chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Osteoarthritis aggravated; Recurred Intestinal tubing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of UNEVALUABLE EVENT (Recurred Intestinal tubing) and OSTEOARTHRITIS (Osteoarthritis aggravated) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    Relevant history includes alcohol abstinence and non tobacco user. Osteoarthritis aggravated started at an unknown date in March 2020 and stopped at an unknown in 2020.  The patient's past medical history included Gastric bypass in 2004 and Knee replacement in June 2020. Concurrent medical conditions included Osteoarthritis since 2019 and Gastrointestinal tube insertion since February 2020.   In March 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 milligram every two weeks. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced UNEVALUABLE EVENT (Recurred Intestinal tubing) (seriousness criterion hospitalization). On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis aggravated) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to UNEVALUABLE EVENT. In March 2021, UNEVALUABLE EVENT (Recurred Intestinal tubing) had resolved. At the time of the report, OSTEOARTHRITIS (Osteoarthritis aggravated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: recurred intestinal tubing (abnormal) Recurred intestinal tubing.     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.   The patient was hospitalized for two days due to recurred intestinal tubing. She had a laparoscopic procedure to visualized the intestine and it there was no cramping or tumor that was found and the intestine was clear. She was told that it was resolved by itself and no additional treatment or procedure was needed at that time. She was scheduled for an Esophagogastroduodenoscopy to determine the cause of recurred intestinal tubing. The alternative etiology for the event Recurred Intestinal Tubing was reported as could be due to previous gastric bypass surgery.  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.
Patient called the pharmacist wondering if it common for her arm to feel hot and itch 3 days after getting the flu shot. Patient had had flu shots in the past without any allergic reaction so it was explained that her symptoms were from a site reaction. She was advised to contact her MD.
Pfizer / BioNTech: 22Dec2020, 13Jan2021, 13Oct2021; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: 22Dec2020, 13Jan2021, 13Oct2021; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 02:00 as dose 1, single (Lot number: EH9899), in left arm, on 13Jan2021 at 02:00 as dose 2, single (Lot number: EL0142), in left arm and on 13Oct2021 at 01:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 13May2022 at 07:00, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: 22Dec2020, 13Jan2021, 13Oct2021; Paxlovid: Treatment of COVID-19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Drug ineffective and COVID-19 which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.
I was given the shot on 9/12/2020 at the pharmacy. As the pharmacist went to administer the vaccine my entire left arm jumped and/or spazzed prior to the administration of the dose. After the needle was pulled out there was more bleeding at the injection site than normal. Now in April, I am starting to notice numbness, tingling, and a cold sensation in my left arm. Also, I feel like sensations are slowly spreading to my upper and lower back. I am afraid that the vaccine was given much lower than the recommended injection site, and now there is nerve damage. Up until this point the sensations were not there, but only recently (within a day or two ago) after massaging the area the sensations started. I can also sometimes still feel the "pricking of the needle" sensation when I lift my arm up. I have an appointment scheduled with my PCP this week to have it looked at. Treatment and outcome are to be determined.
The symptoms that got my attention were the runny nose, sneezing, coughing and fever. Also, I had joint aches, malaise and body aches but I had those after the first 3 shots so I wasn't thinking to much about it. I did the at home COVID test on 05/26/2022 which was positive. I wanted to get the PCR test so I went to urgent care. However, they would not give it to me and instead did an antigen test which showed I had COVID. I went home and isolated. I waited the 5 days before going out. By 05/28/2022, the fever had subsided and most of the other symptoms were gone as well. As of today, I feel like my normal self.
pt recvd vax 3PM 2SEP92 by 4PM pt was uncomfortalbe & local rxn & swelling, redness to 4-5 in x 3" area); taken to MD 4SEP92; no temp; cold packs; APAP used; allergic to tetanus according to MD;
She has been sick with bad cold; She has been sick with bad cold; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 50 years as dose number unknown, single for covid-19 immunisation; treprostinil diolamin (ORENITRAM), first regimen oral since 23Jan2020 (Batch/Lot number: unknown) and second regimen oral (Lot number: 2101810, Expiration Date: 31Jan2023) at 2.5 mg 3x/day for pulmonary arterial hypertension. Relevant medical history included: "Primary pulmonary arterial hypertension" (unspecified if ongoing), notes: Primary. Concomitant medication(s) included: ADEMPAS; OPSUMIT; DILTIAZEM. The following information was reported: NASOPHARYNGITIS (non-serious), ILLNESS (non-serious), outcome "recovering" and all described as "She has been sick with bad cold".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the 4 vaccines at approximately 3:30 pm 07/28/08. Patient began to have lip/mouth swelling, urticaria, and difficulty swallowing approximately 10 minutes after injections. Treated with Epi 0.15 mg SQ in office and 1 1/2 tsp Benadryl 12.5 mg PO.
pt recv vax 31JAN98 & 26FEB97 pt exp labyrinthitis w/extreme vertigo, vomiting, nausea & diarrhea;sx came on instantly;pt was hosp x 5 days;pt recovered from vomiting & nausea but the vertigo persisted @ time of the report;
Injection site was very swollen and warm. Gave Motrin and Tylenol to help with discomfort. Pt does have egg allergies. She is able to eat eggs fine but every year her reaction to this vaccine gets more swollen and red. Injection was also given incorrectly, not in deltoid but about half way down her arm.
COVID pna, receiving IV steroids, Sx onset 4/7, presented to ED on 4/14, ED boarder currently  On RA
Altered mental status. Found in car unaware of how long she had been sitting in car. A&0 x 2
not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional information: The patient missed her 2nd shot as she was not feeling well. But her main concern was if it was okay to drink alcohol after taking the 1st shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few days after her first vaccine she started have hard time breathing and went to nurse on campus (college student) and was told to take advil  and did not help so she returned to nurse a week later and was told the same thing then received the 2nd dose and 10 days later she was in the ER with severe breathing issue and was told it was not a blood clot and sent her home with pain meds but still having pain.  Then 2 days later her primary did a telehealth and called steroids in and symptoms relieved for a few days then pain came back so we called the primary again and was given more steroids with no relief. On June 7 i took her in to primary and when they listened to her heart they heard something and did a echocardiogram and discovered she has pericarditis and was sent to cardiologist immediately  and the diagnosis was confirmed by cardiologist.  He is trying my daughter on medication first before having to drain it from her heart.
Short-term memory loss manifesting as being unable to recall names of people, places and things. Previously this was a rare occurrence for me.  After receiving the second dose of the Moderna Covid vaccine this happens every day.  These are the names of people, places and things I know well, or recently visited, or used/extensively talked about recently.  This includes friends and co-workers names, stores I visit often or within days, and things I bought or used recently.  I draw a complete blank.  If someone prompts me with a name, I instantly recognize if the name is correct, or not.  If not prompted with a name, I will usually recall it minutes or hours later on my own.
This spontaneous report was received from a health care worker refers to a patient of unknown age and gender. On an unknown date in 2011, the patient was vaccinated with dose 1, GARDASIL (lot # expiration date and route not reported0. On 20-MAR-2013 the patient was vaccinated with dose 2, GARDASIL (lot #, expiration date and route not reported). No adverse event reported. The health care worker did not wish follow-up for a safety report for herself or the physician. Additional information is not expected.
This young man is involved in a program.  He was given his influenza vaccine per our hospital policy and at the request of the Director.  Upon entering his vaccine into our system it was discovered that he has already received the vaccine on 10-11-2022 at another facility.  There have been no S/S of reaction or complications pertaining to the second dose administered.  Department of Health notified and stated the only action was to submit a VAERS. director notified as well.
Client reports onset of chills and fever on days 5 and 6 and again on days 11 and 12, following receipt of vaccines.  She states her normal temperature is about 97F and during the above incidents, it was about 100 degrees.  She adds that she experienced generalized body aches and joint stiffness, some neck stiffness and Headache.  Client states she did not seek treatment, nor did she contact her PMD.
Rib cage area is sore; pains throughout arm; redness and swelling at the injection site; redness and swelling at the injection site; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0173) via an unspecified route of administration on 23May2021 at 14:15 (at the age of 34-years-old as a single dose in the left arm for COVID-19 immunization. Medical history included high cholesterol and borderline diabetic. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included pantoprazole (PROTONIX); ethinyl estradiol, ferrous fumarate, norethisterone acetate (TAYTULLA); rosuvastatin; buproprion XL, and "noreth" from unknown dates for unknown indications. The patient previously received hydrocodone from an unknown date for an unknown indication and experienced allergy. On 24May2021 the patient experienced rib case area was sore, pains throughout arm, and redness and swelling at the injection site. The patient did not receive any treatment for the events. The outcomes of rib case area was sore, pains throughout arm, and redness and swelling at the injection site were unknown. It was also reported that since the vaccine the patient was not tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Positive Covid test after a negative result; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive Covid test after a negative result) in a 71-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive Covid test after a negative result). At the time of the report, COVID-19 (Positive Covid test after a negative result) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive COVID test after a negative result. On an unknown date, SARS-CoV-2 test: negative (Negative) Positive COVID test after a negative result.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was provided.  It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Unspecified Pfizer medication was reported with start date 13-May-2022 and stop date 17-May-2022, with active substance information as COVID-19 Treatment.  Device date: 25-May-2022.  Company comment: This spontaneous case concerns a 71-year-old, female patient with no reported medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19, which occurred at an unspecified date after receiving a dose of mRNA-1273.  The patient was diagnosed with COVID-19 at an unknown date and started treatment with an unspecified drug on 13-May-2022 and completed the course for 4 days. On an unknown date the patient tested positive again for COVID-19 after a prior negative result. Further details on the clinical course and diagnostic test were not provided in the case.  The patient's advanced age may be considered as a risk factor for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old, female patient with no reported medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19, which occurred at an unspecified date after receiving a dose of mRNA-1273.  The patient was diagnosed with COVID-19 at an unknown date and started treatment with an unspecified drug on 13-May-2022 and completed the course for 4 days. On an unknown date the patient tested positive again for COVID-19 after a prior negative result. Further details on the clinical course and diagnostic test were not provided in the case.  The patient's advanced age may be considered as a risk factor for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
fainted; fell to floor briefly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 81 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EK41F4, Anatomical site of location: Arm, Route of administration: Intramuscular), administration date: 14Jan2021, when the patient was 79-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EL324F, Anatomical site of location: Arm, Route of administration: Intramuscular), administration date: 04Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FF2590, Anatomical site of location: Arm, Route of administration: Intramuscular), administration date: 14Oct2021, when the patient was 80-year-old, for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 30Jun2022, outcome "recovered", described as "fainted"; FALL (non-serious) with onset 30Jun2022, outcome "recovered", described as "fell to floor briefly".  Clinical Course: Fourth dose, the next morning fainted; fell to floor briefly than recovered.
Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient had no allergies for medications, food and other products. The patient never had COVID positive test or diagnosis. The patient had no history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concomitant products included APIXABAN (ELIQUIS), PAROXETINE, MEMANTINE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), VITAMIN C [ASCORBIC ACID], BIMATOPROST (LUMIGAN) and DORZOLAMIDE for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 07-Feb-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. It was reported that, after 1st dose the patient experienced soreness at the injection site that lasted between 1 and 2 weeks. No treatment details were reported.   This case was linked to MOD-2022-559004, MOD-2022-559005 (Patient Link).
Pt reports hives developed on her left upper arm and trunk,reports upper lip became swollen. Reports taking 1 Benadryl pill and symptoms subsided. Reports hives returned 7/31/16 afternoon. Pt again took 1 dose of Benadryl. Symptoms subsided and have not returned. Denies shortness of breath, syncope, or other symptom.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unspecified date in 2014, "in the last couple of weeks", the patient was vaccinated with a dose of ZOSTAVAX (route and lot # not reported). The nurse reported that on an unspecified date in 2014 after vaccination, the patient developed swelling extending from the injection site down to her elbow. The patient then developed widespread aching, soreness and malaise. The patient stated that even her teeth hurt. The patient was evaluated at the local unspecified care facility and was prescribed an unspecified broad-spectrum antibiotic. At the time of the report, the patient was recovering. Additional information has been requested.
The next morning after vaccination, I noticed that my old BCG scar is swollen, red, and itchy. After another 24 hours, it became extremely itchy and red. The itchiness and redness lasted for almost 3 weeks. To this day, the site of the BCG scar can become itchy at sporadic times. Note: the site of the vaccination injection was about 3 cm above my BCG scar. On February the 6th, I had a virtual visit with a health care provider regarding a rash on my left thigh and other smaller areas on my left arm and leg. Her diagnosis was atopic dermatitis (eczema).
Swelling, redness, pain, warmth at injection site with pain and swelling  down right arm into hand. Pt sent to clinic for evaluation and treatment. Diagnosed with cellulitis and prescribed Keflex 500mg Q.I.D, and Voltaren 75mg B.I.D with 24 hr followup
Right leg swelled from knee to foot; Right Front of leg turns red and outside of ankle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101458025 (Pfizer).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8732) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Diagnosed 8 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot EN6203; Injected on left arm unable to confirm if given in the muscle.), administration date: 01Mar2021, when the patient was 73 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Right leg swelled from knee to foot"; ERYTHEMA (non-serious) with onset 30Apr2021, outcome "not recovered", described as "Right Front of leg turns red and outside of ankle". The events "right leg swelled from knee to foot" and "right front of leg turns red and outside of ankle" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, erythema.  Additional information: The adverse event had not gone away and it has been 6 months now. She went to a walk in clinic. Her PCP sent her for an x-ray and it only showed a little bit of fluid. Then she went to a walk in clinic and they sent her for Ultrasound and that did not show anything. Then, she ended up going to the Emergency. They did an MRI and did not know what it was and treated her for Cellulitis. They gave her an antibiotic and it did nothing. She does not know the name or have the lot or expiration for it. Rheumatologist said it was not arthritis.  End of April, her right leg swelled from her knee to her foot, the right front of her leg turned red, as well as the outside of her ankle on the right side. Per caller, she was seen by several doctors, several tests were done but all were negative and her condition is unknown.    No follow-up attempts are possible. No further information is expected.