chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reactivate hepatitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hepatitis" (unspecified if ongoing), notes: He was diagnosed with hepatitis 30 years ago. The patient's concomitant medications were not reported. The following information was reported: HEPATITIS (medically significant), outcome "unknown", described as "reactivate hepatitis". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No unexpected adverse events - arm pain, chills, generalized muscle aches as typically seen with this vaccine.
Initial literature report received on 03 Jan 2011: This literature was about cases of pediatric influenza-associated deaths. To further investigate the bacterial organisms that may have contributed to death, the authors systematically collected information about bacterial cultures collected at non-sterile sites and about the timing of Staphylococcus aureus specimen collection relative to hospital admission. The authors performed a retrospective, descriptive study of all reported influenza-associated pediatric deaths in 2007/2008 season. This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on Immunization Practices) criteria. This child was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) during 2007/2008 season. It was unknown if the patient was vaccinated completely as per schedule. The child presented with influenza which later lead to death on unknown date. The causality was not reported. The authors commented that influenza-associated mortality among children is a rare event; however, healthcare providers should be mindful of the severe outcomes associated with influenza in children, especially those with high-risk medical condition. Critically ill children should be promptly treated with anti-viral medications, unless contraindicated, upon influenza diagnosis or suspicion. Because isolation of S. aureus potentially representing co-infection was identified in a substantial proportion (19%) of children with influenza-associated mortality within three days of hospital admission, healthcare providers should consider administering antimicrobial agents active against locally circulating strains of S. aureus when empirically treating children with influenza-like illness and severe respiratory illness.
L thigh swollen, hot to the touch 4" x 5" diameter area. Tx ice and heat alternating, also Advil.
Rph gave patient the moderna vaccine. after 5 minute patient felt dizzy, pale and slightly shortness of breathe. Rph took patient in the room and gave her Epipen then call 911. EMS came and evaluate the patient saying patient just panic and have fear of needle.
achy muscles, fatigue, dehydration, chills and nausea, sore arm and headache
rd streaks rash and some blisters, was worse day after injection and more 2 days after. Medical provide had me that clartin and benadryl
Information has been received from a physician concerning a 23 year old female who was vaccinated with the first dose of GARDASIL on unspecified date. The patient broke out with hives one day after her first vaccination. At the report time the patient had recovered. Additional information has been requested.
feels hot; tingling; his arm was inflammed, red and swollen; his arm was inflammed, red and swollen; his arm was inflammed, red and swollen; itching around his bicep area; headache; tired; flu like symptoms; chills; fever; body aches; not feeling well; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis.   On 25th February 2020 05:30, the patient received the 2nd dose of Shingrix. On 25th February 2020, the patient received PNEUMOVAX. On an unknown date, the dose was an unknown dose. In February 2020, 7 hrs 30 min after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fever, general body pain and feeling unwell. On 26th February 2020, the patient experienced headache and tiredness. On 28th February 2020, the patient experienced erythema of extremities, inflammation, swelling arm and pruritus. On an unknown date, the patient experienced feeling hot and tingling. The patient was treated with naproxen (Aleve) and paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, chills, fever, general body pain, feeling unwell, headache, tiredness, erythema of extremities, inflammation, swelling arm, pruritus, feeling hot and tingling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, chills, fever, general body pain, feeling unwell, headache, tiredness, erythema of extremities, inflammation, swelling arm, pruritus, feeling hot and tingling to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at 5:30pm on 25th February 2020 on left arm. The patient stated that received PneumoVax vaccine in the same arm and on the same day. The patient stated that, after vaccination went to bed and woke up about 1am with flu like symptoms, chills, fever, body aches and not feeling well. On wednesday 26th February 2020, the patient went to work but when got home, was very tired and slept. On friday 28th February 2020, the patient's arm was inflammed, red and swollen adnd was itching around his bicep area. One day after vaccination, the patient experienced headache, 2 days after vaccination experienced tiredness, 3 days after vaccination experienced erythema of extremities, inflammation localised, swelling aem and pruritus. Less than a week, after vaccination, the patient experienced feeling hot and tingling. The patient received Aleve and Tylenol but within 6 hours, the events returned. The patient stated that, the adverse events lasted through saturday. The patient was referred to his physician.   Following a correction performed, 'Drug Not Administered' was unchecked.
sore arm; positive COVID-19 test; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Jan2021 as a single dose for COVID-19 immunization. Medical history included arthritis and the patient could hardly walk because of the knee and body, in Jul2020 had the upper lung removed due to lung cancer, exposed to COVID-19 in Jan2021 (prior to the vaccination). Concomitant medications were not reported. The patient received the first vaccination on 08Jan2021 and prior in the week was exposed to COVID-19. On 15Jan2021, the patient tested positive for COVID-19. Per the patient, this was not from the vaccine. On 20Jan2021, the patient received an infusion of monoclonal antibodies as treatment for COVID-19. On an unspecified date after the first vaccination, the patient experienced a little sore arm. The clinical outcome of positive COVID-19 test and sore arm was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of COVID-19.  The reported event likely represent intercurrent medical condition.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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.,Linked Report(s) : US-PFIZER INC-2021461792 same patient/reporter/drug, different dose
Tdap given 6/2/08.  Again Tdap given 9/23/08.
Pt felt tired eve of vaccine, then got sick in the night. He hurt all over like he had flu. Injection site swollen, left lymph (axillary) glands swollen and painful. No redness at injection site and day after still had 101+ fever, pain all over body - could not work. Had chills too. 1st day took Theratin and Tylenol with no relief - then took Ibuprofen 800mg and got some relief. By Friday left axillary lymphs still swollen and sore. Sat 14th feeling much better. Left axillary lymphs down better, no fever or pain and pt went back to work. Since this is 2nd such reaction he doesn't want another in 10 years.
Chills, aches and pains, rash, headache, hard to breathe, tired, sore throat, dizzy, nauseous
24hr lt deltoid site of Td 1-2cm red non tender;24-48hr fever, myalgia, chills, gen site 4cm x 10cm;48-72 fever, chills, nausea, gen myalgia site;red,tender,swollen measured 9x18x6cm;ER visit;960144 site induration 3x4cm;non tender pt afeb
Received influenza vaccination - IM - on Thursday at elementary school. On Saturday, the child's father noted swelling of child's feet, later swelling of his hands accompanied by urticaria, and a spotty rash on his back. BENADRYL 25mg was administered with resolution of symptoms. On Sunday, symptoms in the feet returned but again resolved after administration of BENADRYL 25mg.
pt had vax 28APR94 @ 11AM & woke up crying @ 1AM 29APR94 & felt hot t104 R; pt did not eat all day; ran low grade temp; APAP given;
Took out dressing at night. Next day found blister at injection site. Contacted pharmacist and doctor.
Stiff, weak arm. Faint, sweating, pain radiated to shoulder, neck, chest.
COVID -  8L HFNC- dex start 10/13 6mg IV q12h ( on chronic prednisone at home)  Enoxaparin 100mg q12h afib  PPI 40mg daily  Remdesivir 10/14-10/17
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech; Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 23Mar2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic hypertension and high cholesterol controlled by medication" (unspecified if ongoing), notes: Chronic hypertension and high cholesterol controlled by medication; "Chronic hypertension and high cholesterol controlled by medication" (unspecified if ongoing), notes: Chronic hypertension and high cholesterol controlled by medication. The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline", notes: Known allergies: Tetracycline. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Apr2022, outcome "unknown", described as "Pfizer / BioNTech; Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Negative, notes: Tested on 08Feb2023 and test was negative for COVID; (10Feb2023) Positive, notes: Tested again on 10Feb2023. Test was positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient finished a 5-day course of Paxlovid on 03Feb2023. She started feeling better, less fatigue. Tested on 08Feb2023 and test was negative for COVID. Tested again on 10Feb2023. Test was positive for COVID. Started experiencing a recurrence in symptoms on 11Feb2023. Runny nose, congestion, headache, fatigue, no fever.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Covid + 7/26/22 Hospitalized 8/17/22-8/23/22 Wound on ankle, broken foot,  low hemoglobin, abdominal pain, anemia, GI bleed, PNA,
About 5 days post vaccination, patient developed headache, nausea, photosensitivity.  These symptoms were still lingering when I saw her on April 28th.  I am unsure if they are related to vaccination.
Vaccine on 10/1. Became ill on 10/8. Sinus infection, congestion, cough, fever, chills, fatigue, muscle and joint aches.
Muscle weakness left upper arm and left shoulder since 10/1/2007 (date of flu vaccinations).  Also left shoulder joint pain with movement and limited range of motion. Left arm paresthesia and on down to left 5th finger.
Trouble walking and getting up. Needed walker. Symptoms were similar to paralysis. Patient was better today. Symptoms lasted 6 days. Did not go to physician.
Tingling in hands progressing to weakness- started Mondy morning. Both arms and tingling in both feet.
Immediately after gettint the injection on 1/20/21, I had typical response:  muscle was sore x 2 days then nothing unusual.  I awoke six days after  the injection (1/26/21 feeling anxious, agitated, distracted.  Poor appetite throughout the day.  Later iin evening, I felt something a lot like a hot flash, I felt my face flusing, followed by hives on my chest and abdoman.  The left deltoid muscle started to itch incessantly, and the deltoid muscle began to swell.  A hard nodule at the injection site formed, initially the size of an m&m.   It grew to the size of a golf ball, then to the size of a tennis ball over the next two days.  It resolved on it's own over the next week.
Covid-19 diagnosis and symptom onset 9/7/2021 including cough, pneumonia
This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 18th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, chills, pain and influenza-like symptoms. On an unknown date, the outcome of the fever, chills, pain and influenza-like symptoms were recovered/resolved.  It was unknown if the reporter considered the fever, chills, pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: On 19th September 2018, the patient developed fever, chills and achiness like the flu about 10 hours after getting SHINGRIX. The symptoms lasted about 36 hours.
On 12/5/00, post vax, the pt experienced a reaction on her arm. She presented with diffuse erythema of upper right arm extending into axilla and down to her elbow. It was tender to palpation and hard to touch. In follow-up, the PA reported that the pt was seen on 12/7/00. The pt told the PA that she thought she was having an allergic reaction to the pneumococcal vaccine 23 polyvalent. She reported that within a few hours, post vax, she noticed redness, swelling and pain in the arm. This had progressed over the past day and now she had redness down the elbow and up into the axilla and back onto the right shoulder. On exam, the PA noted she had confluent, erythematous and a somewhat fluctuant area extending from the right axilla down to the right elbow. The fluctuance was mainly over the biceps but the tenderness to palpation was more noticeable in the right axilla and right posterior arm at the base of the right shoulder. The pt stated that she had some chills on 12/6/00. The pt took some extra strength Tylenol on 12/6/00. Pt reported she did not feel ill, just occasionally felt feverish. The affected area did not blanche to palpation. At this time the PA assessed the pt's condition as an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was given Benadryl 50mg IM and was advised to take 25-50mg every 6 hours. A line of demarcation was drawn around the erythematous area. The pt was advised not to take any acetaminophen if she started to feel like she had a fever until she took her temperature and to record it. If her temperature was over 100F she was to take acetaminophen. On 12/8/00, the pt was seen again by the PA. The pt reported that she was "much improved" and had no further chills. Her temperature has been normal and the redness was "resolving nicely". On exam, PA noted that the erythema was fading, however, it had spread down her upper arm to just below the elbow but was resolving on the shoulder area and upper arm. He noted that the area "looks much better than yesterday". The PA's assessment of the pt's condition was that she had an allergic reaction to pneumococcal vaccine 23 polyvalent. The pt was advised that she should take Benadryl on an as needed basis. The pt was also advised not to be vaccinated with this vaccine in the future. Additional information has been requested. The allergic reaction, diffuse erythema of the upper right arm extending into axilla and down to her elbow, and tender to palpation were considered to be an "Other Important Medical Event." F/U The pt's adverse experiences were considered to be other important medical events by the reporter. Follow -up info rec'd from the physician's assistant indicated that the pt adverse events improved with Benadryl and tylenol. It was reported that the pt recovered on 12/7/00. No further info is expected.
Tightness and pounding in chest, shakiness, light headedness, dizziness, weakness  - like my knees were going to give out, , shortness of breath
Major stroke within 24 hours; Left me mentally impaired; Took my eye site, my left side; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Major stroke within 24 hours) and MENTAL IMPAIRMENT (Left me mentally impaired) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. 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 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 CEREBROVASCULAR ACCIDENT (Major stroke within 24 hours) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Left me mentally impaired) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Took my eye site, my left side). At the time of the report, CEREBROVASCULAR ACCIDENT (Major stroke within 24 hours), MENTAL IMPAIRMENT (Left me mentally impaired) and VISUAL IMPAIRMENT (Took my eye site, my left side) outcome was unknown.            Concomitant medication was not provided. Patient reported that there were young athletes those were suffering from non-specific heart failure. Treatment information was not reported.  Company comment: This is a spontaneous case concerning a patient of unknow age and gender with no medical history reported, who experienced the unexpected serious (medically significant) events of cerebrovascular accident (AESI) and mental impairment and the non-serious event of visual impairment. The events occurred after a dose of mRNA-1273.222 vaccine. It was reported that the event of cerebrovascular accident occurred within 24 hours after vaccination. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Breakthrough case admission after 2 vaccine  MOderna 3/12/21 lot# 002B21A;  Moderna 4/8/21 lot# 025B21A
Small bumps appeared on 09/25/04 and began spreading. Appears to be Varicella. Benadryl as needed.
Case number PHEH2013US004187 is an initial spontaneous report received from a consumer on 15 Feb 2013 with the follow-up received on 15 Feb 2013. This report refers to a patient of an unknown gender and age. The medical history and concomitant medication of the patient were not reported. The patient received only Men A lyophilized powder of MENVEO (batch number: M11042 and expiry date: Mar 2014) intramuscularly, reconstituted with something (solvent) other than Men CWY liquid conjugate component. It was reported that during a routine inventory, it was discovered that one MenA vial was missing. No adverse event was reported following this administration error. Follow-up received on 15 Feb 2013: Updated vaccine expiry date.
Immunocompromised Patient did not received 3 full primary series doses; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised Patient did not received 3 full primary series doses) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 036A21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised Patient did not received 3 full primary series doses). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised Patient did not received 3 full primary series doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. Patient received first and second dose of Moderna in left arm shoulder deltoid muscle. Paitent had no adverse event after first and second dose of Moderna vaccine. Patient also reported no other adverse events to booster dose as well. The weight of the patient was unknown. No treatment details reported.