINE (strength- standard) [lot UJ165AAA and expiry date 01-Mar-2021) via intramuscular/right vastuslaterallus route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Developed a 2" circular, raised, red wheal at injection site with soreness and pruritus. Approximately 18 hours after vaccine given.
I originally had a lymph lump under my left arm.  I went to a doctor about 5 days after the vaccine. It lasted about ten days.  I reported this.   During the spring throughout the summer until now I have developed tachycardia  POTS.  I didn't have these symptoms prior to the vaccine.  It is now compromising my life.
Covid symptoms started the night of 04/27/22; tested positive on 04/28/22 with home test. It started with sore throat, headache, and runny nose. Otherwise symptoms were mild and the sore throat was gone in a day and the runny nose, headache, and fatigue lasted 3 days. I had monoclonal antibody infusion on 05/02/22 and continued quarantining and I've been fine. It was a very mild course and colds have been much worse.
pt was found dead w/in 48 hrs of vax administration; preliminary investigation indicates probable SIDS;
Patient was administered a Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Manufacturer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated 03/19/21 and has since received dose 2 on 04/09/21
inj site became red & swollen approx 1 1/2" diameter, low grade temp, hives over buttocks & back of legs last 4 days;
DRUG EXPOSURE VIA  BREAST MILK; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transmammary, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20210428439.
Pain in shoulder after vaccine never dissipated and progressed to limitations in motion and pain with movement. Physical therapy is ongoing and months later problem not resolved
19 year old with no significant past medical history presented to the ED with c/o chest pain. He was noted to have chest pain starting on 4/30. Patient stated that he had 2nd COVID vaccine on 4/29. He was noted to have one episode of vomiting and developed coughing. He has been c/o of sharp chest pain for the past two days. He was noted to have arm pain. He had chest pain when he breaths. He took advil and noted to have slight improvement in his pain.  He was noted to have an elevated troponin and CK. Cardiology was consulted. His initial troponin came back 4.49 with a CPK of 294.   Serial troponins were obtained. Troponin peaked to 44.8 and CPK to 1345, Echo showed newly reduced LVEF of 55%.   Diagnosed with myopericarditis possibly related to the Covid vaccine and pt was transferred to the Hospital for cardiac MRI and further work-up. Upon transfer to the hospital, cardiac MRI was performed and showed acute myocarditis with no evidence of pericardial thickening or pericarditis. It also showed left ventricular function was at the lower limits of normal with a calculated left ventricular ejection fraction of 50% and no focal wall motion abnormality. He was treated with colchicine 0.6mg, pepcid 20 mg, and ibuprofen 600mg for the myocarditis and oral morphine 15mg and tylenol 1,000mg for chest pain. He was counseled on avoiding strenuous activity for the next 3 months and following up with cardiology upon discharge.
fatigue x 5 days, including day of vaccination, death the night of day 5/early morning of day 6
About 22 hours after Flumist was administered , patient began having symptoms including headache, myalgia (severe), extreme malaise, a low grade fever, chills and sweats; loss of appetite, slight nasal congestion. These symptoms were severe for the first 4 days and continue for 2 additional days with a decreased intensity. Patient missed 2 days of school.
21 y.o female woke up had breakfast and while at rest Developed palpitation , shortness of breath and some pain in lower middle teeth. The teeth pain lasted less than 30 minutes , other symptoms  lasted from 7 am till about 1 pm and then gradually subsided except mild "racing heart" feeling. Patient went to urgent care. EKG showed some non specific ST depression in AVF and lead II. Sinus arrhythmia with rate between 65-85. . Sent to ED. In ED EKG was same as in urgent care. Troponin elevated slightly at 0.36 ( normal less than 0.30) and the repeat in 1 hour 0.37 ( normal less than 0.30) . D dimers noted slightly elevated at 260. POssible diagnosis of "inflammatory syndrome" by ED physician . Patient was offered admission , but refused and went home to follow up with cardiologist as outpatient. As per ER attending : "it almost looks like COVID or post COVID syndrome"  Rapid COVID test negative. Symptoms started in the morning of the 3rd day after  2nd COVID vaccine.
Urticarial rash all over body. Was seen in hospital ER (5 hours after vaccine). Seen in office 1 day after with persistent rash, prescribed BENADRYL.
PAIN AT INJECTION SITE WITH RIGHT SHOULDER AND CHEST PAIN 2 DAYS AFTER INJECTION.
Redness, swelling and pain to site and surrounding area. Start Benadryl capsule 25 mg orally TID 5 days cold compress to area q 2 hours.
has the same feel 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "has the same feel 3 times". Additional information; No it won't work  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Junctional Bradycardia; S/P Dual Chamber Pacemaker Implantation; resolved
My period, which is normally very regular and predictable, has been completely thrown off since receiving the vaccine. It has never been more than 2 days late but since getting the vaccine, it has been one week late and 2 1/2 weeks late.
Patient vaccinated with Pfizer, last dose 04/06/21, who admitted to the hospital with a positive COVID test.  Provider discharge summary below:  "71 year old female who presented to the ED on 11/12/21 due to shortness of breath and weakness and was noted to be covid positive. She was started on COVID directed therapies and her symptoms continued to improve. Her stay was complicated by the development of an anterior pelvic hematoma without any active bleeding evident so no intervention was required. Her plavix and DVT prophylaxis were held with improvement in her symptoms. Her CBC remained stable and her abdominal pain substantially improved. She will have to follow up with her PCP for a CBC tomorrow and possible re-initiation of plavix. She also continued to have elevated blood sugars due to steroids that were initiated for COVID treatment. Her home medications were held and she required higher doses of insulin. She will be sent home with her home regimen in addition to prandial insulin and instructions to take her blood sugar 4x daily. She only has 1 additional day of steroids. Her PO medications were restarted on discharge. The patient also did have notable hyperkalemia during her stay. Her ARB was discontinued and her HCTZ dose was increased per nephrology recommendations with improvement, she will have a BMP checked tomorrow outpatient and her family physician/nephrologist can adjust BP medications as necessary. On day of discharge she was in improved and stable condition, she was still requiring O2 so she will be sent home with home O2 and home care."
I woke up at 2am this morning with a headache on the top of my head and my head was ringing (not my ears, my actual head). Then I started having vertigo which i have never had before - felt like i was falling even though i was laying in bed and started feeling nausea. I took 1 tylenol and after a long time was finally able to go back to sleep. About 830am I woke up with an even worse headache, even worse dizziness and worse nausea. I ended up vomiting twice. After that the symptoms started to subside. I did not have a fever at all. If anything I felt cold (not chills, just generally cold). I fell asleep again for a few hours and when i woke up I had a little bit of dizziness and nausea but it went away.  I napped again for a few more hours and when I woke up I felt better and was hungry. I also wanted to report that a red patch reappeared at the injection site on March 11 and has been there ever since. It does not hurt like it did for a few days after the injection, but is a bit tender. Just redness, no bumps, and it's the same size as it was when it initially showed up after the injection.
This case was reported by a nurse via sales rep and described the occurrence of dizziness in a female patient who received FLUARIX QUADRIVALENT (2017-2018 season) for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2017-2018 season, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. The reporter considered the dizziness to be related to FLUARIX QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The age at vaccination was not reported. The patient received one dose of prefilled FLUARIX QUADRIVALENT 2017-2018 season. The patient felt dizzy and that was impactful to her. The patient felt the event was related to the product. This case has been linked with US2018GSK155551, reported by the same reporter.
Significantly worse tinnitus (I would occasionally have mild tinnitus before - now it is constant and loud)
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided. Treatment medication was not reported.
5 minutes after receiving the vaccine, room started to spin and I felt warm in my chest and felt like I was going to pass out
Information has been received from a physician's assistant concerning a 19 year old female patient, with allergy to abacavir and acquired immunodeficiency syndrome, who on 22-MAY-2007 was vaccinated with her first dose of GARDASIL, (lot # expire date and route not reported). About one month after her first vaccination, on approximately June 2007, the patient developed a nickel size area of alopecia. In November 2007,  the patient received her second dose of GARDASIL, (lot #, expire date and route not reported). She did not develop alopecia after her second vaccination. There were no laboratory diagnostics studies performed. The patient did not seek medical attention. On an unspecified date, the patient recovered from a nickel sized area of alopecia. Additional information has been requested.