chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rheumatoid arthritis flare up; hand got numb; issues in spine and collar area; back pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and NAPROXEN SODIUM (ALEVE) for an unknown indication.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and NAPROXEN SODIUM (ALEVE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) (seriousness criterion medically significant), HYPOAESTHESIA (hand got numb), SPINAL DISORDER (issues in spine and collar area) and BACK PAIN (back pain). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) and HYPOAESTHESIA (hand got numb) had not resolved and SPINAL DISORDER (issues in spine and collar area) and BACK PAIN (back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.  Action taken with co-suspects ADALIMUMAB (HUMIRA) (Subcutaneous) and NAPROXEN SODIUM (ALEVE) (unknown route) was unknown.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
SORE ARM; SORE ARM; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 68 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Lot number: EN6202) as dose 1, single and intramuscular, administered in arm left (Lot number: EP6955) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Mar2021, outcome "recovered" (2021), PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovered" (2021) and all described as "SORE ARM". Therapeutic measures were not taken as a result of pain in extremity, pain in extremity.  Additional information: Prior Vaccinations: None, Family Medical History Relevant To AE(S) was reported to be good Health, No Relevant Test was performed.  No follow-up attempts are possible. No further information is expected.
Right arm mild swelling and warmth from shoulder to elbow.  Injection was in deltoid.  very pruritic from shoulder to hand on right only.
No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 26-SEP-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA009929: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA012652: US-009507513-1904USA012654:
Injection site was sore; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose 1, single, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient's injection site was sore. The outcome of the event was unknown.  Information on Lot/batch number cannot be obtained. No follow-up attempts are possible. No further information is expected
Client received 1 dose Janssen vaccine on 3/25/15.  Client tested positive for VOCCID-19 on 4/25/21.
This spontaneous report as received from a medical assitant, refers to a currently 4 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II, (which had a lot # of N014486 and an expiration date of 10-MAY-2019; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA006354:
Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. Reporter said that they were filling out a temperature excursion assessment at this time and she was calling in to report the same to Moderna. Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing.  It was reported that no adverse reactions were reported by any patients.  No treatment information was provided.
20 minutes post vaccination Pt felt tingling in throat, swelling of the cheeks, and heaviness in the chest. Pt was escorted to lie on cot and vitals were obtained: B/P - 122/70, P - 88, Resp - 24, O2 - 99%. EMS was called and Fire Dept arrived on scene at 1650. Pt released by Fire Dept at site at approximately 1720.
I had a bad headache on the first day getting the shot and had a mild headache for the few days.  on Feb. 14th I had stomach ache and diarrhea and vomiting, and then I felt dizzy and fainted.
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with influenza virus vaccine 2007/2008 (manufacturer unknown, batch number; unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody at titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 20, 10 and 5 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient did not have 4-fold increase in titer value and tested negative for seroconversion of A/H1N1 strain but PCR (polymer chain reaction) tested positive. Therefore this patient was considered as an LCI case of Influenza A/H1N1. The outcome was not reported.
Began to experience a facial numbness and pulling sensation to left side of face.  As of today, symptoms still occurring intermittently.  Also experiencing vision changes, difficulty focusing on some objects while feeling pulling sensation to face.  Discussed with neurologist and still having imaging pending, current suspected diagnosis is trigeminal neuralgia.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 13-MAR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Cellulitis right leg, Keflex for 10 days.  Pt returned to clinic 2 days later for additional vaccines (IPV, Prevnar).  Right thigh noted to be red and swollen.  Left thigh was slightly swollen, non-tender.
Received influenza vaccine 10/17/12 at 2100 started getting chills, nausea, headache 10/18/12 at 0600. On commute home same sxs & threw up. Treated with ADVIL, TYLENOL, ZOFRAN.
Large red swollen area surrounding injection site. Very tender to touch. Got worse over first 2 days, larger, then started receding slowly and becoming very itchy. Took about 5-7 days to fully go away. Took ibuprofen for discomfort.
Local redness & swelling - same day, persistent nausea, achiness, malaise - started after 2-3 days.
"allergy type reactions"; "sinus infections"; "dizziness"; "broke out in lesions on his skin"; "some adverse events"; "headaches"; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY ("allergy type reactions"), SINUSITIS ("sinus infections"), DIZZINESS ("dizziness"), SKIN LESION ("broke out in lesions on his skin") and ADVERSE EVENT ("some adverse events") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY ("allergy type reactions"), SINUSITIS ("sinus infections"), DIZZINESS ("dizziness"), SKIN LESION ("broke out in lesions on his skin"), ADVERSE EVENT ("some adverse events") and HEADACHE ("headaches"). At the time of the report, HYPERSENSITIVITY ("allergy type reactions"), SINUSITIS ("sinus infections"), DIZZINESS ("dizziness"), SKIN LESION ("broke out in lesions on his skin"), ADVERSE EVENT ("some adverse events") and HEADACHE ("headaches") outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.
Two weeks after the second COVID-19 Pfizer shot, on April 12, 2021, I started to experience constant dizziness and headaches that has continued to last to this day (April 19th), a total of 7 days so far. No over the counter medication has helped the symptoms. I have never experienced Vertigo before, but based on my research, my symptoms are similar to that of Vertigo.
Red round bump under his left armpit that is painful to the touch  Currently using Ibuprofen and ice packs to help
Pt is a 3-1/2-month-old male who presented for evaluation of recurrent mucousy blood in the stool. He was asymptomatic until 06/04/08. He received a rotavirus vaccine. Two days later, his mom noticed mucousy blood in the stool, small in amount, gradually with every bowel movement mom noticed mucousy blood in the stool, loose in consistency, continued and the patient was seen in emergency room. He was admitted overnight. Workup was done, which include normal CBC except 13% eosinophils, which is high. PT, PTT, and INR were normal. Stool studies negative for C. diff toxins A and B, and culture for bacterial pathogens. Barium enema was also unremarkable. Mom stopped taking any protein in her diet because mom is exclusively breast feeding. Within 72 hours, no more visible blood in the stool seen. Baby has been gaining weight very well, feeding well. No history of any respiratory, urinary, or neurologic symptoms or rash. No weight loss. No vomiting. 7/29/08-records received with report for DOS 6/7-6/9/08-DC DX: Hematochezia,  Presented to ED after having blood in stools with every bowel movement for past day. Breast fed. PE: WNL. Note from GI consultant for DOS 6/20/08-impression:allergic colitis.
Right at the time I got my vaccine. Three people in the group started fainting and having seizures immediately after. I had my vaccine at 1:46pm   I wanted to report it since Im not sure the facility or nurses will. One you g lady fainted, then and old man passed  out, then another young man in his 30s had a violent seizure. Even ripped his shirt. The organizers stopped the vaccinations until the ambulances left. I was left horrified, as was everyone else there. Im not sure what kind of poison. We have been injected with. Please send more information about the ingredients of this vaccine to me. Thanks
about 8 minutes post vaccination client presented to monitoring staff with erythema in cheeks and possible erythema on chest. Client invited into ambulance stationed for monitoring for additional assessment. Initially just facial erythema and a 2"x2" section of redness on left chest wall. Vital signs normal at this time. No itching. in less than 5 minutes the redness progressed to full facial, neck, and chest erythema with some redness on right shoulder as well. Client reported itchy face, then upper body, then buttocks and abdomen in less than 5 more minutes. EMS was called, Benadryl 50 mg given PO. Vitals remained stable. EMS arrived, however client declined transport. Husband of client agreed to drive client to ER, and notify us on arrival. at 6:03 PM we received notification of arrival at ER and were able to speak with staff onsite as well. Per ER dose of steroid was given , no epinephrine given, pruritus resolved.
Information has been received from a pharmacy technician concerning her 18 year old daughter with no medical history and an allergy to pollen, who in April 2007, was vaccinated with a first dose of Gardasil.  There was no concomitant medication.  The patient reported that the dose was painful.  Subsequently, the patient had difficulty driving home.  In June 2007 the patient was vaccinated with a second dose of Gardasil.  The patient reported that the dose was painful.  Subsequently, the patient had difficulty driving home.  On 27-DEC-2007 the patient was vaccinated with a third dose of Gardasil.  The patient reported that the dose was painful.  The patient's mother went with her daughter for the third dose.  The patient began her menses on 30-DEC-2007 (she had it 2 weeks prior) in which there was a lot of pain prior to and during the menses.  The patient was also very tired.  The menses lasted five days.  It was reported that after the New Year the patient returned to college and felt very congested.  The patient went to see a physician near college who told the patient that she probably had a virus.  The patient began to feel worse and was seen by the physician a second time.  The physician treated her with azithromycin (ZITHROMAX).  The time between the two doctor visits was unspecified.  Two weeks later on 13-JAN-2008 the daughter began her menses and experienced a lot of stabbing pain of the lower abdomen prior to and during menses.  The patient was also very tired.  The menses lasted five days.  On 20-FEB-2008 the patient began her menses with pain prior to and during the menses.  The patient was also very tired.  The menses lasted three days and was very light.  On 06-MAR-2008 the patient experienced pain in the abdomen (a sign her menses could be starting again).  It was reported that the patient was experiencing headaches during her periods, which have been more frequent then before.  In order to treat the headaches the patient was taking ibuprofen (MOTRIN).  The patient's mother spoke to the physician on 25-FEB-2008.  A throat culture was performed for strep throat and was negative.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  The pain during injection, stabbing pain in the lower abdomen, painful menses, tiredness, headaches, light menses, difficulty driving, congestion, frequent menses, and probable virus were considered to be disabling due to the patient not being able to "concentrate" and not being able to "keep up with her school work."  Additional information has been requested.
Had chicken pox rash all over body on arm, chest, back, scalp, feet, legs. Really itchy. Lumps behind ear lobes.
PATIENT ERRONEOUSLY RECEIVED THE JOHNSON & JOHNSON INSTEAD OF THE SECOND DOSE OF MODERNA  VACCINE. ABOUT 8PM THAT SAME DAY PATIENT BEGAN FEELIING SIDE EFFECTS OF HEADACHE, FEVER, CHILLS AND BODY ACHES FOR 4 TO 5 DAYS . PATIENT STATES SHE STILL GET HEADACHES AND BODY ACHES.CONTINOUSLY TIRED AND  HAVING PROBLEM WITH BLURRY VISION IN RIGHT EYE.
Pain in shoulder/arm more than what would be described as being "punched in the arm" for three days.  Intermittent chest pain/squeezing sensation over the period of 10-14 days tapering off in frequency and intensity during that time period.