chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BRUISING ON BODY AND FACE; This spontaneous report received from a consumer concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, and lymph nodes removal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included alprazolam for drug used for unknown indication, linaclotide for drug used for unknown indication, sumatriptan for drug used for unknown indication, tramadol hydrochloride for drug used for unknown indication, and acetylsalicylic acid. On an unspecified date, the subject experienced bruising on body and face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising on body and face was not reported. This report was non-serious.
2 weeks after vaccine upper arm became very red, oval shape, approx 4" long, hot to the touch, itchy.  Took a Benedryl that night, Zyrtek next morning.  Put Benedryl on topically as well, next day Neosporine and then continued with Benedryl.  4 days later it has faded with a faint circle of the area
feeling unwell; headache; Fatigue; This is a spontaneous report from a contactable consumer (patient).   A 72-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Mar2021 15:00 (Batch/Lot Number: EN6205) as single dose for covid-19 immunisation. First dose (Lot number: EL9261) was administered on 11Feb2021 03:15 PM, left arm. Medical history included diabetes mellitus, coronary artery disease, osteoporosis. No other vaccine was received in four weeks. Patient received unspecified concomitant medications in two weeks. No covid prior vaccination. No covid tested post vaccination.  The patient experienced feeling unwell on 05Mar2021 07:00, headache on 05Mar2021 07:00, fatigue on 05Mar2021 07:00. No treatment for the events. The events outcome was recovered.    No follow-up attempts are possible. No further information is expected.
09/30/2010 AM - woke up - noticed swelling and redness to left arm where chicken pox shot was given. Mom reports she put cold compress on it and swelling gone but redness remains. Today redness about 1 inch and warm to touch. Mom has notified MD. Encouraged mom to continue TYLENOL and to let me know if it gets worse and go to MD or ER. Mom reports it is a lot better today.
Received flu vaccine during employee flu clinic on Wednesday, 10/5/05. States are sore/hurting afterwards. On Sunday 10/9, after waking, noticed arm red and swollen from shoulder to elbow on underside of arm. States injection given in lower portion of deltoid.
patient got the COVID, patient was tested positive; This is a spontaneous report from a contactable consumer(patient). A 67-year-old patient of an unspecified gender received first dose of BNT162B2 (Pfizer COVID-19 vaccine, solution for injection, lot# EL9262) via an unspecified route of administration on 29Jan2021 (at the time of 67-year-old) at single dose for COVID-19 immunization. The patient medical history included blood pressure, arthritis, depression and cholesterol. Concomitant medication included rosuvastatin at 10 mg for blood cholesterol, losartan potassium via oral at 25 mg once daily, venlafaxine at 75 mg twice daily, meloxicam via oral at 5 mg once daily, colecalciferol (D3) at 2000 daily, fish oil at 1000 mg, ascorbic acid (VITAMIN C), magnesium at 500 mg, ubidecarenone (COQ-10) once daily and hydrochlorothiazide at half of 25 mg. On an unspecified date it was reported that patient got the vaccination on 29Jan2021, 3 days later patient got the COVID, patient was tested positive. Patient went to the hospital last day at the vaccination centre and had diffusion that caused help with vial. Patient has to wait 9 days before got another shot. Didn't know whether it would be affective and patient might have to start all over again. Because it might not helped because it's been so long. Confirmed the date of getting positive as 29Jan2021, patient got the first shot on 29Jan2021 and then patient went next week and the COVID test and it tested positive. Patient tested positive probably around the 03Feb2021. Then patient went to have the diffusion on the 5Feb2021. Patient need to do diffusion because of high blood pressure at the hospital. So, patient had diffusion. Patient need to take another shot and patient might have to start back again with another first shot. Indications of the medications reported that for cholesterol, blood pressure, arthritis and depression. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
patient reported arm is swollen, warm, and looks like a rash is starting. no reaction after first shot. recommended to follow up with pcp if symptoms do not resolve over the weekend or become worse
Horrible men steal like cramps that woke me up at night. I don?t even get cramps anymore with my period for years. & I'm not even on my period.
Patient complaint of pain on shoulder and arm. Patient also complaint of lack of mobility and movement of arm. Patient was prescribed Tramadol for pain.
After my vaccines I get an IBS flare up, much more intensive diarrhea more than once a day. I have very bad gas cramps and odorous gas response. I just have a really bad autoimmune response. This is a condition I manage, but I have noticed these flare ups after all of my vaccines. This is something I have had previously, and is easy to live with except after the vaccines the flare ups are hard to manage. Moderna 3rd booster was on 12/07/2021 Lot #014F21A same issues. I saw my pcp but was not prescribed any medication. I am now trying probiotics and Psyllium fiber. Overall it has calm down on it's own.
Information has been received from a registered nurse concerning a 16 year old white female who on 23-OCT-2008 in the PM was vaccinated with GARDASIL IM in the right arm.  Concomitant therapy included INFLUENZA (unspecified) (manufacturer unspecified).  On 23-OCT-2008 the patient experienced vomited immediately after the injections.  The patient felt better afterwards.  At the time of the report, the patient was recovered.  No further information is available.
This spontaneous report was received from a registered nurse and refers to a 3-year-old patient of an unknown gender. No information about patient's concomitant medications, pertinent medical history, drug reactions or allergies was provided. On 24-SEP-2013, the patient received an unspecified dose of (Oka/Merck) VARIVAX (route of administration, lot# and expiration date not reported). On 07-OCT-2013, less than 28 days apart as per spacing guidelines for live vaccines, the patient was vaccinated with an unspecified doses of MMR II (route of administration, lot# and expiration date not reported). No adverse effects were noted. Additional information has been requested.
Lightheadedness, Temperature 100.1 Large area (approximately 8 inches by 3 inches) on left upper arm at injection site: red, warm, hard, painful. Lasted for several days.
Received first dose of the vaccine and was pregnant; A spontaneous report was received from a other healthcare professional concerning 29 years old, pregnant female patient, who received Moderna's Covid-19 Vaccine (mRNA-1273) during pregnancy (Vaccine exposure during pregnancy).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 17 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. Her last menstrual period and conception date was unknown. The patient's estimated due date is on date. The patient's treatment included prenatal vitamins and baby aspirin.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event received first dose of the vaccine and was pregnant was considered resolved on 17-Feb-2021.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Moderna COVID-19 Vaccine EUA Full dose of Moderna Vaccine. 0.5 ml administered to individual meeting criteria for booster dose 0.25 ml.  11/04/2021 per patient she experienced a few aches that resolved in a couple of days and "thought it was normal"  "feels fine now".  Primary COVID-19 vaccine was Janssen vaccine 3/05/2021.
Inject site cellulitis: 10/20/99 pt was vax w/ first pneumococcal vax 23 polyvalent in left deltoid. 10/21/99 pt exp cellulitis of left arm at inject site & surrounding area. Treated w/ cephalexin. Pt recovered.
soreness and painful and rash on 1st day then stomach cramping, feverbarely under 100, blood red swollen 6 inches on the area o f the vaccine and hot to feel and couldnt touch
Experienced leucocytoclastic vasculitis in both calves 14 days 4th covid vaccination. Easy bruising on arms and legs. No history of either condition. Wore compression stockings and applied topical hydrocortisone ointment 1%. Resolving 5 weeks out. J&J 1805022 03/08/21 Moderna booster 939964 10/29/21 Pfizer booster FK9893 04/15/22 Moderna booster 052B22A 08/15/22
Pharmacist pushed in the plunger the vaccine sprayed on left arm, neck, cheek; Gave a second shot; A spontaneous report, was received from a consumer (patient), a 63-years old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pharmacist pushed in the plunger the vaccine sprayed on left arm, neck, cheek (wrong technique in device usage process) and gave a second shot (incorrect dose administered ).  The patient's medical history was not provided. Concomitant medications were not reported.  On 01 Mar 2021, prior to the onset of the symptoms, the patient received their second planned doses of mRNA-1273 (Batch number: 011A21A), intramuscularly for the prophylaxis of COVID-19 infection.  On 01 Mar 2021, the needle was bent or gone in incorrectly because when the pharmacist pushed in the plunger the vaccine sprayed on left cheek, neck and ran down arm. The patient doesn't think that the vaccine went into arm, so the pharmacist gave a second shot. The patient reported that he washed off the vaccine that got sprayed on him with dawn dish detergent. Treatment details were not provided.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.  The outcome of the events, pharmacist pushed in the plunger the vaccine sprayed on left arm, neck, cheek and gave a second shot were considered as recovered on 01 Mar 2021.; Reporter'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.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unspecified dates, since June 2016 through 31-AUG-2016, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L037574, expiration date 01-JUL-201 or lot # L038536, expiration date 19-AUG-2017; strength, dose, frequency and route were unknown), which were exposed to temperature excursion of 0 degree centigrade for 1 minute, max 7 degree centigrade for a worst case scenario of 450 hours. There were no previous temperature excursions. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved). This is one of several reports received from the same reporter. Additional information has been requested.
Right arm (site of administration) started to hurt mid-afternoon on Thurs the day of administration and was Very painful by the evening. Pt did not have use of her arm for 2 days, but when I contacted her Monday morning she felt like she had 1/2 use of it. Pt also had some flu like symptoms, which had mostly resolved, but was still feeling dizzy and lightheaded Monday morning. She did not seek medical attention, but reported severe pain that felt "like her joint was separating". Still painful to raise further that elbow level. Pt took Tylenol for the pain.
feel unwell; all the joints in my body started to ache; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 14:00 (Lot number: 30145BA) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ECHINACEA. Past drug history included: Sulfa, reaction(s): "Known allergy:Sulfa". The following information was reported: MALAISE (non-serious) with onset 28Sep2021 17:30, outcome "not recovered", described as "feel unwell"; ARTHRALGIA (non-serious) with onset 28Sep2021 17:30, outcome "not recovered", described as "all the joints in my body started to ache"; HEADACHE (non-serious) with onset 28Sep2021 17:30, outcome "not recovered", described as "headache". The events "feel unwell", "all the joints in my body started to ache" and "headache" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of malaise, arthralgia, headache.  Follow-up attempts are completed. No further information is expected
After the vaccination, patient presented with an elevated pulse and blood pressure. He complained of blurry vision and requested to remain seated in the office. He sat in the office for 30 minutes and drank 3 cups of water. Ammonia inhalants were also administered as syncope was suspected. After 40 minutes, all of his vitals returned to normal and he no longer had blurry vision.
Suddenly got COVID just 3 months after having it in Jun2022; Suddenly got COVID just 3 months after having it in Jun2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EL0140), in left arm and on 12Jan2021 as dose 2, single (Lot number: EL0140) at the age of 46 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Smoker: No" (unspecified if ongoing), notes: smoker/former smoker: No. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Suddenly got COVID just 3 months after having it in Jun2022". Clinical course: The patient believed that she got the illness from the vaccine and/or it was a strange coincidence that she had vaccine reaction and suddenly got COVID just 3months after having it in Jun2022. The patient consider the Pfizer product had a casual effect to the adverse event.; Sender's Comments: Vaccination failure depends on many factors including pharmacokinetics, the epidemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
On Feb. 24.2021, my left arm at the vaccine site started to itch.  It now has a red patch about 5 inches long and 3 inches wide which itches and is sensitive to my touch.  I tried putting anti-itch cream on it but that had no effect/  It itches and is sensitive to my touch, not pain but  bothersome
Choking approx 2 hrs after injection pt was at home "throat closed up on me and yellow drainage coming from eye shivering hot and cold lasted for the whole night. Next day I had upper back pain - after taking BENADRYL and MOTRIN.
mom called on 7MAY stating pt had been crying & has had a fever 103 @ 105.2 (adjusted ax) since evening of 5MAY; pt been given APAP & sponge baths; MD advised to hold future pertussis; mom states eyes don't look nl;
Swelling of lymph nodes in neck after 3 hours lasting 36 hours. Swelling in lymph node in armpit of injection arm after 12 hours lasting roughly 36 hours. Vertigo after 10 hours lasting roughly 4 days but calming down after 48 hours.
10 to 12minutes after injection of vaccine pt began to feel dizziness and nausea, followed by vomiting. After pt vomited and felt better pt asked to lay on examination table at Semi-Fowler's with knees bent position. Vitals taken WNL (B/P=111/67, Temp=98.8, HR=92, R=17). Pt offered apple juice and granola bar. Pt remained at semi-Fowler's position for 10 to 15min afterward pt stated she felt fine. Pt keep sipping apple juice little by little till she felt better. Pt left home accompanied by father.
Nausea, diarrhea, headache, dizziness, pain in arm, numbness and tingling in hand and forearm.
Nausea, convulsions, sore red eyes, high fever, joint and body aches, headache, gas, diarrhea, fatigue, throat swelling, heart palpitations, patient stated could hear heart rate banging in head, dizziness, weakness.
The evening after the vaccinations the patient started running a high temperature became delirious and rambling incoherently. His arm swelled from the site of the vaccination to the elbow. The wife took him to the hospital where they did numerous different tests. It was concluded that the symptoms were from an adverse reaction to one of the vaccines. However, since both vaccines were given in the same arm they do not know which caused the reaction. The wife stated that the doctor gave him an antibiotic and sent him home.
first symptom  began about and hour after injection .  I felt hyper and it last until about 8pm when I began to experience a very bad headache and body pains.  I was unable to sleep that night, experiencing hot and cold flashes and joint, and muscle pain intensified.  By the next morning I was running a fever of 100.9.  I continued to have extreme body pain, headache, and fever between 100.5 and 100.9 until Friday, March 26, 2021
Have a slight rise in temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 08:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 04Mar2021, for covid-19 immunisation. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 25Mar2021 11:15, outcome "unknown", described as "Have a slight rise in temperature". The patient underwent the following laboratory tests and procedures: body temperature: (25Mar2021) slight rise, notes: at 11:15.  Additional information: Patient felt fine and was not dizzy or anything else, just the rise in temperature.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rt arm 5th shot, area of erythema, induration and tenderness. No systemic effects.
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of an improperly stored VARIVAX, lot number K026386, expiration date 15-DEC-2016, (dose and route were not reported). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports from the same reporter link. Additional information has been requested.
This spontaneous report as received from an approximately 87 years male patient with none drug reactions/allergies and none pertinent medical history. In November 2010 the patient was vaccinated with ZOSTAVAX (dose and strength were unknown). Concomitant therapies included gabapentin. About a year later (onset on 2011) the patient got a case of the shingles which in his upper arm going towards the armpit, going towards his back, and ever since then (2 years now) has had the nerve pain. No lab diagnostics studies performed. The patient sought medical attention. The outcome of the nerve pain was reported as not recovered/not resolved. The outcome of shingles was unknown. Action taken and the causality of events and ZOSTAVAX were not provided. Additional information has been requested.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On 22-OCT-2015 at 6:58pm, vaccine alarm was received, then the worker came into clinic and found freezer out of range. She reported (storage unit temperature at the time was 7.3F, room temperature at the time was 72.0F). She reported to supervisor, and the supervisor called the reporting nurse. As the showed alarm, the supervisor and the nurse discussed whether or not to move vaccine. On the time they were on the phone, the temp reading came down to 5.9 degrees F in 10 min, so the reporter felt confident it would be back within range in a matter of minutes and told the supervisor to leave vaccine in freezer and the reporter would review and submit data next morning. Upon arrival Friday morning 23-OCT-15, freezer was within range. The reporter put X on doses for which this was the first temperature excursion, and put XX on doses that were also involved on out of range incident in October 2015. On unknown dates the patients were vaccinated with doses of these improperly stored PROQUAD (Merck) (20 doses of lot # L032759 with expiration 24-FEB-2017, 5 doses of lot# L024125 with expiration 30-DEC-2016, dose, frequency and route were not reported). This is one of several cases received from the same source. Additional information has been requested.
Day 2-1/26/21-Left shoulder sore, stiff, very limited ROM especially with dressing, pain down to elbow, fever 102-103, severe left upper arm pain, using ice packs and Motrin q 4-6 hours.  Day 3-1/27/21-Fever 103, all symptoms same as those of Day 2 using ice and heat alternating, and Tylenol and Motrin alternating. Day 4-1/28/21-improved ROM and improved symptoms.
Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Patient called complaining of not being able to move her arm in full range of motion. Some soreness/swelling at injection site. Going to try APAP or NSAID to see if reduces pain/swelling. If continues to tomorrow or gets worse will seek urgent care.
Pt. received Tdap on 6/17/10.  Pt called HD on 6/24/10 stating her arm was still sore at site of injection and that there was a 25 cent size area of redness and tenderness below the injection site.  Pt. saw MD on 6/24/10 and diagnosed with cellulitis and treated with Augmentin.  HD called pt. on 6/25/10, and pt. states the redness has not increased and she is taking an antibiotic.