chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills and headache 15 minutes after injection.  Tylenol given 0600 next morning, chills and frontal throbbing headache.  Tylenol given & headache resolved. No further symptoms at 7:30am.
PT STATES SHE DEVELOPED A HEAD TO TOE ITCHY, RED RASH 1/2 HOUR AFTER RECEIVING THE FLU VACCINE
Tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "BMI 25" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunisation. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tinnitus". Therapeutic measures were taken as a result of tinnitus. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took paracetamol (TYLENOL) as treatment for the event and "turned off right away". The patient experienced tinnitus for 4 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of a sore arm that began 1-2 days post vaccination, and patient believes that this may have been due to vaccination. Patient is still has lingering soreness 48 days post vaccination.
Received Infanrix by mistake instead of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 12-MAY-2023, the patient received Infanrix (intramuscular). On 12-MAY-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Received Infanrix by mistake instead of Boostrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-MAY-2023 The reporter reported that the patient received Infanrix vaccine by mistake when Boostrix should have been given. The reporter consented to follow up. The patient received Infanrix who was elder than the indicated age which led to inappropriate age at vaccine administration.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Pt recvd dose of Hep B vax & immed following vax devel fever which lasted for 2 wks; it was noted that pt devel splenomegaly & elevated liver function tests; pt was hospitalized; addtl details are being requested;
Began to feel fatigued on afternoon of 041821. Also began to feel aches in middle to lower back and hips. Increased in severity into the evening and night. Restless night with chills and sweats.   Heart rate averaged between 85 bpm and 99 bpm while resting in bed throughout the night. Aches decreased in severity throughout morning and day of 041921. Feeling fatigued and sweaty throughout morning and day of 041921.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FE3590), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin"; Midazolam, reaction(s): "Known allergies: Midazolam". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment from 02May2022 to 07May2022. No other medication in 2 weeks of vaccination. Three days after completing my treatment course, the initial Covid symptoms returned. Start date of events was 10May2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Device Date was documented as 13May2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 01-AUG-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M010478, expiration date: 01-SEP-2017, route of administration was not reported). No adverse effects were reported. This is one of several reports received from the same source, Additional information has been requested.
Slight pain first evening, swelling and feverish next day at shot location area of three inches across.  Very red, terribly swollen and feverish two days later, and still itchy and feverish four days later, now swelling is one inch hard knot.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "91 year old male with PMHx significant for sick sinus syndrome s/p PPM, HFpEF, COPD, and HTN who presented to the emergency department from home for evaluation after a ground level fall.  He was found to have hypernatremia, AKI on CKD, and elevated troponin.  He was treated with IV fluids with resolution and hypernatremia.  Unfortunately he developed poor PO intake and confusion.  He continued to decline in terms of his mental status.  Ultimately he had almost essentially stopped eating.  He developed recurrent hypernatremia with trial off IV fluids.  Following a family meeting, he was enrolled in hospice care.  Unfortunately discharged to hospice was delayed by incidentally positive COVID-19 test.  He waited out his isolation.  In the hospital and was subsequently discharged to hospice care."
Shot on Jan. 19th, one week out and this morning when I woke up my left arm at injection site has become swollen, red, tender, painful to touch, hot, and itchy. It has gotten more swollen throughout the day. It hasn?t been swollen and painful since day 3 after the shot. Taken ibuprofen.
Pt states at the moment needle went into arm she started to feel left facial numbness. The numbness lasted 6 hours and resolved on it's own. Pt describes as a sensation as when you go to dentist and anesthesia is wearing off.
Admitted with severe COVID19 on 9/10/2021 and subsequently declined and deceased on 9/11/2021
Information has been received from an RN concerning a 42 year old Caucasian male physician who on 11/1/01 at 10:00, was vaccinated SC in the right arm with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 640981/1050L). Concomitant therapy that same day at 10:00, included the 1st dose IM in the left deltoid of influenza virus vaccine (Fluzone) (lot 00694AA). Subsequently, on 11/2/01 at 08:00, the pt developed red swelling, hot to touch, hard from injection, pain from injection, low-grade fever and general joint aches from right arm injection site to the elbow. The physician was treated with 2 tablets of Vicodin for the pain. The pt recovered on 11/5/01. The nurse felt that the physician's low-grade fever and joint aches were related to the flu vaccine. The nurse reported 2 other cases of injection site swelling and redness (lot 640981/1050L) (WAES 01111735 and 01111376). Additional information is not expected.
Immediate burning and numbness of entire arm where injection was done. Redness, heat and induration present on entire upper arm. Shortness of breath and coughing from airway swelling, and itching on chest and extremities, decrease in oxygen saturation as shown by pulse ox. Pre treated with Zyrtec due to prior severe reaction and treated with epinephrine and liquid Benadryl at time of reaction onset. After initial reaction was controlled treatment continued with oral steroids and oral Benadryl for a course of 7 days. Joint aches and weakness were present for 2 weeks after vaccination and numbness of arm and hand on the side of the vaccination. GI upset including diarrhea was experienced as well. A fever of 101.2 was noted the night of vaccination and continued off and on for 3 days. 15 days after vaccination, labs drawn by Primary MD showed a TSH of 26, Thyroid panel was normal in Sept of 2015 and no changes had been made to medication prior to the vaccine. Thyroid continues to be unregulated at this time.
Area of erythema approx 4 cm on right forearm at site of injection generalized discrete erythematous macular rash all over body. Information has been received from a physician concerning a 79 year old female consumer with no known allergies and hypothyroidism who on 17-MAR-2008 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot # 659759/1837U). Subsequently, one day after vaccination on 18-MAR-2008 the patient developed a generalized red rash. The patient contacted the office by phone and was prescribed BENADRYL. The patient was examined in the office on 21-MAR-2008 and the rash was fading. There were no lab studies performed. "On an unspecified date the patient recovered." There was no product quality complaint involved." Follow-up information has been received froma health professional concerning this 79 year old white female who on 17-MAR-208 was vaccinated in the right arm with ZOSTER vaccine live (Oka/Merck) (lot # 659759/1837U). There was no illness at the time of vaccination. Subsequently, on 18-MAR-2008 the patient developed an area of erythema approximately 4 cm on the right forearm at the site of injection. The patient also developed a generalized discrete erythematous macular rash all over. The patient recovered on an unspecified date. Additional information is not expected.
The injection site is a itchy raised bump. I didn?t experience this with the first injection.
12 hours - Slight Nausea 24 Hours - Moderate Nausea 24-36 hours - Moderate Chills/Aches  By 36 hours I felt 100% normal again.
Small (dime sized) bright pink slightly bumpy rash appeared on upper arm about 2 inches away from where I received my injection. It was itchy otherwise not bothersome. I  put a non medicated  ointment on it overnight. Rash grew in size overnight. When I woke it was larger than a quarter with an extension or piece. It remained itchy and  bright pink.  I washed the ointment off and dried the rash.  This time I applied an anti itch cream. The cream seemed to tone the itch a lot and also stopped it from growing in size. By the next morning (today) it was light pink in color and less itchy. Now (6pm) it is hardly visible any more. I can still feel it when I run my fingers over it softly and it still itches, but color and raised bumps have improved significantly.
Wrong vaccine administered to patient, patient was supposed to get a Hep B, MA grabbed from blue box without double checking and grabbed Kinrix accidentally.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 26-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager. Concomitant medication of the patient was not reported. The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of Dec-2021, Jan-2022 and Feb-2022. The reporter was filling out a temperature excursion assessment with the State. The reporter mentioned that the patient was administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient. No treatment information was provided by the reporter.
Sore arm next day.  Day after shot:  Fever (+3 degrees), chills, bad headache, no appetite, lethargy.  3rd day after shot thru 5th day: Fever, chills, nausea, no appetite, body aches, lethargy.  Better on 6th day after vaccination.
This spontaneous report as received from a physician via a field employee refers to a female teenager of unknown age. In June 2013 (9 months ago) the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and dose unspecified). The representative did not know which dose in the GARDASIL series the patient received "9 months ago". In June 2013 (9 months ago) the patient developed lupus-like symptoms and the patient was "basically wheel-chair bound". The field employee did not know any other details of the patient's condition beyond the fact that the patient had not received a confirmed diagnosis. The patient had sought medical attention. The event outcome was reported as not recovered/not resolved. The reporter considered the event to be disability. Additional information has been requested.
I began to experience positional vertigo, which is not something I've ever experienced.  Certain angles of the head and motion of the body, such as turning over in bed, would trigger it.  There was a "woozy" feeling that persisted as well.  This started the evening of 4/1 and has mostly cleared up by now, 4/7.  On the advice of my primary internal MD, I sought evaluation at an urgent care clinic.  The doctor performing my exam stated that, based on my empty medical history and no recent illnesses, he suspected that the body's immune system reaction  caused an inner ear disturbance, leading to the vertigo.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 71 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EM9809), on 11Mar2021 as dose 2, single (Lot number: EP6955), on 07Oct2021 as dose 3 (booster), single (Lot number: 30155BA) and on 13Jul2022 as dose 4 (booster), single (Lot number: FK9895) for covid-19 immunisation. The patient's relevant medical history included: "CVID Common Variable Immune Deficiency" (unspecified if ongoing); "Known allergies: Codene Products" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Sep2023 to 07Sep2023.
Information has been received from a physician concerning a patient who was vaccinated with ROTATEQ vaccine live (human-bovine). It was reported at a lunch the representative had for the clinic the adverse events they had in general were one case of mucus in the stool. The week after the patient was administered with ROTATEQ vaccine live (human-bovine), the mother brought the child in with the mucus in the stool. At this time, it is unknown if the patient recovered. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 02/16, Pfizer, dose #1 03/08, Pfizer, dose #2 09/28, Pfizer, dose #3 08/21 pt cc: chills, diarrhea, fatigue, fever, headache, loss of taste or smell, myalgias, rhinorrhea, dyspnea exposure: unknown 08/24 COVID swab, result: detected
After vaccines, patientt developed redness to the site on both arms, but 48 hrs later he had large whelp to left upper arm (Kinrix); 72 hrs had hives all over his body. Bendryl did not help patient, was started on oral steroids Nov 17th
chills; I had chills, muscle aches and ran a temperature between 101.7 and 100.1 for 30 hours; ran a temperature between 101.7 and 100.1 for 30 hours; This is a spontaneous report from a contactable consumer (patient) A 61-Years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: en6210) on 17Feb2021 at 02:30 at single dose via an unspecified route of administration on left arm  for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (lot #: en5318) on 27Jn2021 at 02:30 am on left arm.  On 17Feb2021 at 12:00 am the patient presented chills, muscle aches and ran a temperature between 101.7 and 100.1 for 30 hours. No treatment was administered for the events. The patient recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and ASTHENIA (Weakness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Lupus anticoagulant, Allergy to chemicals (Patient is allergic to potassium due to a diuretic treatment she had to take) and Penicillin allergy. Concomitant products included METOPROLOL for Hypertension, TRAMADOL for Pain, LEVOTHYROXINE for Thyroid disorder NOS, PREDNISONE, HYDROCORTISONE, VITAMIN B12 [VITAMIN B12 NOS], IRON and CALCIUM for an unknown indication.  On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (Weakness). At the time of the report, DIZZINESS (Dizziness) and ASTHENIA (Weakness) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter.
Day 2- fever blister,  day 3 right eye, dry, red, swollen, day 3 back pain, right hip pain, right knee pain, burning pain upon urination, and tingling nerve pain all on right side of body per patient.
Headaches, nausea, passed out, EMT administered Narcan, went into afib in the ambulance 160 beats per minute.  Toxicology negative. Given eliquis and metoprolol. CT scan, MRI and ECG showed nothing.  AFIB resolved itself without a cardioversion or ablation.  No AFIB to date.
Information has been received from a physician referring to a 24 years old female patient. The patient had no concomitant medication, pertinent medical history or drug allergies/reactions. On 31-OCT-2016, the patient was vaccinated with first dose of GARDASIL 9 (dose and frequency not provided; Lot# M017983, expire date 30-MAY-2018) intramuscularly (IM) as prophylaxis. After the vaccination, the patient had been experiencing persistent pain in arm where vaccinated through whole humerus region for about one month. The patient sought medical attention for the event via contacting doctor office. There was no treatment employed as yet, and no lab diagnostics study was performed. The physician stated the patient notified office on 30-NOV-2016 (reported as "yesterday") regarding the ongoing arm pain.  The physician did not believe there was any error since it was a senior nurse who gave the injection. At the time of this report, the patient had not recovered from the event. The relationship between the event and vaccine was not reported. Additional information has been requested.
This spontaneous report was received from a pharmacy intern concerning a female patient who was over 60 years old.  Medcial history and concomitant medications were unknown by the reporter.  On 21-FEB-2017, the patient received ZOSTAVAX (route and ot number not provided) for prevention of shingles due to her age.  She then experienced erythema, redness and itchiness at the injection site.  The patient visited the pharmacy for the events but did not receive treatment.  Patient present status was not recovered.  The reporter stated, "I just want to know where the liability lies".   Additional information is not expected as the reporter did not provide consent to follow up.
Flu vaccine administered to R deltoid IM by clinic staff. Pt states site of injection, shoulder and arm distal to site painful, limited movement. Question injection too high, MD states probable injection int bursa.
Patient was accidentally given the second dose of the Moderna Vaccine two weeks after receiving the first dose.
This spontaneous report was received from a certified medical assistant and refers to a 5 months old, male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-APR-2016 at 17:02, the patient was vaccinated with improperly stored dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
I received my shot on Wednesday, and on Saturday I started my period (on time). I use a menstrual cup and I usually have a very light flow, usually not filling the cup throughout the course of the day. Today (Sunday) I woke up with my cup having overflowed. Since then, it has overflowed two more times, so my period is significantly heavier than usual.