chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day #2: Pt reports that he had reaction to PNEUMOVAX shot yesterday. Has chills and then felt hot. Has resolved now. Day #3 Pt calls and states that he still feels ill post pneumococcal immunization. Wife reports that after shot he could not drive home without driving off of road. When he arrived home he had chills and then turned up. Went to ER where he received steroid injections. Treatment: Methylprednisolone.
Patient informed staff upon arrival that this was his first COVID-19 vaccine and would like a moderna shot. Patient filled out COVID-19 Vaccine Documentation/Consent Form and stated "I have never received a covid-19 shot." After patient received shot, staff was in system to update patients vaccination record. Patients record shows 3 doses of pfizer on 02/24/2021, 03/19/2021, and 08/21/2021.  Patient was asked if they had received any COVID-19 vaccine before. Patient stated "No this is my first COVID-19 shot." Patient denied multiple times of receiving any covid-19 vaccine. Staff verified all the contact information in system and was correct with the patient information. Patients wife was present during the vaccination and states "President supporters put that into our records we have never had a shot before."
I woke up on  Sunday morning with extreme wrist and ankle pain, there was swelling in my hands and feet.  I thought I was getting carpal tunnel but it did not seem like that would effect both hands nor would it effect my ankles.  I hit my knee at work and thought the ankle pain was from that but because I am still painful and swollen a week later I looked up side effects of the MMR in adults and see this could be a reaction to the shot, I was not immune to the measles and started a new job at a hospital so had to get this immunization in order to work there.  I have been taking tylenol and motrin but it is not really helping and because of my tummy issues I can not take too much motrin.  It is hard for me to pick things up with either hand it is very swollen and painful to move
THE DAY AFTER I ADMINISTERED VACCINE TO THE CHILD,THE MOTHER STATED THAT THE CHILD WOKE UP IN THE MORNING WITH SWOLLEN LEFT ARM,ON THE INJECTION SIDE,REDNESS ,WARM TO TOUCH AND TENDERNESS WHERE THE SHOT WAS GIVEN.MOTHER DENIED FEVER OR ANY OTHER COMPLAINS.THE CHILD WAS REFFERED TO THE PEDIATRICIAN.
This spontaneous report as received from a nurse practitioner refers to a 23 year old female patient with asthma, allergy to benzonatate and allergy to wheat. On 08-JUL-2014 the patient was vaccinated with the first dose of GARDASIL (intramuscular injection, batch/lot #, expiration date, route not reported). On 09-SEP-2014 the patient was vaccinated with the second dose of GARDASIL batch/lot # J015378, expiration date 09-APR-2016, also reported as 01-APR-2016, dose 2, route not reported). Concomitant therapies included naproxen, NASONEX, budesonide, SYMBICORT, ATROVENT, PROAIR and LO LOESTRIN FE. On 10-SEP-2014, the patient developed body aches, joint pain and chest pain, after the second dose of GARDASIL. The patient also felt warm and sweaty and reported a body temperature of 99 F. The patient sought medical attention by contacting the nurse practitioner, but did not receive treatment for the adverse events. The outcome of the events was reported as not recovered/not resolved. Causality was not provided by the reporter. Additional information has been requested.
Local swelling, redness, heat, firm to touch - area measured about 3 1/2".
hives / still has it; This case was reported by a physician via call center representative and described the occurrence of hives in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2020, the patient received the 1st dose of Shingrix. On 7th September 2020, less than a day after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced hives within hours which was not recovered till the time of reporting. The reporter consented to follow up. No further information was available.
Case number PHEH2014US020681 is an initial spontaneous report received from a pharmacist on 13 OCT 2014. This report refers to a 25 year old female patient. She was going through fertility treatment. On an unspecified date, she received seasonal influenza vaccine (manufacturer and batch number: not reported) and a month later, on 12 OCT 2014, she received FLUVIRIN 2014/2015 (batch number: 1413301) intramuscularly. No adverse events were reported following this medication error (inappropriate schedule of vaccine administered).
vaccine administered 5/27/2022, beyond use date was 04/18/2022, expiration date 05/31/2022
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 19-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L031602 and expiration date 18-FEB-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Day after receiving vaccine patient noted tightness in chest and difficulty breathing.  Went to local urgent care and ambulance called to transport her to hospital as was feared a cardiovascular event.  Admitted to Hospital, 02/12/21 and discharged 02/13/21.  Patient states stress test, echo, and CT with contrast, and xrays all normal.  She states hospital did not know what caused her symptoms and could not tell her if this was caused by vaccine.  She followed up with her PCP on 02/15 and was told that by her xray it looked like she might have had the starting of something like bronchitis.  Administered antibiotic shot and steroid shot and RX inhaler.  Moderna COVID-19 vaccine EUA.
Five days after the vaccine, the injection site on  my left arm became red, painful,  swollen, warm to the touch, and very itchy.  It is at this time I felt a bump or nodule at the injection site.  With oral diphenhydramine HCL -50mg nightly for three days the swelling and redness decreased. Topical Neosporin antibiotic ointment with itch coverage was applied in the AM and PM for five days.   Day six my left arm at the injection site has returned to my baseline normal - but the nodule / bump is still present, and at times my left arm - deltoid area where the vaccine was injected is still sore and stiff at times.
per pat-experienced arm turning bright red and warm to touch from injection site to wrist, tooks weeks to dissipate
got the Covid vaccine and then he got COVID; got the Covid vaccine and then he got COVID; multiple system inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 8 year-old male patient 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: SUSPECTED COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "got the Covid vaccine and then he got COVID"; MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (medically significant), outcome "unknown", described as "multiple system inflammation". Clinical course: While providing information for report caller stated her eight year old great grandson had to be put in withheld because he was having multiple system inflammation and all his systems were trying to shut down. Caller states her great grandson got COVID anyway and they put him at withheld. He was there for a little over a week. He was in bad shape withheld. Caller clarified that her great grandson got the Covid vaccine and then he got COVID. Several family friends have had the Covid vaccine and all have had Covid after it, not omicron or delta variant, the original.    The lot number for bnt162b2 was not provided and will be requested during follow up.
arm swelling and pain starting day after vaccine (including fever, chills, diarrhea), swelling lasting 1 week, pain continues (although slight) through today
This spontaneous report was received from a Nurse refers to a female patient of unknown age. The nurse reported that on an unknown date in 2007, the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency were not reported). On an unknown date in January 2014, the patient was vaccinated with the second dose of GARDASIL (dose, route and frequency were not reported). No adverse effects reported. No further details were provided. Additional information is not expected.
evening after shot patient stated arm pain, swelling, redness near site of injection. called pharmacy next day to report to rph. counseled pt to take ibuprofen for pain and inflammation and follow up with pcp is worsens
Patient sustained witnessed tonic/clonic seizure like activity with loss of consciousness lasting <15 seconds with eyes "rolling back" and skin color change from normal for age/race to pale followed by bilateral upper extremity convulsions. Witnessed by monitoring area Registered Nurse. Hx: Seizures, last seizure secondary to codeine ingestion >1 y ago. Anxiety related to injections.   Timeline:  1759- Vaccinated with Pfizer Lot # EN6199 1st dose 1805- adverse reaction occurred 1806- mental status: slow to respond, skin: pale/diaphoretic, VS: HR 51 (regular at the radial site), BP 80/palp, RR: 12, T: 36.8, Spo2 100% on RA 1807- 911 activated, placed in position of comfort.  1815- EMS arrived, EKG consistent with sinus bradycardia, HR 58, BP 150/130, RR 15, Spo2 100% on RA 1820- EMS placed patient on gurney.  1825- Departed via EMS gurney
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Additional Details: patient suffers from myasthenia gravis. adverse of the vaccine are still showing on day 8 after injection. patient visited her neurologist who informed her she may need infusions as it may be leading up to an episode. patients arm was still heavily bruised, although she said it was starting to feel better.
May 28, 2021, about 28 hours after receiving the second Moderna shot, began to feel light headed and almost passing out. Breathing became labored. 911 was called and the EMTS arrived. Blood pressure was very low below normal readings.  Also did an EKG on site.  Was transported via Ambulance to Hospital. IV fluids administered in the ambulance. More fluids were given by IV in Emergency room.  Blood Pressure monitored at 152/82 in Emergency room, about 2 hours after admitted. EKG, Chest and Lung Xray, full blood work. Emergency Dr gave 2 mg of Doxazosin scheduled meds and was released. Blood pressure continued to elevate after released. BP meds were still taken as scheduled.
Awoke 2:30 am w/burning, itching on left arm est over site of injection. Hives around injection site. Took BENADRYL, helped in 24 hrs, then had spread apart 3 red bumps on lateral upper arm, 2mm size ? bites, insect.
little top piece that attaches to the needle popped out of place and starting leaking the vaccine out from under it, and vaccine dripped out the side and a few drops landed on patient with no reported adverse event; Initial information received on 13-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient of unknown demographics and it was reported that a little top piece that attaches to the needle popped out of place and starting leaking the vaccine out from under it, and vaccine dripped out the side and a few drops landed on patient with no reported adverse event 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 an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Immunization.  On an unknown date the little top piece that attaches to the needle popped out of place and starting leaking the vaccine out from under it, and vaccine dripped out the side and a few drops landed on patient with no reported adverse event (accidental exposure to product) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that that while giving the patient the vaccine the little top piece that attaches to the needle popped out of place and starting leaking the vaccine out from under it, so like it was not secured.Vaccine dripped out the side and a few drops landed on patient. Pharmacist would like to know if they should give the patient another dose because patient was claiming that she was not feeling anything.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
5 days after vaccine shot I woke up with red, itchy and burning sensation on both hands and feet. 15 days later symptoms have not improved. The skin on my hands are shedding, peeling away and my left foot has a right tingling sensation when I stand.
Awoke 7:30 am day after vaccination (16 hrs later) unable to hear R ear.  Unable to access medical care because it was Sunday.  Contacted primary physician who said he would try to get me ENT appointment ASAP, but suggested  I get audiology evaluation ASAP, which I did, on Monday afternoon, 3/22/2021.  Eval confirmed hearing loss with problem in R middle ear.  Developed mild flu-like symptoms on Monday evening that persisted for about 30 hours...mild nausea, headache, malaise.  Appointment with Dr, ENT scheduled for 3/25/2021.  He said I was about the 5th vaccine related hearing loss he had seen, and has prescribed a course of Prednisone, in hopes hearing will return.
Pt in COVID vaccine observation area and reports tingling bilateral extremities, lips and tongue. Pt reports sensation of tongue swelling. Benadryl 25 mg/10ml given. Progressive tingling/numbness reported with mild dyspnea with mild dizziness. No itching reported. Vitals taken and stable. Emergency response contacted; arrived and completed EKG.
The first dose of the vaccine produced minimal side effects. For a day or two, my left arm was sore and puffy around the injection site. About three days after injection (on February 4) a wide-ribbon band of rash appeared below the injection site, accompanied by fierce itchiness.   The second dose of Moderna caused: fever, headache, extreme fatigue, loss of appetite, and general malaise from March 5 to March 8. I was literally bed-bound for 2-1/2 days. It was severe and intense but it was also short-lived. I experienced no difficulty breathing. I recall very little of what happened during that weekend.
dizziness; fatigue; cough; pain from the injection site up to the shoulder; pain from the injection site up to the shoulder; lack of appetite; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles on face back in January 2020).   On 23rd August 2020, the patient received the 1st dose of Shingrix. In August 2020, 1 day after receiving Shingrix, the patient experienced dizziness, fatigue, cough, injection site pain, shoulder pain and appetite absent. On an unknown date, the outcome of the dizziness, fatigue, cough, injection site pain, shoulder pain and appetite absent were unknown.   It was unknown if the reporter considered the dizziness, fatigue, cough, injection site pain, shoulder pain and appetite absent to be related to Shingrix.  Additional details were provided as follows: In January 2020, the patient had  shingles.  The patient reported receiving the 1st dose of Shingrix and that she developed a cough, pain from the injection site up to the shoulder, fatigue and dizziness the day after injection. The patient also reported having a lack of appetite and is concerned about becoming sick if she decides to eat. The reporter consent to follow up.
THICK, BLACKISH-GREEN DISCHARGE FROM ANUS, COULD NOT PASS FLATULENCE WITHOUT SPEWING OUT FROM ANUS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced thick, blackish-green discharge from anus, could not pass flatulence without spewing out from anus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thick, blackish-green discharge from anus, could not pass flatulence without spewing out from anus was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Fever over 100 degrees lasting over 12h. Nausea, diarrhea, stomach pain for 12h. Body aches and muscle pain for over 24 hours at this point. Fever at approx 99.5 when fever reducers wear off. Loss of appetite. These were relatively expected reactions due to my reaction from previous Covid vax doses, however, I missed my v-safe check in and the pharmacist who did my shot said that reporting side effects after the bivalent was important.
Numbness/tingling in extremities, was seen by PMP. Prednisone helped lessen symptom severity. It is ongoing on day 5.
Erythematous area at the injection site; A spontaneous report was received from a physician, who is a 47-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red erythematous area at the injection site.  The patient's medical history was not provided. Concomitant medications were not reported.  On 05 JAN 2021, the patient received their first dose of mRNA-1273 (Batch number: 011J20A) intramuscularly in her left arm for the prophylaxis of COVID-19 infection.   On 13 JAN 2021, the patient experienced red erythematous area at the injection site. Treatment for the event included cetirizine and hydrocortisone.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, red erythematous area at the injection site was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Redness, swelling, itching Left upperarm. fever (low grade) Benadryl given Tx in office - cephalexin, Zyrtec
@9:47 Pt reported chest pain5/10, anxiety and coughing.  V/S 115/71, 78, 15, 97.9F 100% MAR called at 9:51 am for patient complaining of chest pain 2/10 after receiving Moderna Booster vaccine at 0905 am. V/S: BP-113/75, HR- 78, RR-20. O2sat- 100%, MD ordered to place patient on trendelenburg position for 15 minutes, patient tolerated trendelenburg position well, continued to observed patient, patient is A/Ox4, MAE, talking in full sentences, no signs and symptoms of sob or discomfort, patient denies any dizziness,  V/S 9:56 am: BP-107/67, HR-76, RR-20, O2 sat-100% RA 9:57 am: patient denies any chest pain, chest pain, 0/10.  10:08 am: Patient stable, discharged home. MD recommends pt lay down for next vaccination.
Arm pain x 16 days. Unable to abduct arm. Treated with Naprosyn follow up in 5 days.
patient either did not tell them they were immunocompromised before getting the booster dose or became immunocompromised after getting the booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (patient either did not tell them they were immunocompromised before getting the booster dose or became immunocompromised after getting the booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced ACCIDENTAL UNDERDOSE (patient either did not tell them they were immunocompromised before getting the booster dose or became immunocompromised after getting the booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (patient either did not tell them they were immunocompromised before getting the booster dose or became immunocompromised after getting the booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The patient had received 2 doses and a booster dose of Moderna vaccine. The booster dose was given about a month ago and 5 months after the second dose of Moderna Covid-19 vaccine.  The reporter wanted to know if whether they should give another booster dose to the patient that would be equal to a third dose or if they should go ahead and give a full third dose to the patient. The reporter was familiar with the administration errors and deviations information, which did not specify to make a recommendation except in cases of same day under dosing, and wanted to see if Moderna had any information.
Patient presented for evaluation of an episode of chest tightness and possible allergic reaction after receiving the Pfizer vaccination for COVID-19. Patient reports that she initially did well but while she was waiting the 15 minutes of observation after the vaccine she began to note intermittent chest tightness as well as feeling like her heart was racing. This may have represented an allergic reaction although she did not require any medication to treat it.
Severe diarrhea next day and for the next 3 weeks. No fever or other effects. Started to subside day before booster shot, then it started again day after booster. 2 weeks later, it seems to be gradually lessening, but still a problem.
Patient had a rapid heart rate, metallic taste in mouth and noticeably diaphoretic.  Patient also reports slight numbness in lips. Patients vitals were taken; HR 115, BP 122/84, 18 RR. Patient was advised to take Benadryl and call 911 if symptoms worsen. Patient appeared well with steady gate. Accompanied home by husband
Site red, swollen, itchy arm hurt to lay on and hot to touch. BENADRYL all weekend.