chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness; Received an expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 017F21A, 011M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On an unknown date, the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness) and EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient did not tested positive for Covid-19 and did not received any other vaccine within 1 month prior to Moderna Covid-19 vaccine. He has no chronic illnesses. He has no symptoms besides soreness.
Fever: 101.8. Redness, swelling, induration to injection sites (right deltoid, left arm). TX: Per mother prescribed antibiotics.
Mom called 5-1-17 to report macular rash on cheeks, trunk, arms and legs. Mom state no fever or signs of illness other than rash. Mom states no itching or scratching by child, and she believes rash is fading.
Felt tired, slept all day. Have a few blisters that look like shingles. Arm is sore. Nerve pain in arm.
following booster:  3 days of high fever: 103 degree temp body aches all over fatigue, lethargy unable to get out of bed d/t s/s x72 hours
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 11:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 11:20 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 74.08 for dose administered on 24-May-2021.  No concomitant medications were reported.  Batch number 026C21A underwent temperature excursion on 24-May-2021 with temperature 35 degrees Fahrenheit from 08:00 AM to 10:00 AM. This vial was moved to fridge on 18-May-2021 and beyond use date for the vial was reported as 17-Jun-2021. Product moved to clinic on 24-May-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Vaccine injection site on leg had Swelling 4 inches x 4 inches,  redness 6 inches x 6 inches, warm and tender to the touch.
tinnitus/hearing piercing whistling sound.; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (tinnitus/hearing piercing whistling sound.) 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 dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus/hearing piercing whistling sound.). At the time of the report, TINNITUS (tinnitus/hearing piercing whistling sound.) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   A doctor suffers Tinnitus that almost made him crash his car while driving home from getting the covid jab that he believes it could be a new side effect.   No concomitant medication were reported.  No treatment medication were reported.
bumps; hives; Pain at injection site; itchy hips; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (bumps), URTICARIA (hives), PRURITUS (itchy hips) and VACCINATION SITE PAIN (Pain at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PRURITUS (itchy hips). On an unknown date, the patient experienced SWELLING (bumps), URTICARIA (hives) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, SWELLING (bumps), URTICARIA (hives), PRURITUS (itchy hips) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Benadryl.   This case was linked to US-MODERNATX, INC.-MOD-2021-077991 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077991:crosslinked case.
Mom noted red lump at injection site on upper right leg this morning. Called at 250 PM this afternoon to report area has swollen to 4" x 5", is hot and painful. X 12.5mg Benadryl orally evening 4-6 hour (4 doses a day for 2-3 days).
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Severe, Systemic: Seizure-Severe, Additional Details: pt had a series of seizures (3+ as montiored by a np), low bp and confusion. was taken to hospital
06/2021- Started monitoring blood sugar level due to every 3 month lab work; 09/2021- Diagnosed as a diabetic.
Tender lymph node in left armpit; Uncomfortable; Disturb sleep; Swollen lymph node in left armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the arm left on 12May2021 at 13:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer (left breast) from 24 years, diverticulosis, IBS (irritable bowel syndrome), SIBO (small intestinal bacterial overgrowth), malabsorption, osteoporosis, kidney stones, sulfonamide allergy and allergy to GI-intolerant of garlic, onions, cruciferous veg's. Concomitant medications included VITAMIN D3 and vitamin k (MANUFACTURER UNKNOWN) started from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the arm left on 23Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. 30 hours post the injection, on 13May2021 at 19:00, the patient began with swollen, tender lymph node in left armpit, uncomfortable enough to disturb sleep that night. The patient was a breast cancer survivor (24 yrs). Cancer was also in left breast. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tender lymph node in left armpit, uncomfortable, disturb sleep and swollen lymph node in left armpit was not resolved and at 72 hours there was no change yet.   No follow-up attempts are possible. No further information is expected.
PATIENT IS 12 YEARS  OLD AND RECEIVED THE VACCINE MEANT FOR 5-11YEAR OLDS
Patient with history of 3 COVID vaccines who was found to be COVID detected during stay.  "62 year old male s/p traumatic fall from second story roof (~12 feet) onto his face. The patient presented via ambulance with GCS 6; intubated in ED for airway protection.  Incidentally found to be COVID positive. Noted injuries below. Patient was extubated on hospital day three (12/7). He was diagnosed with pulmonary embolism in the right upper lobe on hospital day 5. Given his head bleeds. Neurosurgery recommended continuing heparin SQ BID until stable head CT on 12/15. The patient was then transitioned to xarelto and a repeat head CT showed head bleeds to remain stable. During the patient's stay, he developed symptomatic junctional bradycardia. A temporary pacemaker was placed and eventually removed. The patient also developed atrial fibrillation with RVR and was placed on lopressor and propafenone. During the patient's stay he did have hypokalemia. This resolved after transitioning from chlorthalidone to spironolactone. The patient eventually was discharged in stable condition. The patient was discharged with 30 days total of xarelto; xarelto 15mg BID x 21 days total followed by xarelto 20mg QD.  He was also discharged with Rythmol x 14 days and spironolactone x 14 days. He will follow up Cardiology, as well as with his PCP for management of his medications. "
96 y.o. female with history of atrial fibrillation, CHF with preserved EF, type 2 diabetes mellitus, hypothyroidism, hypertension, hearing impairment, CKD stage IIIB who was brought to ER on 08/24/21 with c/o SOB, cough and congestion, low oxygen level after she tested positive for Covid 19 the same day. Chest x-ray showed findings consistent with pneumonia. Patient was also found to be in AFib with RVR which improved with Lopressor given in ER. Patient was admitted to hospitalist service and placed on IV antibiotics along with symptomatic treatment. Steroids were also added. Patient was seen by infectious disease consultant Dr. who started patient on REmdesivir due to hypoxemia.  Patient's respiratory status decline to a point where she needed BiPAP but she was not tolerating it. Patient's daughters requested the hospitalist to keep the patient comfortable and not place patient on BiPAP. Patient was then switched to high-flow nasal cannula. Family later decided to pursue hospice. Before they could meet with the case manager and hospice staff, patient passed away.
Swollen face Rash on ENTIRE body Uncontrollable itchiness  to a point that I am bleeding from scratching  Benadryl is not working for itchy ness  Loss of appetite Insomnia  Increased heart rate Chills  Body chills and perfuse body sweating
Severe Headache Major Tinnitus Head/Ear Pressure Systemic Inflammtion Vertigo Chills/Aches Rash Fever Vestibular Issues Shortness of Breath Cognition problems Neuropathy
Client had syncope after receiving vaccine.  She lost consciousness for 2 seconds, skin pale, dizzy, and diaphoretic.
48 hrs post vax mom reported redness, swelling & warmth @ inject site of lt upper arm extending to below elbow area; swelling & redness less apparent on 4th day;
THE DAY AFTER VACCINATION, PATIENT HAD BURING SENSATION AND PAIN IN BILATERAL LOWER EXTREMITIES.  REFERRED TO ER.  ULTASOUND SHOWED NO EVIDENCE OF CLOTS
This case involves an unknown age and unknown gender patient who got so sick, patient could not even describe how he/she felt while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided. In 1990, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination. On an unknown date the patient developed a non-serious event "got so sick, patient could not even describe how he/she felt" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that "I had never taken a flu shot until 1990 and my fiancé who was 16 years older than me convinced me to take one when he got his. I got so sick I could not even describe how I felt. He became paralyzed from Guillian Barre Syndrome. President halted flu shots after so many people got GBS, so we assumed that had been dealt with. Apparently not. A couple years ago my doctor asked me if I wanted a flu shot. I told him why I did not. He told me that he had a friend who was in critical condition with GBS after flu shot. My D-I-L (daughter in law) worked as a nurse and gave the doctor she worked for a fu shot. She was so upset when she saw how he deteriorated with GBS that she stopped being a nurse. We just never know. I have not had cold, flu or a kind of stomach virus in at least 30 years, either. But I do stay home most of the time during flu season. Am VERY CAREFUL to wash my hands right after I do grocery shopping once a month, and wash them again after I put things away that other people had touched." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got so sick, patient could not even describe how he/she felt). At time of reporting, the outcome was Unknown for the event got so sick, patient could not even describe how he/she felt.
Information has been received from a consumer concerning an unknown number of child patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history, On an unknown date, the patients were vaccinated with a dose of an unidentified Merck Human Papillomavirus (HPV) vaccine (dose number, dose, route of administration anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-MAR-2017, the reporter stated that she had spoken with other people who said that their child had had seizures (convulsion in childhood) since receiving the unidentified Merck Human Papillomavirus (HPV) vaccine. The outcome of the patients and the relatedness between the seizures and the therapy with the unidentified Merck Human Papillomavirus (HPV) vaccine was not provided. Upon internal review, the convulsion in childhood was considered as medically significant event. This is one of three reports received from the same reporter. Additional information is not expected since the reporter did not want to provide any more information. Sender's Comments: US-009507513-1703USA003781: US-009507513-1703USA004620.
Face is numb; Tongue and mouth on fire; Ringing in ears; Numbness has spread to feet and arms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Face is numb), ORAL DISCOMFORT (Tongue and mouth on fire), TINNITUS (Ringing in ears), HYPOAESTHESIA (Numbness has spread to feet and arms) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Face is numb), ORAL DISCOMFORT (Tongue and mouth on fire), TINNITUS (Ringing in ears), HYPOAESTHESIA (Numbness has spread to feet and arms) and PYREXIA (Fever). The patient was treated with AMITRIPTYLINE for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, HYPOAESTHESIA (Face is numb), ORAL DISCOMFORT (Tongue and mouth on fire), TINNITUS (Ringing in ears), HYPOAESTHESIA (Numbness has spread to feet and arms) and PYREXIA (Fever) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.
My first shot back in August my arm swelled and hurt. This time with the second shot my arm swelled, injection site redness that is continuing to spread and pain.
Patient presented to the ED and was subsequently hospitalized on 3/8/21 within 6 weeks of receiving COVID vaccination.
Running a fever; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer or other non health professional. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0217, Pfizer NTEC), via an unspecified route of administration on 14Jun2021 as 2nd dose, single for covid-19 immunization (at the age of 56-years-old). He was not having medical conditions but every now and then he takes something like for his gas. The patient's concomitant medications were not reported. The patient did not receive any other prior vaccinations. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EW0187, Pfizer NTEC), via an unspecified route of administration on 17May2021 as 1st dose, single for covid-19 immunization The reporter stated this was the second dose, the first dose, he did not get sick. On 15Jun2021 10:00 patient was not feeling well, nausea, patient wife took his temperature he was running a fever and so he was having like chills and muscle pain and joint pain. The reporter seriousness for the events was unspecified. It was further stated that, he took some Tylenol at work that morning, two Tylenol, he only had two dosage, he got some Tylenol at work and he haven't had any since then. The pharmacy said that continue taking Tylenol and liquids and fluids. The clinical outcome for the events was unknown.
Body itching; Rash all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Body itching) and RASH (Rash all over the body) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (Body itching) and RASH (Rash all over the body). At the time of the report, PRURITUS (Body itching) and RASH (Rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included steroid pills.   Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No new information added
pt recv vax; 2-3 wk later had 2 sz w/ t of 104;seen by ped neurologist w/ EEG; febrile sz;
Didn't get the Shingix shot 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had severe shingles outbreak 5 years ago before reporting (could not walk)). Previously administered products included Shingrix (1st dose received in November 2020) and COVID-19 vaccine (unspecified Covid shots, received months after the 1st dose of Shingrix).   On an unknown date, the patient received 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had yet to receive 2nd dose of Shingrix and was outside of the 6-month dosing window. The patient mentioned that the reason she did not get the Shingrix shot 2 was because she was instead getting the Covid shots and did not want to get both. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not want to answer any further questions. The reporter provided limited information.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On an unknown date the patients were vaccinated with PROQUAD (Merck) (lot # L019996, expiry date: 02-DEC-2016; lot # L011079, expiry date: 01-OCT-2016) (dosage, strength and route were not reported), that were improperly stored. No adverse effects were reported. This is one of several report from the same reporter. Additional information has been requested.
Having covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Having covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Having covid). At the time of the report, COVID-19 (Having covid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a patient  of unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), after receiving second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report  No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact; Sender's Comments: Company comment: This is a spontaneous case concerning a patient  of unknown age and gender with no reported medical history, who experienced the non-serious unexpected event COVID-19 (AESI), after receiving second dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report