chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling and pain at the injection site; swelling and pain at the injection site; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), as single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "swelling and pain at the injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe pain with Migraine, dizziness, nausea, lights too bright, noise too loud, it even messes with my eyes, making them blurry.  I tried taking an Amovig shot on 1/21/21, it did not work.  I tried taking motrin, tylenol, and etc... nothing is working... The pain is horrible. I'm having problems concentrating.  This has been 5 days and is still extremely painful... the doctors will not do anything more about it.  I called Moderna and they could suggest nothing either.  I don't know how long this will last, but I'm miserable!
Severe headache, nausea, muscle and joint aches, insomnia, dehydration (I'm always thirsty), lack of appetite, lack of libido, severe exhaustion, weakness, dizziness, fever, hot and cold flashes, muscle twitching, and extreme fatigue.
Fevers, chills, swelling, itches, tenderness. Received at pharmacy.
Patient was given Moderna Booster vaccine on 04/13/22. Lot # 069H21A went out of date on 04/06/22. Temp was in range per CDC guidelines. Patient had no adverse reaction after required 15 minute waiting period. Moderna was called.
Uncontrollable shivering for 3 evenings. Temperature between 99.3 to 100.5 for 9 days and still continuing during evenings
Mother reported child had high fever and a short shaking episode. Child was taken to emergency department for evaluation.
Patient complained of feeling dizzy, anxious, shortness of breath. Did have some pain with injection. Did have mask on while waiting standard 15 minutes.
immediate dizziness and elevated heart rate after vaccine, and somewhat elevated blood pressure after an hour felt better, went home to bed with fatigue, slight nausea and headache
Pain in right arm/no fever, Vomiting, Diarrhea. Pateint is home resting.
Patient states that she noticed increased redness at vaccine injection site the day after receiving the vaccine.  Patient did not report the reaction until today, 11/03/2016. No swelling, no decrease to ROM, and minimal tenderness to touch.  Dr. notified and advised patient to use cool compresses to area and report any worsening symptoms.
Information has been received from a health care worker concerning an 11-year-old female who on 17-JUL-2007 was vaccinated subcutaneously in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 654282/0776U). On 19-JUL-2007, the patient experienced a red, hot to touch area the size of a"playing card". No medical attention was sought. The outcome was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Vertigo, nausea for 36 hours, slept in seated position.  Took diphenhydramine HCL 25 mg.  overall malaise and muscle soreness.
15 days post vaccination states he developed a large bruise, approx. 2.5" x 2.5" on the anterior aspect of his L upper arm. Denies pain, no swelling noted, area non tender and soft to touch. States he takes "blood thinners". Referred him to his PCP.
Immediately after vaccination patients arm become warm, red, raised and a rash developed from above injection site to elbow 1/1 tsp Benadryl given - (+) effect 20 minutes later.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 25 year old female who was vaccinated with the first and second dose of GARDASIL (lot #, dose and route not reported) in January 2009 and on 13-SEP-2011, respectively. The physician reported that the patient had a positive home pregnancy test on 20-SEP-2011, and the pregnancy was confirmed by physician exam on 21-SEP-2011. The physician stated that no adverse effects had been reported by the patient. All telephone attempts to obtain follow-up information have been unsuccessful. The pregnancy outcome was lost to follow up. Additional information is not expected.
This spontaneous report was received from a female patient of unknown age, who was also a physician, regarding herself. The patient's concurrent conditions included scabies, for which the patient was treated with STROMECTOL (detailed in MARRS number 1502USA009858). The patient also had several drug reactions, which included ciprofloxacin that caused shoulder tendonopathy, MEPHAQUINE that caused migraine, tachycardia, chest pain and irregular heart rate, BACTRIM that caused extreme facial swelling, low heart rate and difficulty breathing, unspecified flu and yellow fever vaccines which caused unspecified hives, and metformin that caused her fingers to turn blue, numb and tingly. On an unknown date the patient was vaccinated with zoster vaccine (manufacturer unknown) (reported as unspecified shingles vaccine). On an unknown date, the patient experienced unspecified hives. The outcome of the hives was unknown. Causality assessment was not provided. This is one of two reports from the same source. Additional information has been requested.
Patient experienced severe swelling and bruising. After a few days said the swelling went down but the bruising was still present. Then after a couples weeks stated that the bruising and swelling was gone but now there was scaring and patient stated it was like it was burned and now scarred. She did not go to ER room or Primary care to get it looked at and treated.
Fatigue in morning then flu like symptoms (chills  more serious fatigue,  )slept most of afternoon the  ok
Information was received on 02-NOV-2016 from a company employee who received information from a pharmacist. The pharmacist reported that an unspecified number of patients, names and demographics unknown, received a dose of PNEUMOVAX 23 and experienced "more side effects than with other vaccines, including PREVNAR 13". Details of adverse events were unknown by reporter. No other information was available. Additional information is not expected as pharmacist does not wish to be contacted.
Low grade fever; Aches; This case was reported by a other health professional via other manufacturer and described the occurrence of low grade fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hypertension and obesity (BMI (Body Mass Index) was 30).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced low grade fever and pain. On an unknown date, the outcome of the low grade fever and pain were unknown.   It was unknown if the reporter considered the low grade fever and pain to be related to Shingrix.  Additional details were provided as follows: At the time of reporting, the patient was 68 years of age. The age at vaccination was not reported. The Shingrix administration date was not provided. The patient had low grade fever and ache after vaccination with Shingrix. The patient received Pfizer covid 19 vaccine on 23rd December 2020 (batch number EJ1685, Expiry date April 2021) and on 12th January 2021 (batch number EL3249). On 30th December 2020, the patient was positive with covid 19 and also had sickness on 1st January 2021.  After 2nd dose, the patient had Fever (101.5 F), body ache, malaise and fatigue for 4 days. The patient was treated with Ibuprofen(oral).
5 seconds after the shot pt stood up and then said " I feel nauseated"  I sat the patient down in the chair he started to sweat and go pale and roll his eye's and slid back in chair.  after 5 seconds he jumped up out of the chair and said he wasn't ready for the shot.  His mom then said that he already had it and then i sat him back down in the chair, fanned him with a paper and then asked for ice pack to be brought in to the room.  Another nurse came in with Ice pack and we laid him down on the table with knees up for 3 min.  He said he felt better then we sat him up for 2 min then stood him up and he said he was ready to go.  both  RN's and mother agreed.
Got vaccination approx. 1:00 pm and at about 9:00 pm i started noticing my lip swelling.  I  went to ER and got treated for an allergic reaction.  Got a prescription for Prednisone 20 mg. but i could not afford the prescription.  Had  to go back to ER 5 days later because of a worsening rash that started all over my body.  They gave me a prescription for Prednisone 20mg 3 times a day, I took it and had to go hospital again approx. 2 days after the 1st visit they treated me again for an allergic reaction. Then I went to another clinic today.  They told me to see an allergist which I cannot afford to do. Then tonight I went to hospital because the rash got even worse, plus I have had swelling all over, mild fever, nausea, diarrhea, tightness in my chest, dizziness   numbness in my lips and hands and feet, and blurry eyes since the  first few days after I got the vaccine.  The hospital treated me with Atarax and SoluMedrol.  They referred me to a free clinic but said I really need to see an allergist which I cannot afford.  I have no insurance or job.   I was in CNA school and a new employee at a clinic and they fired me because I did not come to work/school the next day because I was sick with allergic reaction. My mother has digital pictures of my rash.
6 days post vaccine , axillary lymph node on immunization side swollen and painful , continued for 1.5 to 2 weeks.  Pt reports targeted spot of pain continues at 5 weeks.  Occasional shooting or radiating or  pain from axillary to shoulder and occasional down the arm.  Minimal improvement to no improvement at 5 weeks.  Took ibuprofen otc after a couple weeks to help with pain , tried warm showers and ice.
Severe pain where the shot was administered/It's worse than a broken arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain where the shot was administered/It's worse than a broken arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced VACCINATION SITE PAIN (Severe pain where the shot was administered/It's worse than a broken arm). At the time of the report, VACCINATION SITE PAIN (Severe pain where the shot was administered/It's worse than a broken arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment  was provided.
pt recv vax&30-40 sec later pt stood up tried to sit&body was thrusted onto the refrigerator door-striking head;pt appeared to have a grand mal sz;
he had all the shots and the covid booster and still got covid.; he had all the shots and the covid booster and still got covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: ER8734), in arm, on 30Apr2021 as dose 2, single (Lot number: ER20170), in arm and on 14Jan2022 as dose 3 (booster), single (Lot number: PJ6369) at the age of 84 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma States she is an asthmatic and does not remember when that was diagnosed but she was a kid. The patient did not begin any new medications within 2 weeks prior to testing positive for COVID. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 29Mar2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "he had all the shots and the covid booster and still got covid.". The events "he had all the shots and the covid booster and still got covid." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Mar2022) positive. Therapeutic measures were taken as a result of covid-19.
No additional adverse event reported.; wrong vaccine administered; Drug use in unapproved age group; This spontaneous report has been received from a registered nurse referring to a 16 year old patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.  On 25-FEB-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S029265 with expiration date of 31-MAR-2021 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis (wrong product administered and product use issue).  combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
I was expecting to feel ill but this is different than I expected I get a fever, it goes away than it comes back, my head hurts than it doesn?t my body aches than it doesn?t than everything starts all over?now my arm is weird like it?s numb almost, I mean I can use it but it is numb and it itches like crazy around the injection site.  Fever has been as high as 103.5 but averages around 100 since I got the shot? today is stomach issues and headache with slight fever(100.7) how long will this last?!?! Thought it would be just a couple of days?!?!  Also for what it is worth I had COVID 19 in February was sick for about 6 weeks
Vaccine was given inadverantly at 6 month well child care check No adverse reactons at time of discharge Provider was informed within 3 minutes Mother of the child was informed within 10 minutes Review of potential adverse reactions reviewed with mother of child prior to giving vaccine and again upon calling mother to inform her of error.
Same day March 17th, by 2230 or 1030pm slight injection sight pain and minor head ache in temple area mostly. Today the 18th Awoke with much greater injection site pain in the arm in delt area but no swelling or rash. Still minor headache but around the whole head. Approximately  1000-1030-AM and through 1300 hours (pm), extreme headache but tolerable, EXTREME FATIGUE and SHORTNESS OF BREATH and DIZZINESS (ALL CONTINUING) post physical activity.....ie: bending, lifting, moving etc etc.....Sitting now for 30 minutes still have the above listed items in CAPS ongoing. Temp is good and pulse is good. Aside from increased arm pain I have been feeling incredible burning sensation going from injection site left arm across upper  back to right side .....thats it so far
Metallic Taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 25Jun2021 at 12:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disorder, Hashimoto's disease and non-Hodgkin's lymphoma. The patient had no known allergies. Concomitant medications included thyroid (ARMOUR THYROID), omeprazole (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and ubidecarenone, linum usitatissimum seed oil, conjugated linoleic acid (COQ10), all taken for unspecified indications from unknown dates. 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 25Jun2021 at 12:00, the patient experienced metallic taste in mouth instantly as the vaccine was administered and had been continuing 11 days after the vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken as a result of the event. The clinical outcome of the event metallic taste in mouth was not resolved at the time of this report.
Patient presented to the medical with a complaint of nausea/vomiting, diffuse muscle aches, fatigue, and headache which started the night after he received his vaccine. His vital signs were normal and his exam was unremarkable. He was provided symptomatic treatment with acetaminophen and ibuprofen and asked to follow-up if his symptoms fail to improve after two days.
Mother reported he had a fever at 2am on 2-12-19 with a seizure that lasted 4-5 min.
Upon giving the vaccine, it was discovered that the patient was already complete with his 2 dose series of Shingles. Patient was given technically his third dose of shingles.
Patient reported fever, sweating, weakness, shivers 4 hours after vaccine which continued for another 8 hours.
This case was reported by a healthcare professional and described the occurrence of pruritic raised red rash in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent vaccination included TYPHIM VI (non-gsk) ;Sanofi Pasteur MSD given in August 2011. On an unknown date in August 2011 the subject received 1st dose of TWINRIX (1 ml, unknown route, left arm). The healthcare professional reported that the vaccination date was around 19 August 2011, but could not be sure of the exact date. On the same date in August 2011, 2 hours after vaccination with TWINRIX, the subject experienced pruritic raised red rash on both forearms. The rash was greater than 50 mm. The subject's physician considered the rash to be a fixed drug eruption. At the time of reporting the events were resolved. The vaccination course with TWINRIX was discontinued. The subject was referred to an allergist who recommended no further doses of TWINRIX. The healthcare professional considered the events were possibly related to vaccination with TWINRIX.
Depression, Headache, Myalgia & Arthralgia Narrative:  chills, sweats, fatigue, lymph node swelling
I had a fever of 102, nausea, headache, and fatigue a day later. This lasted for a few days. Then fatigue never went away.  Then on May 3, I got vertigo. Then on May 10th, I had severe fatigue, chest pain, and heart complications. I also had diarrhea and complete loss of appetite. I had brain fog and body aches. These lasted for about 6 weeks. I went to my doctor about this. They did blood work, normal result. They did an ultrasound of my abdominal, normal results. They did a EKG of my heart, normal.
PASSED OUT; BOTH ARMS WENT COMPLETELY NUMB; LEGS CRUMBLED/COULDN'T STAND UP; VOMITED; THE DAY GOT THE VACCINE IT BLED AND A BLOOD CLOT CAME ON MY ARM; This spontaneous self-report concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAR-2021, the day the patient got the vaccine it bled and a 'blood clot' came on my arm (coded to injection site bleeding). On 01-APR-2021, the patient passed out in a store, both arms went completely numb, legs crumbled/couldn't stand up, and vomited. The patient believed this was a side effect of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events (passed out, both arms went completely numb, legs crumbled/couldn't stand up, vomited, and the day got the vaccine it bled/blood clot came on my arm) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This patient of unknown age and gender passed out 3 days after receiving the Janssen Covid-19 vaccine. The patient was in a store when when both arms became numb, legs "crumbled" and could not stand; the patient also vomited. No other information regarding the serious loss of consciousness  was provided. Additionally, on the day of vaccination, the patient experienced bleeding at the injection site and a clot formed. Considering the missing information (e.g., age, sex, medical history, concomitant medications, clinical details leading up the event, corrective treatment, event outcome), the serious loss of consciousness is considered unclassifiable. The nonserious injection site reaction is consistent with a causal association with vaccination.
Gave VARIVAX vaccine IM in (L) thigh with 5/8 inch needle.
raised rash, about 4 inches; Injection site warmth; It itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (raised rash, about 4 inches), INJECTION SITE WARMTH (Injection site warmth) and INJECTION SITE PRURITUS (It itches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced RASH PAPULAR (raised rash, about 4 inches), INJECTION SITE WARMTH (Injection site warmth) and INJECTION SITE PRURITUS (It itches). At the time of the report, RASH PAPULAR (raised rash, about 4 inches), INJECTION SITE WARMTH (Injection site warmth) and INJECTION SITE PRURITUS (It itches) outcome was unknown. rash is about 4 inches      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient notified.  She is away at school.  Will get vaccine when she is home from school.