chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Its very very hot; It's going around inside of her arm; Itching; The rash started small around the injection site.; The redness spread and became huge; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    A spontaneous report was received from a consumer concerning a 75-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events small rash started around the injection site, the redness spread and became huge, it was going around inside of her arm, it's very very hot and rash is taking 3 quarters of the arm and it's spreading underneath.  The patient was allergic to penicillin. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not provided) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced rash started small rash started  around the injection site, the redness spread and became huge and going around inside of her arm, it was very very hot and the rash was taking 3 quarters of the arm and it's spreading underneath.  Treatment details included Benadryl gel (topical) and tablet (by mouth).  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of events were not reported.
SHORTLY AFTER RECEIVING HER VACCINATION, PATIENT COMPLAINED OF FEELING HOT, BEING LIGHTHEADED AND NAUSEOUS.  PATIENT APPLIED AN ICE PACK TO HER HEAD & FELT BETTER SHORTLY THEREAFTER.
No additional AEs; HCP called to report a TE. VARIVAX was stored outside of recommended temperature range and administered to a patient.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-DEC-2022, the patient was vaccinated with an improperly stored dose (improper storage of product in use) of varicella virus vaccine live (oka/merck) (VARIVAX) once, lot #W018836, expiration date: 14-JUN-2024 (strength, dose, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.
Rash all over my back; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash all over my back) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RASH (Rash all over my back). On 17-Jan-2021, RASH (Rash all over my back) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Severe muscle and joint pain accompanied by fever and wheezing.  Symptoms began less than 24 hours after infection.  Prescribed prednisone.
Information has been received from a health professional concerning a female who was vaccinated with a first dose of Gardasil.  Subsequently the patient experienced anxiety.  On an unspecified date she received a second dose of Gardasil.  The anxiety reappeared after reintroduction of the vaccine.  The patient sought unspecified medical attention.  Additional information has been requested.
Passed out/ got chills and sweats after receiving vaccine at the Pharmacy. Proceeding the vaccine she had headaches and still gets them and it?s currently 05/27/2021 which it?s been 9 days since also for 3 days after vaccine was extremely exhausted.
Lupus flare up; Sciatica Pain in the Hip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sciatica and Arthritis. Concurrent medical conditions included Sjogren's syndrome and Lupus erythematosus systemic.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant) and SCIATICA (Sciatica Pain in the Hip). On 27-Apr-2021, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) and SCIATICA (Sciatica Pain in the Hip) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. The patient visited the Emergency Room (Does not remember exact date but it happened after vaccination). Treatment medication reported includes Prednisone, Morphine and Phenergan.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
Immunization given on 4/10/02 of MMR. No complaints of side effect immediately following or during time of approx. 1 hour while immunization in clinic was going on. On 4/20/02, she was on a school trip and a rash began while there. Took po Benadryl and used Cortizone cream to rash on entire body that was "blotchy"; no hives noted, however. Also complained of headache and stiff neck. She was treated with IV antibiotics as was felt to be strept infection. Also had visited a place where there are current cases of meningitis reported. Currently, she is still in the hospital.
area on right side of thorax at bottom of ribs with itching and burning. symptoms are in a linear distribution and radiate laterally.
Right after injection redness and pain around site. Within few hours swollen throat, face, major fatigue, chills, felt feverish but only 99.7 degrees, weird pain or schrill, like pulsating, going down left arm to middle fingers.  Took Benedryl, advil and used ice on site. Through first night painful left arm, shoulder, aches, chills. 2nd day, swollen face, pain in left arm, reddening around site is larger and tight hard knot in arm.   No longer feeling pulsating down arm into fingers just pain, ache and red hot spot.  3rd day, still pain through the night reddening increased again around site and down the arm from shoulder. Had fever spots on face, still 99.6. Called advice nurse who directed me to urgent care. They gave me steroid injection and measured the reddening around site it was 8 centimeters. Checked lymph nodes, tenderness but doesn't appear any bacterial infection in them.
Optic neuritis; photophobia; This is a spontaneous report from a contactable consumer.   A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on an unspecified date as dose number unknown, single (age at vaccination: 54 years), for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, on unspecified dates, after receiving the Pfizer-BioNTech vaccine, the patient suffered photophobia and optic neuritis. The seriousness criteria for the events were reported as Intervention/Medically Important (Intervention/Medically Important: Yes) and the rest of the criteria: life threatening, death, hospitalization prolonged disabling/incapacitating, congenital anomaly/birth defect and hospitalization required were denied. No abstracts have been assigned to this case. The outcome of the events were reported as not recovered, at the time of reporting.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient became dizzy and felt "the room was spinning." She was placed into a sitting position, and stated she felt chilled. EMS was called. She is diabetic; therefore given cheese crackers and water. EMS arrived 5:16 pm.
quite a reaction for a day or two, typical symptoms; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (quite a reaction for a day or two, typical symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 IMMUNISATION REACTION (quite a reaction for a day or two, typical symptoms). At the time of the report, IMMUNISATION REACTION (quite a reaction for a day or two, typical symptoms) had resolved.            Concomitant product use was not provided by the reporter.  Normally, the patient would get quite a reaction for a day or two, like the typical symptoms. The patient had the bivalent booster shot for COVID last Monday, which would be the fifth shot overall that the patient received. However, this time the patient had no symptoms or reactions. The patient did not even feel it while receiving the vaccine. The patient's arm was not sore.   Treatment information was not provided.
Rash on back, sides, back, upper legs to knees (both sides), upper arms (both sides)- bumpy, red and very itchy.  Started 8/25- as of 8/29 still very itchy.  Have been taking Benadryl and Claritin
Information has been received from a physician concerning a 22 year old female patient who was vaccinated with three doses of GARDASIL in the physician's office in 2007. It was reported that the patient now had cancer. She visited the physician's practice within the last 3 week, in approximately July 2010, and was presented with cervical dysplasia, abnormal Pap smear, positive HR-HPV, biopsy came back as carcinoma in situ (CIS). She had the loop electrosurgical excision procedure (LEEP). At the time of the report, the patient's outcome was unknown. Upon internal review, carcinoma in situ (CIS) was determined to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax;1 day p/dose 1,exp flu-like sxs which subsided p/ 7 days;2.5 hrs p/dose 2,exp hands tingling,flu-like sxs,ha,achiness,a cough & a sinus infect;the tingling subsided in approx 2 hrs;sxs lasted approx 2 wks;
tested positive for COVID-19 Apr2022; tested positive for COVID-19 Apr2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "tested positive for COVID-19 Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported no issues with first dose. Patient called one day post vaccination to report a head-to-toe rash with hives. Patient claims that he has not changed any at-home products (laundry detergent, soap, etc) and nothing new at work.
10/25/22   I started having joint pain in both shoulders. I thought I had torn a rotator cuff. On my left arm, at my elbow, it felt like tendinitis. Over the following month, I had joint pain in both hips and knees.  No medication, massage or acupuncture would resolve the pain. A couple of weeks ago, it finally lifted.
Tired; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as 53; unit unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tired (reported as on the 1st shot) on an unspecified. The patient did not have did not have COVID prior to vaccination. The outcome of event was unknown.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
SLEEPINESS/COULD HARDLY GET OUT OF BED AND SLEPT MORE THAN USUAL.; TIREDNESS; FEELING TREMENDOUS ELECTRICITY GOING THROUGH BODY AND WAS SHOCKED; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04321A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the patient experienced feeling tremendous electricity going through body and was shocked. On 07-APR-2021, the patient experienced sleepiness/could hardly get out of bed and slept more than usual. On 07-APR-2021, the patient experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling tremendous electricity going through body and was shocked, and the outcome of tiredness and sleepiness/could hardly get out of bed and slept more than usual. was not reported. This report was non-serious. This case, involving the same patient is linked to 20220161445.
Vaccine expired on 24-Oct-2021 but administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 24-Oct-2021 but administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 24-Oct-2021 but administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 24-Oct-2021 but administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown when vial placed into refrigerator. Vial did not undergone any temperature excursion issue. 102 doses were administered from Lot number 026C21A. No concomitant product reported by reporter. No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Non Significant FU - Primary Reporter address updated
This spontaneous report was received from a healthcare worker refers to a multiple, unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored doses (temperature 15F for 3 hours) of PROQUAD, therapy type: HSA, lot# L008355 (expiry date: 11-SEP-2016); lot# L007229 (expiry date: 03-SEP-2016): lot# L002421 (expiry date: 23-JUL-2016) (dosage not reported). No adverse effects reported. The multiple, unspecified patients were exposed to previous temperature excursion; a high temperature of 21F for 14 hours. The cumulative time out of range was 17 hours, including this excursion. The temperature was back in range. This is one of several reports received from the same reporter. Additional information has been requested.
Mom called and stated left upper arm is swollen, has a hard bump, and itchy. No fever.
On 12/29/2020 patient had a really really sore throat, congestions, low grade fever, and chills for one day. On 12/31/2020 when patient left message, was still experiencing lingering congestion and runny nose.
Received vaccine 1/4/21 at 11:40am. Started at 1/5/21 3am with severe aching in knees, lower back & pelvis, nausea, vomiting, headache, fever up to 103, fatigue. Symptoms lasted until 1/6/21 9pm.  Took ibuprofen & Excedrin around the clock to control body aches & fever.
Extreme fatigue and chills, mild body aches, nausea, slight fever (100.8), overall flu like symptoms for 24 hours
Patient received first dose of MODERNA VACCINE on 12/29/20. Had minor reaction type symptoms including fatigue, site arm soreness, headaches, chills. These resolved with Tylenol and Claritin for the first 2-3 days, then stopped taking. Exactly one week later: On the morning of Tuesday 1/05/21 patient began experiencing intense itching, redness, speckled redness and a few hours later a red raised rash, along with new episode of soreness. Also had new fatigue. Took Claritin and Tylenol with slight relief in itch, but not redness. On Wednesday 1/06/21, itch continued with also an increase in circumference of redness, also along with slight fatigue. Wednesday evening patient  fell asleep feeling quite tired, and slept for 12 consecutive hours which is not usually for the patient. On 1/07/21:  patient had a greater circumference of redness and pruritis.
Can barely walk/ Difficulty walking; Tremor; Muscle spasm; Fever of 102 degrees Fahrenhei; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can barely walk/ Difficulty walking), TREMOR (Tremor), MUSCLE SPASMS (Muscle spasm) and PYREXIA (Fever of 102 degrees Fahrenhei) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Inflammation.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Tremor) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscle spasm) (seriousness criterion hospitalization) and PYREXIA (Fever of 102 degrees Fahrenhei) (seriousness criterion hospitalization). On an unknown date, the patient experienced GAIT DISTURBANCE (Can barely walk/ Difficulty walking) (seriousness criterion hospitalization). At the time of the report, GAIT DISTURBANCE (Can barely walk/ Difficulty walking), TREMOR (Tremor), MUSCLE SPASMS (Muscle spasm) and PYREXIA (Fever of 102 degrees Fahrenhei) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 102 degrees fahrenheit (High) 102 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Additional information received included no new information. On 28-May-2021: Additional information received included additional events, information for first dose date, event onset dates, anatomic location for first dose, lab information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Shingles. Had burning pain and discomfort night of vaccination 11/9/21. Low fever and chills next day. Continued discomfort until rash developed on right side 11/12/21.
Pt came back because allergic reaction to MCV 4, side was red & swollen, pt didn't have no temp. Pt told to apply ice to area & take Ibuprofen or TYLENOL for pain.
Pt c/o being clammy and cold. Pt was asked to lie on the floor and feet were elevated. Vitals were taken and first blood pressure reading was 180/120. No Hx of HBP. MD notified and evaluated Pt. Continued to monitor b/p Q10 minutes per MD order.  After aprox 90 minutes MD notified of b/p 148/94 and released pt. Pt reported feeling fine.
Administration of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. No adverse events experienced by the patient On 14-Oct-2021 the vial was initially stored in the refrigerator   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Additional information received and has no events reported for experienced vaccine On 12-Nov-2021: Follow up received and contains no new information
started 1.15.21 at midnight-Fever, chills,muscle ache and pain in left arm where vaccine was administered. Tylenol taken on 1.15.21
devel diarrhea & red spots; was seen by MD 13JAN93; according to mom sx were not because of vax; pt was treated w/ cl liq x 2 days & changed soaps;
4/23/2008 pT DEVELOPED INCREASED REDNESS & SWELLING RIGHT ARM 27CM BY 16CM EXTENDING FROM SITE OF INJECTION TO THE RIGHT ELBOW. aFEBRILE. sEEN BY sCHOOL np & STARTED ON kEFLEX. 4/25 Redness almost reaching wrist, pt seen by MD.
emergency hpi Chief Complaint Patient presents with ? Abdominal Pain     right lower abdominal pain started hurting on monday, sharp. Pain is worse. Hurt with movement. BM this am. No blood. Hx of colon cancer. No burning or frequency with urination. no pain or radiation.    HPI Patient is a 58 y.o. female who presents with complaints of right upper quadrant abdominal pain ongoing now for the past day she reports is moderate to severe right upper quadrant with some radiation down her abdomen is better with rest worse with movement and touch