chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt had mild cough but recv vax & 16 days later had blanching rash, inc itching & scratch urticarial lesions abd
This case was reported by a pharmacist via call center representative and described the occurrence of enlargement of lymph nodes in a adult female patient who received FLUARIX QUADRIVALENT. In October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was not recovered/not resolved. The reporter considered the enlargement of lymph nodes to be unlikely related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. On an unspecified date, within the previous couple of weeks from reporting date, the patient received FLUARIX QUADRIVALENT.  Side and site of injection was unknown. The patient experienced swollen lymph nodes under her arm. The swollen lymph nodes were specific to the opposite side that the patient received vaccine. It was reported that, issue described by the patient was going away and was returning at the time of reporting.
Right eye pain day before Shingles vaccine taken. Suspected dry eye but pain in eyeball and atop eyeball, severe Same day as injection, pangs in head,  Following day continued pangs in head, saw PA, who diagnosed Shingles based on small rash hidden beneath right eye brow, unilateral symptoms Following, rash above right eye and between corner of right eye and nose, forehead, numbness in forehead now extreme itch, burning pain in scalp and forehead, continue pangs right side of head, top and behind right ear Prescribed Valacyclovir 1Gm 3x/day for 7 days and Gabapentin 100mg 3 x/day Now taking Gabapentin 100mg 2x/day and 200mg at bedtime, Aceetaminiphen 500mg 4 x/day, Ibuprofen 200mg 4 x/day, aloe or Caladryl on rashes, Bio True approximately 1-2 drops/day in right eye for what may be dry eye or a symptom of Shingles, Salonpas roll on for pain behind right ear
PATIENT IS 16, WHICH IS UNDER THE AGE OF 18 FOR WHICH THE VACCINE SHOULD BE ADMINISTERED TO.
Swelling to upper arm from elbow to shoulder, redness and itchy feeling. Administered Tylenol & cold pack compression which only helped a little.
Presented with nausea and vomitting. + for covid. pt discharged home to follow up with gatroenterology.
23JAN97 PM awoke from nap, no temp;seemed tired crawled to where dad was & collapsed & was seen @ hosp;episode only lasted 30 seconds;
After giving the vaccine, the patient immediately stood up and walked over to the drop-off window to ask the technician a question. She turned very pale and stated she did not feel well. She said she felt light headed, sick to her stomach, and had ringing in her ears. The pharmacist asked her to go sit on the bench and grabbed her a cold bottle of water. The patient stated she had had breakfast several hours ago and was on her way to lunch after getting the shot. The pharmacist asked the technician to run up front and grab her some peanut butter crackers. The pharmacist paid for the crackers. The patient sat in the waiting room, drank some water, and ate the crackers for around 10 minutes. The pharmacist made sure she was feeling better and ok to get up when she was ready to leave.
A non-serious spontaneous report of some of the H1N1 Mist got into the child's eye was received from a registered nurse concerning a four-year-old female. The patient's medical history and concomitant medications were not provided. The patient's eye was flushed with water. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
Very sharp pains in lower abdomen lasting a few minutes the subsiding.  Felt like contractions.  Day before event ate slot of broccoli.  Believe it to be  diverticulosis. Started taking meta musial have had some relief.
One week after injection- in the evening- had intense itching for about 10 minutes at site of injection ( right bicep ), which then  completely stopped. The following morning I checked my arm and it was slightly red, warm and swollen at entire bicep of injected site. It was a minimal annoyance that lasted about 48 hrs and did not interfere with any range of motion or sleep at night.  As an aside: original injection day and following day was very minimal pain, but I did feel "phantom pain on my other arm ( left ) at same area of bicep...a friend also said this happen to her.
Drop on their sodium levels; A spontaneous report was received from a healthcare professional concerning, a 91-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported drop on sodium levels.  The patient's medical history, as provided by the reporter, included bad fall the patient had a year ago. The concomitant medication included unspecified blood pressure and thyroid medications.  On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient was past due date for the second dose of the vaccine. On 28 Feb 2021, the patient experienced drop in sodium levels and was hospitalized. According to the patient's relative this could be attributed to the hitting of head due to bad fall the patient had a year ago leading to hospitalization. Since then the patient had been instructed to monitor sodium and potassium levels.  Treatment information was unknown.  Action taken with mRNA-1273 was unknown.  The outcome of the event, drop on sodium levels, was unknown.  The consumer assessed the event, drop on sodium levels/hyponatremia, as related to fall.; 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.
severe pain; This spontaneous case was reported by a physician and describes the occurrence of PAIN (severe pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PAIN (severe pain). At the time of the report, PAIN (severe pain) 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.   Treatment and Concomitant medicines were not reported.
Pt. complained of extreme pain around site of injection. Later, he said the pain moved into his shoulder, then eye. He complained of mild headaches.
This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received PREVNAR 13 (lot number and expiration date were unknown), via an unspecified route of administration on 12Feb2018 15:30 at a single dose for immunisation. The patient's medical history included chronic obstructive pulmonary disease (COPD) from 2017 and ongoing, and ongoing allergies that the patient has had for a long time. The patient's concomitant medications were not reported. On an unspecified date in 2018, the patient experienced weight gain. On 13Feb2018, the patient experienced muscle spasms/contracting, redness at injection site, swelling at injection site, fever and hot at injection site, joint pain, and could not move and couldn't get out bed. The patient reported that she has been having symptoms since receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine. She added that she has been in therapy since Mar2018; she had to go to physical therapy after receiving vaccine since Mar2018. The patient also reported that she has also gained weight since getting the shot. She usually weighed 155 to 160 lbs. Currently (2018), her weight is 180 lbs. The patient also reported that she received the vaccine at a clinic, received the shot at 3:30 pm on 12Feb2018. The next morning (13Feb2018) when she got up at 7:00 am, she could not move and couldn't get out bed. She stated that she has taken the other kind of pneumonia shot before and it did not affect her. She has had x-rays (2018). The therapist said she was still having muscle contractions and spasms. She was told by the therapist to call and report symptoms. The outcome of the events weight gain, muscle spasms/contracting, and joint pain was not recovered. Outcome of the events redness at injection site, swelling at injection site, fever and hot at injection site was recovered on Feb2018. And outcome of the event "could not move and couldn't get out bed" was unknown. Information on the batch/lot number has been requested.
Febrile seizure 10/24/10 - Fever 104.3 & one generalized seizure. Seen in ER and diagnosed with sinusitis. Treated with Amoxicillin.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 20-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained.; Sender's Comments:  US-009507513-1611USA004113:
Janssen COVID-19 Vaccine EUA  Onset ~9am Friday,  April 2 Symptoms: excruciating headache in occipital & temporal regions of head, aching joints (especially knees & lower back), cold sweats  Signs: decreased appetite, pale
This spontaneous report was received from a physician via a field representative regarding a female patient of unknown age. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (lot# unspecified) and there was no adverse reactions. Approximately on an unknown date in October 2015 (reported as a month ago), the patient was vaccinated with the second dose of GARDASIL (lot# unspecified) in the arm. No concomitant medications were reported. Approximately on an unknown date in October 2015 (reported as a month ago), the patient experienced "a warm sensation in arm" at injection site. In addition, the patient had a knot feeling in arm after injection. Furthermore, the patient stated that this was her first day back to the gym for a workout. No Product Quality Complaint (PQC) was reported. Further vaccination with GARDASIL was discontinued. The outcome of the events were not reported. Causality assessment was not provided. No additional information was provided. Additional information has been requested.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 14-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H010659, expiry date MAR-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Edema in both hands and arms.  Swollen face  Lower lip swelling and tongue swelling
Soreness at injection site, severe flu-like symptoms, weak, loss of apetite, fever of 101 for 2 days, red blotch at injection site for over 2 weeks.
REDNESS & ITCHING THROUGHOUT BODY...STARTED ON LOWER ABDOMEN BUT THEN SPREAD THROUH BODY.
This medically confirmed spontaneous report (initial receipt: 18-Oct-2012) concerns a 12 to 15-month-old female patient. On 15-Oct-2012 the patient received an unspecified flu vaccine (manufacturer, brand name and batch number were not provided). On the same day she also received VARIVAX injection and PREVNAR. At some point on Tuesday evening (16-Oct-2012) the patient developed a fever of 104 degrees Fahrenheit. The mother treated her with paracetamol and ibuprofen. By Wednesday morning (17-Oct-2012) the patient's temperature was 99 degrees Fahrenheit. The mother took the patient to day care on Wednesday morning. At some point during the morning the patient developed a rash. The mother took her to the physician for treatment (treatment unspecified by the reporter). The event outcome was not reported.
Diarrhea; This is a spontaneous report from a contactable consumer (the patient).  A non-pregnant 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 02Feb2021 at 02:30 AM (at the age of 72-years) as a single dose for COVID-19 immunization. Medical history included carpal tunnel syndrome. (The patient stated she received the first dose of the vaccine a week ago. She was prescribed Methylprednisolone for her carpal tunnel problem. She stated its not due to COVID shot as she had it - carpel tunnel syndrome before. She wanted to know if there is any interaction with Methylprednisolone and COVID vaccine). The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included atenolol, cetirizine hydrochloride (CETRIZINE), pantoprazole, celecoxib (CELEXA) , vitamin b complex (VITAMIN B). The patient received other vaccines within four weeks prior to the vaccination, which included varicella zoster vaccine RGE (CHO) (SHINGRIX), dose 2 in the left arm as a single dose on 13Jan2021 for immunization. On 04Feb2021 at 10:00 AM  the patient experienced diarrhea. No treatment was given. The clinical outcome of diarrhea was not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information about lot number has been requested.
Really tired; Initial information was received on 22-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media   This case involves a patient (unknown gender) who experienced really tired (fatigue), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious really tired (fatigue) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "Got my flu shot and was really tired for two days."  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Pt was administered Moderna Covid-19 Vaccine on 2/4/2021.  Pt exhbited no symptoms of an adverse reaction of any sort.  Pt was ambulating alert and attentive.  Pt was observed for the alloted 15 mins by pharmacist and case worker who had escorted pt to vaccination clinic.  It was reported that Either on sunday 2/7/2021 or monday 2/8/2021 pt had passed away.  Circumstances revolving patient death is still unknown.
This spontaneous report as received from a registered nurse refers to approximately 5 patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On an unknown date, approximately 5 patients were vaccinated with improperly stored ZOSTAVAX (dose, anatomical location, route of administration, lot#, expiration date not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected since there is no consent for follow-up.
cried uncontrollably for 5 hrs 30 mins p/inject, t102; could not be comforted; called clinic & MD put pt on Pediaprofen & regular APAP; mom told that was rxn to pertussis; no more pertussis;
I went to the ER because I was experiencing a high heart rate and fever; the doctor gave me Ativan to calm my anxiety and heart rate. I was discharged the same day; a few days later, I used ibuprofen to help reduce my symptoms. Two weeks after, I started having muscle spasms all over my body. When I went in for my annual physical, my doctor suggested for me to take magnesium and vitamin B12 to help with the spasms. Seven months later, they still occur but not as severe and not as often. I still take the magnesium and B12 to reduce the frequency. Then I began experiencing tinnitus; the doctor prescribed me a nasal spray for it, but it didn't help. So now I have a follow-up exam with an ENT this coming May to check on that.
Extreme chills, uncontrolled shaking, slight fever, rapid pulse, rapid short respirations, headache, slight cough, unsteadiness on standing
Painless thyroiditis; palpitations; anxiety; This literature-non-study case was reported in a literature article and describes the occurrence of THYROIDITIS (Painless thyroiditis) in a 39-year-old female patient 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 Hashimoto's disease (Patient with history of Hashimoto's disease for 13 years, euthyroid on levothyroxine.). Concomitant products included LEVOTHYROXINE for Hashimoto's disease.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THYROIDITIS (Painless thyroiditis) (seriousness criterion medically significant), PALPITATIONS (palpitations) and ANXIETY (anxiety). At the time of the report, THYROIDITIS (Painless thyroiditis), PALPITATIONS (palpitations) and ANXIETY (anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Anti-thyroid antibody: normal (normal) Normal and 107 ng/dl 107 ng/dL. On an unknown date, Blood thyroid stimulating hormone (0.45-4.5): low (Low) 0.02 lIU/mL and low (Low) 0.01 lIU/mL after 1 week. On an unknown date, Free thyroxine index (0.7-1.8): 2.95 ng/dl (High) 2.95 ng/dL and 2.10 ng/dl (High) 2.10 ng/dL after 1 week. On an unknown date, Thyroid stimulating immunoglobulin: less than 1.0 less than 1.0.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered THYROIDITIS (Painless thyroiditis), PALPITATIONS (palpitations) and ANXIETY (anxiety) to be possibly related.    Concomitant product use was not provided by the reporter.   Treatment information was not provided.  The patient was asked to hold her levothyroxine and repeat labs 1 week later again. Radioactive iodine uptake 2 weeks after stopping thyroid hormone showed near absent uptake of 0.22%  This is a literature-non-study case concerning a 39-year-old female patient with history of Hashimoto´s disease for 13 years, euthyroid on levothyroxine, who experienced the serious  unexpected event Thyroiditis. The events occurred approximately 10 days after  the second  dose of mRNA-1273 Moderna vaccine, on an unknown date.  The medical history of Hashimoto´s disease remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-372516 (Patient Link).; Sender's Comments: This is a literature-non-study case concerning a 39-year-old female patient with history of Hashimoto´s disease for 13 years, euthyroid on levothyroxine, who experienced the serious  unexpected event Thyroiditis. The events occurred approximately 10 days after  the second  dose of mRNA-1273 Moderna vaccine, on an unknown date.  The medical history of Hashimoto´s disease remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Never received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received couple of years ago ).   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: Never received the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 31-Mar-2023  The pharmacist reported that the patient received Shingrix a couple of years ago and never received Shingrix second dose.  The reporter did not consent to follow up.  No further information was available at the moment of the interaction by phone. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Fever of 102-104 for 31 hours.; A spontaneous report was received from a consumer concerning a 28-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever of 102-104 for 31 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, an hour after the vaccine, the patient experienced the event Fever of 102-104 for 31 hours..  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   On an unknown date the outcome of event fever of 102-104 for 31 hours was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Tinnitus onset day after shot.  Also had temperature of 100 F and swollen lymph node under left arm.  Tinnitus is the side effect that is being reported as it has not gone away and is constant.
As I was administering the Peds Moderna 2nd dose in his left deltoid patient moved when I was almost done and some of it came out at the end.
adverse reaction; This spontaneous report was received from a consumer via Pfizer referring to a male patient of unknown age (the currently age also reported as 16 (unit unknown)). The patient's medical history, concurrent condition and concomitant medication were unknown    On an unknown date (reported as when he was younger), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot# and expiration date were unknown) for prophylaxis.         On an unknown date, the patient had an adverse reaction to his measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The outcome of adverse reaction was unknown. The reporter considered adverse reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).