chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthralgia, Hands and feet were warm and painful, diminished grip strength and unable to make a first with hands due to stiffness Narrative: Employee missed work second to significant foot and hand pain and stiffness
This is a spontaneous report from a non-clinical study program. A contactable male consumer of an unspecified age and ethnicity received PREVNAR. via an unspecified route of administration, on an unspecified date. The consumer's medical history and concomitant medication were not reported. The consumer reported that he had shoulder pain and soreness in his arm; it was confirmed that the events started after receiving the PREVNAR. The consumer's clinical outcome was not specified. Follow-up attempts completed. No further information expected.
Vomiting; dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Spike in blood pressure), PYREXIA (fever), CHILLS (chills), LYMPHADENOPATHY (swelling of lymph node groin) and PAIN (body ache all over and joint, muscle) in a 65-year-old male patient 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 information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Spike in blood pressure), PYREXIA (fever), CHILLS (chills), LYMPHADENOPATHY (swelling of lymph node groin), PAIN (body ache all over and joint, muscle), BLOOD GLUCOSE INCREASED (high glucose), DIZZINESS (dizziness) and HYPOTENSION (hypotension).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
NOSE BLEED; This spontaneous report received from a patient concerned an 81-year-old female. 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: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered at right arm on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 09-JAN-2022, patient experienced nose bleed and called 911, ambulance came and transported her to the ER (emergency room). The hospital kept her overnight and the treatment was packing in both nostrils and was put on put on Cephalexin 250mg 1 capsule by mouth four times daily for 5 days. The patient was released from hospital on 10-JAN-2022, the patient hospitalized for 2 days and was advised to call 911 immediately, if the event recur. The packing was left in for 5 days, the packing was removed by ENT (ears, nose and throat) on 14-JAN-2022. The patient stated it occurred again on 17-JAN-2022, 911 call was placed and the patient was taken to the hospital emergency room via ambulance. She was not admitted and the hospital administered packing on the right side of her nostril. This remained for another 5 days, removed on the 21-Jan-2022 by doctor from ENT and the doctor also catharized her right nostril. The patient stated that it seems to start on both sides and blood also comes out of the mouth. The patient also reported that her hemoglobin dropped to 10.3 (units unspecified) on 10-JAN-2022. The nose bleed occurred again on 26-JAN-2022 with another 911 call placed and was taken to the emergency room. The treatment consisted of no packing. The patient was sent to ENT (after 5-hour emergency room stay). The patient saw doctor and was catharized again and was sent consumer home. The 4th occurrence was on 02-FEB-2022. The patient was able to stop the bleeding herself and went to the ENT immediately. Doctor did catharized the right nostril again which led to bleeding then she had to have balloon packing. The patient was started, again on Cephalexin 500mg 1 capsule by mouth twice daily for 5 days. The balloon packing was removed 08-FEB-2022 and was replaced with a soluble packing that will dissolve on its own. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nose bleed. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220224843-covid-19 vaccine ad26.cov2.s-Nose bleed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On 1/23/01, went to the ER with a high fever of 105.2F. While in the ER, was noted to have a seizure lasting less than 20 seconds. Returned to normal after that.
I have a line of rash forming (lichen striatum maybe?) about five inches long on my left arm opposite of my elbow. Just started forming a few days ago and becoming more itchy.
This spontaneous report was received from a medical assistant and refers to a 5 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 07-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Right antecubital, periarticular elbow swelling, erythema, warmth, tenderness; arm elevation, cold packs.
About a week and a half after receiving Moderna booster shot, entire body began breaking out in itchy hives that would appear/disappear/reappear over time
initial normal soreness in arm at injection site, followed by fatigue and flulike symptoms going on 14 days now.  Some improvement but continue to feel somewhat breathless at times, extreme fatigue  (abnormal for me), decreased appetite, muscle aches (severe at times), tightness in my jaw on left side with noticeable jaw clicking that I have never had, and on day 3 woke with severe, noticeable swelling in my left axilla (egg shaped and protruding) and my left neck/jaw -- also seems to be in the lymph node area.  Underarm swelling improved but still have a sense of tightness in my neck and jaw.
Within 24 hours of vaccine, local tenderness, swelling, erythema, fever, palpitations, HA, dyspnea. Vital signs 24 hours after vaccine: temp 101.5 oral; pulse 134; BP 136/80; R 15; Pulse Ox 95. Patient given Benadryl and Toprol after CXR, EKG and CB work done. Significant improvement after 5 days.
sprained ankle; Got really sick/ kind of a bad cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 12Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Were outside playing also has asthma; "sprain ankle", start date: 2020 (not ongoing). The patient's concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 05Mar2021, outcome "recovered" (12Mar2021), described as "Got really sick/ kind of a bad cold"; LIGAMENT SPRAIN (non-serious) with onset 12Mar2021, outcome "unknown", described as "sprained ankle". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was had a family of around 4 children, wearing masks and social distancing - no other ones got sick. The patient was supposed to receive the 2nd dose of BNT162B2 on 05Mar2021 but could not go to the vaccine location as she was unable to drive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 18-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020353 and expiration date 28-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Antibodies got lower after receiving the bivalent vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (Antibodies got lower after receiving the bivalent vaccine) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Antibodies got lower after receiving the bivalent vaccine). At the time of the report, IMMUNISATION REACTION (Antibodies got lower after receiving the bivalent vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.
PT HAD RECEIVED COVID VACCINE LATE MORNING, SHE WAS DUE FOR HER DEPO SHOT,  SHE RETURNED AFTER LUNCH AND RECEIVED HER DEPO SHOT ON OPOSITE HIP SITE FROM COVID VACCINE  (SAME MANUFACTURER AS PREVIOUS 2 DOSES) ABOUT 2-2 1/2 HOUR LATER.  15-25 MINUTES AFTER DEPO SHOT REPORTED HAVING TROUBLE BREATHING WELL, RED FLUSHING.  SPO2 98%, PULSE 122, BP 100/50.  TREATED WITH BENADRYL  50 MG IM, OBSERVED FOR APPROXIMATELY 1 HOUR AFTER REACTION AND PT'S SX RESOLVED AN DPT ACCOMPANIED HOME BY HER MOTHER.
After receiving vaccine patient complaining of, nausea, dizziness, and back pain. Vital signs: B/P 110/82 Pulse-76 Respirations 20  Oxygen Saturation 100% Patient assessed by a provider, no further treatment necessary.  Patient had family member come pick her up and drive her home.  Advised patient if symptoms worsened to go to nearest hospital.   2pm vaccine administered  2:15pm  Complaining of nausea, dizziness, back pain vital signs taken  2:20pm provider assessed patient  2:30pm provider cleared patient to go home no further treatment necessary  3:15pm patient sister arrived to pick patient up, patient symptoms improving no further complaints.
rt outer arm w/red, warm pruritic area 5x4cm w/small papules, non tender;
NauseaVomiting FATIGUE, TENDERNESS AT INJECTION SITE Narrative:
Massive right MCA stroke 31 hours after receiving vaccine, resulting in death 5 1/2 days later.
Pt is under the recommended age group for this shot and received 1 dose inadvertently.  Pt never had any adverse reactions from the one dose
Tenderness, soreness, and pain at the site of injection, feeling tired and pain when moving the arm. Patient has been using ice pack and ADVIL and still complain of the pain. Her doctor advised increasing ibuprofen to 400 mg every 8 hours and follow up after a couple of days.
Temp 101F, febrile seizure - 30 seconds tonic/clonic then intermittent tremors for 15 minutes. Postictal drowsy for 1-2 hrs.
I took the first Pfizer COVID 19 vaccine and within 4 weeks I had appendicitis. No one in my family has ever had this. I had to have an appendectomy to remove my appendix.
Immunizations given 4/2/14. URI vs allergic rhinitis started on 4/14/14. 4/16/14 pt started with facial droop. Seen 4/16 in urgent care and ED. Dx with Bell's palsy.
Pt came into office stated had shingles vaccine at the pharmacy yesterday. She had reddened area 120cm long 80cm wide on outer left arm c/o itching. No fever, no breathing problems.
Pt had Pneumovax in right arm 10/10/2005 developed redness and pain right upper arm 10/11/2005.
Employee stated after 20 minutes when she received 3rd HEP - b shot, she felt nauseous and hot. Later she stated that she vomited twice. Clinic was contacted condition of employee was related to person on line. That person talked with employee, asked questions  employee stated that now she was having chest discomfort. Clinic advised that 911 should be called or someone transport her to the ER. 911 was called, Fire Department responded and employee to the ER. Unknown of the treatment employee received.
Myalgia, Fever, SkinRash, CHILLS Narrative: STAYED HOME FROM WORK/REC PCP
DEATH Narrative: 73 y.o. male with pmh severe COPD, CAD, HTN, hypothyroidism, OSA treated with CPAP, obesity. Noted to have engaged with Pulmonary clinic in December 2020 for worsening respiratory status. No PFTs since 2015. Was found slumped over deceased in his home on the afternoon of 2/24/2021. Medical Examiner notified. Request sent to ME office for report if one exists. No drugs or alcohol were found on the scene andno sign of trama. Hypertensive cardiovascular disease were reported as an adequate cause for death. "pathologist" reported that Covid vaccine does not need to be listed as it was "more than 24 hours since the shot".
Approximately an hour after vaccination, patient started feeling jittery, nausea, some abnormal tightness in her chest, metallic taste in her mouth, lip tingling. Then began to hyperventilate. Treated with Diphenhydramine 50mg/ml: 25mg, Solu-Medrol 125mg/2ml: 125mg, and Ondanestron (Zofran) 2mg/ml: 4mg through an IV drip. Pt improved and was able to transported home by family member. Not at work today. No other vaccine reaction to past COVID-19 vaccinations other than heavy fatigue.
Information has been received from a nurse concerning a "young" female who was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). "A while ago," the patient fainted after receiving HPV rL1 6 11 16 18 VLP vaccine. The patient's outcome was not reported. Additional information has been requested.
Intense sinus pain and pressure; Intense sinus pain and pressure; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PAIN (Intense sinus pain and pressure), PARANASAL SINUS DISCOMFORT (Intense sinus pain and pressure) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Eustachian tube dysfunction. Concurrent medical conditions included Asthma, Drug allergy (Codeine allergy), Allergy to antibiotic (Flagyl allergy) and Anxiety. Concomitant products included ALBUTEROL [SALBUTAMOL], PARACETAMOL (TYLENOL) and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced SINUS PAIN (Intense sinus pain and pressure), PARANASAL SINUS DISCOMFORT (Intense sinus pain and pressure) and NAUSEA (Nausea). The patient was treated with ONDANSETRON HYDROCHLORIDE DIHYDRATE (ZOFRAN [ONDANSETRON HYDROCHLORIDE DIHYDRATE]) for Nausea, at an unspecified dose and frequency. At the time of the report, SINUS PAIN (Intense sinus pain and pressure) and PARANASAL SINUS DISCOMFORT (Intense sinus pain and pressure) outcome was unknown and NAUSEA (Nausea) had not resolved.            It was reported that the patient started treatment with a co-suspect product on 03-May-2022 for COVID-19 treatment with the batch number FY8914 and stopped therapy on 07-May-2022.  The device date was reported as 14-May-2022.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment and the patient had also previously received a COVID-19 vaccine.  The event of nausea was not resolved by taking Zofran.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2012, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Approximately 1 hour after receiving vaccine, pt states he felt chills/body sweats/all over body ache/sore throat. Pt states he saw white patches on the back left side of throat.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Shingrix for prophylaxis. The patient's past medical history included breast cancer (didn't get any vaccine or blood work done in right arm). Previously administered products included herpes zoster (received ZVL vaccine 5 years before the reporting date) and Shingrix (1st dose received on an unknown date). In July 2018, the patient received the 2nd dose of Shingrix. In July 2018, 1 day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The patient received 1st dose of Shingrix without any issue. The age at vaccination was not reported. The patient received shingrix vaccine in left arm. The patient experienced minimal achiness in arm and it resolved quickly. This case was linked with case US2018156128 (wife's case), reported by the same reporter for the same patient. The reporter's healthcare professional was not asked.
a ringing in the ears, tinnitus,It's like a hissing and it's been consisting; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (a ringing in the ears, tinnitus,It's like a hissing and it's been consisting) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced TINNITUS (a ringing in the ears, tinnitus,It's like a hissing and it's been consisting). At the time of the report, TINNITUS (a ringing in the ears, tinnitus,It's like a hissing and it's been consisting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-075096 (Patient Link).
I had a really sore arm (right).  I couldn't move it, I had a fever, chills, body aches, bad headache.
Cellulitis and induration with erythema and warmth.  Keflex 500mg TID q 7 days PO
This spontaneous report as received from a registered nurse refers to a female patient of unknown age (currently 19 years old, age at the time of event unspecified. Nurse stated that other patient's mother told her that she recently (date unspecified) saw on the internet a news story about 2 women who are sisters, the first 19 years old. On an unknown date, the patient was vaccinated with GARDASIL series (dose, route, dates not specified) and on an unknown date, the patient experienced early menopause. The outcome of early menopause was unknown. Relatedness was not reported. This is one of several reports from the same source (MARRS # 1311USA009480 sibling, MARRS # 1311USA004306). Additional information has been requested.
Information has been received from a registered nurse concerning an approximately 17 month old female who in May 2005, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In October 2005, the patient presented to the office with singles on her face, chin and neck. On 10/11/2005 swabs and slides were obtained from a papule lesion. The specimen was adequate. On 10/12/2005, the VZV DNA sample was amplified and the VZV strain was identified as vaccine type. Additional information has been requested.
This spontaneous report as received from a registered pharmacist refers to a 90 years old female patient with arthritis and coronary artery disease (CAD). The patient's medical history included breast cancer, transient ischaemic attack (TIA), cerebrovascular accident (CVA), hysterectomy, cholecystectomy and appendicetomy. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) IM on 08-DEC-2012. No other co-suspects were reported. Concomitant medications included hydrocodone, acetaminophen and vitamin E. The pharmacist reported that on 08-DEC-2012 the patient started shaking, got chills, and her nail beds turned blue. Her blood oxygen saturation dropped and the health care providers present called 911. The pharmacist did not know if the patient was hospitalized or if any life sustaining measures were performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Patient began taking oral typhoid pills every other day.  He took the capsule at 7:00 AM every other morning.  By 1:00 PM on the day he took the vaccine, he began to have bouts of diarrhea.  The diarrhea was significant enough that he self-treated himself with Immodium AD.  He did complete the series of 4 capsules.  He did not have diarrhea on the days he did not take the oral typhoid vaccine.  Patient had previously used the oral typhoid vaccine in 1998.  He does not recall any side effects at that time.