chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented in my office on 10/18/2018 with an acute pruritic rash which appeared to be hives to both arms, posterior trunk, and scalp. Pt reported the rash initially began on RUE between 10/14/2018 to 10/15/2018, and progressively spread to other areas as noted above. Pt mentioned having pre-travel vaccinations on 10/11/2018 for preparation for trip at clinic as listed. Other than the recent vaccinations, we cannot pinpoint any relative causes for the signs and symptoms described.
Site reaction (L) deltoid; positive edema, positive erythema, positive induration, positive warmth to palpation.
Vaccine administered after the 31 day refrigerated beyond use dat but before the 45 day excursion date.
Information has been received from a licensed practical nurse concerning a 4 year old female with asthma and no siblings, who on 24-APR-2006 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot# 650233/0912R, site of administration not reported) and on the same she was also vaccinated intramuscularly with the fifth dose of PREVNAR (Wyeth, lot# B08638H). On 04-AUG-2009 the patient developed rash on leg for 2 days, papular-vesicular in crops on upper back, abdomen and it was itchy. On 11-AUG-2009 the patient recovered. Additional information is not expected.
Pt received vaccines on 3/17/2006. Pt died 3/18/2006. Autopsy pending. 8/3/06 Received autopsy report which revealed COD as undetermined.  Pathological diagnoses was intra-alveolar hemorrhage/ss
Narrative: Pt was given a Moderna COVID-19 vaccination at Facility 1/30/2021. Per immunization registry information, he received a J&J vaccination on 5/22 at outside pharmacy. Pharmacy notified. Unknow if patient had any adverse reaction to vaccine as second vaccine was administered outside the facility.
not feel like her usual self; Fever 99.9 F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feel like her usual self) and PYREXIA (Fever 99.9 F) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING ABNORMAL (not feel like her usual self) and PYREXIA (Fever 99.9 F). At the time of the report, FEELING ABNORMAL (not feel like her usual self) and PYREXIA (Fever 99.9 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: fever 99.9 f (High) 99.9 F.         No relevant concomitant medication was reported.   Treatment information was not provided.
pt recv vax 13NOV95 & pt exp fever greater than 100, lethargy & was edgy;pt was vaccinated @ work & then fell into a deep sleep;
Patient received the COVID-19 Pfizer vaccine at 9:06 am on 2/28/2021. Patient began to experience an itchy throat and body. Benadryl IM Injection was given in the right arm at 09:32 AM lot number 6124005, EXP 04/22. Patient was also given a Kenalog 40mg IM at 10:10 AM. Kenalog lot number AP200265C, EXP 9/22.
Case was vaccinated for Covid in November, then hospitalized for Covid 2 months later.  Hospitalized at:     Acute respiratory failure with hypoxia Patient presented hypoxic on admission, requiring 5 L supplemental O2. Had been previously discharged on 1/29/22 after positive COVID test (1/24) requiring 1L O2. CXR in ED showing new linear opacity in major fissure of right lung, changed from prior on 1/31. Likely represents atelectasis. Also considered pneumonia given worsening O2 requirement, elevated WBC with neutrophil predominance, procalcitonin of 2.05. Renal-dosed Augmentin started 2/6/22, received 6 doses (bid dosing), discontinued 2/9 given lack of improvement in respiratory status, lack of convincing evidence on CXR. Dexamethasone continued given concern for reactive airway with smoking/asthma hx, may have undiagnosed COPD. ON 2/8 and 2/9 she continued to have worsening of her symptoms and so alternate differentials were considered including PE, bacterial pneumonia, etc but with stable vitals and so her condition was conservatively managed with watchful waiting. She was improving by 2/10 and off oxygen by 2/11 and was discharged home. She did receive Combivent inhaler Q6h during admission and worked with PT/OT.
Inflammation; Swollen lips; Cracked lips; lips peeling; Tongue dark red; Dry cough; Rash; skin discoloration; skin peeling from bottom of feet; nail broken; redness mouth; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling) and TONGUE ERYTHEMA (Tongue dark red) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 41L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling), TONGUE ERYTHEMA (Tongue dark red), COUGH (Dry cough), RASH (Rash), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (skin peeling from bottom of feet), ONYCHOCLASIS (nail broken) and ORAL MUCOSAL ERYTHEMA (redness mouth). At the time of the report, INFLAMMATION (Inflammation), LIP SWELLING (Swollen lips), CHAPPED LIPS (Cracked lips), LIP EXFOLIATION (lips peeling), TONGUE ERYTHEMA (Tongue dark red), COUGH (Dry cough), RASH (Rash), SKIN DISCOLOURATION (skin discoloration), SKIN EXFOLIATION (skin peeling from bottom of feet), ONYCHOCLASIS (nail broken) and ORAL MUCOSAL ERYTHEMA (redness mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant information was not provided.  The treatment information was not provided.  The inflammation was on  80% of patients body.
Pt fainted about 2 minutes after the completion of both vaccinations.  Talking with family, father looked over and pt's head was slumped over.  We moved patient to bench with head elevated and she immediately recovered consciousness.  Asked current event questions and he responded immediately and correctly.  Patient sat around for 5 minutes and father decided to take her home.
Hospitalized 1/6/22-1/7/22 Weakness, dizziness, SOB, cough, UTI
a lot of infections; titers for 21 out of the 23 serotypes; This spontaneous report was received from a pharmacist referring to a female patient of unknown age.  The patient's concurrent conditions included asthma. Her historical conditions and concomitant medications were not reported.  On an unknown date, presumably, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route, anatomical location, lot # and expiration date not reported) for prophylaxis.  On an unknown date, the patient had an immunology test that showed she had titers for 21 out of the 23 serotypes in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (antibody test negative). Additionally, the patient got a lot of unspecified infections. At the time of the report, the outcome of antibody test negative and infection was unknown.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), antibody test negative and infection was not reported.
Had Menactra immunization administered 09/14/2005 went to school nurse 09/15/2005 with fluid filled vesicles, irregular shaped. One inch above and one to two inches below injection site. No redness or firmness. Observed by school nurse. No fever. Denies pain. Vinyl gloves used denies latex allergy.
10/24/18 Patient called, states bruise "the size of an orange" at the injection site. No pain, getting better.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperatures was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperatures was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Very bad chills, and all over body aches. Injection site was very swollen and red and hot to the touch.  PS. Just so you know i was poked twice, according to the person administering the shot the fluid was not fully injected, so i was poked twice.
This spontaneous report was received from a physician refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with M-M-R II (dose, route and frequency were not reported). On an unknown date, the patient experienced cold-like symptoms. No further description of symptoms was provided. The outcome of the event was unknown. The reporter did not provide the casualty between the event and the suspect drug. Additional information has been requested.
Started about 10 hours after the vaccine was administered. Symptoms lasted for about 18 hours   Chills Pounding Headache Full body ache Full body soreness Slight nausea
WITHIN APPROXIMATELY 20 MINUTES OF RECEIVING INACTIVATED H1N1 FLU VACCINE.  DEVELOPED GENERALIZED ITCHING AND FLAT RED RASH ON TRUNK, ARMS, AND FACE.  MOST PRONOUNCED ON ARM NEAR SITE OF INJECTION.  ORAL DIPHENHYDRAMINE AT 2:30 PM AND 3:00 PM.  AT 5:00 PM, MINIMAL ITCHING AND SLIGHT REDNESS NEAR INJECTION SITE.
On 23 February 2001, the vaccinee received her first left deltoid "adult"dose of Engerix-B. Within one hour post-vaccination, on 23 February 2001, the vaccinee experienced numbness and pain in her left arm. As of 6 March 2001, the outcome of the event was resolved.
Itchy swelling injection site. Other red spots on lower arm. Sore on tongue.
weakness; arm pain; knee pain; which increased daily for over 6 weeks; This is a spontaneous report received from contactable Consumer or other non-HCP. The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:15 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Latex" (unspecified if ongoing); "known allergies: Eye drops" (unspecified if ongoing), notes: known allergies: Eye drops. Concomitant medication(s) included: VIT D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Right), administration date: 12Mar2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "First dose felt like waking from anesthesia". The following information was reported: ASTHENIA (non-serious) with onset 07Apr2021, outcome "recovered with sequelae", described as "weakness"; PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "recovered with sequelae", described as "arm pain "; ARTHRALGIA (non-serious) with onset 07Apr2021, outcome "recovered with sequelae", described as "knee pain"; CONDITION AGGRAVATED (non-serious) with onset 07Apr2021, outcome "recovered with sequelae", described as "which increased daily for over 6 weeks". The events "weakness", "arm pain ", "knee pain" and "which increased daily for over 6 weeks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, pain in extremity, arthralgia, condition aggravated.  Additional information: The patient did not receive no other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination as Vitamin d multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Device Date mentioned as 30Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient reported nausea and vertigo immediately following administration. patient reports feeling this way after not eating enough food in the morning. patient reports possibly having hypoglycemia. her symptoms persisted for 30 minutes. the symptoms were relieved with a granola bar, water and OTC ginger dramamine.
delayed reaction at the injection site on her upper arm, itchy papule reaction; Initial information regarding this unsolicited valid non-serious case received from a physician and transmitted to Sanofi on 04-Jan-2021.  The case involved a female patient of unknown age who had a delayed reaction at the injection site on her upper arm, itchy papule reaction (vaccination site papule), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route in the upper arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious delayed reaction at the injection site on her upper arm which was a was a localized itchy papule reaction (vaccination site papule), unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It did not spread to the entire body. It persisted for days. The patient wanted to gather information on one ingredient in the vaccine. Ingredient name was Octyl phenol ethoxylate, it was related to Polyethylene-glycol. She was an essential worker and needed Covid 19 vaccine. Given the concern of allergic reaction she would like to know if that ingredient was concerning or not.  Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
She got her vaccine at 3:00 PM, and around 8:30 she got chills and had her regular clothes on, one bathroom, put on a 2nd longer and heavier bathrobe and her comforter.  Later on she started shaking uncontrollably to the point that she was thinking of calling an ambulance.  She remember around 9:30 she was watching TV and then blacked out or something and the chills went away, but the shaking then started.  She stayed up for a couple  of more hours and was OK.  She was trying to read the reactions and could not as she was shaking so bad that she couldn't look them up or make chills.   She went to bed around 2:00 AM and is OK this morning.  She does believe that she did black out.   She did not take anything for her symptoms.   She is going to call her doctor this morning.   Her arm is not red or hurting her.
This spontaneous report has been received from a physician concerning a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K009482, exp. date on 06-MAR-2017), (strength, route of administration and dose were not provided). No adverse symptoms reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient complained of dizziness, palpitations, shortness of breath 6 min after injection.   Patient's vitals at 2:35PM were 158/86 with a pulse of 71. At 2:36PM patient was transported to Patent Assistance Area for further observation.  She was discharged home.
Itching began immediately after vaccination. Injection site became red, hot, swollen and child started to run a fever of 99.8. Mother scheduled virtual visit on Saturday and gave topical benadryl and oral benadryl. Saturday evening child started to feel like something was stuck in his throat, kept clearing his throat and had trouble breathing. Mother gave benadryl again. Sunday mother used epi pen due to difficulty breathing. Injection site continued to swell, was red, hot and tender to touch. After patient received EPI all symptoms resolved. Injection site redness was gone by Monday evening and patient had no more difficulty breathing or felt like something was stuck in his throat.
Lost 17 pounds; Not getting second dose; Vomiting; Blood pressure shoot up; Heart rate shoot up; Fibromyalgia; headache; Fever; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (Fever), FATIGUE (Extreme fatigue), VOMITING (Vomiting) and WEIGHT DECREASED (Lost 17 pounds) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, METOPROLOL and ATORVASTATIN for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (headache), PYREXIA (Fever), FATIGUE (Extreme fatigue) and FIBROMYALGIA (Fibromyalgia). On 17-Mar-2021, the patient experienced VOMITING (Vomiting), BLOOD PRESSURE INCREASED (Blood pressure shoot up) and HEART RATE INCREASED (Heart rate shoot up). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 17 pounds) and PRODUCT DOSE OMISSION ISSUE (Not getting second dose). At the time of the report, HEADACHE (headache), WEIGHT DECREASED (Lost 17 pounds) and PRODUCT DOSE OMISSION ISSUE (Not getting second dose) outcome was unknown and PYREXIA (Fever), FATIGUE (Extreme fatigue), VOMITING (Vomiting), FIBROMYALGIA (Fibromyalgia), BLOOD PRESSURE INCREASED (Blood pressure shoot up) and HEART RATE INCREASED (Heart rate shoot up) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not provided.
I started to have severe chronic pain and inflammation of my joints. I was eventually diagnosed with a form of rheumatoid arthritis. I also lost 15 lbs
Pt reports 7 inch x 8 inch red induration hot to touch with red streaking . Temp 101 degrees x 2 days self care of Ibuprofen - TYLENOL then rested without being seen.
7x10cm area of erythema, induration, warmth surrounding injection site, no systemic sx, onset  1 day after immunization Rx'd with Benadryl and Prednisone and Keflex.
2 days after the second dose of the moderna vaccine I suddenly started seeing blurry out of my right eye I let it go for about 4 days thinking it was something just in my eyes I sent after that went to an urgent care at my doctor's office where they sent me to the ER I had an MRI done nothing was found was then sent to opthamologist specialist who at first diagnosed me as a torn retina second day I went to a retina specialist who confirmed it was not a torn right now but swollen behind my eyes I wasn't to be seen until another week later and hopes the swelling would go down and February 25th I return back to dr. When the retina specialist who indicated that it was still swollen and it's a possibility I will not see clearly out of that high again still waiting for various specialties
I started having pain on the inside part of my elbows. There are days I have more pain or less pain. If I touch that part it hurts a lot. Sometimes if I bend my elbows it hurt. I thought I had injured myself at the gym do I decided to rest and after resting the pain was still there so it was not a gym injury. I decided to go to the doctor and she touched my elbows and checked them out. She ordered some x-rays and on Wednesday I have an appointment with her to see the results. She told me to take aspirin for the pain.
Coughing; can't speak that good right now; Restless; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 21Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "He has kidneys" (unspecified if ongoing), notes: He has kidneys; "he is diabetic" (ongoing), notes: he is diabetic; "rather emesis his body is just staining'" (unspecified if ongoing), notes: rather emesis his body is just staining'; "rather emesis his body is just staining'" (unspecified if ongoing), notes: rather emesis his body is just staining'. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset Nov2021, outcome "unknown", described as "Coughing"; SPEECH DISORDER (non-serious) with onset Nov2021, outcome "not recovered", described as "can't speak that good right now"; RESTLESSNESS (non-serious) with onset Nov2021, outcome "unknown", described as "Restless".  Additional Information: Is COVID-19 was Vaccine a Pfizer product. COVID-19 Vaccine manufacturer was unspecified. Dates for COVID-19 Vaccine Start and stop date was unspecified. NDC number of COVID-19 Vaccine was unknown. UPC number of COVID-19 Vaccine was unknown. Reason for no lot number of COVID-19 vaccine was patient was unwilling to complete the report. Expiry Date of COVID-19 Vaccine was unknown. Patient complained about her husband that he has kidneys (Further clarifications unknown) and he is diabetic (Intent: Medical history) and he has rather emesis his body is just staining (Further clarifications unknown) or what but today he got the arm booster (Pfizer COVID-19 Vaccine). He got his booster today (means yesterday) and noticed that he started a little coughing and cannot speak that good right now, restless.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   Follow-up (01Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.      No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.