chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccine 4/3/21. Symptoms started 4/10/21 . Noticed slight itch left arm just distal to  COVID vaccine injection site. Developed small quarter sized welt. It started to enlarge over the next 48 hours. Tear drop shaped area 2 in wide x 4-5 in long.  Area was warm and hot to touch. Began noticing a numbness, coldness in the lower left arm, wrist, thum and index finger. Area that was raised started to reduce, redness has started to improve to pink by April 13 in the aftenoon. Small tingling lasted until April 15 but numbness and cold has resolved. The red ares changed to dull color was gone bu April 18.  Warm redness appeared 28 hours after the second shot in the same area by the injection site but on Day 3 is is less warm and red.
RASH, SWELLING, ERYTHEMA TO LEFT DELTOID X2 DAYS.
Approximately 24 hours after the vaccine was injected, the patient had a red rash around the injection site. This red rash was warm to the touch, and felt hard as well. The rash continued to grow until it was approximately 2.25 inches from the injection site, approximately 48 hours after the procedure.  Doctor visit has so far resulted in treating it as an allergic reaction to the flu vaccine.
has heavy pain in diaphragm area; muscle pain; This is a spontaneous report from a contactable consumer or other non health care professional. A female patient (consumer's sister) of an unspecified age (Age: 37; Unit: Unknown, as reported) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and experienced muscle pain. It was reported that, reporter calls on behalf of sister. He reports that his sister received second dose of vaccine and has heavy pain in diaphragm area and muscle pain. He reports that she did have muscle pain after first dose but not this form of pain. Reporter would like to know if this has been reported by others or what should they do. The reporter assessed the seriousness as non-serious. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided    This case was linked to MOD-2021-209011.   See case MOD-2021-209011 for details regarding the related case.
From the morning of April 16th, there has not been a day that he is not in pain with extreme stiffness.   After blood work, our regular physician sent Pt to a rheumatologist who confirmed the diagnosis of polymyalgia rheumatica. Both drs agree that it is probably from the Shingrix shot and encouraged us to report it. He has been on various mg of prednisone, currently 2.5, was at 10mg. The rheumatologist had him on 200mg hydroxychloroquine, but after over 3 months, it has not worked. Changing to DICLOFTNAC sodium next week.  He is no better today than he was at the first dr. Visit unless he is on the 10mg of prednisone, but we are weaning him off that as it is SO bad for you.
dose was administered greater than 12 hours after initial vial punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered greater than 12 hours after initial vial punctured) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered greater than 12 hours after initial vial punctured). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (dose was administered greater than 12 hours after initial vial punctured) 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 considered EXPIRED PRODUCT ADMINISTERED (dose was administered greater than 12 hours after initial vial punctured) to be possibly related.    No concomitant medication was given.   No treatment information was provided by the Reporter.   This case was linked to US-irms-MOD21-273539 (Linked Report).; Sender's Comments:  US-irms-MOD21-273539:
Had varivax on 5/23/96 and started breaking out with papulo-vesicular lesions on 4/12/00 with a low-grade fever and itching. Seen in office on 4/13/00.
During the monitoring period after receiving the vaccine, the patient was casually chatting with co-workers. Approximately 15 minutes later, she mentioned "I am dizzy" while seated on a chair, then she immediately fell off the chair to the side.  The pharmacist rushed to support her head, and she did not hit her head against any objects around. With assistance she was laid flat on the floor. When asked "can you hear me" she responded "yes". She did not entirely lose consciousness, however she had a brief seconds of pre-syncope and body stiffness, rigidity. Pharmacist requested to call 911 to evaluate her. Upon arrival of emergency team, her vitals were stable, BP 130/82 and normal HR and RR. She continued to report feeling shaky but with no difficulty breathing. She was able to stand and walk approximately 20-25 minutes after the onset of symptoms.
Information has been received regarding a case in litigation concerning a male minor child who was vaccianted with three doses Thimerosal-containing hepatitis B virus vaccine on 2/14/98 (lot # 623209/0453E), 04/02/98 (lot #625097/1313E) and 8/4/98 (lot # 625402/1560E) respectively. It was alleged that as a result of the child's exposure to thimerosal from the vaccines, he sustained neurological injuries and as a result of those injuries was diagnosed with autism spectrum disorder. Upon internal review, autism spectrum disorder was considered to be an other important medical event (OMIC). No further information is available.
Vomiting, low grade fever, anemia, electrolyte imbalance, seizure like activity, and cardiopulmonary arrest. Received autopsy report which revealed COD as hemolytic uremic syndrome w/glomrulo microthrombi & bilateral acute interstitial nephritis.  Other findings at autopsy: cerebral edema, hemolytic anemia, acute renal failure, pulmonary congestion c/w aspiration pneumonia.
13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is tenth of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
pt exp swelling, burning & pain in rt arm between elbow & shoulder shortly p/vax 7APR94;had fever of 101.5;seen in clinic dx severe inj site rxn;rx w/antihistamines & codeine for pain;
This spontaneous report was received from certificated medical assistant referring to an adult female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-MAR-2017, the patient was vaccinated with a properly stored dose of M-M-R II, lot # L005290 with an expiration date of 17-FEB-2017 (product use issue) (strength, dose, route and anatomical location were not provided), for prophylaxis. No adverse effect and no product quality complaint were reported. Additional information is not expected because there was no consent to contact the reporter.
Side effects included patient's arm being immediately sore. Over night she had chills and didn't sleep well. The next morning on the 28th, as she attempted to take a shower,  she started seeing spots before her eyes. She stated that she felt very strange as if she was going to faint and fortunately was able to get out of the shower, dry off, and get into bed to stabilize herself. From that point on for the rest of the day, she was achy, tired, and lacked appetite.
Information has been received from a physician concerning a 6 year old female with no pertinent medical history or drug reactions/allergies, who on 21-SEP-2007 was vaccinated with a first 0.5mL dose of varicella virus vaccine live (Oka/Merck), (lot number 658018/1007U). On 23-SEP-2007, two days post vaccination, the patient developed a rash on her legs and then on her arms, and complained of itching. The physician reports the patient was without fever, cough, or cold. Observations included erythematous, papule lesion over the legs. The outcome was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. No treatment was required. No follow up was required. No relevant diagnostic testing was performed. At the time of vaccination the patient had a scalp infection, for which fungal and pus cultures of the scalp were sent. Results were positive for MRSA. Additional information has been requested.
Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days; Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date/few people vaccinated with a vaccine beyond usage date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul-2022 after 30 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case contains information of the sixth patient out of 12 patients who received the vaccine on Jul-2022 as described by the reporter.  No concomitant medication information was provided.  Number of patients who received the vaccine beyond usage date were 12 patients.  Number of doses/vials that were affected were 3 vials and 12 doses.  The vial was initially stored in the refrigerator on 13-Jun-2022 and all the vials were moved to the fridge on the same day.  The number of patients who received the vaccine on 16-Jul-2022 was 3, the number of patients who received the vaccine on 23-Jul-2022 was 5 and the number of patients who received the vaccine on 24-Jul-2022 was 4.  The vial did not undergo any temperature excursion.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow-up received includes updated reporter's email address.
This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The dose of PROQUAD (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Injection site reaction - pt had redness and swelling beginning approximately 48 hrs after administration; swelling was larger than golf ball size and spread down back of arm. Pt. saw Dr. and received corticosteroid tx.
At 10:30am on 7/14/2023The  nurse administered TDaP (Adacel)  into right deltoid and then HPV (Gardasil 9) IM into Left Deltoid.  Immediately after administration, patient started to vomit The. Nurse Practitioner and Doctor were notified and patient was evaluated by the providers. Patient blood pressure was checked and  patient was given water and instructed to lie down on table. Patient stayed in office for extra 15 minutes.
Pfizer Dose 1 4/8/21 (ER8737) Pfizer Dose 2 4/30/21 (ER8736) COVID Dose 1/21/22  1/21/22: The patient is a 67 year old female with baseline cognitive impairment that presented to ED with complains of generalized weakness and fever for the past 2 days.  Patient is a poor historian.  History was obtained per chart review and from ED staff.  According to chart review the patient has been having fevers, generalized weakness and increasing confusion for the past 2 days.  She was also endorsing abdominal tenderness on exam.  The patient has past medical history of chronic hyponatremia, hypothyroidism, CAD, ischemic cardiomyopathy, CHF EF 30-35%, atrial fibrillation anticoagulated on Eliquis, history of embolic stroke, anxiety/depression, hypertension, dyslipidemia, asthma, bipolar disorder, CKD, obstructive sleep apnea not on CPAP and cognitive decline.   On arrival to ED the patient was febrile 100.8. Laboratory findings were significant for hyponatremia 127. CKD stage G 3B creatinine 1.54.  Transaminitis ALT 49. Lactic acidosis 2.5.  ProBNP 252. Rapid COVID positive.  CT abdomen no acute findings.  CT head unremarkable.  Chest x-ray no acute findings.  IV fluid hydration was given with NS 0.9% 1 L bolus.  1/24/22: Patient is a 67 yo female who was admitted for altered mental status , acute on chronic hyponatremia and stroke rule out and she was found to be COVID positive. MRI ruled out stroke. Her sodium improved with IV saline fluids, free water restrictions and salt tabs . Mentation improved with improvement in sodium levels. She is asymptomatic with regards to her COVID and did not require oxygen supplementation and treatments for COVID ( steroids, remdesivir). Blood culture grew staph capitis 1/2 bottles which is likely contaminant and repeat cultures were negative, she was on short course of IV Vancomycin but stopped with culture results. Patient hemodynamically stable for discharge today. Discharge with home program.
Small lump in thigh about the size of a quilting needle head where vaccine was given.  Showed up about 36 hours after shot was given and lasted about a week.
Pt's wife called stating pt. had a fever of 100 degrees F and had a bump where vaccine was given. Also, pt. had all over aches and pains.
pt devel an inj site rxn characterized by pain, redness, & swelling p/vax;
Extreme swelling of lymph nodes near collarbone and trachea causing throat restriction, swelling leading to intense pain around the collarbone, inability to move arm and head comfortably. All only on my  left side where  I received my injection.  Additionally, a low grade fever of 99.7, dizziness, dry mouth, swollen mouth tissue and tongue and fatigue.
Felt lightheaded and congested with some sob. Paramedics checked and cleared go.
patient reports feeling short of breath and mild difficulty breathing for 24-36 hours.  Did not require medical treatment.
First wheal was not created. Had to repeat ID injection. Pt left in NO Distress.
Pt with start of maculopapular rash on face, chest, back and arms. Starting to show vesicles. Concern for chickenpox.
Patient's mom called our office on 11/8/22 stating the patient was falling asleep in gym class and had a 101 fever. Advised mom to give tylenol and motrin if needed for comfort and assured her that this is a common reaction that should only last a day or two.
Immediately felt strange after injection...next day started with headaches on one side of my head, then soon after tingling in my head...dizziness...ear ringing, ear pain, seeing spots to the side, being hot like on fire & not being able to sleep - my mind felt wired.                       I was feeling just plain horrible then April, 24, 2021 sitting on the couch it was like someone bonged a huge high pitched  bell right next to my head...pain was unbearable and I passed completely out (never in my life had I passed out before)  I then vomited (while passed out) Ambulance came took me to the hospital.  I was advised to contact my doctor soon - which I had already been doing but could not get an appointment.
Coughing problem; This is a spontaneous report from a contactable consumer (Patient's husband). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 15Feb2021(at the age of 80 years old) and dose 2 via an unspecified route of administration on 05Mar2021(at the age of 80 years old) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced coughing problem on an unspecified date on 2021. Reporter stated, "I am calling for my wife (consumer). She was vaccinated for first shot (dose) on 15Feb2021 and second dose vaccine on 05Mar2021 and since then she is having coughing problems and she keeps going to Doctors, Pulmonologist specialist, Nose Throat and Ear specialist. I have a list of all the medicines that she was prescribed in the last 4-5 months. She is still coughing and came to make a solution, she can have sort of problem, so she is concerned that it could be a problem that she got the vaccine. Adverse event resulted in physician office visit. Therapeutic measures were taken as a result of coughing problem. Outcome of the event was not recovered.  Information about Lot/batch number has been requested.
On 08/03/2021 I developed really severe fatigue and headaches. They have been consistent. Since then my doctors say I have developed general autonomic disfunction. My heart is very irregular. I also developed a variety of skin rashes. That has been ongoing since 08/03/2021. I have been put on medication for headaches. I am currently being treated with a large dose of antiviral. I started getting weekly B12 shots. I have had a lot of blood work done, a CAT scan of my head, 4 MRIs of my head and spine, and a lumbar puncture. Everything came back completely clear. I developed shingles during all of this, which I have never had before. I have been to the ER 5 times mostly related to the neurological issues.
Flu-like symptoms: light-headed, loose bowels.  After breakfast I felt I needed to return to bed. I stood up and walked part-way across dining room when I passed out. I came to a few seconds later, confused about what happened. I was taken by ambulance to Hospital. After being admitted, I was kept there for overnight evaluation.
Swollen ankle, lower leg itching, sore swollen arm, shortness of breath, dizzy,
received Menveo reconstituted with Pfizer Covid diluent; received Menveo reconstituted with Pfizer Covid diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo lyophilized powder portion after being reconstituted with pfizer covid diluent when the patient was supposed to get the covid pfizer, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up. This case was linked with 12 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243469:Same reporter US-GLAXOSMITHKLINE-US2021AMR243472:Same reporter US-GLAXOSMITHKLINE-US2021AMR243470:Same reporter US-GLAXOSMITHKLINE-US2021AMR243473:Same reporter US-GLAXOSMITHKLINE-US2021AMR243475:Same reporter US-GLAXOSMITHKLINE-US2021AMR243476:Same reporter US-GLAXOSMITHKLINE-US2021AMR243477:Same reporter US-GLAXOSMITHKLINE-US2021AMR243478:Same reporter US-GLAXOSMITHKLINE-US2021AMR243479:Same reporter US-GLAXOSMITHKLINE-US2021AMR243480:Same reporter US-GLAXOSMITHKLINE-US2021240689:Same reporter
After my first dose, I had a sore arm for a few days. After my second dose, I had a sore arm for the rest of that day, and the next day I experienced many symptoms. In the morning, I was extremely tired and nauseous. By the afternoon, I had a headache and my whole body ached. In the evening, my injection arm was swollen and red, and my chest ached and made it harder to breath or sit up. I was bed ridden and unable to get up for a couple hours because it hurt too much. After some rest, water, and aspirin, I was able to get up late that night the day after my second dose. Two days after my second dose, I felt much better without any symptoms.
This spontaneous report as received from a certified medical assistant (CMA) refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported) that was exposed to temperatures outside of the proper storage range. There was no adverse effect. This is one of the four reports from the same reporter. (Linked to 1411USA002768, 1411USA002890 and 1411USA002891). Additional information has been requested.
Heavy-feeling limbs, muscle aches, sore feet, swollen gland in armpit