chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report refers to a 72 year old female patient without history of severe infections. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot#, dose, route and dose number were unspecified). On an unknown date the patient with COP presented for immune deficiency evaluation. Symptoms of cough and dyspnea along with computerized tomogram (CT) chest findings of multiple bilateral opacities improved with a prolonged course of high-dose steroids. As a result, she developed significant adverse effects of chronic steroid use. Attempts to reduce untoward effects of steroids by decreasing prednisone dose to below 20mg/day resulted in recurrence of symptoms and lung consolidation. Laboratory evaluation (date unspecified) revealed mildly decreased immunoglobulin G (IgG) 630mg/dl with low IgG2 108mg/dl and IgG3 8.5mg/dl, normal IgA/IgM; protective titers to tetanus and diphtheria, with suboptimal response to PNEUMOVAX23; low CD3 390/micro-L, CD4 268/micro-L, and CD8 103/micro-L on oral steroids; normal B cells. It was unclear if the patient's immune profile was secondary to prolonged steroid use or if preceded development of COP. SCig with globulin, immune (HIZENTRA) at a dose of 150mg/kg/week was initiated. Concurrently, MMF was started by her pulmonologist. Over 4 years of follow-up, combined SCig and MMF therapy, notably without steroids, resulted in an maintained clinical and radiographic remission. The outcome of suboptimal response to PNEUMOVAX23 was not provided. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
I was diagnosed for the first time with atrial fibrillation I have received 2nd Moderna vaccination 4/6/21
PT Describes Body aches, shakes, and chills all over her body that started in the Left arm approximately 2 hours after vaccination. Pt also describes nausea and headaches.
Woke up Friday Morning and could not feel my face and my teeth hurt. I passed out in my bathroom floor. Rushed to the ER because they thought I had a stroke. I have Bell?s palsy.
About 2 to 3 hours after the shot I was hit with severe fatigue and in both legs on the back of my thighs they hurt and I felt like I was about to fall because I was walking at the time. I had some chills and arm pain the day after the 2nd shot and where I got the shot it was hard, raised, Red and hot to the touch. And a slight headache. I woke up today 3/21/21 and my arm still hurts and it seems like the knot is even bigger with redness and still hot to the touch.
On day 8 after the injection, I developed a large local reaction  in my upper right arm. It was warm, red, swollen, sore and itchy. It resolved without treatment  after approximately 2 days.  It was not a severe reaction, but odd that it developed so many days after the injection. I work as an RN  and my doctor said she saw this  as a complaint from several who have received the vaccine and that I should report it for your records.
Myalgia, NauseaVomiting,  fatigue, fuzzy thinking Narrative:
Narrative: COVID infection following COVID vaccine series 02/09, Pfizer, dose #1 03/02, Pfizer, dose #2 10/28 pt cc: exposure: unknown 10/29 COVID swab, result: detected 10/29 CXR impression: Possible small right midlung pneumonia. Findings of central airway inflammation/bronchitis. 10/29 pt admit to ED cc: n/v,diarrhea dx: LOS: Gastronenteritis & COVID +
I was not aware that I was pregnant at the time of the vaccine, a week later I found out I was pregnant, and a couple days after that I had a miscarriage.
Received 1st SHINGRIX vaccine 8/13/18 and had significant fatigue, body aches and a fever up to 102 degrees for 2 days. Patient states other sxs lasted 1 week.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium, Additional Details: Patient initially lost consciousness within a minute of vaccine administration. Patient then proceeded to have a seizure for about ten seconds. patient woke up, but did not recognize surroundings. Patient did not recognize his wife nor me (I administered the vaccine). Patient became violent and aggressive. I called 911. After ambulance arrived, patient returned to normal and recognized his surroundings. Patient complained of lightheadedness, dehydration, and severe sweating.
Sleeping a lot; No energy; Not feeling hungry; Right arm sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping a lot), ASTHENIA (No energy), DECREASED APPETITE (Not feeling hungry) and VACCINATION SITE PAIN (Right arm sore) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MELOXICAM, TRAMADOL, PROPRANOLOL HYDROCHLORIDE (CARDENOL), ATORVASTATIN and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced HYPERSOMNIA (Sleeping a lot), ASTHENIA (No energy), DECREASED APPETITE (Not feeling hungry) and VACCINATION SITE PAIN (Right arm sore). On 24-Apr-2021, HYPERSOMNIA (Sleeping a lot), ASTHENIA (No energy) and DECREASED APPETITE (Not feeling hungry) had resolved. At the time of the report, VACCINATION SITE PAIN (Right arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that he was taking water tablet.  The treatment information was not provided.   This case was linked to MOD-2021-181954 (Patient Link).
"Knots on back of my head." 10/2/2009. Rash all over body 10/3/09. Today unable to move neck.
Mom states when baby woke up, she had a high fever (by touch) at 08:00. She found the thermometer at 12:00 noon and it was 104.5F (rectally). By 10:00, she had developed diarrhea and vomiting. Took baby to MD at 15:00. Was given Rx antibiotics; gave IV's and drew blood. Took baby to Medical Ctr at 20:00. Temperature 105.5F at 03:00 on 3/23/01.
Bilateral PE with right heart strain and pulmonary infarct.  COVID negative.  Symptoms started 2 days after the vaccine progressively worsened.  Diagnosed to day - 02/13/2021. Unknown whether this is an adverse event, but no history of coagulopathy or risk factors
Patient reports he got pfizer vaccine on 3/31. He developed metallic taste, and numbness on the left side of the face and left hand on 4/3. He was seen in my clinic on 4/6/2020. MRI brain ordered, showing right thalamic sub-acute infarct.
Received injection at flu clinic on 10/10 had immediate nerve (shooting) pain down arm, continued to be "sore" despite warm compresses, 2 weeks post injection cannot bring arm across chest without shooting pain from left shoulder to left hand medial aspect.
The day the patient received the vaccination, the patient had a manic burst of energy that ended up lasting for months. Prior to the vaccination, the patient had stable behavioral patterns. Post vaccination, the patients psychiatric medications were changed and risperidone was added to the regimen and benztropine and gabapentin were discontinued.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with 0.5 ml dose of improperly stored PEDVAXHIB intramuscularly (strength reported as "7.5 mcg", lot # M025192, expiration date was not provided) for prophylaxis. No adverse effects were reported. It was stated that vaccination with PEDVAXHIB was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1609USA008360: US-009507513-1611USA012030: US-009507513-1609USA010831: US-009507513-1611USA012032.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017) (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 34 degrees Fahrenheit for four hours. This is one of two reports from the same reporter. Additional information has been requested.
Patient reports intense itching and subtle hives to the upper body (arms, trunk) starting 2 days after vaccine administration. Itching is not responsive to antihistamine (Benadryl).
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On 29-OCT-2015, the patient was vaccinated with an expired dose of VAQTA injection 50/1.0 U/ml, 1 ml intramuscular, lot # K008984, expiration date 21-OCT-2015. No adverse effects were reported. Additional information has been requested.
pain in right arm.  As the days past on the pain in arm became worse and could not raise arm or hold anything that was heavy.  Extreme pain in right arm; was unable to sleep because of the pain.  I am right handed and it is extremely difficult to do anything, it is very hard to eat, dress myself and do household chores because of the pain in the right arm,
Localized reaction with erythema, edema, induration & warmth.  No edema at lips/tongue/throat.  No mental status changes.
On my way home from receiving the vaccine, I felt slight numbness in my lips (no further swelling, etc.).  Noticed some circumoral cyanosis around my lips after  arriving home. Had a fine afternoon (sleeping following vaccine and 16 hr. shift).  Had dinner and usual evening. Upon going to bed about 11pm,  I experienced chills for several hours, and shortness of breath. Very weak. Called 911 about 3 am - went to hospital ER - O2 sat. 90% enroute. Vital signs stable in hospital ER. Had neg. CXR, EKG, and labs. Also had slight cough and slight bronchial congestion. Received some IV fluids in ER. Left ER at 7am. Went home and slept all day, slight nausea in am. Awoke at 7pm - had good breakfast for dinner. Fine evening and night. Off the next day from work - usual day. It was like having Covid all over again (positive X2 in April - out of work for 5 weeks).  Although the symptoms began about 12 hrs. following the injection and subsided about 24 hrs. later).   My colleagues (work as a nurse in long term care - rehab) who had Covid in the past have experienced similar symptoms following the vaccine, even though we had Covid back in the spring. Dreading vaccine number 2 on Jan. 19th - hopefully I will be ok.
Pt recv vax on 3/11/99; on 3/21/99 pt exp chicken pox-type lesions
Narrative: A 74 year old MALE who received the 1st dose of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction related to  the vaccination-------------------------------------------------------------------------- SYMPTOMS: Fever No if yes temp: n/a Fatigue No Myalgia No Arthralgia No Rash/Hives No SOB No Bell's Palsy No injection Site Reaction Yes Other No if yes describe: sore arm x1 day
Hives all over body and extremely itchy all over body for 3 days; body turns red with raised welt for over an hour from being slightly scratched continuing 9 days later.
Muscle aches; Arm feels like it was punched, after first vaccine; Bad headache, after first vaccine; Slept for 3 hours, after first vaccine; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A 58-year-old female patient received BNT162B2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Aug2021 (at the age of 58-year-old) as dose 1, single for COVID-19 vaccination. Medical history included fibromyalgia, migraines, headache and muscle aches (muscle aches as well from the fibromyalgia). Concomitant medications were not reported. Historical vaccine included Influenza vaccine and usually got a headache. The patient got the first dose on 09Aug2021 (reported as today) and her second dose already scheduled. On 09Aug2021, the patient experienced arm feels like it was punched, muscle aches and a bad headache, after the vaccine. She came home from getting the vaccine and slept for 3 hours. She was not saying any of that was from the vaccine. The patient would like to know if a person had to quarantine after getting the vaccine. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
Information has been received regarding a case in litigation, from a lawyer concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX as permanent prevention and protection against shingles and zoster-related injuries (prophylaxis). (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) due to a health care professional recommendation. On an unknown date, the patient experienced shingles (herpes zoster) and other zoster-related injuries despite being inoculated with the ZOSTAVAX vaccine (vaccination failure). On 03-JAN-2017, the patient was treated by it's health care provider for shingles. It was also reported that the patient suffered serious physical, emotional and economic damages as a result. In addition, the patient would continue to suffer ongoing injuries, included but not limited to: mental and physical pain and suffering (Emotional distress and pain), extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of pre-existing conditions and activations of latent conditions, lost wages, loss of earning capacity and other losses and damages. At the time of report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and  the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
Pain, posterior head, BP 137/78, pulse 74, O2 sat 98%, given juice and rested.
Monovalent mRNA vaccine administered for a bivalent mRNA dose. Patient was dosed with monovalent vaccine prior to me being notified that the monovalent vaccine had had it's EUA withdrawn by the FDA.  The noticed that was released by the Agency dated 05/01/2023 that my supervisor received and was forwarded to me on 05/02/2023.  I read the email on 05/03/2023 after I returned to the clinic office following vaccines.  The noticed from the Agency announcing the withdrawal of the EUA, did NOT specify the date the withdrawal went into effect.  Once I read the notice, I immediately destroyed the remaining stock of monovalent mRNA vaccine FP7136.   The patient did NOT suffer any adverse effects or have any adverse events following the vaccination.  The patient was notified on 05/24/2023  of the issue and that we wanted to vaccinate him with the updated Pfizer Bivalent vaccine but patient declined stating that he was  going to be transferred soon and that when he got there he would just have them give it there.  Patient was released from our custody and transferred on 06/02/2023.
Pt had a rash in  the leg and groin area after injection. Mom also reports he has had a lump at the site of injection the size of a dime since vaccination.
The most severe headache I had ever experienced, as well as pain when I move my eyes around, lastly pain in the injection site for 4 days since
I started having fevers and chills along with headaches 7 hours after getting the vaccine that lasted about 40 hours.  I started having vaginal bleeding 9 days after my injection. I do not get a period or have vaginal bleeding due to my depo shot/birth control. I haven?t bleed in almost 3.5 years. Now I haven?t stopped having vaginal bleeding at it?s been 8 days of bleeding.  I also am a runner and have heart palpations and chest pain on exertion, currently in the process of a cardiac work up to figur out the problem. I have ran almost 900 miles just this year alone, I?ve never experienced anything like this before. And I?ve ran for many years and thousands of miles and again never experienced anything like this. The heart palpations and chest pain started during one of my runs 12 days after my vaccine
Information has been received from a physician concerning a 14 year old female with no medical history, who on 02-JAN-2008 was vaccinated with a first dose of Gardasil (Lot# 659653/1448U).  Concomitant suspect vaccinations included Varivax.  Other concomitant vaccinations included HAVRIX.  On 03-JAN-2008 the patient experienced urinary urgency and frequency.  On 03-JAN-2008 a urinary analysis was performed and showed a trace of blood in the urine.  The patient improved within 48 hours.  The patient then experienced right flank pain, chest pain with chills, and no fever.  On 10-JAN-2008 the patient was admitted to the hospital and experienced nausea and loss of weight.  The patient was better by 11-JAN-2008 and was released from the hospital.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.  03/03/2008 MR received for DOS 01/6-10/2008 with DX: Pyelonephritis. Pt presented to ED with c/o sudden onset flank pain (R chest, flank, back).  Pt txd x 3 days for UTI sx of frequency and urgency). On abx.
1. Fainting/vasovagal at vaccine administration, 2. Inflammatory response at vaccine site R deltoid with moderate myalgia and axillary lymphadenopathy
Pain at injection site. Red raised area around injection site. Pain up and down left arm, some tingling in lower left arm. Felt faint immediately after injection.
Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster dose that had undergone a temperature excursion.).    No concomitant medications were reported.  The case was reported for 53rd out of 77 adult patients who had received the vaccine as reported by the reporter.  It was reported that the vaccine was administered approximately to 77 patients before it was known if the vaccine was ok to use after the excursion.  No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-696122:Master case
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The healthcare worker reported the patient was vaccinated with her second dose of GARDASIL 0.5 ml, intramuscularly, in her right arm at her OB/GYN office on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The healthcare worker reported they did not know the patient had her second dose of GARDASIL, so the patient was again vaccinated with her third dose of GARDASIL at their office on 08-OCT-2012. No adverse effects were reported. No other information was provided. Additional information has been requested.
Vaccination is required by employer. If you decline vaccination they make you wear a mask for months so you basically have no choice but to receive the vaccine. Vaccine was administered with a safety syringe which malfunctioned, causing the needle be retracted from my arm during injection. I felt the vaccine run down my arm and the nurse said that I had to have it again so I was injected a second time. Don't know how much I actually received during the first injection. Within the next 3 hours I developed a productive cough with chest tightness, sore throat and fever, had general body aches and fatigue that lasted about 24 hours.
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot #: M009377 with expiration date: 17-JUN-2017, lot #: M011116 with expiration date: 17-JUN-2017 and lot # M017982 with expiration date: 13-SEP-2017 (route and dose were not reported). The reporter stated that the vaccine temperature excursions were of 35F for 30 minutes and 34.2F for 2 hours. No adverse event was reported in any patient. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information is not expected as there is not consent to follow-up.
AT the time of the injection there was a nodule that formed under the injection site.  There was no discoloration, pain, paresthesias or any subjective or objective  abnormality other than the palpable "nodule."  This was presumed to be a possible hematoma possibly due to puncture of a small vessel.  The IM injection was not affected that we know of.