chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1min after vaccination patient experienced syncope and lost consciousness for <2 seconds. Pt then felt nausea, lightheaded, pulse slow and weak, skin pale. RN placed cool towel on back of neck and forehead. RN assisted client to supine position with elevated legs. Pt started to feel better after 3 minutes, then abdominal cramping started. Pt states cramping was moderate/severe and felt need to go to bathroom for a bowel movement. Pt assisted to bathroom and nurse at other side of door for easy assistance if she felt weak/or lightheaded. Pt also had alarm button w/in reach should assistance be needed. Pt continued to have cramping for 15 minutes. She requested to lay down in bathroom as she was frequently needing to have bowel movement, however was still feeling weak. Nurse at patient's side while laying down continuing to monitor status. Pt BP taken at intervals. Pulse after syncope was 52 and weak. Pulse remainder of recovery time 60-62 and strong. Patient given warm pack to place on abdomen for cramping and felt better with heat applied. After cramping resolved patient assisted to patient room and layed supine for 5 minutes. After full recovery pt then sat up on bed for further monitoring. Pt then moved to standing position with no return of symptoms. Patient felt she was ready to leave and was going to be one block away going to work. She states she still wanted to go to work, but when she arrived to work she would eat, hydrate, and sit for 20-30 minutes.
patient received dose around 1:30 pm and stated that round 8 pm that night developed hives on her face. Hives resolved without incident
Pfizer  02/28, 03/18, 11/20 Patient already had heart disease, pain all through arm after 1st dose, 2nd dose wasn't too bad, booster, glands swelled up, severe pain, and is unable to eat without getting sick . Caused fibromyalgia symptoms to flare up. Unable to stay warm. Tinnitus has been uncontrollable since booster shot.
it had gradually getting worse./ In both eye, left was worse; My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAPILLOEDEMA (My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In August 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced PAPILLOEDEMA (My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started) (seriousness criterion medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (it had gradually getting worse./ In both eye, left was worse). At the time of the report, PAPILLOEDEMA (My granddaughter has 'ptseubotatill' (edema of optic nerve)./ Her eye problems started) and CONDITION AGGRAVATED (it had gradually getting worse./ In both eye, left was worse) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient 1st dose was in August 2022, the 2nd in September 2022. Her eye problems started in October 2022. Patient went to the eye Dr (Optometrist) & he found it. Physician gave some medicine, but it didn't help. Since then it had gradually worsened. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event of papilloedema approximately 1 month after a second dose of mRNA-1273 vaccine was administered. It was reported that patient had edema of optic nerve in both eyes, left was worse. She was seen by the eye Dr (Optometrist) and he gave patient some medicine, but it didn't help. Since then, it has gradually got worse. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
PATIENT AND MOTHER REPORTED FAINTING EPISODE WITH PREVIOUS HEPATITIS B SCHEDULE. NEITHER REPORTED ISSUES WITH PREVIOUS FLU SHOTS. THE FLU SHOT WAS ADMINISTERED AT 5:30 PM AND LESS THAN 30 SECONDS AFTER PATIENT FAINTED IN HER SEAT BUT I WAS ABLE TO CATCH HER HEAD FROM HITTING ANYTHING. I LAID HER DOWN ON THE GROUND AND SHE REGAINED CONSCIOUSNESS. HER MOTHER AND I BOTH MONITORED HER FOR 15 MINUTES UNTIL THE MOM DROVE HER HOME.
Patient reports redness/rash at the site of administration. Rash appeared same day of administration.
itching at injection site and around upper arm region, fatique, headaches, rash up and down upper arm region
Information has been received from a nurse concerning a 2-year-old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed joint pain and was unable to walk. The patient sought unspecified medical attention. At the time of the report the patient's status was recovering. A product quality complaint was not involved. No further information is available.
Arm pain, rash around injection site, and periodic numbness which all came on a week after the injection and continue. I take Motrin 2x per day to deal with the discomfort which doesn't completely eliminate it. Also experiencing unusual level of fatigue. These symptoms have been occurring for 7 days now and show no sign of abating. Initial reaction to this vaccine injection was extreme nausea, vomiting, headache and fatigue which began on 02/13/2021 and lasted about 1.5 days. Then I felt fine until the arm symptoms described above began.
Pt reports she developed, rash and shortness of breath. Presented to Emergency Room where she was treated, and then sent to L & D for monitoring.
13 doses administered out of possibly expired vial; 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 EXPIRED PRODUCT ADMINISTERED (13 doses administered out of possibly expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered out of possibly expired vial). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered out of possibly expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment history was reported.
Pt. states that after receiving the 1st dose Tdap 07/23/2021, started experiencing symptoms the evening of 07/23/2021 of a dry cough, swollen shoulder, pain in the shoulder, headache (left-side), eye pain, and short-term memory loss. Reported to treating Physician 08/03/2021, no recommendations. Re-visit to treating Physician 08/17/2021, treated for dry eye and headache.
8 year old boy was administered a 0.25 ml Moderna booster dose instead of the pediatric Pfizer vaccine. Patient's mother was instructed to monitor son closely, counseled that side effects may be similar to what he may have experienced with Pfizer dose (ie sore arm, fever, aches, fatigue). Pediatrician on call was called, and no additional instructions were provided, other than to return for second dose of Pfizer-Pediatric in 4 weeks. Patient was to follow up with pediatrician as well.
Shortness of breath, facial swelling, trouble swallowing, rash, itching.
Expired IPOL administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (Nurse practitioner).  This case involves a five-year-old male patient who received expired dose of vaccine IPV (VERO) [IPOL] (expired product administered).   The patient had a history of vaccination with DTAP and Hep B vaccine.  Medical history, medical treatment and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, VARICELLA ZOSTER VACCINE [MMRV].  On 22-Jul-2021, the patient received a 0.5 mL first dose of suspect IPV (VERO) [oral solution, lot R1D973M, expiry date: 17-Jul-2021, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5 mL, strength: standard except for Fluzone HD-standard] via an intramuscular route at the left arm for prophylactic vaccination (expired product administered, latency: on the same day).  It was a case of actual medication error due to expired vaccine used.  It was reported that, 'Caller is looking for information on next steps. As per NP this should have been the 4th dose with this being the patient's initial visit to this practice and there was a language barrier had all dtap and hep b but missing Ipol'  At the time of report, no adverse event reported.  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.
Patient came into clinic 2 days later with left shoulder swelling, pain and decreased range of motion.
She received 2nd COVID vaccine and experienced side effects that evening. She complains of "pins and needles in elbows and knees" and body aches, nausea, headache, fever, localized swelling and erythema around injection site to elbow.
Systemic: Fainting / Unresponsive-Mild, Additional Details: passed out shortly after the shot. regained consciousness right after
Broke out in hives, really bad fever (the next day  - 05/07/2005).  Not reported to this office until 07/21/2005.
Fever so high I couldn't think or get to thermometer,  shaking, muscle aches and weakness, headache, 1AM to 5AM vomiting, couldn't hold down water, got a little better by 11AM the next day when I could take tylenol, still fatigued and weak for 2 days, headache for 3 days
Information has been received from a registered nurse concerning a 8 year old male who was vaccinated on 5/31/96 with a dose of varicella virus vaccine live (lot number was unavailable). In April 2003, the patient had a few pox after a known exposure. The child was noted to have chicken pox breakthrough. Unspecified medical attention was sought. There was no product quality complaint. The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine life and developed chicken pox breakthrough/shingles (WAES0404USA00205, 0404USA00418, 0404USA00419, 0404USA00420, 0404USA00421, 0404USA00422, 0404USA00423, 0404USA00424, 0404USA00425, 0404USA00426, 0404USA00427, 0404USA00428, 0404USA00429, 0404USA00430, 0404USA00431, 0404USA00432, 0404USA00433, 0404USA00434, 0404USA00435, and 0404USA00436). No further information is expected.
Lymphoma after receiving the 2nd dose; Occlusion in leg; Lump the size of a golf ball that never went away; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Lymphoma after receiving the 2nd dose), PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Occlusion in leg) and MASS (Lump the size of a golf ball that never went away) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOMA (Lymphoma after receiving the 2nd dose) (seriousness criterion medically significant), PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Occlusion in leg) (seriousness criterion medically significant) and MASS (Lump the size of a golf ball that never went away) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Lymphoma after receiving the 2nd dose) and PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (Occlusion in leg) outcome was unknown and MASS (Lump the size of a golf ball that never went away) had not resolved.            No concomitant medications reported.  The patient under oncologic treatment. Company comment: This spontaneous case concerns a male patient of unknown age, who experienced the unexpected, serious event of Lymphoma ,mass and pheripheral artery occlusion (seriousness criteria medically significant) which occurred on an unspecified date after receiving the second dose of mRNA 1273 vaccine. It was reported that after vaccination patient developed lymphoma and which was a mass grown to the size of a golf ball with Occlusion in leg and was reported to be under oncologic treatment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-065289.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age, who experienced the unexpected, serious event of Lymphoma ,mass and pheripheral artery occlusion (seriousness criteria medically significant) which occurred on an unspecified date after receiving the second dose of mRNA 1273 vaccine. It was reported that after vaccination patient developed lymphoma and which was a mass grown to the size of a golf ball with Occlusion in leg and was reported to be under oncologic treatment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Chills, fever, stomachache, headache, large red swollen raised patch on arm inches below injection site - all have lasted 60 hours after injection
HCP said that 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP said that 606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. No adverse events were reported. Vials were placed in refrigerator on 01-Mar-2022. No temperature excursion was reported.
Patient experienced redness and soreness that radiated from the injection site down her arm almost to her elbow. The red, irritated area was hot to the touch. She did not complain of fever, but she did say she did not feel well the day after receiving the vaccine. Patient was referred to her doctor, and was informed that she should be seen as soon as possible. Patient stated that her doctor informed her that she had a fever of 99 degrees F. She was given a seven day supply of Keflex by her primary care physician, Dr.
Within first month after vaccination began to experience feeling of intermittent tightness in upper chest and throat - had been taking Rx Aciphex with no relief - was changed to Nexxium on 4/16/03
Expired Pediarix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 9X3T5, expiry date 05-MAR-2023) for prophylaxis.   On 06-MAR-2023, the patient received Pediarix. On 06-MAR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Pediarix administered).  The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAR-2023 The reporter was a clinic supervisor. The reporter reported that the patient was inadvertently administered an expired dose of Pediarix vaccine. The reporter did consent to follow up. Additional supportive information: The patient received a Pediarix vaccine which was already expired, which led to expired vaccine used.
Unrelated symptoms starting earlier in the week: and pain, sense of impending doom; Possibly related symptoms onset tonight: Chills, dizziness, denies fever, Likely unrelated symptoms onset tonight: Describes an intermittent chest/back discomfort, dry mouth/throat; BEFORE The shot had gone to PCP and saw a paramedic. No evaluation with medical professional since Thursday (well before the shot)Caller is worried about heart attack and says his provider assessed he is at high risk of this. I adv based on medical history and chest discomfort tonight, I adv be evaluated in person. Discussed which of the side effects are probably/possibly related to the vaccine and which may be more medically related. The more concerning side effects tonight are likely unrelated but still warrant eval. Don't drive to the ED, reasonable to call EMS and have them evaluate and transport as needed.   PCC will call back tomorrow. 4/26-Patient continues with chills, sore throat and abdominal pain, saw PCP about these ongoing symptoms, no new orders were established.  Pfizer lot number: EW0170.-JD
Presented with CP & exertional SOB x3 weeks; Covid + ED.; dx with Covid & PE; tx with singulair, zinc; no hypoxia; He is stable for d/c home. No intervention required
Patient received HPV vaccine and was doing fine after receiving that. She walked to the nurse who was going to do her COVID vaccine and gave the patient the COVID vaccine. After receiving the COVD vaccine, the patient passed out while she was sitting down about 30 seconds after receiving the COVID vaccine. Patient was unconscious for about 15 to 20 seconds and then came back to being alert. Patient was offered crackers and water and we had her lie down for about 5 to 10 minutes. Patient stated she felt light headed and dizzy before passing out but does not recall actually being passed out. Patient also stated that she had ringing in her ears, which patient states the ringing in her ear has happened multiple times before.
I woke up fever, chills that lead to my fever spiking to 102.9F, tachycardia, my heart rate spiking. I called my doctor who suggested I go to the emergency room to rule out heart attack. Once in the emergency room they ran a CAT scan, EKG, bloodwork, PCR COVID-19, urinalysis. The only that came back was a slight elevation in my white blood cell count. I was given an IV antibiotic while at the hospital and given a prescription to continue taking an antibiotic for another week. They said.
Sweating; Shaking; Chills/ shivering; Head throbs; Did not sleep at all last night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep at all last night), HYPERHIDROSIS (Sweating), TREMOR (Shaking), CHILLS (Chills/ shivering) and HEADACHE (Head throbs) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concurrent medical conditions included Sleep disorder (normally has trouble sleeping, but gets some sleep).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced INSOMNIA (Did not sleep at all last night). On 26-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), TREMOR (Shaking), CHILLS (Chills/ shivering) and HEADACHE (Head throbs). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency; Physical therapy (wrapped in blankets and a heating pad) for Hyperhidrosis; Physical therapy (wrapped in blankets and a heating pad) for Tremor; Physical therapy (wrapped in blankets and a heating pad) for Chills and Physical therapy (wrapped in blankets and a heating pad) for Headache. At the time of the report, INSOMNIA (Did not sleep at all last night), HYPERHIDROSIS (Sweating), TREMOR (Shaking), CHILLS (Chills/ shivering) and HEADACHE (Head throbs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 97.3 °F (Inconclusive) 97.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Brief seizures x 2 associated with fever on 08/23/2003. Observed overnight in hospital. No complications associated with febrile seizures.
Doctor ordered PEDIARIX, HIB, PREVNAR, & oral Rotavirus. However, Hepatitis B was given instead of the HIB.
Patient phoned in 2-3 weeks after Td in December 2004 to state left arm still sore. Told her this was not unusual. Phoned back May 2005 that arm still a little sore and also has discomfort left breast (near sternum). Wants to know if related to tetanus injection. Told her to inform her doctor and I would submit a report to state.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SINUS TACHYCARDIA; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: antibiotic allergies (erythromycin and amoxicillin), topical reactions (unspecified), grapes and chocolate allergy, penicillin allergy, and gluten allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 in total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date after vaccination, patient's heart rate was going up and down. Patient visited urgent care a few times. On 22-APR-2021, urgent care recommended to visit hospital, where the patient was diagnosed with palpitations and sinus tachycardia. Laboratory data included: Heart rate (NR: not provided) heart rate up and down. On 27-DEC-2021, the patient was diagnosed with covid-19 (suspected covid-19 infection) and thus had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, sinus tachycardia and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0:20220147539-Covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure-This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS