chrisvoncsefalvay/vaers-outcomes huggingface dataset:
later diagnosed as being immunocompromised sometime; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (later diagnosed as being immunocompromised sometime) 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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNODEFICIENCY (later diagnosed as being immunocompromised sometime) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (later diagnosed as being immunocompromised sometime) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment drug details was reported.  The pharmacist stated the patient was later diagnosed as being immunocompromised sometime after 29 Oct 2021.  Company Comment: This case concerns a female patient of an unknown age, with no reported medical history in this case, who experienced the serious unexpected event of Immunodeficiency. The event occurred in an unknown date after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of an unknown age, with no reported medical history in this case, who experienced the serious unexpected event of Immunodeficiency. The event occurred in an unknown date after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Unknown. The rechallenge could be considered not applicable since the event occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
A non-serious spontaneous report of flu symptoms was received from a consumer involving an 47-year-old male subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST on 09-Aug-2010. On 11-Aug-2010, the patient developed watery eyes, sore throat, runny nose, fever, aches, tiredness, and headache. On 13-Aug-2010, the events resolved. The event of flu symptoms resolved on 13-Aug-2010.
The day after my daughter received her vaccine, she began to feel congested and tired. This was on Sunday, May 23. We got up for school on Monday, May 24, but she was complaining about a really bad sore throat. The school nurse called and I picked her up from school because she was also getting more congested. She began to cough and sneeze constantly and took a long nap. When she woke, she was saying that she was getting short of breath and it felt like her heart was racing, even though she was just sitting. The next day her throat felt better, but the congestion was the same - still coughing and sneezing but her shortness of breath started getting more obvious. I emailed her pediatrician to ask about bringing her in, and they said to report this to the CDC and bring her if if she's not better in the next few days. Today is Wednesday, May 26 and she is still congested, short of breath and overall feels lousy. She is coughing up lots of mucus - greenish and thick. Yuck. I just gave her one pill of a mucus reducer to see if that would help. My biggest worry is about the shortness of breath because that is exactly what I experienced after my first dose of the vaccine. Mine was Moderna and I have seen dr's about it - and actually ended up in the hospital, but they do not believe it to be connected to the vaccine. I will contact them and let them know about my daughter's shortness of breath and perhaps they will think differently. Oh, she's had a slight fever of 99 F on occasions during this.
Pt developed prickly/burning feeling in her neck and back and shortness of breath 20 minutes after she received the vaccination. Resolved with BENADRYL, ATIVAN and reassurance.
This spontaneous report as received from a nurse refers to a female patient of unknown age. Medical history, concurrent conditions and concomitant medication were not provided. The nurse reported that on 12-OCT-2016 the patient was administered a dose of improperly stored PNEUMOVAX 23 (lot # L035687, Exp date 16-FEB-2017), intramuscular. No adverse events were reported. The outcome of the event was unknown. Excursion details included: temperature 47.5F; time frame: 25 minutes. Previous temperature excursion: 33.5F for 20 minutes. Additional information has been requested.
Moderna vaccine #2 given to individual who was not 18 at time of administration.  Patient was 17 years and 6 months old.  No adverse reaction at time of administration.
Patient received Shingrix vaccination on 01/14 and reported soreness, swelling and redness at injection site on the following day 1/15 when she returned to pick up a different medication.  Pt reported taking tylenol and was told to use a compress at the site and to report if additional symptoms appear or if gets worse and doesn't improve.
Bad pain and stiffness in joints, muscles, toe joints, index fingers, etc.  Lasted for 10 days straight. Pain was so bad..I took Vicodin..which I rarely, if ever, take. I hate it..but it was that bad. Ibubrofen didn't work..and Vicodin helped a little. I ended up going to see Dr. and all we could determine was this was a side effect of the MMR shot back in December.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Pt was 89 years of age with a PMH significant for hyperlipidemia, htn, neuropathy. No notation regarding death or recent illness. Lack of cause of death.
Heart palpitations, nausea and headache  Began on 4/5/2021 at 2PM and  mostly resolved by 4/7/2021 around Noon. Heart rate consistently bouncing with little activity. Used Apple watch to  monitor. Heart rate would go from 65-95 or more in a second. Heart rate would be in 120's when walking around or brushing teeth.
Arm pain, followed by headache, general body ache and redness plus hot skin in the injection area (about 2x6 inch spot). Lasted at least 3 days
HERPES ZOSTER DIAGNOSIS IN TWO-DOSE VARICELLA VACCINE RECIPIENT. DX ON 8/19. PAINFUL ITCHY RASH ON RIGHT CHEST AND UPPER BACK. SYMPTOMS IMPROVED BY 8/22. NO TREATMENT.
Rash at injection site 9 days following injection. Rash is oblong and measures 6" across and 3" wide. It is itchy.
The literature marketed report as received from a physician, author of the literature article, referred to 11 patients (age of 1-25 years old) who were diagnosed with blood malignancies (leukemias and lymphomas). Multiple studies indicated loss of immunity after chemotherapy and bone marrow transplant among pediatric cancer patients. Due to high probability of transfusions and reactivation of hepatitis B, some protocols recommend pre-screening of patients for hepatitis Bs antigen and antibody prior to the first dose of chemotherapy. We have noted that many cancer patients had negative prechemotherapy hepatitis Bs antibody even after standard immunization, while healthy controls mount a 90% response with detectable antibodies. This pilot study was developed to test the hypothesis that children with oncologic diagnoses have a prior defective immune response to standard immunization. All patients with a new malignant diagnosis from the institution over the last 2 years were included in this retrospective study. Physicians have found 44 cases from which they excluded 2 with infantile acute lymphoblastic leukemia diagnosed before one year old. All had received their full immunizations (lot#, dose/frequency and route were unspecified) prior to diagnosis.  From the included cases (age of 1-25 years old), 15/42 were found to have mounted an immune response to hepatitis B immunization, 16/42 were not reactive and 11/42 were not tested, resulting in an approximately 50% lack of immunity towards hepatitis B from the evaluated patients. When the diagnoses were analyzed, it was noted that there were 24 blood malignancies (leukemias and lymphomas) and 18 solid tumors (including brain tumors). For the blood malignancies: 11/24 had positive Hepatitis Bs antibodies, 11/24  had negative and 2/24 were not tested. For the solid tumors: 4/8 were reactive, 5/18 non-reactive and 9/18 were not tested. Even though half of solid tumors patients were not evaluated for immunity status, still the numbers show that a similar lack of immunity. This pilot study revealed that 50% of children with new cancer diagnosis have no immune response to standard hepatitis B immunization, compared with 10% of normal controls. Above data brings a different perspective on the current belief that chemotherapy results in loss of immunity suggesting a pre-existent deficiency in the immune response. A larger study would be developed shortly to confirm the pilot data and infer the significant implications of current findings. This was one of several reports that derived from the same literature link. Additional information has been requested.
Redness and swelling and hard lump at site.  Almost gone in 3 days. Then redness swelling and itching  came back much worse. Large hard itchy lump feels hot but no longer sore. About 1 or 2 inch raised hard warm spot at injection site now.  No fever headache or other symptoms.  Itching bothers Sleep a little.
Very fatigued; Nausea; Puffy eyes; Spinning sensation; Moderna same date; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 17:45 (Lot number: FJ1620) at the age of 26 years as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), administration date 06Dec2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Dec2021, outcome "unknown", described as "Moderna same date"; FATIGUE (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "Very fatigued"; NAUSEA (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "Nausea"; PERIORBITAL SWELLING (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "Puffy eyes"; VERTIGO (non-serious) with onset 07Dec2021 11:00, outcome "recovering", described as "Spinning sensation". Therapeutic measures were not taken as a result of fatigue, nausea, periorbital swelling, vertigo.  Additional information: The patient had no other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected.
Random cold 10 days after first dose low grade fever, chills, tired, runny/stuffy nose nothing helped Tylenol reduced fever lasted 4days
Left arm pain, arm tingling down to fingertips following vaccine immediately. 5 days post vaccination pain in armpit. One week post vaccination left arm pain, swelling, redness and warmth at injection site.
Developed severe knee/joint pain (right more than left, mostly while standing/walking) over a few months.  Serious pain lasted approximately 4 months with painful limping and reduced activity.  Pain gradually subsided over a few months.  X-rays did not show anything unusual.  Specialist thought inflamation was a problem in the right knee. No trauma was suspected. Treatment consisted of exercise (as able), high doses of Curcumin, and Tylenol.  It is worth noting that I also received my first ever Flu Vaccine in September of 2021 (before onset of symptoms) and a COVID Booster in January 2022 (during onset of symptoms) that may have aggravated these symptoms.
Patient developed nasal congestion (but also crying reallyt at the same time) and possible itchiness/hives during 15 minute observation period following vaccination. No difficulty breathing through the mouth.
Patient received Pfizer EW0150 by Nurse. Patient in observation area notified Nurse stated feeling of dizziness, flushness, numbness in tongue, throat itching and metallic taste. No audible wheezing, no shortness of breath, and no difficulty swallowing. (BP 153/99, HR, 77, Spo2: 98%) Patient with history of Asthma/Anaphylactic reactions. Allergies to Penicillin. Under observation, patient reports of improvement in condition, although still persistent throat itching and tongue numbness. 25mg Benadryl PO administered. HR: 83, BP:118/80, Spo2: 99%, patient further monitored and states feeling well with all symptoms completely resolve. Pt dc/ed educated on s/s to look out for. (HR 77, BP:112/70 O2:99%)
Developed a few hives (urticaria) 8 hours after vaccination and more generalized urticaria involving trunk the next morning
numbness and tingling left side of face a few hours after vaccine, persisted for 3 days seen by internist Dr. 8/10/21 sent immediately to ER for diagnostic tests received CT scan of head and blood work which were normal
I couldn?t catch my breath and drove to LOCAL Health ER. A CT show a massive Pulmonary Embolism. I was immediately moved to ICU and had a procedure to remove 50% of the clots from my lungs. I consulted with a hematologist and blood tests showed I had no condition or history that would have caused the clots.
I felt soreness in my left shoulder, approximately 8:00 a.m. on the morning of October 12th, 2016.  I also felt a pain in the elbow (felt like on the bone), almost like I had bumped it, but I noticed that it hurt to lift objects or use my arm.  These symptoms lasted for weeks (and still persist).  I thought that they would go away.  I have trouble sleeping and using my left arm.  I finally told the nurse at the Health Dept. (on 11/22/2016) when I had an appointment for the 2nd dose of my immunization (Hep B) and she sounded surprised.  I told her everything that happened and when I noticed it.  I told her that I had an appointment to see my primary care physician on that same day.  I told my doctor the same thing and upon questioning and X-rays he determined that I had bursitis and tendonitis.  He prescribed a medication (either Prednisone or Baclofen).
This patient received a full dose of Moderna monovalent instead of a bivalent dose. The patient had a prior history of completing a primary series of Pfizer.
erythema and warmth to left deltoid area greater than 7 days post inoculation; spreading and intense itching
Patient had previously received all routine vaccines, including a prevnar 7 on 06/03/09, 08/04/09, and 10/02/09.  She had sudden onset high fever, and presented to emergency room.  Blood culture was positive for S. Pneumonia, serotype currently unknown.
COULD NOT MOVE HER ARM, GETTING A POKE FEELING AT LEASE ONCE A DAY, ITCHING, HOT ARM, RED PATCH AND SWELLING.
Large localized reaction to thigh of erythema and edema, with small area of vesicle formation overlying erythema (not adjacent to injection site).
Monitored q 15 min. after vaccine given as child said "not feeling well." Child fainted in lobby, ice applied to neck, legs elevated, and monitored till able to stand. Child left with mom.
On January 3rd, I had a lot of sneezing for about 2 days. January 5th, I had congestion in my head and nose. I also had a cough. Today I still have a lingering cough, congestion, and shortness of breath. I had mild body aches. The most severe issue through the process and now is the cough and shortness of breath. Every other symptom was mild. I have been unable to work since January 3rd because we have to be symptom free to work. When I went to the doctor I was prescribed with Guaiatussin AC and an albuterol inhaler. I was also told to take take OTC meds like Zinc and Tylenol.
(L) deltoid quarter size bump, hard, swollen, hot to the touch, pain to touch.
Vomiting; Diarrhea; Body aches; Headache; Fever; Slept 17 hours after my second shot; This is a spontaneous report from a contactable healthcare professional. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 25Aug2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), loratadine (CLARITIN), citalopram hydrobromide (CELEXA), famotidine (MANUFACTURER UNKNOWN) and atenolol (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received cefalexin (KEFLEX), cyclobenzaprine hydrochloride (FLEXERIL) and thiomersal (MANUFACTURER UNKNOWN) from unknown dates for unknown indications and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration on 04Aug2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Aug2021 at 21:15, the patient experienced vomiting, diarrhea, body aches, headache and fever, all for 4 days and slept 17 hours after the second shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, diarrhea, body aches, headache and fever was resolved on 29Aug2021. The clinical outcome of the event slept 17 hours after the second shot was not resolved at the time of this report.
Patient stated she had fever/chills for first 24 hours after vaccination then resolved. States vaccination site turned bright red for about 2 days,  and about four blister like dots appeared along with bruising. PCP prescribed antibiotics as precaution. Went to ED on 7/10/21 to address bruising/swelling/redness, MD and nurses acknowledged bruising , explained area is healing, no cellulitis.  ED staff advised patient to finish course of antibiotics.
Subsequent to receiving one dose of varicella virus vaccine live on 3/12/96, the pt developed varicella like rash on his trunk and arms on 4/6/99. At the time of this report the rash was still spreading. Additional information has been requested.
COVID Breakthrough. Patient tested positive for COVID sometime in January per notes and again on 2/22/22. She has gestational diabetes on insulin during this pregnancy. No COVID symptoms for 2/22/22 test date. She delivered the baby at 39 weeks gestational age at 10 lb 3.3 oz.
Within 5miniutes of receiving the shot, the thumb and 3fingers of the same arm were tingling with pins-&-needles.  10 minutes after the shot this symptom was still there so I informed the pharmacist.  This was on October 11th and its still the same now on Nov 2nd.  I am concerned that having the 2nd follow-up shot might exacerbate the condition: Ought I be concerned?  I am due my 2nd shot now.
Runny nose for a few days after vaccine administration  Severe rash and burning skin starting on Aug 20th at night, much worse the next morning and has persisted daily. Rash is identical to the rash she had when eating eggs the first time. Screaming that her legs burn. Rash has circular spots and other spots that are large with jagged edges. Improves with Benadryl and cortisone cream but comes back throughout the day.
Patient reports via spouse that she experienced papules on various area of skin in days following vaccination, not near or at site of vaccine injection however.  Papules resolved.
Dose Number: 3; Fatigue; Chills; muscle soreness (entire body); swollen lymph node under left arm; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-years-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 (Lot number: 330258D) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known_allergies:Sulfa Drugs" (unspecified if ongoing); "known_allergies:Dill" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "No AEs occurred with previous two Doses"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left), administration date: 24Mar2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "No AEs occurred with previous two Doses". The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Dose Number: 3"; FATIGUE (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Fatigue"; CHILLS (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Chills"; MYALGIA (non-serious) with onset 22Dec2021, outcome "not recovered", described as "muscle soreness (entire body)"; LYMPHADENOPATHY (non-serious) with onset 22Dec2021, outcome "not recovered", described as "swollen lymph node under left arm". Therapeutic measures were not taken as a result of immunisation, fatigue, chills, myalgia, lymphadenopathy.  Additional Information: The patient had fatigue, chills, muscle soreness (entire body), swollen lymph node under left arm within first 24 hours. No adverse events occurred with previous two doses. The patient had known allergies: SULFA Drugs, DILL. The patient had no other medical history. The patient had no other vaccine in four weeks. Other medications in two weeks: LEXAPRO. No treatment received for adverse events. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination.  No follow-up attempts are possible. No further information is expected.