chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediate local reaction: arm (inj. site) swelled up and slightly bruised. Mild itch for few mins. No trouble breathing. Pt. refused BENADRYL. Iced site and kept pt. here for 45 mins to 1 hour. Swelling slowly went down. Pt. had no one to drive him home. Offered to have mgr. drive home, pt. refused. Said he felt fine and didn't want to take any OTC to help w/RXN. Requested pt. to call when he got home and he did. Said swelling cont. to go down and he felt fine. Called pt. 10/19/2018 for F/U, said swelling gone just bruised.
1/23/21  3 hours after injection: burning all over the body, low voltage electrical feeling throughout body, right eye lid drooping, insomnia, elevated tinnitus level.   1/24/21 Continued same symptoms plus itching, left arm sore and swollen 1/25/21 Continued symptoms listed above plus redness/flushing in cheeks.  Lips feel swollen but do not appear swollen 1/27/21  Continued symptoms plus asthma like breathing, tightness in bronchioles and cough 1/28/21 Continued symptoms plus headache, fatigue 1/29-1/30/21  All symptoms continue 1/31/21 Asthma symptoms improving, cough intermittent.  Continued burning, electrical feeling, itching, flushing in face, eye lid drooping. 2/1-2/10/21  Continued symptoms of burning, electrical, itching, eye lid drooping, occasional cough, elevated tinnitus levels.
Flu vaccine but I don't know which. Stiff neck on same side as shot. Stayed in neck and back of my head for about 6 weeks. Had 2 urgent care visits during this time as well as an x-ray and 2 chiropractor visits. Seemed to slowly fade away the end of first week of December.
TD administered 9NOV94 TC recv 11NOV94 430PM fr school nurse states pt c/o numbness & pain lt cheek, neck, arm, rib area & buttocks; encouraged to seek med attention;
flares,; arm pain.; body aches; nausea; This spontaneous case was reported by a physician and describes the occurrence of CONDITION AGGRAVATED (flares,), PAIN IN EXTREMITY (arm pain.), MYALGIA (body aches) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced CONDITION AGGRAVATED (flares,), PAIN IN EXTREMITY (arm pain.), MYALGIA (body aches) and NAUSEA (nausea). At the time of the report, CONDITION AGGRAVATED (flares,), PAIN IN EXTREMITY (arm pain.), MYALGIA (body aches) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter. Treatment included medication for nausea.
Evening of immunization of ActHIB, edema, erythematous macular patch at site. Patient instructed to circle area with pen by on call physician. 1 day s/p ACTHIB hives reported on left arm/wrist 2c s/p urticaria on scalp, legs, arms reported. 4 d s/p seen in office. Urticaria noted left wrist with edema of hand and digits similar to lesser degree right hand with urticaria of forearm. Upper back also noted. Treated with Benadryl at visit 6/11/04.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L007225, expiration date 03-MAR-2017; lot # L026407, expiration date 15-JUL-2017; lot # reported as M000433 (invalid), expiration date 26-JAN-2018; dose and route were not reported). It was reported that the vaccine was improperly stored at -13.5 Celsius degree (C) for 2 hours 9 minutes and at -14.7 C for 56 minutes and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient received COVID vaccine on 4/22/21 and diagnosed with brachial vein DVT in her right arm on 4/25/21 via doppler.  Patient started on Eliquis to treat.  Patient does have a history of PE in the past.  Hypercoagulable workup showed prolonged dilute Russell viper venom time at 49.8.  Cardiolipin antibodies are negative.  Patient needs further eval as outpatient.  Patient was discharged to home on Eliquis.
Red, hot, raised 6 inch diameter rash at site of injection.  Some mild itching, pain.
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had other medications Amlodipine, Hydrochlorothiazide and Trazodone in 2 weeks. The patient had anti viral treatment Paxlovid which was started on 03Sep2022. On 03Sep2022 12:00 PM, the first dose was given to the patient after which the patient experienced felt queasy and after the second dose, the patient had bad taste in mouth. On 04Sep2022 the patient had the third dose which made the patient very sick to the stomach. So, the treatment with Paxlovid was discontinued on 04Sep2022. The adverse events were not treated. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician, concerning a 14-week-old patient, who on an unspecified date received the first dose of ROTATEQ vaccine (lot number unknown) orally at 14 weeks of age. At the time of reporting, the patient did not experienced any known
This spontaneous report was received from a 56 year old female patient who was reporting on herself. The patient's pertinent medical history included unspecified "immune disorder" and postural orthostatic tachycardia syndrome. She did not have any drug reactions or allergies. On 06-JUL-2016, the patient was vaccinated with the first dose of PNEUMOVAX 23 intramuscularly (dose, lot # and expiration date were not reported). The patient was also taking unspecified concomitant medications. On unknown dates in 2016 reported as "while on PNEUMOVAX 23", the patient became sleepy, spacey, lightheaded, dizzy and did not want to talk to people (and normally liked to talk to people). The patient also felt like she had a brain inflammation. On an unknown date in July 2016 (reported as "sometime after receiving PNEUMOVAX 23"), she had balance issues and fell on 29-JUL-2016. The patient sought medical attention, she talked with her physician. No treatment was given to the patient for the events and no lab diagnostics procedures were performed. The outcome of all events was reported as not recovered. The relatedness between the events and PNEUMOVAX 23 was not provided. Upon internal review the event of the patient feeling like she had brain inflammation was considered to be medically significant. Additional information has been requested.
Approximately 45 minutes to 1 hour following the Moderna booster administration on 11/16/2021, patient had sudden onset expressive aphasia, which lasted 1 hour in duration before resolving spontaneously.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness in left arm at injection site) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 024M20A) for COVID-19 immunization. Concurrent medical conditions included Marfan's syndrome and pneumothorax. On Jan 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 12, 2021, patient experienced pain in extremity (soreness in left arm at injection site). At the time of the report, pain in extremity (soreness in left arm at injection site) outcome: unknown. Concomitant medication and treatment information not reported. The patient would like to receive the booster dose. This case linked to MOD-2021-299740 (patient link).
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received HAV (Havrix pediatric) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   On 17th February 2023, the patient received the 1st dose of Havrix pediatric. On 17th February 2023, unknown after receiving Havrix pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-FEB-2023 Reporter's Comment: The reporter was practice coordinator. The reporter reported that one of the medical assistant staff administered an expired Havrix pediatric. The reporter consented to follow up and accepted by mailing Additional Supportive Information: The reporter reported that one of the medical assistant staff administered an expired Havrix pediatric, which led to expired vaccine used.
first dose and second dose little over 30 days apart; Felt like the pharmacist hit a nerve; pain / injection site upon administration / first dose /  then it was just sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, drug dose administration interval too short and wrong injection technique. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the drug dose administration interval too short and wrong injection technique were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced pain in arm after the 1st dose of Shingrix, which lasted for a day and then it was just sore for 3-4 days. The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule. The ptient felt that the pharmacist had hit a nerve, which led to wrong injection technique. No reactions were reported for the 2nd dose of Shingrix. The reporter consented to follow up. The case was considered as medication error with harm.
Got Flu shot 5 days ago. Now have cellulitis vs reaction. Localized skin reaction w/sloughing pain. Seen 10/15: reaction is resolving.
Pt recv vax on unknown day; 3 days post vax pt exp swelling of supraclavicular lymph nodes; pt imp approx 1 wk
This spontaneous report as received from an unspecified healthcare professional, via company representative, refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were unspecified. On an unknown date, "many years ago", the patient was vaccinated with a dose of GARDASIL (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were unspecified by reporter. The same day, the patient experienced syncope at the physician's office after the vaccination. The reporter stated that the office called 911. Subsequently the patient was "OK" after this experience. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as the reporter did not wish further contact.
tonic clonic sz activity-brief duration of <1min occurred w/in 24hr of vax;occurred again 3 days later;pt was on APAP every 4 hr p/vax max recorded t100.8;unknown if sz will reoccur
Eight days after receiving the Moderna vaccine, I developed a rash on my left arm, and it remained for 6 days.  It encircled the arm, was hot to the touch, and tender at the injection site.  The rash grew from a circular (approx 1.5 inch diameter) rash at first, to a band approximately 2-2.5 inches wide, encircling the arm.
This spontaneous report as received from a other health professional refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 25-OCT-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # M017334. No adverse effects were reported. Additional information has been requested.
This is spontaneous report from a non clinical study program (IBCC (inbound Call Center for HCP's) for a contactable consumer. A retired consumer mentioned that he wanted know the ingredients of PRENVAR13 as he had the arm reactions from PREVNAR13 vaccination. Consumer mentioned that it was the first time he had reactions from the vaccination and he went to his Doctor's office and asked what components that reacted to him.
9 hours after second dose, I started to get joint and muscle pain, chills, fever of 101, headache across my forehead, fatigue.  This lasted for about 20 hours.  I took Excedrin Migraine after about 7 hours into reaction.  Back to normal now.
Mild to moderate muscle pain.  Some minor swelling and redness.  Chills. Temperature about 1 to 1.5 degrees higher than normal for me though I tend to run sub 98.6 as normal (like in the 97s or even high 96s).  Mild to moderate upper GI pain
Case number PHEH2014US017008 is an initial spontaneous report from a nurse received on 21 Aug 2014 and a follow up report from the nurse received on 03 Oct 2014. This report refers to 17 year old male patient. Past medical history and concomitant medication were not provided. It was reported that the past vaccinations were well tolerated by the patient. He was vaccinated with MENVEO (batch number: M14030) at a dose of 0.5 ml intramuscularly on 20 Aug 2014 (at 01:45 pm), which was stored at 48 F for 5 minutes. No adverse event was reported following this administration error. Follow up report from the nurse received on 03 Oct 2014: Added vaccination history, MENVEO vaccination time and dose.
Patient obtained initial dose of Moderna vaccine on Thurday, Jan 14. No adverse effects reported during initial 15 minute post vaccine waiting period. Saturday morning (Jan 16), patient developed severe cough, labored breathing, and fever. Additionally patient mental status changed suddenly, became non-communicative (unable to speak, but would scream if she was touched). O2 status was irregular, dropping to 78.  Sunday morning, EMT and then hospice was hospice called. Monday morning, after hospice emergency kit was initiated, patient passed away.
Developed Lichen Planus on scrotum 2 days after receiving the 1st dose of the vaccine.  Swelling/bump appeared on scrotum. No pain associated.  1 week after 1st dose of vaccine and 5 days after first sign of swelling/bump I saw my PCP. Diagnosis of Lichen Planus made during visit. Doctor recommended steroid cream.
I had some redness, pain, and swelling for the first couple days after the shot, but then that went away. But one week after the shot, it got red and swollen again, as well as itchy. Now it's been 8 days, and the site is a hard, hot lump, still red and itchy. It's not terribly annoying, but it is slightly worrying for the symptoms to be getting worse instead of better.
Note that I had covid in February 2021.  I got the JJ vaccine Friday evening at around 6 PM. It hurt right at the outset, but most shots do. Early the next morning I woke up very tired and with a fever. The fever escalated to 102, and that was with alternating dosage between ibuprofen and acetaminophen. The fever broke late Sunday evening - about 40+ hrs. Since then, I have had serious sinus pressure to the degree that some days the pressure and swelling is so bad behind my eyes (especially my left) that my vision is impaired.  I've had respiratory issues so bad that I have had to use my inhaler more in the past 2 months than I have in the past 5 years. I've had really bad brain fog and lethargy as well. All I do during the week is work and sleep.  I don't know if this is related or not, but I have also had a lot of joint pain. Parts of my body are hurting that have never hurt before, and areas of my body that generally are in mild pain have been significantly worse. Literally every joint, from my neck to my back to my hips, knees, ankles, fingers and toes. I've also experienced some mild chest pains.
fever and chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (fever and chills) and PYREXIA (low grade fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included CHOLESTEROL for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (fever and chills) and PYREXIA (low grade fever). At the time of the report, CHILLS (fever and chills) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were thyroid medication as well.
Report describes rash in a 51 year old male who received hep a vaccine (havrix). The vaccinee's allergies were not specified. prior to vaccination with havrix, the vaccinee had experienced similar rash episodes without etiology. concomitant vaccines:typhoid and flu. On 02/23/2001, the vaccinee received his first dose of Havrix, and a dose of typhoid vaccine and flu vaccine. Four days later, on 02/27/2001, he developed a raised rash, firm with nodules and clusters on hands and feet and legs. As of 03/02/2001, the outcome of the event is unknown.
This case was reported by a consumer and described the occurrence of wrong injection technique in a 65-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included severe allergies (she had to carry an EPIPEN). The subject had received influenza vaccinations previously and had no adverse events. Concurrent medications included SYNTHROID, PREVACID, CRESTOR, Fish oil; VIVELLE, Iron, Vitamin C, Vitamin B and Multiple vitamin. On 1 September 2010 at 13:00 the subject received unspecified dose of FLULAVAL. The vaccine was not shaken prior to administration. The subject did not consult a healthcare professional regarding this event. Follow-up received from the consumer on 03 September 2010: The subject's past medical history included neck pain and shoulder pain. On 01 September at 18:00, 5 hours after vaccination with FLULAVAL, the subject experienced neck pain and shoulder pain. At the time of reporting, the evens were unresolved. The consumer reported that she had consulted a healthcare professional regarding these events. The consumer noted that she had experienced neck and shoulder pain prior to vaccination with FLULAVAL, and that it might be flaring up because she was anxious about developing Guillain Barre Syndrome since she has a history of sensitivity to so many other things.
Reported 1 month after given the vaccination. Patient reports pain in arm (say it's not the shoulder joint but upper "meaty" part of arm). States that there is a constant dull pain but no limited mobility (he is able to play his guitar with no difficulity) states that he experiences most pain when laying on his side at night. Reports no swelling or redness. Pain scale 3.
Pt had localized swelling induration warmth and lymphadenopathy he thought  he had a fever but did not check
pt recv vax 20OCT95 & 19FEB97 pt devel a chickenpox-type rash that consisted of approx 20 disseminated lesions;
2/21/2022: Chest pressure/ pain began.  2/23/2022: I went to my primary care doctor, at the office and was sent to the ER. I was admitted to the hospital and diagnosed with a pulmonary embolism.
fatigue; flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu like symptoms".  Additional Information: When the patient received the Pfizer for first two vaccines, experienced flu like symptoms and fatigue for two days. The patient wanted to report symptoms seeing as they were not the norm. The patient was interested in knowing if others have reported similar side effects and was looking forward to have some feedback.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Progressively worsening numbness near the injection site starting about 14 days after the injection. Numbness also 'shoots' down the arm and is sporadic.   Also had severe stomach pain as well on April 11th with has subsided.
Completely loss of sense of taste.; sweet and salty taste has become savory; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Completely loss of sense of taste.) and TASTE DISORDER (sweet and salty taste has become savory) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20H and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, METFORMIN, DUTASTERIDE (AVODART), DOXAZOSIN MESILATE (CARDURA), DIAZEPAM (VALIUM), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and APIXABAN (ELIQUIS) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced AGEUSIA (Completely loss of sense of taste.) and TASTE DISORDER (sweet and salty taste has become savory). At the time of the report, AGEUSIA (Completely loss of sense of taste.) and TASTE DISORDER (sweet and salty taste has become savory) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported