chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient informed that since the same day, later at night, her arm was swollen at the injection site and feeling warm and pained. She called two days later to the pharmacy and we recommended that she visits her doctor. She did so and informed MD didn't prescribed her any medication.
sudden onset of limpness, eyes rolled back;listless;no response to pinching;called MD & was seen 330PM;eyes were rolled back for 15-20min;@ MD's started vomiting;2 loose BM's;did not nurse until 8-9PM;color was pale;by next AM responding;
24 hours, swollen 1/2 way down her arm, warm red. Fever to 101.6  wbc 6.5 Ice applied and Ibuprofen. Swelling went down and fever resolved 1 day later.
Within 1 hour, increasing dizziness and vertigo like symptoms, loss of appetite, followed by fatigue weakness and febrile episodes by 10pm that evening.  These persisted until 0300AM on the 19th.
CLIENT WOKE UP WITH LIPS SWOLLEN 2-3 TIMES THEIR NORM. CLIENT WENT TO ER AND RECV'D STEROID AND ANOTHER MED. CLIENT COULD NOT GIVE NAMES OF MEDS. LIPS RETURNED TO NORMAL SIZE.
No adverse event; product storage error; This spontaneous report was received from a nurse, referring to a 19-month-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 26-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) lot # S020160, expiration date 30-JUN-2021, at a dose of 0.5 milliliter once for prophylaxis (route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature above 46 degree Fahrenheit (°F) (67.6°F) for 8 hours 30 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Information has been received from a nurse practitioner concerning a 20 year old female with no pertinent medical history or drug reaction/allergies who on 23-MAR-2007 was vaccinated  IM with the first 0.5ml dose of GARDASIL, on 23-MAY-2007 was vaccinated IM with the second 0.5ml dose of GARDASIL and on 25-SEP-2007 was vaccinated IM with the third dose of GARDASIL. There was no concomitant medication. It was reported the patient had a positive DNA test for high risk Human Papilloma Virus (HPV) on 24-FEB-2009. The patient was seen by physician. Additional information has been requested.
Numbness tingling  on right had/ confusion for  two weeks later after first dosage , 2nd dosage tingling and  numbness on both arms  and legs that lasted for a week, the vertigo started and back pain (lower) . Started having trouble swallowing and concentrating for a month will see doctor especially for vertigo  in a month .  Lower pain take Tylenol or ibuprofen daily to help with pain. Pain in right and left shoulder having difficulty  keeping arms raised during work.
16 y/0 female received Trumenba in one arm and Menactra and Hep A in other arm and next day reported to her mom feeling dizzy; This is a spontaneous report from a contactable nurse via Pfizer sales representative.   A 16-year-old female patient received on an unspecified date for immunization,meningococcal group b rlp2086 (TRUMENBA) at single dose in one arm and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and hepatitis a vaccine (unknown manufacturer)  in other arm. The patient medical history and concomitant medications were not reported.  On an unspecified date, the day after vaccinations, patient reported to her mom feeling dizzy. Patient was seen by pediatrician and vitals checked and patient monitored and sent home.The outcome of the event was unknown.  Information on the batch number has been requested
1 day after administration of tetanus, noted rash on face.  Notes worse when in sun.  P.O. benadryl as needed.  Note: no urticaria, no reaction or rash in area of vaccine.  Note: on OTC weight loss medication.
Dizziness, nausea, diaphoretic  BP 118/64, pulse 70  Discharged to home without incident
From phone correspondence received at manufacturer on 8/21/02, it was reported that an 18 y.o. female PT received a Menomune A/C/Y/W-135 vax, on 8/14/02. W/in 24-36 hrs, the PT developed a fever of 104 deg F and a sore throat. A throat culture was done and results were negative. Reportedly, the PT also "passed out". She was seen in ER, where she was treated and released. Reportedly, the PT's Sx's were fully resolved when seen in the MD's office on 8/16/02.
Covid positive; Covid positive; High fevers; Severe body aches; Lethargy; Severe headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Dec2020 14:30 in right arm, at single dose for covid-19 immunization. Medical history included allergy to adhesive tape. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included flecainide. The patient previously took morphine, demerol, codeine, dilaudid and allergies to morphine,demerol, codiene, dilaudid, golytle (as reported). The patient received any other vaccines within 4 weeks prior to the COVID vaccine: product was GSK (as reported, lot number: hs75g) first dose, on 30Nov2020, in left arm. The patient experienced severe headache on 24Dec2020 04:00, lethargy on 25Dec2020, severe body aches on 26Dec2020, high fevers on 27Dec2020, covid 19 nasal swab: positive on 28Dec2020. Seriousness criteria was reported as disabling/incapacitating. Event result in clinic visit. Treatment antibiotics and prednisone was for Covid respiratory infection. The outcome of the all events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Diagnosed with arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Diagnosed with arthritis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine allergy), Drug allergy (Aspirin Allergy) and Penicillin allergy.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced ARTHRITIS (Diagnosed with arthritis). At the time of the report, ARTHRITIS (Diagnosed with arthritis) outcome was unknown.            .
Subsequent to receiving vax, the pt developed a large local reaction at the injection site measuring 2.5 X 2.5 inches. Further information is requested.
A non-serious spontaneous report of administration to a pregnant female was received from a heath professional concerning a 29-year-old female. The patient's medical history and obstetrical history were not reported. No concomitant medications were reported. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The reporter was asked to inform when the pregnancy has ended and also to inform if the patient experiences any adverse events during the pregnancy.
Shortness of breath, flushed, stomach ache, itching, wheezing, coughing.
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender not reported). Pertinent medical history, drug reactions or allergies were not reported. On 05-APR-2014 the patient was vaccinated with improperly stored dose of ZOSTAVAX, LOT number: J011548, expiration date: 19-DEC-2014, (dose, route not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (pericarditis) in a 69-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant). The patient was treated with COLCHICINE for Pericarditis, at an unspecified dose and frequency. At the time of the report, PERICARDITIS (pericarditis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PERICARDITIS (pericarditis) to be related.    Concomitant information was not reported. This report describes a 69-year-old female who presented with three days of chest pain that started one day after a booster shot of the Moderna COVID-19 vaccine. The patient was diagnosed with pericarditis. Treated with Colchicine and later steroids.  Company comment:  This literature non-study case concerns a 69 year old female, with no reported medical history, who experienced the serious (medically significant), expected AESI of pericarditis. Patient experienced 3 days of chest pain which started 1 day after the booster dose of mRNA 1273 COVID-19 vaccine. The patient was diagnosed with pericarditis and was treated with Colchicine and later on steroids. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This literature non-study case concerns a 69 year old female, with no reported medical history, who experienced the serious (medically significant), expected AESI of pericarditis. Patient experienced 3 days of chest pain which started 1 day after the booster dose of mRNA 1273 COVID-19 vaccine. The patient was diagnosed with pericarditis and was treated with Colchicine and later on steroids. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Entire body ache Chills, (could not get warm) Pain at injection site Pain at touching of site Lg harden area at injection site , the size and shape of half a small orange Presently, the size of a walnut, still hard and painful at touch.
Brain fog and feels disoriented; Diarrhea; brain fog and feels disoriented; Nausea; Severe chills; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Brain fog and feels disoriented), DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog and feels disoriented), NAUSEA (Nausea) and CHILLS (Severe chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DISORIENTATION (Brain fog and feels disoriented), DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog and feels disoriented), NAUSEA (Nausea), CHILLS (Severe chills) and MYALGIA (Muscle aches). At the time of the report, DISORIENTATION (Brain fog and feels disoriented), DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog and feels disoriented), NAUSEA (Nausea), CHILLS (Severe chills) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient is scared of the second dose and does not want to take it. She would like to know if she can take the second dose
PT HAS A FEAR OF NEEDLES W HX OF SYCOPE EPISODES THIS HAPPENED WITH THE FIRST VACCINE AND SHE KNOWS THAT  THIS HAPPENS SHE WAS MONITORED AND EMT DID VSS SHE WAS DROVE HOME BY FRIEND SHE FELT BETTER AFTER 15 MIN
PATIENT REPORTS LYMPHADENOPATHY OF THE RIGHT ARMPIT WITHIN 18 HOURS OF VACCINATION.  PATIENT ALSO STATES HE HAD THE EXACT SAME REACTION WITH BOTH MODERNA VACCINATIONS (NOT GIVEN AT OUR FACILITY).  HE STATES THAT THE LYMPHADENOPATHY LASTED NEARLY TWO MONTHS WITH MODERNA VACCINATIONS.
Client states had 1st Pfizer injection on 34/2021 in the left arm. She states approximately one week later she noted left shoulder pain, light black bruising to back of left arm(states only lasted a few days), and what "felt like fluid" around the injection site. She states she never noted redness, no rash, and no hardness at the injection site. She states she believes the nurse gave the injection" a little lower than the deltoid area where shot is normally given". She states she went to get her 2nd Pfizer injection on 3/27/2021 and received it in the right arm. She states she did not tell the nurse giving her the  2nd Pfizer injection about the left arm pain or issues re: the left arm. She states she did fine with the 2nd injection and has had no problems in the right arm. She states on 4-2-2021 she noted left arm warmth at the site if injection. She states she finally went to her Dr's office on 4/8/2021 because of the left shoulder pain. She states the NP she saw prescribed her anti-inflammatory meds. She states she returned on 4/21/2021 to see her Dr. and he gave her a "steroid shot" and that it improved the shoulder pain "drastically". She states today 5/5/2021 her range of motion is better, but still has arm pain when she reaches back behind her with her arm. She states she still feels the "fluid feeling" is still the at the injection site area. She states she is still taking the anti-inflammatory meds as well. She states she will be  calling and following back up with her Dr.'s  office today.
11/26/22 presents to ED for "cough, chest pain". PMHx of "MCI, urinary incontinence, HTN and CKD 3b"
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. It was reported that on 03-AUG-2010, the patient received the first dose, on 04-OCT-2010, the second dose and on 10-FEB-2011, the third dose of GARDASIL. On 11-AUG-2015, the patient was vaccinated with the fourth dose of GARDASIL. It was confirmed that all four doses were not GARDASIL 9. Additional information has been requested.
ID: 3012360 patient felt hot and dizzy and nauseous (after COVID vaccine). once in the (EMS) tent, the patient was able to sit down and take her mask off. blood pressure was elevated but was coming down with time. Pt was released with no complaints. 14:34 142/86 p100 r16 14:37 138/67 r16
I started getting hives on Friday 9/3, after receiving my shot on Monday, 8/30. Then on 9/7, my left arm became really sensitive and sore and a large red circle about the size of an egg appeared. The red circle included the injection site at the bottom and spread up towards my shoulder.
after intercourse she hurts in the morning with abdominal cramps and bleeding; after intercourse she hurts in the morning with abdominal cramps and bleeding; after intercourse she hurts in the morning with abdominal cramps and bleeding; bleeding, spotting; bleeding, spotting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 29-year-old female patient received BNT162b2 (BNT162B2), in Jul2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMORRHAGE (medically significant), DYSPAREUNIA (non-serious), ABDOMINAL PAIN (non-serious), outcome "unknown" and all described as "after intercourse she hurts in the morning with abdominal cramps and bleeding"; INTERMENSTRUAL BLEEDING (non-serious), VAGINAL HAEMORRHAGE (non-serious), outcome "unknown" and all described as "bleeding, spotting". Clinical Course: Her Daughter in law got the initial covid 19 vaccine in Jul or original dose. Her Daughter in law is trying to have a child with her husband. Before the vaccine her period was every 40 days, but after the vaccine in Jul she began hurting the next morning after intercourse and having abdominal cramps and bleeding. Her Daughter in law thinks its just spotting but her Daughter in law is healthy. Caller clarified her Daughter in law's Initial Dose was Jul2021. Caller again asks that she just wanted to know if this was experienced. The previous agent (withheld) spoke about periods being longer and spaced out but not if this was a side effect. Caller states that she just doesn't know. Caller states that she thinks the second dose was spaced 3 months after the first she is not sure. Furthermore, reporter stated, "I am calling about my daughter in law because she had the Pfizer vaccine (Later confirmed as  Pfizer COVID 19 vaccine) before she married my son like in last Nov, the wedding was in Sep. So, she had the vaccine in probably like Jul I think she had it in Jul and then she got the next vaccine by Pfizer, prior to that she had regular periods coming every 40 days okay. So, then after having the vaccination and the second one she is been having pain after she has intercourse. I mean it doesn't hurt, it is cramps. It is the day after and she has cramps and then she bleeds a little bit after the day after. Isn't it crazy, have you heard anything from other people. She wanted to get child, she want to get pregnant."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201170253 same reporter/patient/vaccine, different doses/events;
Child immediately began to complain of not feeling good. Kept stating he was sleepy; stated both arms are numb. Complaints of increased sleepiness and color went from pink to ashen, lips blue tinged and stated his legs felt funny and collapsed to floor. Remained conscious with stable vital signs.
patient developed weakness and onset of increased shortness of breath with rapid heartrate. She was taken to emergency room and found to have Atrial Fib. She had multiple episodes over 3 weeks and now hasn't had anymore since
When patient arrived at pharmacy, he said he needed his 2nd dose of pfizer covid vaccination.  We gave him form to fill out, he listed 1st dose as 2/20/21 and said he didn't have his card with him.  After vaccination when going to enter into system, it was discovered that patient lied on vaccination form and to the pharmacy, system showed a 1st dose on 2/3/21 and 2nd dose on 2/24/21.  When we notified out vaccine coordinator and let them know, they said to report it to VAERS.  Patient was told to wait 15 minutes in the chair at pharmacy after vaccination, pt got up and left.  We tried to call patient regarding prior doses, left voicemail,  patient has not returned phone call.
A couple days later I developed a 101.4 fever which lasted for about 3 days. I had terrible sweats from the fever and an awful headache. I was coughing and my whole body ached for 3 days. I was hurting so bad. Awful nausea and loss of appetite and energy. I alternated Tylenol and Motrin throughout the day to help with the symptoms
Moderna COVID 19 EUA - Extreme pain in vaccine arm going from my neck to my wrist.  I was not able to move my arm without help and with extreme pain.  Used cold compress, Tylenol and  Ibuprofen alternately.  Next day the same continues except pain is limited to my upper arm.
deviation of recommended dose- partial first dose given; syringe being a twist needle and not being securely on leding to leak; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an under dose due to "twist needle not being securely on the syringe".  The patients medical history and concomitant product use was not provided.  On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On 27 Jan 2021, patient received a partial dose of mRNA-1273 during the immunization administration, the nurse noted the dose had leaked, "because of the syringe being a twist needle and not being securely on".  She stated she is not aware of how much mRNA-1273 leaked or how much of the dose the patient received.    Action taken with mRNA-1273 in response to the event is not reported.  The events, partial dose of mRNA-1273 received and syringe being a twist needle and not being securely on was considered resolved.; Reporter's Comments: This case concerns a patient, who, experienced a non-serious unexpected event of incorrect dose administered and device connection issue for mRNA-1273, lot # unknown. There was no AEs associated with incorrect dose administered and device connection issue.
Pt recvd vax in 1988 & approx 10 to 14 days following the vax devel a rash; No further details were provided;
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "Clinical depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Allergy: Compazine". Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same reporter/patient/product, different dose/event;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;
a 74 y.o. female admitted with covid-19 pneumonia. Treated with remdesivir / steroids / supplements. Treated for uti. Treated for rhabdo. Seen by gi for occult + stool, anemia. Treated for c diff. Overall pt did not improve and was unable to wean off of bipap / high flow. Pt struggle with delirium and pain. Family decided to pursue comfort care. Pt dies at 1326 from complications of covid-19 pneumonia.