chrisvoncsefalvay/vaers-outcomes huggingface dataset:
all over prickly skin; sweating all over; low pulse; feeling cold; vomiting; Diarrhea; feeling very weak.; This is a spontaneous report from a contactable consumer, the patient. A 82-year-old female non-pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history included cardiovascular disease and thyroid. The patient received unspecified medication within two weeks of vaccination. The patient previously took PLAVAX on unknown date for unknown indication 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 01Apr2021 at 21:00 the patient experienced all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak was recovering.  No follow-up attempts are needed. No further information is expected.
Pt came to ER c/o palpitation, unwell, nausea, diarrhea, lack of appetite and diagnosed with Covid 10 days prior.
Next day - Significant pain in chest, ribs, and back.  Pain from moving, laughing, & even talking. Headache and malaise which subsided the next day.  Chest/rib pain subsided completely on 3rd day after vaccine.  Almost no pain at injection site. On 8th day - Significant redness near injection site. Itching and hardnes of the tissue where redness was. Still present.
paralysis, hallucinations, lack of speech, no bowel control, slept for 2 days straight, no mental reasoning or control of bodily functions
patient felt dizzy, vision disturbance, and skin was cold to touch.  within about 5 to 6 minutes after vaccination
Mild ear pain/discomfort in left ear and slight ringing in ear. Chewing exasperates the pain/discomfort.
Patient had sudden onset left facial paralysis consistent with Bell's palsy. Treated with prednisone 60 a day for seven days and Valtrex 1000 TID times seven days.
Patient reports rash beginning 9/2/21. No itching present.  Patient visited dermatologist on 9/13/21.  Rash flares up and then subsides.  Still present. Rash present on torso, arms.
The day after vaccine administration, pt experienced an injection site that was raised, red, itchy and warm. She contacted per PCP and he said the rxn was secondary to the vaccine administration. He recommended she receive the 2nd dose of the vaccine in the opposite arm. 1 week later she still had a knot at her injection site but it was getting smaller daily.
Achey, chills, fever, general feeling poorly  approx 22 hrs after vaccination
I?m having heart palpitations since my first injection.  Pretty frequently.  No other signs or symptoms.
My left elbow became sore, then my shoulders began to ache, and the skin on my back became very sensitive.  The next day,Sunday, I developed a sore throat and lost my voice somewhat, and my left knee became very sore, to the point that I was limping; I generally felt tired.  On Monday, all of the above symptoms continued through Wednesday, but additionally I lost more and more of my voice which was accompanied with a lot of congestion in my chest and a unremitting cough.  By Thursday, the pain in the elbow, knee and back had disappeared, but the other symptoms remained, and remain at this time.
Patient had itching in left arm with in a few hours of vaccine administration. Two days later the patient develped an itchy rash on her legs.
Acute myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a child male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Acute myocarditis) outcome was unknown.   The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  This study demonstrated that children who developed vaccination-induced myocarditis and may not receive another vaccination, could be susceptible to infection with Omicron and emerging variants.  It was observed higher neutralizing antibody titers in myocarditis patients vs. healthy vaccinated children, but significantly lower neutralization titers against Omicron in both groups.  Company Comment: This is a literature non-study case concerning a child male patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) expected, AESI of myocarditis (reported as Acute myocarditis), which occurred after the mRNA-1273 vaccine, dose number not provided. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a literature non-study case concerning a child male patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) expected, AESI of myocarditis (reported as Acute myocarditis), which occurred after the mRNA-1273 vaccine, dose number not provided. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
5/21 - fever, chills, arm and leg fatigue, swelling on arm from shoulder to elbow - per patient. Also c/o dark urine, no Rxs.
Initial report received from a health care professional on 01-Oct-2013. A male and female adult patients, whose age, medical history and concomitant medications were not reported, had FLUZONE HD vaccine (Lot number UT4719AA, Intradermal on deltoid site), on September 2013. On an unspecified date (at the time of vaccination), after receiving vaccine the patients experienced stinging more than last year reported. Patients also experienced red and warm to the touch at injection site. At the time of reporting, outcome of the events were unknown. No further relevant information was reported. Documents held by sender: none.
Pt mother called 8/23/22 and reported that her son began having a red, swollen, and warm to touch right arm on (8/17/2022), the day after he received his vaccines. In the right arm he received Dtap.  She states that it is still red and lumpy today and he is not complaining about it but does not want anyone to touch it. He has difficulties communicating. She states it is approximately the size of a tennis ball today.  She denies fever or any streaking down his arm.  Mom will call family doctor today to be seen.
12/06/23 05:00 a.m. Resident voiced complaints of SOB at around 0005. Vitals collected O2 SAT recording low 80% on 2LNC. BP 113/75 HR 134 R-28 Temp 98. Resident stated to writer, "I can't breathe". Sent to emergency room and admitted with dx of myocardial infarction and pna, returned to facility on 12/7/23, went under hospice care on 12/9/23 and expired on 12/23/22
Information has been received from a physician concerning a few patients (ages and genders unknown), who, on an unspecified date, were vaccinated with a dose of Gardasil.  Subsequently, the patients had reactions after receiving the vaccination.  The specified reaction was not provided by the physician.  At the time of the report, the outcomes of the patients were unknown.  No product quality complaint was involved.  This is one of three reports from the same source.  Additional information is not available.
This spontaneous report was received from a registered nurse and refers to a 13 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012132 with expiry date: 17-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Arm became sore mid-afternoon, about 8pm in the evening developed aches/tenderness on all skin surface areas. About 10pm developed headache, facial flushing, painful eyes, fever 101.3, rigors, and muscle cramps in feet and legs.
-Patient presented in shock that responded to norepinephrine. Infectious causes were ruled out.  -Patient says he got his third COVID vaccine (Pfizer booster) on 1/22. Since 1/23, he had daily fevers with Tmax 103F. Patient presented to our hospital 1/27/22. He also reported several days of neck pain and frontal headache, diffuse body aches, fatigue, diffuse abdominal pain, sore throat, and chest pain. He reported one episode of NBNB on the day prior to admission. On day of admission, mother noticed a rash that started on abdomen.  -Pain to palpation on neck -Hypotension, tachycardia
A spontaneous report was received on 11-JUL-2016, from a male registered nurse concerning an unknown patient (gender not specified, but the doctor's office was an OBGYN office) who on 06-JUL-2016 (the second of three patients) was vaccinated with a dose of expired PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The NDC number reported was 0006-4837-03. The second unknown patient (gender not specified) (Reference MARRS # WAES1607USA005542 for the first of 3 (unknown) patients who was vaccinated on 22-JUN-2016 with a dose of expired PNEUMOVAX 23 (Lot # K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported).  Reference MARRS # WAES1608USA010415) for the third of three (unknown) patients who was vaccinated on 11-JUL-2016 with a dose of expired of PNEUMOVAX 23 (Lot # was reported as K012424, expiration date: 05-JUN-2016)(exact dose and route of administration were not reported). The reporting nurse stated that the office staff just realized after the third injection that the vaccine was expired. The nurse had concerns on how to proceed and questioned if the injections should be readministered. The reporting nurse stated there have been no known complaints from any of the patients (3) that were vaccinated, an no treatment has been given thus far. No further information has been provided. Additional information has been requested. This is one of three reports received from the same reporter.
Patient noticed his left arm & about 6" below his left arm was sweating profusely 15 minutes after receiving the vaccine .Shirt on the left side was noticebaly  wet (Not Right side) ."Feeling totally normal" and not noticed anything else. Patient would like to leave facility and willcall us if he feels '"off"
has not yet received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 20-OCT-2020).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2023 The reporter was a pharmacist. The pharmacist reported a patient received the first dose of Shingrix on October 20, 2020 and not yet received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.
24 hour after vaccination right arm swollen, warm to touch with red raised rash, upper arm at injection site 48 hr after vaccination right arm rash spread from injection site to medical site of upper arm. 72 hour rash faded but still noticeable - non itchy.
fever 100.4ºF; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever 100.4ºF) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced PYREXIA (fever 100.4ºF). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever 100.4ºF) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jun-2021, Body temperature: 100.4 (Inconclusive) 100.4 degree fahrenheit.         No concomitant medications were reported.
Collapsed (passed out) and bumped face on check- out counter as he was falling down; syncope. He was taken back to an exam room to lay down and was given and ice pack for his face, and the doctor came in to check that he was okay. This happened approximately 5 minutes after the vaccine was given.
uncomfortable swallowing; swollen lymph nodes, especially on the left side; I've had some sinus issues, sinusitis; feels like if I had TMJ; Jaw pain/right jaw is the one hurting; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 72-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included , gastrooesophageal reflux disease from an unknown date and unknown if ongoing He takes Protonix daily capsule for this, cluster headache from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced jaw pain/right jaw is the one hurting on 22Feb2021 with outcome of unknown, uncomfortable swallowing, swollen lymph nodes, especially on the left side , He had some sinus issues, feels like if he had temporomandibular joint syndrome on an unspecified date with outcome of unknown. Therapeutic measures were taken with Tylenol and Ibuprofen as a result of jaw pain/right jaw is the one hurting (pain in jaw), uncomfortable swallowing (dysphagia), swollen lymph nodes, especially on the left side (lymphadenopathy)  No follow-up attempts are possible. No further information is expected.
Patient developed rash approximately 24 hours after receiving the vaccine.  Rash was on chest, face, and back. Lasted for about a week, but has improved.  Itched the whole time.
This spontaneous report was received from a medical assistant concerning a currently 24-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA (strength, dose, route, frequency, lot number and expiration date were not reported) for prophylaxis. No adverse symptoms were reported.
Barely able to lift arm for 12 hours, fever (102), shaking chills, headache, tachycardia, dizziness
Narrative: Patient with a history of COVID pneumonia and transaminitis 12/29/2020, HTN, PTSD, anxiety, TIA (2016?). Patient presented to outside hospital 5/18/2021 after episode of profound fatigue and possible syncopal episode. While hospitalized, negative for PE, orthostatics negative. Had asymptomatic bradycardic episodes in the 40s. AKI improved with hydration. At last PCP visit, patient with cardiac monitoring in place and receiving follow-up care with local cardiologist. Patient believes episode may be an adverse event to his March 2021 COVID vaccination.
15 month with development of erythema and induration of all vaccine sites.  Patient received DTaP, comvax and prevnar.
This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (Lot # L007230 with expiration date 03-SEP-2016; dose, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Persistent crying/screaming started 24hrs after vaccination and lasted 18hrs, resolved spontaneously. Exam negative. No treatment.
On second dosage, my lips had swollen, from above my upper lip to mid-chin.  Slight breathing difficulty but nothing serious.  Lasted a few hours - reduced in swelling after taking Benadryl.  I have had, since the vaccinations, issues with periodic raised rashes mainly on my left forearm/wrist and occasionally on my right forearm.  Not sure if related but going to contact my doctor to look into it further.
Approximately 12 hours after injection, developed raised red rash in both axillae. Required medication intervention to resolve
08/27/2003: Temperature 98F oral.  Left arm reddened and warm to the touch.  IPV and DTAP administered in left arm (deltoid).  Advised to take antipyritic if spike fever.  If symptoms don't imrpove by 08/29.  Patients mother will call.
Immediately, during injection, baby was crying hysterically. When I picked him up he fell asleep instantly (a deep sleep). He would not awaken through walking to car and going into car seat (this is unusual for him). He slept on car ride and also when he was removed and still sleeping, placed on bed. I tried to wake him to breast feed as he was over due to eat. He would not wake up. I tried rousing him several times but I couldn't get him up until 19:00. This is not usual for him. Still refused to nurse. Finally at 19:30, he nursed but after that cried hysterically. Fell asleep again and slept several more hours. He woke at around midnight again. Next day was awake and alert as usual but had large red and swollen egg type lump at the injection sites. Both done next to each other, so don't know which caused the problem. Swelling lasted 4 days. Doctor said, before administrating it, that there are zero possible side effects so I didn't report them to her, immediately, as it would have fallen on deaf ears.
He noted in January after 1st Moderna vaccine.  Occurred <1 week after vaccine (within a few days).  He notes working with lumber and the wood that was wet, urgent care made an assumption of possible "spider mite" bite but no clear initial bite site.     Neck to ankles all over.  He describes pustules and he felt at least one time, he found a "miniature mite" inside the pustule but it "healed quickly". He does not recall being treated with any scabies medication.   Feels his immune system was "preoccupied" because of the Covid vaccine and developed this.  Was given 2nd Moderna and also booster but no worsening of symptoms.   Skin is much improved but continues to have chronic itchiness, opening wounds (without obvious trauma).
Red, warm swollen upper arm which over the course of the next three days spread to entire arm.  Contacted dr. office by phone and spoke with nurse. Was told to ice and take ibuprofen 3 X a day.  Which I did, Arm did not return to normal for 7 days and shoulder pain lingers.  Incident of overall warmth, sweating, light-headedness, which went away after sitting down, deep breathing and rest.   Did not return.
79yo zaotive cancer under treatment per recent guidelines given 3rd does Modern vaccine. 0.5ml unfortunately bottle was opened 12 Aug and confused w/ active bottle by operator error (nine)
On 11/3 it was discovered that vaccine which was administered on 10/26 had been stored in the freezer longer than the recommended 14 days.  Pt did not have an adverse event.
arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient experienced arm soreness in both arms. The reporter did not consent to follow up. For tolerance with 2nd dose of Shingrix, refer linked case US2021AMR025715.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025715:same reporter
Information has been received from a nurse practitioner concerning a female patient who on 17-MAY-2010 was vaccinated with a second dose of GARDASIL (Lot number not provided). The nurse reported that about 15-20 minutes after receiving the vaccine the patient felt like her throat was tightening and had trouble speaking. The nurse practitioner reported that the patient contacted the office on 18-MAY about experience and came in the office. At the office the patient was given BENADRYL (manufacturer unspecified) and since the patient had not gotten worse. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Pt admitted to hospital from ED for UTI on 4/17/21, 9 days after receiving 2nd dose of the vaccine
This spontaneous report was received from a physician refers to five patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. ON an unknown dates, the patients were vaccinated with improperly stored (temperature minimum 30F, 32.F, 92.5 Hours, because of date logger) GARDASIL, lot# L040459, expiry date 06-APR-2017, (dose, frequency and route of administration not reported). Previous temperature excursion was reported as no. No adverse events reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.