chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who was vaccinated with the first dose of GARDASIL.  No lot number provided.  Physician reported that a patient received her first dose of GARDASIL and shortly thereafter the patient experienced convulsions and had to be hospitalized (the length of the hospitalisation was unspecified).  Physician reported that the patient was not going to received the second and third dose due to the experience.  At the time of reporting the patient had recovered, and stated, "the patient is fine now."  Additional information has been requested.
Needle attached to PFS, stored until next day; The needle was attached to a prefilled syringe stored until the next day; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in product usage process in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong technique in product usage process (Verbatim: Needle attached to PFS, stored until next day) and circumstance or information capable of leading to medication error (Verbatim: The needle was attached to a prefilled syringe stored until the next day). The outcome of the wrong technique in product usage process and circumstance or information capable of leading to medication error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-MAR-2023 The reporter was the nurse. The reporter reported that a needle was attached to a prefilled syringe around 3:00 pm, after receiving the recommendations to the disease control on this matter, nurse stated that such vaccine was going to be stored until the next morning.  The reporter did not consent to follow-up. The needle was attached to a prefilled syringe stored until the next day which led to wrong technique in product usage process and Circumstance or information capable of leading to medication error.
Nausea, vomiting, diarrhea, chills, headache. Sx began 12 hrs after vaccine given. Sx improved in 24 hrs. I was given the TDAP vaccine (0.5ml, Lot# U4329AA) on 5/30/2012 for having a metal wire pierce my foot. To this day I am experiencing: a dull pain, itching, prickly burning sensation in the area at the injection site. There is nothing visually seen in the area on the surface of the Lt deltoid where the vaccine was administered (no swelling, not hot with fever, and not red). There is just an uncomfortable feeling in the area of the dose administration constantly.
pt recvd vax p/childbirth when found to have no rubella immunity; rash over entire body, arthritis in knees, wrists, elbows; 3-4 day duration; rash again 23JAN93; arthritis more severe;
Fever of 101 for 48 hours; stabbing pain in joints; sore arm; This is a spontaneous report from a contactable consumer. This 69-year-old (at the time of vaccination) female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EN6201) via an unspecified route of administration on 15Feb2021 at 01:30 pm at single dose on right arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient's medical history included high blood pressure (dates unspecified). Past drug included known allergies; lisinopril. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL8982) on 25Jan2021 at 02:00 pm at single dose on right arm for covid-19 immunisation. Vaccine facility type was reported as other. Concomitant medications (in two weeks) included losartan potassium (LOSARTIN), meloxicam, ascorbic acid, copper gluconate, fish oil, tocopherol, xantofyl, zeaxanthin, zinc oxide (OCUVITE ADULT 50+), fluticasone. No other vaccine was administered in four weeks. Patient experienced fever of 101 for 48 hours, stabbing pain in joints, sore arm on 16Feb2021 at 03:00 am. No treatment was given for the adverse events. Patient did not have covid prior vaccination and was not tested for covid post vaccination. The outcome of events was recovering.
Moderna Covid-19 Vaccine EUA Booster caused arm pit lymph node swelling
About 20 minutes after shot, infant began to cough up thick Karo syrup like phlegm. Called MD right away, told to watch. Later night, woke to infant not breathing, resuscitated at home, taken to ER. Large knot on thigh (mom unclear of what one at this time anymore).
7 days after the injection, the site is red, feels a little warm, and itchy.  It had gotten better a couple days after the shot, but the symptom I have described just appeared today.
9/4/08 - arrived in office. Complained of vomiting 2 hours after shot yesterday. And x1 today; nausea, T98.1
Next day - right upper arm red swollen hot tender to touch - shoulder to elbow. Tx DECADRON 1.5 m/IM. Cool compresses - ibuprofen 800 mg TID BENADRYL Tx.
Fatigue, beginning 12 hours after injection and lasting 3 days. Fever of 101.4 beginning 2 1/2 days after inj and lasting about 10 hours. Stiff and sore shoulders and neck, beginning about 24 hours after inj and lasting 3 days.  Treated with ibuprofin for fever and headache.
Pt complained of left sided chest pain after vaccination.  No associated SOB, radiation.  EKG without ST elevation. BP elevated (missed morning meds). EMS consulted, patient refused EMS care/transport and departed on her own.
On November 7, 2022, I was having chills, vomiting, diarrhea, pain. I was diagnosed with E.coli. I have been having whooshing sound in the ear. I am a kidney transplant recipient.
Vaccinated at 1:00 p.m. - chills at 11:00 p.m., fever that reach 102 and stayed 102 for 24 hours.  Body/muscle aches.  No energy.  Itching in armpits, inner elbows, neck, around face, hips and thighs.  Welts and redness.  Nausea, loss of appetite.  Started feeling better Wednesday evening and by Thursday morning felt pretty normal.  I had the same reactions with my 2nd shot, but they only lasted 36 hours.  This time they lasted more than 72 hours.
Body aches, head ache, chest tightness, nausea, fatigue, foggy head
Afflicted with Bell?s Palsy on 06/20/2021. Out of nowhere!
Information has been received from a pharmacy student concerning a female patient who in 2009 was vaccinated with the first dose of GARDASIL and in 2011 was vaccinated with the second dose of GARDASIL (doses, routes and lot numbers not reported). No adverse events were reported. Additional information has been requested.
Severe swelling of entire arm. (per RN on 11/1/11). Went to ER. Diagnosed as cellulitis. Given steroid & antibiotics.
On 2/8/00, the pt experienced significant local swelling (twice as big), hot to the touch, redness, pain, hardness and tenderness at the injection site. He could not walk. Outpatient treatment was required. Physician prescribed Benadryl and a warm towel compress to treat injection site swelling. The most recent information received on 3/14/00 reports the condition of the pt as resolved.
pt began having ataxia; stopped progressing developmentally; 3/99 began having psychomotor sz - now having 20-40/day
DOSE AT 12:50 PM, ABOUT 5 PM GOT VERY NAUSEAND LAID DOWN IN BED ABOUT 8:00 PM, WITHIN MINUTES BECAME VERY VERY COLD. WAS VIOLENTLY SHAKING FROM CHILLS, THEN VIOLENT SHAKING WITH MUSCLE TENSION FOR SEVERAL SECONDS  THEN RELAXED FOR A FEW MINUTES THEN MORE  TENSION. ALL OF THIS ALONG WITH THE CHILLS.I DO NOT KNOW HOW LONG THIS HAPPENED BEFORE I FELL ASLEEP. NEXT  DAY WAS VERY TIRED,  AND ACHED ALL OVER AND WAS WEAK.
Pt recvd 1st dose of Engerix-B 12JUL90 & 1 hr p/12JUL90 dose given pt exp SOB, severe h/a, wheezing persistent >6 months, arthralgias, persistent >6 months myalgias, fibromyalgias, & depression; Taken to ER;
Continous crying for 6 hrs; cry was highter pitched than usual, but not really cat-like; no sz; hospitalized x 24 hrs for observation;
pt recv vax 14NOV96 @ 230PM & while driving became dizzy, passed out & crossed median, when awoke was hysterical, went to work;1hr later pt vomited, t99.6-went home & went to bed 5PM & slept all noc x/getting up once;
PROQUAD vaccine since excursion date on 7/14/2022; This spontaneous report has been received from a medical assistant concerning a 5-year-old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date in 2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) (rHA) subcutaneous injection, 0.5 milliliter (lot number W016358, expiration date 16-NOV-2023) as prophylaxis (strength, route of administration, vaccination scheme frequency, and anatomical location were not reported). According to temperature stability evaluation, the vaccine administered had been suffered a temperature excursion since 14-JUL-2022 (Product storage error).  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA004135: US-009507513-2208USA004105: US-009507513-2208USA003988: US-009507513-2208USA004086: US-009507513-2208USA003812: US-009507513-2208USA004011: US-009507513-2208USA004012: US-009507513-2208USA004060: US-009507513-2208USA004223:
Rashes over her body; maybe she was having an allergic reaction; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself.  A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on Apr2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after the vaccination, the patient experienced rashes over on her body. She just thought maybe she was having an allergic reaction. She brought it up to someone who told her that is a side effect of the Pfizer-BioNTech Covid-19 Vaccine. She asked for information on rashes, if that is a side effect of the Pfizer-BioNTech Covid-19 Vaccine, and if the rashes over her body get worse. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
One day after vaccine developed diarrhea with nause and vomiting. She also reported general malaise similar to "Influenza like symptoms". She stay at bed and improved from the general malaise symptoms but persisted with nausea and vomiting. On day 3, she reported at night that her pulse Ox dropped to 88% and was taken to ER. She was admiited with suspected atelectasis of left lower lobe abd possible pneumonia which is difficult to evaluate due to her chronic lung condition. She had improved and is no longer having vomiting or general malaise and expected to be discharge home soon.
This spontaneous report as received from a pharmacist refers to a female patient of approximately 68 years old with no pertinent medical history and no drug reactions/allergies. On 28-AUG-2009 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously. Concomitant therapies included CRESTOR and DETROL. Last summer, around August 2012, the patient developed shingles. The patient saw her unspecified primary care provider, on an unspecified date, who stated she had a severe case of shingles. The patient did not receive any treatment. No laboratory tests were done. The patient's rash was no longer present however the patient still had nerve pain and tingling that "come and goes". Additional information has been requested.
The client came to the clinic and requested her "first" Pfizer vaccine and stated she did not have a vaccine card. Her electronic record was looked up, but none was found. Her last name was entered incorrectly at check-in. The client added an "e" in the spelling of her last name. This was corroborated by 2 people at check-in. Upon entry into Immunization Registry, it was found that she was already fully vaccinated with Pfizer.
swelling and tenderness with palpable lump and lymph nodes at rt clavicular region and right axilla, starting approximately starting 45 hours post injection and continuing at time of this report
Narrative:  Patient with anaphylactic reaction to covid vaccine at hospital. vaccine date/manufacturer not known. Pt required IM epinephrine, steroid burst and albuterol at hospital. exact doses not recorded in rapid access clinic note
prescription of Arexvy to patient under 60 years; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: prescription of Arexvy to patient under 60 years).  The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 15-Sep-2023 The pharmacist requested data on the use of Arexvy for a patient under the age of 60. Pharmacist stated that the MD had sent a prescription for the patient under 60 years of age to receive the Arexvy vaccine which led to intercepted drug prescribing error. Arexvy not administered at time of call. The reporter did not consent to follow up. Pharmacist declined Safety team follow up. No patient demographics available.
Headache, Myalgia, Arthralgia, Fever, inj site pain, chills, tiredness, swollen glands Narrative:
c/o limping next day p/shot given; c/o soreness @ site of inject;
MUSCLE PAIN; This spontaneous report received from a parent concerned a 69 year old female. 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 not reported, batch number: Unk) dose was not reported, administered on 17-MAR-2021  on left arm  for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle pain was not reported. This report was non-serious.
Pt vaccinated with FLUOGEN; 17 days later developed synovitis/arthritis in wrist and ankle.
patient broke out with shingles in his eye and on scalp 102 weeks after receiving vaccine.
The pharmacist said "this muscle doesn't like this injection...you'll have some pain". I did have pain that night and it lasted "for over a month. But THEN noticed that I was having severe shoulder pain and from probably late Novemebr 2014, had difficulty lifting my right arm without pain. The pain is now such that beyond a certain level I can't lift my arm without pain that makes me drop anything I might be holding. Hard to put on a coat or fix my hair as that takes two hands. I continued taking IBU and putting warm compressed...to no avail. In the meantime I started physical therapy for a return of a neck injury. This clearly made my left arm worse. I saw my physician and she stopped PT and diagnosed my left as tendonitis. I am to continue IBU and hot compresses and return to her in a month (2 weeks from now,) My arm is no better nor worse, but the limits of range of motion are distressing and painful.  A few evenings ago I was with a group of womem who both were experiencing what I had, I asked, and yes, they both had that double dose flu shot.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a nurse concerning a patient of unknown age in a pediatricians office. This case is submitted in accordance with Medimmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. There was no adverse event associated with this medication error at the time of the report, nor when contact was made with the site approximately two weeks later, therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up received on 17-Oct-2008. No adverse events had been reported. Follow-up information received on 20-Mar-2009 included Product Compliant Invetigation Products.
(1/15) Knew I was exposed and woke with phantom limb pain, Flu-like symptoms mild, and decided to get test that Monday (1/17) that was a PCR and came back positive for Covid. But before that on 1/16, I did a video visit with doctor and was advised to have a supportive care at home. 1/19 Asthma issue that required attention (Cold air, prone, Nebulizer was used) 1/20 Feel much better today and I seem to be recovering.
Large swollen knot on left thigh at MMR injection site.  Initially noticed the afternoon of the injection about 2:30 PM. Area is warm to the touch and red welt that gradually spread over the evening and through the next day. Child complained of a headache and had a low grade fever the evening of the injection. Still complaining of headache the following day.  Small rash on thighs and groin area appeared the morning after the injection was given.  Phone call to pediatric clinic  placed on 24 July at 3:00 PM to notify of the reaction. I was advised to watch the area for further spreading of irritation and to monitor for fever. Due to the COVID19 outbreak  it was not suggested that we return to the clinic unless the reaction became worse.
A little high from the vaccine; Redness of the injection site; Swelling of the injection site; Delayed hypersensitivity reaction; Infection; Lymph nodes tenderness; Lymph nodes swelling; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), INFECTION (Infection), EUPHORIC MOOD (A little high from the vaccine), VACCINATION SITE ERYTHEMA (Redness of the injection site) and VACCINATION SITE SWELLING (Swelling of the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM LEVOMEFOLATE, DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (BEYAZ), MINOXIDIL (ROGAINE), EPHEDRINE HYDROCHLORIDE (EPHEDRIN) and BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Headache.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced LYMPH NODE PAIN (Lymph nodes tenderness) and LYMPHADENOPATHY (Lymph nodes swelling). On 13-Jan-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), INFECTION (Infection), VACCINATION SITE ERYTHEMA (Redness of the injection site) and VACCINATION SITE SWELLING (Swelling of the injection site). On 15-Jan-2021, the patient experienced EUPHORIC MOOD (A little high from the vaccine). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed hypersensitivity reaction), INFECTION (Infection), EUPHORIC MOOD (A little high from the vaccine), VACCINATION SITE ERYTHEMA (Redness of the injection site), VACCINATION SITE SWELLING (Swelling of the injection site), LYMPH NODE PAIN (Lymph nodes tenderness) and LYMPHADENOPATHY (Lymph nodes swelling) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment were included Keflex, Zyrtec and Ice.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash underneath injection site - red, raised, itchy, 2.5 inches in diameter - appeared the day after the 2nd dose, assuming it will go away in a few days, but thought to report it just for records.
After I went to bed at about 10pm, I kept waking up with feelings of anxiety, even though I wasn't particuilary anxious about anything. At about 5am, I woke up again with pain in my joints and a headache. During the day, the pain got worse. Almost like when you were a kid and had growing pains - how it ached down to your bones and it just kept getting worse through the day. I had a low fever all day that got worse after about 8pm until I finally fell asleep at around 11:30pm. During this time with the fever my skin was hot to the touch, but yet I was so cold I was shaking, which didn't help the pain. The next day I woke up and while I kinda felt better, I was extremely sore all over and still had the headache which I more or less had the whole weekend.
Inflammation in my chest cavity that caused severe chest pain and tightness that also caused shortness of breath.
Viral encephalitis; This case was reported by a other health professional via sales rep and described the occurrence of viral encephalitis in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced viral encephalitis (serious criteria GSK medically significant). On an unknown date, the outcome of the viral encephalitis was unknown.   It was unknown if the reporter considered the viral encephalitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The reporter had third hand information about the case from  the clinic and did not wish to be contacted. This case is 1 of the 3 cases reported by the same reporter.
Next day had severe pain in muscles and some muscle weakness; this was not reported to me until 1/16-he does have some chronic back pain-but this was different
Approx 3 hrs after the PPSV23, extreme pain, radiating from the left upper arm (injection site) up the shoulder, up the left side of my neck to the base of head. The pain was at a level 10 (on a scale of 1-10). Unbearable pain if I moved my shoulder/neck. The pain got less for a few days and then re-occurred. I needed ER visit for pain - 1/5/2017. Same pain as 12/28/2016.
Racing heart HR . 100 BPM, L arm tenderness -even at rest "weak" feeling chest, fever 100.8 and 11/7/09, fatigue nausea chills. Seen in the office 11/9/09 - temp 100.4 HR 100 BP 110/60 erythema of L distal upper arm.
She first started feeling numbness in her feet and hands and by 03/12/2010 she started to having numbness in her lips and tongue.  On 03/12/2010 she was admitted to hospital and diagnosed with Guillain-Barre Syndrome. She is currently still in the hospital and they are estimating she can be discharged on 05/28/2010
Fever; headache; swollen lymph node- left armpit; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 14:45 (Lot Number: EN5318) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included allergy to red dye. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) and birth control pills. The patient previously took tylenol with codeine and experienced allergy and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) in the left arm on 29Jan2021 at 12:30 pm (age: 39 years) for COVID-19 immunization. On 20Feb2021 06:00, the patient experienced fever, headache, and swollen lymph node- left armpit. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Pt. states woke up feeling nauseous and hot. States she feels like she has a fever.