chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red blood cell sedimentation rate: 35; Inflammation in my pericardial sac of my heart, around my heart my lungs; Inflammation in my pericardial sac of my heart, around my heart my lungs; This is a spontaneous report from a contactable consumer (patient). A 74-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202) via an unspecified route of administration, administered in left arm on 27Feb2021 (at the age of 74-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included heart valve replacement and heart surgery. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9269) on 06Feb2021 (at the age of 74-year-old) for COVID-19 immunisation. Concomitant medications included prednisone (PREDNISONE) for atrial fibrillation prophylaxis; colchicine (COLCHICINE) for atrial fibrillation prophylaxis; amiodarone (AMIODARONE) for atrial fibrillation prophylaxis; losartan (LOSARTAN) taken for an unspecified indication; metoprolol (METOPROLOL) and  rivaroxaban (XARELTO) taken for an unspecified indication. On an unspecified date after vaccination patient underwent lab test and procedures which included inflammatory marker test that showed the patient's inflammation markers was way up the charts, patient had a lot of laboratory work with unknown result and had a red blood cell sedimentation rate of 35. It was reported that the patient had a huge inflammatory response and experienced inflammation in the pericardial sac of the heart; around the heart and lungs on 09Mar2021. The patient was inquiring if the company has any information on this that could help the situation. Outcome of events was unknown.
Allopecia Areata. First noticed in October 2021 ; though it developed before the day noticed.
12 hrs p/2nd capsule devel severe cramping & had diarrhea & vomited; believes pt had fever because has chills; no skin reaction;
anxiety; tremors/ shaking; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), TREMOR (tremors/ shaking) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D1DF21A, 008B21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Muscle disorder NOS and Immunocompromised.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ANXIETY (anxiety), TREMOR (tremors/ shaking) and CHILLS (Chills). At the time of the report, ANXIETY (anxiety), TREMOR (tremors/ shaking) and CHILLS (Chills) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-361351, MOD-2021-361352 (Patient Link).
tested positive for covid-19 after completing primary series with moderna cov-19 vaccine/Asymptomatic; This spontaneous case was reported by a pharmacist and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for covid-19 after completing primary series with moderna cov-19 vaccine/Asymptomatic) in a  patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for covid-19 after completing primary series with moderna cov-19 vaccine/Asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for covid-19 after completing primary series with moderna cov-19 vaccine/Asymptomatic) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Company Comment: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI event of Asymptomatic COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected AESI event of Asymptomatic COVID-19. The event occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
slightly sore and stiff arm ( similar to tetnis shot)  about 5 hours after; restless, tired, & general feeling "unwell" about 7 hours; fever at 10 hours. Fever of 101.7 sustained from 2 AM through the day until 8 PM when it dropped to 99.8. By 10 PM fever resolved & was asymptomatic. Treatment was Tylenol, hot shower, hot bath, hydration, & rest.
fever, pain, cough--patient says it's extreme and is still sick one month later, he has had to miss work, has seen the dr. and nothing helps.  He insists that the Covid booster shot gave him Covid and says he's very sick and would like a return call to discuss.
At around 12:30 AM Tuesday I woke with minor body aches, minor nausea and chills. The chills became more severe over the next five hours. I took Tylenol at that time (5:30 AM) and the symptoms subsided some, the chills went away completely. I stayed home from work. Around noon I began to get a headache and at 3:00 pm I took Excedrin and my headache and other symptoms seemed to go away. By evening the symptoms returned enough for me to decide not to return to work the next day. At around 1:00 AM Wednesday I got the chills again and this time took my temperature. I had a fever of 100.5. Tylenol helped ease the symptoms again and again I took Excedrin in the late morning for a headache and I felt good the rest of the day. The symptoms did not return this time and I went back to work Thursday. I still feel some fatigue
mom phoned clinic on 25OCT94 stated that 630 or 7PM on noc of vax pt had no fever, but cried out during feeding as if in pain in legs (inject site); mom took pt to another room while holding & pts eyes rolled back, stopped breathing
Initial report received from the non health care professional on 20 October 2013. A 60s female patient whose demographics data (date of birth, age), medical history and concomitant medication details were not reported, had received a dose of influenza vaccine (manufacturer unknown, batch number, route and site of administration were not reported) on 18 October 2013. It was reported that after vaccination, patient experienced "bit under the weather" and thinks she was either coming down with something or having a "stronger than usual reaction to her flu shot yesterday." The patient's outcome was not reported. Documents held by sender: none. Addendum: 30 January 2014. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant corrections were made for reporters e-mail in inbound, patient's age, patient's initials, pregnancy details, first dose of first reaction, event start date, duration in product screen, cycle/series, reporter's occupation, event coding.
On the 2nd shot, my left arm has limited motion. It started a few days after. I have pain and difficulty doing things and limited range of motion. I decided to see the doctor in December. He put me on physical therapy. And I still have limited range of motion. The doctor said it may heal, it will take time. I must do my ROM otherwise it will bother pain. It has not changed. I feel no relief. If I am touched in a certain way, it hurts. The pain was so intense and acute. I could urinate on myself. No one is allowed to touch my arm. The pain is crippling. I have told my doctors.
Patient given influenza Fluzone High Dose vaccine at 11:30 on 11-13-14. She reports that around 2:00 AM on 11-14-14 she awoke with swelling in hands, joint pain, muscle pain and muscle weakness, chills and fever.
Hospitalized 10/2/22-10/7/22 Confusion,  UTI, encephalopathy, thrombocytopenia, hypokalemia, debility,
Left thigh large 10 x 10cm area of redness & heat but not tender. Got BENADRYL and swelling slowly subsided.
Approx. 1 hour post vaccination, employee presented with hives on her chest and redness, soreness at injection site at the right deltoid.
it was rpt fr MD concerning pt who was vax & subsequently exp chickenpox. addl info requested
No Adverse event; received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original.; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original).    No concomitant information was reported. It was reported that there were no temperature excursions involved, and the vaccine was not expired. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666042, US-MODERNATX, INC.-MOD-2022-666046, US-MODERNATX, INC.-MOD-2022-666016, US-MODERNATX, INC.-MOD-2022-666044, US-MODERNATX, INC.-MOD-2022-666045 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666042:Same reporter US-MODERNATX, INC.-MOD-2022-666046:Same reporter US-MODERNATX, INC.-MOD-2022-666016:Same reporter US-MODERNATX, INC.-MOD-2022-666044:Same reporter US-MODERNATX, INC.-MOD-2022-666045:Same reporter
This spontaneous report as received from a nurse 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 between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006778.
Pt was administered a whole vial of vaccine (ie she received 6 dose at one time)
This literature report concerns a healthy 36-year old female patient. On an unknown date the patient received influenza vaccination (manufacturer unknown). Two weeks after influenza vaccination, the patient developed headache, personality change and encephalopathy. She worsened over 1 week and developed gait ataxia and a dense left hemiparesis. CSF (cerebrospinal fluid) showed lymphocytic pleocytosis (white blood cell count 20/uL), elevated total protein (53 mg/dL), elevated IgG index (0.65) and absence of oligoclonal bands. Laboratory studies excluded infectious etiologies. The patient was diagnosed with ADEM (acute disseminated encephalomyelitis) and received a 5-day course of IV (intravenous) methylprednisolone. The patient stabilised and made a substantial recovery with rehabilitation. After 3 years of clinical and imaging follow-up (without further treatment), no additional relapses occurred.
This spontaneous case was reported by a health care professional and describes the occurrence of OFF LABEL USE (not immunocompromised), COVID-19 (Positive for COVID-9), PAIN IN EXTREMITY (Sore arm), PAIN (Achy) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 006B21A and 015M20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 3 dosage form. On 31-Aug-2021, the patient experienced OFF LABEL USE (not immunocompromised). On 08-Sep-2021, the patient experienced COVID-19 (Positive for COVID-9). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PAIN (Achy) and PYREXIA (Fever). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Head cold, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (not immunocompromised) and PAIN IN EXTREMITY (Sore arm) had resolved and COVID-19 (Positive for COVID-9), PAIN (Achy) and PYREXIA (Fever) outcome was unknown. Caller is not immunocompromised but got the third dose/ booster. Concomitant medication use was unknown.
Pt. given first set of immunizations.  Found dead at 8am the next morning.  Autopsy shows cause "undetermined".
Pregnant women received the first dose of the moderna vaccine/ pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant women received the first dose of the moderna vaccine/ pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Aug-2020 and the estimated date of delivery was 02-Jun-2021. On 31-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant women received the first dose of the moderna vaccine/ pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 31-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant women received the first dose of the moderna vaccine/ pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
tested positive for COVID-19; fever of 100 degrees Celsius; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) and PYREXIA (fever of 100 degrees Celsius) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN D3, ASCORBIC ACID (VITAMIN C ACID), ZINC, PROBIOTICS NOS, MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), METOPROLOL SUCCINATE (TOPROL), PRAVASTATIN, CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN LOW), CLOPIDOGREL BISULFATE (PLAVIX) and LANSOPRAZOLE (PREVACID) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19) and PYREXIA (fever of 100 degrees Celsius). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID-19) and PYREXIA (fever of 100 degrees Celsius) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 100 (High) 100 degree Celsius. On 10-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         Action taken with mRNA-1273 in response to the event was not applicable.
Discharge Provider: MD Primary Care Provider:  MD Admission Date: 12/28/2022 Discharge Date: Jan 5, 2023 COVID positive date: 12/28/2022 PRESENTING PROBLEM: Weakness [R53.1] Pedal edema [R60.0] Dyspnea, unspecified type [R06.00] COVID-19 [U07.1]   HOSPITAL COURSE:   Patient is a 84 year-old female with past medical history of chronic AFib, type 2 diabetes, anxiety/depression, diastolic heart failure who presented to the ER with shortness of breath, cough, right chest pain radiating to back and swelling of lower extremities.  In the ER she was found to be COVID positive.  CXR showed right-sided lower lung opacities with mild cardiomegaly.  Was also noted to have mild hyponatremia with sodium 128 in the ER.  Of note, patient noted symptoms of lower extremity swelling, feeling anxious and occasional visual changes after starting Paxil a few weeks prior.  She was never hypoxic in the ER but there was concern about her ability to ambulate due to generalized weakness.  Patient was admitted to the hospital with concern of COVID pneumonia; she was not started on remdesivir/Decadron as she was not having hypoxia on admission.  She was given 1 time dose of IV Lasix for mild hyponatremia.  EKG with afib but no new signs of ischemia, trops collected and flat 18-- >19.  Mildly elevated BNP at 3101.    After admission, patient continued to saturate well on room air above 95%. Due to lower extremity edema did perform echocardiogram which came back showing new systolic CHF with EF of 35% and moderate global left ventricular systolic dysfunction. She was diagnosed with Acute Combined Systolic and Diastolic CHF - started on IV Lasix and Cardiology consulted.  Due to anemia did also check iron studies which came back consistent with iron deficiency anemia for which she received IV Iron.   Her edema improved and she was transitioned to oral Lasix 20 mg daily,  ToproL XL. Losartan 12.5 mg daily added per Cardiology recommendations and continued on home Xarelto. Her hyponatremia resolved.   She had anxiety concerns - offered to restart Paxil and/or alternative including Cymbalta but patient declined any additional therapy. She was prescribed as needed Atarax for 7 days (this was helpful to her in the hospital) until she can follow up with PCP. Pt's constipation had resolved.   I reviewed all medication changes, need for PCP follow up and routine labs, daily weights, 2g Na/2L fluid restriction, consideration for ASA 81 mg (pt wanted to discuss w/her Cardiologist), all medication changes and COVID precautions. I also called son and updated the same. Son stated he did not receive any calls from me the past 2 days, but I did clarify that his phone rang and ultimately went to a business voicemail so I did not leave a message to protect patient's privacy.    Patient is discharged home on 01/05/2023 in stable condition.
The shot burned much more than usual while it was being injected. It was around 9.30am EST. I felt fine immediately after until 3-5 hours later when I noticed I was having very severe nausea and intense abdominal pain. I took 4mg of ODT ondansetron around 4pm EST and had no relief.  I tried taking a dose of Pepto Bismol also around 4pm and had no relief. The pain got progressively worse so I called the Clinic  around 12.05am earlier today and asked to speak to the infectious disease doctor on call. There was confusion about which injectoon I received. The doctor said he believed I received the Bexsara and said if the pain was that bad, I should go to the ER. I told him that I?d rather wait until morning to go in to an ER, so he advised me to take 1g of acetaminophen and keep a heating pack on my abdomen. I took 1 gram of acetaminophen and 4mg if tizanidine as well and was able to fall asleep.  I woke up to moderate  arm pain and redness at the injection site. There is a very hard bump where I received the injection. I have some minor itching on my neck, chest, and right shoulder.