chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine Breakthrough Case - Hospitalized  The individual was fully vaccinated for COVID-19 and was hospitalized due to the severity of her symptoms.   Symptoms started 09/21. She was a contact of a case with last date of exposure 09/15 and had no symptoms when interviewed on 09/17. She is a private caretaker for that case. She and the case had a PCR done on 09/14 and she was negative then.   Currently in the hospital (as of last contact from the Health Dept on 9/25) -  Medical Center admitted 09/24 - Breathing more difficult than normal as she has asthma and COPD. She was lethargic, had a lot of tightness in her chest, and was very pale/bluish. Patient is experiencing the following symptoms: Rigors, runny nose/sinus congestion, fatigue, cough, shortness of breath (dyspnea), difficulty breathing, chest pain, abdominal pain, diarreha, low oxygen levels, inability to wake or stay awake (lethargy), pale, grey, or blue-colored skin, lips or nail beds, depending on skin tone (cyanosis). If they've ever had any adverse events/reactions, post-vaccination in the past: NO  **Reaction to COVID vaccine - was weak for about 24 hour, 3 days after 2nd shot she believes
Case previously recorded as MA2009-6263. Initial case report received from a health care professional on 25 NOV 2009. Twenty children younger than 04 years of age received FLUVIRIN intramuscular inadvertent administration on an unknown date. No adverse events reported. Medical history: Not reported. Reference no. NA09-008851.
Chest tightness, skin rash (chest), BP 160/80,  RR18, HR 106.
Swelling, pain, itching, rash - thigh, face, low grade temp 99.4, redness.
tinnitus; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Hot flash/ got hot in first 5 minutes lasting until bedtime.  Face, especially cheeks itchy for ,4 hours
I'm not sure if this is related; Was at work in out patient hospital facility and placed a mask on from a new box. I noticed my nose was itching a bit (I'm very sensitive to certain masks and usually air them out) A little while later I had an intense itching / prickly, sensation in my nose and started itching on my face under the mask. I took it off and found a different brand and took some benedryl.  Seemed to get some relief and later that evening, I started to itch again including my head and inside ears, face had flushed with hive like rash. This continued throughout the weekend on and off eventually my whole body was randomly itching/tingly. No problems breathing. Took allergy meds and felt good but noticeably annoying. Called our covid info line on Monday and they gave me a few numbers for allergists. Mine retired. Had an appointment Tuesday morning. Dr felt it probably was reaction to mask not vaccine. Did a patch test with a piece of mask and did itch some but had a reaction to the tape that held the piece of mask in place so results not good. Took medrol dose pack and increased allergy meds. Still itching on and off randomly all over body, not as severe  Delaying second vaccine by a week or two until this resolves per DR
After four days with no noticeable side effects or problems, I laid down for the night & noticed that my heart seemed to be struggling a great deal as in it seemed to be pounding hard, racing, & along with arrhythmia.  This continued with a severe & continuous struggle around the clock, but more extreme throughout the night.  I at first thought maybe I had some dehydration, but this did not seem to be the case.  I was diagnosed with light Tachycardia in 1987, but have never experienced anything like what has happened since the COVID-19 vaccine.  I searched the internet & noticed there are reports of other people suffering with the same issue & that a country has opened an investigation related to these heart struggles resulting in Myocarditis following the vaccine.  I am under the care of a cardio Dr. in a city who prescribed Metoprolol ER Succinate 50 mg  1 x daily, ordered a 30 day event monitor which just arrived in the mail, & has ordered an MRI, along with some lab work.
mom reports pt screamed and very irritable x2.5 hrs, fever 103ax x2days, cont'd irritable for 2-3 days.
Done in Health: Benadryl 25mg tablet, Epi 0.3mg IM, Sent ER.  ER per patient: Liquid Benadryl, Fluids, Labs and EKG
Localized upper lip swelling. No lower lip or tongue swelling. No rash. No shortness of breath. No throat swelling or pain. Resolved in approximately 1 hour with Claritin PO
6/1708- 6:12pm TC from mom reporting rash increasing flat red spots over body - started night before.  6/18/08 at 10:45am seen by Dr. -S: hx of fever & irritability x2 nights; decreased appetite.  O: crying, inconsolable; petechiae up to 3 (most pinpoint) on trunk, face, neck & extremities.  Referred to local ER; discharge dx ITP - given 20cc of NS & ROCEPHIN.  Clinically looks great at discharge.  F/U appt 6-23-08.
pain; numb; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received the 1st dose of Shingrix. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and numbness of upper extremities. On an unknown date, the outcome of the pain in arm and numbness of upper extremities were unknown.   It was unknown if the reporter considered the pain in arm and numbness of upper extremities to be related to Shingrix.  Additional details were provided as follows: The patient's husband is the reporter of the case. The patient received Shingrix and experienced severe pain and numbness from shoulders to finger.
Felt tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (Felt tired) and HEADACHE (Headache). At the time of the report, FATIGUE (Felt tired) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-044373 (Patient Link).
On the day I got my vaccine, I felt fine. The following morning, on 4/9/2021, I felt dizzy when I woke up. My legs also felt heavy, like lead. I wasn't able to bend my knees, so I had to use my hips to move my legs to shuffle around. I was able to stand, but I wasn't able to walk properly. At about noon that day, I went to the ER locally. They checked to see if I could feel my legs and move my feet, and I was able to do both. They also did blood work. Since no discernible cause for my symptoms was detected, I was basically told that I wasn't dying and that I should just go home. The symptoms continued for 3 days, and I just camped out on the sofa during that time. On 4/11/2021, the symptoms were finally gone, I felt fine, and I was able to carry on with my normal activities.
Upon injection, I felt a sharp pain, not the same as I had felt with my previous injection. Later on the morning, I saw that the clear bandaid had some blood on it. Later on, I noticed that the bandaid was coming off, when I removed it, it was filled with clear liquid. The amount was to the point that it soaked my bandaid that it was coming off. At this point, I do not know how much of the vaccine was injected in me or how much of it leaked out. Symptoms post vaccination: soreness and a large bump, injection site is red, warm, and pain to touch.
I've had twice now / into my right eye...; I've had twice now on top of my head; Incomplete course of vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient stated he/she received the 1st dose of Shingles vaccine and the patient had shingles twice and at the time of reporting on top of head and into right eye. The reporter stated that he/she hated it and the 2nd time got shingles was year later. Till the time of reporting the patient did not receive the 2nd dose of Shingles vaccine,which led to incomplete corse of vaccination. The reporter asked anything I could do help.
Within 5 - 10 minutes after administration of DTAP, HIB, and IPV; this child developed erythematous blotches on his lower extremities mainly one or so arms on the back. No welding noted, child fussy. Mother stated the child had similar effects after 2 month shots. Which faded shortly after they developed. Mother also states more areas this time. By 4:10 PM areas fading, advised to see a doctor.
Patient was hospitalized due to breakthrough COVID infection. Patient received Pfizer vaccine (2nd dose in series) on 01/23/21. Patient was hospitalized from 12/14/21 to 12/16/21. Below is copied from discharge summary:   Hospital Course:  COVID 19 infection  Superimposed PNA  Completed first 2 COVID vaccine Good O2 sat on RA   Leukopenia resolving and CRP downtrending  CXR showed new subtle patchy pullm opacities bibasilary, concerning for developing PNA Dc dexamethasone  Legio, strep pna negative    DM2 Uncontrolled due to steroids  A1C Sept 2021 8.9%  Continue home insulin therapy    Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
intense pruritis accompanied by an urticarial rash and erythema multiforme over the trunk and extremities lasting 4 hours and treated with loratadine 10 mg tid and topical 0.8% lidocaine gel.  Afebrile. Duration of treatment approximately 8 hours. (Photos of rash are available with date and time stamp).
patient's arm felt tingly, his head felt "wierd, sluggish. or foggy" he felt as though he might "pass out or faint" , his face grew very pale, he reported that his chest felt warm. He did not actually suffer a LOC.
Injection was given directly into my shoulder joint. I have had significant pain since and I am now in physical therapy for a rotator injury/frozen shoulder. I haveextreme loss of motion and significant weakness.
Fever for 10 days. Generalized weakness. Hospitalized 3/1/21 - 3/3/21 atrial fib, acute cystitis with hematuria, positive blood cultures
Temperature Excursion as Temperature reached: 28 F for a duration of 41 hours and 30 minutes for Adacel and it was administered post excursion with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 11 years old male patient and reporter reported temperature excursion as temperature reached: 28 f for a duration of 41 hours and 30 minutes for diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] and it was administered post excursion with no reported adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot 2CA23T1, expiry date- 08-DEC-2024) via unknown route in unknown administration site for prophylactic vaccination (Immunisation)  post excursion, which was exposed temperature excursion as temperature reached: 28 f for a duration of 41 hours and 30 minutes with no reported adverse event (poor quality product administered) (latency- same day).  Reportedly, Human error was not involved. temperature excursion due to Refrigerator malfunction.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.; Sender's Comments:  US-SA-2023SA220996:01697707 (Vaxelis) US-SA-2023SA221785:related inquiry
We administered a Pfizer vaccine that expired the day previously, 8/26/22. I notified the patient and they did not report any adverse effects.
None. Expired Covid 19 vaccine on 10/25/2022,  given 01/26/2023
This spontaneous report as received from a Licensed Practical Nurse. On 25-APR-2013, multiple unspecified patients were vaccinated with VAQTA (lot # 0273AE exp. 06-DEC-2014 and lot # H012669, exp. 17-APR-2015). The nurse reported the dose of VAQTA were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
After being administered with Anthrax vaccine, the same day experienced pain, swelling, itching in the arm. Continues symptoms 2 days after. Symptoms worse; reaction locally is 4"x4".
WEIRD BLOOD SYMPTOMS (BLOOD SYMPTOMS); EARLY PERIOD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced weird blood symptoms (blood symptoms). On APR-2021, the subject experienced early period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient thought symptoms would have passed by now was still experiencing them. The patient had not recovered from weird blood symptoms (blood symptoms), and the outcome of early period was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
4/2 5:15pm hives-no medicine given-2hrs later better. 4/3 5pm Rt arm was red, swollen and hot. 4/4 all day same-checked with doctor-said give Motrin. 4/5 still red swollen sore and lump-but getting better. 4/6 much better.
No additional AE; Pedvaxhib was improperly stored and administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-JUL-2020, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S03150, expiration date 21-APR-2022 for prophylaxis (dose and route of administration were not reported). Administered doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion of 50 Fahrenheit degrees (F) for 1 hour and 46 minutes. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion.o additional adverse event was reported.; Sender's Comments:  US-009507513-2008USA000266: US-009507513-2008USA000316: US-009507513-2008USA000307: US-009507513-2008USA000372:
No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions and allergies were not reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number: S012467, expiration date: 20-OCT-2020) 0.5 ml (route of administration was not provided) diluted in properly stored sterile diluent. The vaccine was stored in temperatures between -9 and 8 degrees Celsius (-2.8 degree Celsius) for 5 hours and 2 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.
vaccine go out of the temperature range and the warmest temperature was 14.8C for a total duration of 8 hours and 41 min; Initial information received on 04-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced vaccine go out of the temperature range and the warmest temperature was 14.8c for a total duration of 8 hours and 41 min while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UT7378LA via (unknown route , expiry date) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "vaccine go out of the temperature range and the warmest temperature was 14.8c for a total duration of 8 hours and 41 min" (product temperature excursion issue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the event (vaccine go out of the temperature range and the warmest temperature was 14.8C for a total duration of 8 hours and 41 min).  At time of reporting, the outcome was Unknown for the event vaccine go out of the temperature range and the warmest temperature was 14.8c for a total duration of 8 hours and 41 min.
pt recvd vax 1030AM cough started 11AM, hoarseness, hives; next day totally asymptomatic;
Pain, redness, extreme swelling nausea, faint, fever, temporary loss of site.
Approximately 25 minutes after receiving the vaccine I experienced tingling sensation of throat and lips.  Lips were not swollen. This lasted 40 minutes then resolved without any medication taken.
The first shot Moderna Lot 039K20A was not a problem, sore arm The second shot Moderna Lot 027L20A  made my entire body ache to tears. (As when going through chemo therapy for breast cancer and had to take Nulasta injections which made my bones, muscles, tissues, everything ache unbearably. )A few chills. Why was I given a different lot # ? This achy pain lasted a good 2-3 days. :(
PATIENT NOTICED SWELLING OF THE TONGUE BUT NO ITCHING OR FEVER.  SHE TOOK BENADRYL AND SOME ROCOLA.  SHE ALSO NOTICED TROUBLE BREATHING, BUT SAID IT WAS DUE TO POSSIBILITY OF ANXIETY.  SHE THEN FELT BETTER AND WAS OK.
Pt developed palpitations, and felt like her legs were cold and tingling. BP 110/60, HR 65, SP02 99%. She later admitted that it felt like she was having a panic attack. She improved with observation only. Her family member drove her home.  She declined EMS services/911.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 64 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Body aches; shivering; headache; Body aches; shivering; headache; This spontaneous report was received from a consumer referring to 53-year-old female patient.  The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On an unknown date in January 2020 (reported as "6 months ago"), the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (reported as "unknown zoster vaccination") (dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On an unknown date in January 2020, after administration of the zoster vaccine live (manufacturer unknown), the patient experienced body aches (pain), shivering (chills) and a headache. On 20-JUL-2020, the patient was again administered with a dose of zoster vaccine live (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 21-JUL-2020, the patient experienced the same symptoms of body ache (pain), shivering (chills), and headache. No product quality complaint (PQC) was involved. The outcome of 2 episodes of events of pain, chills and headache was unknown. The causality assessment was not reported.
Pt woke next AM w/swollen lymph nodes, fever, pain swallowing to ER - Strep diagnosis. TX w/ABX and steroid, per ER MD flu shot contributing factor.
Headache dry throat  Narrative:  Employee reported headache started ~1 hour after COVID-19 Moderna Vaccine. He received, IVF of 1 LNS, 50 mg IV benadryl, 60 mg IV norflex, and 15 mg of toradol IV in the emergency department with resolution of his headache.