chrisvoncsefalvay/vaers-outcomes huggingface dataset:
they bit me up a little bit; achy all over; Felt like a good flu; tired; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (they bit me up a little bit), PAIN (achy all over), INFLUENZA LIKE ILLNESS (Felt like a good flu) and FATIGUE (tired) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Lymphoma (The patient was the cancer survivor and was on 24 th year of remission.) in 1997. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (they bit me up a little bit), PAIN (achy all over), INFLUENZA LIKE ILLNESS (Felt like a good flu) and FATIGUE (tired). At the time of the report, VACCINATION COMPLICATION (they bit me up a little bit), PAIN (achy all over), INFLUENZA LIKE ILLNESS (Felt like a good flu) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter. Reporter was a health care worker who had the first and second dose of Moderna. He was a cancer survivor (late stage lymphoma), diagnosed in 1997, 24th year remission. He participated in an study with (place name removed).   This case was linked to MOD-2021-400106 (Patient Link).
looked like cellulitis; rash at 7 days at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) in a 50-year-old female patient 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 VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site). At the time of the report, VACCINATION SITE CELLULITIS (looked like cellulitis) and VACCINATION SITE RASH (rash at 7 days at the injection site) had resolved.        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.   Treatment for the events included oral prednisone for 5 days.   The mastercase  (MOD-2021-006526) has already been to MR and CP and its non-serious.  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.; Sender'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.
PAIN AT INJECTION SITE; CHILLS; BODY ACHES; HEADACHE; DULLED SENSE OF TASTE; This spontaneous report received from a patient concerned a 30 year old white male (Not Hispanic/Latino). The patient's height, and weight were not reported. The patient's concurrent conditions included obese, and no known drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 expiry: UNKNOWN) .5 ml, 1 total, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced pain at injection site, chills, body aches, headache and dulled sense of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site, and chills on 06-MAR-2021, and was recovering from body aches, headache, and dulled sense of taste. This report was non-serious.
Initial information received on 11-Sep-2018 regarding an unsolicited pregnancy valid non-serious case received from a nurse. This case is linked to case 2018SA258055 (same reporter). This case involves a 20 years old female patient who received 0.5 ml booster dose of ADACEL (expiry date 22 June 2020 and lot details U5980DA) on 10 Sep 2018 while she was pregnant. It was a case of vaccine exposure during pregnancy. The patient was at 32 weeks gestational age at the time of event. The date of last menstrual period was reported as unknown. The estimated due date is 06-Nov-2018 (based on ultrasound). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had no concomitant. It was a case actual medication error due to incorrect product storage as adacel too long in shipping (greater than 2 days) after dose given to pregnant female outside of stability recommendations. It was unknown if any adverse event occurred. 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 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. Documents held by sender: none.
Extreme pain in upper arm/shoulder.  Impingement syndrome of left shoulder, and bursitis of left shoulder. Soreness when raising arm. Limited left arm mobility.  Treatment included Advil, Meloxicam, Prednisone, rest.
rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 08Feb2021, the patient experienced rash. It was reported that female consumer was scheduled to get her 2nd dose of Pfizer's COVID vaccine today 10Feb2021. On Monday, she went to see her doctor for a body rash in which she was prescribed steroids (she was given a steroid injection) and he told her to delay her second shot for 1 month. The reporter wanted to see if she really needs to wait 30 days or if she can go in today for her second dose. Stated that it is a pretty bad rash all over her body. She declined to complete a report and just wanted to know if the second shot can be delayed. The clinical outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
My son started having chest pain, nousea, severe body pain, right arm swelling, both feet swelling, pain so severe cannot be touched anywhere on the body. Went to the ER for three days Monday 6/25, Tuesday 6/26/ and Wednesday 6/27. Returned to ER on Thursday 3 am . Doctor does not know what is causing the pain and swelling admitted into the hospital, has not been discharged
On 3/14/14 (per M.O.C.) developed red raised areas to left thigh that became purulent (no drainage) accompanied by non-draining red dots to bilat. legs and stomach. Fever 3/16/14.
Received flu shot at 10:35 11/21/02. Returned at 10:45-lightheaded, nausea P64 10:50 drinking water 130/100 P68, 11:00 eating small danish. No trouble swallowing. 11:10 120/80, 56, chatty. 11:20 ambulated to front upstair area in building. 11:25 diaphoretic, pale, lightheaded 130/82 52 0.5cc Epi SQ. 11:35 EMT's arrive report given and received transported to ER.
cyanotic & limp; taken back to MD's office, then adm to the hosp;
Spotting and signs of ovulation even though I'm on birth control. I've been spotting since the shot
Narrative: Hospitalization-Fully vaccinated, COVID positive on admission with history of recent exposure. No oxygen requirements but desat on ambulation. Discharged 1 day following admission.
redness & swelling from knee to hip @ rt thigh inj site, fever, irritability & crying up to 4hr p/vax, dec appetite, tx w/DPH & APAP;
Red rash with raised white blister like areas noted 5 minutes after shots given.  Pt was given Benadryl and cool compress applied to leg.  After 20 minutes Red area had decreased and white raised area's are gone.
pt recvd vax;exp cellulitis; 24 hrs p/ vax devel inject site rxn consisting of swelling, erythema, hot to touch; cultures were neg;
This patient received both covid vaccines > 2 weeks ago and tested positive for covid 3/3/21
Large local reaction - swelling/redness at injection site. Started within 24 hours of immunization. Reaction at site of MMR/V injection, not DTap/IPV. Supportive care (BENADRYL, ibuprofen, cool compresses) recommended.
Woke with terrible headache. Took Ibuprofen and vomited 1 hour latter. Very fatigued
MY 15 MONTH OLD DAUGHTER WOKE UP IN THE MIDDLE OF THE NIGHT AT 1:15 AM SHAKING AND CRYING.  SHE HAD 102.1F FEVER AND SCREAMING UNCONTROLLABLY.  SHE DIDN'T GO BACK TO SLEEP UNITL 6:00 AM.  AT 8:15AM WE NOTICED A LARGE ROUND SWELLING WHERE THE CHICKEN POX vaccine WAS ADMINISTERED. EVERY MORNING SINCE THE vaccine SHE WAKES UP SCREAMING FOR ABOUT 2 HOURS AND DOES NOT GO BACK TO SLEEP UNTIL 1 TO 2 AM. SHE HAS ALSO STOPPED EATING. SHE HAS NEVER DONE THAT. SHE ATE, SLEPT AND WAS A HAPPY BABY UPTO THE CHICKEN POX VACCINE. HER NORMAL TIME HAS ALWAYS BEEN 9:15 PM.  SHE IS CONSTANTLY HAVING FEVERS AND IS ALWAYS IRRITABLE.
This spontaneous report as received from a nurse practitioner refers to an 18 year old male patient. On 22-FEB-2013, the patient was vaccinated with the first dose of GARDASIL (Lot # H011350, expiration date 21-FEB-2015) intramuscularly. The nurse reported that on 22-FEB-2013, after administration of the vaccine, the patient passed out. The patient's blood pressure dropped to 86/40. The patient was shaking, cold and had nausea. The patient's pulse dropped to 62 bmp and the tongue turned grey. The patient did not eat or drink in the morning of the shot. The patient received water and juice as treatment for the adverse events. At the time of the report, the patient was recovering. Additional has been requested.
Report received from ZLB Plasma Center 0n 27-Oct-2008.   A 26 year-old female (S.L. / DOB 08-AUG-1982) received AFLURIA (CSL influenza vaccine, lot 03549111A) on 22-Oct-2008 at 13:27.  On 20-Oct-2008, patient was given two doses IM of HEPATITIS vaccine, lot 0398x.   At the time of her AFLURIA vaccination, patient had no illness.  Patient had no pre-existing allergies, concomitant medications or medical conditions.  On 23-Oct-2008 at 9:30am, approximately 20 hours after receiving AFLURIA, patient complained of nausea, malaise, and muscle pain.  Per the reporter, the patient recovered.  Additional information had been requested.  Assessment:  No serious criteria mentioned.  Causality: Possible.  Follow-up information was received on 28-Oct-2008 from ZLB Plasma Center on 28-Oct-2008.  The patient's symptoms resolved in about 48 hours.  She did not contact her primary care physician (PCP) and was not treated for her symptoms.  Patient is not pregnant.  No additional information is expected.  No change is assessment.  Information derived from this AE report does not change the current safety profile of the product.
Spiking fever and chills. Lasted roughly 2 hours then recurring less severely. Arm soreness. Headache
Breakthrough case of COVID, I had chest congestion, sore throat, running and stuffy nose, and headache.
Nightly waking up to sweat soaked sheets; This spontaneous case was reported by a non-health professional and describes the occurrence of NIGHT SWEATS (Nightly waking up to sweat soaked sheets) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Nightly waking up to sweat soaked sheets). At the time of the report, NIGHT SWEATS (Nightly waking up to sweat soaked sheets) outcome was unknown.      It was reported two weeks after the booster, Patient was nightly waking up to sweat soaked sheets.  No Concomitant medication were reported. No treatment medication were reported.
This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 at 05:00 as dose 1, single (Lot number: EJ1685), in right arm, on 09Jan2021 at 08:45 as dose 2, single (Lot number: EL3248), in right arm and on 29Sep2021 at 15:00 as dose 3 (booster), single (Lot number: EW0191) at the age of 49 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Low HDL" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of Covid-19. No follow-up attempts are needed. No further information is expected.
Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023; No adverse event; Patient received expired vaccine that was administered on 15-March-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown that patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023).    No concomitant medication details was reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patient. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Information has been received form a registered nurse concerning a 71 year old white male who hypothyroidism and penicillin, sulfa and emycin allergies who on 18JUL2003 was vaccinated IM in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent. There was no concomitant medication or illness at the time of vaccination. On 19JUL2003 the pt developed a site reaction on his arm that was swollen, red, hot and tender to touch. There was no treatment required for the adverse event and no lab tests were performed. There was no product quality complaint involved. Unspecified medical attention was sought. Follow up information indicated that the pt was advised to take Benadryl and the pt recovered on 22JUL2003. No further information is available.
Fever, swollen eyes, swollen throat, fatigue, body aches , still present almost 2 weeks after vaccine. Allergic reaction (swollen eyes abs throat) occurred 5 days after vaccine
Rash to face, bilateral arms, upper back- very itchy, macular in appearance.
Patient woke up having seizures around 1:20am.  He is a known epileptic.  He tried to relax, and return to sleep which is normally fine for him, but the seizures continued to increase.  At 1:30am he took additional medication to help try to arrest his seizures as they were increasing in number and length.  By 6am, we headed to the hospital ER.  There his seizures progressed despite further medication until he had to be restrained, sedated, and intubated in order to stop them (which has never happened before).  Patient was further tested and eventually moved to the ICU for an overnight stay.  He was also suspected to have an infection and was spiking a fever.  On the second day in the hospital, the ventilator was removed.  Tests came back in a positive manner, and patient ended up being moved to a regular hospital room, but had to remain into a third day.  On the third day, he was finally well enough to be discharged.  All tests came back with no real answer as to why this incident spiked this event for him.
Patient does not report any adverse events after vaccination, but the vaccine was given too soon.  The second dose was due on 9/18/21 but he was mistakenly given the second dose on 9/8/21 instead
About 5 minutes after the vaccine was given patient describes numbness and tingling from injection site to pinky and that lasted about 5 minutes. Patient started feeling a flush/warm feeling across chest about 15 minutes after vaccine.  No dizziness  or lightheadedness.  Flushed feeling lasted about 30 seconds. Patient feels much better after 25 minutes of waiting time.  She states she does not require any further treatment.
Information was from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 23-APR-2013, at a pharmacy, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles.  It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster.  On or about 07-APR-2016, the patient was treated by a physician for a painful outbreak that was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
The day at 7:00 PM symptoms started with headache, chills, temperature, fatigue, nausea.  48 hours later your feeling much better.  Took Tylenol and also Ibuprofen and stayed hydrated.  Also had arm soreness, which she had with 1st vaccine as well.
Felt itchy on back, and got worse. Looked in mirror, covered in welts, got worse, all over her body.  At injection site has a large lump, redness but no fever and lump the size of her palm.
Initial unsolicited report received from a non-healthcare professional (consumer) on 19 MAY 2015. A female patient, had received a dose of INFLUENZA (batch number, expiry date, dose, dose number, route and site of administration were not reported) on an unspecified date. Patient had previous medication of NATALIZUMAB on 01 JANUARY 2003, COPAXONE on 02 JANUARY 2000, AVONEX on 01 JANUARY 1995, aspirin for indication heart problems, JANUMET for diabetes and multiple medications for the indication hypertension and high cholesterol. It was reported that patient legs were hurt (HCP aware) and moved to south due to her intolerance to cold.  On an unspecified date, patient had experienced allergy to vaccine. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of event was unknown. Documents held by sender: none.
That evening my lymph nodes in my left armpit started hurting and this lasted a couple of days.  When that pain went away both of my breasts became tender and slightly swollen and continued for several days when slight uterine cramping started.  Both continued when  I had menstrual bleeding on the 4th and 5th of November.  The cramps stopped by the 18th but my breasts are still tender.  Because I have been in menopause for two years, my gynecologist required me to have an ultrasound on the 17th at which time he stated everything appeared to be healthy
Client started feeling slightly faint/ dizzy at 2pm, but wanted to sit in her office after 15 minutes and watch the time. Patient stated her ears felt red and swollen. EMT had patient drink fluids and sit with a fan. EMT checked on patient at 2:15pm and there was  no changed. Patient came back to waiting room and EMT continued to assess, but no change in condition. Patient had an orange juice and a snack. Patient stated ears were still swollen and hot, her cheeks also felt hot and swollen. There was no closing or tightness in chest or throat. At 2:50pm gave 20ml of benadryl and patient stated her swelling in her ears was improving. EMT assessed and swelling and redness was improved.
Rash at site of Dtap injection on left arm. DECADRON given in office (10 mg oral).
About 3 minutes after injection, the patient began to feel dizzy. The patient sat down and continued to feel dizzy and have blurry vision.  About 5 minutes after injection the patient vomited.  After vomiting, the patient began to feel better. About 5 minutes after vomiting, the patient and her mother insisted on leaving the store and going home.  The patient seemed fine when she left. The patient did not have any  of these symptoms after her first dose of the vaccine.  I called to follow up with the patient about an hour later and she said she was fine.