chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joint pain in the shoulder started a couple of days after the vaccination. Injection site pain persisted for several weeks after vaccination. Joint pain has subsided over time. Currently no joint pain if arm is at rest, however if I lift my arm I still have minor discomfort in the joint. It does not affect my ADLs, it is just nagging at this point.
patient came into clinic on 5/24/07 to have reaction evaluated.cellulitis of left arm was diaagnosed, erythema,warmth, diffuse induration, no fever, about 15-20 cm.  patient hospitalized 5/24-27/07 given iv ancef and vancomycin, blood cultures and nasal swab cultures done both negative, cbc and differential-wnl, patient discharged  home on bactrim and keflex 06/12/07-records received for DOS 5/24-5/27/07-DC DX:Left upper arm cellulitis, resolving. Obesity, rule out metabolic syndrome. HX of present illness:erythema, warmth and induration diffusely over lateral left upper arm. Temperature on admission 37.3 and remained afebrile for duration of hospital stay. WBC 6.6 with normal differential. Question of metabolic syndrome versus prediabetes. Given this cellulitis reaction and the patient's obesity there was a question of an immunocompromised host.
Iritis (i-RYE-tis) is swelling and irritation (inflammation) in the colored ring around your eye's pupil (iris). Another name for iritis is anterior uveitis. The uvea is the middle layer of the eye between the retina and the white part of the eye. The iris is located in the front portion (anterior) of the uvea.
Pt. did a rapid test per standard operating procedures at community, tested positive, rapid repeated with same result.  Pt. went for PCR test awaiting results. No symptoms at time of test. Report of sore throat later that evening.
Patient seen 6/3/03 for check-up was given Prevnar #3 in left thigh. Came back to our office on 6/5/03 had 3 cm x 1 cm red area with nodule. Given 3/4 tsp of Benadryl.
head & eyes deviated to right;jerking of head, lasting 10-15sec occurred several times; went to ER, where no abn found;
2nd time I got side effects. 1st shot just got mild fatigue and nausea. 2nd shot my arm got a Red hot ball under skin where I got injection,  woke up next morning with a fever, nausea, exhausted, throat hurt, 2 days later I have rash where I got injection and site itches and has a big red hot ball on it. I also have a headache and my body aches.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. From 01-MAY-2018 to 31-MAY-2018, the patients were vaccinated with improperly stored ROTATEQ lot # R002052, expiration date 22-MAY-2019; GARDASIL 9 lot # N022583, expiration date 20-JUN-2020; VAQTA lot # R002086, expiration date 22-APR-2019. The vaccines underwent a temperature excursion of 0 to -9.8 degrees Celsius for 15 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.
Fever; Chills; Fatigue; This is a spontaneous report from a contactable consumer.   A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EE9231) single dose for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, colitis ulcerative from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported; mesalazine (LIALDA) taken for colitis ulcerative, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported.   The patient experienced fever (non-serious) on an unspecified date with outcome of unknown, chills (non-serious) on an unspecified date with outcome of unknown, fatigue (non-serious) on an unspecified date with outcome of unknown.   No follow up attempts are possible. No further information is expected.
I walked out in the cold for about an hour, and about 5 mins after coming inside, I broke out in hives on my left leg above the knee. I'm reporting this because according to the RA, urticaria has been reported as a side effect of receiving an mRNA vaccine, and I have never experienced this type of skin reaction in the past.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning an approximately 52 year old female patient. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2016, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. Later in 2016, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
Severe joint pain where I currently have arthritis, severe headache, flu-like muscle aches, chills, fatigue for approximately 24 hours.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness for 4 days) and NAUSEA (Nausea for 4 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (Dizziness for 4 days) and NAUSEA (Nausea for 4 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Mar-2021, DIZZINESS (Dizziness for 4 days) and NAUSEA (Nausea for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: significant  follow up received on 21 Jul 2021, Event outcome updated.
Muscle pain (day of shot). Dizziness and syncope (2 days after shot). (L) arm swelling, weakness.
Pt brought to med obs #1 c/o nausea/feeling "queasy." Denies vomiting, changes in vision, dizziness, or LOC. Emesis bag provided to patient. Pt reports she ate breakfast PTA. Denies water/snack when offered. Reported improvement on symptoms shortly after arrival to med obs #1. Pt s/o brought to bedside to wait with patient. VSS. No s/s of distress noted. VS are as follows: 1020: BP 121/81, HR 71, RR 17, O2 sat 97% on RA 1025: BP 114/81, HR 72, RR 16, O2 sat 98% on RA
patient was given a vaccine that reached a temperature excursion and should have been discarded; Based on information previously received with CSD: 13-MAR-2019, the following information have been amended.   Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case is linked to case 2019SA072022 (same reporter).  This case involves a 11 years old male patient who was vaccinated with a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U153AA and expiry date: 21-Mar-2020, dose, dose in series and route of vaccination was not reported) in the arm on 11-Mar-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines given.   It was a case of actual medication error due to incorrect product storage. It was reported that Menactra vaccine that had experienced a temperature excursion. The vaccine was deemed expired as a result of the excursion.   It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Addendum: Based on information previously received: 13-MAR-2019, the following information have been amended.
Itchiness that lasted from 10:30 AM to about 1:45 PM. Started on arm, moved to head and belly. Improves after taking ZYRTEC.
sore arm; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (Headache) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, PAIN IN EXTREMITY (sore arm), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication was reported . no treatment medication was reported .   Reporter did not allow further contact
Parent reported redness and swelling that grew quickly and wrapped around her left thigh. It was tender, hot to the touch, patient would not crawl and "wailed in pain"  Message was sent to the provider Dr. and they were advised to get seen in urgent care, support care suggested (ibuprofen)
26OCT91 t101 cont off & on-would go up when sleeping; slept a lot; t103 ax Monday went to 105; MD found nothing wrong x/sl red throat given meds told fever was from getting too many shots; whining, legs & arms sore, little knot, didnt walk;
Mother phoned on 6/11 to report that approximately 10 minutes after leaving immunization clinic child developed a bump like rash on his stomach, face, and legs. Mother did not seek medical attention at time of out break. Stated that she continued the use of Tylenol, mother said he seemed warm she did not take his temperature. PHN advised mother to contact pediatrician, or return to local hospital emergency room. Mother expressed understanding. Agreed that she would contact PHN to disclose condition and treatment of child. Mother did not contact me and I have been unsuccessful at contacting family, two non-function phone numbers.
TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1128) was received from a caregiver on 07-May-2019. It describes a male consumer who "took unrefrigerated doses", while being on oral Vivotif (one dose every other day; lot no: 3003275 and expiry date: May 2020) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 02-May-2019 after it was unrefrigerated for 4 hours, which was good to use. Later, he did not refrigerate the remaining doses and took another two doses on 04-May-2019 and 06-May-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
This spontaneous report was received from a pharmacy employee referring to a female patient of unknown age who was a pharmacist. The patient's concurrent conditions, medical history, drug reactions and allergies were unspecified by the reporter. On approximately 12-MAR-2016 (reported as "about 5 days ago"), the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (dose, concentration, dose number, anatomical site of vaccination, lot# and expiration date were not provided). Concomitant therapies were not reported. On the same date and shortly after the vaccination with ZOSTAVAX, the patient experienced an injection site reaction and complained of pain, redness and itching at injection site, which the reporter stated that "lasted about 4 days". No product quality complaint was involved. There was no intervention to prevent serious criteria, the events were not cancer or overdose, the patient did not die, there was no significant disability or incapacity, no hospitalization and the events were not life-threatening. The patient did not seek for medical attention and was unspecified by the reporter if lab tests were performed. At the time of the report, the outcome of the injection site reaction, injection site pruritus, injection site erythema and injection site pain was reported as recovering. The reporter did not assessed a causality assessment between ZOSTAVAX and the events. Additional information is not expected, as no contact details were provided.
late administration of dose 2. Was given after month 2 from original dose given; This spontaneous report was received from a medical assistant on behalf of a health care professional concerning to a 26-year-old patient. The patient's concurrent conditions, medical history, concomitant medications, and previous drugs reactions or allergies were not provided.   On an unknown date, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, formulation, dose, route of administration, anatomical site of injection, lot number and expiration date were not reported).  On an unknown date, the patient received a late administration of second dose. It was given after month 2 from original dose given (inappropriate schedule of product administration).
PERIPHERAL NEUROPATHY 4/28/2023 HYPERCHOLESTEROLEMIA
This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 03-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiration date 17-JAN-2016, exact dose and route of administration were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient began to complain of shortness of breath, tingling in left arm (in which she received the vaccine), dizziness, and "seeing spots" approximately 5 minutes after administration of COVID-19 vaccine. Patient was found to have low blood pressure of 86/58. A code blue was called by COVID clinic staff. Upon rechecking vitals,  the patient's blood pressure had improved to 136/79 and her oxygen saturation on room air was 100%. The patient was advised to go to the emergency department for continued monitoring but refused.
Swollen lymph node started on (R) side of neck on 12/31/2020.  Also has had neck and arm tenderness since day after injection (12/25/2020)
Faint redness and rash with pain under axilla x 5 days. Redness and swelling around injection site.
40hrs insomnia 40hrs of my heart booming (feeling of beating out of my chest) 4 days of itching skin on my back of my hands, forearms, back of my knees, and around my neck.
pt recvd 3 doses of Engerix-B & was a non responder;
pts daughter states she has severe confusion with slow speech with difficulty speaking and slow movement  Also has  extreme muscle pain and double vision.  Pt had urge to urinate but could not.  Pts daughter states she is still having some symptoms but is improving and will see her doctor next week for a regular scheduled appt.  Pt started the medicine Cymbalta in November 2020 for her Fibromyalgia but had developed confusion from it so the doctor took her off of it on January 11th 2021 and was doing well until the day of the vaccination.
Pt developed a rash on the injection site and it spread down right side of arm and right leg and eventually to left lower leg.
I woke up with a sore throat, sinus pain, nasal congestion. Over the next couple of days those symptoms got worse and I developed ear pain, a cough, and diarrhea. I went to the doctor on 6/13/2022 because I thought I may have had a sinus and ear infection. I was tested for COVID-19 and it came back positive. I also had an ear infection. I was given antibiotics for my ear infection and instructed to take MUCINEX DM, and TYLENOL as needed. My symptoms lasted for about 9 days.
Patient states she developed a rash and sore inside her mouth. She went to her doctor and discovered she developed shingles.
Initial presentation Patient was in his usual state of good health until 4/19 when he received his first dose of the Pfizer COVID-19 vaccine. Two hours after the injection he became nauseous and vomited multiple times. Overnight he experienced diffuse myalgia and suprapubic pain. He awoke the next day to a pustular rash on his chin, forehead, chest and back. The patient describes similar previous rashes that have resolved spontaneously. The next day he began to experience gross hematuria and presented to the ED with a temperature of 98.9, blood pressure of 100/69mmHg, heart rate of 110bpm, respiratory rate of 18 breaths per minute and an O2 saturation of 97% on room air. On examination, patient was ill-appearing with diffuse pustules on his face, chest and back, periorbital edema, and leukoplakia of the tongue and buccal mucosa. His abdomen was soft and tender to palpation in the suprapubic area and at both costovertebral angles. Hospital course In the ED the patient was found to have a metabolic acidosis of pH 7.33 with an anion gap of 16, lactate 2.6, neutrophilic leukocytosis (22k), acute renal insufficiency with a BUN of 45 and creatinine 3.81 (baseline is 0.76). The patient?s urine demonstrated packed RBCs and 5-10 WBCs. He was admitted to the medicine service for further management. On the medicine floor he was initially found to have rhabdomyolysis (CK 584), worsening renal failure (Creatinine 8), follicular conjunctivitis by skin biopsy, a low CD3/CD4 count (CD4 91, CD3 47, CD8 258) with normal complement, and bilateral tinnitus. CT A/P without contrast showed increased attenuation of renal pelves and ureters consistent with hemorrhage, but no renal stones or hydronephrosis was seen. The patient was treated with pulse dose 500mg IV Methylprednisilone for 3 days and then transitioned to 60mg Prednisone. The patient?s pustular rash and oral leukoplakia greatly improved while on pulse dose steroids, but his kidney function continued to decline (Creatinine rising from 8 to 11), and the patient?s bilateral tinnitus progressed to bilateral sensorineural deafness over 2 days. Bilateral hearing loss prompted an MRI of the brain which identified several punctate infarcts across multiple vascular territories in bilateral cortices and left cerebellum. The patient?s kidney function has continued to decline, with progressive hyperkalemia and hemodialysis was begun.
Patient had vaccine at 4pm stopped to eat after. Patient states was in air conditioning when returning home went to dinner in home approx 930 pm and felt warm and when stood up had syncopal episode felt warm and lost vision.
Received Flumist Thursday developed Rt ear pain 24 hrs later and at 36 hours later noticed face swelling. At 48 hours had palsy of Rt side of face.
Got Moderna Covid-19 vaccine first dose on 12/29/2020. Developed delayed onset red, itchy, elevated rash at the site of injection approximately 10 days after first dose of series. No treatment provide, rash resolved on its own in about two-three days. Second dose of vaccine given on 1/26/21 and now on 1/27/21 in PM noted that red rash has re-emerged on the same site as before (around the area where first dose was injected), this time the rash is not itchy-just a red bump. No treatment given as of yet.
UPPER RESPIRATORY ISSUE; INSOMNIA; FATIGUE; INTERMITTENT HEADACHE; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included morphine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) dose was not reported, administered on 12-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced insomnia. On 13-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced intermittent headache. On 28-MAR-2021, the subject experienced upper respiratory problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, upper respiratory problem, insomnia, and intermittent headache. This report was non-serious.
When administering my 2nd Covid 19 Moderna Vaccine  on 04-13-21 the gave me a shot in mt right arm. I felt the needle go in, I also felt something go down my arm that I thought was blood. The told me that the Vaccine did not go into my right arm and that she had to give me another shot in my left arm. I told her that I felt the needle go in my right arm thus surely some if not all of the Vaccine went in my arm. She told me it did not and that it was the vaccine that she wiped off my arm not blood. I told her I was concerned about getting more than the recommended dosage if she gave me a second shot. I asked her if it is possible to be over vaccinated, she said no. I didn't know what to do so I allowed her to give me another shot in my left arm also on 4-13-21 within a minute of receiving the first shot. Presently, on 04-14-21, both my arms are extremely sore at the injection sites and I have body aches all over my body. I'm concerned about receiving more than the recommended dosage. Please advise.
PATIENT HAD A SORE ARM AND BODY ACHE. SHE DID NOT NEED ANY MEDICAL HELP. HER ENTIRE ARM WAS IN AGONY AND SHE FELT FATIGUED FOR 24 HOURS. SHE WAS ALSO NAUSEAUS. SHE WAS IMMOBILE FOR A LITTLE OVER 24 HOURS. SHE IS OKAY NOW
Small lump developed at the injection site within a week of receiving dose #2. Approximately 6 months after receiving the second dose the lump remains at the injection site and has become enlarged and tender to the touch.
This spontaneous report as received from a registered nurse refers to 3 patients of unknown age. On 15-NOV-2013 the patients were vaccinated with expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA, Exp 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
No additional AE; 2 patients were administered an expired dose of ROTATEQ; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.      On 04-JAN-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter/1 time dose (expired product administered) (lot number T033510 and expiration date 28-DEC-2021) for prophylaxis.    No additional event (no adverse event) was reported. No PQC was reported.