chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; Not feeling well/he just doesn't feel up to par; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 15Feb2021 (batch or lot number was not reported) as dose 1, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced chills but patient not sure if he had chills before the vaccine or after, not feeling well and he just doesn't feel up to par. Patient stated he got the shot first shot 15Feb. He confirms the Pfizer COVID 19 vaccine. He felt good for quite a while then he started getting chills. He may have had some chills before, but he is supposed to go up this morning to the drug store and have them run a test to see if had the COVID or if he doesn't have it. He asks will that test tell him if had the COVID or if this is a reaction from the shot. He hasn't had fever, he is not sure if he had chills before the vaccine or after but about week after had the vaccine, maybe a little less, he wasn't feeling really well, he just doesn't feel up to par. it just so happens he has a pacemaker and he was going to see his doctor for a check up on Thursday of this week and he told them he was not feeling well and they said okay they told him they were going to have him go into the (Specialty Pharmacy name) this morning and have them run a test to see if he has the COVID virus and he is wondering if that would tell if he had the COVID virus or if it's a reaction to the vaccine, he asks does call handler think they will be able to tell him that. He stated his main concern is he is going in week from next Monday for the second shot. He asks is there any chance that they will tell him not to get the second shot because he would be due to have the other shot so if he gets that he wants to know if he will have the same reactions or little bit less. He can't answer questions right now because he has to go have that test ran so he is short on time. Patient stated what he would like to know is when that test comes back it could be next Monday or Tuesday or it could be back this week but once they get the test back will they be able to tell if he had COVID or if it is reaction and then will they tell what to do the second one. No treatment received for the event Not feeling well/he just doesn't feel up to par. The outcome of the events was unknown.   Information about Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.
After vaccination patient felt lump in throat. RN gave Cetirizine 10mg PO x1, patient felt lump subsided and went home.
VERY ITCHY RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced very itchy rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very itchy rash was not reported. This report was non-serious.
Twitching, seizure like effects, weakness, tired feeling, spasm continued for several days afterwards.
pt recv vax & exp fever, chills, swelling @ inj site, swelling & soreness the injected arm & in the breast, along w/inflamed lymph glands;pt recovered;
Miocarditis/Pericarditis, He stayed at the Cardiad ICU at Hospital for 3 days.
headache; dizziness; ear problem/hurting; ear problems at times, it swells,; eye/ nose back of the neck hurts; allergies; Sinus infection/ congestion; don't feel good; feels like act up right now/feels lousy; congestion; swelling on the right side of nose and eye; swelling on the right side of nose and eye; After taking it, all the sinus infection and congestion has increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 88 year-old female patient received bnt162b2 (BNT162B2), administration date 04Jan2022 13:00 (Batch/Lot number: unknown) at the age of 88 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Migraine" (unspecified if ongoing), notes: She takes Imitrex for her migraine; "neck problem" (unspecified if ongoing), notes: due to car accident; "sinus infection" (unspecified if ongoing); "congestion" (unspecified if ongoing). Concomitant medication(s) included: AMITRAZ taken for migraine. The following information was reported: HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "headache"; DIZZINESS (non-serious) with onset Jan2022, outcome "unknown", described as "dizziness"; EAR PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "ear problem/hurting"; EAR SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "ear problems at times, it swells,"; NECK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "eye/ nose back of the neck hurts"; HYPERSENSITIVITY (non-serious) with onset Jan2022, outcome "unknown", described as "allergies"; SINUSITIS (non-serious) with onset Jan2022, outcome "unknown", described as "Sinus infection/ congestion"; MALAISE (non-serious) with onset Jan2022, outcome "unknown", described as "don't feel good"; FEELING ABNORMAL (non-serious) with onset Jan2022, outcome "unknown", described as "feels like act up right now/feels lousy"; NASAL CONGESTION (non-serious) with onset Jan2022, outcome "unknown", described as "congestion"; NASAL OEDEMA (non-serious), EYE SWELLING (non-serious) all with onset Jan2022, outcome "unknown" and all described as "swelling on the right side of nose and eye"; CONDITION AGGRAVATED (non-serious) with onset Jan2022, outcome "unknown", described as "After taking it, all the sinus infection and congestion has increased".  Additional information: she has received 1st dose of Pfizer COVID 19 vaccine yesterday and she has dizziness, headache and swelling on the right side of nose and eye. Her neck hurts. She also had sinus infection before taking vaccine and congestion. After taking it, all the sinus infection and congestion has increased. She also had migraine, arthritis, and was feeling lousy. She was transferred from Pfizer Medical Information and wanted to know if these were because of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 15 year old female who on 06-MAR-2009 was vaccinated with GARDASIL IM 0.5ml.  Concomitant therapy included a recent shot of DEPO-PROVERA.  The patient experienced dizziness on 06-MAR-2007, 07-MAR-2009 and 09-MAR-2009.  The physician did not say if there was any dizziness occurring on 08-MAR-2009.  The patient "had to leave school".  The patient sought unspecified medical attention.  Dizziness was considered to be disabling.  Additional information has been requested.
3/27/21 5:07 PM Temperature 99 F, repeat 97 F, Pulse 74, B/P 140/100, repeat 138/95.  Patient complained of rash, tickle on lips, tightness in throat, dizziness had patient lie down in First Aid area, evaluated by FNP, Benadryl 50 mg administered IM to left arm.  Patient transported to Medical Center via ambulance at 5:26 PM. 4/6/21 Follow up telephone call to patient.  stayed overnight in the hospital ,throat and lip still numb on and off, rash at POD down neck and right arm, developed itchy rash in the hospital on left arm and leg, rash on torso 3/29/21, experienced confusion in the ambulance, doctor thought might be related to Benadryl, did not reoccur when Benadryl repeated at the hospital, metal taste in mouth right after vaccination, still occurring on and off, temperature 101.7 F 3/28/21, resolved with Advil, seen by PCP (does not wish to identify) 3/31/21 and 4/5/21, blood work 4/5/21, follow up appointment with PCP scheduled 4/9/21, currently taking Prednisone 10/10, had similar reaction after eating salmon last summer, tingling including face, tongue, fingers and extremities, took one week to fully resolve, had eaten salmon previously without reaction.
Patient was vaccinated Wednesday and states she experienced no adverse events until Thursday.  Thursday she reported sore arm.  Thursday through Friday she experienced a headache, which patient states is very rare for her (resolved by Friday evening).  Saturday she noticed large area of redness/swelling/warmth around injection site.  All are documented ADRs, but pt requested it be reported.  This was patient's 2nd vaccination (with first vaccine 8/16/2019 and reported no adverse reactions)
Received GARDASIL 6/4/2007, 7/31/2007, 12/28/2007 - Normal PAP 6/13/2006, 6/14/2007, 3/26/2008 - ASCUS HPV + 8/3/2009.
pt recv vax; to MD's office w/ rash & fever; reporter felt like exp possibly related to vax;
Patient presented to the ER with recent admission to the hospital for acute exacerbation of COPD as well as COVID-19 infection, currently present to the hospital with complaints of shortness over the last 2-3 days and noted to be in acute respiratory failure with hypoxia.  Patient diagnosed with COVID-19 pneumonia complicated by acute respiratory failure as well as acute COPD exacerbation again. Patient was discharged to SNU. Patient diagnosed with acute hypoxic respiratory failure with hypoxia and hypercapnia possibly in the setting of acute COPD exacerbation as well as COVID-19 associated pneumonia:  Patient with prolonged hospitalization course and required ICU care in the beginning.  Patient is status post remdesivir, tocilizumab as well as dexamethasone.  She was also treated on bronchodilators, IV antibiotics and now on oral steroids.  Her oxygen requirement has significantly improved and is currently down to 5 liters/minute which is her baseline at the time of discharge.
DEVELOPED DIZZINESS AFTER VACCINE. BP 168/90 DIZZINESS RESOLVED AND ABLE TO GO HOME
injection site pain; inappropriate reconstitution technique; Inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose and Shingrix at an unknown dose. On an unknown date, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received the diluent portion of the vaccine only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Then the patient was re-vaccinated with full dose the same day and reported pain at the injection site. The reporter had no other information available, as the reporter was calling from home. The reporter consented to follow up.
Dizziness that gotten worse 36 hours after the 2nd dose. Vertigo that gotten worse after 36 hours from receiving the 2nd dose. Pain in feet, legs, waist bones and muscles.  Fatigue and lathargy that started 15 hours after the 2nd dose and is continuing after 48 hours from 2nd dose.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Medium, Systemic: Nausea-Severe, Systemic: Weakness-Severe, Additional Details: Patients daughter, reported to the pharmacy on 10/5/21 that patient experienced severe adverse reaction after receiving her moderna booster on 9/20/21. Patient developed flu-like symptoms on 9/21/21 along with nausea and reduced appetite. Patient subsequently developed dehydration and was admitted to the hospital on 10/4/21. Stated that patient was also in a state of confusion.
On 4.6.21 I started having blood nose events, headache, body ache, and fatigue.  This continued for the next day.  One of the bloody nose events occurred in my sleep waking me up.  A fair amount of blood.
This is a spontaneous report from a contactable nurse. A 72-year-old female patient received dose 2 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the arm on 26Mar2021 at 11:00 (at the age of 71-years-old) (Batch/Lot Number: ER8732) single, for COVID-19 immunization (also reported as so she wouldn't get COVID and die). Medical history included ongoing neurogenic bladder and frequent UTI's (from 3 years ago; she was incontinent but could only half trust the first urologist so she switched to a specialist which was at another hospital). The patient's concomitant medications were not reported. The patient had no additional vaccines administered on the same date as the Pfizer vaccine considered as suspect and had no prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. The patient received dose 1 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) via an unspecified route of administration, administered in the arm on 05Mar2021 at 11:00 (Batch/Lot Number: EN6205) single for COVID-19 immunization. The patient experienced suspected COVID-19 in 2021, wheezing on an unknown date, and flu symptoms, nasal congestion, cough, and malaise on 25Jul2021. The patient got the Pfizer vaccine back in Mar2021 and right now, as of last Sunday, she had felt like she was sick. She hadn't been sick in years. She had the flu symptoms, the stuffed up nose, the coughing, the whole bit. She was better, but not perfect yet. The patient confirmed that symptoms have improved. According to the patient, she lived in an apartment building where a number of people did not get vaccinated and she thinks that may be the cause of her sickness. Also stated that she had no external reaction to either one of the vaccines. The patient kept in mind that the air quality had gone directly gone downhill since the fires even though she was on the east coast and apparently their air quality had gone down which could be contributed to her experience because she's having some wheezing on an unspecified date. The events did not require a visit to the Emergency Room or Physician's office (sent a message on Monday and haven't heard back). On 04Aug2021, the patient reported that she had the vaccine and was having COVID symptoms. Outcome of the events 'suspected COVID-19' and wheezing was unknown, while for the rest of the events was recovering (also reported as ongoing).
Fever, pain all over the body, extreme fatigue and brain fog for the first 24 hrs, then fever and pain lessened a bit but remained until 4/9/21. Brain fog and fatigue for 4/10-11. Started to feel better, but asthma symptoms  and very mild chest pain came on 4/12/21 at 7p. Still in brain fog and fatigue. Peeing much more often, during this whole time. Can't seem to stay hydrated.
pt recv vax 14APR98 930AM & noticed a raised rash over chest & back;epi given;911 called;rash beginning to fade;no other sx;pt transferred  by amb to another hosp;seems sleepy & sl more pale;
I was very tired and had extreme fatigue. I had a sore throat with a painful dry cough. I had body aches. I had chills and was shivering but I was not cold. I did not have a fever until I was 4 days in. It was 101.4. I completed 2 home COVID-19 test and they were both positive. The doctor put me on PAXLOVID, and I am scheduled to take my last dose tomorrow. I still tire easily, and I have a little bit of a cough that is mildly productive. I am uncertain whether or not I have recovered. On Monday, I started feeling like a tight band around my chest and I started feeling short of breath, like I had to take a deep breath. I got a pain radiating I my back where the tightness was. I went to the ER, and they completed a COVID-19 PCR, a Flu test.
head cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 02Dec2021, outcome "unknown", described as "head cold".  Additional information: The patient was scheduled to get his booster shot on 02Dec2021 and he was not sure if he should get it. Reporter asked what was the recommendation for getting the shot while he has a cold?   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection was on 11/20, Cold and flu-like symptoms started 11/21 (head congestion/increased nasal drainage and mucous, sneezing, watery/red eyes, HEAVY wet coughing, low-grade fevers and loss of appetite for days) followed by total-body rashes and hives which emerged on 11/28 and again 11/29.
pt recvd vax & mom called because arm started to get swollen & red & fever; referred to MD MD said infection started on ATB;
Pfizer 1/5/21, 1/26/21, 10/22/21. Positive on 1/18/22
The injection site is swelling; The injection site is swelling, redness; Arm pain; No fever other than at the injection site; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 04Jan2022 at 12:15 (Lot number: 330258D) at the age of 57 years as dose 1, single for COVID-19 immunisation. The patient did not have any relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 05Jan2022 at 13:00, outcome "unknown", described as "The injection site is swelling"; VACCINATION SITE ERYTHEMA (non-serious) with onset 05Jan2022 at 13:00, outcome "unknown", described as "The injection site is swelling, redness"; PAIN IN EXTREMITY (non-serious) with onset 05Jan2022 at 13:00, outcome "unknown", described as "Arm pain"; VACCINATION SITE WARMTH (non-serious) with onset 05Jan2022 at 13:00, outcome "unknown", described as "No fever other than at the injection site". It was unknown whether therapeutic measures were taken as a result of events.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Severe: fatigue headache diarrhea muscle pain joint pain chills nausea lasting 48 hours Had problems staying hydrated due to nausea
Extremely sore arm on the 5th day after injection. Red ring around injection site about the size of a half dollar that was not there after initial injection. Then Shingles outbreak on my forehead.
swelling in her right knee, not sore or hurt, just swelling.; This is a spontaneous report from a contactable consumer (patient reported herself) via sponsored Program . A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, NDC number: Unknown) via an unspecified route of administration on 14Jan2021 at single dose to avoid COVID 19. The patient's medical history and concomitant medications were not reported. It was reported that, "caller received the first dose of the Pfizer vaccine on 14Jan2021. Caller reports swelling in her right knee, not sore or hurt, just swelling. Caller wanted to know if that was anything she needed to be concerned about. Caller already reported to DSU. Potential duplicate AE. A little bit of swelling in knee after she had first dose of the Covid-19 vaccine". She has had swelling in her right knee. "Caller is calling about Pfizer shot. She got it about two weeks ago and she was waiting for the second shot 04Feb2021. She has had swelling in the right knee and she was wondering if that would be anything she should be concerned about. Later on today she could answer some questions. She said she could answer some now if it did not take too long. She thinks it was on 14Jan2021. When she got her first dose. She noticed her right knee was swollen about a week ago. It was slightly swollen, just a little bit, it was not hurting, just swollen. It had improved since it began. Product details: She confirmed she got the Pfizer COVID-19 vaccine. All she had was a doctors office card that had a date and time for her to be back. She saw her name and the date and time she was supposed to be there. It was just the name of her primary care doctor then it had their name and address and the phone number and they told to her to bring it back with her. She did not see any NDC, lot number, or expiration date. She said it was just a doctors office card like they use to write you an appointment reminder. History and investigations: She did not think there was anything that needs to be added. There was nothing that she had not been taking all along". Outcome of the event was recovering. No PQC present.  Information on the lot/batch number has been requested.
tenderness; swelling; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS, SWELLING, and VACCINATION SITE PAIN in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007-M20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included Lymph node transplant. Concurrent medical conditions included Cancer. Concomitant products included CHLORTHALIDONE for Blood pressure high, LETROZOLE for Cancer, ROSUVASTATIN for Cholesterol, GLIMEPIRIDE for Diabetes, CARVEDILOL for Heart rate low.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced TENDERNESS, SWELLING, and VACCINATION SITE PAIN. On 09-Mar-2021, TENDERNESS and VACCINATION SITE PAIN had resolved and SWELLING outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Treatment medicines includes Excerdin.   This case was linked to US-MODERNATX, INC-MOD-2021-096372. Sender's Comments:  US-MODERNATX, INC-MOD-2021-096372: First dose case.
pt. experiencing tingling to the L hand/fingers and L. faces.  patient advised to wait an additional 15 mins.