chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a Solicited report from a Non-interventional (FACILITATED COLLECT) received from a contactable consumer  based on the information received by Pfizer manufacture number (21K-163-4121505-00).   A 81-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose  for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg,1 in 7 D for Crohn's disease  .  The patient medical history and concomitant medications were not reported.  The patient experienced covid-19 (drug ineffective) (death, medically significant) on an unspecified date.  The action taken in response to the event(s)  for adalimumab was unknown.  The patient died on an unspecified date.  It was not reported if an autopsy was performed.  On an unknown date, the patient experienced COVID-19. On unknown date, the patient died. The cause of death was reported as COVID-19. It is unknown if an autopsy was performed. PFIZER BIONTECH COVID-19 VAC-CINE (TOZINAMERAN) was also considered suspect.  The patients caregiver reported that patient died of covid-19.  The reporter assessed the causality between the reported event and the suspect vaccine (BNT162B2) as possible.  The reporter assessed the causality between the reported event and Humira as reasonably possible.  The lot number for vaccine [BNT162B2], was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to allow proper submission to health authorities.; Sender's Comments: Based on the known safety profile and information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19
Left arm pain greater than 3 weeks. Trouble sleeping. Tiny knot at injection site.
Within 12 hours he developed vomiting, cold sweats, an injection site reaction characterized by redness, swelling and warmth and a fever which lasted 4 days.  The injection site reaction an 4 inch area in diameter remained reddened, swollen and hot to touch.
SEVERE headache, not treatable with Tylenol or Advil. Shooting pains and tingling down my left side arm and back, and up the left side of  my  neck, which was the injection side.
A non-serious report of swelling of the glands has been received from a certified medical assistant (CMA) concerning a six-year old male patient, subsequent to FLUMIST.  No medical and drug history information has been reported for this patient.  The patient received 0.2 milliliters of FLUMIST on 27-Oct-2008.  According to the patient's parent, the patient experienced swelling of the glands approximately 16 hours after receiving FLUMIST, at two in the morning of 28-Oct-2008.  The patient was taken to the emergency room.  Information regarding the care the patient received in the emergency room was not available at the time of this report.  The outcome of the adverse event is unknown.
muscles in her hands, arms, legs and feet (not all at the same time; it moved around) would start aching; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscles in her hands, arms, legs and feet (not all at the same time; it moved around) would start aching) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-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 MYALGIA (muscles in her hands, arms, legs and feet (not all at the same time; it moved around) would start aching). At the time of the report, MYALGIA (muscles in her hands, arms, legs and feet (not all at the same time; it moved around) would start aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment information was provided   This case was linked to MOD-2021-308639 (Patient Link).
This case was reported by a nurse and described the occurrence of lightheadedness in a 36 year old female patient who received hepatitis B vaccine recombinant (Engerix-B).  On 03/04/2004, the patient received the first dose of Engerix-B.  At an unspecified time following the administration of Engerix-B, on March 2004, the patient experienced lightheadedness, dizziness, nausea and vomiting.  The patient was seen at a physician's office.  The outcome of the event is unknown.
Moderna vaccine (NDC 80777-0273-98) lot #039D21A and GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna= no need to repeat the dose.
Vaginal bleeding like usual menstruation that has not stopped. Plan for oral contraceptives and/or depo injection to stop the bleeding.
I had Covid-19 in November of 2020. I had symptoms for nine days after getting the first dose of the vaccine. I felt chills, fever, joint pain, headache, nausea, vomiting and diarrhea for four days. I did not get out of bed. It gradually improved over the next ten days. About two weeks after the vaccine, I experienced total loss of night vision which lasted for about an hour and a half. I slept with the lights on because it was terrifying when I couldn't see anything. It did not have any other symptoms after that. I have not gotten the second shot.
Developed red ichy rash starting inside my upper arms. By noon the next day it slowly covered my whole body.  Saw my primary doctor and he perscribed over the counter meds, Zyrtec 10mg, and Pepcid AC 20mg. Take 1 tablet each, once a day for 10 days. Rash started to clear after about an hour after taking first dose. By the next day it was gone.
Patient received a flu vaccine and fell while moving from the immunization room to the blood pressure machine. Blood pressure was low and had to go see the doctor. Blood pressure went up to 200 the night the vaccine was received.
Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125. There are a total of 82 patients involved. The healthcare provider wanted to know if the vaccine administered on 15-MAR-2023 would be considered as valid for the patients.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time. The second potential lot was confirmed to not be used.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
This spontaneous report was received from a healthcare worker regarding an unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with first dose of GARDASIL, dose, route unknown. On 02-FEB-2016, the same patient visited physician's office to receive second dose of GARDASIL 9 dose, route unknown. It was reported that the second dose of GARDASIL 9 was received late. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Patient presents with swelling and rash on left arm approximately 4 inches in diameter. The patient reports no difficulty raising or using arm at this time but mild pain when arm is fully extended. Patient reports the area is warm to the touch and raised in appearance but denies burning, tingling or pain. The affected area has spread since first noticed yesterday but has remained confined to a four inch region.
H1N1 vaccine ordered to be given and Flu vaccine given Pt. already rec'd Seasonal flu vaccine this season, and vaccine expired 6/30/10. (Redness swelling increased it decreased within 24 hours.)
Loss of consciousness; Back pain; Dizziness; Nasopharyngitis; Chills; Nausea; This case was received via  FDA VAERS (Reference number: 1198122) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This regulatory authority case was reported by a health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID in October 2020) in October 2020.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), BACK PAIN (Back pain), DIZZINESS (Dizziness), NASOPHARYNGITIS (Nasopharyngitis), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), BACK PAIN (Back pain), DIZZINESS (Dizziness), NASOPHARYNGITIS (Nasopharyngitis), CHILLS (Chills) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Blood test: unknown (Inconclusive) unknown. On 03-Apr-2021, Electrocardiogram: 03-apr-2021 (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was received FDA VAERS (Reference number: 1198122) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    Other Meds :  Symptom Text : The patient had experienced Severe back pain starting at 5pm on April 2, 2021. Frequent urination throughout the night, cold chills. April 3, 2021, 4:50am got up to use the bathroom and had extreme nausea and lightheadedness. Passed out and seized up. EMS arrived, BP 80's/50's and low grade fever. Put in chair to transport me downstairs and passed out and seized up again. Threw up. Transported to ER and still weak and severe back pain. Was given something for nausea. Two bags of fluid. EKG, blood work, and urine test. Left ER around 10 am. No Concomitant medication was not provided. No Treatment medication was not provided.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt at 9 pm 7-16-2009 could not stop shaking. I took his temp 95.3. I took him to the ER, his temp was 102.1 when we got there. They gave him a IV and something for fever and nausea. At home he got worse. I took him to the Dr where his temp went up to 105 and he was vomiting and still shaking. They then hospitalized him and ran many tests.
According to Dad, noticed swelling on left deltoid and redness, not very clear on time states started to notice it yesterday morning. Pt played yesterday evening and had cut along inner arm left. Will start Tylenol and samples of Zyrtec per PAC.
overactive bladder; frequent urination; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTONIC BLADDER (overactive bladder) and POLLAKIURIA (frequent urination) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Clindamycin), Blood pressure high since 2000, Arthritis (arthritis in left shoulder) since 2016 and Arthritis (arthritis in right knee) since 2018. Concomitant products included LOSARTAN, HCTZ and ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure high.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTONIC BLADDER (overactive bladder) and POLLAKIURIA (frequent urination). At the time of the report, HYPERTONIC BLADDER (overactive bladder) and POLLAKIURIA (frequent urination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-377577 (Patient Link).
Temp 102 F (rectal)-Not relieved by tylenol since 2 pm yesterday.
Skin rash, itchy, papulas to shoulder, then to left lower back and flank, left medial thigh started on 9/27/18, self treated with Benardyl. On 10/1/18 she noted a  rash  to right axilla and chest wall, to continue with Benadryl and if needed an over the counter steroid cream. Employee to follow up with her Dermatologist.
Patient received 1st dose of vaccine at 3.20pm, was accompanied by the daughter to the observation area . The reporter was at the   observation station at that time and did not observe any problems or concerns or changes in behavior. The patient have been sitting the chair and talking to her daughter. In about 20-25 minutes a daughter complained that her mother felt a little  faint. Vitals have been taken and it was noted that level of patient's SpO2 was dropping to 88. Blood pressure was 140/100 which was normal for the patient according to the daughter and pulse was 65. The patient was connected to 4L of oxygen and her saturation improved, however, as soon as the oxygen was weaned, the patient had drops in saturation. Ambulance  have been called and EKG have been performed. The patient has a history of A fib. After 30 minutes of  monitoring the patient have been transported to the hospital with the BP 150/110 and SpO2 88. Patient stated she felt fine and did not have any concerns. the daughter said that the vaccination was a first major event for her mother since last year and she have been very excited about this.
BACK PAIN; FEELING CHILLS; LEG PAIN; INJECTION SITE; FEVER OF 99.4; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 23:55 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced back pain, feeling chills, leg pain, injection site, and fever of 99.4. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling chills, leg pain, back pain, injection site and fever of 99.4 was not reported. This report was non-serious.
pt had swollen glands plus a fever of 103; seen by MD 8SEP92 & stated did not believe this was a reaction to the vax; pt had severe tonsillitis;
3" diameter lump, at site of injection patient reported warmth, itchiness, and redness. Taking topical BENADRYL.
So, the first week I was sore on my left arm. It felt like a lump under my armpit, it was very painful, and I decided to get checked. My doctor suggested a mammogram, but everything came back normal, and it came back as a small cyst.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from a Medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender who on 14-APR-2015, the patient was vaccinated with a dose of ROTATEQ lot # K011663 (expiration date, dose, route and site of administration were not reported) that was exposed to temperatures outside of the recommended range. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Redness, warmth and edema at the site of injection. Started the morning following injection.
Child woke with solid raised skin rash surrounding injection site, measuring 2-3 inches in lengh and width.  Skin very warm to the touch.  Child complained of itchiness as well.  No fever.  Applied hyrdocortisone cream to site. Less than 2 hours later, rash had spread down the leg, more splotchy than the original 'rash'. Original rash still present. No fever. Took picture, called doctor.  2 hours after that, doctor checks out the rash and diagnoses cellulitis.  Doctor prescribed Keflex oral antibiotic 2x per day for 10 days, Rx antibacterial creme to be mixed with hydrocortisone and applied topically.  Recommended Benadryl for the itchiness.
Pt recvd 1st dose of Hep B vax on 17NOV91 & 48 hrs later, pt devel an erythematous papular rash on face, upper trunk & arms; pt dx as having pustular pityrosporum;
shot ~11 AM. Chills began ~11 hours after shot, temp ~21 hours after shot was 101. Too tired to get out of bed the day after the shot until ~8 PM. Felt draggy for ~ days after, but it is possible that cragginess was one of the many bugs going around.
Adacel was given in the right upper arm, Shingrix in the left.  Within about 12 hours, she was at the movies with her sons, started feeling general malaise and some nausea.  Went to bed, developed some fever and general malaise, did not sleep well.  Over the next 48 hours had some diarrhea, malaise, ongoing intermittent fever.  Developed significant soreness in the left upper arm.  Lots of heat in the area.  Now it is turning more red.  The right upper arm did not turn red or feel near as hot.  Overall feeling better today than she was a couple days ago, no more fever, appetite is better.  Now has redness and a firm feeling in the left upper arm. Ambulating independently. Left upper arm: 3 to 4 cm area of erythema, about 2 cm of mild induration around the vaccine site over the deltoid.  No motor deficits.  Mildly tender in the area as well. Right upper arm: No erythema, induration, only mild tenderness. Probably a reaction to the shin Grix. This was her first dose. Because she felt so poorly, we agreed to hold off on the second dose indefinitely.  Reviewed the benefits and risks of skipping the second dose. Reviewed home care of this, symptoms should resolve spontaneously over the next week or so. Call or return any time for new concerns.
Patient came to get 2nd Moderna shot on 07/19/21, patient forgot his immunization card, patient stated Pfizer on consent and release form. He ended up getting the Pfizer vaccine. Patient came back 09/24/21 saying if we can fill out the card because he forgot to bring it back that day 07/19/21 to have filled out because he didn't have it with him initially. So I filled lot number and date he received Pfizer shot. So patient ended up getting 2nd Pfizer somewhere else and came today to have initial filled out. Patient didn't complain of any reaction or problem.  Patient just wanted card filled out. 't
About 5 days after the vaccine I started to feel unwell. I am still experiencing symptoms. I had the following symptoms:  -Brain Fog -Weakness in Arms and Legs -Numbness in Face -Extreme Fatigue   I have been to the walk in clinic and the ER with nothing they can do. I have received blood work and a CT Scan.
Mild body aches, mild headache, low-grade fever. Lasted about 24 hours. Stuffy/runny nose, sneezing, congested sinuses. Lasted about 12 hours.
1 of 2 pts vaxed from the same vial exp an inject site react which included erythema (size of a grapefruit) & a knot (size of a goose egg); react appeared to be a sterile abscess; required ER/MD visit; rx'd w/ATB;
Patient came to our ED on 2/6/2021 with worsening weakness and fatigue, which he claimed that had been experiencing since the date of vaccination on 1/26/2021.  His rapid COVID test came back positive.  He was admitted and treated in our COVID unit.  His condition improved and he was discharged to home on room air on 2/10/2021.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported   This case was linked to MOD-2021-395985 (Patient Link).