chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense joint pain in both hips (right one worse); Pain in the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site), PYREXIA (Fever) and ARTHRALGIA (Intense joint pain in both hips (right one worse)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection site) and PYREXIA (Fever). On 02-Mar-2021, the patient experienced ARTHRALGIA (Intense joint pain in both hips (right one worse)). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site) outcome was unknown and PYREXIA (Fever) and ARTHRALGIA (Intense joint pain in both hips (right one worse)) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020412 (Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow Up  received on 14-JUN-2021 contains Reporter Phone Number,Updated outcome of the Events Pyrexia, Arthralgia to Not Recovered/Not Resolved
Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with PNEUMOVAX 23 (Lot# 667095/1150Z, expiration date on 4-MAR-2012). Subsequently the patient experienced cellulitis and fever after administration of PNEUMOVAX 23. The patient was treated with antibiotics. She did not have the patient's chart so she could not provide patient specific information. She was requesting a lot check. A lot check has been initiated. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, date of vaccination, date of event, recovery status. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender.     On an multiple unspecified dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # L030865, expiration date was not reported) (dosage and route of administration were not reported) for prophylaxis. The temperature excursion, time frame and the temperatures were not reported. No adverse effects was reported. This is one of several reports from the same reporter.       Additional information has been requested.; Sender's Comments:  US-009507513-1704USA008959:
This case was reported by a consumer via call center representative and described the occurrence of tendinopathy in a 79-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 18th November 2018, 223 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced tendinopathy. On an unknown date, the patient experienced arm discomfort and product supply issue. On an unknown date, the outcome of the tendinopathy and arm discomfort were not recovered/not resolved and the outcome of the product supply issue was unknown. The reporter considered the tendinopathy and arm discomfort to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient reported that she received the SHINGRIX vaccine on right arm. The patient has been unable to secure the 2nd dose due to availability issues. Less than a year after receiving SHINGRIX, the patient also reported that she has been having difficulties with her right arm and later, she was diagnosed with Tendinopathy of the right rotary cup. The patient believed that this issue started the last couple of weeksbefore reporting. The patient believed that the issue was totally unrelated to the SHINGRIX vaccine, although she did get her 1st dose in her right arm she thought. The reporter gave consent to follow up. The patient was sorry that, she could not receive SHINGRIX which she need. The patient had the 1st shot in April, and unfortunately has been trying since August to get a 2nd shot, and it has been unavailable, so she thought this time she would call to find out if some way she could get it. And she sated that, she could not make one available, but she certainly was helpful.
Expired vaccine was stored and then administered; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) in a 56-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 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that vaccine did not undergo any temperature excursion and patient did not experienced any adverse event and the date vaccine placed in refrigerator was on 26-Oct-2021.
ache in hamstrings, later in upper back; shaking for a short time after awakening.  Slight temp:  100-101.  Teeth felt sensitive (I ate only an orange, grapes and an apple on Saturday).  This lasted from Friday through Sunday.  Monday I felt wonderful.
DOSING ERROR:  0.5 ml was given instead of 0.25  no adverse reaction
Pt did well before and after vaccination.  A few minutes later in the waiting area he started feeling ill and his mom had him sit down and she called 911.  He complained of weakness, diminished sight and hearing and lightheadedness.  He was very pale and sweaty.  With his mom's permission I activated an ammonia inhalant near his nose.  He said he felt better after the 2nd sniff.  After a couple minutes he said his symptoms were greatly diminished and he was ok.  The paramedics arrived and pt was able to walk to the ambulance for further evaluation.  A paramedic came back and said the patient is feeling much better and declined to go to the hospital.  I talked to the mom a couple hours later and she said he is all better.
Slight swelling at site of injection within a few days after shot, never went down. No pain. As months went by, arm still seemed slightly swollen and pain began at site extending to shoulder and restricting motion.  Doctor said a hematoma had developed and sent me to PT
Received dose 1 about 2 or more years ago, and has yet to receive dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date about 2 or more years ago).   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 age at vaccination was not applicable for this report. Patient received first dose of Shingrix. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Received an expired first dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired first dose of the Moderna COVID-19 vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired first dose of the Moderna COVID-19 vaccine). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired first dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.
Patient reported severe pain (burning sensation) from her neck to her right arm. The pain started at night around 9pm and continue through at the time of report. Patient has trouble raising arm due to pain. She stated her fingers are swollen and part of her arm feels swollen too. Patient was advised to go visit her primary doctor to evaluate her symptoms immediately. Patient said she might have trouble getting an appointment with her primary, therefore she will go to the emergency room to get evaluated.
Immediately itchy when dose was being administered and that night. Have had arm pain at the injection site since that evening. Today left upper arm feels hot and has a large red rash around the injection site.
Crying inconsolably 6pm - 11pm. Only stopped for breath & for 20 minutes at 9pm (during bath) & again at 10pm (during bath). Mother request VAERS documentation.
During Cross Country Race on October 2nd, Pt's heart began to race and skip to the point where he complained of chest pain and had to drop out of the race . He was taken to the the local ED. Subsequently he was referred on to Pediatric Cardiologist for a Holter Monitor on October 5th and follow up on October 11th. Resting and Activity Heartrate was  way too high. Dr  ordered thyroid test which revealed Elevated Thyroid Levels suggesting Graves Disease. Dr  placed Pt on a Beta Blocker. Second Dr  ordered additional Thyroid tests including Nuclear Medicine Thyroid uptake scan and referred pt on to a third dr the Endocrinologist.  third Dr confirmed Graves Disease at appointment on November 4th. Pt is now starting to take medication for hyperthyroid/Graves Disease. At this point in time he still has elevated heart rate and is limited in his ability to participate in sports.
Cancer of colon; Hard of hearing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER (Cancer of colon) and HYPOACUSIS (Hard of hearing) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 1013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLON CANCER (Cancer of colon) (seriousness criteria hospitalization and medically significant) and HYPOACUSIS (Hard of hearing) (seriousness criterion hospitalization). The patient was treated with Surgery (40% of colon removed.) for Colon cancer. At the time of the report, COLON CANCER (Cancer of colon) and HYPOACUSIS (Hard of hearing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: found a mass that looks suspicious (abnormal) found a mass that looks suspicious.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient was scheduled for a booster shot. patient was finished 8th round of chemotherapy out of 8 and that he was immunocompromised. Patient stated he had no side effects from either dose.  Patient had surgery and 40% of his colon removed, patient also was on chemotherapy.  This case concerns a  72-year-old, male patient with no relevant medical history, who experienced the unexpected event Colon cancer. The event occurred after the second dose of Spikevax but the exact date was not reported. The rechallenge was negative. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a  72-year-old, male patient with no relevant medical history, who experienced the unexpected event Colon cancer. The event occurred after the second dose of Spikevax but the exact date was not reported. The rechallenge was negative. The benefit-risk relationship of Spikevax in not affected by this report.
10/09/2019-Patient presented to PCPs office with chief complaint of watery eyes, runny nose, cough, and SOB. Generalized weakness worsening and appetite continues to decline. Memory continues to decline, Itching in hands. Spontaneous bruising. Treatment-Add Megace for appetite, Hold Coumadin and recheck Friday, Increase Ensure to 3 times daily as tolerated, Eat greens today
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old patient who received Shingrix for prophylaxis. On 2nd August 2018, the patient received Shingrix. On 3rd August 2018, 1 days after receiving Shingrix, the patient experienced pain in arm. On 4th August 2018, the patient experienced injection site warmth and erythema of extremities. On an unknown date, the outcome of the pain in arm, injection site warmth and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm, injection site warmth and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right arm. One day after receiving Shingrix, the patient experienced a sore arm. Two days after receiving Shingrix, the patient experienced redness and an injection site that was hot to the touch. On the day after that, the redness increased to a size described as about 5 by 3 inches in size. At the time of report, all symptoms were resolved.
large bruises on the right tight; little blurred vision; feel a little bit loopy, not a totally dizzy but loopy.; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (large bruises on the right tight), VISION BLURRED (little blurred vision) and DIZZINESS (feel a little bit loopy, not a totally dizzy but loopy.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL (CARDINAL), LISINOPRIL and DOPAMINE for an unknown indication.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (large bruises on the right tight), VISION BLURRED (little blurred vision) and DIZZINESS (feel a little bit loopy, not a totally dizzy but loopy.). At the time of the report, CONTUSION (large bruises on the right tight), VISION BLURRED (little blurred vision) and DIZZINESS (feel a little bit loopy, not a totally dizzy but loopy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Fever, chills, body aches, lesion on left chin, nausea, itching upper back (no lesions). 3/6/13 noon - report to clinic with above s/s went home. 3/6/13 saw MD - RTW 3/11/13 ? steroid shot.
Pt received Rotavirus in error on 2/13/2008 @ 12 mos of age.
Swelling; Redness; Severe dizziness 2 days after, slight dizziness 3rd day; Administration date 15Oct2021, dose number=3; This is a spontaneous report from a contactable nurse, the patient. A 65-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 15Oct2021 at 14:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the right arm on 30Dec2020 (at the age of 64-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 22Jan2021 at 08:45 (at the age of 64-years-old) both as a single dose for COVID-19 immunisation. On 15Oct2021 at 14:45, the patient had "administration date 15Oct2021, dose number=3". On 16Oct2021, the patient experienced swelling, redness and severe dizziness 2 days after, slight dizziness 3rd day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events swelling, redness and severe dizziness 2 days after, slight dizziness 3rd day. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling, redness and dizziness was not resolved. The clinical outcome of the event "administration date 15Oct2021, dose number=3" was unknown at the time of this report.
Mild arm pain at injection site; This is a spontaneous report from a non-contactable pharmacist, the patient. An Adult non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. On 02Apr2021, the patient experienced mild arm pain at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event mild arm pain at injection site was resolved in April2021.  No follow-up attempts are possible. No further information is expected.
Tested positive for Covid 19 after receiving the Covid 19 vaccine; Tested positive for Covid 19 after receiving the Covid 19 vaccine; This is a spontaneous report from a non-contactable pharmacist (reported for his wife). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 (Lot number and Expiry date was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID-19 after receiving the COVID-19 vaccine. She was supposed to receive her second COVID-19 vaccine on 30Mar2021 but could not because she acquired the COVID-19 virus after the first dose. The caller wants to know when his wife can receive her second COVID-19 vaccine. The patient got cleared 2 days ago. The pharmacist was getting different information on the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
pt devel a rash all over body w/in hrs of obtaining vax; pt also felt general malaise & fever x 24-48 hrs;
Patient. Received her Pfizer COVID booster dose  (LOT#: FK9896) at 1611 on 1/24/22. Patient alerted  EMT and states she felt her mouth was dry and felt like her tongue was swelling. Patient was moved to the anti gravity chair. EMT took patients vital signs at 1631. BP: 120/70, HR: 121, O2: 100% RR: 20. RN did not see any swelling on patients tongue, throat, or lips. Patients sister stated that the same reaction happened with the patients first dose. Patient stated that she suffers from anxiety attacks and felt like she was going through one, just like her first dose reaction. Patient was moved to a different room where it was quieter. Patient was coached by her sister with breathing. Patient practiced some of her coping mechanisms. EMT retook patients vital signs at 1642. BP: 124/78, HR: 88, O2: 100%, RR: 18. Patient was given a water. Patient drank water without any difficulty. EMT retook patients vital signs at 1653. BP: 124/76, HR: 94, O2: 100%. Patient stated that it would be best for her to go home and practice her coping mechanisms. RN educated patient on adverse reactions of COVID vaccine and when to seek EMS. Patient verbalized understanding. Patient completed her 30 minutes of observation. Patient left with her sister unassisted and with a steady gait at 1700.