chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site warmth; vaccination site discoloration; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE DISCOLOURATION (vaccination site discoloration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE DISCOLOURATION (vaccination site discoloration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE DISCOLOURATION (vaccination site discoloration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.            Concomitant information use was not reported.  Treatment information was not provided.
This spontaneous prospective pregnancy report as received from a licensed practical nurse refers to a 17 year old female patient with adolescent depression. None drug reactions or allergies were reported. On 25-JUN-2014 the patient was vaccinated with GARDASIL lot # J013324, dose 1, expiration date 12-FEB-2016, 0.5 ml and lot # J009243, dose 2, expiration date 23-APR-2016, 0.5 ml, intramuscular for vaccination (strength and anatomical location were unspecified). Concomitant therapies included iron (unspecified), minerals (unspecified), vitamins (unspecified) (reported as PRENATAL VITAMINS). The patient became pregnant with last menstrual period of 26-JUN-2014 and estimated delivery date of 02-APR-2015. Initial exposure to GARDASIL was at 4 weeks. The pregnancy outcome was pending. On 28-JUL-2104, the patient experienced patient who has received 1 doses of GARDASIL while pregnant (reported as the patient who has received 2 doses of GARDASIL is pregnant). Urine pregnancy test was performed at physician's office (positive). The outcome of the event was unknown. Additional information has been requested.
fever; joint pain; back pain; leg pain; shortness of breath; This case was reported by a consumer and described the occurrence of fever in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (1st dose received on 9th January 2019).   On 29th April 2019, the patient received the 2nd dose of Shingrix. On 2nd May 2019, 3 days after receiving Shingrix, the patient experienced fever, joint pain, back pain, leg pain and shortness of breath. The patient was treated with ibuprofen, paracetamol (Acetaminophen), diazepam, cyclobenzaprine hydrochloride (Cyclobenzaprine Hcl Oral Tablet), methocarbamol and naproxen. On an unknown date, the outcome of the fever, joint pain and shortness of breath were unknown and the outcome of the back pain and leg pain were not recovered/not resolved.   It was unknown if the reporter considered the fever, joint pain, back pain, leg pain and shortness of breath to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but the patient could be 73 or 74 years old. On 10th May 2019, the patient visited the physician had blood test and Electrocardiogram done, the patient was prescribed with Ibuprofen 600mg and Acetaminophen 500mg and Cyclobenzaprine HCl. On 15th May 2019, the patient went to emergency department in hospital had blood test and X-ray. The patient was told not to take Cyclobenzaprine HCI and was put on Methocarbamol 750 mg and Diazepam 2mg. The patient still had back pain and leg pain. On 17th May 2019, informed patient  that he should go to the emergency room at clinic. The patient informed that he would not obtain ride on that day. On 18th May 2019, The patient was driven to emergency room and had blood test and informed that emergency room that hospital told him that he should not obtain a MRI of spine. The did not do that nor did they admitted him over night for observation but put him on Naproxen 375mg and Diazepam 2mg.
Client had 1 dose of covid 19 vaccine, client died-due to complications of covid-19
pt states that about a week after getting the covid vax that she has developed severe pain from the upper part of her right hip down to her knee.  Pt had an appt w/ Dr. on 2/25/2021 regarding her symptoms.  She was prescribed tramadol HCL 50mg and methylprednisolone 4mg.  Pt states she is going to have to contact her doctor since this medicine is not working and she is still in severe pain.  She has been off from work for a week but had to go back and states it is very difficult since she cant hardly get up and down.
Case number PHEH2014US004270 is an initial spontaneous report received from a pharmacist on 27 FEB 2014. This report refers to a 9-year-old male patient who was inadvertently vaccinated with FLUCELVAX (batch number: 01003A and expiry date: JUN 2014) intramuscularly at a dose of 0.5 ml on 02 JAN 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 27 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
slight fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever after second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (slight fever after second dose). At the time of the report, PYREXIA (slight fever after second dose) outcome was unknown. Not Provided          No concomitant and treatment  medications were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-078079 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078079:1st dose event
Started out feeling extremely dizzy. Then I started feeling shaky. 5 mins later my body went into extreme uncontrollable jerking. I was accessed by paramedics and they were un able to help control the jerking and I was in a confused state unable to give them my birthdate, name the current president or how many quarters in a dollar. At the hospital I was given iv fluids and benadryl and haldol to control the jerking and this helped.
This is a 61 year old female, with history of hypertension, who presents to the ED via EMS for evaluation of cardiac arrest prior to arrival. Patient's husband came from anouther [sic] room and found patient take a big gasp then suddenly became unresponsive. EMS gave patient a total of 4 rounds of Epi, 1 Narcan, and 2 shocks en route. EMS reports with glucose level of 92. Unknown if patient is on any anticoagulation.  Patient presents in asystole. Epi and bicarb given. Compressions performed. Lungs equal with bagging. Bedside US performed which did not reveal any meaningful cardiac activity. Code called. Discussed with family, they state she had been having some cardiac issues and her daughter died of cardiac problems in her 30s.
I woke up achy, scratchy throat, congestion, and fatigue. I tested positive for COVID-19 at home. I talked to my doctor, and they prescribed me PAXLOVID. In hours I started to feel better. It took me 16 days to test negative.
My son is fully vaccinated and has never had an adverse reaction to vaccines before. After having the GARDASIL vaccine, he reported feelings of dizziness, foggy brain, nausea, and vision problems. We had the family vision tested prior to this vaccine and he tested 20/20 in August. We had his vision retested after his complaints and he now tests at 20/80, 2 months later after receiving GARDASIL vaccine.
Reportedly on March 26, 2000 the pt experienced swelling and pain of the deltoid. On March 27, 2000 more swelling with redness to arm.
Severe back pain.  To the point of not being able to perform daily activities.  Kept getting worse. Then waves of nausea and vomiting. CT scans show swollen lymph nodes.
no adverse event; was administered PROQUAD./ was administered VARIVAX; was reconstituted with saline diluent; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medication or medical history.     On 01-OCT-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S005079 with expiration date on 19-FEB-2019 for prophylaxis (dose and route of administration were not reported) that was reconstituted on a sterile diluent(MERCK STERILE DILUENT) and during the same office visit, the patient was also administered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (dose, route of administration, lot number and expiration date were not reported), which was reconstituted with a saline diluent (manufacturer unknown). However, no adverse effects were reported.
TIRED; DID NOT FEEL HUNGRY/APPETITE SUPPRESSION; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes type 2, osteoarthritis, and clogged arteries, and other pre-existing medical conditions included: Patient had no fever, no diarrhea and no stomach pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced did not feel hungry/appetite suppression. On 08-APR-2021, the patient experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, and Body temperature (NR: not provided) under 98 and normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel hungry/appetite suppression, and tired. This report was non-serious.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients who an unspecified dates were vaccinated with improperly stored doses of GARDASIL (doses, routes and lot numbers not provided). It was reported that the vaccines were exposed to 26.8 F over the days in August 2012. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Date place in refrigerator was 27-Sep-2021 and administered on 03-Nov-2021; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 27-Sep-2021 and administered on 03-Nov-2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date place in refrigerator was 27-Sep-2021 and administered on 03-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Date place in refrigerator was 27-Sep-2021 and administered on 03-Nov-2021) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Reporter stated that vaccine did not undergone any temperature excursion and date placed in refrigerator was on 27-Sep-2021. Also stated that no adverse events were reported for patient. No treatment information was reported.
Reaction at Varivax site.  Area is warm & erythematous with swelling & induration.  Erythema measured at 2 3/4 inches and induration measured at 2 inches.  Instructed to give Benadryl for swelling and itch. Also apply cool compresses.  Call if area enlarges.
I was so sick after all my shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "I was so sick after all my shots".  Additional information: Another shot. Not sure she can do it. She was so sick after all her shots. Reporter (patient) considered event caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age of patient was looked at wrong in (charting system), and gave what was appropriate for a 13 y/o (age thought patient was) instead of a 7 year old.  HPV vaccine given on 9/20/23 at approximately 1710 to right deltoid. Parent of child was called the morning of 9/21/23 (once had interpreter available) and mom states child is doing well and has had no reactions.
itchy from elbow to shoulder; little bumps from elbow to shoulder; Swollen from elbow to shoulder; Red from elbow to shoulder; Rash from elbow to shoulder; Sore arm, same arm as injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy from elbow to shoulder), INDURATION (little bumps from elbow to shoulder), SWELLING (Swollen from elbow to shoulder), ERYTHEMA (Red from elbow to shoulder) and RASH (Rash from elbow to shoulder) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm, same arm as injection). On 11-Mar-2021, the patient experienced PRURITUS (itchy from elbow to shoulder), INDURATION (little bumps from elbow to shoulder), SWELLING (Swollen from elbow to shoulder), ERYTHEMA (Red from elbow to shoulder) and RASH (Rash from elbow to shoulder). On 06-Mar-2021, VACCINATION SITE PAIN (Sore arm, same arm as injection) had resolved. At the time of the report, PRURITUS (itchy from elbow to shoulder), INDURATION (little bumps from elbow to shoulder), SWELLING (Swollen from elbow to shoulder), ERYTHEMA (Red from elbow to shoulder) and RASH (Rash from elbow to shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Vaccine given 9/29/10. Skin rash at site at injection also rash on face, side. Dr. seen 10/5/10. Gave BENADRYL orally. 10/6/10, patient getting better.
Next day legs "felt wobbly" and SOB upon activity. Felt burning in chest within the next few days which is still experienced- worsened when fatigued. SOB continues with activity as well. Continues to feel fatigued with no activity. Has reported to HCP and is undergoing testing. Patient also had developed cellulitis in her right foot without any previous injury in the end of May. Has had increased episodes of atrial fibrillation- last episode had been in August of 2020, now under control.   Currently still experiencing SOB, fatigue and burning sensation in chest.
About two months after receiving my third dose of the Pfizer vaccine, I started to experience a nosebleed. I was trying to pinch my nose, but it kept flowing. I was using a paper towel to try and cover my nose, but I was bleeding so much that it was dripping like a faucet. After a little while, the dripping blood started to clot, and it was they were the size of quarters. I was able to call 9-1-1 and the EMT's came also. While in the back of the ambulance, the blood was still clotting, but a clot the size of the palm of my hand, came out of my nose. I went to the emergency room, and they were not able to find anything wrong with me after all of the scans and tests that were performed. The bleeding finally stopped and I went home. A few days later, I was driving and my nose started to bleed again. The blood was dripping down my face and I went to back to the emergency room. While there, they performed more tests, but they still were not able to find anything wrong. A few months later, I noticed that I was starting to have scabs on my arms. I went to my PCP and he wasn't able to tell me what it was. Eventually, I was told that it was Staph infection. They looked like shingle spots to me, but they had whiteheads on them. I am still fighting this infection and it has been almost a year.
Swollen lymph on his neck; a big one and now it is the small one coming out; This is a spontaneous report from a contactable consumer. This consumer reported for a 13-year-old male patient (Reporter's son). The male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0181/Batch number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0181/Batch number was not reported), dose 1 via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for covid-19 immunisation. On an unspecified date in 2021, the consumer reported that, the patient experienced swollen lymph on his neck; a big one and now it is the small one coming out. The reporter states that it is a lymph node on her son's neck and that it is painless but it sticks and it's not getting better. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 2 year old male with a history of eczema who "one year ago" in approximately 2008 was vaccinated with a dose of VARIVAX (Merck) (lot # not reported).  Concomitant therapy included unspecified topical skin cream.  "Recently" in approximately June 2009, the patient came down with a case of shingles.  The patient had a titer test for varicella and result was unknown.  The patient sought unspecified medical attention.  At the time of report, the patient's outcome was unknown.  No further information is available.
Developed hives on arms, back, legs and  rash over trunk and upper thighs 5 days post vaccine/2nd dose.
Patient called pharmacy on 6/16/22 to report that she developed a headache and swelling in her feet after receiving vaccine on 6/11/22. Swelling has gone down slightly. Patient was advised to inform her PCP right away for further evaluation.
At 1330, patient reported numbness in left arm to lead nurse. Patient denied pain, itchiness, rashes, hives, and difficulty breathing/swallowing. EMT assessed vitals: blood pressure 118/90 mmHg, heart rate 73 beats/minute, SpO2 98%. Patient reported no current medications and no known allergies. Patient advised to wait for further observation. Patient given water. Patient reassessed at 1355. Patient vitals were blood pressure 120/85 mmHg, heart rate 75 beats/minute, and SpO2 98%. Patient reported symptoms subsided. Lead nurse educated patient on signs/symptoms of when to seek emergency care, how to sign up on v-safe, and to follow up with primary care provider regarding her reaction. At 1400, patient left facility with boyfriend. Patient had unlabored respirations and steady gait.
Daughter in law got   moderna shots in april. they now hav e been told they have the covid virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Daughter in law got   moderna shots in april. they now hav e been told they have the covid virus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 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 COVID-19 (Daughter in law got   moderna shots in april. they now hav e been told they have the covid virus). At the time of the report, COVID-19 (Daughter in law got   moderna shots in april. they now hav e been told they have the covid virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications details were provided. No Treatment Medications details were provided.   Reporter did not allow further contact
17year old patient received the vaccine in the right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the right arm) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the right arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the right arm) outcome was unknown.        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 events was not applicable.  No concomitant medication reported  No treatment information was provided
This spontaneous report as received from a patient's mother refers to her son of unknown age. In August 2012 the patient was vaccinated with his first dose of GARDASIL (exact date unspecified) (dose, route and lot number not provided) and did not receive his second dose until 02-AUG-2013. There were no adverse effects reported. Additional information is not expected.
Developed erythema multiforme - started out on 12/4/06 looking like hives but on 12/5/06 looked more like erythema multiforme.  Also had PE tubes placed on 12/1/06 and given Floxin drops.  Also received flu vaccine on 11/29/06.
Transient global amnesia. Occurred four days after shot. Lasted approximately 8 hours, recovered completely.