chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SM reports receipt of third AVA vaccine on 5/2/2009 (AVA #1 8/2/05, #2 8/17/05).  He reported no problems for 2 days.  5/4-7/2009 he c/o:  1) a round raised pimple like bump -rash over injection site that gradually progressed down and around his upper left arm, 2) his left shoulder forearm to elbow region redness, tenderness, and 3)pain with movement of left shoulder/elbow.  He described anterior and lateral areas of forearm as mostly affected.  This area does itched profusely.  He also admits to mild SOB sensation with exertion starting 5/6/09 with no ha, cp, n/v or GI discomfort, fevers, tinnitus, etc.  He sought medical care 5/7/09 and placed on ALBUTEROL for wheezing, given steroid titrating dose pack and TYLENOL.  (allergy to ASA-anaphylactic like).  He advised hypdrocortisone cream to site was ineffective.  AVA vaccine AE discussed with SM.  His reactions sounds like a robust take and we reviewed what this means.  He will f/u with PCP on monday (may be put on AB if s/s persist to r/o cellulitis).  He agreed to keep in touch with VHC.  VAERS will be filed and evaluation for exemption to AVA vaccine initiated.  Symptoms:  Edema @ injection site >120mm not beyond elbow, Erythema, Lesions, papule, Pain, Joint Pain, multiple joints.
No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report has been received from a medical assistant referring to a 12-month-old patient of unspecified age. The patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies were not reported.   On 04-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliters (ml) once (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U022321 has been verified to be valid, expiration date reported and established as 15-JUL-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of minus 8.1 degrees Celsius during a time frame of 4 hours (product storage error). There was not a previous temperature excursion and no additional adverse events were reported (no adverse event).
Information has been received from a office manager concerning a 17 or 18 year old female with breathing issues and unspecified allergies and no known drug allergies who on 19-FEB-2008 was vaccinated with the first dose of GARDASIL (Lot# 658488/1264U).  On 16-APR-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660387/1967U).  There was no concomitant medication.  Twenty four hours after the second dose of the vaccine, the patient was itchy, had a rash on the body and breathing difficulty.  Patient did not experience any problems after the first dose of the vaccine.  Patient outcome was recovered on an unknown date.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  Additional information has been requested.
immed erythema @ site followed by diffuse gen urticarial rxn & pruritus;no joint or mucous membrane involvement;
Started with sore throat an hour or so after vaccination progressed to a cough with shortness of breath, and chest pain.
Severe shaking for 3 hours from being so cold.  Severe headache, neck ache.  Wrist pain, finger pain.  Back was on fire.  Nauseous.  Chills. Missed 2 days of work.
Patient had shoulder pain starting the next day. Pharmacy was made aware when they contacted patient 3 weeks later due to a second shingrix vaccine being due.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, medical history, any known allergies or reactions or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB lot # M020100 with expiration date of 07-MAR-2019 and lot# M045206 with expiration date of 27-JUN-2019, for prophylaxis (dose and route of administration were not reported). Administered doses of vaccines experienced temperature excursion of 47-77 degrees Fahrenheit (°F) for 3 hours. There were not previous excursions. Data logger was involved.  No adverse symptoms were reported. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA001228: US-009507513-1705USA001229: US-009507513-1705USA001230: US-009507513-1705USA001231.
Liquid began leaking down arm; Liquid leaked down arm; Shot was given in top layer of skin; A spontaneous report was received from a consumer, concerning a 61-years-old, female patient who was administered Moderna's COVID-19 vaccine and reported that Liquid began leaking down arm (Vaccination site discharge), Liquid leaked down arm (Underdose) and Shot was given in top layer of skin (Incorrect route of product administration).  The patient's medical history included asthma. Concomitant medications were not provided.  On 10-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  Patient reported that the shot did not feel intramuscular, patient thinks the shot was given in the top layer of skin. After patient received the dose immediately liquid began leaking down her arm, which the patient believes was the Moderna Dose that should have gone in her arm.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, Liquid began leaking down arm, Liquid leaked down arm and Shot was given in top layer of skin was considered as resolved; Reporter's Comments: This report refers to a case of vaccination site discharge, underdose, and incorrect route of product administration for mRNA-1273 (lot # unknown), with no associated AEs.
This case was reported by a medical assistant and described the occurrence of an injection site reaction in a 13 year old female subject who was vaccinated with hepatitis A vaccine inactivated Havrix for prophylaxis. There were no concurrent medications. On an unspecified date before 9/13/2005, the subject received the 1st dose of Havrix. On 9/13/2005 the subject received the 2nd dose of Havrix in the right arm (lot AHAVB032AA). the medical assistant reported that the 2nd dose of Havrix was administered earlier then recommended. The recommended interval between the 1st and 2nd doses of Havrix is 6 to 12 months. on 9/13/2005, less than one day after vaccination of Havrix, the subject experienced an injection site reaction. At the time of initial reporting, 9/14/2005, the outcome of the injection site reaction was not reported. the healthcare professional considered the events to probably related to vaccination with Havrix.
After 2 weeks from my vaccination, my arm began to hurt if I'm reaching in a certain position. There was no discomfort when my arm is just doing normal tasks, however in certain positions or when I sit down and relax my shoulder begins to ache, pain shoots from should below the elbow. It has been continuing for over nine months since initial vaccine. After going to the orthopedic group, they gave me a shot and the symptoms began to subside for about 3 weeks and then the symptoms came right back. I was also given physical therapy work to do at home and it has not been helping.
Flu vaccine administered to infant leg from 6 months of age. No apparent sequelae or complication.
Pt noticed rash on upper chest, back, arms @ 9:30pm on day of vax. /W in 1 wk rash cleared
Received yellow fever vaccine and oral typhoid on 1-30-08. complained of "flu-like" symptoms on 2-6-08, specifically pain up and down back and legs, and pain in stomach. Took Ibuprofen for pain, Vicodin x 1; Resolved within 5 days. Did not go to Dr.; No fever, no vomiting
Pt reports tingling and sweating to R side of the body (face, arm, and leg).  Reports HA R side of body.  As evening progressed, patient reports worsening HA and vomiting.  Pt reports pain in R arm and swelling in armpit area.  Reports s/s resolved the next day.  Recommended f/u with PCP.
patient was with mom and mom reported an hour after vaccine patient's hands had red spots around knuckles and red hands. no trouble breathing, patient mom said redness of hands stayed from Friday to Tuesday which is when she called, she did state allergy pill she gave daughter helped the redness go away patient mom says will find a doctor but otherwise patient is experiencing no other symptoms
Approximately 5 minutes after injection, patient fell down with Nanny in hallway while Dad and sibling were still in exam room with CMA discussing WIR record of sibling. Patient was very still with eyes open and began crying.  RN escorted patient to exam room (she was able to walk) for further examination by RN and PCP and vitals were recorded.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On 15-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042266, expiration date was not reported) (dose and route of administration were not reported as prophylaxis. This is one of several reports received from the same reporter. Additional information has been requested.
3 year old who presented to hospital with the inability to ambulate, speech disturbances and fever.  Workup underway with MRI and LP. Results pending. Symptoms began morning after receiving Influenza vaccine.
Information has been received from a registered nurse concerning an elementary aged child who was vaccinated with a dose of Varivax. The RN reported that in February 2006, the patient developed breakthrough chickenpox which was considered to be a light, mild case. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Vaccine administered came from vial that was kept in fridge longer than manufacturer recommended storage date. The manufacturer informed us via written statement the vaccine "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." Revaccination not advised. We called the patient to inform them of the situation and the information we received from the manufacturer. They did not have any adverse reactions.
Pt developed swelling in right deltoid, fever and a large red area covered all of the deltoid. Was unable to raise arm. Monday, swelling decreasing and redness clearing. Pt can move arm today (4/25) and swelling is almost gone.
no adverse event; expired vaccine used; This spontaneous report was received from a medical assistant referring to a 35-year old patient of unknown gender.  The patient's medical history, concurrent condition and concomitant medication were unknown.  On 16-JUL-2021, the patient was accidentally given an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (first dose, lot # S021924, expiration date 15-JUL-2021; route, strength and dose were unknown) in the right arm for prophylaxis (Expired vaccine used). The patient had no adverse events after receiving the expired varicella virus vaccine live (oka/merck) (VARIVAX). The medical assistant was calling to see if the patient needed to be revaccinated, or if this effected the time line for a second dose of the varicella virus vaccine live (oka/merck) (VARIVAX).
Patient stated she had pain in muscle that was just beginning to subside (7/13/15) pt stated she was still feeling sore but that it was a lot better.
pt recv vax 7MAR97 & 25MAR97 pt devel a rash around the inj site;pt recovered;
Under arm lymph node swelling  Breast pain  Lower back pain  Fatigue  Fever  Migraines
5P Red - scratchy - discharge - eyes - 2 hrs. 6P Cough - 1 hr. 7P Chills - tremors - 6 hrs. 8P Swollen upper lip. 8P Swollen eyelids and under eyes > 20 hrs.
Vaccine administered too high in right arm by CP.  At time of administration pt felt severe burning and pain at and around right shoulder joint.  After vaccine administered there was hardly any R upper arm muscle pain noted. All pain was located in the right shoulder joint 9/10. Pt unable to move or use R arm/shoulder for approximately 3 days post injection. Heat applied several times a day, arm/shoulder rested and ibuprofen 800mg taken every 6 hours. Small range of motion exercises attempted to help alleviate stiffening. Approximately 4 days post injection- very small range of motion returned 25% of baseline- still unable to use right shoulder to complete daily tasks, pain 7/10 in right shoulder joint. Pt continued to use heat, rest and ibuprofen 800mg.   No muscle pain noted in right upper arm. As of 1/19/20- range of motion about 50% in right shoulder, pt has clicking and popping in right shoulder joint with all movement. Pain 5/10 in right shoulder joint with movement. Pt unable to lift object more than approximately 3lbs. Ibuprofen 800mg still taken PRN pain, heat still applied PRN.  All symptoms reported in Vsafe app following injection. 1/19/21 Notified hospital through COVID question hotline- RN charted problem in pts medical record.  Pt concerned because there is not a significant improvement 10 days post injection. Also due to the lack of information about adverse events of the Pfizer COIVD 19 vaccine.
About a month after the vaccine, developed sciatica, got bursitis of shoulder, could not roll over in bed, move light objects, very debilitating. Got physical therapy, but the pain continued to worsen; unable to exercise. Went to doctor on 6/30, given prednisone, within 3 hours of prednisone 90% of symptoms relieved; diagnosed with PMR autoimmune condition. Taking prednisone daily, expected take a long time, may be a lifetime recovery.
Gave vaccine and getting ready to put bandaid on the site grew to a swollen area size of grape. Patient had flu shot before and I confirmed with the his primary doctor. Had patient place ice pack on the area 2 times. By 35- 45 minutes the swelling had gone down some. Told him to take Tylenol for pain. Ask additional help if needed. He was able to walk out of pharmacy area with no problem.
I started experiencing a sore throat; scratchy throat and then a kind of build up of phlegm in the throat. By Monday, I started having a runny nose. I did take a home test on Sunday night and it was negative.  My husband was sick and much sicker than I was at this point. I took another home test on Tuesday night and it tested positive. On Wednesday, I went to Hospital - drive though site   - they told me it was positive. Then they called me for the Monoclonal Infusion. Thursday morning, I had the antibody infusion. I have had more coughing and lack of energy - essentially a bad head cold. We started for home on Saturday - it took three days to get  home because we were both sick. I was feeling better by Saturday and I'm feeling even better today. I am not 100% yet. My energy is better. The symptoms seem to be a lot better since the infusion on the 7th.
Completely numb left arm, rapid heart rate, leg pain and chest pain starting around 12:30am 9/9/21. Went to the ER and heart rate was high. Blood work looked normal and EKG was normal. That was the only tests done.
pt recv skin test w/vax.& described react area 1.5inx3in that swelled, red, hot & itchy. sx lasted 1wk. f/u w/vax MD provided no addl info until yr later. no records of Fluvirin administration
06/12/2003 treated for cellulitis/allergic RXN with Benadryl and Keflex right arm erythematous, warm 5 x 5 area 06/13/2003 seen again increase size +gran cettriaxone given
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 78 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered ZOSTAVAX by a physician at an internal medicine clinic (dose, route, and lot # not provided). On an unspecified date, the patient was treated by the same physician at the internal medicine clinic for the following injuries resulting from her ZOSTAVAX use: shingles. The outcome of the event was unknown. Causality assessment was related. Additional information has been requested.
Patient received the incorrect second dose of the covid 19 vaccine series. Patient had received Moderna as her first dose. Patient was vaccinated with Pfizer for the second dose by one of our nurses.
At approximately 24 hrs after administration, returned to report large erythematous area around injection site. Area was approximately 6 inches in diameter, painful and swollen. She proceeded to the E.D. for follow up and further treatment.
Fever (100.1 F); Nausea; Vaccine location: left leg; This is a spontaneous report received from a contactable reporter (consumer or other non HCP).  A 7-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in leg left, administration date 02Dec2021 at 15:00 (Lot number: 5618) at the age of 7 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1 (TRIS), SINGLE , Lot number: FK5127, Route of administration: intramuscular), administration date: 09Nov2021, when the patient was 7 years old, for COVID-19 immunisation.  The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 02Dec2021 at 15:00, outcome "unknown", described as "Vaccine location: left leg"; PYREXIA (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Fever (100.1 F)"; NAUSEA (non-serious) with onset 03Dec2021, outcome "not recovered", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia and nausea.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
No initial discomfort at site but started feeling it more over the course of the week.  On the 20th (yesterday) after working outside most of the day I came in and showered following which my left arm at site began itching and I noticed it was red.  Later that evening I developed chills, a mild headache, & fever of 100.3F.  Took 2 Tylenol XS before bed.  This morning red area on arm larger & still consistently itchy.  Headache less to gone.  Temperature currently 99F with no antipyretic.  None of these symptoms have impeded my activities of daily living but I feel they are important to report.  I have not contacted my doctor or the Pharmacy where I received the injection.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # R016638 with expiration date of 28-JAN-2020; dose, frequency and route unspecified) for prophylaxis (product storage error). No adverse effect was reported. The temperature excursion was 26.2 degree Fahrenheit with a time frame of 1 hour and 30 minutes. There was previous temperature excursion (32.1 degree Fahrenheit with a time frame of 1 hour). Data logger was involved. No product quality complaint was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA003978.
Within 3 days herpetiform lesions reported by pt. This followed about day 6 herpes zoster outbreak right (time crunch ) L2-4 dermatone. Heightened autonomic sx flare
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 27Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 16Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 22May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: LEVOTHYROXINE; MONTELUKAST. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Treatment of COVID-19; Total number of days since initial positive test is 16; (20Sep2022) Negative, notes: COVID rebound - positive test with symptoms three days after negative test and six days after finishing Paxlovid,; (23Sep2022) Positive, notes: COVID rebound - positive test with symptoms three days after negative test and six days after finishing Paxlovid; (28Sep2022) Positive, notes: Still testing positive five days after the test indicating rebound. Total number of days since initial positive test is 16. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Treatment included Paxlovid from 12Sep2022 to 17Sep2022.
Information has been received from a pharmacist referring to a 69 year old female patient. On 12-OCT-2016 the patient was vaccinated with ZOSTAVAX (lot # M030139 with expiration date of 18-AUG-2017, subcutaneous in the left arm; once), as well as "a flu shot" and PREVNAR. The location of administration for the flu shot and PREVNAR was undetermined. On the same date, the patient experienced a small blister at the injection site of left upper arm and the patient stated it was not painful, but itchy. On 14-OCT-2016, the patient came to the pharmacy. No treatment was given for the events. The reporter accepted the Varicella Zoster Virus (VZV) packet. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Varicella Zoster Virus identification Polymerase Chain Reaction (PCR) test would be performed (result pending). The vents were recovering. The causality was not reported. Additional information has been requested.
The patient states that her arm had muscle pain at the injection site after vaccination that worsened days later resulting in tingling down the arm and to the right pinky finger. The arm is painful to lay on. She has not seen a doctor about it yet.
Needle was not fully secure to syringe.  When vaccine was adminstered, the vaccine came out the side of the hub where needle meets syringe rather than going into the guest.  No untoward issues with guest.  Patient received a full dose of vaccine.
A MMRV was given instead of an MMR vaccine. Mother was notified and reported no adverse reaction.
Within a few hours she started having achy joints, chills, hands and feet were freezing, then hot flushes and sweats.  Fever at home 101.9 F  1 week ago, tested neg for COVID, fever 102.1 F 3 days ago.  More heartburn than usual.  At night palpitations, HR 110-125 bpm.  She has been sweating since AM. Joints were achy all day.  She has been nauseous and had decreased appetite.