chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with known history of fainting spells whenever skin is broken has informed HC provider prior to vaccination.  Appropriate precaution taken for patient safety.  Vaccination administered and after 1-2 minutes, patient felt fainting but alert and able to communicate his symptoms.  911 called for safety precaution.  Team assessed patient who was alert and talking upon arrival of emergency team.  Team advised transport to hospital for further observation.  Patient refused and signed against medical advise.  Patient stable upon leaving facility after 50 minutes post vaccine administration.  Advised to call 911 if any symptoms.
Patient did respond to me just now. He is doing better. He had gotten the vaccine on the 5th of August (this is his 2nd dose) on the left deltoid (and received typhoid on the right). The next day, he began to develop nasal congestion, headache, malaise and fatigue, as well as a red, flat rash that eventually grew to the size of the palm of his hand on the left deltoid.  It was pruritic.  He then noted 5 days later that he had a localized urticarial rash under the left axilla.  He did not have any systemic symptoms then and denied palpating any lymph nodes that were enlarged or tender; he denied weakness or paresthesia of the affected arm.  He presented to the ER and was prescribed Benadryl and Prednisone, about 2 days later, his rashes were gone (by the time I talked to him on 8/13/21) and he was back to his baseline health.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On an unknown date in 2013 the patient was vaccinated with PNEUMOVAX 23. The medical assistant reported that, multiple unspecified patients were administered with PNEUMOVAX 23 that was exposed to unspecified temperature excursions from January 2013 to the present. No adverse effects were reported. This case is linked to 1401USA000054, 1401USA000055, 1312USA012478 (same reporter). Additional information has been requested.
This case was reported in a literature article and described the occurrence of rheumatoid arthritis in a adult female subject who received Flu seasonal TIV Dresden for prophylaxis. Concurrent medical conditions included palindromic rheumatism. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed rheumatoid arthritis. Serious criteria included GSK medically significant. The outcome of rheumatoid arthritis was unknown. The investigator considered that there was a reasonable possibility that the rheumatoid arthritis may have been caused by Flu seasonal TIV Dresden. Additional information provided This case was reported in a literature article and described the occurrence of rheumatoid arthritis (RA) in a middle-aged female who was vaccinated with unspecified inactivated trivalent influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of study in which vaccine side-effects related studies were discussed. The patient was healthy. The patient was treated for palindromic rheumatism. No information on patient's family history or concomitant medication was provided. On an unspecified date, the patient received unspecified inactivated trivalent influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. It was reported that the patient received standard dose of vaccine. On an unspecified date, an unknown period after vaccination, the patient developed RA. Treatment was unknown. The outcome of the event was not provided. The author stated, "The vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart. This might direct to-wards slightly altered pathologic mechanisms directed at vaccine-related phenomena. The incidence of autoimmune reactions to influenza vaccines is currently unknown, but it can no longer be assumed that a coincidental (i.e., un-related) association exists between immunization and the onset of RA and systemic lupus erythematosus (SLE)." The author concluded, "Although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, we might be able to find the at-risk groups and lower the incidence. Similar to analyzing HLA-B*5801 status in the high-risk population before prescribing allopurinol for gout, we might be running special panels for those at-risk communities before vaccinating." This is 1 of the 3 valid cases reported in this literature article.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored VARIVAX (Merck) lot # L033138, expiry date 31-AUG-2017 (dose, route and site of administration were not reported) immunization series. No adverse effects were reported. Additional information has been requested.
Patient felt nausea and started dry heaving.  He was sweating profusely and had tremors.  BP 140/60, HR54, O2 sat 98.  He stated that he had not had a meal today and it could be his sugar.  His glucose was evaluated and was normal.  Pt. was taken to NWMC and was accompanied by his wife.
approx 3-4 hrs p/vax pt awoke from sleep & had very large emesis; no choking noted; pt then became pale, had blue/cyanotic lips, taken to ER via amb; sx resolved w/in 20-30mins; upon arrival @ ER pt t39.4;
Vomited X 1 in office.  Temp 105 in office } 10/29/08.  Vomited X2 10/28/08.  3 loose non-bloody stools 10/28/08.
Started immediately with my arm feeling very heavy then extreme tiredness like everything was in slow-motion and felt like my speech was slightly slurred.  Before the next morning, I was experiencing a fever that progressed even with several doses of Tylenol to a fever of 101.7.  The fever, sore arm, and the tiredness continued for another day.  The upper part of my arm still remains sore.
Pt had a small bump at administration site for 2 days then bruising for 2 weeks,. Now pt has a burning/tingling sensation in that area. He says it is not constant, but sporadic.
*Patient had covid November 28, tested positive Nov 30* Day 1 after vaccine: Arm swelling, lymph node swelling in injection arm, Missed work Thursday and Friday due to Fatigue, Nauseous/vomited x 1, light headed/dizziness, shaking chills, decreased appetite, dry sensitive skin and red/itchy rash on neck, trunk, and face this went through day 3 and decreased severity overtime.   Day 3 cough, tightness in  chest when taking a deep breath, took Mucinex-D to relieve symptoms
was sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "was sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, NauseaVomiting, chills, injection site swelling Narrative:  Other Relevant History:
Heavy weight on chest, fatigue, brain fog. Inhaler, D Dimer, Blood work
Since the 3rd of July which is the day of the 2nd administration of Pfizer, I have continuous nausea, vertigo to the point that I cannot drive my vehicle. Blurry vision, severe pain in the stomach area under the right breast height of liver. Radiates a little to the left. Strong diarrhea that comes and goes and is very clear. Severe pain in upper back area unable to sleep because of the pain. Pain in calves and sensation of heaviness in the legs. I noticed like a knot in my stomach and heaviness and my stomach is bloated. Sensation of indigestion. Reflux and burning esophagus. Rash on breasts and stomach and lichen planus on the foot and left leg. Before the vaccination I was doing very well. Except for a little lack of iron, mild hypertension controlled and ulcerative colitis mild (proctitis).
Patient had redness and swelling on the right leg which has been reduced since the day of the incident to about 3cm in diameter. Day one patient had a 101 fever but has been afebrile since. The parents of the child were informed to monitor and bring in if swelling continues and that a cool compress may be applied. No labs are needed at the time.
Pfizer mRNA vaccines given April and May of 2021. No personal history of diabetes. Diagnosed with type 1 diabetes in DKA  11-9-21.  Given perceived higher risk status with the diabetes diagnosis had the Pfizer booster 12-15-21. Among the hospitalization and booster developed severe constellation of symptoms including muscle aches all over, skin hyperesthesia, mental fog, forgetfulness, insomnia, weakness particularly in both lower legs, poor balance particularly going down stairs. Pain was the most bothersome.
Tremor of R hand already had Essential Tremor of L Hand. Tremulous  cheeks occ when smiling if moving head downward. Lower ext feeling tense quads, gluteus Maximus and chin feeling tremulous
Pt seen in ER 5/27/01 per mom for ? vaccine/allergic reaction or cellulitis R elbow to shoulder- per vaccine administrator DPAT and Varivax were given R arm- Has been on Keflex times 2 days. Much less red and swollen today. Dr aware. Follow up on 10/25/02: "From mailed correspondence received on 08/27/01 it was reported, "Reviewed no additional information at this time.  This case is closed."
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days too early) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     Patient had no acute illness at the time of vaccination and up to one month before and no chronic or long-standing health conditions.  Concurrent medical conditions included Drug allergy (Lansoprazole allergy). Concomitant products included NAPROXEN from 29-Nov-2022 to an unknown date for an unknown indication.   On 19-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 dosage form. On 06-Jan-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days too early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days too early) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           The patient received second COVID vaccine 10 days too early.  Treatment information was not provided.
gen hives mom reports that noted face flushed @ 5PM 3FEB97 & hives noted @ 6PM 3FEB97;
This is a spontaneous report from a contactable nurse via a Pfizer sales representative who reported the same events for two difference patients. This is the second of the two reports. A patient of unspecified age, ethnicity and gender received TRUMENBA in MAY2016, at 0.5 ml, single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced red spot on the arm that was very large, visible, tender to the touch and very painful and rashes, all in MAY2016. Red spot was really big and it was like covering up whole top half of the arm where they were injected. The events lasted approximately for 5 days. The reporting nurse believed that red spots were due to the vaccine, as developed after being vaccinated.
Fog like feeling; lightheadedness; Decrease in appetite; Vomiting; Severe migraine; Dizziness; Tightness of sinuses; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 18May2021 at 13:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to latex, watermelon and seafood. Concomitant medications included fluoxetine hydrochloride (PROZAC), aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) and gliclazide (CLARITIN), all taken for unspecified indications from unknown dates. The patient previously took bactrim, macrobid, ciprofloxacin and monistat and experienced drug allergy. 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 18May2021 at 22:45, the patient experienced severe migraine with dizziness and tightness of sinuses. On 19May2021, the next morning, the patient experienced vomiting twice. On 21May2021, 60 hours after the shot, the patient experienced fog like feeling as well as some lightheadedness and decrease in appetite. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe migraine with dizziness, tightness of sinuses, vomiting, fog like feeling, lightheadedness and decrease in appetite were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt received shot and stood up to go the the waiting area for the 15 minute  observation period.  she  became lighted and sat back down , then she blacked out.  2  members of the pharmacy crew gently lowered to the floor. after  a few seconds   she revived. rx manager questioned  her about any adverse reactions in past and just like her questionnaire , she answered "no".  we gave her about 35 minutes in the waiting area .  she felt fine and we released her.   the pharmacy  crew will call  her  at least two times in near future to follow through  with her well being.
SAW BLACK SPOTS ALL AROUND; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: drinking wine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced saw black spots all around. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of saw black spots all around was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913090 and 20210912958.
Swelling at local site up to six inches in diameter, redness, and hot to touch.  Had a mild headache following day.  Not sure if it was dehydration or from reaction.
normal sore arm after 1st injection.  12/31 arm swelled at injection site, hard ,hot , knot. started having left lymph node cervical pain, swelling. Arm went back to normal after a few days Saw PCP for lymph node, and had chest X-ray to r/o anything serious.  after 2nd injection- started with fever 1/25/21 midnight. fever, 100.5-102 +, chills, body, joint pain, fatigue, headache. Broke out in hives, palms of hands, bottom of feet@ 4:00 PM,  hives over most of body by 5:30 PM.  My head broke out in sweat, pored onto shirt, had to even change clothes.  still have swollen lymph nodes.
felt flushed; This is a spontaneous report from a contactable Nurse.   A 29-year-old female patient received the first dose of of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247 with Expiration Date 31May2021), on 18Jan2021 (at 08:30) at 0.3 ml single dose on the left deltoid for COVID-19 immunisation. No relevant medical history was provided. The patient did not have relevant concomitant medications. She was vaccinated at COVID vaccine center where they are administering the Pfizer vaccine. On 18Jan2021 (at 09:05), she felt flushed. She took cetirizine hydrochloride (ZIRTEC) at home in preparation; she was given juice and cookies. At 9:20, patient was feeling better, she was monitored for 30 more minutes in observation area and stated she was feeling fine and left. The patient had recovered from the events on 18Jan2021.
Fatigue; Fatigue; got pain in her arm/ pain in her arm at the injection site; got pain in her arm/ pain in her arm at the injection site; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Right Upper Arm on 03Jan2021 (around 9:15 to 9:30AM) at single dose for COVID-19 immunization. Medical history included ongoing lupus (diagnosed about 2-1/2 years before 04Jan2021) and fatigue with lupus. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient said later in the evening of 03Jan2021, she got pain in her arm she got the COVID-19 Vaccine. She received her first check-in call after receiving the COVID-19 Vaccine, and at that time she had no pain in her arm. She clarified the pain in her arm at the injection site started in the evening of 03Jan2021. On 04Jan2021 she had fatigue. She stated she got fatigue sometimes with her lupus. No treatment received for the adverse events. No emergency room or physician office involved. The patient reported she saw her rheumatologist and had blood work done. The outcome of pain in arm at the injection site was recovering, of fatigue was not recovered.   The information on the batch number has been requested.
Round, raised, red itchy injection site reaction. Patient advised to take BENADRYL and apply a cold compress.
I sense slight tingling on my face/a tingling in my face and it come from my forehead to my neck and now it just started going to a my other side of the face as well; felt a little tired; it felt like I had food in my mouth. Like, there was food between my cheek and  gum. And there was nothing there; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0151, Expiry Date: unknown), via an unspecified route of administration on 08May2021 09:00 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was reported as none. The patient Concomitant medications were not reported. On 10May2021, the patient experienced I sense slight tingling on my face/a tingling in my face and it come from my forehead to my neck and now it just started going to a my other side of the face as well, felt a little tired, it felt like I had food in my mouth. Like, there was food between my cheek and  gum. And there was nothing there. It was reported that I have received the Covid 19 Pfizer vaccine the BioNtech on Saturday and after I got the vaccine I felt a little tired but nothing of it I slept off ok, yesterday but I sense slight tingling on my face. Last night and it felt like, I slept at something at 2:30 in the afternoon and during night I did not sleep. And  it felt like I had food in my mouth. Like, there was food between my cheek and  gum. And there was nothing there. So it felt like I had food in my mouth, stuck in my mouth but there is nothing there. And so I didn't think anything of it  but then all of sudden  started getting a tingling in my face and it come from my forehead to my neck and now it just started going to a my other side of the face as well. And I am wondering I am having some allergic reactions so just for the vaccine? what is this 3 days later" I haven't had any medication part there no aspirin no nothing I was just hesitated about this vaccine I take it on my but following what the heck did I do? because I haven't had any type of pharmacy report any thing in 5 years, I haven't even had a headache and I didn't get the headache from this vaccine either or I can all I get is tired but last night this popped up so I am just wondering its a cause of concern or not. Therapeutic measures were not taken as a result of events. The outcome of events was unknown.  No follow-up attempts are needed.No further information is expected.
Patient notice trouble swallowing and trouble with speech. When she went into the Emergency department at about 7:30 pm they pointed out the external redness and swelling on her neck and throat.
Had both vaccine then got it again / suspected vaccination failure; got it again; 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.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (had shingles vaccine 15 years ago and had shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had both shingles vaccine and got shingles again. 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
Patient reported having a syncopal episode at home after her first dose of Moderna vaccine. Patient received her 2nd dose of Moderna in our clinic and reported dizziness while in post-vaccination monitoring. Patient was given water and juice. Patient waited an additional 20 minutes for a total of 35 minutes. Patient was observed ambulating and was able to independently leave the facility, reporting that she felt better and denied dizziness.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 03-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 136 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-1.11 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.