chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had Covid 2 months ago, took Plaxovid. Then took flu vaccine. Dec. 12 ,2022 developed bleeding gums, nose bleed, mouth blood spots, petechiae on face and covering legs, bruising on arms and legs was admitted urgently to hospital with sudden ITP. Had a platelet count of 1, (with value range of 150-300). Given high dose steroids, IVIG treatments over 4 days. Platelets at 40 as of 12/21/22. Follow up with hematologist for weekly checks and possible long term treatments!!
hot to touch; hardness underneath the injection site; shoulder felt like a lot of itching underneath the skin where the shot was at; Injection site is also bright pink/Pink moving from side of arm to the front of arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (hot to touch), INJECTION SITE INDURATION (hardness underneath the injection site), INJECTION SITE PRURITUS (shoulder felt like a lot of itching underneath the skin where the shot was at) and INJECTION SITE ERYTHEMA (Injection site is also bright pink/Pink moving from side of arm to the front of arm) 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 No adverse event.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot to touch), INJECTION SITE INDURATION (hardness underneath the injection site), INJECTION SITE PRURITUS (shoulder felt like a lot of itching underneath the skin where the shot was at) and INJECTION SITE ERYTHEMA (Injection site is also bright pink/Pink moving from side of arm to the front of arm).   At the time of the report, INJECTION SITE WARMTH (hot to touch), INJECTION SITE INDURATION (hardness underneath the injection site), INJECTION SITE PRURITUS (shoulder felt like a lot of itching underneath the skin where the shot was at) and INJECTION SITE ERYTHEMA (Injection site is also bright pink/Pink moving from side of arm to the front of arm) outcome was unknown.      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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Body chills; fever that went up to 100.4 degrees F.; fatigue; excess mucus; bone pain 10/10; muscle pain 8/10; other vaccine same date vaccine date 05Jan2021; This is a spontaneous report from a contactable other health professional (patient). A 66-year-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included DM type 2, hypertension (HTN), fibromyalgia, chronic asthma, Covid prior vaccination, No Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered at Nursing Home/Senior Living Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other vaccine same date included other vaccine same date product was Pfizer, other vaccine same date vaccine date 05Jan2021. On 06Jan2021, the patient experienced Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. No treatment received for the adverse events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus. The events were non-serious per the reporter. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events Body chills, fever that went up to 100.4 degrees F., bone pain 10/10, muscle pain 8/10, fatigue and excess mucus was recovering.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bone and muscle pain cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Drew up dose in Safety Syringe. at administration, due to the lurer lock not being tight enough, the pressure of pushing the vaccine into the muscle caused the connection to come apart. the needle tip stayed in the patient's arm as I held the barrel. The serum did not go into patient's arm, instead sprayed onto the patient's arm and shirt. I was able to remove the needle tip from her arm without incident. Administered a new dose into same deltoid muscle. Patient reports arm swelling. Advised to apply ice intermittently.
itchy raised hive-like rash appeared about 1 week after vaccine was given at injection site spreading to approx. 10x6cm
Patient called on 10/20/2017 to mention that she had swelling at her injection site that had not gone down. She also mentioned a small 50 cent size lump next to the injection. It was simply red, tender, and sore. There was no heat reported. I mentioned to the patient that it is a normal reaction from a vaccine and was mentioned to her and on the VIS form however the length that the swelling was present is abnormal. I mentioned that the pharmacist that administered the shot would reach out to her (which he did on the date the ADR was reported) and to also follow up with her PCP that was listed on her Vaccine Administration Record and Informed Consent paperwork.
5 days after getting covid vaccine  vaccine #1 developed a numbness/tingling to posterior legs with a reported bilateral weakness starting in feet and legs that moved up to her upper body. She described it as "feeling like something was pushing down on me making it hard for me to stand" she continued to feel very tired and when she struggled to lift up a milk jug she went to the ER for further evaluation on 4/25/21
Slurred speech, ataxia, change in mental status lasted approximately 30 minutes.  Patient brought in to be seen by doctor again at 8:00 pm.  Normal physical exam and patient acting normally at 8:00 pm.  No seizure activity.  No redness or swelling over arms.Dystonic reaction
08/26/2022: Pt. reports rash and bumps the size of a quarter and itchiness. Taking Benadryl. 08/30/2022: Pt. reports redness was the size of his hand on 08/27/2022 but bumps on the skin remained the size of a quarter. Pt. states that he is using Benadryl spray and rash is improving. No other symptoms.
220 PM (10-26-2017) pt. came back to clinic with co-worker. Described symptoms of itching, twitching of left arm, headache, body aches. Said he has BENADRYL. Said he will take some. Said he also has EPIPEN. Told him to follow up if worse. Follow up with clinic manager. She said he took BENADRYL and all is well at 415 PM.
COVID+ 1/17/2023.  Vaccination status - Moderna x4 + Moderna BIVALENT booster Discharge Summary MD (Physician) ? ? General Medicine  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/17/2023 Discharge Date: 01/19/2023      Active Hospital Problems   Diagnosis Date Noted POA ? Diabetic ulcer of right midfoot associated with type 2 diabetes mellitus, with fat layer exposed  01/18/2023 Yes ? COVID 01/17/2023 Yes ? Type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin     Active Issues Requiring Follow-up:  T2DM Diabetes Discharge Planning: ? The patient's wife is receiving OmniPod some time this week and will transition from V-Go which should make controlling his blood sugars easier.  Should follow with outpatient provider to have this set up and pt/wife be trained in its use ? Transition back to V-GO not advised, as the patient's wife informed provider that pt has multiple episodes of hypoglycemia at home if he does not eat before bed + early in morning.    Discharge Plan: ? Safe for discharge to home with ordered medication doses.  Do not resume Vgo.  Pt to start Omnipod when able/trained. ? Metformin use questionable in this pt due to age and declining renal function.  However his dosage is within the perimeters of his reduced GFR (500mg twice daily), will need close monitoring by PCP. ? SGLT2 would be indicated due to CKD.  This can cause fluctuations in glucose levels and would likely need insulin regimen adjustments Chronic Wounds ?  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID   HOSPITAL COURSE: Patient is a 85 y.o. male who presented with weakness, nausea, vomiting, diarrhea, lightheadedness x 2 days duration. He developed a cough so wife administered a COVID-19 test which was positive. He reported ongoing symptoms on adm. They are concerned about him going home with these symptoms, as his primary caregiver / spouse is also sick with COVID-19 and feeling unwell. Hemodynamically stable in the ED, desaturation on room air. Mild metabolic acidosis on CMP with creatinine at baseline. No leukocytosis. One hypoglycemic reading with three other normal readings. +covid-19 pcr. No cxr. Given 500cc NS once and dextrose in ED.  He was weaned off supplemental o2 and evaluated by pulm rehab/pt/ot who stated patient would need home with pt but no oxygen on discharge. His course was complicated by hypoglycemic episodes after patient refused to remove his insulin pump on admission. Once pump removed from patient, consulted for labile glucose levels. He had adjustments made in his diabetes medications and had improvement in glu levels. He was discharged home in stable conditions with plans for close follow up and teaching of upcoming diabetes medication changes.
A non-serious report of expired dose administered has been received from a nurse concerning a child of unknown age and gender. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 11-Jan-2008. The dose of vaccine that the patient received on 11-Jan-2008 had an expiration date of 10-Jan-2008. No events were reported at the time of the report. Upon follow-up, the Office Manager reported that no adverse events had developed as of 08-Feb-2008. The event resolved. The patient did not experience any rechallenge while receiving the suspect product. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Additional information received 08-Feb-2008 and incorporated into the narrative no adverse events had been reported. This case is limited to MEDI-0006394, the other case from the same reporter.
Monovalent given in error- Pharmacy dispensed original COVID vaccine when facility requested Bivalent.  Facility administered monovalent.
Patient called the pharmacy about 3 hours after the vaccine was administered indicating that she was having heart palpitations and was very dizzy/unable to stand.  It is unknown whether this is directly related to the vaccine so she was instructed her to call her physician immediately.
Swollen, itchy, painful, hot lump about 4 inches under the skin at injection site one week after receiving the shot
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA 25/0.5 (lot #, dose and frequency were unknown). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer BioNTech vaccine on 1/2/22, 1/23/2021 and 10/7/2021. COVID-19+ and hypoxic w/O2 sat of 85% on 5L NC. Clinic exam and initial labs consistent w/Covid PNA, afebrile, labs wnl. Admitted, initially maintaining sats on HFNC, acutely decompensated despite standard of care Covid interventions. Transitioned to inpatient hospice and expired on 10/06/22. Tx'd w/decadron and remdesivir
5 x 3cm faint erythema, firm. Non-tender. May apply warm compress and Flu 2 days.
Pt presented 6/26/08 6"x7" redness noted to L anterior thigh with swelling and warm to touch. Mother stated was fine yesterday and this AM. States it started sometime this afternoon. Seen to ER for eval.
During a review of the local Department of Health?s internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
outbreak of herpes; This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.     Additional Information: Reporter's Comment: The reporter reported this case via interactive digital media. The patient received dose of Shingrix vaccine and experienced outbreak of herpes. The patient was at the 6 month mark for his/her second dose, but was experiencing an outbreak of herpes. The patient asked how long did he/she wait for second dose if had having an outbreak of herpes. The patient also asked how long did he/she need to wait and amp, was that ok for effectiveness. Additional supportive information: The follow-up would not possible, as no contact, details were available.
The morning of 10th of December I woke up with nasal congestion and a sore throat. I tested after being in close contact with someone that tested positive for COVID-19 on 12-6. The results were positive for COVID-19 I the scheduled a virtual visit and the doctor prescribed PAXLOVID. I started taking the medication and with mild symptoms I recovered within hours or so it seems. If I wasn't around a person with a positive COVID-19 test I don't think I would've tested because the symptoms were very mild.
I have a large red, swollen, raised mark at the injection site that did not develop until 8 days post injection; low-grade fever, red mark is warm to the touch;
Patient received MMR  on 10/13/21, vaccine expired on 10/10/21.  No follow-up treatment given and patient did not experience any adverse outcome.
He was limping one day after the shots and was refusing to walk - gait had improve but still walks abnormal - no swelling or redness at sites probable toxic synontis .
Got shot but had shingles/Suspected vaccination failure; shingles/ still have problems; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got shot but had a really bad case of shingles and still had problems. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Client presented to the vaccination site with her sons. Client received Pfizer booster, LOT# FL3197 (left arm) at 10:45 on 01/05/2022. Client received the 1st dose Pfizer Lot# EW0183 on 05/14/2021 and 2nd dose Pfizer Lot# EW0178 on 06/08/2021. At approximately 1055, client complained of tingling, numbness in throat. RN 1 responded. Client was alert and oriented to person, place, time and situation and sitting in chair. Client's vital signs were obtained by RN 2: BP 162/99, P 66, O2 99%. Client reported, "My lips are numb and swelling." Client denied shortness of breath, dizziness, headache. Client has no history of allergies. RN 3 assessed client and prepared 50mg/1ml diphenhydramine. Diphenhydramine 50mg/ml was given IM (right arm) by RN 1 with patient permission at 1110. Client's vital signs were obtained at 1115: BP 141/97, P 65, R 16, O2 99%. Client stated that her lips were better, no tingling, her throat remained numb. Client was able to breath and swallow. Client was not taking any medications. Client denied any allergic reactions with her 1st and 2nd dose of Pfizer Covid vaccines. Client's vital signs at 11:20 AM: BP 157/107, P 74, R 16, O2 99%. Client stated that her throat was still numb and denied difficulty breathing, chest pain or other symptoms. RN 1 educated client on side effects of diphenhydramine, signs and symptoms of when to seek care, follow up with PCP and use of V-safe. Client verbalized understanding. Client's vital signs at 11:30 AM: 156/98, P 66, R 16, 02 99%. Client reported, "I'm feeling better, my throat was less tingling". Client stated that her son will drive her home. Client left facility with unlabored respirations and a steady gait at 1152.
having really bad body aches; bad headaches; Also rash like bruising on both lower legs; Also rash like bruising on both lower legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Sep2021 16:45 (Lot number: 301308A) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma and High Blood Pressure" (unspecified if ongoing); "Asthma and High Blood Pressure" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: PAIN (non-serious) with onset 15Sep2021 17:30, outcome "not recovered", described as "having really bad body aches"; HEADACHE (non-serious) with onset 15Sep2021 17:30, outcome "not recovered", described as "bad headaches"; RASH (non-serious), CONTUSION (non-serious) all with onset 15Sep2021 17:30, outcome "not recovered" and all described as "Also rash like bruising on both lower legs". The events "having really bad body aches", "bad headaches", "also rash like bruising on both lower legs" and "also rash like bruising on both lower legs" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, headache, rash, contusion.  Clinical course: Patient day 8 started having really bad body aches and bad headaches. Also rash like bruising on both lower legs. Went to emergency on day 9 they did COVID, flu and strep test all came back negative. Still having all same symptoms. No COVID prior vaccination.COVID tested post vaccination. No known allergies. No other vaccine in four weeks. Patient took other medications in two weeks. No COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-up attempts are completed. No further information is expected.
Itchy @15min mark, 2hr mark, 12hr mark, 36-72 hr mark.; Increased heat rate @ 15 min mark,12 hr mark.; Mild chest pain right arm down to right butt cheek pain @ 7 day mark.; Mild chest pain right arm down to right butt cheek pain @ 7 day mark.; Mild chest pain right arm down to right butt cheek pain @ 7 day mark.; Cheek pain/Mild chest pain right arm down to rightbutt cheek pain @ 7 day mark.; Injection site itchy & sore callous @ 8 day mark.; Injection site itchy & sore callous @ 8 day mark.; This is a spontaneous report from a contactable other healthcare professional.  A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PfizevER8732) via an intramuscular route of administration in the right arm on 30Mar2021 at 08:15 as a single dose for COVID-19 immunisation. Medical history included chronic sinus (chronic sinusitis). Concomitant medications were not reported. The patient had allergies to medications, food or other products (unspecified).  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at 08:45, the patient experienced itchy at 15min mark, 2hr mark, 12hr mark, 36-72 hr mark and increased heart rate at 15 min mark, 12 hr mark. On an unknown date in Mar2021, the patient experienced mild chest pain right arm down to right butt cheek pain @ 7-day mark, injection site itchy and sore callus at 8day mark. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itchy at 15min mark, 2hr mark, 12hr mark, 36-72 hr mark, increased heart rate at 15 min mark, 12 hr mark, mild chest pain right arm down to right butt cheek pain @ 7-day mark, injection site itchy and sore callus at 8day mark was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Low-grade fever (99.5) that responded to alternating Tylenol and Advil Chills Body aches Swollen lymph node in left armpit Fatigue Lethargy Heart racing
Extreme chills and sweats. Body aches severe enough to not be able to move. Headache for 4-5 days. Nausea for about 8 hours. Extreme fatigue