chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 11/23/2021-currently still admitted; COVID-19 positive 11/17/2021; fully vaccinated  ASSESSMENT / PLAN: Patient is an 89 year old male with past medical history significant for CKD stage 3, chronic afib not on anticoagulation, CAD, chronic combined systolic and diastolic heart failure, and HTN. He was recently admitted 11/17 - 11/20 with fever and AKI. COVID positive but without respiratory symptoms. Discharged in prn 2L nasal cannula (felt to be more related to underlying OSA than COVID). ED reported patient was brought in for SOB although patient denied this. He was noted to have difficulty with ambulation in the ED and then became hypotensive requiring vasopressors. Labs were significant for AKI on CKD, troponin 301, procal .28, and mild leukocytosis. UA was unremarkable. Chest XR diffuse bilateral infiltrates (COVID vs bacterial pneumonia vs vascular congestion). He was started on vancomycin and Zosyn. NE weaned off shortly after arrival to ICU.  Sepsis: Etiology likely pneumonia given chest XR findings  COVID positive 11/17 (but patient reports no symptoms) Procalcitonin mildly elevated at .28 LA WNL  Blood cultures NGTD  Legionella and strep pneumo pending  MRSA screen pending  Sputum culture ordered  NE for MAP >65mmHg, weaned off shortly after arrival to ICU Vancomycin and Zosyn for empiric coverage COVID: Vaccinated in March COVID positive 11/17 Has denied current symptoms  Chest XR with bilateral infiltrates  Decadron 6mg daily  11/29/2021 note: Assessment & Plan: # Septic Shock (Resolved) # Aspiration PNA Presented 11/23 with fever and hypotension and presumed respiratory etiology. Placed on vasopressors Norepi (11/24) and weaned the same day. UA unremarkable. Started on Zosyn and Vancomycin while in ICU and Vancomycin discontinued as MRSA screen negative. Strep pneumonia and legionella antigen negative. Unable to provide sputum sample ---follow peripheral blood cultures x2 (11/23) and no growth to date, maintain MAP >65 ---IV Zosyn (3.375 mg q6 day #6) and continue for now given worsening hypoxia and plan for 5-7 days ---SLP consulted and recommending NPO until respiratory status improves, aspiration precautions ---consult nutrition and likely if respiratory status not improved by tomorrow will need CorPak  # COVID-19 PNA with Acute Hypoxic Respiratory Failure Admitted to hospital (11/17-11/20) with fever and AKI. Treated with UTI at the time with Fosfomycin. Tested positive for COVID-19 (11/17). CXR (11/23) with diffuse bilateral airspace opacities (worsening when compared to prior). Remdesivir (11/18-11/19), Decadron (11/17-11/20). States he is vaccinated against COVID-19, received 2 vaccines a couple months ago.  ---Decadron (6 mg IV daily day #6 - did receive prior to hospitalization),  ---continous pulse oximetry, hold on further lasix at this time given given NPO status    Discharge Coordination/Progress: Pt is currently on high flow O2, per nursing pt continues to aspirate Plan: Pt to d/c when medically stable, to return to assisted living
11:45am Observation nurse alerted charge nurse patient sitting in observation area not feeling well. Patient is primarily , husband and patient are both communicating to charge. Both reports patient is not feeling well and patient is seeing white light. Charge assessed patient. Patient appears flushed. EMS called. Vital signs  BP 124/69, HR 46, O2 100%, R 20. Denies food, fluids or medications before Vaccine. Patient then reports feeling better. 11:52 EMS arrived, assessed Patient. Blood glucose 120, BP 105/61, HR 70, O2 100%, R 18. Patent refuses further evaluation at local hospital. Charge nurse witnessed. Fluids given to patient. Patient and husband informed to contact EMS if symptoms worsen. Patient and husband voiced understanding. Patient and husband left site
he did not give the entire vial, and there was still something left in the syringe.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (he did not give the entire vial, and there was still something left in the syringe.) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (he did not give the entire vial, and there was still something left in the syringe.). At the time of the report, ACCIDENTAL UNDERDOSE (he did not give the entire vial, and there was still something left in the syringe.) had resolved. Not Provided      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.; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.
From initial information received on 05/14/2004 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 40 year old female patient received a TD ADS Adult vaccination, lot number U1017BA, administered intramuscularly in the right deltoid on 05/11/2004.  The next day, on 05/12/2004, the patient developed severe malaise, high fever, pain behind the knees and arthralgia.  Treatment included Tylenol and Motrin.  It is unknown if the patient recovered from these events.
This spontaneous report as received from a health care professional refers to unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with ROTATEQ (dose, route, frequency and lot # unspecified). No concomitant medications were reported. On an unknown date unspecified patients received doses of improperly stored ROTATEQ or ROTATEQ (related case). Patient did not experience any adverse effects. No further information was provided. There was no Product Quality Complaint (PQC) involved. The outcome of incorrect product storage was unknown. This case is linked to: 1506USA002097. Additional information has been requested.
1/19/2021 - sudden onset of chills, headache, muscle pain , joint pain (all joints) & extreme fatigue - continued thru 1/21/2021 1/21/2021 - joint pain resolved, headache & chills, headache & some muscle pain remained - but right groin & inside of right knee were intensely painful & a rash developed on right shin. Rash spread to back of right lower leg & because painful & hot. I called my PCP & went to the ER mid afternoon.
Developed large red, raised wamr to touch area were shot was given, approximately 6cm by 5-7cm. Area was sore, employee able to use arm, no hives, rashes or other problem. Area resloved within couple of days. No residual problem.
Within 16 hours post vax, the pt developed swelling, itching, and redness of left upper arm spreading to lower arm. He also developed a swollen neck, difficulty breathing and swallowing. Treated with an injection of epinephrine and oral anti-histamines.
leg weakness and loss of control of legs that lasted about 24 hours.  spouse had to pick her up for transfers.  there was some muscle activation in legs but not coordinated (knee would move but foot wouldn't move at the right time).  self-resolved.   also some brain fog and confusion
8 day after vaccination got Lump on injection site hot to touch very painful and itchy  now day 9 have under arm pain on injected arm and brown vaginal bleeding
Sore arm at injection site for about five days.  Headache and low grade fever for three days.  Fatigue for three days.  Sudden spotting/light bleeding after menopause (18 days after vaccination, lasting four+ days so far)
Chills and headache beginning approximately 2 hours after injection.  Proceeding to full body aches, fever to 103, sweats and mild nausea over next 24 hours.  Symptoms mitigated by use of Ibuprofen.  48 hours post vaccine, symptoms are resolving - minor headache and sweats remain.  Afebrile.
swollen lymph nodes under left arm; fatigue; This is a spontaneous report from a non-contactable consumer. A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient reported swollen lymph nodes under left arm 24 hours post 2nd injection in left arm as well as fatigue after use of product. Symptoms resolved. The outcome of events was resolved.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
week after the 1st dose, her Blood pressure went up to 210/101/noticed some spikes in her blood pressure; felt a weird sensation; Tingling in her head and her face; pain in the head and got increasing worse/scalp felt on fire/light headache; scalp felt on fire; she felt a little soreness in arm/12 hours my arm hurt; This is a spontaneous report from a contactable consumer (patient's cousin). A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/Lot number: EL9262), via an unspecified route of administration on the left arm, at age 68 years first dose on 20Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included ongoing anxiety from an unknown date. Ongoing concomitant medication included escitalopram 5 mg for anxiety, calcium and an unspecified multivitamins. The patient had flu vaccine in Oct2020. Patient's cousin called on behalf of cousin and reported that patient was very ill for having severe reaction to the COVID Vaccine. Patient was physically fit and thin received first dose of COVID vaccine on 20Jan2021, 10:30 AM. After her 1st dose, she felt a little soreness in arm, 12 hours her arm hurt and light headache the same day. Patient went to bed a little earlier than normal and slept a little longer since she was 69 years, its her body and it needed more sleep and woke up at noon and her arm was fine and very grateful to have the shot. Two nights later, on 22Jan2021, patient woke up in the middle of the night with tingling and pain in the head and got increasing worse, her scalp also felt on fire and had tingling sensation in her face for 3 weeks. Then, a week after the 1st dose on 27Jan2021, her blood pressure went up to 210/101. She went to the hospital, they controlled her pressure and put on a pressure pill 1 a day (amlodipine). She mentioned she had felt a weird sensation on an unspecified date and as she noticed some spikes in her blood pressure, her MD told her to take another 2.5 mg amlodipine if needed (once or twice a day as needed). She confirmed she had no heart rate problems but she actually experienced high blood pressure instead. She never had numbness, instead she had a tingling sensation still present. The outcome of the event 'eek after the 1st dose, her blood pressure went up to 210/101/noticed some spikes in her blood pressure' and 'tingling in her head and her face' was not recovered, for event 'she felt a little soreness in arm/12 hours my arm hurt' was recovered on 21Jan2021, while for the other events, it was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187054 same patient/drug, different event
Chills, body aches and high rapid heart rate while resting for 9 hours consistently running 110-126.
I had the vaccine and I had fever, chills, achy and weak, I almost felt like I had Covid. Then about 3 or 4 days after I continued to remain sick and I passed out on the kitchen floor, my wife called the ambulance and they took me to the ER. They gave me some fluids and ran an EKG on my heart. I was observed for a few hours and released to go home later.  They did not give me any medications.
headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), on 09Jun2021 as dose 2, single (Lot number: EW0172) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose on 19May2021 Lot#EW0164), administration date: 19May2021, when the patient was 14-year-old, for Covid-19 immunization, reaction(s): "headache", "chills". The following information was reported: HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown". Additional information: The patient's mother stated that after the first three doses everything was ok, aside from headache and chills.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039503 same product, event and patient, different dose;
Immunocompromised patient received 0.25 ml as a booster 6 months after the second dose which should have been 0.5 ml as a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 ml as a booster 6 months after the second dose which should have been 0.5 ml as a third dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 ml as a booster 6 months after the second dose which should have been 0.5 ml as a third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received 0.25 ml as a booster 6 months after the second dose which should have been 0.5 ml as a third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The reporter reported that, the patient received 2 doses of the Moderna COVID-19 vaccine 28 days apart. The patient received a booster dose 6 months after the second dose. He received a booster dose 6 months after the second dose. Now, 5 months after the booster dose, his doctor told him to get another booster dose. The reporter reported that the patient's doctor did not tell him to get a third dose and hence he got a booster dose.
Information has been received from a female consumer concerning her 5 year old daughter with seasonal allergy who on 22-MAY-2006 was vaccinated with a dose of PROQUAD (Merck upgrade process). Four days after vaccination, on 26-MAY-2006 the patient presented with a fever of 104 degrees, severe diarrhea, a mild rash on her body, lethargy and an ear infection. The patient sought unspecified medical attention. The patient recovered on an unspecified date. This is one of several reports from the same source. It was also reported that the patient was vaccinated with a dose of MMR II and experienced an adverse event (WAES 1008USA03779). No further information is available.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 16:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 63 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "S/p Gastric Bypass" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 29Dec2022 to 03Jan2023.; Sender's Comments: Based on the available information, the reported events Drug Ineffective and COVID-19 cannot be excluded for the suspect product BNT162b2, BNT162b2 omi ba.4-5.
At 0100 last night, I began having a fever, chills, and contractions. The contractions have continued into this morning. I?m also have body aches, headaches, and nausea. I am G3P2 and currently 34w5d pregnant with an EDD of 2/27/2021.
Patient had a vasovagal syncope episode within a minute of receiving vaccines. Patient was laid on the floor, legs elevated and supplemental oxygen given via NRB. Patient came through about 45 seconds later.
Information has been received from a licensed practical nurse concerning a 26 year old female with no known pertinent medical history or drug reactions/allergies who on 23-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml IM in her arm. There was no concomitant medication. Later on 23-JUN-2008 the patient began to experience itching which developed into hives that night. No lab or diagnostic studies were performed. The patient took oral diphenhydramine hydrochloride (BENADRYL). The patient called the office on 25-JUN-2008 to report this reaction. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 7/15/2008. Information has been received from a licensed practical nurse concerning a 26 year old female with no known pertinent medical history or drug reaction or drug reactions/allergies who at 3:30 pm on 23-JUN-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM in her right deltoid. There was no concomitant medication. The patient began itching 20 minutes (also reported as two hours) after the injection. At 3:30 pm on 23-JUN-2008, 2 to 3 hours past the injection, the patient developed hives in her arms and neck. On 25-JUN-2008 the patient called the office and stated that she still had hives. The patient was self treating with oral BENADRYL and cortisone. Additional information has been requested.
States she had a syncope episode in the shower 10/21/22.  Seen in UC and diagnosed with a viral infection.  Continued to feel "off", had a friend take her to ED 10/28/22 due to "heart fluttering".  Cardiac workup done including wearing a 24 hour Holter monitor and abdominal CT.  Reports decreased hearing, her PCP is unsure of if she has a concussion from initial fall.  States she has felt off since 10/17/22 COVID booster and flu vaccine.  Did see PCP 11/3/22, told to take Sudafed for nasal congestion.  Is also unable to sleep more than 2-3 hours per night.  Has been working remotely as she does not feel it is appropriate to drive with decreased hearing.  Does feel that she can work, but has a MD note stating she requires a flexible schedule.   States her supervisor told her to call EHS, although has not missed 5 or more days.
Significant left arm pain that radiated down arm. Had a 2 cm x 2 cm swollen left lymph node and 2 mm induration at injection site.
Sore Throat; Low Grade Fever after 1st booster; Fatigue after 1st booster; Swollen Gland; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), PYREXIA (Low Grade Fever after 1st booster), FATIGUE (Fatigue after 1st booster) and LYMPHADENOPATHY (Swollen Gland ) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 024M20A, 026A21A and 049L21A) for COVID-19 vaccination.     The patient's past medical history included GERD. Concurrent medical conditions included Atrial fibrillation and Graves' disease. Concomitant products included METOPROLOL SUCCINATE, THIAMAZOLE (METHIMAZOLE) and FAMOTIDINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), PYREXIA (Low Grade Fever after 1st booster), FATIGUE (Fatigue after 1st booster) and LYMPHADENOPATHY (Swollen Gland ). On 19-Nov-2021, OROPHARYNGEAL PAIN (Sore Throat), PYREXIA (Low Grade Fever after 1st booster), FATIGUE (Fatigue after 1st booster) and LYMPHADENOPATHY (Swollen Gland ) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, Body temperature: low (Low) Low grade fever.         Concomitant medication also included as supplements (unknown).  She stated that she received 4 doses of Moderna COVID-19 vaccine. She has a hard time reading the lot numbers. Patient reported that she took first booster dose on 18-Nov-2021 and reported that she had Low Grade Fever, Fatigue, Swollen gland, and  Sore Throat. On 19-NOV-2021 patient was back to baseline.  No treatment medication was reported by patient.   This case was linked to MOD-2022-573656, MOD-2022-573657, MOD-2022-573655 (Patient Link).
Muscle pain, weak tired, headaches, fever, neck pain, body hurting all over, had to go to bed very weak. Went 2 ER on 9-12-2018 - still sick. Doc put me in Hospital stayed 4 days.
Symptoms include fever, congestion, cough, conjunctivitis (both eyes), fatigue, malaise. Onset was one day following vaccine for conjunctivitis, three days for remaining symptoms. I am reporting at day five and symptoms have worsened.
Pt vaccinated with MR Vaccine developed fever, 100.5, HA, Muscle & Joint pain - all treated w/ASA. 22AUG90 visual disturbances began, on 24AUG lost vision in rt eye. Ophthalmologist dx optic neuritis. Mutiple sclerosis was ruled out.
Clinic appt 5PM. Vaccines administered ROTARIX, PREVNAR 13, PEDIARIX, Hib. Presented to Urgent Care at 7:50 PM, "crying for 2-3 hrs after receiving his immunizations" per parents. Parents state "head twitching while crying". Assessment at Urgent Care normal exam, easily consolable.
Approximately 4 hours after receiving the vaccines, I had nasal congestion, swelling of eye lids, wheezing, chest tightness, fever (99.5), hoarseness, headache, nausea, dizziness, and passed out x2 when I stood up.  After about 24 hours after receiving the vaccines, I  was able to get up without being dizzy and gradually felt better over the next day.  I did not go to the emergency room.  I took diphenhydramine 25 mg and used my Albuterol inhaler.  I called my PCP office on 9/30/19 to report this adverse reaction and to obtain information necessary to report this adverse event.   I have never previously. had an adverse event to a vaccine.