chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; aches; fever 100.7F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (aches) and PYREXIA (fever 100.7F) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CHILLS (chills), MYALGIA (aches) and PYREXIA (fever 100.7F). On 28-Mar-2021, CHILLS (chills), MYALGIA (aches) and PYREXIA (fever 100.7F) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 100.7 (High) 100.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
woke 3AM day p/immun fever 102 R; had 3-4 moments of being startled while awoke; stuffy nose; APAP no relief; fever sl above 102 R; MD prescribed Pediaprophen 5MAR PM; pt adviced against receiving pertussis in future;
1 hour after receiving the Tdap vaccine, she started feeling very warm on her head and neck.  She then broke out in very itchy hives.  The warm feeling and hives extended throughout the rest of her body within another hour.  She took a dose of Zyrtec at 5pm that day, following which the reaction completely resolved.  However, since the date of immunization, she has continued to take the Zyrtec.  Once the effect of the Zyrtec dose starts to diminish, the hives reappear.
Patient had Zostavax Immunization on 9/24, around 10 red bumps appeared on her legs on 10/2/2014  She applied benadryl cream to help with the itching.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that went through repeated excursion in the freezer, at various dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that went through repeated excursion in the freezer, at various dates) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that went through repeated excursion in the freezer, at various dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that went through repeated excursion in the freezer, at various dates). In 2021, PRODUCT STORAGE ERROR (Administered vaccine that went through repeated excursion in the freezer, at various dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine that went through repeated excursion in the freezer, at various dates) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and no treatment medication were informed. Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 09-JUL-2021, contains non - significant information.
Headache, chills, muscle aches, dehydration, loss of appetite, blurred vision, loss of taste, and loss of smell.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. On 23rd July 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, back pain and vertigo. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, back pain and vertigo were recovered/resolved. It was unknown if the reporter considered the pain in arm, back pain and vertigo to be related to Shingrix. Additional details were provided as follows: The patient had significant side effects such as 36 hours of arm, leg, and back pain which was somewhat ameliorated with Ibuprofen post vaccination. Following that, the patient had 5 days of vertigo. The patient wanted to know should she receive the second dose,  what side effects can she expect, how effective was the vaccine with just 1 dose.
patient got vaccine at 10:30 am. at 4:30 pm,  patient got a headache and had to lie down. at 8:00 pm, patient woke up with tingling in fingers/toes. after 10 minutes, patient had no feeling in fingers and toes. heart was racing with clenched fists and no control of muscles. patient was hospitalized overnight for adverse reaction to vaccine. *not due to blood clot*
For unknown reason (not documented in chart) patient received the first Moderna COVID-19 Vaccine dose on 10/28/21 and the second dose of Moderna COVID-19 Vaccine on 11/17/21 which is earlier than 28 days and outside of the 4-day grace period. There were no adverse events associated with administration of the vaccine. Per CDC guidance, doses inadvertently administered earlier than the grace period should not be repeated.
Received vaccine 12/19/2020 at hospital around lunch time. Severe abd pain started 10 hours after vaccine administration with vomiting. I went to emergency room next morning  Emergency appendectomy 12/20/2020. Had bleeding after surgery. Second surgery 12/21/2020
super heavy nose bleed.  started feeling like sinuses were draining, could feed running down throat, then started gushing out nose. ran to bathroom and was blood.  covered my shirt, all over sink, floor...took about 5-7 min to stop .   after that was fine. just extremely scary
Flu-like symptoms: 9/18/12 to 9/20/12. Overall body ache head to toe, head felt hot all day, nausea, chills, headache - took Naproxen for headache. Still achy & woozy, no appetite.
Ringing in ears, feeling light headedness. Seen by EMS. Discharged home with mother at 14:30 . Recorded by  RN
tested positive; tested positive; influenza; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "moderately over weight" (unspecified if ongoing), notes: moderately over weight. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, in Sep2022 as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive"; INFLUENZA (medically significant), outcome "unknown". The events "tested positive" and "influenza" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: over 103, notes: fever as high as just over 103.  Clinical course: The patient just tested positive at the hospital with Both Covid 19 and influenza. He's a firefighter paramedic and was moderately over weight. He received flu vaccine in September, but had not yet received the most recent booster for Covid. He's running a fever as high as just over 103. The ER doctor didn't know if he could have both Paxlovid and Tamiflu, so prescribed Paxlovid. His wife was RN for a doctor group considering adding Tamiflu for him. Wanted to know if it was ok to take both.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A spontaneous, non-serious report of back and chest pain has been received from a other involving a patient (demographics unknown) subsequent to FLUMIST use. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 10-Sep-2009, the patient received FLUMIST. Hours later, he was experienced back and chest pain. No further information was available. The outcome of the events, back and chest pain, was unknown. All follow-up attempts have been made per company SOPs. No further information is availbale.
Moderna Covid 19 vaccine EUA - chills, headache, dizziness(causing me to faint)
Approximately 24 hours after being vaccinated with the Moderna Covid vaccine, patient stated that he went into atrial fibrillation.  After taking his medication, dofetilide 500mcg, patient said the a fib stopped.
Leg pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Leg pain".  Additional information:  Patient had a side effect. Patient had already spoke to patient forget her name but patient told her I was having leg pain. Patient had the Pfizer vaccine. Consumer confirmed it was the Pfizer Covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax OCT85 & was hospitalized & dx w/pneumococcal pneumonia & septicemia; Lab eval revealed type 22F pneumococcus;
Within 30-minutes of vaccination, the patient reported a headache, slurred speech, and right side weakness. EMS evaluated the patient on-site. The patient was hypertensive (197/129) with a FSBG of 95mg/dL. During stroke assessment, the patient had new onset facial palsy/droop and need speech abnormality which signaled a stroke alert. 12-lead EKG was unremarkable. EMS transported the patient to Emergency Department. In the ED, the patient presented with a headache, chest heaviness, and slurred speech, but no aphasia. NIH stroke scale was 0. Patient remained hypertensive (170/109). Labs, tests, and imaging did not indicate rtPA administration. ED physician administered 0.4mg SL Nitroglycerin, 10mg IV Hydralazine, and 325mg PO Aspirin prior to admission for suspected Transient Ischemic Attack. Upon admission, differential was TIA vs. CVA vs. ACS. Admitting physician ordered HbA1C, lipid panel, MRI brain, CTA head/neck, 2D echo, and neurology consult. Throughout course of admission, patient had recurring midsternal chest pain that was relieved with Nitroglycerin. Imaging ruled out CVA. Given elevated TGs and Cholesterol, patient was started on Atorvastatin 40mg PO. Suspected TIA and ACS.  Neurology consult reviewed the labs and imaging, and stated the episodes of stuttering are most commonly associated with anxiety or stress reaction. Neuro did not recommend any further workup unless this happened again unprovoked. Patient was discharged after a 3-day admission with diagnosis of cerebrovascular disease, unspecified. The patient was prescribed 81mg PO Aspirin, 20mg PO Lisinopril, and 40mg PO Atorvastatin.
Pt had a warm red swollen 4 1/2 x 3 1/2 inch area around vaccine site. Also a blister around site instructed to apply cool compress and ibuprofen for discomfort.
pt recv vax; devel fever; a blotchy, erythematous, rash and swollen eyelids;
Fatigue, weakness, hot flashes, pain in left shoulder within 24 hours of shot, and woke up drenched in sweat 36 hours after the shot.  48 hours after the shot was still feeling fatigue and weakness, although it had subsided during the day.   Face was red and was sweating 48 hours after the shot.  Symptoms had mostly subsided within 72 hours.
Fever between 103 and 104 f, dizziness, nausea, black outs for several days. Lost consciousness fully 1 week after shot and was admitted to the hospital and told she was covid positive. Dangerously low blood pressure. Given steroids and fluids, and meds to prevent blood clots and sent home the next day. Continued to pass out & vomit for a few more days. Went back to ER for fluids and nausea medication.  13 days since shot, and still running fever. Still very sick.
10min p/vax pt noticed swelling taste buds & itchy mouth-redness in mouth noted;returned to PMD was checked & released-no treatment or meds-9MAR98 only a little swelling now remains;
No adverse effects were reported.; an expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from other healthcare professional (medical student) and referred to patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 05-DEC-2022, an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX) 23 injection 0.5 ml once (valid lot#T032003 with expiration date 08-MAY-2022) was administered to a patient for prophylaxis (Expired vaccine used). There was no additional information provided to further clarify these details. No adverse effects were reported and no additional adverse event reported (No adverse event).
4mo. long Diarrhea, Severe weight loss, Imodium Prescription strength, Pepto Bismol.
Sore arm, fatigue, feeling cold, sinus pressure and nasal congestion. Taking Tylenol and Benadryl, helping minimally .
A non-serious, spontaneous report of "gave half of vaccine" was received from a nurse concerning a 28 year-old female subsequent to FLUMIST. The nurse reported she did not remember to remove the clip from the FLUMIST pre-filled syringe and thinks that she only gave one half of the vaccine. There were no additional events to report after follow-up on day thirteen after vaccination. The patient was re-vaccinated. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Additional information was received on 30-Oct-2008 and incorporated into the narrative: telephone contact received; no adverse events occurred and the patient was re-vaccinated.
12 - 13 hours after receiving my second shot I started feeling extremely sick.  my joints became sensitive and sore, alternating fever and chills, layed up in bed for about 24 to 36 hours in pain, then started to subside.  Surprisingly, I was mostly recovered   by the 3rd day, am fine now.
Extreme weakness, tiredness (lasted months), lack of appetite, uncontrolled blood sugars, shaky legs and pain.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 25th January 2018, the patient received the 1st dose of SHINGRIX. On 25th January 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient reported that she experienced pain on her injection site. For tolerance to the 2nd dose refer case US2018107300, reported by the same reporter for the same patient.
Hasn't been administered a second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2019, received first dose). Concurrent medical conditions included immunocompromised.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Hasn't been administered a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2023 Physician assistant called to report a patient had not been administered a second dose. First dose was given at a different facility so no information on lot number, vaccination date for the vaccine. The reporter did consent to follow up. Till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
breakthrough infection/infection 6-12 months post-D3; breakthrough infection/infection 6-12 months post-D3; This is a literature report for the following literature source(s):  An adolescent patient 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 included: "Adolescent solid organ transplant recipients" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "breakthrough infection/infection 6-12 months post-D3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: unknown result; Positive.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
The adverse event I experienced was more fatigue  (than usual at 36 weeks pregnant) a day after receiving the Covid Janssen vaccine.  I slept a good portion of the day and felt I didn?t have the energy to go about daily chores around the house.  I am now 37 weeks pregnant and due on April 9th.  I was able to return resume normal activities the next day and have not experienced any other side effects since then that have restricted me from performing my daily activities.
That afternoon I was off balance.  I was working and busy and did not stop to assess.  Upon sitting down for dinner 7:30 pm, discovered dizziness was increasing.  Sat down to read and body felt like it wanted to pass out.  Fell into a strange sleep 8:00pm(passed out) and then awoke at 10:30PM.  Full vertigo at this point, felt very queasy and faint.  Began to feel like I was going to pass out.  Became very warm and clammy all over.  Sat in bathroom on floor hugging toilet for about 30 minutes.  Husband thought I needed to go to the ER.  I was in a strange consciousness at this point.  Husband reported very pale color and he stayed with me.  Fell back asleep again, like passing out.  Awoke at 2:00am and felt better, but next day still felt a little strange.
Client c/o not feeling well immediately after complaint, client vomited what appears to be a moderate amount of undigested food.  Medics alerted. Client examined by medics and released in care of her dad.  No acute distress.  Vital signs:  Oxygen sat 98-100% on room air, pulse 94, BP 102/56 and Resp. 22 and slightly labored.
After vaccine, aprox 3 min after, started with hear racing, pain in upper r-chest.  Pain scored 5/10.  Vitals @ 1254; BP 116/76, RR 16, O2 00%, HR 72, Vitals @1307 Heart no longer racing. Pain 5/10, Vitals @1309 BP 116/80, HR 66, O2 99%, RR 12
RIGHT ARM IS FROZEN WITH ALOT OF PAIN. NUMBNESS IN THE FINGERS NOW. ON MEDICATION STEROIDS, AND ANTI - INFLAMMATORY MEDICATIONS.  STILL BEING TREATED FROM A DOCTOR.
Fatigue; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, Lot number: unknown), via an unspecified route of administration on 08Jun2021 (at the age of 49-years) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10Jun2021, the patient experienced fatigue, dizziness and headache. The clinical course included: the patient received the second dose on 08Jun2021 and called to report the adverse reactions he had felt, especially after the second dose. He felt a lot of fatigue, dizziness, was ongoing since yesterday (10Jun2021), even talking was causing fatigue and had a headache. The outcome of event headache was unknown and for other events it was not recovered.  Information on Lot/Batch number was not available. Additional information has been requested
On 12/29/2021 as soon as I woke up I could not get out of bed, I had a fever of 101 or higher, a terrible headache, my nose bleed, a dry non productive cough, also my blood pressure was very high it was around the 170s & 180s at that time. The next morning 12/30/2021 I still had a headache but not as bad as the 29th, no fevers on the 30th. I still had nose bleed but very little. The cough still continued & my high blood pressure still continued the lowest it got 144 over79. I experienced moments of weakness & that's when my blood pressure would shoot up.  I called my doctor on the 12/30/2021 I called my doctor and he started me on medications & he told me to keep track of my blood pressure. On 12/31/2021 everything began to diminish except the blood pressure that one continued. The high blood pressure continued all the way towards the end of January.  On 01/28/2021 I ended up in the emergency room also because of my blood pressure & they did some test there.
Patient states that friends and acquaintances told her that her face appeared swollen, patient states it was. By evening hours 10/01/2014 patient states she noted itchy rash to neck, and chest which has spread to body.
COVID-19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Serious asthma).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included multiple medications for serious asthma.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The patient reported that they want to check if there is information on a bad batch for the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Added email address of the patient.; Reporter's Comments: Lack of Drug Efficacy.
Information has been received from a doctor of pharmacy concerning 3 patients' (60 + years old) who were vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No adverse reactions were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.