chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is still quite sore, left arm; arm red, left arm; arm swollen, left arm; felt like she was hit by a truck; headache; had to go back to bed / still tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt like she was hit by a truck), HEADACHE (headache), FATIGUE (had to go back to bed / still tired), VACCINATION SITE PAIN (arm is still quite sore, left arm) and VACCINATION SITE ERYTHEMA (arm red, left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL and ATORVASTATIN for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (felt like she was hit by a truck) and HEADACHE (headache). 12-Mar-2021, the patient experienced FATIGUE (had to go back to bed / still tired). On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is still quite sore, left arm), VACCINATION SITE ERYTHEMA (arm red, left arm) and VACCINATION SITE SWELLING (arm swollen, left arm). At the time of the report, PAIN (felt like she was hit by a truck) and HEADACHE (headache) outcome was unknown and FATIGUE (had to go back to bed / still tired), VACCINATION SITE PAIN (arm is still quite sore, left arm), VACCINATION SITE ERYTHEMA (arm red, left arm) and VACCINATION SITE SWELLING (arm swollen, left arm) had not resolved.            Additional concomitant product reported was HEMOPRADIN for an unknown indication.  The patient did not report treatment of events aside from drinking a lot of water.
Symptom recurrence; Drug effect decreased; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (Symptom recurrence) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced SYMPTOM RECURRENCE (Symptom recurrence) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). At the time of the report, SYMPTOM RECURRENCE (Symptom recurrence) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) had not resolved.            No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a nurse practitioner (also reproted as physician assistant) refers to a patient (gender unknown) of unknown age. Pertinent medical history or allergies were not reported. In February, 2012 the patient was vaccinated with GARDASIL dose 1. Dose, route of administration, lot number and expiration date were not reported. The second dose of GARDASIL (dose, lot #, expiration date and route were not reported) was given in May 2012 and the third dose of GARDASIL (dose, lot #, expiration date and route were not reported) was given on 11-SEP-2013. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
5 days p/being vaxed pt had swelling of wrists, feet, ankles, rash on underarms, waistband area, hive-like appearance; pt irritable 1st 2 days of rash; t99.6; purpura; 1 yr later had blood in urine;
One week after shot a rash appeared around injection site on upper left arm about 4 inches in diameter. "Covid Arm".
This spontaneous report was received from a consumer (patient's father) refers to a 20 year old male patient. Concurrent conditions and medical history was not reported. On an unknown date in August 2012, the patient was vaccinated with GARDASIL INJ (dose 1, dose and therapy route was not provided). No concomitant therapy was reported. Shortly thereafter on an unknown date the patient started experiencing gastrointestinal symptoms and stomach pain. The patient then received a second dose of GARDASIL on an unknown date in October 2012 and again shortly thereafter the patient was hospitalized on an unknown date approximately in 2012. Ultimately after many tests (unspecified) the patient was diagnosed with pancreatitis (hospitalization and medically significant) on an unknown date in approximately in 2012. Patient sought medical attention and had office visits. The patient had been prescribed many pain medications (unspecified) and this was the only medical treatment identified. On an unknown date the gallbladder was removed after the pancreatitis diagnosis (after the year of 2012). Therapy with GARDASIL was discontinued and the patient never received its third dose and does not plan to do so. Reporter stated that his son should be compensated for the adverse effects. The outcome of the event pancreatitis was reported as not recovered and outcome of cholecystectomy was unknown. The causality assessment was not provided. There was no product quality issue reported. Upon internal review the event of cholecystectomy and pancreatitis were considered medically significant. Additional information has been requested.
I experienced chills, body aches, joint pain more than usual, sore throat, exhaustion and fatigue.
Around 09:00PM after getting the vaccine I started feeling feverish. I got up the next say I had full blown COVID-19 symptoms and felt horrible. I had chills, fever, body aches, diarrhea, headaches. My arm was hot, red swollen and I thought it would pop open. I could not eat by Monday I started coughing horrible. I was drinking PEDIALYTE to stay hydrated. By Tuesday I did have to work but had some of the symptoms. I went to the doctor on Wednesday he gave me steroids and something for the pain. I still cannot eat but my symptoms have lessened. I still do not feel well.
blurred vision; whole body felt like it was on fire; shivers but has normal temp (98.25F); nausea; swelling of the joints; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling of the joints), DYSPNOEA (shortness of breath), VISION BLURRED (blurred vision), FEELING HOT (whole body felt like it was on fire) and CHILLS (shivers but has normal temp (98.25F)) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced JOINT SWELLING (swelling of the joints), DYSPNOEA (shortness of breath), FEELING HOT (whole body felt like it was on fire), CHILLS (shivers but has normal temp (98.25F)) and NAUSEA (nausea). On an unknown date, the patient experienced VISION BLURRED (blurred vision). At the time of the report, JOINT SWELLING (swelling of the joints), DYSPNOEA (shortness of breath), VISION BLURRED (blurred vision), FEELING HOT (whole body felt like it was on fire), CHILLS (shivers but has normal temp (98.25F)) and NAUSEA (nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking Medical for unknown indication.Patient treatment information was not provided.
By midnight I was experiencing minor arm soreness like I did with first dose. By early next morning shot location was red, swollen, raised somewhat, hot to the touch, and had spread up my arm to armpit/lymphnodes, very painful. Felt a sensation as though the allergic reaction was spreading across my chest - but no visible signs of that. Im almost 3 days out and still have swelling from injection site underarm.   Separate from this, I had  a constant headache that started a couple of hours after shot and is finally gone today. I had mild fever the first two days but that seems to have subsided. Was nauseous  the first day. Woke up with terrible stomachache this morning followed by diarrhea. All over body aches and pains - were at their worst the first two days, today still there but less so.
Pt recvd 1st dose of Hep B vax & 2 hrs p/vax devel vomiting, hot flashes, malaise, flu-like sx;
Shoulder Pain, Limited Range of Motion / Glenohumeral  Pain Pain now traveling to Left Elbow Left arm also hurting upon extension (elbow)
Pt. came in Tuesday 4/5/16, stating he had a red area where he previously had vaccine given. He showed me a quarter, sized red area at that time and he was advised to seek medical attention if it got any bigger or didn't go down. The next day, it had gotten worse so he went to MD and was given AUGMENTIN x 7 days.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        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 not provided.  Treatment information not provided.   This case was linked to MOD-2021-034941, MOD-2021-038454 (Patient Link).
Patient presented to the pharmacy with a 5 inch in diameter hive/rash just below the injection site.  Patient received the vaccine 3 days ago and started have reaction 2 days ago.  Advised patient to seek medical treat as hive could go larger.  Patient will take benadryl until he sees a provider.
1.~reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; 2.~FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.   This case is linked to cases 2023SA057733 (CLUSTER) and 2023SA057309 (CLUSTER).   This case involves an adult patient of unknown age and gender and it was reported influenza quadrival A-B vaccine [Fluzone QIV] reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and Fluzone QIV NP PFS was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, it was reported influenza quadrival A-B vaccine suspension for injection (lot number: UT7683NA, UT7682JA; expiry date: 30-06-2023) reached a low temperature of negative 1.3 C and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error; latency: unknown) (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.   Action taken: Not applicable.   Outcome:  Unknown for both the reported events.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
About 1 hour after receiving shots-started crying unconsolably x 4 hours.  Called MD office but did not go to office.  Gave Tylenol before and after immunization.  No fever noted.  Injection site on leg-swollen, red.  Cold compresses x 3.  Discussed event at next visit 05/2003; Recommended ped DT.
This spontaneous report as received from a healthcare student refers to a female patient of unknown demographics. On an unspecified date, the patient might have been vaccinated with dose 2 ZOSTAVAX who came into the pharmacy to receive diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (unspecified). The reporter did not known which vaccine was administered. The administration date of the first ZOSTAVAX was unknown and the possible second dose of ZOSTAVAX or diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid was unknown. No concomitant medications were reported. No adverse symptoms were reported. Additional information is not expected.
Her arm is swollen; Her arm is swollen and red; hot to touch; It hurts from her shoulder to her elbow.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her arm is swollen), ERYTHEMA (Her arm is swollen and red), VACCINATION SITE WARMTH (hot to touch) and ARTHRALGIA (It hurts from her shoulder to her elbow.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PERIPHERAL SWELLING (Her arm is swollen), ERYTHEMA (Her arm is swollen and red), VACCINATION SITE WARMTH (hot to touch) and ARTHRALGIA (It hurts from her shoulder to her elbow.). At the time of the report, PERIPHERAL SWELLING (Her arm is swollen), ERYTHEMA (Her arm is swollen and red), VACCINATION SITE WARMTH (hot to touch) and ARTHRALGIA (It hurts from her shoulder to her elbow.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication information was not provided. Concomitant medication information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow Up information was received on 26-Jul-2021 and  Events Outcome updated.
Complete loss of memory for approximately 6 hours.  Performed several tasks during the period according to spouse, but I kept asking the same questions over and over.  Taken to local ER where MRI, CT and x-ray imaging were performed along with blood tests.  I have absolutely no recollection of these events.  Eventually, I recognized that I was in the ER.  Subsequently, I was transported to main hospital where additional examinations were performed.  Ultimately diagnosed with Transient Global Amnesia (TGA).  Initial treatment consisted of Plavix and Lipitor because potential causes could have included stroke or heart-related issues.  Imaging did not find any evidence of either potential cause.  Follow-up with primary care physician resulted in revision of treatment to include only Lipitor because HDL cholesterol level was low (37mg/dL) and LDL cholesterol was 110mg/DL.  Previous levels were 47 and 100 respectively.  Continued follow-up will include routine monitoring of blood lipids.
Administered a Moderna COVID-19 first dose to a 16 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered a Moderna COVID-19 first dose to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered a Moderna COVID-19 first dose to a 16 year old). On 08-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered a Moderna COVID-19 first dose to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.
The patient devloped hives on his neck, trunk and upper thighs with itching.  No other symptoms noted. The hives lasted 48 hrs.  He took Benadryl 25 mg q.4 hrs for symptoms and applied hydrocortisone 1% cream to hives.
Patient given COVID Vaccine 12hours after vial was opened on 05/14/2021. Patient has been contacted to follow up with any allergic or adverse reactions at 08:33 am on 05/18/2021. Patient states he has not had any adverse reactions or any allergic reactions since given the Moderna vaccine. Patient states he is feeling fine.
Got my second dose in May 2021, no major side effects however when I went to my PCP for an annual checkup in November my labs (specifically Ferritin, Hgb, MCV, MCH, MCHC, Iron, TIBC, %Saturation) were all abnormal. I had labs done the year prior with nothing abnormal. My diet, activity level, meds (none) has not changed within this one year time period. The only thing different was the vaccine which made me wonder if this was the cause of abnormal labs.
Vaccine given on 10/6/00. On 7/6/01, pt developed a mild case of varicella.
Recieved shot at 9:30 in morning, had severe headaches from 11:20pm to 2:30am Could have been a sinus headache but has never been that severe.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
the reporter said patient had it's lips swollen; feeling like a pimple on the lips; upper lip super inflamed; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (the reporter said patient had it's lips swollen), ACNE (feeling like a pimple on the lips) and CHEILITIS (upper lip super inflamed) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included Lip cosmetic procedure (lip fillers).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (the reporter said patient had it's lips swollen), ACNE (feeling like a pimple on the lips) and CHEILITIS (upper lip super inflamed). The patient was treated with LISINOPRIL at a dose of 1 dosage form. At the time of the report, LIP SWELLING (the reporter said patient had it's lips swollen), ACNE (feeling like a pimple on the lips) and CHEILITIS (upper lip super inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were included. Patient reported that symptoms appeared 30 hours after vaccination. Patient went to a hospital to urgencies for 5 hours and they could lower the swollen lip.
swelling in face Pain around both sides around Kidneys Minor Rash Cold Sores General weakness and aches
Cold and flu symptoms, swelling and inflammation of the lymph nodes under arm, soreness at injection site. Same symptoms happened after 2nd dose and 3rd dose.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician via a company representative refers to an 18 months old female patient. On 05-OCT-2012 the patient was vaccinated in her right arm with M-M-R II (lot # 669032/0255AA, expiration date 21-FEB-2013). Other suspect therapies included VARIVAX (Merck). Concomitant medications included a flu vaccine (manufacturer unspecified). On 21-OCT-2012 the patient broke out in a rash. It was reported that the patient "had full body rashes, but no itching". It was unspecified whether the patient sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
Flu vaccine almost killed my friend; 2 years in wheelchair; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening) and wheelchair user. On an unknown date, the outcome of the near death experience was unknown and the outcome of the wheelchair user was recovered/resolved.   It was unknown if the reporter considered the near death experience and wheelchair user to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that flu vaccine almost killed the patient and also was in wheelchair for 2 years. The reporter stated that they would never take it and also mentioned that it was lazy way to protect oneself.  The reporter also said that eating right vitamins increased immunity which was much more effective. The reporter consented to follow-up.
Employee was sick with fever, chills, cough, nausea, vomiting after H1N1 vaccine. Symptoms began approx 16 hrs after vaccine given.
I developed memory loss during the immediate time after the vaccine.  It has not gotten better and I still cannot recall things like a normal person should be able to.