chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a published article, title as stated above. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #27 of 32, a 36 year old male. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. One patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 36 year old male on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. On an unspecified date after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The patient also experienced symptoms of ankylosing spondylitis. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX HB (WAES #1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02351, WAES # 1004USA02353 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Was dizzy after recovering the shot. Lasted 24 hours and then I started getting ringing and sharp pains in the right ear. This lasted for hours.
Began with rash on Monday. Lesions on thigh & forehead. Clear nasal congestion. No fever.
On 8/4/00, the pt developed seizures associated with fevers. On 8/7/00, it was reported that the fevers are gone but the seizures persist. The pt had a evanescent rash with seizures only; which could be related to the altered blood flow during a seizure.
High fever that reached up to 103 degrees Celsius that lasted for 24-30 hours, dizziness that is still occurring almost 48 hours after, severe migraine, difficulty breathing at onset of fever
Vasovagal response approximately 3 minutes following injection; some tonic-clonic movements noted.
Info has been received from a health professional concerning a 36 year old white male with profound mental retardation, "spastic quad", convulsion disorder, dysphagia with aspiration, chronic UTI and hydronephrosis who on 5/10/05 at 16:00 was vaccinated, IM, in the right deltoid with a 1st dose of varicella virus vaccine live (lot 646535/0575N). Concomitant therapy included tuberculin purified protein derivative (lot C2114AB( given, SC, in the left forearm at 10:00 on 5/12/05; polyethylene glycol 3350 (Miralax) daily, bisacodyl (Dulcolax) tablets daily, levofloxacin (Levaquin) 500mg daily (discontinued on 5/3/05), baclofen 10mg BID, famotidine (Pepcid) tablets 20mg BID and phenobarbital 162mg IVS. The pt was treated for a UTI sepsis 1-2 weeks prior to the vaccination. On 5/28/05, at 09:35, the pt experienced a red rash noted on his entire trunk. It was reported that he developed fluid filled vesicles and fever and was treated with isolation, Tylenol, increased fluids and calamine lotion. New areas developed daily, his entire body was covered. Subsequently, the pt recovered as of 6/5/05. Additional info is not expected.
HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterosis (Cholesterol). Concomitant products included LISINOPRIL for Cholesterosis, METFORMIN for Diabetes.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients). On 10-Dec-2021, PRODUCT STORAGE ERROR (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Storage condition at the time of the excursion was refrigerated. Maximum or minimum temperatures reached in between 2-8 Celsius degrees. Excursion duration is almost 24 to 30 hours and one vial is impacted. Treatment medication was not provided by the reporter.
Fever started evening of vaccine and persistent (daily up to now) development of inflamed parotid gland (noted at eval on 9/5, worse on 9/7/11).
Information has been received from a health care professional concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine, lot # 659083/1418U. Subsequently, the patient experienced reaction around the injection site extended to forearm. The outcome was unknown. The health care reporter has requested for a lot check for this report. A standard lot check investigation was performed. All in process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Left arm (arm that had shot) became itchy, red, mildly sore and inflamed one week after the shot. It seems slightly better today but is still red and itchy and a little raised.
13 hours after injection while sleeping had strong urge to go to the bathroom, bowel movement, resulting in massive diarrhea. During process, became very dizzy and felt nauseous and faint. Attempting to get up from toilet, and getting assistance from husband in an adjoining bedroom, made it to a second bathroom, passing out, again, complete empty of bowels severe diarrhea again while passed out on floor. Unconscious for about one minute, until revived by husband. Sweating, faint, very low BP. Taken to hospital by husband after getting composure admitted for observation due to apparent dehydration from massive diarrhea event. Results possible cardiac instability, dehydration from diarrhea, vegas nerve activity with Discharge the next day 03/22/2021 with follow up with cardiac Dr and primary, ongoing
Bronchitis; This is a spontaneous report from a Pfizer-sponsored program VyndaLink Patient Support Hub from a contactable consumer A 82-years-old female patient received tafamidis (VYNDAMAX), NDC number: 0069873030 via an unspecified route of administration from 2020 (Batch/Lot number was not reported) and ongoing, at 61 mg, 1x/day for cardiac amyloidosis and bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included body height decreased, carpal tunnel syndrome, cardiac amyloidosis (she has several heart conditions including cardiac amyloidosis). The patient's concomitant medications were not reported. The patient experienced bronchitis on 21Feb2021 with outcome of recovering. The action taken in response to the event for tafamidis was unknown. Therapeutic measures taken as a result of bronchitis are aspirin, lozenges and fluids.  No follow-up attempts are possible. No further information is expected.
Case investigation interview completed and case manager wrote, "started having symptoms on 7/19- cough, advised isolation period, lives w/ baby who was recently sick but tested negative, case has thyroid problems, has not traveled recently."
This spontaneous report was received from a pharmacist via company representative concerning a patient of unknown age and gender. The patient's medical history included an unspecified lymphoma and bone marrow transplant (date was not provided). On an unknown date, the patient was vaccinated with ZOSTAVAX, subcutaneously (anatomical location, dose, strength and lot number were not provided). Co-suspect or concomitant therapies were not provided. On an unknown date, after receiving ZOSTAVAX, the patient died of possible complications of Epstein Barr Syndrome, it was unknown if an autopsy was performed. The patient sought medical attention through an office visit. No product quality complaint was involved. At the time of the report, the outcome of Epstein-Barr virus infection was fatal. the causal relationship between Epstein-Barr virus infection/death and vaccination with ZOSTAVAX was unknown. Additional information has been requested.
Body pain, joint pain, exhaustion for 3 days, sensitive to light, painful skin similiar to sunburn, low appetite, fever of 100; Treatment-Tylenol and rest for 3 days.  Missed work
Information was been received from a medical assistant concerning an approximately 60 year old male patient who on 08-DEC-2008 was vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) due to simple human error. No adverse effects noted. This is one of several reports from the same source. Further information has been requested.
individual exp delayed onset hypersensitivity rxn approx 12hr p/vax;exp fever, fatigue, lightheadedness & inj site soreness/nodule;pt exp rash approx 5 days p/vax;sx lasted about 6 days;
about 6PM 16NOV devel severe pain in leg cannot walk on it; leg shakes when tries; no swelling to the leg lt leg;
C/O feeling weak. Stated had not eaten today at 130p B/P 138/72, 82, 18, O2 95%. Refused any further tx. Advised to call 911 if feeling worse. Accompanied by nurses aide - gave instructions to her also.
got so sick/she got sick with the flu; like she had the flu/she got sick with the flu; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female 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 sickness and influenza. On an unknown date, the outcome of the sickness and influenza were unknown.   It was unknown if the reporter considered the sickness and influenza to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUL-2022 Reporter's comment: This case was reported by the patient via interactive digital media.  The reported stated that he/she knew someone that had got Shingle vaccine and got so sick like she had the flu and the reporter could not understand why the patient got sick with the flu. Additional supportive information: Follow-up would not possible, as no contact details were available.
vaccine placed in refrigerator after the expire date; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine placed in refrigerator after the expire date) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine placed in refrigerator after the expire date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine placed in refrigerator after the expire date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. There was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned. Date place in refrigerator was 04Nov2021. Patient did not experience temperature excursion and any adverse event   No treatment medication was provided by reporter.
Hemoptysis, flank pain, bilateral leg pain, headache. Found to have thrombocytopenia of 44, extensive bilateral PEs, and nonocclusive aortic thrombus. Treated with IVIG x 2 days and argatroban. Course is ongoing at ~48 hours since presentation.
terrible stomache issues since but getting better/my stomache been awful/I have stomache issues in genersal but now way worse/i have ibs and seems to have made worse but still glad I got the vaccines; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (terrible stomache issues since but getting better/my stomache been awful/I have stomache issues in genersal but now way worse/i have ibs and seems to have made worse but still glad I got the vaccines) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (terrible stomache issues since but getting better/my stomache been awful/I have stomache issues in genersal but now way worse/i have ibs and seems to have made worse but still glad I got the vaccines). At the time of the report, IRRITABLE BOWEL SYNDROME (terrible stomache issues since but getting better/my stomache been awful/I have stomache issues in genersal but now way worse/i have ibs and seems to have made worse but still glad I got the vaccines) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided. Concomitant medication information was not provided.
pt had generalized urticaria w/o wheezing which devel approx 45min to 1hr p/vax;tx w/DPH;mom reports itching gone & urticaria improved;child very irritable;
devel pain & rash lt hand, arm, back on 11JUL98;also had low grade fever & fussiness;rash is papular & vesicular dx shingles;;rx zovirax;
Seven days after first shot, the area of my upper arm under the vaccination site became quite itchy and a bit red and swollen.  Hydrocortizone cream stops the itchiness.  Still swollen but it's not a problem
Headache, TENDERNESS AT INJECTION SITE Narrative: TENDERNESS AT INJECTION SITE LASTED 48HR. HEADACHE LASTED DAY OF INJECTION ONLY AND WAS MILD . SHE TOOK HER REGUALARLY PRESCRIBED TRAMADOL FOR A DIFFERENT CONDITION. NOTING SPECIFIC FOR THIS.
Patient reported for 2nd dose in the Pfizer-BioNTech series. Upon review of patient's consent form, an allergy was noted for the first dose. The patient reported that she experienced swelling of her mouth, tongue, and lips that started at some point overnight the night of her first dose. It was discovered when she woke up the next day.  Patient stated she did not receive treatment, and that the swelling went down after approximately 3 days. Due to the reaction we recommended she not complete her vaccine series at this time and consult with her physician.
PT STARTED WITH FEELING OF A DEAD ARM AND SEVERE PAIN NEAR INJECTION SITE, NOTICED THAT THE BANDAID WAS PLACED AT THE TOP OF HIS ARM AND NOT IN MIDDLE AS PER USUAL WHEN RECEIVED VACCINATION.  HURTS WHEN PATIENT MOVES HIS ARM, ESPECIALLY WHEN RAISING HIS ARM.
Pt. came in the office on 02/08/13. Mom notice induration, redness on pt. LA where DTaP given. 72 x 70 mm induration pt. complaining pain.
Pt recv vax on 5/12/98; on same day pt exp rash & swelling of extremities, red vax site] x 24 hr
Throat got tight a few minutes after shot, and got clammy/sweaty.  Got nauseous on drive home.  Headache developed around 7pm.  Vomited twice over night.  Next morning was still nauseous and had headache.  Slight vertigo feeling and had floaters in vision.  Vertigo and floaters resolved themselves.  Headache and nausea persisted.  Nausea was resolved on Monday 8/30.  Headache persisted.  Traveled on 9/2 for a planned family vacation.  Headaches got severe on 9/3 and developed fever.  Cut trip short as a result.  Upon return home 9/5, headache still pronounced, but fever resolved.  Was feeling light headed and almost like I would black out so went to urgent care on 9/6 morning.  Urgent Care transferred me to Emergency Dept.  Had high blood pressure, tested positive for COVID-19.  Still having high blood pressure and headache as of this time.
Patient experiencing upper extremity pain (not local reaction) after 3rd Engerix-B immunization
15 minutes following the injection, client complained of tingiling lips and feeling "fainty". Client placed in recumbent position. B/P 108/70. Benadryl 25 mgm per os given. 20 minutes following Benadryl administration, client confirmed decrease in feeling "fainty" and decreased tingiling of lips.
seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a 55-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031278) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in April 2020, COVID-19 on 31-Dec-2022 and COVID-19 on 21-May-2023. Previously administered products included for Drug use for unknown indication: Pfizer COVID-19 vaccine. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine. Concurrent medical conditions included Meningioma since August 2022. Concomitant products included LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Meningioma, INFLUENZA VACCINE for an unknown indication.    On 03-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 05-Oct-2023 at 5:00 AM,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced SEIZURE (seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizure) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient had a seizure while she was still in bed. The seizure was mild and lasted for about a minute, after which patient became better and has recovered. It could be because patient received both shots on the same day within minutes of each other.  Treatment medications were not reported. Company comment: This spontaneous case concerns a 55-year-old female patient, with concurrent medical conditions of meningioma in the process of reducing treatment with levetiracetam, who experienced the unexpected and serious (medically significant) AESI of SEIZURE, two days after the dose of mRNA-1273.815 vaccine. The seizure was mild and lasted for about a minute and has recovered. Previously administered products included Pfizer COVID-19 vaccine. Patient´s meningioma in the process of reducing treatment with levetiracetam and the concomitant vaccination with INFLUENZA VACCINE could be confounders for the event. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
5 minutes after the shot my chest felt funny and I was extremely dizzy. I started dripping in sweat and almost fell out of my chair. I was taken back to the clinic and laid down. My face was beet red. The reaction ended about 20 minutes later.
Erythema and swelling of the left thigh.  Patient treated with IV antibiotics for presumed cellulitis.
arms were sore; feels unwell; Tiredness; chills; this morning about 8 am I was running a fever 101.5; muscle ache; joint pain/joint aches; severe injection site pain; swelling and redness in left arm at injection site; swelling and redness in left arm at injection site; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date listed on the card was either 03May2021 or 31May2021), intramuscularly in left arm on 24Jan2021 13:30 at 0.3 ml single for COVID-19 immunization. Medical history included COVID from Jun2020. Concomitant medications were none. Patient received the first dose of the vaccine, initially before bed he noticed his arms were sore, about 2 a.m., his arm was so sore it woke him up when he rolled over on it. It hurt throughout the night, he started to get chills, just like when he had COVID earlier in the year and this morning about 8 a.m. he was running a fever 101.5, muscle ache and joint pain. He felt exactly how he felt, when running a fever. He was experiencing 8 of the 12 side effects, none of the allergic reactions only fever, joint aches. He was experiencing about 90% of the side effects listed on page 3 the paperwork he received. He was not having any breathing issues. He had severe injection site pain on 24Jan2021, it literally felt like he had surgery on his left arm. Since he woke up this morning around 6 a.m. he had been experiencing tiredness, muscle pain, chills, joint pain, and he had a fever of 101.5 all on 25Jan2021. He had swelling and redness in his left arm at injection site on 24Jan2021. He didn't feel any lymph node swelling and he was not sick. He felt unwell. He felt like he twisted his shoulder, he went to bed and he woke up shivering like he had the COVID virus. He had the COVID virus back in Jun2020. The injection site arm pain was severe in the middle of night, and woke him up in the middle of the night. When he rolled over, he explained that he used both arms to help get out of bed and he could barely get up to go to the restroom. He was wrapped up so the chills were pretty good, when he woke up they were racking chills (which he also experienced these type of chills when he had the COVID virus). No treatment was received. He needed a magnifying glass and to get in the light to see the lot number on the card he was given. He took a boatload of drugs. Reported the details about his medications could be obtained from this hcp. He did not know them off the top of his head. Outcome of events arms were sore and felt unwell was unknown and of other events was not resolved.