chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very tired; Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired) and PYREXIA (Had a fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hyperlipidaemia. Concomitant products included ATORVASTATIN and LISINOPRIL for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced FATIGUE (Very tired) and PYREXIA (Had a fever). At the time of the report, FATIGUE (Very tired) and PYREXIA (Had a fever) outcome was unknown.            No treatment information was reported
Information has been received from a physician concerning a female (age unreported) who was vaccinated on an unspecified date with a dose of GARDASIL vaccine (yeast). Subsequently the patient experienced a grief syncopal episode. The patient was reported as "fine" and no follow up was needed. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/15/2008. Additional information is not expected.
Had 3 doses of Engerix-B in late 1990 & 1991 did not convert; had 2 more doses of Engerix-B & still had not converted when titer was checked APR92;
This spontaneous report as received from a physician via company representative refers to 11 year old female patient. Patient's medical history and other previous drug allergic reactions were not reported. On 25-AUG-2014 the patient was vaccinated with GARDASIL injection (strength, dose and frequency unknown) with lot # J011272, expiry date 21-APR-2016. No concomitant medications were reported. On 25-AUG-2014, after receiving her first dose of GARDASIL the patient experienced dizziness, hotness and nausea. On 25-AUG-2014, patient visited office for medical attention to the events. The outcome of hotness, nausea and dizziness was reported as recovered/resolved. The reporter did not provide the causality of dizziness, hotness and nausea to GARDASIL. No further AE information was provided. Additional information has been requested.
No additional AE reported; Office manager reports ROTATEQ was administered after a temperature excursion to 23 patients.; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, previous drug reactions, or allergies were not provided.    On 18-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) once, (lot number W011279 has been verified to be a valid lot number, expiry date 02-NOV-2023) as prophylaxis (strength, dose, route of administration, and anatomical location, date were not provided) (product storage error).  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at a temperature of 9 degree Celcius (C) for the time frame of 1 hour and 32 minutes. There was no previous temperature excursion.  No additional adverse events reported.  This is one of several reports received from the same reporter.
Rash other than @ inject site; Allergic event: hives no temp taken; No other sx;
severe giant hives reaction on legs, thighs, chest and arms. / hives all over body; This case was reported by a consumer via call center representative and described the occurrence of hives in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix. In September 2020, 1 day 12 hrs after receiving Shingrix, the patient experienced hives. The patient was treated with steroids nos (Unspecified Steroids). On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows This case was reported by patient herself. The patient received the Shingrix and a day and a half later developed a severe giant hives reaction on legs, thighs, chest and arms and also severe hives all over body with allergic reaction. The patient was given steroids to counteract the reaction. The PCP advised not to get second dose but allergist recommended that patient could take the 2nd dose but with prednisone. The patient asked if she could take the 2nd dose and  could take Prednisone before and after it. It was stated that advised per PI History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of Shingrix was listed as a contraindication. The patient was referred to healthcare professional. The reporter did not consent to follow up. This case was linked with US2021014423 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021014423:Same reporter. FU3 - Deleted.
Received 2 shots of Moderna.  April and May 2021.  By August 12th, patient was stage 4 germ cell/testicular after seeing lump neck. Spread to lungs, liver, spine, lymphnodes, bone.  Had 4 rounds of aggressive inpatient chemo.  Almost eliminated/reduced most tumors, new ones grew.  Within 4 weeks after stopping chemo, cancer had more than doubled when he was diagnosed.  Lost sensation in leg, and urinary function. (paralyzed from waist down due to spine tumors).  Had 7 days of radiation + 1 day chemo.  Continued to grow aggressively.  He was in so much pain his final days.  Was inpatient for all 4 rounds of chemo and his final 14 days as he became paralyzed as they began radiation.  Diagnosis to death - 4 months!
pt was reported by MD that approx 2 hrs following immun pt became limp & listless; was taken to hosp; recvd note from MD to eliminate pertussis next time;
Patient received the 4 vaccinations and 1-2 minutes after, experienced a syncope episode. He had superficial injuries, no significant lacerations and was able to walk with no further difficulties after 5-10 minutes of rest.
On day 6, Hyper sensitivity on skin of lower back, which progressed to upper back and then down right leg to knee.  On day seven red bumps appeared on lower back. On day eight more red bumps appeared on the center of the back. On day nine, I was diagnosed with shingles. On day 10 the shingles had spread to the right torso. I do not believe I ever had chickenpox as a child.
Initial reaction included sore arm developing into hard and swollen bump at the injection site.  Progressively improved and then on day 8, started noticing large red rash area surrounding the injection site.  Warm to touch, not itchy, but significantly larger than the original site.
10/15-flu vaccination followed by pain in left arm, pain constant for 2 weeks followed by pins and needles feeling by 10/28. Started to have feelings of weakness in left arm. Seeked medical attention in Emergency department on 11/4 than followed up with Neurology 11/9, 11/14, 11/18. Ordered and MRI, EMG.
Headache, soreness at injection site, shivers, body aches, nausea.
Fever, dizziness, nausea, severs bone and muscle ache, headache, general weakness's
Patient reports that the evening of 8/30/21 she broke out in a rash under her left breast. The rash spread to the middle of her back, then up her back, and is now on her left arm. Patient complains of severe itching and a deep pain with rash. Patient denies redness, pain, swelling, or rash to the injection site.
4 days after injection the roof of my mouth became blistered and sore, I thought that I had possibly burned it with hot water, this lasted about 4-5 days and then cleared up. I then received my second dose of the vaccine on 03/05/2021and again 4 days after the injection the same thing happened, it lasted about 5-4 days and then cleared up. There have been no issues since
multiple unspecified patients were administered improperly stored VAQTA; No adverse effects; This spontaneous report was received from a nurse referring to multiple unspecified patients' of unknown age and gender. Information regarding the patients' concurrent conditions, medical history and concomitant medications were not provided. On multiple unspecified dates, unspecified number of patients were vaccinated with improperly stored Hepatitis A Vaccine, Inactivated (VAQTA) injection (strength, dose # and route of administration were not reported) (lot # S009943 and expiry date reported as 26-JUL-2020) (product storage error) for prophylaxis. No adverse effects were reported. Temperature reported as 32.4 Fahrenheit, total time and lowest temperature below 36 degree Fahrenheit per 2 degree Celsius. Multiple excursions timeframe reported as 50 hours. There were no previous temperature excursions. There was an involvement of digital data logger. There was no associated product quality complaint.   This is a non-valid case due to lack of patient identifiers.
On 06/29/2021 I woke with tickle in throat, went to urgent care on July 5th, and I was diagnosed with severe bronchitis.
Needle separated from syringe and entered dose spilled. Pt reinjected with another dose.
I had the first 2 injections at a drive through clinic and the 3rd dose was at a pop up clinic. I was hard hit in recovering from the vaccine 5 days in bed and pain in several places along my left side, which I now believe are all lymph node sites based on their locations. In April I became ill with an infection that started in my head and swollen lymph nodes and parotid glands as well. It lasted for 3 months and I took 4 rounds of antibiotics between the end of April and the end of July. The swelling hasn't gone away but gets a little better then a little worse. I've had a mammogram and a bunch of other blood tests to rule our cancer, heart disease etc since they are all on my left side. Then I got covid on August 31, took Paxlovid because I'm high risk. The lymph nodes are increasingly swollen and painful and have a general feeling of not being fully well. I'm also still experiencing some symptons of covid.
Patient had a febrile seizure within a week after receiving MMR. No prior history. Mom had febrile seizure as infant.
In AM onset of SOB & chest discomfort; pt saw MD that afternoon--SOB had gone, but chest discomfort remained; Dx: muscle inflammation unrelated to vax; pt did not take Rx of anti-inflammatories; next AM sx free; pt did not get 3rd dose;
Information has been received from a physician, via a company representative, concerning a female patient in her mid 60's with diabetes who was on an unspecified date was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot unknown). The patient could not remember getting a previous vaccination.  However, after the vaccination, the office personnel discovered that the patient had received it 3 months earlier.  Concomitantly she was on several medications ( therapy unspecified).  Subsequently, on an unknown date, the patient developed a severe local reaction involving the entire deltoid region which was hot hard, and swollen.  The patient was treated with (ZYRTEC) and with anti-inflammatory mediation.  Within three days of treatment the patient improved.  Patient's present status was reported as recovered.  No product quality complaint was involved.  Additional information has been requested.
Fever began around 1:30AM CST on 9/26/2020 and continued until it broke around 2:30AM CST on 9/28/2020.  This fever was as high as 103.3 at one point.  I also had severe pain in the vaccination arm that I have never experienced before along with two large red spots.
Nose bleeding and also through mouth. Time occurred around 4pm on 08/11/2021.
It was reported that a 32 year old male received Fluzone WV '99-'00 on 10/11/99. On the same day, "the pt became diaphoretic, cold and clammy. Pt was evaluated in an ER and was given oral Benadryl. Episode resolved. Pt was discharged with a prescription for Benadryl." The reporter stated "I am no doing a VAERS report because we operate out of Qatar and this was not a US citizen". No further information is available at this time. From additional information received on 12/30/99, additional pt, vaccine and responsible physician information was provided.
Received injection on 12/27/2004 (MMR and Tetanus Booster) .  Reported to work 12/28 stating had fever to 104, muscle aches, Headache.  No redness at injection sites, just tenderness.  Sent home from work.  Better within 48 hours.
Shortly after vaccines c/o pain, swelling, lump and redness at site. By same evening and until Sunday arm welted over the swelling and itching overall just didn't feel well. TX with ADVIL, BENADRYL, Heat/Cold to swelling. Still swollen and sore 4/17 but started improving.
Intense burning feeling in the back of her throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Intense burning feeling in the back of her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced THROAT IRRITATION (Intense burning feeling in the back of her throat).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
On the morning of Friday 4/16/21, patient came to vaccine clinic to let us know that his wife passed away the night of her second dose of her Pfizer covid vaccine. He states that she complained of arm pain at the injection site that evening (4/14/21) and went to bed around 9:30pm because the pain was excruciating. He said around 2:00am, she woke up stating she couldn't breathe. This has happened before, so she went and sat up in the living room which helped her last time. For whatever reason, she then went into her bedroom where he said she fell out. He noticed foam coming from her mouth and called 911. EMS was unable to revive her. She passed away at home.
Within 5 minutes of getting he second Pfizer COIVD vaccine the patient reported feeling lightheaded. She sat down in he counseling room and passed out> 911 was called, we monitored her breathing and blood pressure until she came to. Then we gave her water and checked her blood pressure which was low (around 101/63). EMA arrived and monitored her but she refused to go to the hospital with hem. She sat in he waiting area until her husband came to ick up her. She did no have this reaction with he first vaccine.
This 65 year old very health woman presented with acute onset of severe back pain and then shaking rigors, with occurred 5 weeks after her RNA gene therapy for Covid. Pt was admitted to hospital for 5 days with a diagnosis of Diskitis, Bacteremia due to Staphylococcus aureus without sepsis.
Swollen left (injection arm) armpit lymph node causing moderate pain throughout upper left quadrant, breast, solar plexus, neck, arm, and lower back. Moderate to severe body aches. Mild persistent headache. Moderate muscle weakness in arm and mild muscle weakness elsewhere. 6 days after shot.
spontaneous rupture of membranes at 36-0 weeks; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable physician. This physician reported information for both mother and fetus/baby. This is the maternal report. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (left arm) on 18Dec2020 and 08Jan2021 at a single dose for COVID-19 immunization. Medical history included cold sores, no active cold sore at time of labor. On an unspecified date, it was reported that a healthy 29-year-old G1P0 with good prenatal care and no pregnancy complications who had spontaneous rupture of membranes at 36-0 weeks, one day after her second Pfizer CoVid vaccine (09Jan2021). She felt well after her vaccine and had no symptoms today. The mother reported she became pregnant while taking BNT162B2. The patient takes prenatal vitamins. The mother was 33 Weeks pregnant at the onset of the event. The mother was due to deliver on 06Feb2021. Therapeutic measures were taken as a result of premature rupture of membranes. The outcome of the event was recovering.  Information about Batch/Lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of spontaneous rupture of membranes due to temporal relationship.  However, the reported event may possibly represent intercurrent medical condition in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.
For the following month till now my eyes have been very dry and red. Focus changes were dramatically slower than normal up to 30 seconds.  While being treated for a retina issue they noted that my eye pressure was was higher that when it was tested a few months previously with measures of 23 and 25 for the eyes. There was no history of this in previous measures and the previous values were 13 and 15 . On their recommendation I have been using lubricating eye drops several times a day. This has helped but stopping brings the irritation back.  I have lived in the same house, alone, for several years and have not experienced this before. It could be allergies but it seemed worth noting.
By next day, extreme pain at injection site. The following week, I developed painful Chilblains on my toes. I also have what appear to be granulomas on my fingers, but those could be due to exposure to Myobacterium marinum (or not, I don't know - I have both an aquarium that I know has that bacteria in it and now these Chilblains, so life is pretty miserable). I have an appointment to see my doctor scheduled but she knows nothing about fish aquarium granuloma so I doubt I'll get a diagnosis from her. The Chilblains on my toes looks exactly like the photos of the examples I found online of the Chilblains on my toes caused by the COVID vaccine though.
Left upper arm, shoulder pain, swelling and redness to vaccine site, few small blisters to area; 4 1/2 in diameter of redness. Treatment consisted of ibuprofen prn and calamine lotion.
he experienced brain fog/mental fog; Confusion; disorientation; anxiety/panic; have a little pain in the shoulder but nothing major, in the right shoulder where he got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Aug2021 14:30 (Lot number: FA7484, Expiration Date: 01Sep2021) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart attack" (unspecified if ongoing); "Stenting", start date: 15Jan2019 (unknown if ongoing); "Gallstones", start date: 2016 (unknown if ongoing); "Cholecystectomy" (unspecified if ongoing), notes: Gallstones removal; "Quintuple bypass" (unspecified if ongoing). Family history included: "Coronary artery disease", start date: 27Nov2012 (ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiovascular disorder, start date: 2012 (ongoing); METOPROLOL taken for myocardial infarction, cardiovascular disorder, start date: 2012 (ongoing); ISOSORBIDE, start date: 2014 (ongoing). The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Aug2021 16:30, outcome "recovered" (Aug2021), described as "he experienced brain fog/mental fog"; CONFUSIONAL STATE (non-serious) with onset 03Aug2021 16:30, outcome "unknown", described as "Confusion"; DISORIENTATION (non-serious) with onset 03Aug2021 16:30, outcome "unknown", described as "disorientation"; ANXIETY (non-serious) with onset 03Aug2021 16:30, outcome "unknown", described as "anxiety/panic"; VACCINATION SITE PAIN (non-serious) with onset 03Aug2021 16:30, outcome "unknown", described as "have a little pain in the shoulder but nothing major, in the right shoulder where he got the shot". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: Approximately 26 hours post vaccination patient experienced a severe mental fog lasting several hours resulting in confusion, disorientation and anxiety/panic. patient nearly got lost going home and for a short time patient did not know where he was when patient got home. Patient had not taken any prior vaccination within 4 weeks Covid-19 Vaccine.Family medical history relevant to adverse events was 3 brothers, 1 sister and 1 mother. All bypass surgery or death due to coronary artery disease. Probably not related to adverse vaccination.   No follow-up attempts are possible. No further information is expected.
Within 15-minutes of vaccination, the patient had a syncopal event preceded by nausea and lightheadedness. EMS evaluated the patient on-site. The patient was pale, diaphoretic, and hypotensive (67/37).  EKG (3/12): Sinus brady, rate 46 bpm, no ST elevation. FSBG (3/12): 89mg/dl. EMS administered 500mL IV saline. EMS transported the patient to Hospital Emergency Department. In the ED, the patient feels back at baseline and was normotensive (119/72). Patient stated they have a history of vasovagal response and vasovagal vomiting, but had never experienced a vasovagal syncope episode. Physician administered 0.5mg Lorazepam. The ED physician admitted the patient to the telemetry unit for vasovagal syncope due to patient's prodrome and prior history of similar near syncopal episodes. Inpatient attending agreed that the patient's vasovagal response may be secondary to poor PO intake with extreme stress. Patient's admission was less than 1-day and stated they were anxious to return home. Discharged with diagnoses of Mild leukocytosis, Vasovagal response, and Orthostatic hypotension secondary to dehydration.