chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20NOV woke up w/puffiness around the eyes, scratchiness in ear "sinus probably"; has had sinus problems itchy spots on both arms; advised to see MD for resp problems & worsening of present sx;
RASH; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included rash. The patient was previously treated with diphenhydramine hydrochloride for rash. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced rash. The action taken with covid-19 vaccine was not applicable. The outcome of rash was not reported. This report was non-serious.
COVID 19; COVID 19; This is a spontaneous report received from a contactable healthcare professional (HCP). A 46-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Iodinated contrast media" (unspecified if ongoing); "Fatty liver" (unspecified if ongoing); "overweight" (unspecified if ongoing). There were no concomitant medications. Patient did not receive other medication in 2weeks. It was reported that patient initially tested 24May2022 and given oral Paxlovid from 24May2022 to 29May2022. Completed treatment and symptoms resolved. Symptoms returned 06Jun2022 with a new positive test on 06Jun2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive; (06Jun2022) Positive. Outcome of the events was recovered.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the reported events cannot be completely excluded.
Fever Nausia Body aches Pain /bruise at injection site Lasted 3 days Tylenol to keep fever down
My left ankle hurt when I got in bed the first night after the shot. My ankle had been sprained in 2018. Pain was less the following day.
Student faint 2 minutes after injection. States she felt weak and "fuzzy" skin pale. Next day after immunization couldn't sleep and felt like she hallucinated. Recovered fully by day 2 (48 hours) 11/11/05.
Received moderna Covid vaccine booster in left deltoid. Flu shot in right.  Sore muscles began 3 hours post shots as to be expected. But at 2:30 this morning (shots were at 10:30am yesterday) heart began racing  (resting asleep was roughly 60bpm- and woke up at 93bpm went up to 114) and chills/ shivering which has continued for 3 hours. I wear a heart monitor that has been tracking it. Took 2 650mg of 8 hour Tylenol at 2300 10/27 for extreme pain in left arm (Covid site) and just had to take some again at 0500 10/28. Waiting for heart to stop racing and chills, pain to subside.   Flu shot site on right arm is tender but not radiating or extremely painful. Only left arm with moderna.
Fever 101.4 degrees F orally/highest since onset around 0300 this morning; tx: Instructed pt's father to give children's ibuprofen as directed on med label every 6 hrs.
extended time period between 1st and 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (extended time period between 1st and 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (extended time period between 1st and 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (extended time period between 1st and 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
PATIENT RECEIVED HER THIRD DOSE OF THE MODERNA VACCINE AND FELT DIZZY THEN BECAME TACHYCARDIC AND FAINT AROUND 30 MINUTES AFTER VACCINE. HER BP WENT TO 90/70 AND SHE BECAME VERY NAUSEOUS .
This case was reported by a pharmacist and described the occurrence of rash in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date on or after 18 October 2005 and on or before 28 October 2005 the subject received a dose of Fluarix. On an unspecified date in October 2005, less than one month after vaccination with Fluarix, The subject experienced rash. The rash resolved on an unspecified date on or before 28 November 2005. The nurse reported that 7 other subjects experienced adverse events following the administration of Fluarix. Please see cases A0583939A, A0583942A, A0583943A, A0583944A, A0583945A, A0583946A, and A0583948A.
Received Covid 19 Moderna dose #1 01/18/2021, dose #2 02/22/2021, dose #3 09/17/2021 and dose #4 04/29/22. Patient had elevated liver enzymes on routine blood work with complaints of itching on 3/7/22. On 5/11/22 following dose #4 patient became confused, jaundice, elvated AST, ALT, ALP and Bililrubin of 8.8. Direct admitted to hospital with CT scan showing dilated heatic ducts and ERCP completed on 5/12/2. Dialation perfomed and plastic Biliary stent placed. Patient had additional ERCP with dilation and stent placement on 6/13/22, 8/29/22, 10/31/22, 2/6/23, 2/8/23, 3/6/23, 7/18/23. Patient had increasing liver fibrosis and resulting in liver failure and death on 7/31/23.
This case involves a patient of unknown demographics who got flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (with an unknown formulation, strength, frequency) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination. On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported" I got mine, a month later I got the flu. Sometimes I swear they shoot you up with water." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (flu). At time of reporting, the outcome was Unknown for the event flu.
Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of 105.2F
This spontaneous report as received from healthcare worker refers to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 03-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # M001200, expiration date: 25-AUG-2016, dose and route of administration were not reported). The vaccine did not have any temperature excursions. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Participant bled after receiving flu shot, pain at injection shot and swelling, ice pack was given, participant was fine.
p/ pt recv vax approx 8 mo later devel a breakthrough case of chickenpox. it was noted the pt had a lot of lesions
pt recv vax 11DEC98 & ran low grade fever  12DEC98 redness started @ site like a hive;widened to the point today the size of adult hand;large red, hot, swollen area noted;
Stated the night of 25 Aug 09 she developed redness, swelling and some pain in posterior left upper and now redness is also going down the medial side of the left upper arm. Pt seen by De 27 Aug 09. Plan: Patient Ed, Self Care, expected response, follow up Instructions.
I was administered the pneumococcal vaccine (23-valent) because I have asthma. At the time when the vaccine was administered (approximately two months ago), I was 42 years old and an otherwise healthy female. About 5 minutes after getting the vaccine, I felt cold and shaky all over, and my head was spinning. I had diarrhea all of sudden. I was extremely dizzy and my thinking became very foggy. It was hard to sit up and my legs felt like jello.
SHAKING OF HANDS AND UPPER TORSO; ACHING IN SHOULDER AND ELBOW JOINTS; FEVER; This spontaneous case report was received from a consumer (PVX2019-676) on 19-Mar-2019. It described a male consumer who experienced fever, shaking of hands and upper torso, and aching in shoulder and elbow joints following the intake of oral Vivotif (one dose every other day) for typhoid prophylaxis.  The consumer's medical history included pneumonia, seizures, and ulcer.  The consumer's concomitant medications included lamotrigine tablet (200 mg) for seizures and omeprazole capsule (20 mg) for ulcer.  It was reported that the consumer took the first and the second dose of Vivotif on 16-Mar-2019 and 18-Mar-2019, respectively. He reported that after taking the second dose, he experienced fever slightly above 100 degrees Fahrenheit and he also had very severe shakes in his hands and upper torso, and some aching in his shoulder and elbow joints. He reported that all the events were resolved within an hour.  He took ibuprofen (two tablets of 200 mg each) for treatment. He stated that a few hours before, he had taken lamotrigine (200 mg) and omeprazole (20 mg). He had been taken them for years but never had any adverse reactions.  The action taken with Vivotif with respect to the events fever, shaking of hands and upper torso, and aching in shoulder and elbow joints was unknown.  The clinical outcome of the events fever, shaking of hands and upper torso, and aching in shoulder and elbow joints was resolved.  Company's Comment: In this case, it was reported that a male consumer experienced fever, shaking of hands and upper torso, and aching in shoulder and elbow joints following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, the reported events are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer experienced fever, shaking of hands and upper torso, and aching in shoulder and elbow joints following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, the reported events are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
This spontaneous report as received from a 69 year old female patient reporting herself. The patient's concurrent condition included high blood pressure and no drug reactions/allergies. On 27-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route, injection site and lot # not provided). Concomitant medication included "ZAFERTIZ" (unspecified dose, frequency and manufacturer). On 10-SEP-2013, she experienced debilitating joint and muscle pain, trouble walking, trouble sleeping, and severe inflammation after being administered ZOSTAVAX. On 18-SEP-2013, the patient had office visit and extensive blood tests were performed, and as a result of those blood tests, she was diagnosed with polymyalgia rheumatica. The patient stated, "The doctor informed to take ADVIL (unspecified dose/frequency and manufacturer) and TYLENOL (unspecified dose/frequency and manufacturer)." The outcome of adverse events was reported as not recovered. The causality between vaccine ZOSTAVAX and adverse events were not provided. Additional information has been requested.
Sore arm; Extreme fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 31Mar2021 at 14:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included rhinitis, sinusitis and mild asthma. The patient received unspecified medication within two weeks of vaccination. 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 four weeks prior to the vaccination. On 31Mar2021 at 16:00, the patient experienced sore arm and extreme fatigue, arm soreness lasted about 12 hours and fatigue started about 2 hours after receiving shot and lasted for about 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sore arm was recovered on 01Apr2021 at 04:00 and extreme fatigue was recovered on 01Apr2021 at 16:00.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
From initial information received on 06/Jun/2005 from a health care professional regarding an adverse event occurring, it was reported that a 46-year-old female patient received a dose of DECAVAC, lot number U1213AA, administered intra-muscularly in the left deltoid on 01/Jun/2005 due to a cut on her finger. That same day, the patient developed a fever of 101 degrees Fahrenheit, general malaise and numbness from the injection site down to her fingers. Additionally, she had a local reaction of redness and swelling, measuring approximately four inches in diameter, at the injection site. The patient was evaluated by a physician and ice was applied to the site. Per the reporter, the patient recovered from the events. The reporter of this case is the same reporter as case 2005-01072. Follow-up received on 04-Oct-2005. As per the additional information, the injection sie redness and swelling occurred with in 8 hours following the vaccination. She did not have any illness at the time of the vaccination.
mom reported pt had horrible rash w/severe itching that started over weekend;had been using oatmeal baths & DPH w/some relief;had numerous large, bullous/erythematous lesions over legs, arms, neck;sever itching;MD office believes chickenpox
101.5 temperature, strong aches in joints muscles and bones- it felt like severe arthritis, loss of strength, heart pains.
T.C. from clients mother. Stated client had pain in left deltoid the day after vaccine 11/1/03.   Mother stated to wait and it would get better.  At one point ( not knoen) client thought pain was better, however he now states to mother that it is very painful at site of injection and it hurts when patient lays on his left side and also when he lifts weights. He is thinking about seeing a physician. Client has moved.
Information has been received from a health professional concerning a female who on 10-SEP-2007 was vaccinated with a first dose of Gardasil. There was no concomitant medication. After the administration the patient passed out. Subsequently, the patient fully recovered within 10 seconds. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a registered nurse concerning a 16 year old female who on 10-SEP-2007 was vaccinated IM with a first dose of GARDASIL. There was no concomitant medication. After the administration, at approximately 10:30 am, the patient passed out and fainted. The patient was caught slumping forward and brought to a side-lying position where she quickly "came to." The patient verbalized she hated needled and just started to "feel funny." Subsequently, the patient fully recovered immediately within 10 seconds. Additional information is not expected.
Fever started 10 days after shots. Injection site got red. Fever lasted two day then bumps started to appear 11 days after shots , all over her body. Face, torso, back, arms and legs. Bumps lasted 3-4 days.
Immediately after administration, entire left arm was burning and stinging from shoulder to fingertips. Symptoms still present about 5 weeks after second vaccination.
Information has been received from a 77 year old female with no medical history or allergies who on 30-APR-2008 was vaccinated SC with a 0.65 ml dose of zoster vaccine live (Oka/Merck). There were no concomitant medications. The patient reported that on 30-APR-2008 " 2 1/2 hours after vaccine" she experienced dizziness, nausea, and vomiting. No diagnostic laboratory tests were performed. No product quality complaint was involved. At the time of this report, the patient had not recovered. No further information is available.
This case was reported by a healthcare professional and described the occurrence of vaccination error in a subject of unspecified age and gender who was vaccinated with HEPATITIS vaccine not otherwise specified (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of HEPTITIS vaccine (unknown). At an unspecified time after vaccination with HEPATITIS vaccine, the subject experienced vaccination error and incorrect storage of drug. A HEPATITIS vaccine was administered after the vaccine had been improperly stored due to refrigeration being down over recent Spring Break. Follow-up received on 23-April-2008 via the nurse. She reported that the subject was a female in her thirties who received the third dose of ENGERIX B at 08:30 am (20mcg, given in left arm) manufactured by GlaxoSmithKline on 15 April 2008. The nurse reported that the refrigerator was turned off for over 11 days during spring break and the ENGERIX B was exposed to warmer temperatures than recommended. The nurse also reported that on the same day the subject was vaccinated with ENGERIX B, she experienced pain at the sith of the injection compared to the previous vaccinations. The symptoms resolved on an unknown date. Follow-up information was received on 20 May 2008 via a registered nurse, who reported that the subject was a 37-year old female. The nurse reported that the onset date of the symptoms was 15 April 2008, which resolved on 17 April 2008. The reporting nurse considered the events to be possibly related to vaccination with ENGERIX B. The nurse indicated that the vaccination series with ENGERIX B was delayed, as the subject was re-administered the 3rd dose of ENGERIX B, the subject again experienced minor pain at the injection site. The outcome of the injection site pain following the repeat 3rd dose ENGERIX B was unspecified.
Stiffness and pain in thumb joint and shoulder, cramping and bleeding and miscarriage. Treated for miscarriage at ER on 9/26/2015.
I had shortness of breath and a severe cough and exhaustion.  I became very weakTey did an EKG
3/30/21 started at 11:00 p.m. :  chills, fever, headache, muscle soreness, nausea (for approx. 12+ hours) 3/31/21  noon:  headache, fatigue 4/1/21 headache, fatigue
Left arm with +erythema, warm 10x9cm,+ induration, no fluctuance. Diagnosis of cellulitis and prescribed Clindamycin 75/5 20ml TID for 10 days.
This case was reported by a healthcare professional and described the occurrence of arm pain in a subject of unspecified age and gender who was vaccinated with HAVRIX (manufacturer unspecified). On an unspecified date the subject received unspecified dose of HAVRIX. At the time of injection with HAVRIX, the subject experienced arm pain and shoulder pain. The reporter stated that it seems to have started occurring in the last 6 months. Subjects complain of a sudden, brief, but significant pain that shoots down the arm to the elbow or sometimes up into the shoulder and neck. This was considered to be a product complaint. The reporter has been giving the vaccine since 1995 and it never happened before. At the time of reporting the outcome of the events was unspecified. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases include A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A and A073244A.
This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 02-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 16-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue
Less than 24 hours after my  second Pfizer shot, I experienced tingling and numbness in the arm that received the injection.  I have since that time continued to experience mild to severe tingling and numbness in that arm, to the point that I cannot at times pick things up and hold them.  Because my sister lost feeling from the waist down from Guillain-Barre as a result of the flu shot in 2013, I am nervous about this loss of feeling in my arm.
Monday, June 20, 2022, I called my doctor and he prescribed Prednisone. I couldn't get out of bed or even walk, I was in so much pain from the PMR. We had driven, stopping on the way. Coming back I noticed my right leg started swelling.  I was worried I was getting a DVT.  My daughter said I had to get to the ER.  They did tests and it was not a DVT.  I was admitted to the hospital on Wednesday morning.  I had CT Scan and saw an orthopedic surgeon. The imaging showed a 14 cm place on my leg, the inside, back side. The surgeon did an ultrasound and thought the radiologist could send the fluid off from my leg but he could not. We also had blood samples sent off in case it was a staff infection.  Two have come back, negative.  We are still waiting on another blood sample to come back. The neurologist said I could take Prednisone and an antibiotic. They started Prednisone yesterday and changed my pain meds.  I was having 10/10 pain and now I am a 5/10. They think the flare up was from the Moderna.
On 3/30/22 patient received influenza vaccine. 45minutes to an hour later she started sweating and felt hot. Around 12 noon her bottom lip started itching. Around 6pm, she noticed swelling and blisters on her bottom lip and swelling of her tongue.