chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a red spot there; my arm is sore and I got a red spot where the needle was inserted; this redness it's about 4 inches wide; I have a red spot there; my arm is sore and I got a red spot where the needle was inserted; this redness it's about 4 inches wide; I have a red spot there; my arm is sore and I got a red spot where the needle was inserted; this redness it's about 4 inches wide; I really didn't feel well for half a day or 2 days really; I felt kind of sick; I really didn't feel well for half a day or 2 days really; I felt kind of sick; Headache; This is a spontaneous report from a contactable consumer or other non hcp. An 87-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm on 09Mar2021 (age at vaccination 87years old) as single dose for covid-19 immunisation. The patient medical history was not reported.The patient had historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 16Feb2021 (age at vaccination 87years old) as single dose for covid-19 immunisation. Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); lisinopril (LISINOPRIL); acetylsalicylic acid (ASPIRIN (E.C.)), all taken for an unspecified indication, start and stop date were not reported. On unspecified date in Mar2021 the patient experienced I have a red spot there; my arm is sore, and I got a red spot where the needle was inserted; this redness it's about 4 inches wide, I really didn't feel well for half a day or 2 days really; I felt kind of sick, headache. Additional Context reported as she had Pfizer second shot the vaccine for COVID and she has my arm, this morning, she had it on the 9th, which was 2 days ago, but she has a red spot there and she just wondering if there is anything wrong with it. she really didn't feel well for half a day or 2 days really, and I am feeling okay. When confirmed the vaccine as Pfizer's COVID 19 vaccine, she received it in (Withheld)." When informed the role of Pfizer Drug Safety and that for the concern we do have a separate department named Pfizer Medical Information, well she is feeling better today but you know she had a reaction, the first afternoon she has got a headache and the next day and then this morning she got up and her arm is sore, and she had a red spot where the needle was inserted but she thinks it's going away and she is feeling better. The patient underwent lab tests and procedures which included blood test: unknown results on unspecified date. The clinical outcome of the event was recovering.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
the same day after 3 hours I had chills it went away and then came back after 2 hours had fever and body ache and my arm was super sore and I had a headache. I had night sweats
24 hour after vaccine, pt developed redness 4-5cm around Dtap site. No fever, no pain, no change in ROM of left shoulder, vaccine given to left deltoid.
Had typical flu-like symptoms the day after the vaccinations (Wed, 10/19), but they subsided and I felt fine on Thu, 10/20.  On Fri, 10/21 I woke up at 6:00AM with a sore neck (right side) and headache. Took ibuprofen and pain subsided.  Had regular checkup with my PCP at 8:15AM on Fri and he heard a heart murmur and told me he would refer me to an cardiologist.  Went home, started feeling chest pain at ~11:00AM Fri, along with neck and head pain.  Went to ER on Sat, 10/21 at 11:00AM.  They ran tests and told me I have walking pneumonia and aortic aneurysm.  I went home late Sat night.  Symptoms have been subsiding since Sat.  Got an antibiotic prescription.
This is a spontaneous report from a Pfizer-sponsored program Pfizer RXPathways, received from a contactable consumer (patient's friend). An 81-year-old male patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient broke his ankle and his leg on an unspecified date. The patient's friend stated that the patient is in like a board and care because of the events. The outcome of the events was unknown. The information on the lot number and expiration date had been requested.
I developed really frequently irregular heat beats and chest pains that were along the left breast bone where the pain would come/go. My heart beat would be irregular when I drank coffee. The doctor had me wear a patch for the irregular heat beat and it was applied at the technician in the cardiology clinic (results will send the results to my doctor's office). I had to wear it for 7 days. The PBCs have diminished somewhat and the Chest pain went away after taking the medication that was prescribed to me. The pain may have been a result of reflux disease but I'm not certain.
Constant sore arm for 3 full days which was so sore to the point that I was unable to sleep comfortably for the entire 3 nights after my 2nd Moderna injection. Also extremely painful headache for 3 days following my vaccination which relegated me to my bed for the majority of the 3 days after the injection. I work from home and I was limited in my ability to work for the 3 days following my injection even from my bedroom.
sore arm, runny nose, ear popping, headaches, a couple days after went into a very deep depression, crying everyday, severe fatigue (sleeping for a large part of the day)
pt under age for moderna.  no side effects noted.  Received 2nd dose  rt arm 05/24/2021 027c21a  no reaction or side effects noted
Sudden onset of severe upper abdominal pain, followed by vomiting, weakness/dizziness, with lingering pain. I went to the ER. Zofran and saline were given via IV. Blood tests, urinalysis, and CT with iodine contrast showed all normal results, with only mild hypokalemia. Discharged from ER after 3 hours with no definitive diagnosis but suggestion of a stomach virus or food poisoning. Fatigue lingered for 36+ hours.  Stomach pain recurs when I eat but nausea has subsided for now.
FATIGUE; ARM SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 73 year old female. 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: 1805018 expiry: 20-JAN-2022) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue, and arm soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and arm soreness at the injection site. This report was non-serious. This case, involving the same patient is linked to 20220702579.
I woke up 4/25/22 with a sore throat and as the day progressed I developed a cough, and when I got home that evening and I was coughing more and I never cough and had stuffed up sinuses and the next morning I did a virtual visit and was prescribed Paxlovid the next day.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing), notes: Other medical history: Htn, pre DM, asthma; "asthma" (unspecified if ongoing), notes: Other medical history: Htn, pre DM, asthma; "pre DM" (unspecified if ongoing). Concomitant medication(s) included: CALCITRATE, start date: 06Jun2009. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine", notes: Known allergies: Compazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
expired dose of ActHIB was administered 25MAR2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Other Health Care Professional (HCP) via Medical Information (Reference number- 00539720) and transmitted to Sanofi on 29-Mar-2021.  This case involves a patient with unknown demographics who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB] lot number not reported, expiry date 23-Mar-2021 via unknown route in unknown administration site for prophylactic vaccination on 25-Mar-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  Health Care Professional (HCP) reported expired dose of ActHIB dated 23-MAR-2021 was administered 25-MAR-2021. No further information available. HCP stated it has been reported already on 25-MAR-2021  At the time of report there was 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 holder's 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.
Upon standing, she felt an extreme heaviness along with feelings like she was going to pass out; heart began racing; felt like she was going to be sick; Upon standing, she felt an extreme heaviness; thinks her blood pressure dropped; shaky; her face was completely pale; This is a spontaneous report from a contactable consumer (the patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EP7534), via an unspecified route of administration on 18Mar2021 16:45 (at the age of 43-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: epilepsy, asthma, environmental allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: lamotrigine, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), and antihistamine all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 03:00, also reported as 8 hours after vaccine, the patient's heart began racing, she felt like she was going to be sick. Upon standing, she felt an extreme heaviness along with feelings like she was going to pass out (she thinks her blood pressure dropped). She was shaky. Her husband confirmed that her face was completely pale. The patient's heart raced on and off for another half hour before she felt more normal. No treatment was received for the events. The outcome of the events was recovered on an unspecified date in Mar2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Adverse event: Achy, feverish, dry cough, and headache.  Treated with: 1. Rest and plenty of fluids 2. IBUPROFEN 800MG TAB: TAKE ONE TABLET BY MOUTH DAILY AS NEEDED FOR PAIN, TAKE WITH FOOD 3. GUAIFENESIN 100MG/5ML (ALC-F/SF) LIQUID: TAKE 2 TEASPOONFULS BY MOUTH 4 TIMES A DAY
Follow-up info received provided a revised investigator assessment (possibly related) and event details. Information has been received from an investigator concerning a 12 month old female who received her first dose of MMR II, control for Prevnar vaccine on 2/1/02 as part of the study "Non-Inferiority Study of Immunogenicity of MMR II Administered Concurrently with Prevnar Compared to MMR II Alone." On 2/7/02, she developed a fever. On 2/8/02, she was seen in the ER for a febrile seizure. She had a reported temp of 104 deg F. The seizure occurred as the child was being taken out of the bath and was characterized as tonic clonic in nature and of 1 minute in duration. On 2/11/02, the child returned to the clinic for follow-up and was observed to have a resolving upper respiratory infection. The investigator assessed the child as status post febrile seizure and neurologically intact. The febrile seizure was considered medically important (OMIC). The investigator considered the febrile seizure to be moderate in severity and "possibly related" to vaccine administration.
Panic; Very dizzy; Very nauseous; Felt a lot of pressure in eyes; Left arm went numb, left leg went numb; Light sensitivity; Right arm pain; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERTENSION (Felt a lot of pressure in eyes) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Right arm pain). On 16-Apr-2021, the patient experienced OCULAR HYPERTENSION (Felt a lot of pressure in eyes) (seriousness criterion medically significant), HYPOAESTHESIA (Left arm went numb, left leg went numb), PHOTOPHOBIA (Light sensitivity), DIZZINESS (Very dizzy) and NAUSEA (Very nauseous). On an unknown date, the patient experienced PANIC REACTION (Panic). At the time of the report, OCULAR HYPERTENSION (Felt a lot of pressure in eyes), PAIN IN EXTREMITY (Right arm pain), HYPOAESTHESIA (Left arm went numb, left leg went numb), PHOTOPHOBIA (Light sensitivity), PANIC REACTION (Panic), DIZZINESS (Very dizzy) and NAUSEA (Very nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment details were provided.  Company Comment: Very limited information regarding these events has been provided at this time. The events may be related to the preexisting anxiety the patient has. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events may be related to the preexisting anxiety the patient has. Further information has been requested.
Temp 100 that night.  Then has localized swelling and erythema of deltoid area, got to Palm size.  Improved over course of next week
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unspecified date, the patient was inadvertently vaccinated with VARIVAX (Merck) (route, dose, strength not reported) which was reconstituted with sterile water that did not come supplied with the shipment of the VARIVAX (Merck) (product preparation error). No adverse effects were reported. No product quality (PQC) was involved. No further information provided. Additional information has been requested.
I developed Alopecia areata; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (Dose Unknown, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: ALOPECIA AREATA (non-serious), outcome "unknown", described as "I developed Alopecia areata".  Additional Information: Customer Verbatim was reported as "I am a physician, convinced that I have an adverse reaction to vaccine booster. I developed Alopecia areata. Please help me with samples of Xeljanz."  The lot number for bnt162b2 was not provided and will be requested during follow up.
PT EXP PAIN AND STINGING AT SOI AFTER RECEIPT OF ENGERIX-B.  TREATMENT:  PT COUNSELING.  DOSE #2 22Jan90 PT AGAIN EXP PAIN AT SOI.
"Immediately following the injection, I had severe facial flushing and a fever. They kept me at the clinic for a while to monitor heart and blood pressure as my head also felt strange. My heart rate went high after a series of palpitations and light headedness. There were a few nurses involved contemplating sending me to the ER. Severe tremors also began after the heart issue. I am still dealing with the tremors today. I know the arm pain is to be expected, but has been extreme and  into my chest. I have also been having tingling in my hand".
Migraine, extreme histamine reaction in head producing ear symptoms and stiff neck, swallowing difficulties, fever, extreme fatigue...unable to get out of bed...24 hrs.
only the reconstitute agent was given; only the reconstitute agent was given; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were reported as follows: The age at vaccination was not reported. Nurse only administered one part of the product.  She explained that only the reconstitute agent was given which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.  The reporter did not know any more information. The reporter agree to follow up.
Numbness in feet and lower legs/numbness in my feet and my lower extremities; This is a spontaneous report from a contactable consumer(patient). A 63-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on an unspecified date as dose 1, single for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. Pregnant at the time of vaccination was reported as no. 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 patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 15Apr2021 the patient stated, she was calling because she had numbness in her feet and her lower extremities after getting the vaccine and she wanted to know if anybody else was experiencing these symptoms as well. When clarified the concern, patient stated, Numbness in her lower leg and in her feet and she wanted to know if other people are experiencing these symptoms. The Ae resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the adverse event was reported as no. The clinical outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received the second dose of vaccine at store at about 10:30am on Saturday March 20, 2021.  About 8:00am the next day on Sunday March 21, 2021 he started feeling some epigastric pain, radiating to the heart which became worse as the day went on and around 3:00pm that day, March 21, 2021 he went to the ER where he was diagnosed with having acute pancreatitis.  He was was admitted to the hospital for days, receiving  hydration, pain medications and antibiotics.  He experienced a large amount of leg and abdominal swelling while in the hospital.  He was discharged that following Sunday on March 28, 2021.  He experienced a severe amount of pain in the epigastric area; he was not able to eat while in the hospital.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 38-year-old, adult male patient. The patient had no relevant medical history. The patient did not receive any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 1.5 ml instead of 0.5 ml, batch number: 252235, expiry date: 30-Jun-2019, anatomical location and route of administration: not reported). On the same day, after vaccination, the patient experienced fever and body aches. On 11-Oct-2018, the patient had recovered from the events and he was fine. This case 201804666 was cross-linked with the original case 201804657 due to the same reporter. Significant case amendment (19-Oct-2018): The description to be coded for the verbatim Received 1.5 ml dose instead of 0.5 ml in the event tab was changed from extra dose administered to overdose. The narrative and case comment amended accordingly.