chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she was still not doing well; joints hurt; bad headache; Evening she began to not feel well; Feels sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Evening she began to not feel well), ILLNESS (Feels sick), MALAISE (she was still not doing well), ARTHRALGIA (joints hurt) and HEADACHE (bad headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FEELING ABNORMAL (Evening she began to not feel well), ILLNESS (Feels sick), ARTHRALGIA (joints hurt) and HEADACHE (bad headache). On an unknown date, the patient experienced MALAISE (she was still not doing well). At the time of the report, FEELING ABNORMAL (Evening she began to not feel well), ILLNESS (Feels sick), MALAISE (she was still not doing well), ARTHRALGIA (joints hurt) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 10 (High) 101, 102 degrees Fahrenheit, today it's a 99.         No Concomitant medications were provided by the reporter. Treatment medications included Tylenol was noted   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional Information received on 14-MAY-2021 Included no new significant information and Patient stated that she was still not doing well.
Jaundice of skin and eyes, symptoms of anemia (shortness of breath, extremity tingling, difficulty exercising), dark urine, yellow tinged stool, yellow tinged body fluids, shortened menstruation. Physically noticed symptoms in early February 2021. Symptoms did not improve so scheduled a clinic visit. Lab tests revealed critical low H&H with no signs of hepatic malfunction or disease. ER visit and consultation with hematologist pointed to diagnosis of Warm Autoimmune Hemolytic Anemia. No family history of autoimmune disease, no previous history of condition, no previous cancer, no prescription medication. Suspect that the vaccine caused condition. Current treatment is high dose prednisone. Treatment ongoing.
administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 027L20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022 at 2:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Feb-2022 at 2:45 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) and PRODUCT STORAGE ERROR (administered Moderna Covid-19 vaccines beyond the 30 day use by date to 20 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that, the vaccines were initially placed in the refrigerator on 19 Jan 2022. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow-up information received includes patient demographics, new reporter and suspect product details were added. On 04-Mar-2022: Follow-up document received includes no new information
Redness at site of injection. By the next morning progression in redness and started getting harder. Red area about 3 inches in diameter on left back arm. Diagnosed with a cellulitis and was given oral antibiotics.
Intense headache  for 24 hours, chills, fatigue, muscle pain, soreness  on injection site.  I took Tylenol every 4 hours.  Today Sunday, 11/20/22 I feel tired but pretty much my headache is gone.
ON 2/17/22 patient was administered vaccine that had expired on 2/12/22.
FEVER; HEADACHE; CHILLS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included surgery on her finger recently, and developed an infection after the surgery, and concurrent conditions included cholesterol, thyroid, no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient was previously treated with cefalexin for developed an infection after the surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headache. Laboratory data included: Fever (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-MAR-2021, and had not recovered from fever, and headache. This report was non-serious.
Post-vax the patient experienced a fever ranging from 101 - 102.8F and a rash.
Longer itching; fever 99.1 or 99.2; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Longer itching) and PYREXIA (fever 99.1 or 99.2) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013a21a and 004m20a) for COVID-19 vaccination.     Concomitant products included METFORMIN, SITAGLIPTIN (JANUVIA [SITAGLIPTIN]), ALLOPURINOL, LEVOTHYROXINE, LISINOPRIL, ATORVASTATIN and ESOMEPRAZOLE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Longer itching) and PYREXIA (fever 99.1 or 99.2). At the time of the report, PRURITUS (Longer itching) and PYREXIA (fever 99.1 or 99.2) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: (High) 99.1 or 99.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported
Arm sorenesss within hour of shot, arm redness with raised bump about 2 inch circumference 14 hrs after , Flushed face with hot flashes 14 hrs after shot, then slight fever of 99.8 (normal temp for me is 97.8) 24 hours later body aches and chills. I?ve been taking ibuprofen every 4 hours while awake, first 24 hours, then switched to Tylenol.
Pt presented on 04/06/21 with injection site displaying redness, edema and warmth.  She is not sure on exact date symptoms started but about a week to 10 days after dose #2.
Information has been received from a nurse practitioner concerning a patient who on 17-NOV-2009, was vaccinated with the first dose of PNEUMOVAX 23 (lot# 664653/1337Y). Then the patient developed redness and soreness at the injection site. The patient would be seen in the clinic on 20-NOV-2009. At the time of the report, the outcome was unknown. Additional information has been requested. This is one of two reports received from the same source.
I had a tetanus shot.  About 24 hours after I received the vaccine I got the chills which lasted for 24 hours.  My arm was very swollen and red and extremely hot to the touch, itchy and painful to move.  The swelling and heat lasted about a week. The Arm was swollen from the shoulder to the elbow.  The itching has lasted until about two days ago, and it is still red today, but considerably less red than what it was. Today is 8/15/2022
This spontaneous report received from a licensed practical nurse refers two unspecified patients of unknown ages and genders who on unknown dates were vaccinated with two improperly stored doses (Incorrect product storage) of VARIVAX (Merck) (dose, lot #, expiration date and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. Additional information has been requested.
Pt experienced redness, warmth and swelling around the injection site within several minutes of receiving the Pfizer injection. She denied difficulty breathing, chest tightness, dizziness, itching, or any discomfort. She was given 2 tsp of Siladryl (diphenhydramine hydrochloride) at 945 as well as an ice pack. Pt stayed 30 min after receiving injection. Redness and swelling had improved by the time her 30 minutes were up. She denied any discomfort or difficulty breathing. Dad will give benadryl if rash appears and tylenol if she experiences flu-like symptoms. Instructed to notify vaccinator of reaction at next appointment.
17 days after receiving varicella vaccine-child became febrile, developed mild vesicular rash, and had grand mal seizure.  Had rash compatible with varicella.  The history of recent exposure to varicella-child remained leboite for 5 days.  Rash abated after 1 week.  Child was lethargic and irritable day long.
Subsequent to receiving vax, the pt developed acute pain at the injection site. The pt was treated with unspecified steroid injections and physical therapy. The reporter indicated that the physician stated that the pain was because the injection was administered too high in the deltoid.
rt eye started swelling on way home p/getting shots;swelled almost shut;has resolved rapidly;no hives or diff breathing
Patient reported headache and chest pain rated at 7 15 minutes post vaccination. Denied SOB, palpitation, n/v. Able to talk and swallowing. Vital signs: BP 130/80 HR 65 R 18, O2 sat 98% BP 134/88 HR 66 R 18, O2 sat 98%
Feeling like a brick of concrete. Elevated pulse. Balance off, feeling like vertigo, Sore muscles low back and neck
Welt over artery on  right side of face between eye and ear. Current diagnosis unclear as whether it auto immune reaction in the artery or infection in the skin above the artery. Blood drawn and placed on antibiotic (Cephalexin). Additional follow up depending on results of the blood work.
A 47 years old, male patient has a prescription to receive Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 47-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were provided as follows: The reporter stated that the 47 year old patient had a prescription to receive Shingrix which led to intercepted drug prescribing error. The patient did not receive the Shingrix vaccine till the time of reporting. The reporter consented to follow up.
Patient reported loss of consciousness approx 8 mins post COVID-19 injection, fell out of chair and hit head on tile floor. Reported LOC for 10-20 seconds, sustained hematoma on forehead w/pain rated 3/10. Initially felt nauseated which resolved. Denied headache, dizziness, vomiting, numbness, tingling h/o seizure disorder, h/o cardiac disorder. Referred to ED.
6 minutes post vaccination he reported feeling lightheaded. his BP was 147/77, pulse 60. About a minute later, he reported chest pain. 911 was called. They had him chew 4 81mg ASA until the paramedics could arrive. Around 15 minutes after vaccination, he reported chest tightness, he thought he was breathing at 80%, and light sensitivity. Around 20 min post vaccination, EMS arrives and escorted him outside. I never received further info on his condition from EMS. The next day, I tried to reach the patient twice via phone, but there was no answer and no voicemail.
Patient is currently being treated for Axonal Guillain Barre Syndrome. On the morning of 5/30, patient woke to use the bathroom at home. Upon getting off bed, both legs gave way, causing patient to fall. Patient attempted to pull herself up with arms, but was unable to due to weakness. Patient called spouse who then had her hold on to him while heading to the car and went straight to the ER. Upon arrival at ER, patient indicated complete inability to use arms and legs. Patient admitted to hospital. Patient is currently in rehabilitation to regain muscle strength of arms and legs.
Patient with new onset of severe dizziness after his first COVID19 vaccine. Pt began having dizziness and then felt nauseated, weak, and diaphoretic. Patient left ED.
Information has been received from a 56 year old female patient concerning herself. The patient's concurrent condition included multiple myeloma and Crohn's disease. VENOFER infusion and iodine gave her hives (drug allergy). On 12-JAN-2015, the patient received PNEUMOVAX 23 (strength, dose, lot#, route not reported) in her left arm. On the same day, the patient developed an injection site reaction and her arm was sore. No treatment was given for adverse events. The patient had not sought medical attention. The outcome of injection site reaction and arm sore was reported as not recovered. Additional information is not expected because the reporter did not allow us to contact the physician.
rash began 22MAR95 w/swollen lymph glands seen in ER by MD began w/swollen parotid glands 25MAR95;
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3247), in left arm and on 11Feb2021 as dose 2, single (Lot number: EN9581) at the age of 80 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: O37F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "gout" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: COVID 19 Treatment; (Jul2022) Positive, notes: One week later my testing remains positive; (15Jul2022) Negative, notes: I had been negative on 15Jul; (19Jul2022) Positive, notes: Then on evening of 19Jul had low grade fever, just as before, SEVERE runny nose and positive home test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, Anti-viral were taken as treatment from 10Jul2022 to 14Jul2022 for the treatment of COVID-19. After completing course on 15Jul2022, patient felt well, only some fatigue. Then on evening of 19Jul2022 had low grade fever, just as before, severe runny nose and positive home test. Patient had been negative on 15Jul2022. Some tiredness. One week later her testing remains "positive". Had some nasal congestion, at times patient had large amounts of mucus. Otherwise, she feel well.
I had infection in my right ear. I went to the urgent care, and they gave me antibodies for treatment. I had pain and drainage in my ear.  I did not have any ringing or tinnitus.
Pt given two vaccine in Left arm on 11/10/2008. Has received flu vaccine yearly for last 9 years without reaction. At this time, Also received pnemovax vaccine. Within 24 hours, red, raised area to arm with flu like symptoms consisting of fever, chills, nausea and body aches.
Pt developed a severe urticaria, bollous - large open ulcers all over the body including oral cavity, skin peeling,feet and toes blistering rash. This patient is now going on 4 months duration of this occurance.
got the shot and still got shingles/ suspected Vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated get the Shingles shot but could still get shingles, they said not as bad than if did not get the Shingles shot. The reporter stated personally know people who got the Shingles shot and still got shingles. The reporter stated the patient experienced shingles after having the Shingles shot.  The reporter saw patient suffer every day and they never went away. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This spontaneous case reported by a consumer, describes the occurrence of unexpected therapeutic response (right away, his infection started clearing up; he dramatically cut back on inhalers) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 0035C21A, 007B21A and 022M20A) for COVID-19 immunization. Concurrent medical conditions included lung infection. On Feb 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 26, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 1, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 1, 2021, patient experienced unexpected therapeutic response (right away, his infection started clearing up; he dramatically cut back on inhalers). At the time of the report, unexpected therapeutic response (right away, his infection started clearing up; he dramatically cut back on inhalers) outcome: unknown. The reporter did not provide any causality assessments. The doctor gave 3 inhalers to patient but that did not help for his infection. This case linked to MOD-2021-329780, MOD-2021-329750 (patient link).
2 hrs after receiving vaccine donor experienced hives with itching. Did not receive any medications and did not require any hospitalization, lasted for approx 12 hrs.
neuropathy; This case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neuropathy (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy was unknown.   The reporter considered the neuropathy to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter knew the patient who had terrible reactions to the shingles shot. The reporter stated that the shots had metal in them and caused neuropathy. One of the patient's friend sued and won her case.  It took 2 years to receive the settlement. This case has been linked with US2021AMR199718, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199718:Same reporter
body itching with some welts. all over. itching felt to be from the inside out.
Patient contacted us after 3 to 4 days and showed a pancake size swelling on her vaccinated arm. Advised to contact doctor and recommended ice and an antihistamine for any itching. No breathing or tingling problems noted.
This spontaneous report was received from a licensed practical nurse and refers to a 16 year old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection (dose, route of administration were not reported; lot # M026306, expiry date: 30-APR-2018) for prophylaxis. The dose was exposed to the temperature of 32 degrees Fahrenheit (F) for a time frame of 26 days (from 05-NOV-2016 to 30-NOV-2016). There were no prior temperature excursions. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008528:.
approx 5-10min p/vax mom stated pt cried as was dressed to leave the office & fell right to sleep;pt was difficult to arouse & was whining in a sleepy, dazed state, pt fully alert smiling & cooing 5min later;
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 12-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 300 hours (sum of hours in excursion). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19 symptoms started the evening of 04/06/2022, tested positive the morning of 04/07/2022. Initial onset symptoms were scratchy throat, and a mild runny nose that was commenced on Wednesday evening. Thursday morning, I had mild head congestion and I called my PCP, and they did a telehealth appointment with me and prescribed Paxlovid but pharmacy didn't have it and so they prescribed me Molnupiravir. Symptoms never progressed beyond mild head cold. I was symptom free a week later.