chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fever; Muscle soreness; Diarrhea; Nausea; I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life; I kept thinking everyday will get better and it's just haven't; Anatomical site of administration-The consumer stated, "On my shoulder, left shoulder."; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left shoulder on 26Feb2021 (Lot Number: EL3247) as single dose (at 63 years old) for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included curcuma longa (TURMERIC [CURCUMA LONGA]), colecalciferol (VITAMIN D 3). Previously the patient received the first dose of BNT162B2 (Lot Number: EM9810) on 05Feb2021 in the left shoulder for COVID-19 immunisation.  On an unspecified date (as reported), the patient experienced chills, fever, muscle soreness, diarrhea, nausea, I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life, I kept thinking everyday will get better and it's just haven't. Therapeutic measures were taken as a result of diarrhea included antidiarrheal. The outcome of the events was unknown (as reported). The consumer stated, "I had my Pfizer second shot on 26Feb2021 and I had chills and the fever and sore muscles and about four days later I started having Diarrhea, nausea and I had it the entire month and I still have it and I tried to eat, if I eat anything normal I just , it didn't works and I take OTC but it's not getting better and I never had this in my life". Anatomical site of administration, the consumer stated, "on my shoulder, left shoulder".  No follow-up attempts are needed. No further information is expected.
Left-arm very painful, foggy brain, tired, nightmares, left arm and leg numbness
Patient reported that he got his flu and COVID vaccine and two days later he developed the flu; Patient reported that he got his flu and COVID vaccine and two days later he developed the flu; Patient reported that he got his flu and COVID vaccine and two days later he developed the flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US182641.  A 73-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), INFLUENZA (non-serious), outcome "unknown" and all described as "Patient reported that he got his flu and COVID vaccine and two days later he developed the flu".  Additional information: It was reported that patient got his flu and COVID vaccine and two days later he developed the flu.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Fever 103F 3 hours after injection given. Went away with bath and Tylenol.
Recipient complained of burning in throat, swelling in lips, and "racing" heart with dizziness approximately 30 minutes after vaccine administration. Transported by EMS to emergency department.
Some Swelling; 3-year-old patient went in for a flu shot and received BNT162B2 instead; 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 parent. Other Case identifier(s): US-PFIZER INC-202101587674.  A 3 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) at the age of 3 years as dose 1 (tris), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "Some Swelling"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "3-year-old patient went in for a flu shot and received BNT162B2 instead".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
(R) arm baseball size swelling, pain, erythema - after MMR and DTAP placed, resolving when seen 7/12/13.
PATIENT HAS SWELLING BETWEEN SHOULD AND NECK ON THE ARM OF INJECTION. TENDER BUT DOES NOT HURT.
Headache, Fever, Diarrhea, NauseaVomiting Local Symptoms: Pain- discomfort, swelling. General symptoms: Fever, headaches, nausea, diarrhea. Narrative:
admitted to hospital with positive test for COVID, COVID pneumonia; hx of COPD, type 2 diabetes, cirrhosis, and known liver mass; stayed in ICU, then admitted to in-house hospice where she later died
each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot. EN6200), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Second dose, Lot. EN6206), administration date: 19Mar2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Third dose, Lot. FH8027), administration date: 14Nov2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch". The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided.   This case was linked to MOD-2021-395985 (Patient Link).
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative who reported the same event for 2 patients. This is for the 2nd of 2 reports. A patient of an unspecified age, race and gender received PREVNAR 13 via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient developed a lump underneath the injection spot since an unspecified date with unknown outcome. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017142827 same reporter/drug/event different patient.
pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2020, the patient received the 2nd dose of Shingrix .5 ml. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced pain at the injection site.
On second night following the second dose, I experienced racing thoughts and images (not hallucinations) while awakened from sleep. I could not control the thoughts and it felt like what I imagine a bad recreational drug experience would be like. It was frightening because I never experienced anything like it.  It was as if my mind was trying to solve visual word and number problems in flashes. I was drowsy but not asleep. I was sweating but did not have a fever.  I had some nausea but did not vomit.  Over the course of the night, it gradually resolved and felt like a "fever" had broken, even though it was not a fever. I wanted to report it because I have not heard of such cognitive symptoms and there is no other explanation I know of. Prior to this episode after the second shot, I had a variety of  minor headaches, body aches, and chills but nothing significant. I had no symptoms after the first shot.  I woke up exhausted   the following day and am still tired but almost back to normal (third 24 hour period after shot). Thank you for your consideration.
mom noticed rash on pt's abdo day p/inject spread over 24 hrs to face & head; recede over the next 24 hrs; mom reports no fever, no ill effect @ time of rash;
Pt received injection on 01/09/2004-client complained of progressive pain and swelling which she reported to our clinic on 01/12/04, advised client to seek medical care to rule out cellulitis/infection.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. From 16-APR-2015 to 30-APR-2015, the patients were vaccinated with improperly stored ROTATEQ rote defaulted to oral (dose, lot # and expiration date were not reported). The reporting nurse stated she had no research the medical records, so it was unknown how many patients were involved. The nurse stated no adverse effects were experienced by any patient. This is the one of several reports from the same reporter's source. Additional information has been requested.
Localized redness and swelling to left thigh at site of Varicella vaccine, clustering of vesicular lesions noted. Slightly painful and warm to touch. Supportive treatment as needed.
The morning after patient received the Hepatitis A vaccine he developed stuttering which progressed over 2 months and then gradually resolved.  He had excellent language skills prior to the vaccine and now is back to his usual state.
COVID-19; COVID-19; Sneezing; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4497527-00 (Agency).  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19"; SNEEZING (non-serious), outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Unknown date covid test: positive. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of drug ineffective, covid-19, sneezing.  Clinical course: The patient was treated with Paxlovid. Solicited report from a consumer of an elderly female with events of non-serious Sneezing and Covid-19 with Humira (Adalimumab). The patient experienced Sneezing and Covid-19. On an unknown date, Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. There was no reported medical history. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. On 16Aug2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information, treatment drug information and narrative description. The event of "tested positive for covid" was amended to "covid-19". The event of "sore throat" was removed.  Reporter's causality of events Sneezing, COVID-19 with suspect Pfizer BioNTech COVID-19 vaccine (Tozinameran) was reported as possible. Causality of events Sneezing, COVID-19 with suspect HUMIRA was not reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective, covid-19, sneezing and BNT162B2.
Temperature: 101.2; lethargic with glazed eyes, Mouth was ajar and resident mouth was unable to closed, unresponsive
patinet supposed to have the 2nd dose on 14May but did not get it, no AE; Initial information was received on 18-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient with unknown demographics who supposed to have the second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] on 14-May-2020 but did not get it.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication were not reported.  On 11-May-2020, the patient received a first dose (day 0) of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date were not reported) via unknown route in unknown administration site for post exposure immunization. Then was supposed to have the next dose on 14-May-2020 but missed that dose and came on 18-May-2020.  It was an actual medication error due to missed dose.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
9/18/06 Received 4 shots.  Left arm red, swollen & hot.  No fever.  Has not been to PCP.
Persistent pain in left arm after second dose of Moderna. Mild presentation in relaxed position. More pronounced when deltoid is in flexed position.
little bit of muscle soreness on her right arm; little bit of muscle soreness on her right arm; This is a spontaneous report from a contactable consumer (patient's daughter). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 23Mar2021 17:38 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunization, at the age of vaccination of 59 years old.  Medical history reported as none. Concomitant medications included esomeprazole magnesium (NEXIUM 24HR) taken for antacid from an unspecified start date and ongoing, taking for a couple of years.  The patient experienced little bit of muscle soreness on her right arm (non-serious) on 23Mar2021 with outcome of recovered on 24Mar2021. Reported her mother received the first dose of the Pfizer COVID 19 vaccine on 23Mar2021 at 17:38PM in the right arm. She only had a little bit of muscle soreness on her right arm after the first dose and it went away the day after.   No follow-up attempts are needed. No further information is expected.
Post vaccine pt became lightheaded and dizzy. Pt placed in supine position. Pt transferred to med obs. Pt reported feeling better after laying on stretcher. Pt had no complaints of chest pain. Pt had no complaints of SOB. Vitals obtained and monitored. Pt released at 5:18 PM. Vitals as follows: 1711 LYING BP 164/79 HR 71 RR 16 SpO2 99% 1717 STANDING BP 149/98 HR 58 RR 16 SpO2 98%
All-over body rash/Terrible red rash down legs, more on left arm than right arm; Red, chapped skin on both sides of her legs/ Rash gradually cleared from dark red to light red to pink and disappeared; Rash as blotchy, bumpy, ugly, and sensitive; Rash as blotchy, bumpy, ugly, and sensitive; This is a spontaneous report from a contactable consumer. An 80-years-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EL3247; Expiration Date: 21May2021) via an unspecified route of administration in Arm Left on 26Jan2021 15:00 as single dose for covid-19 immunisation. Medical history included dental care from Jan2021 to an unknown date. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) None. There were no concomitant medications. Co-suspect medication included amoxicillin (AMOXICILLIN), oral from Jan2021 (Batch/Lot number was not reported) and ongoing, at UNK, (2 tablets by mouth right away, then 1 tablet by mouth twice daily for a week) for dental discomfort. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. On 27Jan2021, the patient had all-over body rash. The patient states she woke up the next morning to red, chapped skin on both sides of her legs. The rash move down both of her legs, then both arms, but more prevalent on her vaccinated arm (left arm). She describes the rash as blotchy, bumpy, ugly, and sensitive, but not very itchy. Both sides of my legs by my hip looked kind of red, like chapped. Terrible rash all the way down both of my legs. Both arms- more prevalent on left arm and a little blotchier than the Bump ugly rash - called MD took some Benadryl- on a Steroid and the rash went away. Sensitive but not really itchy- just ugly. States she woke up Wednesday and took a shower and noticed on both sides of hips and wonders what it was since the areas was reddish. By the Wednesday evening there was a red rash down the legs from the hips to the ankle. It has cleared up. It gradually got better each day for 5 days. Was treated for the rash with Prednisone 20 mg tablets, where she took 3 tablets for 3 days, 2 tablets for 3 days, 1 tablet for 4 days. Notified the doctor and was told to take Benadryl to help the rash and if she is concerned to have someone to look at it at the Urgent Care. Rash gradually cleared from dark red to light red to pink and disappeared. Outcome of the event was recovered in 2021.
Received my COVID booster vaccine. By the evening, not even 8 hours later, I presented with body aches and a headache. Into the next day, I still present with these symptoms
HEAVINESS IN LEGS; UNABLE TO USE RIGHT LEG TO WALK; NUMBNESS IN HANDS, FINGERS, FEET, & TOES; CHEST PAIN; SHAKING/TREMBLING INSIDE; DIZZINESS; WEAK FEELING.  UNABLE TO DRIVE.  UNABLE TO WALK STEADILY.
Next day after 2nd shot, I had mini-stroke, limp left arm, and drooping left lip. Took one aspirin and left for hospital.  Stayed overnight at hospital.
Patient had no issues when receiving Pfizer Vaccine #1.  Presented on 3/8/21 for Pfizer Vaccine #2.  10:47AM: Received Pfizer Vaccine #2 in Right Deltoid.  10:58AM: Patient reported itching and rash on B/L UE.   10:59AM: Assessed by CRNP. Patient has erythema rash RUE>LUE. However the actual vaccination site was clean, dry, intact with no erythema. The erythema was located below the site and went down to her wrist. Erythema on LUE from elbow down to wrist. No rash noted on chest, trunk, stomach. Patient reports only itching on arms. She has multiple drug allergies and states she only has hives from them. Of note, patient also had very dry skin. Lotion applied to skin and Benadryl 25mg PO administered. Patient continued to be monitored in observation area.  11:15AM: CRNP reassessed and rash appeared to be improving but patient still had some itching 11:30AM: CRNP reassessed and rash on LUE resolved but scratch marks noted. RUE rash still present but improved with scratch marks noted. Encouraged patient to keep sleeves covered over arms and to stop scratching. Patient felt well enough to leave.  11:32AM: CRNP called nephew and updated him on patient's status. Patient was assisted to lobby by MA. Nephew was waiting in lobby for patient to drive her home.
Patient was found unresponsive in her bed on 11/16/2018 by mom and HH nurse. CPR performed. Patient did not respond. ? possible adverse reaction.
Case Completed primary Covid vaccine in March 2021, then was hospitalized for Covid in March 2022. Hospitalized at:  local hospital.   C/o 3 weeks of sob, dx with covid on arrival though fully vaccinated.  She presented to the hospital in respiratory distress with acute respiratory failure. Received Solu-Medrol 125 mg IV, magnesium along with DuoNeb x1 and albuterol x2 in the ER. Flu negative. No F/leuk or any GI distress. CXR unremarkable. Diffuse insp and exp wheezing on exam. Admitted and treated with usual therapies. Did have one medical team for chest pain which was more like chest tightness. This has resolved with improvement of her asthma - still congested on the day of discharge.  --Treated with decadron and will send home with 9 day steroid taper  --continue trelegy, albuterol PRN --continue to follow up with allergy and immunology - on H1 blocker. Encouraged asthma action plan.  --She was on 4L - was on RA overnight and again this am.
pt recvd vax 24FEB94 & 3MAR93 exp 2" raised area @ site that is inflammed;
pt recvd vax;T 103;apap given but still elev;to er; apap given;was sleepy, did want eat; wanted to be held all the time; MD felt had some viral infect;
Extreme pain (8 out of 10) with baseball size swelling at the injection site.  No redness or heat.
Now suffering from Gulf War illness, IBS, chronic fatigue, blurred vision, headaches, PTSD.
Pt noticed "rash" on trunk that spread to both legs in one week. Patient had about 30 "scabby" rash. Slightly itchy.
Redness and swelling to injection site. Pt's wife called the next day to report symptoms and was instructed to use heat on site. TYLENOL pain and BENADRYL for itching.
First and second shot, cold sweats, extreme fatigue, chest pain, heart palpitations, and shortness of breath. Booster shot: extreme fatigue, shortness of breathe, sweating, too hot.
Left sided chest pain few days after second shot. Noted troponin to be elevated. Troponin: 1.27 -> 1.62 -> 1.74 -> 1.62->1.05 -> 1.06 -> 0.99. Normal ECHO. Normal EKG. Dx with myocarditis. Patient's pains symptoms resolved in 1-2 days; observed in hospital until troponin trended down.