chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 Year well child exam.  Healthy prior to visit. Normal physical exam.  Recived Havrix booster dose(#2) and Varivax booster dose(#2).  Within 10 minutes of leaving office, mom returned with patient actively wheezing and in anaphylaxis. Sats 91%.  Gave epinephrine times one, then 10 mg of loratidine. Pt status dramatically improved.  Clear lungs, improved sats, resolved urticaria. No history of egg allergy(eats eggs all the time).  8/18/2008 Office records received from PCP for WCC 8/4/08. 10 minutes after receiving vax pt developed wheezing and respiratory distress, coughing, hives and SOB. Tx with epi and antihistamine in office and d/c on Benadryl at home.  Sx resolved, no further hives. 04-AUG-2008: Within 20 minutes of vaccinations of chicken pox (2nd booster) and hepatitis my child began coughing, his face and eyes swelled and had severe breathing difficulties. We rushed back to doctor and received epinephrine.
He got his first dose of Pfizer. I believe he was suffering from anxiety attack. He told me that is how he often feels seeing needles. His blood pressure and heart rate were all normal. EMS services were called and the patient was checked out and ok.
This spontaneous report was received from a nurse and refers to two patients (twins) of an unknown age. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 05-JUN-2017, the patients were vaccinated with doses of PROQUAD injection (dose, route of administration, lot# and expiry date were not reported) for prophylaxis and VARIVAX injection, lot# M028546, expiry date 07-AUG-2018 (dose and route of administration were not reported) for prophylaxis. Sterile diluent (lot# and expiration date were not provided) was used to reconstitute the vaccine. No adverse effects were reported. Additional information has been requested.
Information has been received from an allied health worker referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medications, pertinent medical histories and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L036301 with expiration date 20-DEC-2017, and lot# L037554 with expiration date 25-DEC-2017; dose and route were not reported). There were no prior excursions. Temperature/Time Frame as follow: 29.5 Fahrenheit (F) for 1 hour, 23 minutes; 32 F for 3 hours, 47 minutes; 33.6 F for 2 hours, 47 minutes; 33.6 F for 1 hour, 2 minutes 32.1 F for 1 hour, 2 minutes; 32.1 F for 5 hours, 44 minutes; 33.8 F for 1 hours, 46 minutes. No adverse effects were reported. Additional information has been requested.
Headache, Fever, ACHES & PAINS, CHILLS Narrative:
Patient had no noticeable side effects at this time.  Patient received Pfizer 0.3 ml IM. Patient previously received J&J vaccine without clinician knowing of previous inoculation.  Patient marked on his consent form that he had not received any COVID vaccine. When patient was asked again post Pfizer vaccine, he said to another clinician, he didn't tell us that he had a J&J vaccine before because he wanted to get a second vaccine and he needed the money.  He was informed that getting two different COVID vaccines by different manufactures was not recommended by the CDC and we do not give away money.  He was monitored for 30 minutes.
Daily headaches  with only 2 episodes of nausea. Ibuprofen and Tylenol altered but ibuprofen helps the most . Headaches keep coming back. Stronger headaches started on day 5 and I'm now at day 14 post 2nd moderna vaccine. Increased water intake significantly with no ease of headaches.
I had my vaccination on 09/30/2022. I started to have symptoms on 02/23/2023 to include fatigue and unwell. I took an at home COVID-19 test and it was positive. I was prescribed PAXLOVID and started immediately. I presently feel great on 05/22/2023.
INADVERTENT ADMINISTRATION OF 1ML OF COVID-19 VACCINE; This spontaneous report received from a physician concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) 1 ml, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-AUG-2021, the patient experienced inadvertent administration of 1ml of covid-19 vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of inadvertent administration of 1ml of covid-19 vaccine was not reported. This report was non-serious.
Thursday, I had a mild reaction like flu-like symptoms and it seemed to be going away Friday. By Saturday it started getting worse and Sunday wasn't too good, and I had aches and a little bit of a headache but no fever. I didn't have a fever at any point during this. Sunday night it felt better, and Monday I had a doctor appointment and she checked me out and didn't see anything unusual and she did blood work and the blood work looked fine. Tuesday it got worse, and Wednesday and Thursday I was living on Pedialyte and was in pain and couldn't have any food, so I was just drinking Pedialyte. Friday afternoon it went away but during that time I got permanent A Fib and I've had A Fib since. I've been working with a doctor to control the medicine. That halted some of my activities like strenuous activities and I can't take long walks with my dog and sometimes I'll be working and instead of doing tasks I'd normally do I've had to cut back on the amount of heavy work I can do. I tire easily and I don't have any joint pain as a residual, it's just the A Fib and could be the mitral valve prolapse that caused it. It seems with the balance of medicine they give me it's seeming to help.
allergic reaction; Based on information received on 28-Oct-2020, the report previously considered as non-valid became valid: [unevaluable event updated to allergic reaction].  Initial information received on 28-Oct-2020 regarding an unsolicited non-valid non-serious case received from a pharmacist.  This case involves female patient (age not reported) who experienced allergic reaction (hypersensitivity), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past  vaccination included FLUBLOK for prophylactic vaccination in 2019.  The patient's medical history, concomitant therapy, medical treatment and family history were not provided.   On an unknown date in 2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2020, the patient developed non-serious allergic reaction (hypersensitivity) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.  Follow up information received on 28-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  Event updated
The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023; No adverse event; Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD), PRODUCT STORAGE ERROR (The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD), PRODUCT STORAGE ERROR (The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered dose of the bivalent vaccine to patient from vial which was beyond the BUD) and PRODUCT STORAGE ERROR (The vial was stored in the fridge on 14-Mar-2023 and dose was administered on 21-Apr-2023).    Concomitant medication was not provided. It was unknown if patient ever been diagnosed or tested positive with COVID-19. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (E2B Linked Report). This case was linked to MOD-2023-722195 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case
Weak; Nausea; Headache; This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weak), NAUSEA (Nausea) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 542L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021 at 6:00 AM, the patient experienced ASTHENIA (Weak), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weak), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment medications were not provided by reporter.
Extreme arm pain starting 3 hours after injection.; This is a spontaneous report from a non-contactable consumer. A 35-year-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 24Feb2021 at 15:30 (at the age of 35-year-old), as first dose, single dose in left arm for COVID-19 immunization at Physician office. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 at 18:00, reported as 3 hours after injection, the patient experienced extreme arm pain and started resolving completely after 2 days. Pain returned to arm 9 days after injection, however, less painful than initial reaction. Patient did not receive treatment for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was resolved with sequelae.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Covid19 breakthrough.  1st vaccine received on 01/27/2021.  66 y/o PMH ESRD on peritoneal dialysis, DM, HTN , Breast CA presents to ED for c/o progressive weakness, dizziness and unable to walk.  Pt initially had symptoms begin 12/31 with fever, cough, congestion, N/V/D which improved but then returned.  CT A/P multifocal PNA, Rm air sat 98%.  Pt treated with low dose oral steroids.
Swelling in the neck on the right side. Sever pain for two days with continued pain but not as sever.
Three vaccines and I still get Covid; Three vaccines and I still get Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 13Aug2022, outcome "unknown" and all described as "Three vaccines and I still get Covid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
some blood tests and surface ab blood and core ab total were non reactive and surface ab quantitative was less than 5. CDC and CMP were normal.; This non-serious case was reported by a consumer via call center representative and described the occurrence of therapeutic response decreased in a female patient who received HAB (Twinrix adult) for prophylaxis.   Concurrent medical conditions included crohn's disease. Concomitant products included risankizumab (Skyrizi).   On 03-JAN-2014, the patient received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced therapeutic response decreased (Verbatim: some blood tests and surface ab blood and core ab total were non reactive and surface ab quantitative was less than 5. CDC and CMP were normal.). The outcome of the therapeutic response decreased was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-OCT-2023 Reporter is the patient, who received a series of Twinrix on 3rd January 2014. She states that she went to a new gastroenterologist who did some blood tests and surface ab blood and core ab total were non-reactive and surface ab quantitative was less than 5. CDC and CMP were normal. Her doctor told her she is not immune to the virus and wanted her to get the vaccine series again. The patient has Crohns disease and is on a biologic (Skyrizi). The patient already received 1 dose of the new series and is waiting to get the next 2 doses. The reporter did not consent to follow up.
It started with a racing heart and premature ventricular  contractions. His heart rate went up to 140 while sleeping. He woke up out of his sleep cause it was bothering him.  I took him to his PCP and referred to Pediatric Cardiology in January 2022 had a EKG and wear a Holter Monitor.
Information has been received from a licensed practical nurse concerning now a 7 year old male with no known allergies who on 08/04/1999 was vaccinated with the first dose of varicella vaccine in the right arm. There was no concomitant medication or illness at the time of vaccination. On 06/27/2001, the pt had tubes in ears with bilateral drainage and was followed with antibiotics. On 07/28/2001 the pt developed chicken pox with 15 pox, "reddened spots" and had no fever. The pt sought unspecified medical attention and was being treated at home. It was reported that the pt recovered. Additional info has been requested.
numbness on arm and leg and very tiredness and it hasn't left since she began feeling it. She experiences this feeling twice a week
On 7/8/21, patient contacted the pharmacy to report that she experienced chills and swelling, itchiness, and muscle pain in both legs starting on 7/6/21, Tuesday night. She took Tylenol around 8pm, which helped. The next day the chills resolved, but she is still experiencing itchy and swollen legs. She tried Cortizone 10 cream and Bactine Max spray, but neither helped. She received her 2nd COVID-19 vaccine on 6/28/21, and she has experienced an allergic reaction when taking Tylenol previously.
11/01/21, 4pm: body cold, wheezing, coughing 11/02/21, 9am: body completely frozen, could not thaw or warm up despite hot baths and hot drinks, constant shivering; pain in right butt check (as if i received an immunoglobulin shot, which i didnt), painfully sore neck, pain radiating outwards from lower back, oxygen level fluctuated between 95-97 11/02/21, 5pm: finally thawed, major lower back pain and intense painful headache 11/02/21: 7pm: fever with swollen lymph glands in both side of throat 11/03/21: 9am: fever broke sometime last night, but woke up with swollen lymph glands in throat and in right underarm pit; fluctuate feeling hot/cold
Client complained of feeling hot, sleepy and tired after about 1 hr and 30 minutes of receiving injection. Client sat in chair and exhibited an episode of syncope. Client aroused with ice pack to forehead; Epinephrine 0.3ml administered IM to the right deltoid. Client's T 97.6 R 18 Pulse 100 and BP 148/107. 911 dialed et EMS arrival at approx. 5:30pmet transported client to another medical facility.
Rash with dermatographia, sometimes severe itching. Began in hands, eventually arms, back, chest, legs, head. Lasted up to 4 weeks.
C/o dizziness. Observed for 20 min, provided lollipop,  BPs monitored, placed in supine position, elevated legs, dizziness resolved. Discharged to mom feeling better.
Information has been received from a Nurse, referring to a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-JUN-2018, the patient was inadvertently vaccinated with GARDASIL 9, intramuscularly (anatomical location, lot number and expiration date were not reported) for prophylaxis. The nurse reported it was a human error. No adverse effects were reported.
Body aches; Migraine; Their arm felt heavy/Arm ache; Had fever of 100.2°F; Strong headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), MIGRAINE (Migraine), PAIN IN EXTREMITY (Their arm felt heavy/Arm ache), PYREXIA (Had fever of 100.2°F) and HEADACHE (Strong headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer in remission.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced PAIN (Body aches), MIGRAINE (Migraine), PAIN IN EXTREMITY (Their arm felt heavy/Arm ache), PYREXIA (Had fever of 100.2°F), HEADACHE (Strong headache) and CHILLS (Chills). On 22-Feb-2021, PAIN (Body aches), MIGRAINE (Migraine), PYREXIA (Had fever of 100.2°F), HEADACHE (Strong headache) and CHILLS (Chills) had resolved. On 23-Feb-2021, PAIN IN EXTREMITY (Their arm felt heavy/Arm ache) had resolved.            Concomitant product use was unknown by the reporter. Treatment information was not provided.
Moderna COVID?19 Vaccine  Fever with Tmax of 102.5F at 24 hours - resolved after 2 days. Headache (occipital) - resolved after 2 days. Very mild vertigo and tinnitus - resolved after 2 days. Elevated heart rate for 1-2 days - resting heart rate typically 60-65 increased to 75-90.
NOT reporting adverse drug reactions.  ** It was vaccine error that did not reach the patient  Normal saline was added to the gray cap Pfizer COVID vaccine when it shouldn't have been.  Pharmacist caught the mistake prior to leaving the pharmacy - vaccine did not reach the patient.
Patient broke out in hives on face and trunk approximately 5 minutes after vaccine administration. Doctor was immediately notified and evaluated patient reaction. Administered 12.5mg of PO Benadryl. Patient waited in office and was repeatedly checked on by nursing staff and physician.
Localized reaction s/p DTaP left arm. Redness, swollen, itchy, warm. No nontender, No fever, No SOB/CP/wheeze. A/P (1) Localized allergic reaction s/p DTaP- Benadryl prn, reassured, ok to give future booster doses.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness in the arm) and fatigue in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 046A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Apr 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 7, 2021, patient experienced pain in extremity (soreness in the arm) and fatigue. At the time of the report, pain in extremity (soreness in the arm) and fatigue outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
a rash all over my back and sides and legs. Maybe 40 spots ranging in size from 1mm - 1cm (commonest) - to 4 cm diamiter Very red, very itchy, on larger ones are bumps, some clear liquid, some bleeding. Not any improvement after 6 days
First 24 hours; waves of dizziness and nausea, short in duration. I felt some pressure on the right side of my chest.  Night 2 woke up with chills.; First 24 hours; waves of dizziness and nausea, short in duration. I felt some pressure on the right side of my chest.  Night 2 woke up with chills.; First 24 hours; waves of dizziness and nausea, short in duration. I felt some pressure on the right side of my chest.  Night 2 woke up with chills.; First 24 hours; waves of dizziness and nausea, short in duration. I felt some pressure on the right side of my chest.  Night 2 woke up with chills.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 09:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included diverticulitis. The patient had known allergies (unspecified). It was reported that two weeks in between the shots the patient was receiving treatment (unspecified) for diverticulitis from an unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 09:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. 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. On 09Apr2021 at 09:30, first 24 hours; the patient experienced waves of dizziness and nausea, short in duration. The patient felt some pressure on the right side of her chest. On 10Apr2021, night at 02:00, the patient woke up with chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events first 24 hours; waves of dizziness and nausea, short in duration, felt some pressure on the right side of chest, night 02:00 woke up with chills was resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.