chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an unspecified reporter referring to a 9 week old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 06-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
suspected vaccination failure; got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 and shingles were unknown.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received shingles shot and still got the shingles.  This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
This patient was admitted to Hospital on 1/3/2022 for COVID related symptoms. This is considered a breakthrough case.
On 10/16/2022 I started feeling lower back pain; fatigue, dry cough, loose stools and a slight fever. I tested positive for COVID 19 on 10/18/2022. I had a telehealth appointment and was put on a course of PAXLOVID.
c/o extremely sore arm w/high fever;both lasted through noc;did not seek med care;
Fever, shakes, chills, mottled palms, severe body pains, and swelling, induration, redness, warmth, pain at injection site and over injected arm.
Extreme fatigue, joint pain, lack of energy, chills, and dizziness for about 3 days.  Tightness in chest and shallow breathing for one day.  Fatigue and joint pain has continued to this day.
Ear canals blocked and are extremely painful; Ear canals blocked and are extremely painful; congestion in head; no appetite; fever; bodyaches; A spontaneous report was received from a consumer concerning a 93-year old, male patient who experienced ear canals blacked and are extremely painful, pyrexia (fever), Myalgia (body aches), head discomfort (congestion in head), and decreased appetite (no appetite).   The patient's relevant medical history was not provided. Concomitant product use was not provided by the reporter.    On 09-Mar-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030A21A) intramuscularly [injection site not reported] for prophylaxis of COVID-19 infection.   On 11-Mar-2021, the patient experienced ear canals blocked and are extremely painful, fever, body aches, congestion in head, feels like flu and no appetite. Reportedly, fever is better now. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome for the events of ear canals blacked and are extremely painful, fever, body aches, congestion in head, and no appetite was unknown.  The outcome of the event of pyrexia was recovered on an unknown date.  The patient consented to Safety follow-up.  This case was linked to MOD-2021-046118 (Patient Link).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
First dose: Body aches; First dose: Joint Pain; First dose: headache; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), dose 1 via an unspecified route of administration, administered in left arm on 13Apr2021 09:15 (at age of 53-year-old) as dose 1, single for covid-19 immunization. Medical history included atrial fibrillation (Verbatim: Afib; Caller wants to say this occurred like 8 years ago), inflammation, blood pressure abnormal. Concomitant medications included metoprolol (METOPROLOL) taken for blood pressure abnormal; diclofenac (DICLOFENAC) taken for inflammation. The patient previously took flu shot for immunisation (caller receives flu shot every year with no issue). On 13Apr2021 20:00, the patient experienced first dose: body aches, first dose: joint pain, first dose: headache. The outcome of events was recovered on 14Apr2021.  No follow-up attempts are possible. No further information is expected.
Approx 24hrs later on 5/1812 patient c/o red, very itchy, hot to touch and hard from mid (R) arm thru shoulder and reported on 5/21/12 reported that slowly got better and is now still itchy and pink as of 5/20/12 evening.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Weakness-Mild, Additional Details: warm to touch
Broke out in hives the second day. Spread from my neck to my chest and on my face. Went to urgent care and received a steroid shot ,solu-medrol
Developed petechial rash on 12/25/04.  Platelets 18k on 12/27, dropped to 5k on 12/29.  Patient started on Orapred 2mg/kg/day divided BID with taper over 3-4 weeks.  Patient's care transfered to pediatric hematologist.  Platelets have rebounded, not sure of time frame. Information from Medical records states bruising. msv
received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021). On 05-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first Moderna vaccine in Jan/Feb2021 and her second vaccine in June 2021) had resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  Patient states that she received her first Moderna vaccine in what she thinks was January but possibly February of 2021.
I gotten the Shingrix vaccine, but I've gotten shingles 5 times/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: I gotten the Shingrix vaccine, but I've gotten shingles 5 times/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-SEP-2023 The patient got shingles 5 times even after administration of Shingrix vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
4:30 AM Vomiting, Stomach Cramps, Nausea 5:30 AM Vomiting, Stomach Cramps, Nausea, Diarrhea 12:00 PM Pepto Bismol (524mg bismuth subsalicylate) 15:00 PM Woke-up with nausea, headache, diarrhea which continued off and on for the rest of the day. 600 mg ibuprophen taken. 23:30 PM Ibuprophen 600 mg and Imodium (loperamide HCl 4 mg) taken
p/recv 4th dose of anthrax pt immed exp severe burning sensation that lasted few minutes; area around inject turned red & swollen; unable to touch direct site of vax w/o having severe pain that would bring tears; swelling & pain lasted 5mo
Mild erythema to left deltoid with mild induration. Benadryl PRN.
After receiving all shots the pt developed redness and rash. After 30 mins the rash was almost completely gone. Told parents to watch her for 48 hrs and if difficulty breathing develops then take her to ER.
Body aches, fever, chills, flu like symptom, severe headache, sinus dripping.
Vomiting on day of vaccine achiness throughout body since day of vaccine "hives" developed across body 7 days after receiving vaccine.
Patient falsified DOB when registering for vaccination, stating the minor was 01/25/2009. Guardian consented to the vaccination. Local Department of Health verified with statistical records that the patients actual DOB is 01/25/2010 which made the vaccine a contraindication.  No known adverse reactions noted.
Sudden vision loss (L) eye 1/2/14 (10 wks after flu vaccine) optic neuritis/papillitis (L) eye.
The intended COVID-19 vaccination was the Pfizer Bivalent booster for the patient's 4th dose. However, the administered vaccine was the Pfizer monovalent primary series product. The patient did not experience any adverse events due to this error.
Itchy, red, rash with confluent raised area hive-like and hives area.  Claritin reditab; Hydrocortisone cream; Aveeno baths; Atarax 25mg hs.
10/29/21 2100 - 2400hrs:  Minor fever (<100), chills  10/30/21 0000 - 0600hrs:  Night sweats, headache  0600 - 1500hrs: ear ache  1500 - present (11/1/21  1700hrs):  ringing in ears and mild hearing loss.   11/1/21 1800hrs:  scheduled virtual doctor visit (pending at time of submission)
Because I was not informed of all the ingredients in FLUARIX in advance, I didn't realize it contained gentamycin. I had a reaction that included a sinus infection, and swollen lips. I cannot tolerate antibiotics in the gentamycin family. I developed hearing loss after using Vancomycin for MRSA in 2008.
More than 45 days to get second dose; Fatigue; Mild fever; Mild weakness, limited activity; Itching; Blister appeared next day on my arm on the same spot where the vaccine was injected; Minor bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Minor bleeding), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 45 days to get second dose), VACCINATION SITE VESICLES (Blister appeared next day on my arm on the same spot where the vaccine was injected), ASTHENIA (Mild weakness, limited activity) and VACCINATION SITE PRURITUS (Itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure since 15-Aug-2011. Concomitant products included ESOMEPRAZOLE from 15-Aug-2020 to an unknown date for Acid reflux (esophageal), LOSARTAN POTASSIUM from 07-Feb-2021 to an unknown date and NEBIVOLOL from 07-Feb-2021 to an unknown date for Hypertension.    On 15-Apr-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced ASTHENIA (Mild weakness, limited activity) and PYREXIA (Mild fever). On 27-Apr-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Minor bleeding), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 45 days to get second dose), VACCINATION SITE VESICLES (Blister appeared next day on my arm on the same spot where the vaccine was injected) and VACCINATION SITE PRURITUS (Itching). The patient was treated with FUSIDATE SODIUM (FUCIDIN [FUSIDATE SODIUM]) (topical) for Blister, at a dose of 1 UNK. At the time of the report, VACCINATION SITE HAEMORRHAGE (Minor bleeding), VACCINATION SITE VESICLES (Blister appeared next day on my arm on the same spot where the vaccine was injected) and VACCINATION SITE PRURITUS (Itching) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 45 days to get second dose), ASTHENIA (Mild weakness, limited activity), FATIGUE (Fatigue) and PYREXIA (Mild fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       PCR Covid Test- Saliva was done but no results were mentioned   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05 JUL 2021: Updated patient demographics, Past medical history, Concomitant and treatment medications and Events and Event outcome. On 19-Jul-2021: Follow up received on 19 JUL 2021 and contains no new information On 20-Jul-2021: Follow up  additional 2 report received and contains no new information On 20-Jul-2021: Follow up additional information  received and contains no new information On 23-Jul-2021: Follow up additional information 3 received containing No New Information On 30-Jul-2021: Follow-up received on 30-Jul-2021 included no new information.
04/10/2022 Vaccination  06/25/2022 I started to have a sore throat.  06/26/2022 I went to the ER. My husband had gone a few days before me. I went with my MIL and my FIL went a few days after us. I had cough, fatigue, NO fever. COVID-19 POSITIVE Since being home from trip, the DR gave me a prescription for Plaxovid but I haven't tried it yet. There is such mixed reviews, I wanted to wait.  *Still experiencing some fatigue and fluid in one ear. I think the fluid is from flying.
Large red/itchy rash approximately 2 inches in diameter at injection site, formed ~7 days after first injection, consistent with other reported cases of "covid arm"
COVID-19 (Confirmed); This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID-19 (Confirmed)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Bursa disorder, Back disorder, Prostate cancer in 2010 and Gout. Concurrent medical conditions included Psoriatic arthritis since 1984, Spondylarthritis since 1984, Psoriasis since 1984 and Smoker (approximately 8 cigarettes per day). Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) from 22-Nov-2021 to an unknown date, UPADACITINIB (RINVOQ), METHOTREXATE and PREDNISONE for an unknown indication.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (COVID-19 (Confirmed)). At the time of the report, COVID-19 (COVID-19 (Confirmed)) outcome was unknown.            The patient's other concomitant medications included unspecified oral non-steroidal anti-inflammatory drugs (NSAIDs) (ongoing) and narcotics (unspecified to current).  In Jan-2022 Xeljanz XR was discontinued due to inadequate initial response.  No treatment details were reported.
Optic Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. Information regarding concomitant medication, current condition and historical condition was unknown. On or around 31-AUG-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered drastically visual acuity in both eyes and was diagnosed with optic neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the company's conduct, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of optic neuropathy was considered as not recovered. The reporter considered optic neuropathy to be related to zoster vaccine live (ZOSTAVAX).     Optic neuropathy was considered as disabling. Upon internal review, optic neuropathy was considered as medically significant.
EXPIRED LOT VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced expired lot vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired lot vaccine administered was not reported. This report was non-serious.
The use by date on the Moderna BiIvalent vaccination was 07/29/2023, no symptoms from the patient were reported.
low grade fever/low grade fever of 103; chills; dry cough; lethargy; This is a spontaneous report from a contactable nurse. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 with expiry date Mar2021), via an unspecified route of administration in left deltoid on 30Dec2020 14:30 at a single dose for COVID-19 immunization. The administration was one in a local pharmacy. There were no relevant medical history and concomitant medications. On Saturday night, 02Jan2021, the patient started getting a low grade fever of 103, had chills, lethargy and an intermittent dry cough. The outcome of the events was not recovered. The events were considered medically significant events.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded.  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.
Seen in ED for a 1-2 day history of chest tightness and syncopal event. Found to have elevated troponin I concerning for myocarditis at 0.178 ng/mL. ECG unremarkable without concerning features for pericarditis. No ST segment elevations/depressions or T wave inversions. Bedside limited echocardiogram without evidence of pericardial effusion. Hospitalized to be pulled from employee training and undergo inpatient echocardiography.
Narrative: Received 1st dose of COVID vaccine on 1/18/2021. Developed sore arm/fatigue om first day. Day 2 developed generalized hives/ Self-administered diphenhydramine x 1  and felt "a little better". Repeated 2nd dose. Felt like hives were improving. No new foods, medications, creams or lotions. Wife reports patient often get hives when anxious. She believes hives were related to anxiety rather than vaccine. Patient currently planning 2nd dose with more extended monitoring given the long length of time between when hives developed following vaccine. Symptoms: & hives Treatment: DIPHENHYDRAMINE 1 TAB unknown self treated with OTC product
In 11/97, pt spiked fever and had ear infections every 10 days, following every month, until 8/98. Treated with various antibodies, then had ear infections every 3 months. At 23 months, lost language, had high-pitched screaming, light hurt his eyes, acted like he was deaf and can't stand change. Was dx'd with full blown Autism.
pt recv vax 18AUG96 & same day pt exp lt eye pain & was dx w/periorbital cellulitis;6 to 12 hr later pt exp tingling in rt leg;cellulitis was treated w/ATB & resolved p/5 doses;leg tingling resolved p/about 1 day;
Itching and rash. Severe itching at times. Thought it due to something else but it continues. Saw Dr in Febuary 29. She said never heard of rash\itching due to this drug, refused to report it and said it was probably due to my BP med and changed that, even though I had been on the BP drug for one and half year prior with NO reaction. She told me to see an allergist if the rash/itching continued. Rash/itching seems to be getting worse. Red welts at itching sites, hands and bottom of feet itch as well as all over body. I don't know what to do at this point. Disappointed with Dr.
At 1:10 p.m., headache, pupils pin point, eyes blood shot, heart rate up/down/hard, difficulty breathing, diarrhea. Rpt to DSHS 4 pm. Went home 4:15, took Nyquil and Excedrin, slept. No sx on awakening. Gets sever headache 1x/month.
pt recvd vax;devel rt sided motor deficit p/ vax;CT scan showed lesions in brain stem & parietal lobe;Biopsy on 9mar95;past ovarian cancer that was tx by chemotherapy 1 yr ago;no current meds;
Leg/muscle pain bilaterally. Complained of not wanting to walk because she felt like she would fall or legs were going to give out. Pain has is still ongoing for over 6 hours.
Patient developed severe body aches, fever of 102.1, and diarrhea lasting about 2 days.
Within 10 hours of receiving the pfizer booster the area between my breast and armpit started to swell. It continues to swell and is the size of an easter egg. It is painful and I cannot rest my arm to my side. My neck is swollen and very tight on the side that I received the shot.   This also happened to me after I received the second dose of the Moderna vaccine. The swelling lasted for over 6 months. The pain and discomfort have never gone away. After six months the primary physician referred me for imaging which then results in a very expensive biopsy. Insurance refused to cover any of it since I was never Covid positive.   Because of this side effect I do not believe I will be able to receive any additional boosters. The pain, discomfort is unbearable. My family and I are now suffering financially. We owe over $3000 for all of the bills associated with the vaccine. And I am now once again dealing with the swollen lymph nodes and all that comes with it.