chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 10/24/2021; COVID-19 positive 10/21/2021; fully vaccinated Assessment/Plan  COVID-19 pneumonia Acute hypoxic respiratory failure - Admit to hospital as inpatient, anticipate >2 midnight hospital stay. - Symptom onset 10/18, PCR+ on 10/21 and again on 10/24. - Desat to 86% on baseline RA, now on 2L via NC. - CXR with extensive bilateral patchy airspace disease. - Continue Decadron started in ER - plan for 10-day course. - Start remdesivir - plan for 5-day course. - Check CTA thorax. - Supportive care, symptom control, proning PRN, encourage IS. - CPO monitoring, wean supplemental oxygen as able. HISTORY OF PRESENT ILLNESS: Patient is a 57 y.o. female with h/o HTN, HLD, GERD, anxiety/depression and obesity, who presented to the ER on 10/24 with 6-day h/o progressive dyspnea, chest tightness, fevers and loose stools.  She was diagnosed with COVID-19 on Thursday and has since been monitoring her SpO2 via home pulse oximeter.  She has been mostly saturating normally at rest, but with any exertion will drop into the 80's.   10/26/2021 note:    CHIEF COMPLAINT: Pneumonia due to COVID-19 virus ASSESSMENT / PLAN: Principal Problem: Pneumonia due to COVID-19 virus COVID-19 pneumonia Acute hypoxic respiratory failure - Vaccinated - 2nd dose pfizer 2/17/21. Hadn't qualified for booster yet unfortunately.  - Symptom onset 10/18, PCR+ on 10/21 and again on 10/24. - Increased oxygen requirements now up to 75% FiO2 HFNC  - CXR with extensive bilateral patchy airspace disease. - Continue Decadron started in ER - plan for 10-day course. - continue remdesevir  - CTA negative for PE  - Supportive care, symptom control, proning PRN, encourage IS. - CPO monitoring, wean supplemental oxygen as able. SUBJECTIVE: Patient overnight had increasing oxygen requirements. Initially required increased regular nasal cannula followed by NRB then was transitioned to HFNC which she is tolerating well. Feeling like air is being pushed in a bit more than usual with the HFNC but overall doing okay with it. She is very grateful for the care she is receiving here. She is proning as often as she can, using the acapella.  10/27/2021 note: CHIEF COMPLAINT: Pneumonia due to COVID-19 virus  Assessment/Plan  Pneumonia due to COVID-19 virus COVID-19 pneumonia Acute hypoxic respiratory failure - worsening.  - Vaccinated - 2nd dose pfizer 2/17/21. Hadn't gotten booster yet unfortunately.  - Symptom onset 10/18, PCR+ on 10/21 and again on 10/24. - Increased oxygen requirements now 100% HFNC with NRB  - CXR with extensive bilateral patchy airspace disease. - Continue Decadron started in ER - plan for 10-day course. - continue remdesevir  - CTA negative for PE  - Supportive care, symptom control, proning PRN, encourage IS. - CPO monitoring, wean supplemental oxygen as able. - will trial push of lasix 40 given coarse breath sounds - consult pulmonology given maxing out on HFNC with NRB overtop periodically ?higher steroids
Patient fainted in front of the billing office after 10 minutes of being vaccinated. Initial Vitals BP 114/75 Pulse 78 Temp 98.4 Oxygen 98% at room temperature Pain 0. Patient was alert and oriented X 3. Patient was stable after 2 vitals BP 111/66, Pulse 67, R 98, and in no pain.
PT RECEIVED SHOT, SAT ON CHAIR FOR 5 MINUTES. PT STATES SHE DOESN'T FEEL GOOD AND SLOWLY FELL OUT OF HER CHAIR. I WAS ABLED TO CATCH HER IN TIME AND LAY HER DOWN ON THE GROUND. PT LOST CONSCIOUSNESS AND STOPPED BREATHING. WAS ABOUT TO PERFORM CPR BUT PT WOKE UP BY HERSELF AND ACTED NORMAL AGAIN.
Two Doses First: 6/25/2018 (lot #TP5E5), Second 11/1/2018 (lot #EH927) Within 12-18 hours of both injections, I developed a high fever. First time it reached 102 degrees, 2nd time 103 degrees. Motrin was able to bring down the fever to about 100 and within 24 hours after it was gone. I experienced extreme muscle aches and pains, headache and pain in my sinuses and teeth and gums too. Injection sight was hot and very sore and tender for 3-4 days. This reactions seemed to me to be excessively severe for a vaccine. I am a very healthy and active 55 year old woman and have never had a reaction to a vaccine (besides muscle soreness) before.
heart rate went up to the 120s or 150s; chills; fever; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 31Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the first dose of the COVID-19 vaccine last 31Dec2020 and did not have any immediate adverse effect. During the night of 31Dec2020, she experienced chills and fever, but the patient wasn't concerned because she knows other people experience it too: some individuals she knew were getting, the fever (could not be clarified further). She was concerned since she had fast heartbeat. Her heart rate went up to the 120s or 150s (ranging to 120s to 140s, 150s). She was concerned if she should go to the hospital to get an IV bolus. Patient had to go to the ER and they gave her some IV Bolus. Patient asked if she should be concerned about the second dose. The outcome of the events was unknown.  Information on the batch number/lot number has been requested.; Sender's Comments: Based on a compatible temporal association, a causal relationship between event "heart rate went up to the 120s or 150s" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Pt developed rhinorrhea, sneezing, eyelid swelling about 20 after vaccination. Pt given dose of Benadryl then returned to office 20 persistent eyelid swelling. Received Benadryl, PN, Observe closely
Started feeling pain in left ribs and chest. Developed bleeding ulcer in November, then admitted to hospital and was hospitalized for 2 days where they found out he had cancer. Had a biopsy a week after and saw his Oncologist the next week. Ended up finding out that he has Liver Cancer. The Oncologist gave him a permanent prescription to take Chemo medication. Participant doesn't think that he had cancer before this and wonders if the vaccine accelerated his condition.
arm was very sore; hard to lift; felt very unwell; lightheaded; was very cold; very minor soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (very minor soreness at the injection site), PAIN IN EXTREMITY (arm was very sore), LIMB DISCOMFORT (hard to lift), MALAISE (felt very unwell) and DIZZINESS (lightheaded) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (very minor soreness at the injection site). On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore), LIMB DISCOMFORT (hard to lift), MALAISE (felt very unwell), DIZZINESS (lightheaded) and NASOPHARYNGITIS (was very cold). At the time of the report, INJECTION SITE PAIN (very minor soreness at the injection site), PAIN IN EXTREMITY (arm was very sore), LIMB DISCOMFORT (hard to lift), MALAISE (felt very unwell), DIZZINESS (lightheaded) and NASOPHARYNGITIS (was very cold) outcome was unknown.             Treatment reported include Ibuprofen Motrin 200mg 3 tabs.      This case was linked to MOD-2021-035895 (Patient Link).
Repetitive vomiting and fever right away.  Followed by swollen lymph nodes, pallor, fatigue, swollen lymph nodes in neck and under chin, stiff neck, lack of appetite, nightmares/moaning in sleep, teeth grinding nightly and sensitivity/irritability.
Phlebitis, Fever, Fatigue, chills, swollen left axillary lymphnode, tenderness in left side of neck Narrative:
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 13-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8736), at the age of 13, on May 15, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had nausea and vomiting, onset May 15, 2021, with outcome of not recovered. Patient stated "I have been having nausea and throwing-up every evening. This never happened before the vaccine." The events evaluated at a physician office visit. Relevant laboratory tests and procedures available in the appropriate section. Therapeutic measures were taken as a result of nausea and vomiting. Additional information: The patient did not receive any other vaccine in four weeks. The patient did not receive other medications in two weeks. Patient did not have COVID-19 prior to vaccination, nor tested post vaccination. AE treatment included bloodwork, upper GI endoscopy/biopsies and series. No follow-up attempts possible. No further information expected.
During the course of the month following the vaccination, my arm has been sore and gotten progressively worse. At the end of the month, I have limited range of motion. Here today with right shoulder pain since she got the flu shot on 12/3/14. Pain started initially in arm with flu shot, Tdap in other arm with no problems. The arm has progressively gotten worse is swollen at injection site and 4 inches surrounding, and now hard to lift her arm. Patient was given both antibiotics and steroids, she will follow up if not improved in 3 days. Vaccine report will be submitted.
Hive like rash appeared on forehead after vaccination. No SOB, wheezing or throat tightness. VS taken and stable. Zyrtec 10mg given PO.
Fever and body aches and now hives all over my body except my vagina and face. Been ongoing for a week and no resolution yet. I have had no shellfish or nuts or prior allergies. Doctor prescribed me with prednisone and levoceterizine which I am using right now, but stopped levoceterizine because it wasn't strong enough and I was having insomnia so am using benedryl up to 3 times a day as needed 25-50mg each.
Nausea/vomit x 72 hours; Arm pain x 2 wks, no redness/swelling.
Pt contacted his primary care doctor the day after he had the PNEUMOVAX vaccination w/ complaints of flu-like symptoms. Also, the area around the injection site was red and swollen. He was physically seen 3 days after vaccination and was diagnosed w/ cellulitis.
This spontaneous report as received from a nurse refers to patients of unknown age. The nurse assumed that since 03-JUL-2014, the patients received PNEUMOVAX 23 for vaccination (lot no, route not reported). There was no concomitant medication. The nurse reported about temperature excursions, with first excursion was on 03-JUL-2014. The worst case temperature was 0 Celsius and the total timeframe was 54 hours. ROTATEQ was one of the affected products. Other products involved were RECOMBIVAX HB, ROTATEQ, and GARDASIL and MMR-II. Excursion was supported. No patient concerns or effects were reported to office post administration of these vaccines, The patients did not seek medical attention. Product quality complaint was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Woke up with sore throat and nose congestion. Feels like there is a ball of mucus stuck in my throat that I can?t get rid of.
I did receive the  Booster in October but unfortunately got Covid in January 2022; I did receive the Phuket Booster in October but unfortunately got Covid in January 2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "I ran a slight temperature after the first shot"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "Rheumatoid Arthritis". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I did receive theBooster in October but unfortunately got Covid in January 2022". The clinical course reported as patient was diagnosed with Rheumatoid Arthritis 3 months after receiving my second Pfizer vaccine for Covid. Patient ran a slight temperature after the first shot and none with the second. Patient did receive the Booster in October but unfortunately got Covid in Jan2022. Patient wondering if you had any feedback similar to experience.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Narrative: Pt developed nausea and emesis of gastric contents without hematemesis 15 minutes following first dose of covid vaccine, leading to ED visit. Pt reported upset stomach throughout the day prior to receiving vaccine and vomited the night before. Lactated Ringers given to patient in ED.
Moderna COVID 19 Vaccine EUA: I received the injection at 1:30 pm, about 5 minute after injection I felt tingling down my left arm.  I was made to wait 30 min  for monitoring  and left the site at approximately 2:10 because the arm issue appeared to have subsided .   As I was half way home - 10 /15 min later, I began to feel tingling of my lips and tongue; soon after that I felt swelling  at the back of my throat and tongue. It was difficult to swallow saliva but did not have issues breathing.  I took a Zyrtec as soon as I got home,  I started to feel the swelling subside about 20-30 min after. I took an additional benadryl  as I still had difficulty swallowing and felt some swelling.  It is now 4:30 pm and my throat and tongue are feeling  more normal now.
Diagnosed with Cellulitis on October 27, 2021 Redness, pain and swelling in right foot
At 34 weeks pregnant, I received my second Moderna vaccination.  I was hesitant to get vaccinated due to not having enough research on vaccine during pregnancy.  I finally decided to vaccinate out of fear from doctor and  variant spread.  My pregnancy was otherwise healthy.  I had a previous pregnancy that resulted in a healthy full term baby with no complications.  I was diagnosed with gestational diabetes about a month prior to second vaccination.  I was managing my blood sugar with diet and I did not require any additional medications.  I exercised daily and maintained a healthy pregnancy weight. This baby was my only viable embryo conceived through two long years of IVF.  Before she was transferred, she had PGT testing done, and she did not have any chromosomal abnormalities.  My scheduled due date from this IVF pregnancy was 11/27/2021.  On 10/15/21, I received my second Moderna vaccination at 6pm.  On 10/16/21, I began to experience a low grade fever around 2pm. I took one regular strength Tylenol for fever along with chills and body aches.  I went to sleep at 8pm. I woke up at 10:30pm.  I was experiencing contractions.  My baby was born 10/17/21 at 6:23am through vaginal birth.  She was 5lbs 1oz at birth, and she was taken to and stayed in the ICU for 15 days before coming home.  Her and I were otherwise healthy, besides her needing oxygen for first 24hrs and having feeding issues due to gestational age.  Thank Goodness.
red, warm pruritic area 6-12 in surrounding ingectionsite. onset 9 days after vaccine administration, Selfresolved within 2 days. No pain, fever, chills
Child developed injection site redness and swelling. Over the next day after the vaccine started to get fevers. Fevers as high as 105 on the second day after the vaccine was administered.
Event: Breathing difficulties, shortness of breath Treatment: Exercise, steroid pills and steroid inhaler Outcome: Slight improvement from steroid pills
Came in for Gardisil #3. Layed down before shot administered to right arm. After 5 mins patient experienced syncope episode while laying on table. Feet were elevated, cool compress to head and back of neck. Kept and monitered for approx 30 mins.
This case was reported by a healthcare professional and described the occurrence of nausea in a 32-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 2 September 2009 and 14 September 2009 the subject received 1st dose adn 2nd dose of TWINRIX (1 ml, unknown, left arm). On 4 September 2009, after starting 'low dose birth control' and 1 hour after vaccination with TWINRIX, the subject experienced nausea and vomiting. On 14 September 2009, 1 hour after vaccination with TWINRIX, the subject experienced nausea and vomiting. The subject started to take low dose birth control on the same date as the initial TWINRIX injection. The nausea and vomiting resolved within one hour of the first injection on 4 September 2009. I was unknown how long the nausea and vomiting lasted after the second TWINRIX injection. At the time of reporting the outcome of the nausea and vomiting after the 2nd dose of TWINRIX events were unspecified. Follow-up information was received on 15 September 2009, via sales representative, who reported the subject still had a headache, fatigue slight fever, but is no longer vomiting. The subject is not taking LOESTRIN, but is using a topical CLEOCIN T. Follow-up information received on 25 September 2009, via nurse practitioner who stated that she thinks that the subject was malingering when she complained about her symptoms. She believes that subject wanted to get out of work and that is why she complained. Follow-up information received on 30 September 2009, indicated that the events resolved and were considered possibly related to treatment with TWINRIX.
mild pain in the site of injection; This spontaneous report received from a consumer concerned a 35 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the subject experienced mild pain in the site of injection. The action taken with covid-19 vaccine was not applicable. The outcome of mild pain in the site of injection was not reported. This report was non-serious.
Painful ache in both knees when I would move the knee. The ache was 24/7.  If I didn't move the knee I did not feel it. Any movement to change position, stand, or walk, would cause the ache. I've never had anything like that before. Taking 2 Advil would alleviate the pain for roughly 8 hours only to then return. The pain was always the same, never more or less. On July 6, 2022 I went to Dr, my Orthopedic doctor, who gave me a corticosteroid injection in each knee. That eliminated the pain to this date. Time will tell if the pain returns.
I had a sudden onset of numbness to the left side of my face.  There was no facial drooping or slurred speech.  I did have some occasional left arm weakness during the event as well. I went to see my PCP the next day.  She prescribed a Medrol dose pack.  We didn't necessarily associate the symptoms with the flu vaccine at that time.  The symptoms improved slightly on the first 2 days of the Medrol dose pack and then returned.  I saw a Neurologist, and I had an MRI of my head and neck. The MRI's didn't show any findings that would be a causation for the facial numbness.  The symptoms finally resolved completely within approximately 3 months.  I didn't report the event, because I thought it was just a coincidence that I had my flu shot on the day my symptoms started.  However, I have recently learned that several others experienced similar symptoms after receiving their flu vaccine last year.  I did get a flu shot this year and didn't experience any adverse reactions.  I did notice that the vaccine and manufacturer were different on the vaccine that we received this year.  Last year the vaccine was Afluria, Lot #09249211A, Manufacturer was CSL Limited.  This years vaccine was Fluvirin, Lot #1411301, Manufacturer was Novartis.
She received 2nd dose Moderna vaccine in her left arm last Tuesday, arm was sore Wednesday, woke up early Thursday morning, couldn't feel hand; after that she developed a headache, sore throat and body aches. States that arm is still "kind of numb and feels cold", employee states that it is "about the same" as when it first happened. States arm is still "reddish, like a rash" at site of injection and further down. She states that she feels rash and redness are spreading. She states that she is comfortable giving this condition time to see if it gets better or worse, and will call EH again on 02/3.
The day after the vaccine chronic nausea, feeling passing out, disorientation. overall weakness for ten days. Including hot flashes... Called doctor and was advised not to take 2nd shot. Called  pharm and tried to cancel the next shot without success. Now reporting it here. Mom does not want 2nd shot
plaques changed to pustules; plaques changed to pustules; Pain worse; pain in medial area of both knees; This spontaneous case was reported by a consumer and describes the occurrence of PUSTULE (plaques changed to pustules), SKIN PLAQUE (plaques changed to pustules), PAIN (Pain worse) and ARTHRALGIA (pain in medial area of both knees) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Rheumatoid arthritis.    Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and FOLIC ACID for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced PUSTULE (plaques changed to pustules), SKIN PLAQUE (plaques changed to pustules), PAIN (Pain worse) and ARTHRALGIA (pain in medial area of both knees). At the time of the report, PUSTULE (plaques changed to pustules), SKIN PLAQUE (plaques changed to pustules), PAIN (Pain worse) and ARTHRALGIA (pain in medial area of both knees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 6.         No relevant medical history was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment drug was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.