chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 15-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. On 8th January 2018, the patient received the 2nd dose of BEXSERO. On 8th January 2018, less than a day after receiving BEXSERO, the patient experienced injection site erythema. On 9th January 2018, the patient experienced injection site burning. On an unknown date, the outcome of the injection site erythema and injection site burning were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site burning to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. GlaxoSmithKline representative reported the vaccine coordinator at the hospital told that one of the patients came to the office on 8th January 2018 for 2nd dose of BEXSERO. The patient had no side effects for first time that she received the vaccine. On 9th January 2018, 1 day after receiving BEXSERO, the patient experienced injection site burning. The patient was taken to the emergency room for the burning. The sales representative did not have full address of the reporter. The patient did not receive any other vaccine other than BEXSERO.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: About 2-3 minutes after vaccine went back into vaccine area and pt was diaphoretic and pale and fainted post vaccine. Pt was assisted to a flat postions and she regained consciousness approx 15-30 seconds after she was flat.  She was monitored in the pharmacy area for 30 minutes and given water. Pt reports that she is needle phobic.
Mom stoped by office 4OCT91 w/o pt stating pt "leg was swollen dramatically", however was unclear about actual size; on questioning, denied any other side effects; due to lack of provider, sent to ER for eval; Pt given Atarax & Epi;
Patient presented with sharp right lower quadrant abdominal pain with associated nausea and emesis beginning the day he received the COVID vaccine, after vaccine injection. He had decreased appetite and pain was made worse by eating.  He presented to the hospital 3 days (2/6/21) after receiving the vaccine/symptom onset. His vital signs were T 101.5, HR 78, BP 156/67, RR 20, SpO2 94 on RA.   As discussed below, imaging showed acalculous cholecysitis. The day after presentation, pain was more localized to RUQ.  He was treated with IV ceftriaxone and flagyl. He underwent percutaneous cholecystomy tube place on 2/7/21 with plan for delayed cholecystectomy following drain placement x 6 weeks. Bile fluid culture has been no growth. We are attempting to test bile fluid for COVID-19 via PCR.   He tested positive for COVID-19 via nasal swab RT-PCR and developed a 3L oxygen requirement and mild dyspnea. He was treated with remdesivir and dexamathasone 2/6-2/10 with resolution of hypoxia and dyspnea.
Right deltoid to elbow area had a 6-7" longitudinally by 4" horizontally patch of erythema which is indurated and it blanches, onset of redness was day after vaccination, no adenopathy or abscess. Tx: necessary Zyrtec 5mg. Sore throat clearing since vaccines given.
Severe pain in arm Unable to equally lift arms Tingling down radial side of arm into thumb
Sore throat with white patches in back of throat started 2 days after vaccine. Missed work (work at hospital) the next day and went to urgent care. Tested negative for strep. Sore throat resolved that evening.
pt recv vax 8DEC95 & 27DEC95 pt devel chicken pox;f/u from patient's MD indicated that pt devel 5 chicken pox like lesions;pt given Zovirax;MD reported lesions cont to appear up to approx 20 & mostly papular w/only a few vesicular;
Fever, malaise, headache, myalgias Missed one day of work Fully recovered by 3/10/2021 6am
Sore arm, swelling of lymph nodes under armpit, vasovagal syncope, fever, chills, insomnia, fatigue, body aches.
C/O right shoulder pain, Nausea-Recommended application of cool packs, TORADOL was given for pain, promethazine for nausea-BENADRYL was used at home.
PATIENT EXPERIENCED SYNCOPE IN OBSERVATION AREA AFTER VACCINATION.  WAS TREATED BY EMS ON SITE BUT NOT TRANSPORTED
Information has been received from a physician concerning a 10 year old male who on 26-OCT-2000 was vaccinated with a first dose of MMR II (HSA) (route, site, dose and lot number not reported). On 10-AUG-2003, the patient was vaccinated with a second dose of MMR II (HSA) (route, site, dose and lot number not reported). On 02-JAN-2010, the patient experienced mumps (thought the date diagnosed was reported as 19-NOV-2009). The patient was afebrile and did not have parotitis. The outcome for mumps was not reported. Follow up was received from a physician. It was reported that the 10 year old (also reported as 9 year old) patient experienced mumps on 19-JAN-2010. The diagnosis date was on 19-JAN-2010. On the same date, the patient had several tests performed: IgM <1:10, IgG was 1.96 and serum amylase was 36. The patient had left facial pain, and left parotitis. It was unknown if the patient had orchitis, there were no other symptoms. It was unknown if the patient had exposure to other with mumps (sib, classmate) or if there was other case in same household. There was no third dose of MMR II given. At the time of reporting, the patient's outcome was unknown. Additional information is not expected.
Episode lasting 30 minutes on 5/22/21: Distorted vision  Numbness in both arms Lightheadedness  Sensitivity to light  Headache Lasting 6 hours: Fatigue   From 5/21/21-5/28/21: Symptoms similar to shingles - skin sensitivity above ribs around torso. Nerve pain/?shocks? 10-20 per hour in same area above ribs circling around entire torso.  Fatigue.
Fever 102 15 hours after vaccines given. Cough, fatigue, nasal congestion. Treatment - observation, fluids, Tylenol.
2nd dose administered greater than 35 days after 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered greater than 35 days after 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered greater than 35 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered greater than 35 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.    Reporter did not allow further contact
No additional AE information; Reported a temperature excursion for PROQUAD/administered to patients; Information has been received from an office manager, concerning to a 13 year old patient (gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 25-FEB-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. T027111 exp. date 07-FEB-2022) (rHA), 0.5 milliliter for prophylaxis which on 16-FEB-2020, went through temperature excursion (product storage error). No adverse event reported.   Temperature: -10°C Timeframe: 1 hour 15 min Previous excursion temperature: N/A Data logger: No
Erythema, muscle pain, swelling at injection site. Acetaminophen 1000 mg BID.
No additional adverse events (AEs) or product compliant (PQC) were reported.; expired Merck Sterile Diluent used to reconstitute vaccine that was administered; expired Merck Sterile Diluent used to reconstitute vaccine that was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.    On 10-NOV-2021, expired sterile diluent (manufacturer unknown) (lot # S002625; expiration date: 09-NOV-2021) was used to reconstitute vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA) (PROQUAD) (lot # U006312; expiration date: 24-AUG-2022; strength, dose and route were not reported) that was administrated to patient for prophylaxis (product preparation issue and expired product administered). No additional adverse events (AEs) or product compliant (PQC) were reported (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA004629: US-009507513-2112USA004666: US-009507513-2112USA004424: US-009507513-2112USA004364: US-009507513-2112USA004666:
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). It was reported that the subject's past medical history included three pre-term pregnancies; however, the pregnancy outcomes were specified as three normal births, two spontaneous abortions and one elective abortion. The subject was not using contraception at the time of the pregnancy. On 4 October 2011 the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown). Her last menstrual period was on 05 April 2011 and estimated date of delivery was 10 January 2012. The subject was exposed to BOOSTRIX during unknown trimester. On 04 October 2011, at the time of vaccination with BOOSTRIX, the subject experienced vaccine exposure during pregnancy. The pregnancy was by normal conception. The outcome of the pregnancy was unknown. Follow-up information was received on 13 March 2012. It was reported that the conception was normal. The subject received ranitidine concurrently at 150 mg daily from 14 November 2011 to 18 December 2011 (31 to 36 weeks gestation). The subject had a history of tobacco use, but quit during pregnancy. She also had a history of 3 preterm labors (3 births all at 36 weeks). The subject gave birth prematurely, at 36 5/7 weeks gestation, on 18 December 2011 to a live, male neonate via normal vaginal delivery. The neonate weighed 6 pounds at birth. APGAR scores at 1 and 5 minutes after birth were 09 and 09 respectively. No defects were noted.
pt recv vax & devel chickenpox w/63 pox noted on 3/31/98;4/2/98 pt recovered;
104+ fever followed by rash. Platelets & WBC dropped to a dangerous level, then went extremely high. Six weeks following vaccination, WBC & platelets returned to normal. Seen by hematologist.
Information has been received from a certified medical assistant concerning a female patient who was vaccinated with the first dose of GARSASIL vaccine (yeast) 0.5ml intramuscularly. The medical assistant reported that the patient fainted after receiving HPV vaccine. At the time of the report the patient had fully recovered. It is unknown if the patient sought medical attention. Additional information has been requested.
Rcv'd high dose flu at 1:30PM.  At 2:00PM c/o sore throat, at 4:00 PM c/o bilateral swollen glands and "raw underside of tongue", 7:30 PM bilateral bloodshot and watery eyes with thick white drainage, temp 99.9 with chills.  Please note, flu clinic was a drive thru flu clinic held outside.
No additional AE information provided; the patient was administered an improperly stored dose of PNEUMOVAX 23; This spontaneous report was received from a licensed practical nurse concerning a patient of unknown age and gender. Information on pertinent medical history, concomitant medications and drug reactions/allergies was not reported.   On 09-OCT-2019 the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S004548, expiration date 12-AUG-2020 for prophylaxis (dose, dose number, route of administration and anatomical location were not reported).   The vaccine was exposed to a temperature of 47.3 degrees Fahrenheit (F) for a time frame of 20 minutes as recorded by a digital data logger. There were no previous temperature excursions. No additional adverse event information was provided.  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
red area near the areola; tingling in the back of my head; lethargic; moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; overall yucky; lump arise in my right breast, which caused a soreness and red area near the areola; Lump in breast; Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder; fever; fatigue; nausea; severe headache; chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola) and FEELING ABNORMAL (overall yucky) in a 60-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.     Concurrent medical conditions included Rheumatoid arthritis since 1996, Cystitis interstitial since 2018 and Barrett's esophagus since 2017. Concomitant products included VITAMINS NOS for an unknown indication.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), LETHARGY (lethargic), FEELING ABNORMAL (overall yucky), BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola), BREAST MASS (Lump in breast), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting). On an unknown date, the patient experienced PARAESTHESIA (tingling in the back of my head) and ERYTHEMA (red area near the areola). In September 2021, BREAST MASS (Lump in breast) had resolved. At the time of the report, JOINT RANGE OF MOTION DECREASED (moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), VACCINATION SITE PAIN (Pain in right arm/moved right arm more pain/ mobility issues in right shoulder, around joint of right shoulder), PYREXIA (fever), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (severe headache), CHILLS (chills) and VOMITING (vomiting) had not resolved and PARAESTHESIA (tingling in the back of my head), LETHARGY (lethargic), ERYTHEMA (red area near the areola), FEELING ABNORMAL (overall yucky) and BREAST PAIN (lump arise in my right breast, which caused a soreness and red area near the areola) outcome was unknown.            No treatment information was provided   This case was linked to MOD-2021-269309 (Patient Link).
Symptoms are variable but some combination troubles me every day since March 6, excepting the twelve days I was on the Prednisone prescription.  In general, pain increases during sleeping hours, when I grow stiff and less flexible. I wake several times during the night (almost hourly) dry-mouthed. I don't know if pain wakes me or not. I rise with great difficulty and hobble to the bathroom.  Mornings are the worst part of the day, but I find if I keep moving, I loosen up and the general inflexibility goes away, and to some degree, so does the pain. It is never entirely gone. I also find that the pain seems to generally occur during movement and not at rest, although the pelvic pain and upper leg pain has and does occur while at rest.  The most regularly-occuring pain is hamstring and shoulder (shot locations). Rising from a laying or seated position has always been the most difficult.  Lately, pelvic pain has been rare, and knee pain intermittent.
headache, a really bad headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache, a really bad headache) and MYALGIA (muscle aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache, a really bad headache) and MYALGIA (muscle aches). At the time of the report, HEADACHE (headache, a really bad headache) and MYALGIA (muscle aches) outcome was unknown.            No concomitant medications were reported.  This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history reported, who experienced non serious, expected events of headache and myalgia. The events occurred on an unknown date day after the third dose of mRNA-1273 vaccine. No information about first and second dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no relevant medical history reported, who experienced non serious, expected events of headache and myalgia. The events occurred on an unknown date day after the third dose of mRNA-1273 vaccine. No information about first and second dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Bruise about 2 inches in diameter that showed up the night of the vaccination about 10 hours after administration.  It had swollen up "like a goose egg" and only noticed it because it was itchy. No treatment, just allowed it to take its course and the swelling went down the next day but the bruise was still there.
7 hours following shot: extreme fatigue  that continued for 45 hours 11 hours following shot: headache, extreme body aches, chills, nausea, lethargy, feverish feeling (not confirmed because no working thermometer).  Alternated with Advil and Tylenol which did not relieve symptoms.  Symptoms finally subsiding 45 hours following shot.
On the day of my injection approximately 20 minutes later i had tingling down the arm I received the vaccine in and in my face which lasted for about 2 hours but went away. Other symptoms began 12/25/20 including body aches, fatigue, chills, and fever.
Left arm began to swell from 4 to 5 inches from the shoulder to 2 inches from the crease of her elbow, in the front, after second vaccine; her arm was swollen and red and the shape of an eggplant, it was that large; Itching on left arm, after the second vaccine; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EWD175, Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 07May2021 at 15:55 (at the age of 82 years old) as second dose, single for COVID-19 immunisation. The patient has no medical history (including any illness at time of vaccination) and no family medical history relevant to adverse effect. The patient previously received the first dose of BNT162B2 (lot number: EWD162, expiration date:01Jul2021), via an unspecified route of administration administered on left shoulder (as reported) on 16Apr2021 at 1:45pm (at the age of 82 years old) as single dose for COVID-19 immunisation. There were no concomitant medications. On 11May2021, the patient experienced that her left arm began to swell from 4 to 5 inches from the shoulder to 2 inches from the crease of her elbow, in the front, after second vaccine. It was further reported that redness and swelling of left arm are the size of an eggplant, 2.5 inches on the top part of the arm and 4.5 inches at the base of the swelling, a total of about 6 inches from top to bottom in length. There was also itching on left arm. Events did not result in Emergency Room nor Physician Office Visit. The patient stated that the for the redness, it has improved by a small amount, and was ongoing, she can still see the redness; for the swelling, it was still there, but was not as swollen as it was before and for the itching of left arm it was still ongoing a little and it was described as a minor itching. Patient was recovering from left arm swelling and redness of left arm but was not recovered from itching in arm.  No follow-up attempts are needed. No further information is expected.
Information has been received from a clinical medical assistant referring to patient of unknown age and gender. On 27-JAN-2015 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot K005180, expiration date 10-APR-2016, (dose, frequency, therapy route unspecified). No adverse effects were reported. The outcomes of events reported were unknown. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same source. Additional information has been requested.
Sudden onset pain in  posterior and anterior neck, numbness and heat on left side of head/neck, lightheaded and nauseous. Symptoms have persisted for the past three and half weeks with no medical reason (labs clear, MRI clear, CT scan clear)
Patient received vaccine morning of 10/5/12. One hour later she noticed the injection site to be sore, aching and hurting. In the afternoon she had sharp, shooting pains and in the evening she was cold and shivering. Saturday 10/6 she could barely lift her arm to comb hair. On 10/15/12 it was still sore. She saw her doctor on 10/12/12 and dismissed her complaint and didn't get physical. Went for yearly physical and asked about shots.
1 week after the first dose I developed a rash on the injection site(left arm) and had soarness in my left armpit and a tightness bulge that moved over my left collarbone. After the second covid shot the bulge feels like there are now two of them and they are more tender and moves around my collarbone. They are about the size of the tip of my pinky finger. I have body aches and diarrhea.