chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine came back out and rolled down the patient's arm; Approximately 0.2cc of vaccine leaked at site of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine came back out and rolled down the patient's arm) and DEVICE CONNECTION ISSUE (Approximately 0.2cc of vaccine leaked at site of injection) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced UNDERDOSE (Vaccine came back out and rolled down the patient's arm) and DEVICE CONNECTION ISSUE (Approximately 0.2cc of vaccine leaked at site of injection). On 01-May-2021, UNDERDOSE (Vaccine came back out and rolled down the patient's arm) and DEVICE CONNECTION ISSUE (Approximately 0.2cc of vaccine leaked at site of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No Treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18-MAY-2021 was added the patient details and provided the vaccination dates. On 21-Jul-2021: Significant FU-patient chose to take another vaccine and no adverse events reported
Redness and swelling of left deltoid at vaccination site. Cool compresses and Ibuprofen or TYLENOL.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 08-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M025870 and expiration date 18-MAY-2018. (Dose and route of administration were not reported). It was stated that the temperature excursion was 6C (Celsius degrees), the time frame was 1 hour and there were not previous temperature excursions. It was stated that the alert of the temperature excursion was not because of a data logger. There was not a product quality complaint (PQC) involved. This is one of two reports from the same reporter. Additional information has been requested.
While walking to waiting area from vaccination area patient became dizzy and was caught by father.  Escorted to chair.  Vitals checked and appropriate for age. Given juice and crackers as she had not had any food today.  Monitored and stated feeling better. Left with father.
Information has been received from a medical assistant reporting on a 5 day old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 11-OCT-2017, the patient received an unspecified dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) for prophylaxis (anatomical location, route of administration, lot number and expiration date were not reported) and on 16-OCT-2017, the patient received an unspecified dose of RECOMBIVAX HB) lot # N002920, expiration date 30-SEP-2018 for prophylaxis (anatomical location and route of administration were not reported). The dose administered on 16-OCT-2017, was given as the family was sure that the newborn did not previously receive a dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). No adverse effects were reported.
a pt inadvertently recv an intradermal inject of vax & developed a ``huge'' welt.
Significant fatigue for 3 days. Large knot the size of an orange formed on the arm, red and hot to the touch. Bump itself registered 101.5 on infrared thermometer, pt forehead temp was normal.
States 2-3 days after recieving 1st Gardasil dose in LD, she developed a red, dry, itchy skin rash to left arm, shoulder to knuckles. Also present on knuckles. Self-treated initially with hydrocortisone cream. Seen at health center for same symptoms on 1-27-09. Treated with rx for triamcinolone cream. Diagnosis at that time was eczema. No prior hx of same. Resolved after approx. 2 weeks; student gave this history upon returning for 2nd Gardasil dose on 3-31-09. After discussion with manufacturor and MD, second dose was not given due to the possibility of an allergic reaction and student advised that it would be recommended that she discontinue series at this time. Student given info. sent from Merck as well as CDC and websites for further information.
When the vaccine was administer it bleed. The lady giving me the vaccine clean the area and cover it with a bandage. Two/three days later the skin had peel back in the area where I got the shot a small sore had formed. It was painful in the area then a scab had formed over it.
Received vaccine on 1/16/21 and had a sore arm and headache the next day that went away by the Monday after. On 1/23/21 injection site was sore and started having body aches and injection site was red. Sunday 1/24 no boy aches but still had redness and soreness on injection site and started experiencing itch on site. Monday 1/25 still have redness, sorness and itch on site but now have extreme headache
felt like an injury; pulsing in her chest and arms and legs; felt like an injury; pulsing in her chest and arms and legs; she experienced some nervous system side effects/What she feels like is her nervous system overly responding to something; right arm which she got the injection in was sore; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 67-years-old female patient (Consumer) received bnt162b2 (COMIRNATY ; Solution for injection, Lot Number: FD0809), dose 1 via an unspecified route of administration, administered in Arm Right on 02Sep2021 12:30 as DOSE 1, SINGLE for covid-19 immunization .The patient medical history was not reported. The patient's concomitant medications were not reported. On 2Sep2021 at 22:00 in the evening right arm which she got the injection in was sore , the event ended on 03Sep2021. On 03Sep2021 she felt like her nervous system overly responding to something (Nervous System Disorder). On 03Sep2021 she had a little bit of something going on in her body; felt like an injury; pulsing in her chest and arms and legs for a bit that seemed to have gone away but when she woke up in the morning there was some other energy that feels like her nervous system is overly responding to something. This event went away in the day but is still happening in the morning. She still had a little bit of strange nerve impulses that she felt are getting through. The patient reported that the feelings kind of shifted from the individual body areas to a more general internal pulsing that is experienced strongest in the mornings but is a little better now. Patient reported she has only contacted her Naturopathic provider and inquired with her Internist because she was thinking about getting a second shot of Covid Vaccine by a different manufacturer than Pfizer, like of the J&J Covid Vaccine but they don't have any information on that to provide. The outcome of nervous system overly responding to something (Nervous System Disorder) is not recovered . The outcome of event right arm sore was recovered on 03Sep2021. The outcome of the events pulse abnormal and Nerve injury(chest and arms and legs) was Recovered in 2021. She asked if there was information on getting a different manufacturer's vaccine for the second dose of Covid Vaccine, like the J&J Covid Vaccine. She has not been administered any additional doses of Pfizer Covid Vaccine or any other manufacturer's Covid Vaccine.  No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Patient receiving the 1st dose on 08-feb-2019  2nd dose was never administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th February 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: Pharmacist reported that second dose was never administered yet. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 40 year old female of unspecified race and ethnicity Initial information was processed along with the additional information received on 24-MAY-2022. The patient's weight was 155 pounds, and height was 161.5 centimeters. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: 043A21A, expiry: unknown) dose was not reported, 1 total, administered on 25-APR-2021 12:00 to left arm for prophylactic vaccination. On 01-MAY-2021, the patient experienced itchy rash all over the body (but not at injection site), left eye became red, left eye became itchy, and hives all over the body (but not at injection site) (all events in dose number in Series 1). The patient recovered from itchy rash all over the body (but not at injection site), left eye became red, left eye became itchy, and hives all over the body (but not at injection site) on 02-MAY-2021.  The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: unknown) dose was not reported, 1 total, administered on 01-NOV-2021 for prophylactic vaccination. Age at time of vaccination 39 years old. No concomitant medications were reported.  On 18-MAY-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) positive and the patient experienced suspected clinical vaccine failure (dose number in series 2). On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210502244. This report was associated with product quality complaint: 90000232582.; Sender's Comments: V0.20220546376-covid-19 vaccine ad26.cov2.s -suspected clinical vaccine failure . The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
fatigue resulting in sleeping 14 hrs+/day for 3 days; fatigue resulting in sleeping 14 hrs+/day for 3 days; muscle and joint pain; muscle and joint pain; Underarm swelling; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9266 and expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 17Feb2021 09:30 (at the age of 72-years-old) at dose 1, single for covid-19 immunization. Medical history included hypothyroidism, high cholesterol, depression and sulfonamide allergy. Concomitant medications included rabeprazole sodium (ACIPHEX); rosuvastatin calcium (CRESTOR); desvenlafaxine; levothyroxine. The patient had allergies to xanax and azithromycin. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Feb2021, the patient experienced underarm swelling and on 25Feb2021, the patient experienced fatigue resulting in sleeping for 14 hours+ per day for three days, muscle and joint pain for several days that appeared day 10 out. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events underarm swelling, fatigue, muscle pain and joint pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Was given HPV during her pregnancy she was apx 6wks gestation. She was also given varicella at hospital. When she was apx 5 week gestation
Extended mensuration - currently for 12 days, normal is 5-6 days and has been for the entire duration since I began menstruating at 12 years old   Start date - 9/16/21 and no end date as of 9/27/21
Extreme nausea that resulted in vomiting. Also headache and dizziness. Lasted a minimum of 12 hours.
Patient said his right arm where he got the Moderna vaccine then started hurting; Fever; Worsening of pain on a different arm where non Moderna Vaccine (Flu vaccine) was received./ still experiencing pain on both arms.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient said his right arm where he got the Moderna vaccine then started hurting), PYREXIA (Fever) and MYALGIA (Worsening of pain on a different arm where non Moderna Vaccine (Flu vaccine) was received./ still experiencing pain on both arms.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 013L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLUZONE [INFLUENZA VACCINE] (redness on injection site and pain in arm.) on 22-Oct-2020. Concomitant products included VALSARTAN and HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE) for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRIN 81), CLOPIDOGREL and ISOSORBIDE MONONITRATE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Feb-2020, the patient experienced MYALGIA (Worsening of pain on a different arm where non Moderna Vaccine (Flu vaccine) was received./ still experiencing pain on both arms.). On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Patient said his right arm where he got the Moderna vaccine then started hurting) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 325 mg twice a day. On 20-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Patient said his right arm where he got the Moderna vaccine then started hurting) and MYALGIA (Worsening of pain on a different arm where non Moderna Vaccine (Flu vaccine) was received./ still experiencing pain on both arms.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Body temperature: 100.8 (Inconclusive) fever of 100.8.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Treatment included cold gel pack.  Patient reported no adverse event with dose 1. Patient reported physician prescribed lidocaine patch and Tylenol but didn't took lidocaine.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 72 years old female patient who experienced heart was pounding, her tongue felt a little thick, started to feeling swirling in her head (not dizzy) then it spread through her whole body and nausea, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included has allergies with Sulfite, PCN and iodine. The patient's past vaccination included FLUZONE HD last year with no reaction. At the time of the event, the patient had ongoing diagnosis of Multiple Sclerosis. The patient took 2 BENADRYL before the injection. Concomitant medications included ZYRTEC every night. She takes Alprazolam prn for anxiety. On 25-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number, expiry date not reported via unknown route in unknown administration site. On 25-Sep-2018, the patient developed a non-serious heart was pounding two hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 25-Sep-2018, the patient developed a non-serious her tongue felt a little thick two hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 25-Sep-2018, the patient developed a non-serious started to feeling swirling in her head (not dizzy) then it spread through her whole body two hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 25-Sep-2018, the patient developed a non-serious nausea two hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient also has these symptoms but worse when patient ingests Sulfite. The symptoms were less in the AM. The patient still has a little of the tongue thickness. Lab data was not provided. Final diagnosis was nausea, started to feeling swirling in her head (not dizzy) then it spread through her whole body, her tongue felt a little thick and heart was pounding. It was not reported if the patient received a corrective treatment. Drinking water helps her. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for started to feeling swirling in her head (not dizzy) then it spread through her whole body, as Not Recovered / Not Resolved on an unknown date for her tongue felt a little thick, as Not Recovered / Not Resolved on an unknown date for nausea and as Not Recovered / Not Resolved on an unknown date for heart was pounding. List of documents held by sender- none.
Visibly red and swollen spot on arm, spreading down from the deltoid and intowards her elbow.
Tingling lips and tongue. Oral Benadryl 25 mg at 2:45 p.m.  Second 25 mg Benadryl at 3:40 p.m.  Tingling has subsided somewhat
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 84-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 2nd February 2021) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced erythema, swelling and skin warm. On an unknown date, the outcome of the erythema, swelling and skin warm were unknown. It was unknown if the reporter considered the erythema, swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reported that the patient received a dose of SHINGRIX on and experienced a red, swollen and warm circle on the arm 3 to 4 inches below the injection site.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. Patient received Paxlovid for COVID-19 Treatment from 01Jul2022 to 05Jul2022 and COVID-19 was tested negative on an unspecified date. Outcome of the events was recovered in 2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and swelling of R upper arm.  Warmth to touch noted mother also reports Pt had stomach pains.  Pt was taken to ER on 9/19/2007.  BENADRYL and AMOXICILLIN Q6 hour X 7 days were prescribed.
vesicular rash @ & around site;hands numb & tingling;devel SC nodules on hands;treated w/DPH & ASA w/o relief;8JUL94 f/u vesicular cellulitis treated w/DPH & ASA;recovered
Patient not experiencing any side effects; patient receivedan expired dose of VARIVAX; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 27-OCT-2020, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) dose reported as 1 injection, lot # R022116, expiration date 02-AUG-2020 (dose number and route of administration were not reported) for prophylaxis. The patient was not experiencing any side effects.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M008551 and expiration date: 02-JUN-2018; (route, therapy type and dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
The twin boys are now 18 years old and did not complete the series.; No additional AE reported; This spontaneous report was received from a registered nurse, referring to a 18-year-old male patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.   In September 2018, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), as prophylaxis (formulation, strength, route of vaccination, anatomical site of vaccination, lot number and expiration date were not reported).   At the reporting time, the patient was 18-year-old, and he did not received yet the second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No additional adverse event were reported.   This is one of several reports received from the same reporter.
SIDS death 9-28-09 - went to hospital. 12/4/09 Autopsy report received. DOD 9/28/09. Final Cause of Death: Sudden unexpected death of a neonate while bed-sharing with adults. Additional information abstracted: History that decedent was placed on bed for sleep between his father and mother. That mother found decendent unresponsive when she awoke and that neither parent was covering the decedent. That cardiopulmonary resusitation was performed by parents and EMS. No lethal traumatic injuries. No evidence of a lethal natural disease process. Body weight 10-25th percentile for age; body length 25-50th percentile for age. Organ weights consistent with 3-week-old neonate. No history of medical conditions.