chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis after the 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDITIS (Myocarditis after the 2nd dose) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis after the 2nd dose) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis after the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Reporter consulted patient's primary care physician and cardiologist. Reporter did not have patient's vaccination details. Treatment information was not provided.  Company comment:  This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced the serious (medically significant) expected AESI of myocarditis after the second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event were not reported; hence latency cannot be properly assessed. No further information on diagnostic tests, clinical course and treatment received was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced the serious (medically significant) expected AESI of myocarditis after the second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event were not reported; hence latency cannot be properly assessed. No further information on diagnostic tests, clinical course and treatment received was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
01-13-03 Mom called on patients immunization on 11-21-02 on left leg at site of immunization - had egg size knot and warm, no other syptoms other than fussy.  Says knotis down in size, but still has knot.  Recommend that she follow-up with PMD.  Says when got home patient immunization - egg size knot and warm for 3 days, still knot felt deep.  Mom reports still has knot at site.
Pt said his skin went pale/yellow Under eyes were purple Pain around heart  Lightheaded/Dizzy
Patient presents to clinic requesting flu shot. Flu shot was administered post consent forms signed and questions answered if there were any. Upon entering in flu vaccination information into epic, MA noticed that the patient had already received flu vaccine on 10/2022. MA made Nursing Supervisor aware of situation. Adverse occurrence report was made. Patient was notified to monitor self at home and notify the clinic in the event that she has any adverse reactions. MA was educated by the Nursing supervisor on the proper way to verify if the patient has had a flu vaccination and if they are eligible. MA verbalized understanding. Patient never did contact us in regard to incident.
Information has been received from a consumer who is the mother of a 36 month old white male with no relevant medical history who on 10/13/1996 was vaccinated with a dose of varicella virus vaccine live.  There was not concomitant medication.  There was no illness at the time of vaccination.  It was noted that the patient's mother developed chickenpox at age 37 and 2 weeks later in October 1998, the patient developed a "small case of chickenpox", "with a 6 pox marks total" and was "not sick at all".  There were no diagnostic laboratory tests performed.  It was also noted that the patient was in nursery school at the time.  Subsequently, the patient recovered.  Additional information has been requested.
Information has been received from a nurse practitioner (NP), via a company representative, concerning an 11 year old female who on 12-APR-2007 was vaccinated with the second dose Gardasil. Concomitant therapy included Boostrix. On 16-APR-2007 the patient experienced intermittent hives that look like tiny pimples that are not itchy. The event persisted as of 20-APR-2007. Follow up information from the NP, via the company representative, confirmed that the patient's hives/rash was "diagnosed as a case of chicken pox." The NP stated that there was an outbreak in the patient's school district. At the time of this report, the patient had not recovered from the chicken pox. The patient sought unspecified medical attention. Additional information has been requested.
states had 2nd covid vaccine yesterday (2/3/21), had cosmetic lip filler in November 2020. Noted/felt  lower L lip swelling this am which appears sl better, then noticed upper L lip swelling (nothing on R).  No itching or pain. No resp or thrt sx. Does have localized injection site redness and swelling, ? sl generalized body aches, otherwise no sx. Takes Zyrtec daily for other allergies. Did not have any lip reaction with 1st vaccine. 15 yo child at home does not notice any difference in her appearance. did do google search and there was reference to others who had lip filler having similar reaction s/p covid vaccine
Next morning, I had fever and it last 2 days. On the site where I had the vaccine my arm became red, and I had an infection. The area was 1 ½ wide and it was in all my arm. It was itchy, burned, and painful. I went to the emergency room. The doctor said that my infection was due to the vaccine and gave me antibiotics for 10 days. After 10 days my arm was brown. No need to go back to the doctor but I still have the brownish line in my arm.
Narrative:  68 yo male with PMH significant for HTN, HLD, Gout, Impaired fasting glucose, CKD3a, and obesity admitted to VA for eval/managment of episodes of SVT seen on monitor after presenting to ED on 2/15.2022 w/ c/o Vomiting/Diarrhea and found to be COVID+. Patient initally left AMA from ED but returned 2hrs later for admission. COVID+ - possibly cause of vomiting/diarrhea. No current pulmonary symptoms, no hypoxia and CXR neg for infiltrates. Patient s/p monoclonal AB in ED. Pt received Vit C, Vit D and Zinc during hospital stay. Patient had noted intermittent sinus tachycardia during vomiting/diarrhea. Pt discharged to home on 2/16 w/ event monitor ordered.
pt had high pitch shrill cry for 30-45 mins; 2 1/2 hr p/vax; also had inconsolable cry for 2 hr; APAP given every 4 hr for 36 hr post vax;
SUSPECTED COVID-19 INFECTION; NO LONGER HAS THE ABILITY TO WALK; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection, and no longer has the ability to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from no longer has the ability to walk, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
approx 4-6 hr p/vax pt had episode of arching, LOC followed by lethargy (brief period) & 3 days of irritability; low grade fever 101 max;
Patient screamed and cried uncontrollably for hours. Patient was unable to be consoled and felt very warm to the touch. Pt's thigh was also very swollen and red.
Day 1- sore at injection site Day 2- sore under arm of injection arm and side of that breast. Muscles aches through mid back and chills Day 3 - Exhausted and achy, nauseous, chills, sweats Day 4- Adverse reactions gone.
Information has been received from an investigator concerning an 8 week old female with gastrooesophageal reflux disease and a history of right lacrimal duct obstruction congenital and toxic erythema who entered a study. Previous vaccine history included 0.5 ml IM injection, one dose on 02-NOV-2011 of ENGERIX-B. On 03-Jan-2012 the subject was randomized to receive DTaP-HepB-Hib-IPV at 2 months, 4 months and 6 months. On 03-JAN-2012 the subject was vaccinated with the first in series of IM 0.5 ml (injection site not reported) DTaP-HepB-Hib-IPV. Additional vaccine therapy on 03-Jan-2012 included oral 2.0 ml ROTATEQ and IM 0.5 ml PREVNAR 13 as part of the childhood series. Concomitant therapy included TRI-VI-SOL. On 03-JAN-2012 the subject experienced fever (moderate intensity) and was hospitalized on 04-Jan-2012. The subject presented to the local ER on 03-JAN-2012 reporting a fever of 102.2 degrees Fahrenheit (previously unit of measure not provided) taken rectally at home. Temperature taken in the ER was 100.8 degrees Fahrenheit (previously unit of measure not reported) rectally after TYLENOL had been given at home. The subject was admitted for observation and to rule out infection only and discharged on the same day (04-Jan-2012) in stable condition, (previously reported as remained hospitalized at time of reporting). No medications given during hospitalization. The lab/diagnostic results (previously reported as unknown) revealed the following: 03-Jan-2012 urine culture negative, 03-Jan-2012 blood culture negative, 03-Jan-2012 urinalysis WBC 5-10 (units unknown), otherwise normal urine, on 03-Jan-2012 (day approximate) CBC negative and CRP normal. On 04-Jan-2012, lumbar puncture was attempted but was unsuccessful during hospitalization (date not reported). The action taken with the study vaccine therapy was none. On 04-JAN-2012, the fever resolved (previously at the time of initial reporting, the subject had not recovered from the fever). The subject was discharged from the hospital on 04-JAN-2012. The hospital discharge diagnosis was fever, no other etiology was determined for fever. No discharge summary was available as the hospitalization was for observation only. The history and physical were reviewed by the investigator and no other diagnosis was given other than fever. The reporting investigator considered that the fever was possibly related to all three study vaccines. Follow up information was received from the investigator on 06-Jan-2012 and the following fields were update: AE screen, episodes profile, lab/diagnostic screen and the narrative. Follow up information was received from the investigator on 10-Jan-2012 and the following fields were updated: episode profile and the narrative. Follow-up information was received on 12-JAN-2012 from the investigator. The following field was updated: narrative. Additional information is not expected. This is an amended report, it was requested to provide the relationship to ROTATEQ and Pneumococcal 13 as related.
The backs of both knees seem tight and tender.  They are NOT red or swollen on the outside.  About 2 weeks into it the inside of one knee began to hurt - Tylenol and ice does help.
Mild congestion starting the night of injection The day after injection I experienced a low grade fever, chills, extreme muscle soreness, headache, and soreness at the injection site. These symptoms lasted approx. 24 hours and then subsided.
Client presented at the vaccination site on 12.18.21. Client reported she received first dose of Moderna COVID vaccine on 04/20/21 (lot #: 001C21A) at the clinic with no issues. She reported with second dose of Moderna COVID vaccine on 05/18/21 (lot #: 024C21A), after 30 minutes observation and left the vaccination site, she developed tingly and numbing lips, stuffy nose, and watery eye but denied shortness of breath (SOB) or any other symptoms. She reported she took one oral pill Benadryl 25 mg at home and all symptoms resolved on the same day. She denied any chronic illnesses or taking any medications. She told she didn?t follow-up with any doctor since she didn?t have any health insurance. PHN referred client to call to apply for insurance. PHN educated client to seek EMS if she experienced any reactions to the COVID vaccine even if she doesn?t have any health insurance. She reported she had a history of aspirin allergy with her throat closed and SOB. Then she reported she took three Benadryl pills 25 mg each with help for the aspirin allergy. Client is requesting for the booster dose of Moderna COVID vaccine today. PHN submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Moderna COVID vaccine. Per the doctor, approval to proceed with the booster dose of Moderna COVID vaccine was obtained via text message from clinical project coordinator. Client received the booster dose of Moderna COVID vaccine, LOT#: 069H21A on 12/18/21 at 1309 by RN. The client did not report any symptoms during the 30-minute observation period. PHN educated client on possible adverse reactions and when to seek EMS. Client verbalized understanding. Client left vaccination site at 1339 unassisted and with a steady gait.
Severe (L) UE pain/numbness, which radiated to entire trunk. Fever 102.4 degrees po.
no energy; fatigue; this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down my spine,; this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down my spine,; nauseous; Immediately I felt heat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Lot number: EW0164) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING HOT (non-serious) with onset 15Apr2021, outcome "recovered" (15Apr2021), described as "Immediately I felt heat"; ASTHENIA (non-serious), outcome "unknown", described as "no energy"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN (non-serious), outcome "unknown", BURNING SENSATION (non-serious) with onset 15Apr2021, outcome "not recovered" and all described as "this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down my spine,"; NAUSEA (non-serious) with onset 15Apr2021, outcome "not recovered", described as "nauseous".  Additional information: Caller had her first dose of the Pfizer Covid 19 vaccine on 15Apr2021, "Immediately she felt heat. She has had the flu and pneumonia vaccines and never felt this before. As soon as it was injected, she could feel heat in the arm. When she brought the needle out, it's like the heat went down her arm and then just stopped within 5 minutes. she sat there until it dissipated. She has been struggling ever since. every day she has absolutely no energy, she suffered from fatigue but have never felt anything like this. She was completely depleted from this. She suffered with chronic pain anyway. She has diseases in her spine, this pain hits between my shoulder blades, real deep, real burning, deep, deep burning pain, down her spine, it just hits her. She was also very nauseous, been nauseous ever since she took the thing, to the point where she can't eat.  No follow-up attempts are possible. No further information is expected.
Fatigue; Congestion; Headache; Low grade fever; Sore throat; Anatomical location at left leg; This is a spontaneous report from a contactable consumer, the parent. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0168) via an unspecified route of administration in the leg left on 15May2021 at 09:00 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and penicillin allergy. Concomitant medications included cyanocobalamin (B12) on unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered in the left leg hence there was a medication error (vaccine administered at the inappropriate site). On 15May2021 at 15:00 the patient experienced fatigue, congestion, headache, low grade fever and sore throat. On 16May2021, the patient underwent rapid antigen test for COVID-19 virus and the result was found to be negative. On 16May2021, the patient underwent PCR test for COVID-19 and the result was pending. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events fatigue, congestion, headache, low grade fever and sore throat were not recovered.  No follow-up attempts are needed. No further information is expected.
HEADACHE (MIGRAINE) 8/10 . PATEINT REFUSED EMERGENCY SERVICES AND/OR CALL MD B/P 141/94 PR 64 @11:35 PM  B/P 185/98 PR 60 @11:45  NO N/V NO CHEAT PAIN
Difficult to walk; Arthritis; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficult to walk) and ARTHRITIS (Arthritis) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced GAIT DISTURBANCE (Difficult to walk) and ARTHRITIS (Arthritis). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (Difficult to walk) and ARTHRITIS (Arthritis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Information has been received from a nurse concerning a male patient who on an unspecified date was vaccinated with Pneumovax 23 (lot # 651328/1046P). Subsequently, the patient developed swelling and redness at the injection site which spread all over his arm. IT was reported that the patient had previously received vaccination with Pneumovax and did not experience any reaction. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Sore Throat, pain in ears, Cough with green phlegm, swollen glands.  Treatment is a 7 day course of Amoxicillin taken twice a day. The app doesn't give you an option to explain further about the symptoms. I do  not think the symptoms are related to me receiving the Covid vaccine. I did go to Urgent Care and they did not think it was related either. This is a virus that caused me to develop a sinus infection. I did however test positive for Covid on 6/24/22 after I had received my 4th dose of the Covid vaccine on 6/2/22.  I did however travel from 6/10 - 6/22. I do believe I caught Covid while I was away, most likely the BA.5 variant. It seemed that the 4th dose did not provide protection to prevent me from catching Covid however I did not have a severe case so it did protect me from hospitalization.
pt devel 2cm x 4cm abscess like lesion @ inj site; pt was treated w/10 days of augmentin, however abscess has not resolved; may require I&D & referral to dermatologist
Swelling within 2 hour at site of injection. Ice applied swelling continued for 3 days. Swelling from site of injection to mid forearm. Red and warm to the touch. Ice and elevation continued. No systemic symptoms. Improved day 4. No symptoms by day 6.
Patient was give the 3rd dose too early (4 weeks from the 2nd dose instead of 8 weeks). Pfizer was contacted and recommended patient to get a 4th dose 8 weeks after the 3rd dose.  Patient contacted and appointment was scheduled.
Itching at injection site immediatly after administration. Half dollar side pink very sore lump at injection side for approx. 3 days following injection. Four days after injection extreme fatigue and headache for 2-3 days before symptoms subsided.
pt says about 4 hours after taking the vaccine she started experiencing a rapid heart rate w/ nausea.  She developed headache and body aches.  The next day around 9:30 AM she another episode of rapid rate. This lasted about 2-5 minutes.  About 4 days later she woke up having chest pain and rapid heart rate.  On 4/26/2021 she went to  Urgent Care.  She had chest x-ray, EKG, labs. She was referred to a Cardiologist.  On 5/4/2021 she went to Cardio Clinic.  She was placed with a heart monitor to wear for 14 days.  Results were normal with the exception of having a rapid heart rate.  Pt still has these episodes with chest pains.
Got my shot w/my covid vaccines. It hurt.; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine. Additional Information:  Receipt Date: 23-APR-2022 Reporter's Comments: This case was reported via (Shingrix page) interactive. The patient received his/ her shot with covid vaccines, it hurt but did not make sick.
"my tongue got sore (not swelling), and had a cold sweat and nauseated feeling, anxious."  c/o mild soreness to back of tongue.  sent for obs.  took zyrtec, tylenol prior to getting vaccine.  eupneic, a/ox4, skin w/d.  no distress"    Blood pressur 160/91
Patient describes vertigo and bilateral tonal tinnitus that started several days after her second booster vaccination (Pfizer). Her dizziness has improved but her tinnitus has persisted one year later.
After a few weeks i developed a swollen occipital lymph node on the left side of my head. A couple of weeks after that I started to experience some minor lip swelling. By beginning of July I was having severe hives full body, with angioedema. My swelling and hives did not respond to allergy medication and there was no cause of it in my blood tests. I ended up having to start allergy shots to try and stop them.
Redness of thigh at injection site that progressed to cellulitis requiring hospital admission and IV antibiotics. She had increased seizures due to fever/illness, so she was initially admitted to the pediatric ICU.
02/16/22 presents to Birth Center Triage for "contractions" "39w0d". "No pertinent past medical history"